ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01135017
Conditions: Atrial Fibrillation
Sponsor: Sanofi
Start date: 2010-07-01; Completion date: 2012-02-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.

Secondary objectives were to evaluate:

* the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF;
* the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS);
* the incidence of electrical cardioversion (or overdrive pacing) during treatment;
* the safety of dronedarone.

Detailed description:
The maximum duration of the study period for a participant was 18 weeks (approximatively 4.5 months) including up to 4 weeks screening, 12-week Treatment period and a post-treatment follow-up of 2 weeks.

Arms: arm 1: Dronedarone 400 mg twice a day for 12 weeks arm 2: Placebo (for Dronedarone) twice a day for 12 weeks
Interventions: intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner) intervention 2: Film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Protocol documents:
Clinical trial NCT01145625
Conditions: Alopecia
Keywords: Female Pattern Baldness
Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Start date: 2010-06-01; Completion date: 2012-02-01
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).

This trial will determine if the benefit of using either study product outweighs the risks.

Detailed description:
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.

This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), using objective efficacy measures and safety assessments.

Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 270 to complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF or 2% MTS, for 52 weeks for efficacy and safety evaluations.

Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.

During the trial following enrollment at Baseline, participants will return to the study site at regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.

Arms: arm 1: 5% Minoxidil Topical Foam arm 2: 2% Minoxidil Topical Solution
Interventions: intervention 1: 5% Minoxidil intervention 2: 2% Minoxidil
Intervention descriptions: intervention 1: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks intervention 2: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks

Protocol documents:
Clinical trial NCT01151904
Conditions: Glaucoma, Angle-Closure
Sponsor: Allergan
Start date: 2009-11-01; Completion date: 2012-02-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.

Detailed description:

Arms: arm 1: Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Interventions: intervention 1: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution intervention 2: latanoprost
Intervention descriptions: intervention 1: COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks. intervention 2: Latanoprost administered in the affected eye(s) as prescribed by physician.

Protocol documents:
Clinical trial NCT01155154
Conditions: Simple Hand Lacerations
Keywords: wounds and lacerations hand infection Antibiotics antibacterial agents
Sponsor: State University of New York - Downstate Medical Center
Start date: 2010-02-01; Completion date: 2012-02-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?

Detailed description:
Simple hand lacerations, defined as hand lacerations that do not involve special structures such as bones, tendons, vessels, or nerves, are common in the emergency departments. The exact rate of infection in such wounds is unclear. It is also not clear whether prescribing prophylactic antibiotics reduces the risk of infection in simple hand lacerations. The objective of this randomized double blind controlled study is to: 1. Identify the rate of infection in simple hand lacerations, 2. Identify factors or wound characteristics that increase the risk of infection, and 3. Assess whether prescribing prophylactic antibiotics decreases the risk of infections in such wounds compared to placebo.

Arms: arm 1: clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days arm 2: None arm 3: None
Interventions: intervention 1: cephalexin intervention 2: clindamycin intervention 3: placebo
Intervention descriptions: intervention 1: 500 mg (two 250 mg capsules) every 6 hours for 7 days intervention 2: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days intervention 3: Two placebo capsules every 6 hours for 7 days

Protocol documents:
Clinical trial NCT01156051
Conditions: Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder Insomnia Sleep Disorders
Keywords: ADHD ADD sleep disturbance
Sponsor: Children's Specialized Hospital
Start date: 2010-06-01; Completion date: 2012-02-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.

Detailed description:

Arms: arm 1: Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg arm 2: Placebo control
Interventions: intervention 1: Guanfacine extended-release tablets intervention 2: Placebo comparator
Intervention descriptions: intervention 1: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated intervention 2: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).

Protocol documents:
Clinical trial NCT01159600
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2012-02-01
Enrollment: 1504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: BI 10773 once daily high dose arm 2: Placebo matching BI 10773 arm 3: BI 10773 once daily high dose open label arm 4: BI 10773 once daily low dose
Interventions: intervention 1: Placebo identical to BI 10773 high dose intervention 2: Placebo identical to BI 10773 low dose intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: Placebo identical to BI 10773 low dose intervention 6: BI 10773 intervention 7: Placebo identical to BI 10773 high dose
Intervention descriptions: intervention 1: Placebo tablets matching BI 10773 high dose intervention 2: Placebo tablets matching BI 10773 low dose intervention 3: BI 10773 tablets once daily high dose open label intervention 4: BI 10773 tablets once daily high dose intervention 5: Placebo tablets matching BI 10773 low dose intervention 6: BI 10773 tablets once daily low dose intervention 7: Placebo tablets matching BI 10773 high dose

Protocol documents:
Clinical trial NCT01160770
Conditions: Lennox-Gastaut Syndrome
Keywords: Lennox-Gastaut Syndrome (LGS) Epilepsy Drop Seizures Clobazam
Sponsor: Lundbeck LLC
Start date: 2005-12-01; Completion date: 2012-02-01
Enrollment: 267 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.

Detailed description:
This multi-center, open-label study is designed to evaluate the long-term safety and effectiveness of clobazam as adjunctive therapy in subjects with LGS. Subjects enrolled in Lundbeck LLC (formerly Ovation Pharmaceuticals, Inc.) sponsored studies 13108A/OV1002/NCT00162981 and 13110A/OV1012/NCT00518713 who either completed the study or who prematurely discontinued were offered the opportunity to rollover into this open-label study. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After 48 hours, investigators will be able to increase, decrease or maintain the subject's dose, up to a maximum target daily dose of 2.0 mg/kg (maximum dose of 80 mg/day). During the treatment period, seizures will be recorded during the week preceding each study visit or 30 days immediately following each study visit (dependent on Amendment approval). The subject or subject's caregiver will record daily counts of seizures, including drop seizures in the subject's seizure diary.

Arms: arm 1: None
Interventions: intervention 1: Clobazam
Intervention descriptions: intervention 1: Clobazam will be provided in 5 mg, 10 mg and 20 mg tablets and will be dispensed in bottles as needed at each visit. Bottles may be dispensed between visits if necessary. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After the first 48 hours of the treatment period, investigators will be able to increase, decrease or maintain the subject's dose, up to an approximate maximum daily dose of 2.0 mg/kg (maximum dose of 80 mg/day).

Protocol documents:
Clinical trial NCT01167010
Conditions: Asthma
Sponsor: Eurofarma Laboratorios S.A.
Start date: 2011-04-01; Completion date: 2012-02-01
Enrollment: 552 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

Detailed description:
The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

Arms: arm 1: formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks. arm 2: Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. arm 3: Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
Interventions: intervention 1: Formoterol/Budesonide intervention 2: Foraseq intervention 3: Alenia
Intervention descriptions: intervention 1: formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks. intervention 2: foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks. intervention 3: Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.

Protocol documents:
Clinical trial NCT01175590
Conditions: Bacterial Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-06-01; Completion date: 2012-02-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Detailed description:

Arms: arm 1: besifloxacin ophthalmic suspension 0.6% arm 2: Vehicle of Besivance
Interventions: intervention 1: Besivance intervention 2: Vehicle
Intervention descriptions: intervention 1: Ocular administration to affected eye for 7 days intervention 2: Vehicle of Besivance administered to affected eye for 7 days

Protocol documents:
Clinical trial NCT01177098
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2010-10-01; Completion date: 2012-02-01
Enrollment: 561 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. arm 2: One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Interventions: intervention 1: bimatoprost /timolol formulation A fixed combination ophthalmic solution intervention 2: bimatoprost/timolol fixed combination ophthalmic solution
Intervention descriptions: intervention 1: One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. intervention 2: One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Protocol documents:
Clinical trial NCT01188798
Conditions: Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Chronic Myelocytic Leukemia Hodgkin's Disease Myelodysplastic Syndrome
Keywords: Allogeneic Bone Marrow Transplantation Graft versus host disease Tacrolimus Sirolimus Methotrexate Pentostatin
Sponsor: St. Jude Children's Research Hospital
Start date: 2010-09-01; Completion date: 2012-02-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if participants who receive the GVHD prophylaxis medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin recipients.

Detailed description:
Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor. All participants will receive a standard backbone GVHD prophylaxis regimen (tacrolimus and sirolimus) and conditioning (cyclophosphamide/TBI). A risk-adapted approach will be used during conditioning to further minimize the risk of leukemia relapse based on two factors:

1. Lymphoid versus myeloid primary disease.
2. KIR compatibility between donor and host.

Arms: arm 1: Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin) arm 2: Participants will be biologically stratified according to disease, donor, and KIR match.between donor and host.In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)
Interventions: intervention 1: Methotrexate intervention 2: Pentostatin
Intervention descriptions: intervention 1: Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor. intervention 2: Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor.

Protocol documents:
Clinical trial NCT01190007
Conditions: Hypertension Hypercholesterolemia Angina Pectoris
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-08-01; Completion date: 2012-02-01
Enrollment: 159 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Caduet
Intervention descriptions: intervention 1: One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

Protocol documents:
Clinical trial NCT01197794
Conditions: Asthma Patients
Keywords: Efficacy safety tolerability dose finding asthma patients
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2012-02-01
Enrollment: 1144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Detailed description:

Arms: arm 1: AZD1981 10 mg arm 2: AZD1981 40 mg arm 3: AZD1981 100 mg arm 4: AZD1981 400 mg arm 5: AZD1981 80 mg arm 6: AZD1981 200 mg arm 7: None
Interventions: intervention 1: AZD1981 intervention 2: AZD1981 intervention 3: Placebo
Intervention descriptions: intervention 1: AZD1981 twice daily intervention 2: AZD1981 once daily intervention 3: Placebo to match AZD1981

Protocol documents: