ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02653417
Conditions: Vasomotor Symptoms Hot Flashes
Sponsor: Radius Pharmaceuticals, Inc.
Start date: 2015-12-01; Completion date: 2018-05-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to determine the clinical safety of RAD1901 and to evaluate whether RAD1901 reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS; "hot flashes") in postmenopausal women.

Detailed description:
This was a Phase 2b outpatient, prospective, multicenter, double-blind, randomized, placebo-controlled study to determine whether elacestrant reduces the frequency and severity of vasomotor symptoms (VMS; "hot flashes") in postmenopausal women with moderate to severe hot flashes. Postmenopausal women who met study criteria were followed for 12 weeks on double-blind study medication and two weeks off study medication.

Treatment was randomized 1:1:1:1 to ensure that an approximately equal number of patients were exposed to each of three RAD1901 (elacestrant) doses (5, 10 and 20 mg/day) or placebo. The total period of placebo exposure was 14 weeks.

Enrolling approximately 300 patients was expected to provide power for testing superiority of the primary efficacy endpoint outcomes.

Arms: arm 1: RAD1901 5 mg/day arm 2: RAD1901 10 mg/day arm 3: RAD1901 20 mg/day arm 4: Placebo
Interventions: intervention 1: RAD1901 intervention 2: Placebo
Intervention descriptions: intervention 1: RAD1901 intervention 2: Placebo

Protocol documents:
Clinical trial NCT02708186
Conditions: Dementia With Lewy Bodies REM Sleep Behavior Disorder Parkinson's Disease Dementia
Keywords: Dementia with Lewy bodies Lewy bodies REM sleep behavior disorder Parkinson's disease dementia
Sponsor: Axovant Sciences Ltd.
Start date: 2016-03-01; Completion date: 2018-05-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

Detailed description:
This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD.

Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.

Arms: arm 1: Nelotanserin 80 mg arm 2: Placebo
Interventions: intervention 1: Nelotanserin intervention 2: Placebo
Intervention descriptions: intervention 1: once daily, oral, 20-mg tablets intervention 2: once daily, oral, matching tablets

Protocol documents:
Prot_SAP_000.pdf: 






























Primary Efficacy Evaluation: 
Key Secondary Evaluation: 
Other Secondary Efficacy Evaluation: 


Safety Evaluation: 
Pharmacokinetic Evaluation: 
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Primary Efficacy Analysis: 
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Pharmacokinetics/Pharmacodynamics (PK/PD):






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Baseline Sleep Laboratory Visits (Visit 3 – up to 10 days) 
Management of patients with OSA and CSA: 


Baseline/Randomization (Visit 4 – Day 0) 


Phone call/Liver Function Tests (Day 14, +/- 3 days) 
End of Study Sleep Laboratory Visits (Visit 5 on Day 28 – up to 10 days)
Final Study Clinic Visit (Visit 5 on Day 30, + 10 days) 














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RBC Indices 
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Curr Neurol Neurosci Rep. 
Alzheimers Dement
J Clin Sleep Med
Biol Psychiatry
Acta Neurol Scand
. CNS Drugs
J Neural Transm (Vienna).
Brain
Lancet.
J Psychiatr Res
Expert Opin. 
Pharmacother


Lancet Neurol
Lancet Neurol
Swiss Med 
Wkly
J Am Geriatr Soc
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Mov Disord. 
Parkinson’s disease and non-motor function, Second edition
Biometrics
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Clinical trial NCT01473940
Conditions: Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: Northwestern University
Start date: 2012-06-11; Completion date: 2018-05-06
Enrollment: 21 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
This phase I trial studies the side effects and best dose of ipilimumab when given together with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor cells or stop them from growing. Giving monoclonal antibody therapy together with chemotherapy may kill more tumor cells.

Detailed description:
OUTLINE: This is a dose-escalation study of ipilimumab.

INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes in weeks 1, 4, 7, and 10, and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.

MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

After completion of study treatment, patients are followed up monthly for 6 months and then every 3 months.

Arms: arm 1: INDUCTION: Patients receive ipilimumab IV over 90 minutes in weeks 1, 4, 7, and 10 and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.

MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.
Interventions: intervention 1: ipilimumab intervention 2: gemcitabine hydrochloride intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01695135
Conditions: Prostate Neoplasms
Keywords: Prostate neoplasms Prostate cancer Metastatic castration resistant prostate cancer Abiraterone acetate JNJ-212082
Sponsor: Janssen Research & Development, LLC
Start date: 2012-08-09; Completion date: 2018-05-08
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when co-administered with prednisone in Asian patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.

Detailed description:
This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives) placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study with a randomization allocation ratio of 2:1 between the abiraterone acetate group (abiraterone acetate plus prednisone) and the placebo group (placebo plus prednisone). Approximately 200 (133 in the abiraterone acetate group and 67 in the placebo group) medically or surgically castrated male patients with mCRPC who have failed docetaxel-based chemotherapy will be enrolled in this study for up to 27 months. The study protocol includes the following phases: screening (within 28 days prior to randomization on Cycle 1 Day 1), double-blind treatment (28-day cycles until protocol-defined disease progression or unacceptable toxicity), and survival follow-up (up to Month 60). During the follow-up phase, patients with disease progression will be provided open-label (identity of assigned study drug will be known) extension treatment with abiraterone acetate. In the event of a positive study result at the time of the final analysis, participants in the placebo group who have not shown progressive disease in the double-blind treatment Phase of the study will be enrolled in an open-label extension treatment with abiraterone acetate treatment based on the participant's choice and treating physician's endorsement if they meet the criteria for subsequent abiraterone acetate. Abiraterone acetate 1000 mg tablets or placebo will be taken orally (by mouth) once daily plus prednisone 5 mg tablet orally twice daily. Efficacy and safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abiraterone acetate intervention 2: Placebo intervention 3: Prednisone
Intervention descriptions: intervention 1: Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily intervention 2: Placebo (4 tablets) taken orally once daily intervention 3: Prednisone 5 mg tablet taken orally twice daily

Protocol documents:
Clinical trial NCT01029262
Conditions: Anemia
Keywords: Myelodysplastic Syndromes MDS transfusion dependent anemia Erythropoiesis stimulating agents non-del 5q
Sponsor: Celgene
Start date: 2010-01-26; Completion date: 2018-05-09
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.

Detailed description:

Arms: arm 1: Lenalidomide 10 mg by mouth (PO) daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and \< 60 mL/min. arm 2: Three placebo capsules once daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
Interventions: intervention 1: Lenalidomide intervention 2: Placebo
Intervention descriptions: intervention 1: One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug) intervention 2: 3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)

Protocol documents:
Clinical trial NCT00910910
Conditions: B-Cell Chronic Lymphocytic Leukemia
Sponsor: Celgene
Start date: 2009-10-13; Completion date: 2018-05-09
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

Detailed description:
After notification from the US Food and Drug Administration (FDA) on 12 July 2013, Celgene agreed to discontinue the lenalidomide treatment for all patients due to an imbalance in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. No specific causality for this imbalance has been identified to date. Investigators were instructed to immediately discontinue all participants from experimental lenalidomide treatment and inform their patients accordingly. Participants on the Chlorambucil arm may continue up to 12 months (13 cycles) with the last participant completing in March 2014. All randomized participants will continue to be followed for overall survival and secondary primary malignancies.

Arms: arm 1: 1 - Lenalidomide arm 2: 2- Chlorambucil
Interventions: intervention 1: Lenalidomide intervention 2: Chlorambucil
Intervention descriptions: intervention 1: For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.

For patients with moderate renal impairment (defined as CrCl ≥ 30 to \< 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first. intervention 2: Patients assigned to the chlorambucil arm will receive oral chlorambucil tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Protocol documents:
Clinical trial NCT03346538
Conditions: Acute Ischemic Stroke
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2017-11-17; Completion date: 2018-05-14
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen (administration twice daily for 14 days) as the control.

Detailed description:

Arms: arm 1: High-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes. arm 2: Low-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes. arm 3: A placebo will be administered as a bolus, and then as a continuous infusion. In addition, MCI-186 30 mg will be administered as an intravenous infusion twice a day over 30 minutes.
Interventions: intervention 1: Continuous infusion high-dose MCI-186 intervention 2: Continuous infusion low-dose MCI-186 intervention 3: Continuous infusion placebo intervention 4: Approved dosing regimen MCI-186 intervention 5: Approved dosing regimen placebo
Intervention descriptions: intervention 1: intravenous injection intervention 2: intravenous injection intervention 3: intravenous injection intervention 4: intravenous injection intervention 5: intravenous injection

Protocol documents:
Prot_000.pdf: 

















































































































































SAP_001.pdf:
Clinical trial NCT01358734
Conditions: Acute Myeloid Leukemia Acute Myelogenous Leukemia
Keywords: AML elderly acute myelogenous leukemia vidaza azacitidine elderly AML revlimid lenalidomide
Sponsor: Celgene
Start date: 2012-04-27; Completion date: 2018-05-15
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Detailed description:
On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Arms: arm 1: Repeated cycles of azacitidine 75 mg/m\^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care arm 2: Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care arm 3: Repeated cycles of azacitidine 75mg/m\^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
Interventions: intervention 1: Azacitidine intervention 2: Lenalidomide intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7 intervention 2: Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily intervention 3: The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support

Protocol documents:
Clinical trial NCT00078897
Conditions: Colorectal Cancer Adenomatous Colorectal Polyps Precancerous Condition
Keywords: colon cancer rectal cancer colorectal cancer adenomatous polyp
Sponsor: University of Arizona
Start date: 2005-01-20; Completion date: 2018-05-17
Enrollment: 1621 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.

Detailed description:
OBJECTIVES:

Primary

* Compare the effects of selenium vs placebo on the recurrence of adenomatous colorectal polyps, in terms of histologic type, degree of dysplasia, number, size, and location, in patients with adenomatous colorectal polyps.
* Compare the type, incidence, and outcome of side effects in patients treated with these regimens.
* Determine patient adherence to long-term treatment with these regimens.

Secondary

* Determine the effects of regimen modification by baseline blood selenium level, low-dose aspirin, selenoprotein genetic marker polymorphisms (e.g., GPx-1, GPx-2, and SEP15)
* Determine the effects of low-dose aspirin (81 mg/day) modification by ornithine decarboxylase promoter genotype, and toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UT1A6 loci in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to use of low-dose (≤ 81 mg/day) aspirin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral selenium once daily.
* Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for up to 5 years\* in the absence of disease progression or unacceptable toxicity.

Patients undergo follow-up colonoscopy approximately 5 years\* after baseline colonoscopy.

NOTE: Some patients will continue participation for up to 7 and a half years

PROJECTED ACCRUAL: A total of 1,600 patients with an adenoma will be randomized to this study, followed by a second group of randomization of 200 patients with at least one advanced adenoma (at baseline) for a substudy. Total planned randomizations = 1,800 participants.

Arms: arm 1: Participants receive oral selenium 200 mcg once daily. arm 2: Participants receive oral placebo once daily.
Interventions: intervention 1: Selenium
Intervention descriptions: intervention 1: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.

Protocol documents:
Clinical trial NCT00426764
Conditions: Peripheral T-cell Lymphoma
Keywords: peripheral T-cell lymphoma T-cell lymphoma romidepsin
Sponsor: Celgene
Start date: 2007-06-19; Completion date: 2018-05-17
Enrollment: 131 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.

Detailed description:
This is a Phase II, non-randomized, open-label, single-arm trial. This study is designed on the basis of complete response (CR) or unconfirmed CR \[CR(u)\] as the measure of efficacy, based on the best overall response of each patient. The sample size of 65 patients evaluable for efficacy would yield lower 95% confidence limits on the rate of CR + CR(u) that would range from 2.2% to 7.7%, if the observed rate of CR + CR(u) ranges from 8% to 15%. The study was amended to include an Extension Phase, during which patients at non-US sites who are benefitting from treatment can continue to receive romidepsin. The Extension Study Phase is active in EU countries where currently no Marketing Authorisation exists for romidepsin. Patients may remain on study until progressive disease occurs or they withdraw their consent and only serious adverse events and study drug administration data will continue to be collected and reported for these patients.

Arms: arm 1: Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Interventions: intervention 1: Romidepsin
Intervention descriptions: intervention 1: Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.

Protocol documents: