Datasets:

alicemkyn
/

ivbench

Error code:   DatasetGenerationCastError
Exception:    DatasetGenerationCastError
Message:      An error occurred while generating the dataset

All the data files must have the same columns, but at some point there are 33 new columns ({'n_ctrl', 'y_treat', 'treat_group', 'ctrl_group', 'y_ctrl', 'ctrl_arm_desc', 'treat_intervention_types', 'delta', 'ctrl_intervention_desc', 'treat_intervention', 'treat_arm_matched', 'treat_group_desc', 'completion_rate_treat', 'treat_arm_type_v21', 'treat_type_source', 'n_treat', 'ctrl_arm_matched', 'ctrl_intervention', 'scale', 'cid', 'ctrl_group_desc', 'v21_status', 'ctrl_role', 'repair_type', 'v2_cid', 'treat_arm_desc', 'treat_intervention_desc', 'v2_treat_group', 'ctrl_type_source', 'v2_ctrl_group', 'ctrl_kind', 'completion_rate_ctrl', 'ctrl_arm_type_v21'}) and 34 missing columns ({'completion_rate', 'start_date', 'y', 'intervention_types', 'group_title', 'arm_type_v21', 'arm_label', 'n_analyzed', 'low', 'spread', 'sd', 'arm_label_v21', 'title', 'role_v21', 'role', 'group_desc', 'n_arms_outcome', 'primary_completion_date', 'high', 'stage_key', 'arm_type', 'arm_desc', 'results_posted_date', 'intervention_desc', 'completion_date', 'intervention_names', 'arm_matched', 'group_id', 'value_raw', 'dispersion_type', 'type_source', 'enrollment', 'healthy_volunteers', 'pooled_reason'}).

This happened while the csv dataset builder was generating data using

gzip://benchmark_contrasts_v2.1_final.csv::hf://datasets/alicemkyn/ivbench@40f200521b422bb088e22976d2a9f9bf9cc122d3/data/benchmark_contrasts_v2.1_final.csv.gz, ['hf://datasets/alicemkyn/ivbench@40f200521b422bb088e22976d2a9f9bf9cc122d3/data/benchmark_arms_v2.1.csv.gz', 'hf://datasets/alicemkyn/ivbench@40f200521b422bb088e22976d2a9f9bf9cc122d3/data/benchmark_contrasts_v2.1_final.csv.gz']

Please either edit the data files to have matching columns, or separate them into different configurations (see docs at https://hf.co/docs/hub/datasets-manual-configuration#multiple-configurations)
Traceback:    Traceback (most recent call last):
                File "/usr/local/lib/python3.14/site-packages/datasets/builder.py", line 1856, in _prepare_split_single
                  writer.write_table(table)
                  ~~~~~~~~~~~~~~~~~~^^^^^^^
                File "/usr/local/lib/python3.14/site-packages/datasets/arrow_writer.py", line 811, in write_table
                  self._write_table(pa_table, writer_batch_size=writer_batch_size)
                  ~~~~~~~~~~~~~~~~~^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
                File "/usr/local/lib/python3.14/site-packages/datasets/arrow_writer.py", line 822, in _write_table
                  pa_table = table_cast(pa_table, self._schema)
                File "/usr/local/lib/python3.14/site-packages/datasets/table.py", line 2381, in table_cast
                  return cast_table_to_schema(table, schema)
                File "/usr/local/lib/python3.14/site-packages/datasets/table.py", line 2309, in cast_table_to_schema
                  raise CastError(
                  ...<3 lines>...
                  )
              datasets.table.CastError: Couldn't cast
              nct_id: string
              family: string
              area: string
              phase: string
              sponsor_class: string
              sponsor: string
              allocation: string
              masking: string
              purpose: string
              year_posted: int64
              split_time: string
              conditions: string
              mesh_conditions: string
              outcome_title: string
              outcome_desc: string
              outcome_timeframe: string
              unit: string
              param_type: string
              eligibility_text: string
              brief_summary: string
              min_age: string
              max_age: string
              sex: string
              treat_group: string
              ctrl_group: string
              treat_intervention: string
              ctrl_intervention: string
              treat_intervention_desc: string
              ctrl_intervention_desc: string
              treat_arm_desc: string
              ctrl_arm_desc: string
              treat_group_desc: string
              ctrl_group_desc: string
              treat_arm_matched: bool
              ctrl_arm_matched: bool
              treat_intervention_types: string
              ctrl_role: string
              n_treat: double
              n_ctrl: double
              y_treat: double
              y_ctrl: double
              delta: double
              scale: double
              age_mean: double
              frac_female: double
              completion_rate_treat: double
              completion_rate_ctrl: double
              treat_arm_type_v21: string
              ctrl_arm_type_v21: string
              treat_type_source: string
              ctrl_type_source: string
              ctrl_kind: string
              v21_status: string
              repair_type: string
              v2_treat_group: string
              v2_ctrl_group: string
              v2_cid: string
              cid: string
              intervention_model: string
              -- schema metadata --
              pandas: '{"index_columns": [{"kind": "range", "name": null, "start": 0, "' + 7549
              to
              {'nct_id': Value('string'), 'title': Value('string'), 'sponsor_class': Value('string'), 'sponsor': Value('string'), 'phase': Value('string'), 'allocation': Value('string'), 'masking': Value('string'), 'purpose': Value('string'), 'enrollment': Value('int64'), 'conditions': Value('string'), 'mesh_conditions': Value('string'), 'start_date': Value('string'), 'primary_completion_date': Value('string'), 'completion_date': Value('string'), 'results_posted_date': Value('string'), 'min_age': Value('string'), 'max_age': Value('string'), 'sex': Value('string'), 'healthy_volunteers': Value('bool'), 'eligibility_text': Value('string'), 'brief_summary': Value('string'), 'outcome_title': Value('string'), 'outcome_desc': Value('string'), 'outcome_timeframe': Value('string'), 'param_type': Value('string'), 'dispersion_type': Value('string'), 'unit': Value('string'), 'family': Value('string'), 'n_arms_outcome': Value('int64'), 'group_id': Value('string'), 'group_title': Value('string'), 'group_desc': Value('string'), 'arm_type': Value('string'), 'arm_label': Value('string'), 'arm_desc': Value('string'), 'intervention_names': Value('string'), 'intervention_types': Value('string'), 'intervention_desc': Value('string'), 'arm_matched': Value('bool'), 'role': Value('string'), 'n_analyzed': Value('float64'), 'value_raw': Value('float64'), 'spread': Value('float64'), 'low': Value('float64'), 'high': Value('float64'), 'y': Value('float64'), 'age_mean': Value('float64'), 'frac_female': Value('float64'), 'completion_rate': Value('float64'), 'sd': Value('float64'), 'year_posted': Value('int64'), 'area': Value('string'), 'split_time': Value('string'), 'arm_type_v21': Value('string'), 'arm_label_v21': Value('string'), 'type_source': Value('string'), 'role_v21': Value('string'), 'intervention_model': Value('string'), 'pooled_reason': Value('string'), 'stage_key': Value('string')}
              because column names don't match
              
              During handling of the above exception, another exception occurred:
              
              Traceback (most recent call last):
                File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1379, in compute_config_parquet_and_info_response
                  parquet_operations, partial, estimated_dataset_info = stream_convert_to_parquet(
                                                                        ~~~~~~~~~~~~~~~~~~~~~~~~~^
                      builder, max_dataset_size_bytes=max_dataset_size_bytes
                      ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
                  )
                  ^
                File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 956, in stream_convert_to_parquet
                  builder._prepare_split(split_generator=splits_generators[split], file_format="parquet")
                  ~~~~~~~~~~~~~~~~~~~~~~^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
                File "/usr/local/lib/python3.14/site-packages/datasets/builder.py", line 1702, in _prepare_split
                  for job_id, done, content in self._prepare_split_single(
                                               ~~~~~~~~~~~~~~~~~~~~~~~~~~^
                      gen_kwargs=gen_kwargs, job_id=job_id, **_prepare_split_args
                      ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
                  ):
                  ^
                File "/usr/local/lib/python3.14/site-packages/datasets/builder.py", line 1858, in _prepare_split_single
                  raise DatasetGenerationCastError.from_cast_error(
                  ...<4 lines>...
                  )
              datasets.exceptions.DatasetGenerationCastError: An error occurred while generating the dataset
              
              All the data files must have the same columns, but at some point there are 33 new columns ({'n_ctrl', 'y_treat', 'treat_group', 'ctrl_group', 'y_ctrl', 'ctrl_arm_desc', 'treat_intervention_types', 'delta', 'ctrl_intervention_desc', 'treat_intervention', 'treat_arm_matched', 'treat_group_desc', 'completion_rate_treat', 'treat_arm_type_v21', 'treat_type_source', 'n_treat', 'ctrl_arm_matched', 'ctrl_intervention', 'scale', 'cid', 'ctrl_group_desc', 'v21_status', 'ctrl_role', 'repair_type', 'v2_cid', 'treat_arm_desc', 'treat_intervention_desc', 'v2_treat_group', 'ctrl_type_source', 'v2_ctrl_group', 'ctrl_kind', 'completion_rate_ctrl', 'ctrl_arm_type_v21'}) and 34 missing columns ({'completion_rate', 'start_date', 'y', 'intervention_types', 'group_title', 'arm_type_v21', 'arm_label', 'n_analyzed', 'low', 'spread', 'sd', 'arm_label_v21', 'title', 'role_v21', 'role', 'group_desc', 'n_arms_outcome', 'primary_completion_date', 'high', 'stage_key', 'arm_type', 'arm_desc', 'results_posted_date', 'intervention_desc', 'completion_date', 'intervention_names', 'arm_matched', 'group_id', 'value_raw', 'dispersion_type', 'type_source', 'enrollment', 'healthy_volunteers', 'pooled_reason'}).
              
              This happened while the csv dataset builder was generating data using
              
              gzip://benchmark_contrasts_v2.1_final.csv::hf://datasets/alicemkyn/ivbench@40f200521b422bb088e22976d2a9f9bf9cc122d3/data/benchmark_contrasts_v2.1_final.csv.gz, ['hf://datasets/alicemkyn/ivbench@40f200521b422bb088e22976d2a9f9bf9cc122d3/data/benchmark_arms_v2.1.csv.gz', 'hf://datasets/alicemkyn/ivbench@40f200521b422bb088e22976d2a9f9bf9cc122d3/data/benchmark_contrasts_v2.1_final.csv.gz']
              
              Please either edit the data files to have matching columns, or separate them into different configurations (see docs at https://hf.co/docs/hub/datasets-manual-configuration#multiple-configurations)

Need help to make the dataset viewer work? Make sure to review how to configure the dataset viewer, and open a discussion for direct support.

nct_id string	title string	sponsor_class string	sponsor string	phase string	allocation string	masking string	purpose string	enrollment int64	conditions string	mesh_conditions string	start_date string	primary_completion_date string	completion_date string	results_posted_date string	min_age string	max_age null	sex string	healthy_volunteers bool	eligibility_text string	brief_summary string	outcome_title string	outcome_desc string	outcome_timeframe string	param_type string	dispersion_type string	unit string	family string	n_arms_outcome int64	group_id string	group_title string	group_desc string	arm_type string	arm_label string	arm_desc string	intervention_names string	intervention_types string	intervention_desc string	arm_matched bool	role string	n_analyzed float64	value_raw float64	spread null	low float64	high float64	y float64	age_mean float64	frac_female float64	completion_rate float64	sd float64	year_posted int64	area string	split_time string	arm_type_v21 string	arm_label_v21 string	type_source string	role_v21 string	intervention_model string	pooled_reason null	stage_key null
NCT00193596	Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site	OTHER	SCRI Development Innovations, LLC	PHASE3	RANDOMIZED	NONE	TREATMENT	198	Neoplasms, Unknown Primary	Neoplasms, Unknown Primary	2003-09	2008-09	2009-06	2013-05-03	18 Years	null	ALL	false	Inclusion Criteria: To be included in this study, you must meet the following criteria: * Carcinoma of unknown primary site * Biopsy-proven metastatic carcinoma * Able to perform activities of daily living with minimal assistance * No previous treatment with any systemic therapy * Measurable or evaluable disease * Ad...	In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	Length of time, in months, that patients were alive from their first date of protocol treatment until death.	24 months	MEDIAN	95% Confidence Interval	months	continuous	2	OG000	Paclitaxel/Carboplatin/Etoposide/Gefitinib	Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval	null	null	null	null	null	null	false	treatment	93	7.4	null	4.67	10.28	7.4	61	0.526882	0.397849	13.801245	2,013	oncology	train	EXPERIMENTAL	Regimen A	rematched	treatment	PARALLEL	null	null
NCT00193596	Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site	OTHER	SCRI Development Innovations, LLC	PHASE3	RANDOMIZED	NONE	TREATMENT	198	Neoplasms, Unknown Primary	Neoplasms, Unknown Primary	2003-09	2008-09	2009-06	2013-05-03	18 Years	null	ALL	false	Inclusion Criteria: To be included in this study, you must meet the following criteria: * Carcinoma of unknown primary site * Biopsy-proven metastatic carcinoma * Able to perform activities of daily living with minimal assistance * No previous treatment with any systemic therapy * Measurable or evaluable disease * Ad...	In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	Length of time, in months, that patients were alive from their first date of protocol treatment until death.	24 months	MEDIAN	95% Confidence Interval	months	continuous	2	OG001	Irinotecan/Gemcitabine/Gefitinib	Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval	null	null	null	null	null	null	false	treatment	105	8.5	null	6.64	10.58	8.5	59	0.4	0.371429	10.299231	2,013	oncology	train	EXPERIMENTAL	Regimen B	rematched	treatment	PARALLEL	null	null
NCT01408303	[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL	INDUSTRY	AstraZeneca	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	646	Hypertriglyceridemia\|Cardiovascular Disease	Hypertriglyceridemia\|Cardiovascular Diseases\|Dyslipidemias\|Hyperlipidemias	2011-08	2012-06	2012-06	2014-12-05	18 Years	null	ALL	false	Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL. 3. The subject is a high risk for a future cardiovascular event. 4. The subject is treated with a statin and at or near LDL-C goal. Exclusion Criteria: 1. Allergy or intolerance to omega-3 fatty acid...	The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.	Serum Non-HDL Cholesterol	The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.	6 weeks	LEAST_SQUARES_MEAN	95% Confidence Interval	Percent change from baseline	continuous	3	OG000	Epanova 2 g	omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks	EXPERIMENTAL	Epanova, 2 g	omega-3-carboxylic acids, 2g/day + prescription statin	omega-3-carboxylic acids, 2g	DRUG	Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin	true	inert_control	209	-3.86	null	-7.316	-0.277	-3.86	60.9	0.427907	null	25.959603	2,014	cardiometabolic	train	EXPERIMENTAL	Epanova, 2 g	released	inert_control	PARALLEL	null	null
NCT01408303	[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL	INDUSTRY	AstraZeneca	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	646	Hypertriglyceridemia\|Cardiovascular Disease	Hypertriglyceridemia\|Cardiovascular Diseases\|Dyslipidemias\|Hyperlipidemias	2011-08	2012-06	2012-06	2014-12-05	18 Years	null	ALL	false	Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL. 3. The subject is a high risk for a future cardiovascular event. 4. The subject is treated with a statin and at or near LDL-C goal. Exclusion Criteria: 1. Allergy or intolerance to omega-3 fatty acid...	The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.	Serum Non-HDL Cholesterol	The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.	6 weeks	LEAST_SQUARES_MEAN	95% Confidence Interval	Percent change from baseline	continuous	3	OG001	Epanova 4 g	omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks	EXPERIMENTAL	Epanova, 4 g	omega-3-carboxylic acids, 4g/day + prescription statin	omega-3-carboxylic acids, 4g	DRUG	Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin	true	treatment	207	-6.91	null	-10.204	-3.504	-6.91	60.1	0.365741	null	24.590871	2,014	cardiometabolic	train	EXPERIMENTAL	Epanova, 4 g	released	treatment	PARALLEL	null	null
NCT01408303	[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL	INDUSTRY	AstraZeneca	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	646	Hypertriglyceridemia\|Cardiovascular Disease	Hypertriglyceridemia\|Cardiovascular Diseases\|Dyslipidemias\|Hyperlipidemias	2011-08	2012-06	2012-06	2014-12-05	18 Years	null	ALL	false	Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL. 3. The subject is a high risk for a future cardiovascular event. 4. The subject is treated with a statin and at or near LDL-C goal. Exclusion Criteria: 1. Allergy or intolerance to omega-3 fatty acid...	The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.	Serum Non-HDL Cholesterol	The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.	6 weeks	LEAST_SQUARES_MEAN	95% Confidence Interval	Percent change from baseline	continuous	3	OG002	Placebo	placebo, 1 g capsule placebo : 4 x 1 g capsule daily for 6 weeks	null	null	null	null	null	null	false	inert_control	211	-0.91	null	-4.509	2.822	-0.91	61.5	0.432558	null	27.165542	2,014	cardiometabolic	train	null	null	unmatched	inert_control	PARALLEL	null	null
NCT00096161	Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant	OTHER	Fred Hutchinson Cancer Center	PHASE2	null	NONE	TREATMENT	36	Acute Lymphoblastic Leukemia\|Acute Myeloid Leukemia\|Chronic Lymphocytic Leukemia\|Chronic Myelogenous Leukemia, BCR-ABL1 Positive\|Graft Versus Host Disease\|Hodgkin Lymphoma\|Myelodysplastic/Myeloproliferative Neoplasm\|Non-Hodgkin Lymphoma\|Plasma Cell Myeloma\|Waldenstrom Macroglobulinemia	Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Leukemia, Myeloid, Acute\|Leukemia, Lymphocytic, Chronic, B-Cell\|Leukemia, Myelogenous, Chronic, BCR-ABL Positive\|Graft vs Host Disease\|Hodgkin Disease\|Myelodysplastic-Myeloproliferative Diseases\|Lymphoma, Non-Hodgkin\|Multiple Myeloma\|Waldenstrom Macroglobulinemia	2003-05	2015-02	2015-08	2017-05-04	null	null	ALL	false	Inclusion Criteria: * Patients having received a preceding allogeneic transplantation from either a human leukocyte antigen (HLA)-matched related or unrelated donor are eligible for this protocol * Related donor: HLA genotypically identical at least at one haplotype and may be phenotypically or genotypically identi...	This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell transplant may stop the patient's immune system fro...	Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism	A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regime...	From the time of enrollment maintained to day 56 after the last DLI, up to Day 112	NUMBER	null	percentage of participants	binary	3	OG000	Group 1A (Pentostatin, DLI Dose Level 1)	Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chi...	null	null	null	null	null	null	false	treatment	20	60	null	null	null	0.6	55	0.1	1	null	2,017	oncology	train	EXPERIMENTAL	pentostatin, DLI, mycophenolate mofetil, cyclosporine	rematched	treatment	SINGLE_GROUP	null	null
NCT00344370	Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia	INDUSTRY	Kowa Research Europe	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	214	Type II Diabetes Mellitus\|Dyslipidemia	Diabetes Mellitus, Type 2\|Dyslipidemias	2006-08	2008-04	2008-04	2010-01-18	null	null	ALL	false	Inclusion Criteria: * Type II diabetes mellitus * Combined dyslipidemia * Completed NK-104-305 (NCT00309751) Exclusion Criteria: * Withdrawal from NK-104-305 (NCT00309751)	This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.	NCEP LDL-C Target Attainment	Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.	44 weeks	NUMBER	null	Participants	binary	2	OG000	Pitavastatin 4 mg	Pitavastatin 4 mg once daily	EXPERIMENTAL	Pitavastatin	Pitavastatin 4 mg QD	Pitavastatin	DRUG	Pitavastatin 4 mg QD	true	treatment	141	110	null	null	null	0.780142	59.3	0.475524	0.895105	null	2,010	cardiometabolic	train	EXPERIMENTAL	Pitavastatin	released	treatment	PARALLEL	null	null
NCT00344370	Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia	INDUSTRY	Kowa Research Europe	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	214	Type II Diabetes Mellitus\|Dyslipidemia	Diabetes Mellitus, Type 2\|Dyslipidemias	2006-08	2008-04	2008-04	2010-01-18	null	null	ALL	false	Inclusion Criteria: * Type II diabetes mellitus * Combined dyslipidemia * Completed NK-104-305 (NCT00309751) Exclusion Criteria: * Withdrawal from NK-104-305 (NCT00309751)	This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.	NCEP LDL-C Target Attainment	Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.	44 weeks	NUMBER	null	Participants	binary	2	OG001	Atorvastatin 40 mg	Atorvastatin 40 mg once daily	ACTIVE_COMPARATOR	Atorvastatin	Atorvastatin 40 mg	Atorvastatin	DRUG	Atorvastatin 40 mg	true	active_comparator	71	55	null	null	null	0.774648	60	0.422535	0.957746	null	2,010	cardiometabolic	train	ACTIVE_COMPARATOR	Atorvastatin	released	active_comparator	PARALLEL	null	null
NCT00784654	Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17	INDUSTRY	Shire	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	276	ADHD	Attention Deficit Disorder with Hyperactivity	2009-01-27	2011-10-26	2011-10-26	2012-10-02	6 Years	null	ALL	false	Inclusion Criteria: 1. Subject's parent or legally authorised representative(LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrict...	The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months	Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period	Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and \>= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the r...	Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)	NUMBER	null	percentage of participants	binary	2	OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.	EXPERIMENTAL	Lisdexamfetamine dimesylate (LDX)	Open-label 30, 50, or 70mg	Lisdexamfetamine dimesylate (LDX)	DRUG	LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)	true	treatment	76	15.8	null	null	null	0.158	null	null	null	null	2,012	neuro_psych	train	EXPERIMENTAL	Lisdexamfetamine dimesylate (LDX)	released	treatment	PARALLEL	null	null
NCT00784654	Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17	INDUSTRY	Shire	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	276	ADHD	Attention Deficit Disorder with Hyperactivity	2009-01-27	2011-10-26	2011-10-26	2012-10-02	6 Years	null	ALL	false	Inclusion Criteria: 1. Subject's parent or legally authorised representative(LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrict...	The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months	Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period	Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and \>= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the r...	Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)	NUMBER	null	percentage of participants	binary	2	OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.	null	null	null	null	null	null	false	inert_control	77	67.5	null	null	null	0.675	null	null	null	null	2,012	neuro_psych	train	null	null	unmatched	inert_control	PARALLEL	null	null
NCT06374394	A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above	INDUSTRY	GlaxoSmithKline	PHASE3	RANDOMIZED	NONE	PREVENTION	841	Respiratory Syncytial Virus Infections	Respiratory Syncytial Virus Infections	2024-04-29	2024-11-01	2025-03-31	2025-12-26	50 Years	null	ALL	true	Inclusion Criteria: • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff ...	This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.	Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination	RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group...	At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group)	GEOMETRIC_MEAN	95% Confidence Interval	Titers	continuous	2	OG000	Co-Ad Group	Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms.	EXPERIMENTAL	Co-Ad Group	Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms.	RSVPreF3 OA investigational vaccine\|COVID-19 mRNA vaccine	BIOLOGICAL	1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1 to participants in the Co-ad Group and on Day 31 to participants in the Control Group. ; 1 dose of COVID-19 mRNA vaccine is administered intramuscularly on Day 1 to participants in the Co-ad and Control Groups.	true	treatment	382	7,885.8	null	7,168.1	8,675.3	7,885.8	63.7	0.517986	0.980815	7,514.783963	2,025	infectious	test	EXPERIMENTAL	Co-Ad Group	released	treatment	PARALLEL	null	null
NCT06374394	A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above	INDUSTRY	GlaxoSmithKline	PHASE3	RANDOMIZED	NONE	PREVENTION	841	Respiratory Syncytial Virus Infections	Respiratory Syncytial Virus Infections	2024-04-29	2024-11-01	2025-03-31	2025-12-26	50 Years	null	ALL	true	Inclusion Criteria: • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff ...	This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.	Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination	RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group...	At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group)	GEOMETRIC_MEAN	95% Confidence Interval	Titers	continuous	2	OG001	Control Group	Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31.	ACTIVE_COMPARATOR	Control Group	Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31.	RSVPreF3 OA investigational vaccine\|COVID-19 mRNA vaccine	BIOLOGICAL	1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1 to participants in the Co-ad Group and on Day 31 to participants in the Control Group. ; 1 dose of COVID-19 mRNA vaccine is administered intramuscularly on Day 1 to participants in the Co-ad and Control Groups.	true	active_comparator	364	8,803.4	null	7,985	9,705.7	8,803.4	63.5	0.536058	0.956731	8,374.710122	2,025	infectious	test	ACTIVE_COMPARATOR	Control Group	released	active_comparator	PARALLEL	null	null
NCT01890122	Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes	INDUSTRY	Takeda	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	647	Diabetes Mellitus	Diabetes Mellitus	2013-09	2015-09	2015-10	2016-11-28	18 Years	null	ALL	false	Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. ...	The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.	Baseline and Week 26 (or Early termination)	MEAN	Standard Deviation	percentage of glycosylated hemoglobin	continuous	4	OG000	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.	ACTIVE_COMPARATOR	Metformin HCl 500 mg	Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.	Metformin HCl\|Alogliptin Placebo\|Alogliptin and Metformin FDC Placebo	DRUG	Metformin HCl capsules ; Alogliptin placebo-matching tablets ; Alogliptin and metformin FDC placebo-matching tablets	true	inert_control	160	-0.32	null	null	null	-0.32	53.6	0.493827	0.833333	1.067	2,016	cardiometabolic	train	ACTIVE_COMPARATOR	Metformin HCl 500 mg	released	inert_control	FACTORIAL	null	null
NCT01890122	Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes	INDUSTRY	Takeda	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	647	Diabetes Mellitus	Diabetes Mellitus	2013-09	2015-09	2015-10	2016-11-28	18 Years	null	ALL	false	Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. ...	The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.	Baseline and Week 26 (or Early termination)	MEAN	Standard Deviation	percentage of glycosylated hemoglobin	continuous	4	OG001	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.	ACTIVE_COMPARATOR	Alogliptin 12.5 mg	Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.	Alogliptin\|Metformin Placebo\|Alogliptin and Metformin FDC Placebo	DRUG	Alogliptin tablets ; Metformin placebo-matching capsules ; Alogliptin and metformin FDC placebo-matching tablets	true	inert_control	160	-1.23	null	null	null	-1.23	55.4	0.398773	0.773006	0.877	2,016	cardiometabolic	train	ACTIVE_COMPARATOR	Alogliptin 12.5 mg	released	inert_control	FACTORIAL	null	null
NCT01890122	Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes	INDUSTRY	Takeda	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	647	Diabetes Mellitus	Diabetes Mellitus	2013-09	2015-09	2015-10	2016-11-28	18 Years	null	ALL	false	Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. ...	The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.	Baseline and Week 26 (or Early termination)	MEAN	Standard Deviation	percentage of glycosylated hemoglobin	continuous	4	OG002	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	EXPERIMENTAL	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	Alogliptin and Metformin Fixed-Dose Combination (FDC)\|Alogliptin Placebo\|Metformin Placebo	DRUG	Alogliptin and metformin FDC tablets ; Alogliptin placebo-matching tablets ; Metformin placebo-matching capsules	true	inert_control	158	-1.06	null	null	null	-1.06	53.4	0.427673	0.918239	0.97	2,016	cardiometabolic	train	EXPERIMENTAL	Alogliptin 12.5 mg + Metformin HCl 500 mg FDC	released	inert_control	FACTORIAL	null	null
NCT01890122	Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes	INDUSTRY	Takeda	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	647	Diabetes Mellitus	Diabetes Mellitus	2013-09	2015-09	2015-10	2016-11-28	18 Years	null	ALL	false	Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. ...	The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.	Baseline and Week 26 (or Early termination)	MEAN	Standard Deviation	percentage of glycosylated hemoglobin	continuous	4	OG003	Placebo	Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	PLACEBO_COMPARATOR	Placebo	Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.	Alogliptin Placebo\|Metformin Placebo\|Alogliptin and Metformin FDC Placebo	DRUG	Alogliptin placebo-matching tablets ; Metformin placebo-matching capsules ; Alogliptin and metformin FDC placebo-matching tablets	true	inert_control	157	-1.72	null	null	null	-1.72	52.2	0.417178	0.638037	1.024	2,016	cardiometabolic	train	PLACEBO_COMPARATOR	Placebo	released	inert_control	FACTORIAL	null	null
NCT05849922	A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa	INDUSTRY	Sanofi	PHASE2	RANDOMIZED	QUADRUPLE	TREATMENT	86	Hidradenitis Suppurativa	Hidradenitis Suppurativa	2023-06-06	2024-08-22	2025-01-09	2026-01-29	18 Years	null	ALL	false	Inclusion Criteria: * Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline. * Participants had to have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one o...	This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.	Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16	The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as \>=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defi...	Week 16	NUMBER	null	percentage of participants	binary	2	OG000	Period A: Placebo	Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).	PLACEBO_COMPARATOR	Placebo	Participants received placebo Q2W in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).	Placebo	DRUG	1 mL extractable volume of placebo filled in 2 mL glass vial	true	inert_control	23	39.1	null	null	null	0.391	37	0.535714	0.928571	null	2,026	other	test	PLACEBO_COMPARATOR	Placebo	released	inert_control	PARALLEL	null	null
NCT05849922	A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa	INDUSTRY	Sanofi	PHASE2	RANDOMIZED	QUADRUPLE	TREATMENT	86	Hidradenitis Suppurativa	Hidradenitis Suppurativa	2023-06-06	2024-08-22	2025-01-09	2026-01-29	18 Years	null	ALL	false	Inclusion Criteria: * Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline. * Participants had to have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one o...	This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.	Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16	The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as \>=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defi...	Week 16	NUMBER	null	percentage of participants	binary	2	OG001	Period A: SAR442970	Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).	EXPERIMENTAL	SAR442970	Participants received SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).	SAR442970	DRUG	1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial	true	treatment	48	66.7	null	null	null	0.667	36.3	0.655172	0.896552	null	2,026	other	test	EXPERIMENTAL	SAR442970	released	treatment	PARALLEL	null	null
NCT05438602	A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System	INDUSTRY	Pfizer	PHASE2	RANDOMIZED	TRIPLE	TREATMENT	158	COVID-19	COVID-19	2022-08-03	2023-07-17	2023-11-13	2024-09-23	12 Years	null	ALL	false	Inclusion Criteria (applicable for both the main population and population with rebound): * Participants aged 12 years or older and weighing ≥40 kg at screening. * Immunocompromised * ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. Participants for the main population must have: \- Co...	The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from...	Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44	NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study v...	From Day 15 to Day 44	NUMBER	null	Percentage of participants	binary	3	OG000	Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day	Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \>=30 to less than (\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\^2) or estimated creatinine clearan...	null	null	null	null	null	null	false	inert_control	52	61.54	null	0.483	0.748	0.6154	57.09	0.518519	0.925926	null	2,024	infectious	test	null	null	unmatched	inert_control	PARALLEL	null	null
NCT05438602	A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System	INDUSTRY	Pfizer	PHASE2	RANDOMIZED	TRIPLE	TREATMENT	158	COVID-19	COVID-19	2022-08-03	2023-07-17	2023-11-13	2024-09-23	12 Years	null	ALL	false	Inclusion Criteria (applicable for both the main population and population with rebound): * Participants aged 12 years or older and weighing ≥40 kg at screening. * Immunocompromised * ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. Participants for the main population must have: \- Co...	The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from...	Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44	NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study v...	From Day 15 to Day 44	NUMBER	null	Percentage of participants	binary	3	OG001	Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day	Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \>=30 to \<60 mL/min/1.73 m\^2 or eCrCl \>=30 to \<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatr...	null	null	null	null	null	null	false	inert_control	48	70.83	null	0.58	0.837	0.7083	54.77	0.576923	0.942308	null	2,024	infectious	test	null	null	unmatched	inert_control	PARALLEL	null	null
NCT05438602	A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System	INDUSTRY	Pfizer	PHASE2	RANDOMIZED	TRIPLE	TREATMENT	158	COVID-19	COVID-19	2022-08-03	2023-07-17	2023-11-13	2024-09-23	12 Years	null	ALL	false	Inclusion Criteria (applicable for both the main population and population with rebound): * Participants aged 12 years or older and weighing ≥40 kg at screening. * Immunocompromised * ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. Participants for the main population must have: \- Co...	The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from...	Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44	NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study v...	From Day 15 to Day 44	NUMBER	null	Percentage of participants	binary	3	OG002	Nirmatrelvir + Ritonavir 15 Day	Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \>=30 to \<60 mL/min/1.73 m\^2 or eCrCl \>=30 to \<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Part...	EXPERIMENTAL	Nirmatrelvir plus ritonavir for 15 days	Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.	Nirmatrelvir\|Ritonavir	DRUG	Participants will receive 2 tablets of nirmatrelvir every 12 hours ; Participants will receive 1 capsule of ritonavir every 12 hours	true	treatment	50	66	null	0.529	0.791	0.66	55.63	0.509804	0.843137	null	2,024	infectious	test	EXPERIMENTAL	Nirmatrelvir plus ritonavir for 15 days	released	treatment	PARALLEL	null	null
NCT00262639	Prometa Protocol for Alcohol Dependence	OTHER	Medical University of South Carolina	PHASE2\|PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	60	Alcohol Dependence	Alcoholism	2005-12	2008-02	2008-03	2009-08-14	18 Years	null	ALL	false	Inclusion Criteria: 1. Age 18 - 70. 2. Participants will meet criteria for primary DSM IV alcohol dependence, drink on at least 70% of days in the last 30 days prior to assessment, and drink at least 5 drinks per drinking day. 3. No more than 72 hours since last drink of alcohol. Rationale: to focus on symptoms occurr...	This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will be utilized to treat ...	Percent Subjects Completely Abstinent	percent of subjects completely abstinent during the six week medication study study	6 week trial	NUMBER	null	percent of participants	binary	4	OG001	Low CIWAar Placebo	20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.	null	null	null	null	null	null	false	inert_control	26	19	null	null	null	0.19	47.2	0.222222	1	null	2,009	other	train	PLACEBO_COMPARATOR	II	rematched	inert_control	PARALLEL	null	null
NCT03592277	Vitamin C & Thiamine to Treat Sepsis and Septic Shock	OTHER	Trinity Health Of New England	PHASE2	RANDOMIZED	QUADRUPLE	TREATMENT	120	Sepsis\|Septic Shock	Sepsis\|Shock, Septic	2018-09-14	2021-02-22	2021-02-22	2022-09-28	18 Years	null	ALL	false	Patients must meet all inclusion criteria: 1. Between the ages of 18 and 90 years old 2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines. 3. Weight more than 30 kg 4. Full code Exclusion Criteria: 1. Not diagnosed with severe sepsis or septic...	Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.	Mortality Rates	All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)	From time of treatment to 30 days post hospital discharge, up to 87 days.	COUNT_OF_PARTICIPANTS	null	Participants	binary	2	OG000	Vitamins C and B1	Patients in this arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days...	EXPERIMENTAL	TREATMENT with Vitamins C and B1	Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal sal...	Vitamin C\|Vitamin B1	DRUG	Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). ; Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until I...	true	treatment	54	12	null	null	null	0.222222	66	0.518519	0.9	null	2,022	infectious	train	EXPERIMENTAL	TREATMENT with Vitamins C and B1	released	treatment	PARALLEL	null	null
NCT03592277	Vitamin C & Thiamine to Treat Sepsis and Septic Shock	OTHER	Trinity Health Of New England	PHASE2	RANDOMIZED	QUADRUPLE	TREATMENT	120	Sepsis\|Septic Shock	Sepsis\|Shock, Septic	2018-09-14	2021-02-22	2021-02-22	2022-09-28	18 Years	null	ALL	false	Patients must meet all inclusion criteria: 1. Between the ages of 18 and 90 years old 2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines. 3. Weight more than 30 kg 4. Full code Exclusion Criteria: 1. Not diagnosed with severe sepsis or septic...	Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.	Mortality Rates	All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)	From time of treatment to 30 days post hospital discharge, up to 87 days.	COUNT_OF_PARTICIPANTS	null	Participants	binary	2	OG001	Placebo	Patients in the control arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively.	null	null	null	null	null	null	false	inert_control	52	7	null	null	null	0.134615	69	0.442308	0.866667	null	2,022	infectious	train	NO_INTERVENTION	PLACEBO with saline only	rematched	inert_control	PARALLEL	null	null
NCT01201265	A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer	INDUSTRY	Hoffmann-La Roche	PHASE2	null	NONE	TREATMENT	40	Breast Cancer	Breast Neoplasms	2011-02	2015-04	2015-04	2016-05-27	18 Years	null	FEMALE	false	Inclusion Criteria: * Female participants, \>/= 18 years of age * Metastatic breast cancer * Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease * Treatment-naïve for metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequat...	This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1...	Progression-free Survival (PFS)	Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography...	From the date of registration until the disease progression or death (up to 1541 days).	MEDIAN	95% Confidence Interval	days	continuous	1	OG000	All Participants	Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve \[AUC\]= 2) along with gemcitabine 1000 mg/ metre square (m\^2) on days 1 and 8 of each 3 week cycle.	EXPERIMENTAL	Overall Participants	Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.	Bevacizumab\|Carboplatin\|Gemcitabine	DRUG	15 mg/kg iv every 3 weeks ; to an AUC = 2, on days 1 and 8 of each 3-week cycle ; 1000 mg/m2 iv on days 1 and 8 of each 3-week cycle	true	treatment	40	255	null	157	465	255	47.5	1	0.05	496.929347	2,016	oncology	train	EXPERIMENTAL	Overall Participants	released	treatment	SINGLE_GROUP	null	null
NCT01887600	Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis	INDUSTRY	Astellas Pharma Europe B.V.	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	594	Anemia in Chronic Kidney Disease in Non-dialysis Patients	Anemia\|Renal Insufficiency, Chronic	2013-09-03	2017-11-01	2017-11-01	2020-12-17	18 Years	null	ALL	false	Inclusion criteria: * Participant has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m\^2 estimated using the abbreviated 4-variable Modification of Diet in Rena...	This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in pati...	Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response	Hemoglobin (Hb) response was measured as Yes or No. Response Yes (responders) was defined as: Hb ≥11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL, for participants with baseline Hb \> 8.0 g/dL; or Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at two consecutive visits with ...	Baseline to week 24	NUMBER	95% Confidence Interval	Percentage of Participants	binary	2	OG000	Roxadustat	Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until partic...	EXPERIMENTAL	Roxadustat	Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until partic...	Roxadustat	DRUG	Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieve...	true	treatment	389	79.2	null	74.8	83.1	0.792	60.6	0.567775	0.626598	41.760609	2,020	other	train	EXPERIMENTAL	Roxadustat	released	treatment	PARALLEL	null	null
NCT01887600	Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis	INDUSTRY	Astellas Pharma Europe B.V.	PHASE3	RANDOMIZED	QUADRUPLE	TREATMENT	594	Anemia in Chronic Kidney Disease in Non-dialysis Patients	Anemia\|Renal Insufficiency, Chronic	2013-09-03	2017-11-01	2017-11-01	2020-12-17	18 Years	null	ALL	false	Inclusion criteria: * Participant has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m\^2 estimated using the abbreviated 4-variable Modification of Diet in Rena...	This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in pati...	Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response	Hemoglobin (Hb) response was measured as Yes or No. Response Yes (responders) was defined as: Hb ≥11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL, for participants with baseline Hb \> 8.0 g/dL; or Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at two consecutive visits with ...	Baseline to week 24	NUMBER	95% Confidence Interval	Percentage of Participants	binary	2	OG001	Placebo	Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until ...	PLACEBO_COMPARATOR	Placebo	Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until ...	Placebo	DRUG	Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved c...	true	inert_control	203	9.9	null	6.1	14.8	0.099	61.7	0.512315	0.438424	31.621408	2,020	other	train	PLACEBO_COMPARATOR	Placebo	released	inert_control	PARALLEL	null	null
NCT03226392	Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma	INDUSTRY	Novartis Pharmaceuticals	PHASE3	RANDOMIZED	DOUBLE	TREATMENT	704	Asthma	Asthma	2017-10-31	2019-07-05	2019-08-01	2020-02-28	12 Years	null	ALL	false	Inclusion Criteria: * A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months. * Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus ...	A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forc...	Change From Baseline in Pre-dose FEV1	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.	Baseline and Week 12	LEAST_SQUARES_MEAN	Standard Error	Liters	continuous	2	OG000	QAW039	QAW039 150mg once daily	ACTIVE_COMPARATOR	QAW039	QAW039 once daily	QAW039	DRUG	QAW039 once daily	true	active_comparator	352	0.126	null	null	null	0.126	50.4	0.613636	0.96875	0.033208	2,020	immune_inflam	train	ACTIVE_COMPARATOR	QAW039	released	active_comparator	PARALLEL	null	null
NCT03226392	Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma	INDUSTRY	Novartis Pharmaceuticals	PHASE3	RANDOMIZED	DOUBLE	TREATMENT	704	Asthma	Asthma	2017-10-31	2019-07-05	2019-08-01	2020-02-28	12 Years	null	ALL	false	Inclusion Criteria: * A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months. * Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus ...	A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forc...	Change From Baseline in Pre-dose FEV1	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.	Baseline and Week 12	LEAST_SQUARES_MEAN	Standard Error	Liters	continuous	2	OG001	Placebo	Placebo once daily	PLACEBO_COMPARATOR	Placebo	Placebo once daily	Placebo	DRUG	Placebo once daily	true	inert_control	350	0.157	null	null	null	0.157	50.2	0.622857	0.977273	0.331137	2,020	immune_inflam	train	PLACEBO_COMPARATOR	Placebo	released	inert_control	PARALLEL	null	null
NCT00296036	Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer	OTHER	Alliance for Clinical Trials in Oncology	PHASE3	RANDOMIZED	DOUBLE	SUPPORTIVE_CARE	137	Breast Cancer\|Drug/Agent Toxicity by Tissue/Organ\|Unspecified Adult Solid Tumor, Protocol Specific	Breast Neoplasms\|Drug-Related Side Effects and Adverse Reactions	2006-06	2009-07	null	2017-03-16	18 Years	null	ALL	false	DISEASE CHARACTERISTICS: * Histologically confirmed breast and/or other cancer * Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease * Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 course...	RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo i...	To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia	A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Even...	First 3 weeks of treatment	NUMBER	null	percentage of participants	binary	2	OG000	Urea/Lactic Acid Cream	Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.	null	null	null	null	null	null	false	treatment	59	13.6	null	null	null	0.136	null	0.776119	null	null	2,017	oncology	train	null	null	unmatched	treatment	PARALLEL	null	null
NCT00296036	Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer	OTHER	Alliance for Clinical Trials in Oncology	PHASE3	RANDOMIZED	DOUBLE	SUPPORTIVE_CARE	137	Breast Cancer\|Drug/Agent Toxicity by Tissue/Organ\|Unspecified Adult Solid Tumor, Protocol Specific	Breast Neoplasms\|Drug-Related Side Effects and Adverse Reactions	2006-06	2009-07	null	2017-03-16	18 Years	null	ALL	false	DISEASE CHARACTERISTICS: * Histologically confirmed breast and/or other cancer * Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease * Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 course...	RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo i...	To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia	A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Even...	First 3 weeks of treatment	NUMBER	null	percentage of participants	binary	2	OG001	Placebo Cream	Patients receive placebo cream applied to palms and soles twice daily.	null	null	null	null	null	null	false	inert_control	49	10.2	null	null	null	0.102	null	0.816667	null	null	2,017	oncology	train	null	null	unmatched	inert_control	PARALLEL	null	null
NCT00446511	Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension	INDUSTRY	Novartis Pharmaceuticals	PHASE3	RANDOMIZED	TRIPLE	TREATMENT	250	Hypertension	Hypertension	2007-06	2009-06	2009-06	2011-06-06	6 Years	null	ALL	false	Inclusion Criteria: * Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302. * Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and heigh...	The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.	Number of Patients With Adverse Events	null	Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)	NUMBER	null	Participants	binary	4	OG000	CKD Patients: Valsartan+Enalapril	Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or ...	EXPERIMENTAL	CKD patients: Valsartan+enalapril	null	Valsartan\|Enalapril	DRUG	Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. ; Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or ...	true	treatment	21	16	null	null	null	0.761905	11.4	0.380952	0.52381	null	2,011	cardiometabolic	train	EXPERIMENTAL	CKD patients: Valsartan+enalapril	released	treatment	PARALLEL	null	null
NCT00446511	Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension	INDUSTRY	Novartis Pharmaceuticals	PHASE3	RANDOMIZED	TRIPLE	TREATMENT	250	Hypertension	Hypertension	2007-06	2009-06	2009-06	2011-06-06	6 Years	null	ALL	false	Inclusion Criteria: * Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302. * Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and heigh...	The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.	Number of Patients With Adverse Events	null	Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)	NUMBER	null	Participants	binary	4	OG002	Non-CKD Patients: Valsartan	Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or witho...	EXPERIMENTAL	Non-CKD patients: Valsartan	null	Valsartan\|placebo matched to enalapril	DRUG	Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. ; Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.	true	inert_control	103	51	null	null	null	0.495146	13.1	0.398058	0.932039	null	2,011	cardiometabolic	train	EXPERIMENTAL	Non-CKD patients: Valsartan	released	inert_control	PARALLEL	null	null
NCT00446511	Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension	INDUSTRY	Novartis Pharmaceuticals	PHASE3	RANDOMIZED	TRIPLE	TREATMENT	250	Hypertension	Hypertension	2007-06	2009-06	2009-06	2011-06-06	6 Years	null	ALL	false	Inclusion Criteria: * Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302. * Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and heigh...	The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.	Number of Patients With Adverse Events	null	Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)	NUMBER	null	Participants	binary	4	OG003	Non-CKD Patients: Enalapril	Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without fo...	ACTIVE_COMPARATOR	Non-CKD patients: Enalapril	null	Enalapril\|placebo matched to valsartan	DRUG	Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. ; placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.	true	inert_control	109	53	null	null	null	0.486239	13.3	0.247706	0.944954	null	2,011	cardiometabolic	train	ACTIVE_COMPARATOR	Non-CKD patients: Enalapril	released	inert_control	PARALLEL	null	null

End of preview.

ivbench (v2.1)

Intervention-blind benchmark of real within-trial contrasts for measuring interventional skill of clinical-trial simulators.

Paper: Does Your Trial Simulator Know What the Drug Does? An Intervention-Blind Test of Interventional Validity on 7,207 Registered Trials · HF Papers

Code / full release: github.com/alicemkyn/ivbench (tag v2.1.0)
Archived Zenodo release: doi:10.5281/zenodo.23521618

File	Description
`data/benchmark_contrasts_v2.1_final.csv.gz`	Primary table: 9,996 audited within-trial contrasts (treatment − comparator on the primary endpoint) from 7,207 trials
`data/benchmark_arms_v2.1.csv.gz`	Arm-level records used to build contrasts (40,450 rows)
`data/datacard_v2.1.json`	Construction / cohort datacard

Code is MIT; these data tables and result tables in the GitHub release are CC BY 4.0. Records are derived from ClinicalTrials.gov (public domain); please cite ClinicalTrials.gov as the primary source alongside this benchmark.

Load

from datasets import load_dataset

# contrasts (gzip CSV)
contrasts = load_dataset(
    "alicemkyn/ivbench",
    data_files="data/benchmark_contrasts_v2.1_final.csv.gz",
    split="train",
)

arms = load_dataset(
    "alicemkyn/ivbench",
    data_files="data/benchmark_arms_v2.1.csv.gz",
    split="train",
)

Or with pandas:

import pandas as pd
contrasts = pd.read_csv(
    "hf://datasets/alicemkyn/ivbench/data/benchmark_contrasts_v2.1_final.csv.gz"
)

Splits and fields (summary)

Temporal split on results-posting year: train = posted before 2023, test = 2023+.
Binary endpoints → risk difference; continuous → standardised mean difference.
Key columns include nct_id, family, split_time, delta, intervention / endpoint text fields, and v2.1 pairing metadata (ctrl_kind, v21_status, …). See the paper appendix and datacard_v2.1.json.

Citation

@inproceedings{koyun2026ivbench,
  title={Does Your Trial Simulator Know What the Drug Does? An Intervention-Blind Test of Interventional Validity on 7,207 Registered Trials},
  author={Koyun, Alicem},
  booktitle={NeurIPS 2026 Workshop on World Models for High-Stakes Health (WMHS)},
  year={2026},
  url={https://arxiv.org/abs/2611.05907}
}

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Paper for alicemkyn/ivbench

Does Your Trial Simulator Know What the Drug Does? An Intervention-Blind Test of Interventional Validity on 7,207 Registered Trials

Paper • 2611.05907 • Published 3 days ago

ivbench (v2.1)

Contents

Load

Splits and fields (summary)

Citation

Paper for alicemkyn/ivbench