ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00472199
Conditions: Restless Legs Syndrome
Sponsor: Boehringer Ingelheim
Start date: 2007-05-01; Completion date: 2008-07-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo.

The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.

Detailed description:

Arms: arm 1: 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. arm 2: 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.
Interventions: intervention 1: Pramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00488618
Conditions: Bipolar Disorder
Keywords: Mania Bipolar I Disorder Acute Mania Associated with Bipolar I Disorder
Sponsor: Forest Laboratories
Start date: 2007-06-01; Completion date: 2008-07-01
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Detailed description:

Arms: arm 1: Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. arm 2: Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Interventions: intervention 1: Cariprazine (RGH-188) intervention 2: Placebo
Intervention descriptions: intervention 1: Cariprazine 3 mg - 12 mg oral administration, once per day. intervention 2: Dose-matched placebo oral administration, once per day.

Protocol documents:
Clinical trial NCT00492297
Conditions: Melanoma
Sponsor: Bayer
Start date: 2005-04-01; Completion date: 2008-07-01
Enrollment: 83 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

Detailed description:
Issues on "Safety" outcomes are addressed in the Adverse Event section.

Arms: arm 1: Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
Intervention descriptions: intervention 1: Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)

Protocol documents:
Clinical trial NCT00503009
Conditions: Asthma
Keywords: Rhinovirus Asthma
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2008-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: fluticasone propionate/salmeterol intervention 2: fluticasone propionate intervention 3: placebo
Intervention descriptions: intervention 1: comparator intervention 2: Comparator intervention 3: Placebo

Protocol documents:
Clinical trial NCT00504829
Conditions: Dyslipidemia
Keywords: LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol LDL cholesterol Atorvastatin Fenofibrate
Sponsor: Veloxis Pharmaceuticals
Start date: 2007-07-01; Completion date: 2008-07-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

Detailed description:
This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia.

After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.

Arms: arm 1: LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia arm 2: atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia arm 3: fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia
Interventions: intervention 1: LCP-AtorFen intervention 2: atorvastatin intervention 3: fenofibrate
Intervention descriptions: intervention 1: 40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia intervention 2: dyslipidemia and mixed dyslipidemia intervention 3: dyslipidemia and mixed dyslipidemia

Protocol documents:
Clinical trial NCT00505284
Conditions: Diabetic Neuropathy
Keywords: Diabetic neuropathy
Sponsor: Eisai Inc.
Start date: 2007-06-01; Completion date: 2008-07-01
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.

Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: E2007 (2 mg) intervention 3: E2007 (4 mg) intervention 4: E2007 (6 mg) intervention 5: E2007 (8 mg)
Intervention descriptions: intervention 1: Placebo tablets, once daily, for 15 weeks (taken orally). intervention 2: Perampanel, 2 mg once daily, for 15 weeks (taken orally). intervention 3: Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally). intervention 4: Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally). intervention 5: Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).

Protocol documents:
Clinical trial NCT00509925
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2007-07-01; Completion date: 2008-07-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.

Detailed description:
The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study

Arms: arm 1: Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart arm 2: Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
Interventions: intervention 1: insulin detemir intervention 2: insulin NPH intervention 3: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection intervention 2: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection intervention 3: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

Protocol documents:
Clinical trial NCT00517634
Conditions: Asthma
Keywords: asthma allergen challenge IL-5 eosinophils
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.

Detailed description:
A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

Arms: arm 1: Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period arm 2: Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period arm 3: Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period arm 4: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period arm 5: Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period arm 6: Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Interventions: intervention 1: FP intervention 2: SFC intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone Propionate 100 mcg BD intervention 2: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD intervention 3: Matching Placebo

Protocol documents:
Clinical trial NCT00522041
Conditions: Fissure in Ano Pain
Keywords: Pain associated with chronic anal fissure
Sponsor: Forest Laboratories
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.

The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.

Detailed description:

Arms: arm 1: Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. arm 2: Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
Interventions: intervention 1: Cellegesic intervention 2: Placebo
Intervention descriptions: intervention 1: Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin. intervention 2: Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.

Protocol documents:
Clinical trial NCT00522418
Conditions: Epilepsy Partial Epilepsy
Keywords: Epilepsy VNS Therapy
Sponsor: Cyberonics, Inc.
Start date: 2006-02-01; Completion date: 2008-07-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

Detailed description:
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.

Arms: arm 1: VNS Therapy + Best Medical Practice arm 2: Best Medical Practice
Interventions: intervention 1: Vagal Nerve Simulation (VNS) Therapy intervention 2: Best Medical Practive
Intervention descriptions: intervention 1: VNS Therapy + Best Medical Practice including anti-epileptic drugs intervention 2: Best Medical Practice including anti-Epileptic Drugs

Protocol documents:
Clinical trial NCT00525499
Conditions: Acne Vulgaris
Keywords: acne
Sponsor: AndroScience Corp
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Detailed description:
Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Arms: arm 1: Vehicle control cream applied topically to the face twice daily for 12 weeks arm 2: 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks arm 3: 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks arm 4: 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Interventions: intervention 1: ASC-J9 cream intervention 2: placebo
Intervention descriptions: intervention 1: Topical application to the face twice daily for 12 weeks. intervention 2: vehicle control applied topically twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00529126
Conditions: Postoperative Pain
Keywords: hemorrhoidectomy pain Postoperative analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2007-09-01; Completion date: 2008-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.

Detailed description:
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Arms: arm 1: SKY0402, single administration arm 2: SKY0402, single administration arm 3: SKY0402, single administration arm 4: Bupivacaine HCl
Interventions: intervention 1: SKY0402 intervention 2: Bupivacaine HCl
Intervention descriptions: intervention 1: SKY0402 intervention 2: Bupivacaine HCl

Protocol documents:
Clinical trial NCT00529451
Conditions: Hypertension
Keywords: Hypertension, Aliskiren, Ramipril
Sponsor: Novartis
Start date: 2007-09-01; Completion date: 2008-07-01
Enrollment: 1613 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

Detailed description:

Arms: arm 1: Aliskiren 300 mg once daily arm 2: Aliskiren 150 mg once daily arm 3: Aliskiren 75 mg once daily arm 4: Ramipril 5 mg once daily
Interventions: intervention 1: Aliskiren intervention 2: Ramipril
Intervention descriptions: intervention 1: Aliskiren intervention 2: comparator

Protocol documents:
Clinical trial NCT00541229
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-08-24; Completion date: 2008-07-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: sitagliptin 100 mg arm 2: sitagliptin 200 mg arm 3: Placebo
Interventions: intervention 1: sitagliptin phosphate intervention 2: sitagliptin phosphate intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: sitagliptin 100 mg tablets q.d. (once daily) for 7 days. intervention 2: sitagliptin 200 mg tablets q.d. (once daily) for 7 days. intervention 3: sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.

Protocol documents:
Clinical trial NCT00546260
Conditions: Myocardial Infarction
Keywords: STEMI ACS
Sponsor: Portola Pharmaceuticals
Start date: 2007-11-01; Completion date: 2008-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Detailed description:
Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.

Arms: arm 1: Placebo for each Dose cohort: 10, 20, 40, and 60 mg arm 2: Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg
Interventions: intervention 1: placebo intervention 2: PRT060128 Potassium
Intervention descriptions: intervention 1: administration of iv bolus prior to angiography intervention 2: administration of iv bolus prior to angiography

Protocol documents:
Clinical trial NCT00549770
Conditions: Hypertension
Keywords: Hypertension, valsartan, LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2007-09-01; Completion date: 2008-07-01
Enrollment: 1334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

Detailed description:

Arms: arm 1: Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 2: Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 3: Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 4: Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 5: Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily. arm 6: Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 7: Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. arm 8: Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
Interventions: intervention 1: LCZ696 intervention 2: Valsartan intervention 3: AHU377 intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00550953
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2007-10-01; Completion date: 2008-07-01
Enrollment: 314 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to:

Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.

Detailed description:

Interventions: intervention 1: telmisartan+amlodipine intervention 2: telmisartan
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: