ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00474630
Conditions: Obesity Overweight Diabetes Mellitus, Type 2
Keywords: Obesity Overweight Diabetes Mellitus, Type 2
Sponsor: Orexigen Therapeutics, Inc
Start date: 2007-05-01; Completion date: 2009-06-01
Enrollment: 505 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is determine whether the combination of naltrexone SR and bupropion SR is safe and effective in treating obesity in subjects with type 2 diabetes.

Detailed description:
Optimal care of patients with diabetes mellitus includes vigorous and persistent efforts to achieve physiologic control of blood glucose as well as other often associated conditions including hypertension, dyslipidemia and excess weight. Pharmacologic interventions for the treatment of obesity in type 2 diabetes have shown significant reductions in HbA1c. Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with type 2 diabetes mellitus.

Arms: arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day with ancillary therapy arm 2: Placebo with ancillary therapy
Interventions: intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Ancillary therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Protocol documents:
Clinical trial NCT00486044
Conditions: Alzheimer Disease
Keywords: amyloid protein apolipoprotein cerebrospinal fluid cerebrovascular circulation inflammation magnetic resonance imaging prevention & control
Sponsor: University of Wisconsin, Madison
Start date: 2005-02-01; Completion date: 2009-06-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function.

Detailed description:
Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects a substance in the spinal fluid around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's disease. This study also evaluates whether simvastatin improves regional brain blood flow (on magnetic resonance imaging \[MRI\]), reduces inflammation, and improves cognitive function.

The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100 middle-aged adults with a parental history of Alzheimer's disease. Participants were randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets. Fifty of the ESPRIT subjects participated in the MRI sub-study.

Participants had the following data collected: fasting blood tests (baseline and months 3 and 9), medical history and medication questionnaires (each visit), study medication side effect review (all visits), lumbar puncture procedure (baseline and month 9), memory testing (baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants).

Arms: arm 1: simvastatin 40 mg nightly for 1 month then 80 mg nightly for 8 months arm 2: Matching placebo tablet nightly for 9 months
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg tablet each night for one month, then 80 mg for 8 months intervention 2: Matching tablet each night for 9 months

Protocol documents:
Clinical trial NCT00487461
Conditions: Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm
Keywords: SAH Vasospasm
Sponsor: University of Illinois at Chicago
Start date: 2007-05-01; Completion date: 2009-06-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.

Detailed description:
Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.

One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.

Arms: arm 1: Placebo tablet arm 2: Simvastatin 40 mg arm 3: Simvastatin 80 mg
Interventions: intervention 1: Simvastatin 40 mg intervention 2: Placebo intervention 3: Simvastatin 80 mg
Intervention descriptions: intervention 1: Comparing two doses of Simvastatin to placebo intervention 2: Placebo tablet intervention 3: Comparing two doses of Simvastatin to placebo

Protocol documents:
Clinical trial NCT00489489
Conditions: Multiple Sclerosis
Keywords: MS interferon-beta adjunctive therapy relapses
Sponsor: Sanofi
Start date: 2007-05-01; Completion date: 2009-06-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\].

Secondary objectives were:

* to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.

Detailed description:
The study period per participant was approximatively 44 weeks broken down as follows:

* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.

'\*' participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Arms: arm 1: Teriflunomide 7 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 2: Teriflunomide 14 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 3: Placebo (for Teriflunomide) once daily concomitantly with Interferon-β (IFN-β) for 24 weeks
Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for Teriflunomide) intervention 3: Interferon-β
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration intervention 3: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection

Protocol documents:
Clinical trial NCT00490568
Conditions: Alzheimer's Disease
Keywords: cognition Alzheimer's disease Rosiglitazone extended-release (XR) safety adjunctive therapy BRL-049653 tolerability open-label extension
Sponsor: GlaxoSmithKline
Start date: 2007-08-08; Completion date: 2009-06-01
Enrollment: 1461 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.

Detailed description:

Arms: arm 1: Investigational drug
Interventions: intervention 1: Rosiglitazone XR
Intervention descriptions: intervention 1: Experimental drug

Protocol documents:
Clinical trial NCT00495612
Conditions: Asthma
Keywords: Xolair Allergic asthma Cat allergy
Sponsor: Genentech, Inc.
Start date: 2007-09-01; Completion date: 2009-06-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms.

Detailed description:
A cat dander allergen challenge model was used to collect data for all of the Outcome Measures. The cat allergen levels in the model are similar to those found in homes with cats and are capable of inducing lower- and upper-airway responses that have been used to assess the efficacy of several asthma and allergy therapies.

Cat allergen exposure was performed in a room furnished with upholstered furniture, a blanket, and a cat litter box. The door was kept closed at all times, except when personnel or study patients were entering or leaving the room. The ventilation system was operating at all times except during cat allergen challenges. Two neutered adult cats were kept in the room at all times and were free to move about except during challenges, at which time they are placed in wire cages. Immediately before a challenge, the blanket was shaken vigorously to distribute cat allergen throughout the room.

Arms: arm 1: Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. arm 2: Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection. intervention 2: Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.

Protocol documents:
Clinical trial NCT00501540
Conditions: Neuroendocrine Tumors
Keywords: low-grade neuroendocrine tumors lithium
Sponsor: University of Wisconsin, Madison
Start date: 2007-07-01; Completion date: 2009-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.

Detailed description:
Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks.

Arms: arm 1: Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment.
Interventions: intervention 1: Lithium Carbonate
Intervention descriptions: intervention 1: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks.

Protocol documents:
Clinical trial NCT00508001
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma Advanced solid, malignant tumour
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-07-01; Completion date: 2009-06-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, phase II study to assess the efficacy and safety of ZD6474 in patients with Child-Pugh class A, inoperable HCC. This study comprises 2 phases, the primary treatment phase and the secondary treatment phase. The primary treatment phase is a randomised, double-blind, parallel-group phase II study to assess the efficacy and safety of ZD6474 300 mg plus best support care (BSC), ZD6474 100 mg plus BSC, and placebo plus BSC. The secondary treatment phase is an open-label expanded access program of ZD6474. In the primary treatment phase, patients will be randomised in a 1:1:1 ratio to receive ZD6474 300 mg plus BSC, ZD6474 100 mg plus BSC, or placebo plus BSC, respectively. Randomisation will be stratified on the basis of Cancer of the Liver Italian Programme (CLIP) tumour staging (CLIP score 0-2 versus 3-4). The primary treatment will continue until objective disease progression, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or until patients meet any other withdrawal or discontinuation criteria.The primary endpoint is tumour stabilisation rate, and the secondary endpoints are objective response rate, progression-free survival, and overall survival. The purpose of the secondary treatment phase is to expand the access of ZD6474 so that every patient who is enrolled into this study can have the chance to receive the active medicine.Once an individual patient has progressive disease in the primary treatment phase, the blind will be broken for this patient. If this patient is in the ZD6474 100 mg arm or placebo arm, the patient will be offered the secondary treatment with ZD6474 300 mg per day. If this patient is randomised to the ZD6474 300 mg arm, the study medication will be discontinued unless the patient wishes to remain the treatment, and the patient is to be followed up for survival.

Detailed description:

Arms: arm 1: Best Supportive Care + Placebo arm 2: Best Supportive Care + ZD6474 100 mg arm 3: Best Supportive Care + ZD6474 300 mg
Interventions: intervention 1: Vandetanib intervention 2: Vandetanib intervention 3: Best Supportive Care
Intervention descriptions: intervention 1: ZD6474 300mg intervention 2: ZD6474 100 mg intervention 3: Placebo + Best Supportive Care

Protocol documents:
Clinical trial NCT00509106
Conditions: Bacterial Pneumonia
Keywords: ceftaroline Community-acquired pneumonia CAP Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella ssp multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci beta-lactam ceftaroline fosamil ceftriaxone antibiotic
Sponsor: Forest Laboratories
Start date: 2007-07-01; Completion date: 2009-06-01
Enrollment: 622 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Detailed description:
Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Arms: arm 1: Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h). arm 2: Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Interventions: intervention 1: Ceftaroline fosamil for Injection intervention 2: Ceftriaxone intervention 3: Placebo
Intervention descriptions: intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days intervention 3: Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind

Protocol documents:
Clinical trial NCT00509769
Conditions: Metastatic Breast Cancer
Keywords: Trastuzumab emtansine MBC Breast cancer HER2-positive breast cancer HER2
Sponsor: Genentech, Inc.
Start date: 2007-07-01; Completion date: 2009-06-01
Enrollment: 112 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Detailed description:

Arms: arm 1: Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
Interventions: intervention 1: Trastuzumab emtansine [Kadcyla]
Intervention descriptions: intervention 1: Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.

Protocol documents:
Clinical trial NCT00511342
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2009-06-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).

Detailed description:

Arms: arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC arm 2: Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC
Interventions: intervention 1: NOMAC-E2 intervention 2: LNG-EE
Intervention descriptions: intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). intervention 2: Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).

Protocol documents:
Clinical trial NCT00523939
Conditions: Neoplastic Meningitis Lymphoma, B Cell
Keywords: Lymphoma Leukemia Leukemic Meningitis Lymphomatous Meningitis
Sponsor: Duke University
Start date: 2006-06-01; Completion date: 2009-06-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

Detailed description:
DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.

DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures will be done throughout the study.

Arms: arm 1: Subjects with Lymphomatous Meningitis arm 2: Subjects with Leukemic Meningitis
Interventions: intervention 1: cytarabine liposome injection
Intervention descriptions: intervention 1: 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Protocol documents:
Clinical trial NCT00526097
Conditions: Constipation
Sponsor: Boehringer Ingelheim
Start date: 2007-09-01; Completion date: 2009-06-01
Enrollment: 368 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.

Detailed description:

Arms: arm 1: patient to receive two enteric-coated tablets containing 5 mg bisacodyl arm 2: patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl
Interventions: intervention 1: Bisacodyl 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 2 x 5 mg bisacodyl once daily intervention 2: Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily

Protocol documents:
Clinical trial NCT00542425
Conditions: Osteoporosis
Keywords: osteoporosis postmenopausal bone loss
Sponsor: Radius Health, Inc.
Start date: 2007-04-01; Completion date: 2009-06-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Detailed description:
This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: teriparatide intervention 2: Placebo intervention 3: BA058 20 µg intervention 4: BA058 40 µg intervention 5: BA058 80 µg
Intervention descriptions: intervention 1: teriparatide 20 µg subcutaneous daily intervention 2: Placebo subcutaneous daily intervention 3: BA058 20 µg subcutaneous daily intervention 4: BA058 40 µg subcutaneous daily intervention 5: BA058 80 µg subcutaneous daily

Protocol documents: