ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01742078
Conditions: Healthy
Keywords: Postmenopausal females Volunteers
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2010-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.

Detailed description:

Arms: arm 1: Single dose of 7.5 mg LY2541546 administered intravenously (IV) arm 2: Single dose of 25 mg LY2541546 administered IV arm 3: Single dose of 75 mg LY2541546 administered IV arm 4: Single dose of 225 mg LY2541546 administered IV arm 5: Single dose of 750 mg LY2541546 administered IV arm 6: Single dose of 150 mg LY2541546 administered subcutaneous (SC) arm 7: Single dose of placebo administered IV or SC arm 8: Single dose of 225 mg LY2541546 administered IV, open label (OL) arm 9: Single dose of 750 mg LY2541546 administered IV, OL
Interventions: intervention 1: LY2541546 - IV intervention 2: LY2541546 - SC intervention 3: Placebo
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered SC intervention 3: Administered IV or SC

Protocol documents:
Clinical trial NCT01820559
Conditions: Migraine
Keywords: migraine; ESL; eslicarbazepine acetate
Sponsor: Bial - Portela C S.A.
Start date: 2009-04-01; Completion date: 2010-06-01
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.

Detailed description:
The study consisted of a Screening Period of 2 to 4 weeks, a 4-week placebo Baseline Period, a 2-week Titration Period, a 12-week Maintenance Period, and a 4-week Follow-up Period. During the entire study the subjects had a diary to document the occurrence, duration, and intensity of headaches, the occurrence or not of aura and its nature, as well as other related symptoms, and the use of study medication and acute medication.

Arms: arm 1: eslicarbazepine acetate 1200 mg arm 2: eslicarbazepine acetate 800 mg arm 3: Placebo tablets
Interventions: intervention 1: Placebo intervention 2: ESL 1200 mg intervention 3: ESL 800 mg
Intervention descriptions: intervention 1: Tablets intervention 2: Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route. intervention 3: Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.

Protocol documents:
Clinical trial NCT00850642
Conditions: Asthma
Keywords: Sputum cell counts Neutrophils Severe Asthma ICS Inhaled corticosteroids
Sponsor: GlaxoSmithKline
Start date: 2009-06-26; Completion date: 2010-06-02
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid therapy in patients with moderate to severe asthma with elevated sputum neutrophils.

Detailed description:

Arms: arm 1: 12 day repeat dosing with placebo arm 2: 12 day repeat dosing treatment phase with 100mg GSK2190915.
Interventions: intervention 1: GSK2190195 100mg intervention 2: Placebo
Intervention descriptions: intervention 1: GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor. intervention 2: Placebo :

2% (w/w) Ethanol, sucralose (5 mg/100 mL of oral solution) to 100 % (w/w) aqueous sodium carbonate buffer (0.010 M, pH 9-10)

Protocol documents:
Clinical trial NCT00878072
Conditions: Herpes Labialis
Keywords: Herpes labialis cold sores herpes simplex type 1
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-25; Completion date: 2010-06-02
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose

Detailed description:
Uncontrolled study

Arms: arm 1: None
Interventions: intervention 1: Famciclovir
Intervention descriptions: intervention 1: Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.

Protocol documents:
Clinical trial NCT00408603
Conditions: Epithelial Ovarian Cancer
Keywords: second line treatment platinum resistant ovary ovaries cancer epithelial carcinomas tumor
Sponsor: Sunesis Pharmaceuticals
Start date: 2006-12-20; Completion date: 2010-06-09
Enrollment: 183 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.

Detailed description:
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Arms: arm 1: All patients will receive voreloxin injection
Interventions: intervention 1: Voreloxin Injection
Intervention descriptions: intervention 1: All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.

Protocol documents:
Clinical trial NCT00079183
Conditions: Graft Versus Host Disease
Sponsor: Fred Hutchinson Cancer Center
Start date: 2002-04-01; Completion date: 2010-06-10
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/mL in patients with chronic GVHD.

II. To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment.

OUTLINE:

Patients receive sirolimus orally (PO) once daily (QD). Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
Interventions: intervention 1: sirolimus
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00665223
Conditions: Huntington's Disease
Keywords: Huntington's Disease
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2008-04-24; Completion date: 2010-06-14
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.

Detailed description:
The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease based on the Unified Huntington"s Disease Rating Scale (UHDRS) subscale. These symptoms seem to be most important for the functional disability associated with the disorder. To achieve this, participants are randomized to ACR16 45 mg once daily, ACR16 45 mg twice daily, or placebo treatment in equal proportions in a parallel design for a treatment duration of 26 weeks.

Arms: arm 1: Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses. arm 2: Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses. arm 3: Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg)
Interventions: intervention 1: ACR16 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules will be swallowed whole with water. intervention 2: Capsules will be swallowed whole with water.

Protocol documents:
Clinical trial NCT00563524
Conditions: Psoriasis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-12-20; Completion date: 2010-06-14
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ILV-094
Intervention descriptions: intervention 1: SC and IV administration on days 1, 14, 28, and 42

Protocol documents:
Clinical trial NCT00852202
Conditions: Bipolar Depression
Keywords: bipolar depression
Sponsor: Forest Laboratories
Start date: 2009-06-30; Completion date: 2010-06-15
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Detailed description:

Arms: arm 1: 0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. arm 2: 1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing. arm 3: Matching placebo capsules, oral administration, once daily dosing.
Interventions: intervention 1: cariprazine intervention 2: cariprazine intervention 3: placebo
Intervention descriptions: intervention 1: Drug: cariprazine (0.25 - 0.75 mg/day) intervention 2: Drug: cariprazine (1.5 - 3.0 mg/day) intervention 3: placebo capsules, oral administration, once daily dosing

Protocol documents:
Clinical trial NCT00243386
Conditions: Hemophilia A
Sponsor: Baxalta now part of Shire
Start date: 2006-01-04; Completion date: 2010-06-16
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient's pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks.

Detailed description:

Arms: arm 1: Standard prophylaxis arm 2: PK-driven prophylaxis
Interventions: intervention 1: Antihemophilic factor, recombinant, manufactured protein-free intervention 2: Antihemophilic factor, recombinant, manufactured protein-free
Intervention descriptions: intervention 1: Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator intervention 2: PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data

Protocol documents:
Clinical trial NCT00733980
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major
Sponsor: GlaxoSmithKline
Start date: 2008-10-02; Completion date: 2010-06-18
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder

Detailed description:
This is a double-blind placebo controlled study to assess the CRF1 receptor antagonist, GSK561679, for treatment of depression in adult females diagnosed with Major Depressive Disorder (MDD). A treatment regimen of 350mg/day will be utilized to assess both efficacy and tolerability. Subjects will be randomized in equal numbers (n=75/arm) to the treatment arm and the placebo arm for a 6-week treatment period.

Efficacy will be assessed by determining the change from baseline in symptoms of MDD and anxiety utilizing the Bech Melancholia scale (Bech), Hamilton Rating Scale for Depression (HamD17), Inventory of Depressive Symptomatology-Self-Report (IDS-SR), Clinical Global Impression - Severity of Illness (CGI-S), Clinical Global Impression - Global Improvement (CGI-I), Medical Outcomes Study 12-item Sleep Module (MOS 12), Cohen Perceived Stress Test (PSS), Hamilton Anxiety Scale (HamA), and Dexamethasone Suppression Test (DST). Safety and tolerability will be assessed by determining the incidence of adverse events (AEs), vital signs, BMI, weight, clinical laboratory parameters, including ECGs, during the treatment and pre \& post-treatment phases, and Discontinuation Emergent Signs and Symptoms (DESS). In addition, the incidence of suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).

Arms: arm 1: Double blind GSK561679 arm 2: Double blind placebo
Interventions: intervention 1: GSK561679 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK561679 intervention 2: Placebo

Protocol documents:
Clinical trial NCT00819507
Conditions: Atopic Dermatitis
Keywords: Skin barrier Atopic Dermatitis Corticosteroid Effects on skin severity and barrier function
Sponsor: Oregon Health and Science University
Start date: 2009-01-01; Completion date: 2010-06-21
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effect of short-term therapy using "VANOS Cream," a super-potent topical steroid cream on skin barrier function in patients with atopic dermatitis. This cream is already approved for this indication, but the investigators will further examine its effects on the skin barrier. This cream is a novel formulation of fluocinonide designed to enhance compliance with a cream base, but have the skin barrier repair properties of an ointment.

Detailed description:

Arms: arm 1: glucocorticoid cream
Interventions: intervention 1: Fluocinonide
Intervention descriptions: intervention 1: Fluocinonide 0.1% cream topical daily for two weeks

Protocol documents:
Clinical trial NCT01010906
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-07-01; Completion date: 2010-06-21
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.

Detailed description:

Arms: arm 1: Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir arm 2: Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir arm 3: Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir arm 4: Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir arm 5: Participants with severe HI administered a single 200 mg oral tablet of vaniprevir arm 6: Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir
Interventions: intervention 1: Vaniprevir 300 mg intervention 2: Vaniprevir 200 mg
Intervention descriptions: intervention 1: single dose administration of 300 mg oral tablet intervention 2: single dose administration of 200 mg oral tablet

Protocol documents:
Clinical trial NCT00661505
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-05-14; Completion date: 2010-06-22
Enrollment: 132 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 hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms iv every 4 weeks (starting dose)

Protocol documents:
Clinical trial NCT00428844
Conditions: Osteomyelitis
Keywords: Osteomyelitis Prosthetic Hip Prosthetic Knee MRSA Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint Staphylococci
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2007-06-26; Completion date: 2010-06-23
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.

Detailed description:

Arms: arm 1: Daptomycin (6 mg/kg every 24 hours \[q24h\]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week). arm 2: Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week). arm 3: Vancomycin was administered at 1 gram every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
Interventions: intervention 1: daptomycin intervention 2: daptomycin intervention 3: vancomycin intervention 4: teicoplanin intervention 5: nafcillin intervention 6: oxacillin intervention 7: flucloxacillin
Intervention descriptions: intervention 1: 6 mg/kg intervention 2: 8 mg/kg intervention 3: 1 gram intervention 4: 6 mg/kg; used only at UK sites intervention 5: 1-2 gram intervention 6: 1-2 gram intervention 7: 1-2 mg

Protocol documents:
Clinical trial NCT00606502
Conditions: Non-small Cell Lung Cancer
Keywords: Stage IIIB/IV non-small cell lung cancer Non-small cell lung cancer NSCLC Lung Cancer Pralatrexate Erlotinib Tarceva PDX Smoking Smoker
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2008-01-01; Completion date: 2010-06-24
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)

Detailed description:

Arms: arm 1: Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). arm 2: 150 mg orally in tablet form

Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.
Interventions: intervention 1: Pralatrexate intervention 2: Erlotinib intervention 3: Vitamin B12 intervention 4: Folic Acid
Intervention descriptions: intervention 1: Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.

Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met. intervention 2: 150 mg orally in tablet form

Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met. intervention 3: 1 mg intramuscular injection

Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment. intervention 4: 1-1.25 mg orally

Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.

Protocol documents: