ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01172847
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2009-08-01; Completion date: 2010-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between treatments. Anticipated time on study is up to 11 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: oseltamivir [Tamiflu] intervention 2: rimantadine
Intervention descriptions: intervention 1: multiple oral doses intervention 2: multiple oral doses

Protocol documents:
Clinical trial NCT01181102
Conditions: Venous Thromboembolism
Keywords: anticoagulant venus thromboembolism thrombosis thromboembolism embolism and thrombosis deep vein thrombosis DU-176b Edoxaban factor Xa total knee arthroplasty Enoxaparin sodium
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2009-03-01; Completion date: 2010-02-01
Enrollment: 716 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Detailed description:

Arms: arm 1: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. arm 2: enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
Interventions: intervention 1: edoxaban intervention 2: enoxaparin sodium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01181141
Conditions: Venous Thromboembolism
Keywords: Anticoagulants Enoxaparin sodium venous thromboembolism. thromboembolism Thrombosis deep vein thrombosis DU-176b Edoxaban factor Xa hip fracture surgery embolism
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2008-10-01; Completion date: 2010-02-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

Detailed description:

Arms: arm 1: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery arm 2: Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
Interventions: intervention 1: DU-176b (edoxaban) intervention 2: Enoxaparin sodium 20mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01199926
Conditions: Obesity Insulin Resistance Inflammation
Keywords: 25-hydroxyvitamin D Parathyroid hormone Lean mass Muscular strength Glucose tolerance
Sponsor: Purdue University
Start date: 2008-08-01; Completion date: 2010-02-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. The investigators hypothesis for these studies is that vitamin D supplementation enhances exercise-induced increases in strength and lean mass, potentially through enhancing insulin sensitivity and reducing inflammation.

Detailed description:
The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. It was a double-blind, randomized, placebo-controlled, clinical trial with participants randomized into either a 4,000 IU/day vitamin D or placebo group and all participants completed 12 wks (3 d/wk) of exercise training.

Arms: arm 1: Participants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program. arm 2: Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
Interventions: intervention 1: Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: 4000 IU of vitamin D per day for 12 weeks. intervention 2: Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.

Protocol documents:
Clinical trial NCT01231321
Conditions: Rheumatoid Arthritis
Keywords: Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis
Sponsor: Abbott
Start date: 2007-12-01; Completion date: 2010-02-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.

Detailed description:
This is an open-label, multicenter study designed to establish the safety and efficacy of adalimumab in the treatment of moderate to severely active rheumatoid arthritis. A total of 100 subjects with inadequate preexisting standard anti-rheumatic therapy were enrolled at 5 sites in Russia.

Arms: arm 1: Adalimumab / pre-filled syringe 40 mg/0.8 ml
Interventions: intervention 1: adalimumab
Intervention descriptions: intervention 1: Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Protocol documents:
Clinical trial NCT01263132
Conditions: Diabetic Neuropathies Polyneuropathies
Keywords: Polyneuropathy Diabetes Mellitus Diabetic peripheral neuropathy
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-02-01; Completion date: 2010-02-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.

Detailed description:
Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period.

OBJECTIVES

* To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: F0434 intervention 2: Gabapentin
Intervention descriptions: intervention 1: F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2). intervention 2: Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)

Protocol documents:
Clinical trial NCT01400698
Conditions: Children Born With Serious Intra-uterine Growth Retardation
Keywords: Intra-uterine growth retardation (IUGR) Saizen Recombinant human growth hormone (r-hGH) Final height Bone age SGA (Small for Gestational Age)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 1998-11-01; Completion date: 2010-02-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.

The study enrolled children who have completed 3 or 2 years of treatment and at least one year of post treatment observation in the Sponsor Studies GF 4001 (Safety and Efficacy of Saizen in the Treatment of Young Children Born with Severe IUGR) or GF 6283 (Effect of Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR), respectively.

Detailed description: Serious IUGR is a syndrome characterized by low birth length and weight for gestational age (less than 10 percentile). The secretion of growth hormone in response to provocative stimuli (e.g. arginine, insulin) is normal in these children. Apart from low birth weight, children born with IUGR may have minor or major malformations.

A catch-up period with a supraphysiological growth velocity generally occurs during the first 6 to 24 months of life in 80 to 90 percent (%) of these children. This generally allows them to reach normal height. That means that conversely, approximately 10 to 20% of children do maintain a statural handicap. Puberty occurs at a normal age and the retardation in bone maturation present during the first years of life disappears very quickly. This leads to short adult stature in subjects who have not shown spontaneous catch-up during the first years of life. A safe and effective means of promoting growth without accelerating the timing or tempo of puberty would therefore be desirable.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Saizen® A intervention 2: Saizen® B intervention 3: Observation only
Intervention descriptions: intervention 1: Continuous or intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc). intervention 2: Observed until the first signs of puberty and then continuous treatment with r-hGH 0.067 mg/kg/day sc or observed without treatment. intervention 3: Subjects were only observed.

Protocol documents:
Clinical trial NCT01429584
Conditions: Diaphragm Paralysis
Keywords: bupivacaine concentration interscalene nerve block diaphragm function diaphragm weakness
Sponsor: University of Utah
Start date: 2008-05-01; Completion date: 2010-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.

Detailed description:
Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.

Arms: arm 1: interscalene nerve block with 0.25% bupivacaine arm 2: interscalene nerve block with 0.125% bupivacaine
Interventions: intervention 1: interscalene nerve block with 0.25% bupivacaine intervention 2: interscalene block with 0.125% bupivacaine
Intervention descriptions: intervention 1: interscalene nerve block performed with 20 ml of 0.25% bupivacaine intervention 2: interscalene block with 20 ml of 0.125% bupivacaine

Protocol documents:
Clinical trial NCT01463033
Conditions: Epilepsy Post-traumatic Epilepsy
Keywords: Post-Traumatic epilepsy Traumatic brain injury Epilepsy prevention Levetiracetam
Sponsor: Pavel Klein
Start date: 2005-04-01; Completion date: 2010-02-01
Enrollment: 126 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury (TBI). However, there has been no experience in administering levetiracetam rapidly to individuals with acute TBI. The investigators propose to initiate the evaluation of levetiracetam in prevention of post-traumatic epilepsy by determining the safety, tolerability, pharmacokinetics and feasibility of acute and chronic administration of levetiracetam to individuals with head injury with a high risk for developing post-traumatic epilepsy. Further, the investigators will follow subjects for 2 years after injury in order to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.

Detailed description:

Arms: arm 1: 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care. arm 2: 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: 55 mg/kg/day given in 2 divided doses 12 hours apart

Protocol documents:
Clinical trial NCT01533077
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-03-01; Completion date: 2010-02-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.

Detailed description:
Single-centre, open-label, randomized, gender-balanced, crossover study with four consecutive single-dose treatment periods.

Arms: arm 1: Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25 arm 2: Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25 arm 3: Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg arm 4: Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg
Interventions: intervention 1: BIA 9-1067 intervention 2: Sinemet® 100/25 mg
Intervention descriptions: intervention 1: 50 mg of BIA 9-1067 (single-dose) intervention 2: immediate-release levodopa/carbidopa 100/25 (single-dose).

Protocol documents:
Clinical trial NCT01568034
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-04-01; Completion date: 2010-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

Detailed description:
This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide

Arms: arm 1: Treatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 2: Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 3: Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 4: Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
Interventions: intervention 1: BIA 9-1067 intervention 2: BIA 9-1067 intervention 3: BIA 9-1067 intervention 4: Placebo intervention 5: Levodopa/Carbidopa intervention 6: Levodopa/Benzerazide
Intervention descriptions: intervention 1: BIA 9-1067 - 25 mg single-dose intervention 2: BIA 9-1067 - 50 mg single-dose intervention 3: BIA 9-1067 - 100 mg single-dose intervention 4: single-dose intervention 5: Levodopa 100 mg Carbidopa 25 mg intervention 6: Levodopa 100 mg Benzerazide 25 mg

Protocol documents:
Clinical trial NCT01631812
Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2006-12-01; Completion date: 2010-02-01
Enrollment: 130 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day

Protocol documents:
Clinical trial NCT00464685
Conditions: Diabetic Macular Edema
Sponsor: Allergan
Start date: 2007-05-01; Completion date: 2010-02-08
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Detailed description:

Arms: arm 1: Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. arm 2: Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Interventions: intervention 1: Dexamethasone intervention 2: Sham injection intervention 3: Laser Photocoagulation
Intervention descriptions: intervention 1: Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. intervention 2: Initial sham injection with up to 1 additional treatment based on re-treatment criteria. intervention 3: Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Protocol documents:
Clinical trial NCT00932737
Conditions: Abdominal Pain
Sponsor: Boehringer Ingelheim
Start date: 2009-06-09; Completion date: 2010-02-08
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.

Detailed description:

Arms: arm 1: Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode arm 2: patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode
Interventions: intervention 1: Placebo intervention 2: HBB 20 mg
Intervention descriptions: intervention 1: 1-5 tablets per episode intervention 2: Active drug, one to five tablets per episode

Protocol documents:
Clinical trial NCT00896363
Conditions: Depressive Disorder
Keywords: anti-depressant Severe Depression Efficacy Major Depressive Disorder Major Depressive Episode
Sponsor: GlaxoSmithKline
Start date: 2009-04-23; Completion date: 2010-02-09
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.

Detailed description:
This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.

Arms: arm 1: Parallel Group - High Dose Arm, Low Dose Arm arm 2: Parallel Group
Interventions: intervention 1: GSK163090 1 mg intervention 2: GSK163090 Placebo intervention 3: GSK163090 3 mg
Intervention descriptions: intervention 1: Developed for the treatment of Major Depressive Disorder intervention 2: Developed for the treatment of Major Depressive Disorder intervention 3: Developed for the treatment of Major Depressive Disorder

Protocol documents: