ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00257166
Conditions: Bipolar Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-01-01; Completion date: 2007-07-01
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ziprasidone oral capsules intervention 2: placebo oral capsules
Intervention descriptions: intervention 1: Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. intervention 2: Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Protocol documents:
Clinical trial NCT00289874
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-03-01; Completion date: 2007-07-01
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Detailed description:

Arms: arm 1: montelukast arm 2: placebo
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment. intervention 2: Placebo. Up to 3 weeks of treatment

Protocol documents:
Clinical trial NCT00063362
Conditions: Bipolar Disorder
Keywords: Depression
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2002-02-01; Completion date: 2007-07-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

Detailed description:
Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lithium intervention 2: Lamotrigine intervention 3: Divalproex intervention 4: Placebo
Intervention descriptions: intervention 1: Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent /L (mEq/L). intervention 2: Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (\< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day. intervention 3: Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL. intervention 4: Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (\< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.

Protocol documents:
Clinical trial NCT00087490
Conditions: Skin/Soft Tissue Infections Methicillin Resistant Staphylococcus Aureus (MRSA)
Sponsor: Pfizer
Start date: 2004-10-01; Completion date: 2007-07-01
Enrollment: 1077 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects

Detailed description:

Interventions: intervention 1: linezolid intervention 2: vancomycin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00094094
Conditions: Lung Neoplasms Carcinoma, Non-small Cell Lung
Sponsor: Pfizer
Start date: 2005-02-01; Completion date: 2007-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage

Detailed description:

Arms: arm 1: AG-013736 is a vascular endothelial growth factor \[VEGF\] inhibitor
Interventions: intervention 1: axitinib
Intervention descriptions: intervention 1: Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.

Protocol documents:
Clinical trial NCT00107952
Conditions: Bacterial Pneumonia
Keywords: Nosocomial pneumonia MRSA
Sponsor: Cumberland Pharmaceuticals
Start date: 2005-02-01; Completion date: 2007-07-01
Enrollment: 761 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Telavancin intervention 2: Vancomycin
Intervention descriptions: intervention 1: Telavancin 10 mg/kg/day IV for up to 21 days. intervention 2: Vancomycin 1 Gm IV q 12 hrs for up to 21 days

Protocol documents:
Clinical trial NCT00165698
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal osteoporosis
Sponsor: Eisai Co., Ltd.
Start date: 2005-05-01; Completion date: 2007-07-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: menatetranone intervention 2: alfacalcidol
Intervention descriptions: intervention 1: 15 mg three times a day orally for 12 months intervention 2: 0.25 μg twice a day orally for 12 months

Protocol documents:
Clinical trial NCT00185900
Conditions: Obstetric Labor, Premature
Sponsor: Stanford University
Start date: 1999-04-01; Completion date: 2007-07-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Detailed description:

Arms: arm 1: Preterm labor treatment with Magnesium Sulfate. arm 2: Preterm labor treatment with Nifedipine.
Interventions: intervention 1: Magnesium Sulfate intervention 2: Nifedipine
Intervention descriptions: intervention 1: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. intervention 2: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Protocol documents:
Clinical trial NCT00189475
Conditions: Upper Respiratory Infection
Keywords: Cold Upper Respiratory Infection
Sponsor: Deborah Gentile
Start date: 2003-10-01; Completion date: 2007-07-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.

Detailed description:
This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during each day of the study. Phlebotomy is performed once for the determination of cytokine genotyping and allergy skin testing is performed once for the assessment of atopy.

Arms: arm 1: Treated for 4 months with montelukast 4 mg per day arm 2: Treated for 4 months with placebo
Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00207740
Conditions: Asthma
Keywords: Asthma Severe Persistent Asthma Subcutaneous injections Immunology disorder Breathlesness
Sponsor: Centocor, Inc.
Start date: 2004-08-01; Completion date: 2007-07-01
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.

Detailed description:
This is a multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical study), parallel-group (each group of patients will be treated at the same time), dose-ranging study to evaluate the efficacy and safety of CNTO 148. The study will consists of run-in phase (2 weeks), treatment period (52 weeks) and follow up period (24 weeks). The patients inhaled corticosteroids (ICS) medication will be standardized in the run-in phase and the treatment period contains first 24 weeks of treatment, the patients are required to remain on stable doses of concomitant corticosteroids (CS) medication (steroid stable phase). The steroid stable phase is followed by a 28-week steroid taper phase, during which a reduction of concomitant CS medication will be attempted. After completion of the study treatment, patients are to be followed for an additional 24 weeks. Patients will receive subcutaneous injections of 75, 150, or 300 mg of CNTO 148 or placebo every 4 weeks for 52 weeks followed 50,100, or 200 mg every 4 weeks through week 52. The safety of the patient will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CNTO148 intervention 2: Placebo
Intervention descriptions: intervention 1: Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms intervention 2: Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.

Protocol documents:
Clinical trial NCT00286455
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes; Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2006-02-01; Completion date: 2007-07-01
Enrollment: 329 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), in adults with type 2 diabetes.

Detailed description:
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

The aim of the current study is to evaluate the efficacy of alogliptin in subjects with type 2 diabetes mellitus who are inadequately controlled and who have failed treatment with diet and exercise. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Placebo
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.

Protocol documents:
Clinical trial NCT00424398
Conditions: Conjunctivitis, Allergic
Sponsor: Bausch & Lomb Incorporated
Start date: 2007-02-01; Completion date: 2007-07-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis

Detailed description:

Arms: arm 1: Bepotastine Besilate Ophthalmic Solution 1.5% arm 2: sterile ophthalmic solution arm 3: sterile ophthalmic solution 1.0%
Interventions: intervention 1: Bepreve intervention 2: Placebo intervention 3: Bepotastine Besilate
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution intervention 3: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT00468312
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2007-03-01; Completion date: 2007-07-01
Enrollment: 429 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.

Detailed description:

Arms: arm 1: 200 mcg daily arm 2: Two sprays in each nostril in the morning
Interventions: intervention 1: Mometasone furoate nasal spray intervention 2: Placebo
Intervention descriptions: intervention 1: Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning intervention 2: Two sprays in each nostril in the morning

Protocol documents:
Clinical trial NCT00491504
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2007-02-01; Completion date: 2007-07-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.

Detailed description:

Arms: arm 1: MFNS 200 mcg total dose (2 sprays each nostril) arm 2: Placebo (2 sprays each nostril)
Interventions: intervention 1: Mometasone Furoate Nasal Spray intervention 2: Placebo
Intervention descriptions: intervention 1: Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg) intervention 2: Placebo: 2 sprays in each nostril

Protocol documents:
Clinical trial NCT00543296
Conditions: Uveitis
Keywords: uveitis Cystoid Macular Edema (CME) fluocinolone acetonide non-infectious uveitis affecting the posterior segment
Sponsor: Duke University
Start date: 2004-03-01; Completion date: 2007-07-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Detailed description:
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.

Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis

Arms: arm 1: 0.59 mg Fluocinolone Acetonide implant
Interventions: intervention 1: 0.59 mg Fluocinolone Acetonide implant
Intervention descriptions: intervention 1: 0.59 mg Fluocinolone Acetonide implant

Protocol documents:
Clinical trial NCT00652327
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2005-12-01; Completion date: 2007-07-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) intervention 2: Double Statin (simvastatin, atorvastatin, or pravastatin)
Intervention descriptions: intervention 1: ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks intervention 2: simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks

Protocol documents:
Clinical trial NCT00713817
Conditions: Pain Peripheral Neuropathy
Keywords: Pain Peripheral Neuropathy
Sponsor: Jazz Pharmaceuticals
Start date: 2007-03-01; Completion date: 2007-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

Detailed description:
A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. Subjects returned to the centre for an end of treatment visit at week 38 of Part A (Visit 5, Day 266), followed by Visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after Visit 5c or withdrawal from the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sativex® intervention 2: Placebo
Intervention descriptions: intervention 1: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient

Protocol documents:
Clinical trial NCT01100320
Conditions: Healthy Volunteers
Keywords: Healthy subjects Opioid
Sponsor: Purdue Pharma LP
Start date: 2007-01-01; Completion date: 2007-07-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms: arm 1: Reformulated OXY 40 mg x 1 dose arm 2: Original OxyContin® (OXY) 40 mg x 1 dose
Interventions: intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 40-mg tablet x 1 dose taken with food intervention 2: Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food

Protocol documents:
Clinical trial NCT01101165
Conditions: Healthy
Keywords: Healthy subjects Opioid Healthy volunteers
Sponsor: Purdue Pharma LP
Start date: 2007-02-01; Completion date: 2007-07-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms: arm 1: Reformulated OXY 40 mg x 1 dose arm 2: Original OxyContin® (OXY) 40 mg x 1 dose
Interventions: intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 40-mg tablet x 1 dose taken without food intervention 2: Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food

Protocol documents: