ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00421889
Conditions: Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Bladder Cancer
Keywords: Ovarian cancer Ovarian Neoplasms Primary peritoneal Epithelial ovarian Fallopian tube Bladder cancer belinostat PXD101 mixed mullerian cancer of ovarian origin
Sponsor: Valerio Therapeutics
Start date: 2005-08-01; Completion date: 2009-02-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in ovarian and bladder cancer patients

The clinical trial is now in the MTD (phase II) portion of the study enrolling bladder cancer patients. Enrollment of ovarian patients is complete.

Detailed description:
MTD Expansion I(Phase II): A total of 18-32 patients with epithelial ovarian, primary peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin, in need of relapse treatment will be enrolled.

MTD Expansion II (phase II): A total of 15 patients with urothelial (transitional cell) carcinoma of the bladder will be enrolled.

Arms: arm 1: Belinostat: 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: Administered IV 2-3 hours after belinostat infusion on day 3 in a 21-day cycle

Carboplatin: Administered IV infusion after paclitaxel on day 3 in a 21-day cycle
Interventions: intervention 1: belinostat intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00433836
Conditions: Hypertension
Keywords: Children pediatrics High Blood Pressure Hypertension Valsartan enalapril
Sponsor: Novartis Pharmaceuticals
Start date: 2007-01-01; Completion date: 2009-02-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Valsartan intervention 2: Enalapril
Intervention descriptions: intervention 1: Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg. intervention 2: Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

Protocol documents:
Clinical trial NCT00435539
Conditions: Vitreomacular Traction
Keywords: Vitreomacular Traction Maculopathy VMT PVD
Sponsor: ThromboGenics
Start date: 2007-02-01; Completion date: 2009-02-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Detailed description:

Arms: arm 1: Ocriplasmin 75µg single injection versus sham injection arm 2: Ocriplasmin 125µg single injection versus sham injection arm 3: Ocriplasmin 175µg single injection versus sham injection arm 4: Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg. arm 5: sham injection
Interventions: intervention 1: ocriplasmin intervention 2: ocriplasmin intervention 3: Sham Comparator
Intervention descriptions: intervention 1: Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin. intervention 2: Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval. intervention 3: Intravitreal sham injection

Protocol documents:
Clinical trial NCT00439244
Conditions: Osteoporosis
Keywords: Bone Mineral Density (BMD) C-Telopeptides (CTx) dual x-ray absorptiometry (DXA) pro-collagen type 1 N-propeptide (P1NP) teriparatide zoledronic acid Osteoporosis postmenopausal women
Sponsor: Novartis
Start date: 2006-12-01; Completion date: 2009-02-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip

Detailed description:

Arms: arm 1: Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks. arm 2: Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. arm 3: Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
Interventions: intervention 1: Zoledronic acid intervention 2: Placebo intervention 3: Teriparatide
Intervention descriptions: intervention 1: Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid. intervention 2: Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle intervention 3: Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL.

Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days.

Protocol documents:
Clinical trial NCT00441103
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Subjects with relapsing remitting multiple sclerosis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2006-12-01; Completion date: 2009-02-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rebif® New Formulation (IFN-beta-1a, RNF) intervention 2: Placebo intervention 3: Rebif® New Formulation (IFN-beta-1a, RNF)
Intervention descriptions: intervention 1: RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks. intervention 2: Matching placebo will be administered subcutaneously three times a week for 16 weeks. intervention 3: RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.

Protocol documents:
Clinical trial NCT00454207
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension, PAH
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-04-01; Completion date: 2009-02-01
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)

Detailed description:

Arms: arm 1: sildenafil citrate 20 mg TID
Interventions: intervention 1: sildenafil citrate (UK-92,480)
Intervention descriptions: intervention 1: sildenafil citrate (UK-92,480)

Protocol documents:
Clinical trial NCT00457795
Conditions: Open-angle Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2006-12-01; Completion date: 2009-02-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: brimonidine 0.1%
Interventions: intervention 1: brimonidine 0.1% (Alphagan® P)
Intervention descriptions: intervention 1: Brimonidine 0.1%, 1 drop three-times daily for 4 weeks

Protocol documents:
Clinical trial NCT00463047
Conditions: Chronic Pain
Keywords: Breakthrough pain Opioid-tolerant Chronic pain
Sponsor: Cephalon
Start date: 2007-07-01; Completion date: 2009-02-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.

Detailed description:

Arms: arm 1: This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order). arm 2: This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).
Interventions: intervention 1: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Intervention descriptions: intervention 1: Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.

Protocol documents:
Clinical trial NCT00473655
Conditions: Hypertriglyceridemia Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemia Type IIb Hyperlipidemia
Keywords: Triglycerides hypertriglyceridemia statins rosuvastatin hyperlipoproteinemia Fredrickson Type IIb or IV
Sponsor: AstraZeneca
Start date: 2007-01-01; Completion date: 2009-02-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.

Detailed description:

Interventions: intervention 1: rosuvastatin
Intervention descriptions: intervention 1: 10mg or 20mg

Protocol documents:
Clinical trial NCT00477633
Conditions: Contraception
Keywords: Contraception
Sponsor: Warner Chilcott
Start date: 2007-06-01; Completion date: 2009-02-01
Enrollment: 1700 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Detailed description:

Arms: arm 1: 1 tablet per day
Interventions: intervention 1: Norethindrone/ethinyl estradiol
Intervention descriptions: intervention 1: 1 tablet per day

Protocol documents:
Clinical trial NCT00490035
Conditions: Epilepsy
Keywords: Epilepsy Brivaracetam Partial Onset Seizures
Sponsor: UCB Pharma SA
Start date: 2007-09-01; Completion date: 2009-02-01
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Detailed description:

Arms: arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 3: Brivaracetam 50 mg/day, 25 mg administered twice a day arm 4: Brivaracetam 100 mg/day, 50 mg administered twice a day
Interventions: intervention 1: Placebo intervention 2: Brivaracetam intervention 3: Brivaracetam intervention 4: Brivaracetam
Intervention descriptions: intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period intervention 3: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period. intervention 4: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.

Protocol documents:
Clinical trial NCT00492726
Conditions: Infection
Keywords: Complicated Intra-Abdominal Infections
Sponsor: Bayer
Start date: 2006-07-01; Completion date: 2009-02-01
Enrollment: 804 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

Detailed description:

Arms: arm 1: Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours. arm 2: Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Interventions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Ertapenem intravenous
Intervention descriptions: intervention 1: Moxifloxacin, 400mg, administered intravenously once daily intervention 2: Active treatment: Ertapenem 1.0g, administered intravenously once daily

Protocol documents:
Clinical trial NCT00501293
Conditions: ADHD
Sponsor: Noven Therapeutics
Start date: 2007-08-01; Completion date: 2009-02-01
Enrollment: 163 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD

Detailed description:
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).

Arms: arm 1: Methylphenidate Transdermal System
Interventions: intervention 1: Methylphenidate Transdermal System
Intervention descriptions: intervention 1: One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months

Protocol documents:
Clinical trial NCT00510276
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2009-02-01
Enrollment: 445 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atomoxetine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: 20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks intervention 2: twice a day, by mouth for 12 weeks

Protocol documents:
Clinical trial NCT00518011
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-08-01; Completion date: 2009-02-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles. arm 2: Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Interventions: intervention 1: Erlotinib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 150 mg po daily intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00525421
Conditions: Oral Lichen Planus
Keywords: curcuminoids oral lichen planus c reactive protein interleukin 6
Sponsor: Nita Chainani Wu
Start date: 2007-10-01; Completion date: 2009-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week follow-up.

The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels.

Detailed description:

Arms: arm 1: Curcumin C3 Complex arm 2: Placebo
Interventions: intervention 1: Curcuminoids intervention 2: Placebo
Intervention descriptions: intervention 1: Curcuminoids tablets 2000mg three times per day for 12 days intervention 2: None

Protocol documents: