ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01024946
Conditions: Malignant Pleural Mesothelioma
Keywords: mesothelioma pleural RAD001 Everolimus 09-142 thoracic lung epithelioid sarcomatoid
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-12-01; Completion date: 2012-07-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
For patients with malignant pleural mesothelioma that has grown despite treatment with standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus works by blocking a protein that helps the cancer grow. The goal of this clinical research study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma. The safety of this drug will also be studied. The patients' physical state, changes in the size of the tumor, and laboratory findings taken during the study will help us decide if everolimus is safe and effective.

Detailed description:
This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.

Arms: arm 1: This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
Interventions: intervention 1: everolimus
Intervention descriptions: intervention 1: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity of toxicity encountered. One cycle will be considered 28 days. Patients will have CT scans to evaluate for response after cycle 1 and cycle 2, and then every two cycles thereafter.

Protocol documents:
Clinical trial NCT01025284
Conditions: Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-12-01; Completion date: 2012-07-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.

Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.

Detailed description:

Arms: arm 1: 8 milligrams per square meter (mg/m²) per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity. arm 2: 5 or 6 mg/m² per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, 3 plus granulocyte colony-stimulating factor (G-CSF) support administered subcutaneously beginning on Day 4 of each 21-day cycle, until disease progression or unacceptable toxicity.
Interventions: intervention 1: LY2523355 intervention 2: Granulocyte colony-stimulating factor (G-CSF)
Intervention descriptions: intervention 1: Administered intravenously as a 1-hour infusion intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01027364
Conditions: Severe Hemophilia B
Sponsor: Bioverativ Therapeutics Inc.
Start date: 2009-12-01; Completion date: 2012-07-01
Enrollment: 123 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.

Detailed description:

Arms: arm 1: 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.

Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling. arm 2: 100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39. arm 3: 20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes arm 4: The surgical period and dosing are dependent on the type of surgery the participant undergoes. Participants who started the study in one of the other treatment arms prior to surgery will return to the original treatment arm. Participants who joined the study in the Surgery arm will be assigned to one of the other treatment arms following post-operative rehabilitation.
Interventions: intervention 1: Factor IX (rFIXFc) intervention 2: rFIX
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01074814
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Molecular profiling
Sponsor: Translational Drug Development
Start date: 2010-03-01; Completion date: 2012-07-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.

Detailed description:
To determine the percent of patients with refractory breast cancer where molecular profiling and RPMA-based protein pathway activation analysis of their tumor, can change the clinical course of their disease (i.e. produce a Growth Modulation Index (GMI) ≥1.3). The GMI is calculated as the ratio of Progression-free survival (PFS) under molecular profiling and RPMA analysis selected treatment to the time to progression (TTP) for the most recent regimen the patient has progressed on.

Arms: arm 1: Blood drawn for molecular profiling
Interventions: intervention 1: Approved therapy will be assigned based on molecular profile and RPMA results
Intervention descriptions: intervention 1: treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results

Protocol documents:
Clinical trial NCT01081249
Conditions: Behavior Anxiety
Keywords: psychotherapy
Sponsor: MacDonald, Kai, M.D.
Start date: 2008-12-01; Completion date: 2012-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal behavior in the therapy session, as well as have positive effects on subjective anxiety, cortisol and heart rate.

Detailed description:

Arms: arm 1: Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit. arm 2: Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
Interventions: intervention 1: Placebo then intranasal oxytocin intervention 2: Intranasal oxytocin then placebo
Intervention descriptions: intervention 1: Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session. intervention 2: Participant received a single dose of 40 IU intranasal oxytocin at the first psychotherapy session, and received a similar dose of intranasal placebo spray at the second session.

Protocol documents:
Clinical trial NCT01082965
Conditions: Alzheimer's Disease
Keywords: ASL MRI perfusion cognition donepezil alzheimer's disease translational medicine
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2012-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesizes that donepezil will have a positive impact on brain blood flow deficits in subjects with memory deficits and/or mild dementia and that improvements in brain blood flow will be accompanied by improvements in memory.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Donepezil intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg tablets once daily for 7 days and then 10mg on 8th day intervention 2: matching placebo

Protocol documents:
Clinical trial NCT01111838
Conditions: Colon Cancer Rectal Cancer
Keywords: STA-9090 colon rectal 10-029
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-04-01; Completion date: 2012-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad STA-9090 has on colorectal cancer. This is a phase II trial which tests both how well the drug works in fighting your cancer as well as any possible side effects it will have on the patient.

Cancer is a disease of uncontrolled growth. This growth is controlled in part by a series of proteins that are part of a growth pathway. Some of these proteins are destroyed by a protein called HSP90 and STA-9090 is a test drug which blocks one of the proteins that helps cancer grow. This study will also look at molecular markers that may affect how the cancer grows, and how it responds to treatment.

Detailed description:

Arms: arm 1: This is an open-label Phase 2 clinical study in patients with advanced colorectal cancer (CRC). Patients will be treated with 200mg/m2 of STA-9090 during a 1-hour intravenous infusion 1 time per week for three consecutive weeks followed by a 1 week dose-free interval. Patients tolerating STA-9090 will be permitted to continue treatment until disease progression.
Interventions: intervention 1: STA-9090
Intervention descriptions: intervention 1: Patients will be enrolled and receive 200mg/m2 of STA-9090. Patients will receive single agent STA-9090 intravenous (I.V.) infusion (an indwelling catheter may not be used) over 60 minutes weekly (three weeks on and one week off). Follow-up imaging will be performed every 8 weeks to evaluate response.

Protocol documents:
Clinical trial NCT01115491
Conditions: Glioblastoma Multiforme
Sponsor: Hoffmann-La Roche
Start date: 2010-06-01; Completion date: 2012-07-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: temozolomide
Intervention descriptions: intervention 1: Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks intervention 2: Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle

Protocol documents:
Clinical trial NCT01118624
Conditions: Breast Cancer Breast Tumors Neoplasms, Breast Cancer of the Breast Human Mammary Carcinoma
Keywords: Female Advanced Metastatic
Sponsor: Acrotech Biopharma Inc.
Start date: 2010-03-01; Completion date: 2012-07-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.

Detailed description:
This is an open label, multi-center, Phase 2 study of pralatrexate with vitamin B12 and folic acid supplementation in patients with advanced or metastatic breast cancer who have failed prior treatment(s).

The start of study treatment is defined as the initiation of pralatrexate administration.

Pralatrexate will be administered as an intravenous (IV) push over 3-5 minutes on days 1 and 15 (± 1 day at each time point) of a 4-week cycle (ie, every \[q\] 2 weeks). The initial dose of pralatrexate will be 190 mg/m2. Dose reduction to 150 mg/m2 with further reduction to 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity (see Section 7.3). If 100 mg/m2 is not tolerated, pralatrexate must be discontinued.

Patients will receive vitamin supplementation consisting of vitamin B12, 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1-1.25 mg by mouth (PO) once a day (QD). Patients must have received 1 mg vitamin B12 within 10 weeks prior to the initiation of pralatrexate and have received 7 days of 1-1.25 mg folic acid PO QD prior to the initiation of pralatrexate.

Vitamin supplementation will continue throughout the study and for at least 30 days after the last administration of pralatrexate.

Arms: arm 1: Intravenous (IV) push administration over 3-5 minutes. Initial dose: 190 mg/m2 Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.
Interventions: intervention 1: Pralatrexate Injection intervention 2: Vitamin B12 intervention 3: Folic Acid
Intervention descriptions: intervention 1: Intravenous (IV) push administration over 3-5 minutes.

Initial dose: 190 mg/m2

Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met. intervention 2: 1 mg intramuscular injection

Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate. intervention 3: 1.0-1.25 mg orally

Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate.

Protocol documents:
Clinical trial NCT01118780
Conditions: Generalized Anxiety Disorder
Keywords: GAD Generalized Anxiety Disorder Anxiety
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2012-07-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (GAD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by mouth, daily for 10 weeks intervention 2: Administered by mouth, daily for 10 weeks

Protocol documents:
Clinical trial NCT01120405
Conditions: Elevated Cardiac Risk Coronary Arteries Disease Risk
Keywords: Xenon Cardiac safety Cardiovascular risk Non cardiac surgery Atherosclerotic vascular surgery
Sponsor: Air Liquide Santé International
Start date: 2010-05-01; Completion date: 2012-07-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

Detailed description:
The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;

Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.

Arms: arm 1: 0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A) arm 2: 0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
Interventions: intervention 1: Xenon intervention 2: Sevoflurane
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01120691
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: QVA149 NVA237 COPD exacerbation combination bronchodilator
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2012-07-01
Enrollment: 2224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

Detailed description:

Arms: arm 1: QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study. arm 2: NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study. arm 3: Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
Interventions: intervention 1: QVA149 intervention 2: NVA237 intervention 3: tiotropium intervention 4: Salbutamol/albuterol
Intervention descriptions: intervention 1: QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). intervention 2: NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). intervention 3: Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). intervention 4: As needed throughout the study

Protocol documents:
Clinical trial NCT01132690
Conditions: Gaucher Disease
Keywords: gaucher disease pediatric
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2012-07-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to \<18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12 months. At the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Taliglucerase alfa
Intervention descriptions: intervention 1: Taliglucerase alfa for infusion every two weeks for 12 months

Protocol documents:
Clinical trial NCT01144949
Conditions: Ureteral Calculi Kidney Stones Urolithiasis
Keywords: ureteral calculi renal colic ureteral stones kidney stones medical expulsive therapy
Sponsor: Watson Pharmaceuticals
Start date: 2010-06-01; Completion date: 2012-07-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: silodosin intervention 2: placebo
Intervention descriptions: intervention 1: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks intervention 2: one placebo capsule orally, once daily, with food for up to 4 weeks

Protocol documents: