ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00365352
Conditions: Restless Legs Syndrome
Sponsor: XenoPort, Inc.
Start date: 2006-08-01; Completion date: 2007-12-01
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description:
This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo. The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.

Arms: arm 1: XP13512 600MG ONCE DAILY arm 2: XP13512 1200MG ONCE DAILY arm 3: PLACEBO ONCE DAILY
Interventions: intervention 1: XP13512 600MG intervention 2: XP13512 1200MG intervention 3: PLACEBO
Intervention descriptions: intervention 1: XP13512 600MG ONCE DAILY intervention 2: XP13512 1200MG ONCE DAILY intervention 3: PLACEBO ONCE DAILY

Protocol documents:
Clinical trial NCT00370032
Conditions: Irritable Colon
Keywords: mucosal blood flow d-IBS
Sponsor: GlaxoSmithKline
Start date: 2006-12-01; Completion date: 2007-12-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS) patients.

Detailed description:

Interventions: intervention 1: alosetron
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00371566
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: squamous cell carcinoma of head and neck lapatinib ErbB1/ErbB2 inhibitor apoptosis
Sponsor: GlaxoSmithKline
Start date: 2006-03-01; Completion date: 2007-12-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and neck.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lapatinib oral tablets intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00373386
Conditions: Growth Hormone Deficiency Panhypopituitarism Short Stature
Keywords: growth hormone endothelial function
Sponsor: Ohio State University
Start date: 2005-01-01; Completion date: 2007-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objective: This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries. This may play a role in increasing or decreasing the risk of heart disease.

Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be studied before and 3 months after starting growth hormone. Subjects can be on other hormonal replacements but no other medications.

Each study will be done in the fasting state. The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes. Blood will be drawn after the test to measure glucose, insulin and fats.

Detailed description:
The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) is affected by growth hormone treatment in children and adolescents. Poor function by the blood vessels is associated with increased risk of heart disease or stroke. This research is being done because growth hormone treatment has been shown to make the endothelium work better in adults. Growth hormone treatment may have the same or different effects in children because the dose is larger in children.

Children between 8 and 18 years who are to be started on growth hormone will be eligible to participate. Blood vessel function will be studied before starting growth hormone and 3 months after. This will be done by measuring blood flow to the arm before and after 5 min of stopping blood flow to the arm. The three months of growth hormone will be given free.

Arms: arm 1: Growth hormone treatment 0.3 mg/kg/min
Interventions: intervention 1: growth hormone
Intervention descriptions: intervention 1: Growth Hormone treatment

Protocol documents:
Clinical trial NCT00388973
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2007-12-01
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed description:

Interventions: intervention 1: Quetiapine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00396656
Conditions: Hypertension
Keywords: hypertension valsartan atenolol hydrochlorothiazide microcirculation arterial compliance pulse wave analysis
Sponsor: Novartis
Start date: 2005-12-01; Completion date: 2007-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.

Detailed description:

Arms: arm 1: After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.

After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning. arm 2: After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.

After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.
Interventions: intervention 1: Atenolol intervention 2: Hydrochlorothiazide (HCTZ)) intervention 3: Valsartan
Intervention descriptions: intervention 1: 100 mg tablets orally once a day (od) in the morning. intervention 2: 12.5 or 25 mg tablets orally once a day (od) in the morning. intervention 3: 80 mg, 160 mg, or 320 mg tablets orally once a day in the morning

Protocol documents:
Clinical trial NCT00403481
Conditions: Hypertension
Keywords: Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension Type II Diabetes
Sponsor: Daiichi Sankyo
Start date: 2006-11-01; Completion date: 2007-12-01
Enrollment: 192 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Detailed description:

Arms: arm 1: Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide.
Interventions: intervention 1: olmesartan medoxomil intervention 2: Olmesartan medoxomil plus Hydrochlorothiazide
Intervention descriptions: intervention 1: Olmesartan medoxomil tablets, once daily intervention 2: Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary

Protocol documents:
Clinical trial NCT00410150
Conditions: Status Asthmaticus
Keywords: Status asthmaticus Asthma Helium Children
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2006-04-01; Completion date: 2007-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.

Detailed description:
We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation \>90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique:

Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.

Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Arms: arm 1: Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. arm 2: Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.
Interventions: intervention 1: Helium-oxygen-driven albuterol nebulizer intervention 2: Oxygen
Intervention descriptions: intervention 1: Subjects will be treated with continuous albuterol nebs with Heliox intervention 2: Subjects will be treated with continuous albuterol nebs in oxygen

Protocol documents:
Clinical trial NCT00421993
Conditions: Acne Vulgaris
Keywords: Acne vulgaris Adapalene Benzoyl Peroxide
Sponsor: Galderma R&D
Start date: 2006-10-01; Completion date: 2007-12-01
Enrollment: 1670 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Detailed description:

Arms: arm 1: Adapalene/Benzoyl Peroxide Topical Gel arm 2: Adapalene Topical Gel arm 3: Benzoyl Peroxide Topical Gel arm 4: Topical Gel Vehicle
Interventions: intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene intervention 3: Benzoyl Peroxide intervention 4: Topical Gel Vehicle
Intervention descriptions: intervention 1: Topical Gel, One application daily in the evening for 12 weeks intervention 2: Topical Gel,One application daily in the evening for 12 weeks intervention 3: Topical Gel, one application daily in the evening for 12 weeks intervention 4: Topical Gel Vehicle,one application daily in the evening for 12 weeks

Protocol documents:
Clinical trial NCT00426751
Conditions: Infarction, Myocardial
Keywords: Eptifibatide ST-elevation Myocardial Infarction STEMI Abciximab
Sponsor: GlaxoSmithKline
Start date: 2006-10-01; Completion date: 2007-12-01
Enrollment: 429 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion

Detailed description:

Arms: arm 1: Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI. arm 2: Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.
Interventions: intervention 1: Abciximab intervention 2: Eptifibatide
Intervention descriptions: intervention 1: Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI. intervention 2: Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.

Protocol documents:
Clinical trial NCT00428792
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD methylphenidate children food effect Attention-Deficit Hyperactivity Disorder (ADHD) in children
Sponsor: Novartis
Start date: 2007-04-01; Completion date: 2007-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).

Detailed description:

Arms: arm 1: Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. arm 2: Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Interventions: intervention 1: Methylphenidate 20 mg long-acting capsules
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00432237
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-03-01; Completion date: 2007-12-01
Enrollment: 1703 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

Detailed description:

Arms: arm 1: MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack arm 2: MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack arm 3: MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack arm 4: Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Interventions: intervention 1: MK0974 50 mg intervention 2: MK0974 150 mg intervention 3: MK0974 300 mg intervention 4: Comparator: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Protocol documents:
Clinical trial NCT00434122
Conditions: Infertility, Female
Keywords: Assisted Reproductive Technology (ART) oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies
Sponsor: Ferring Pharmaceuticals
Start date: 2007-03-01; Completion date: 2007-12-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

Detailed description:
For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase.

After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.

Arms: arm 1: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. arm 2: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.

or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
Interventions: intervention 1: Degarelix mid-luteal, 2.5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. intervention 2: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.

or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.

Protocol documents:
Clinical trial NCT00439179
Conditions: Metastatic Pancreatic Cancer
Keywords: Pancreatic Cancer
Sponsor: Brown University
Start date: 2006-07-01; Completion date: 2007-12-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

Detailed description:
The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study.

Trial finished and no further data will be collected.

Arms: arm 1: Weekly gem + GW572016, 1000mg/day (combination) arm 2: Weekly gem + GW572016, 1500 mg/day (combination) arm 3: GEMOX + GW572016 1000 mg/day (combination) arm 4: GEMOX + GW572016 1500 mg/day (combination)
Interventions: intervention 1: cohort 1 intervention 2: cohort 2 intervention 3: cohort 3 intervention 4: cohort 4
Intervention descriptions: intervention 1: Weekly gem + GW572016, 1000mg/day (combination) intervention 2: Weekly gem + GW572016, 1500 mg/day (combination) intervention 3: GEMOX + GW572016 1000 mg/day (combination) intervention 4: GEMOX + GW572016 1500 mg/day (combination)

Protocol documents: