ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00637416
Conditions: Dysphonia
Keywords: horseness
Sponsor: University of Kansas Medical Center
Start date: 2008-03-01; Completion date: 2009-07-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.

Detailed description:

Arms: arm 1: Lansoprazole and dietary control arm 2: Dietary control and placebo
Interventions: intervention 1: Lansoprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Lansoprazole 30 mg taken by mouth daily for 3 months intervention 2: placebo taken by mouth daily for 3 months

Protocol documents:
Clinical trial NCT00640822
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2008-02-01; Completion date: 2009-07-01
Enrollment: 782 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

Detailed description:

Arms: arm 1: Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks arm 2: Tacalcitol once daily for up to 8 weeks arm 3: Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks
Interventions: intervention 1: Calcipotriol plus hydrocortisone ointment vehicle intervention 2: Tacalcitol Ointment intervention 3: Calcipotriol plus hydrocortisone ointment
Intervention descriptions: intervention 1: Once daily application for up to 8 weeks intervention 2: Once daily application for up to 8 weeks intervention 3: Once daily application for up to 8 weeks

Protocol documents:
Clinical trial NCT00642850
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 188 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms iv monthly (starting dose)

Protocol documents:
Clinical trial NCT00648895
Conditions: Hypertension
Keywords: Hypertension Blood pressure Nebivolol Bystolic (TM) Metoprolol ER (TM)
Sponsor: Forest Laboratories
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.

Detailed description:

Arms: arm 1: Nebivolol arm 2: Metoprolol ER (TM)
Interventions: intervention 1: Nebivolol intervention 2: Metoprolol ER (TM)
Intervention descriptions: intervention 1: nebivolol 10mg, 20mg, 40mg daily dosage, oral administration intervention 2: Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration

Protocol documents:
Clinical trial NCT00650767
Conditions: Rheumatoid Arthritis
Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer
Start date: 2008-03-01; Completion date: 2009-07-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: ARRY-438162, MEK inhibitor; oral intervention 2: Placebo; oral
Intervention descriptions: intervention 1: multiple dose, single schedule intervention 2: matching placebo

Protocol documents:
Clinical trial NCT00654628
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2007-08-01; Completion date: 2009-07-01
Enrollment: 173 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.

Detailed description:

Arms: arm 1: Patients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks
Interventions: intervention 1: ezetimibe (+) simvastatin
Intervention descriptions: intervention 1: Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.

Protocol documents:
Clinical trial NCT00655928
Conditions: Acute Lung Injury
Keywords: Acute lung injury Lung resection
Sponsor: Imperial College London
Start date: 2007-08-01; Completion date: 2009-07-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.

Detailed description:
Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.

Arms: arm 1: Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively arm 2: Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Interventions: intervention 1: N-acetylcysteine intervention 2: 0.9% saline
Intervention descriptions: intervention 1: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively intervention 2: 0.9% saline 1 litre intravenous over 12 hours pre-operatively

Protocol documents:
Clinical trial NCT00656201
Conditions: Infertility
Keywords: Infertility In vitro fertilization Embryo transfer Crinone Intramuscular Progesterone Progesterone support
Sponsor: Brigham and Women's Hospital
Start date: 2003-07-01; Completion date: 2009-07-01
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).

Detailed description:
The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).

Arms: arm 1: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. arm 2: Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.

.
Interventions: intervention 1: Crinone 8% Vaginal Gel intervention 2: Intramuscular Progesterone
Intervention descriptions: intervention 1: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. intervention 2: Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.

Protocol documents:
Clinical trial NCT00656799
Conditions: Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-04-01; Completion date: 2009-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.

Detailed description:
The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.

Arms: arm 1: IV single bolus dose of 4.0 mg/kg sugammadex
Interventions: intervention 1: sugammadex intervention 2: Rocuronium
Intervention descriptions: intervention 1: At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered. intervention 2: After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered

Protocol documents:
Clinical trial NCT00672490
Conditions: Acute Mania in Bipolar Disorder
Keywords: Acute Mania Bipolar Disorder Quetiapine Fumarate Lithium
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2009-07-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation

Detailed description:

Arms: arm 1: Quetiapine Fumarate - tablets arm 2: Quetiapine Fumarate - tablets and Lithium
Interventions: intervention 1: Quetiapine Fumarate intervention 2: Lithium
Intervention descriptions: intervention 1: Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator.

Tablets intervention 2: Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.

Protocol documents:
Clinical trial NCT00673452
Conditions: Fibromyalgia
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2009-07-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.

Detailed description:

Arms: arm 1: 60-120 mg, oral, every day, 12 weeks arm 2: oral, daily, 12 weeks
Interventions: intervention 1: duloxetine hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase). intervention 2: oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)

Protocol documents:
Clinical trial NCT00677092
Conditions: Nephrogenic Systemic Fibrosis
Keywords: Treatment Chronic kidney disease Fibrosing disorders Imatinib mesylate
Sponsor: Massachusetts General Hospital
Start date: 2007-12-01; Completion date: 2009-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The study will also work to assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and NSF.

Detailed description:
Nephrogenic systemic fibrosis (NSF) is a recently described, extremely debilitating and painful condition that affects individuals with renal failure. Recent reports suggest an association between gadolinium exposure during magnetic resonance (MR) studies and the subsequent development of NSF in patients with chronic renal failure. NSF is characterized by rapidly progressive skin hardening, tethering and hyperpigmentation, predominantly on the extremities. Visceral involvement is rare. Skin biopsies of early NSF lesions demonstrate thickened collagen bundles, mucin deposition, angiogenesis and numerous dermal spindle cells that stain with antibodies to cluster of differentiation 34 (CD34) and procollagen. Cutaneous changes of NSF are present in up to 13% of individuals receiving hemodialysis. Among those patients with clinical evidence of NSF, the principle investigator of this protocol has recently reported that NSF is associated with increased early mortality at 24-months.

There is no proven therapy for this devastating disorder. Anecdotal reports have shown modest improvement in joint mobility and decreased skin thickening with extracorporeal photopheresis and pentoxyphylline.

Increased transforming growth factor (TGF)-beta1 messenger ribonucleic acid (mRNA) on immunostaining has been observed in skin, fascia and striated muscle. Imatinib mesylate, a tyrosine kinase inhibitor, prevents TGF-beta-induced stimulation of collagen and extracellular matrix protein synthesis as well as mRNA expression by normal fibroblasts. This observation led the principal investigator to evaluate imatinib mesylate 400 milligrams (mg) orally (p.o.) daily for 1 year in two participants with NSF. The result was significant softening of previously hardened skin with increased mobility of skin that previously had been tethered to the underlying fascia. After one month of imatinib mesylate, one of the two participants had a 20 degree reduction of his knee flexion contractures.

Arms: arm 1: Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
Interventions: intervention 1: Imatinib mesylate
Intervention descriptions: intervention 1: 400 mg p.o. daily for 4 months. Dosage was reduced to 200 mg if participants develop gastrointestinal intolerance or alopecia.

Protocol documents:
Clinical trial NCT00683618
Conditions: Hypercholesterolemia
Keywords: HMG-CoA LDL-C CHD
Sponsor: AstraZeneca
Start date: 2008-05-01; Completion date: 2009-07-01
Enrollment: 934 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.

Detailed description:

Arms: arm 1: Rosuvastatin 5mg qd arm 2: Rosuvastatin 10mg qd arm 3: Atorvastatin 10mg qd
Interventions: intervention 1: Rosuvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: Capsule/Tablet, oral, qd, 6 or 12 weeks intervention 2: Capsule/Tablet, 10mg, oral, qd, 6 weeks

Protocol documents:
Clinical trial NCT00687908
Conditions: Acne
Keywords: Acne
Sponsor: Galderma R&D
Start date: 2008-11-01; Completion date: 2009-07-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Detailed description:
This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Arms: arm 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily arm 2: Vehicle Gel once daily
Interventions: intervention 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel intervention 2: Vehicle Gel
Intervention descriptions: intervention 1: Topical Gel to the face, once daily in the evening for 24 weeks. intervention 2: Topical Gel to the face, once daily in the evening for 24 weeks.

Protocol documents:
Clinical trial NCT00695864
Conditions: Substance Withdrawal Syndrome
Sponsor: Stanford University
Start date: 2008-05-01; Completion date: 2009-07-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.

Detailed description:

Arms: arm 1: Placebo - sugar pill arm 2: Ondansetron
Interventions: intervention 1: Ondansetron and Placebo crossover
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00696137
Conditions: Respiratory Depression
Keywords: Chronic Pain Ventilatory Response to Hypercapnia (VRH)
Sponsor: BioDelivery Sciences International
Start date: 2008-06-01; Completion date: 2009-07-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.

Detailed description:
This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

Arms: arm 1: BEMA Fentanyl
Interventions: intervention 1: BEMA Fentanyl
Intervention descriptions: intervention 1: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Protocol documents:
Clinical trial NCT00696774
Conditions: Depressive Disorder, Major
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2009-07-01
Enrollment: 242 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.

Detailed description:

Arms: arm 1: Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.

Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.

Protocol documents:
Clinical trial NCT00702650
Conditions: Hypogonadism
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2009-07-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

Detailed description:

Arms: arm 1: Participants received Testosterone Metered Dose (MD)-Lotion for 120 days. Participants started by receiving 3.0 mL (60 mg) of 2% Testosterone MD-Lotion, and based upon restoration to eugonadal levels, may have had their dose of testosterone adjusted upwards or downwards on Days 45 and 90.

Doses could be titrated to one of the following:

1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 1 dose to the axilla (1.5 mL to one axilla).

3.0 mL (60 mg) of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to each axilla).

4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied daily by 3 doses to the axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).

6.0 mL (120 mg) of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla).
Interventions: intervention 1: Testosterone MD-Lotion
Intervention descriptions: intervention 1: 30 mg to 120 mg administered topically once daily for 120 days

Protocol documents: