ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01067521
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis Glatiramer Acetate
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-06-22; Completion date: 2017-05-12
Enrollment: 1404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods:

* Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
* Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

Detailed description:
Participants who were randomized to the GA 40 mg treatment arm in the Double-Blind Period, continue that treatment in the Open-Label Extension Period and are referred to as "Early Start" participants. Participants randomized to the Placebo arm in the Double-Blind Period and switched to GA 40 mg subcutaneous injections three times a week in the Open-Label Extension are referred to as "Delayed Start" participants.

Arms: arm 1: Also referred to as the 'Early Start' treatment arm, participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the Double-Blind Period, and then continued that treatment as open-label therapy until the drug was commercially available or development stopped. arm 2: Also referred to as the 'Delayed Start' treatment arm, participants were administered placebo subcutaneous injections three times a week for 12 months during the Double-Blind Period, and then switched to GA 40 mg/mL subcutaneous injections three times a week as open-label therapy until the drug was commercially available or development stopped.
Interventions: intervention 1: Glatiramer acetate (GA) intervention 2: Placebo
Intervention descriptions: intervention 1: GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period. intervention 2: Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period.

Protocol documents:
Clinical trial NCT01450761
Conditions: Small Cell Lung Carcinoma
Sponsor: Bristol-Myers Squibb
Start date: 2011-12-13; Completion date: 2017-05-17
Enrollment: 1351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Detailed description:

Arms: arm 1: Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached

Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses arm 2: Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached

Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Interventions: intervention 1: Ipilimumab intervention 2: Placebo matching Ipilimumab intervention 3: Etoposide intervention 4: Cisplatin intervention 5: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02038010
Conditions: HER2-positive Breast Cancer Recurrent Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: Northwestern University
Start date: 2014-05-21; Completion date: 2017-05-20
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this study is considered standard treatment for the type of cancer in this study. Participants in this study have already been treated with trastuzumab and chemotherapy in the past, and their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth) that the researchers think may help T-DM1 to work better.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine safety, tolerability, feasibility, and the maximum-tolerated dose (MTD) of dose-escalating BYL719 in combination with ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer (MBC) after progression on trastuzumab and taxane-based therapy.

SECONDARY OBJECTIVES:

I. Evaluate pharmacokinetics (PK) of BYL719 administered in combination with T-DM1.

II. Assess any preliminary evidence of efficacy of BYL719 and T-DM1 in combination in patients with HER2-positive MBC.

TERTIARY OBJECTIVES:

I. Explore efficacy in patients whose tumors have an alteration (mutation or amplification) of the PIK3CA gene and decrease of phosphatase and tensin homolog gene (PTEN) expression. (Optional) II. Examine other v-akt murine thymoma viral oncogene homolog 1 (Akt)/mechanistic target of rapamycin (mTOR) downstream markers by immunohistochemistry. (Optional)

OUTLINE: This is a dose-escalation study of PI3K inhibitor BYL719.

Patients receive PI3K inhibitor BYL719 orally (PO) daily on days 1-21 and ado-trastuzumab emtansine (T-DM1) intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity, or at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 3 months.

Arms: arm 1: Patients receive PI3K inhibitor BYL719 PO daily on days 1-21 and ado-trastuzumab emtansine IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: PI3K inhibitor BYL719 intervention 2: ado-trastuzumab emtansine intervention 3: pharmacological study intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given IV intervention 3: Correlative studies intervention 4: Optional correlative studies

Protocol documents:
Clinical trial NCT02399228
Conditions: Oral Mucositis
Keywords: radiation therapy chemotherapy head and neck cancer
Sponsor: Santalis Pharmaceuticals, Inc.
Start date: 2015-10-04; Completion date: 2017-05-20
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care. Santalis believes that the proposed study is a prudent and appropriate approach to investigate the potential of their product to prevent or improve oral mucositis symptoms commonly seen in subjects undergoing radiotherapy with or without chemotherapy.

Detailed description:
The objectives of this proof of concept trial are: to evaluate the efficacy, safety and tolerability of SAN005 when administered to adults for the prevention and treatment of radiation induced oral mucositis.

Subjects will be instructed on the administration of study medication thrice daily till oral mucositis resolves. Subjects will return to the clinic once a week while receiving radiation and then once every two weeks once their radiation has been completed and then until their mucositis has resolved for the Final Study Visit.

Preliminary Efficacy Evaluation will be the severity of pain rated by the Numeric Pain Rating Scale (NRPS) and mucositis grade by Radiation Therapy Oncology Group (RTOG) criteria at Visit 7 (Day 36). Additional secondary efficacy evaluations will include the severity of pain rated by the NRPS and mucositis grade by RTOG criteria at each study visit, frequency of the percutaneous endoscopic gastrostomy (PEG) tube for feeding during the duration of treatment and weight loss from baseline through Visit 5 and 7. The time of mucositis onset and duration will also be used in assessing efficacy. Additional secondary and exploratory endpoints will be outlined in the statistical analysis plan. The overall efficacy is determined by comparing the data to historical controls. Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug. In addition, tolerability evaluations will be performed at each study visit.

Arms: arm 1: A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to "swish, gargle and spit".
Interventions: intervention 1: 0.25% EISO mouth rinse
Intervention descriptions: intervention 1: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis

Protocol documents:
Prot_SAP_000.pdf: 



















































































ICF_001.pdf:
Clinical trial NCT00938964
Conditions: Cognitive Decline
Keywords: Cognition
Sponsor: Duke University
Start date: 2009-07-01; Completion date: 2017-05-23
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.

Detailed description:

Arms: arm 1: Lidocaine infusion for 48 hours arm 2: Normal saline infusion for 48 hours
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Lidocaine versus placebo infusion for 48 hours intervention 2: Lidocaine versus placebo infusion for 48 hours

Protocol documents:
Clinical trial NCT02143713
Conditions: Endometriosis
Keywords: Endometriosis-associated pain Elagolix Gonadotropin-releasing Hormone Antagonist Dysmenorrhea (DYS) Non-menstrual Pelvic Pain (NMPP) Dyspareunia
Sponsor: AbbVie
Start date: 2014-05-27; Completion date: 2017-05-23
Enrollment: 496 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal Study M12-671 (NCT01931670).

Detailed description:
The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg once daily (QD) or elagolix 200 mg twice daily (BID) for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

Arms: arm 1: Participants received elagolix 150 mg tablets once a day (QD) for 6 months. arm 2: Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.
Interventions: intervention 1: Elagolix
Intervention descriptions: intervention 1: Elagolix tablets administered orally

Protocol documents:
Clinical trial NCT00496769
Conditions: Atrial Fibrillation
Sponsor: Bristol-Myers Squibb
Start date: 2007-08-31; Completion date: 2017-05-25
Enrollment: 6421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Detailed description:
An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Apixaban intervention 2: Acetylsalicylic acid
Intervention descriptions: intervention 1: Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks intervention 2: Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Protocol documents:
Clinical trial NCT01958918
Conditions: Neovascular Age-related Macular Degeneration
Keywords: wet age-related macular degeneration (AMD) ranibizumab aflibercept Best Corrected Visual Acuity (BCVA) Spectral Domain Optical Coherence Tomography (SD-OCT)
Sponsor: Novartis Pharmaceuticals
Start date: 2013-10-23; Completion date: 2017-05-29
Enrollment: 712 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

Detailed description:
Patients attended 14 scheduled study visits during 12 months.

Arms: arm 1: 1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity arm 2: 1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months
Interventions: intervention 1: Ranibizumab intervention 2: Aflibercept
Intervention descriptions: intervention 1: 0.5 mg intravitreal injection intervention 2: 2 mg intravitreal injection

Protocol documents:
Clinical trial NCT02753946
Conditions: Urinary Tract Infection Symptomatic Acute Pyelonephritis Urinary Tract Infection Complicated
Sponsor: Nabriva Therapeutics AG
Start date: 2016-04-01; Completion date: 2017-05-30
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).

Detailed description:
This is a multi-center, randomized, double-blind, parallel-group study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of ZTI-01 (IV fosfomycin) compared to piperacillin/tazobactam in the treatment of hospitalized adults with cUTI or AP. Diagnosed and prescreened hospitalized patients will be randomized 1:1 to receive one of two intravenous treatments: 6 g ZTI-01 three times daily (18g total daily dose) or 4.5 g piperacillin/tazobactam three times daily (13.5g total daily dose) for 7 calendar days, with option to extend treatment up to 14 days in patients with positive blood culture at pretreatment. Patients will participate in the study for approximately 26 days. Urine cultures will be obtained and organisms quantified for qualified patients at baseline, during treatment, at end of treatment (EOT), at test of cure (TOC) and late follow up visits (LFU). Blood cultures will be obtained at baseline and repeated if positive throughout the study. Safety and efficacy evaluations will include vital signs, labs, physical exams, ECG and overall response as evaluated by the Investigator. Pharmacokinetic samples will be obtained (sparse sampling) for all patients.

Arms: arm 1: 6 g ZTI-01 (IV fosfomycin) intravenously administered every 8 hours (18g total daily dose for 7-14 calendar days) arm 2: 4.5 g piperacillin/tazobactam (4 g piperacillin/0.5 g tazobactam) intravenously administered every 8 hours (13.5g total daily dose for 7-14 calendar days)
Interventions: intervention 1: ZTI-01 intervention 2: Piperacillin-tazobactam
Intervention descriptions: intervention 1: 6g ZTI-01 intravenous infusion TID q8 hours intervention 2: 4.5g piperacillin-tazobactam intravenous infusion TID q8 hours

Protocol documents:
Clinical trial NCT01709513
Conditions: Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-09-30; Completion date: 2017-05-31
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.

Detailed description:

Arms: arm 1: Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable lipid-modifying therapy (LMT). arm 2: Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT. arm 3: Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
Interventions: intervention 1: Atorvastatin intervention 2: Ezetimibe intervention 3: Alirocumab intervention 4: Placebo
Intervention descriptions: intervention 1: Atorvastatin over-encapsulated tablets. intervention 2: Ezetimibe over-encapsulated tablet. intervention 3: Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. intervention 4: Placebo for alirocumab, ezitimibe and atorvastatin.

Protocol documents:
Clinical trial NCT01969435
Conditions: Hodgkin Disease Lymphoma, Non-Hodgkin
Sponsor: Washington University School of Medicine
Start date: 2014-03-19; Completion date: 2017-05-31
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT

Detailed description:

Arms: arm 1: * Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant.
Interventions: intervention 1: Carmustine intervention 2: Etoposide phosphate intervention 3: Cytarabine intervention 4: Melphalan HCl (propylene glycol-free)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01170117
Conditions: Anorexia Nervosa
Keywords: Eating Disorders Anorexia Nervosa
Sponsor: New York State Psychiatric Institute
Start date: 2010-08-01; Completion date: 2017-06-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and mortality. Weight restoration is a treatment priority, and better treatments are needed.

Detailed description:
This study is a 16-week randomized, double-blind, placebo-controlled trial of olanzapine in adult outpatients with AN. 160 individuals with AN, ages \> 18, will be randomly assigned to receive olanzapine or placebo for 16 weeks together with a medication management treatment. Primary outcomes will include weight gain as well as psychological symptoms known to be associated with AN, including obsessionality, mood, and anxiety.

This project is based on evidence from a recently completed 8-week pilot study comparing the efficacy of olanzapine to placebo in outpatients with AN (PI: Evelyn Attia, MD), as well as a recently published 12-week trial of olanzapine vs placebo (Bissada et al, Am J Psychiatry, 2007) in which outpatient treatment with olanzapine was associated with weight improvement, improved psychological status, and no untoward metabolic effects among low-weight patients.

The investigators hypothesize that among underweight adult outpatients with AN receiving olanzapine vs. placebo, together with medication management treatment: 1)patients with AN receiving olanzapine will gain weight at a faster rate than those receiving placebo; and 2) patients with AN receiving olanzapine will demonstrate greater reduction in psychological symptoms, including obsessionality, mood, anxiety and eating disorder symptoms, than those receiving placebo.

Arms: arm 1: Control group receiving placebo arm 2: Group receiving olanzapine
Interventions: intervention 1: Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients. intervention 2: Control Group will receive placebo pill

Protocol documents: