ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01029704
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Sponsor: Theracos
Start date: 2009-12-01; Completion date: 2010-07-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.

The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.

Detailed description:
This was a phase 2 study to evaluate the efficacy of

EGT0001442. The study included two segments:

Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.

Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EGT0001442 intervention 2: Placebo capsules to match EGT0001442
Intervention descriptions: intervention 1: Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.

Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days. intervention 2: Segment 1: Not applicable.

Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.

Protocol documents:
Clinical trial NCT01042236
Conditions: Stress Urinary Incontinence
Keywords: Phase 2 stress urinary incontinence Fesoterodine
Sponsor: Pfizer
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Fesoterodine
Intervention descriptions: intervention 1: Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods

Protocol documents:
Clinical trial NCT01045993
Conditions: Pain
Keywords: Pilot Study to Assess Methodologies
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2010-02-01; Completion date: 2010-07-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to assess methods used in clinical research.

Detailed description:

Arms: arm 1: Heat device arm 2: Placebo arm arm 3: Marketed analgesic arm 4: (Oral) Placebo comparator
Interventions: intervention 1: Heat Device intervention 2: Sham Device intervention 3: marketed analgesic intervention 4: Placebo
Intervention descriptions: intervention 1: 8-Hour Heatwrap intervention 2: Inactive wrap worn for 8 hours intervention 3: 2 x 200 mg ibuprofen tablets intervention 4: 2 x placebo tablets

Protocol documents:
Clinical trial NCT01052844
Conditions: Vomiting Cisplatin Adverse Reaction
Keywords: Vomiting Antiemetics Dexamethasone Cisplatin Antineoplastic combined chemotherapy protocols
Sponsor: Faculdade de Medicina do ABC
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis.

The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.

Detailed description:
This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent.

Arms: arm 1: Placebo:

* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily arm 2: Gabapentin 300mg:

* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
Interventions: intervention 1: Placebo intervention 2: Gabapentin
Intervention descriptions: intervention 1: Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3) intervention 2: Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)

Protocol documents:
Clinical trial NCT01064882
Conditions: Eyelash Hypotrichosis
Sponsor: Allergan
Start date: 2010-03-01; Completion date: 2010-07-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence

Detailed description:

Arms: arm 1: bimatoprost ophthalmic sterile solution 0.005% arm 2: bimatoprost ophthalmic sterile solution 0.015% arm 3: bimatoprost ophthalmic solution 0.03%
Interventions: intervention 1: bimatoprost ophthalmic solution 0.005% intervention 2: bimatoprost ophthalmic solution 0.015% intervention 3: bimatoprost ophthalmic solution 0.03%
Intervention descriptions: intervention 1: One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) intervention 2: One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) intervention 3: One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

Protocol documents:
Clinical trial NCT01066546
Conditions: Alzheimer's Disease
Keywords: Delirium Dementia Amnestic Cognitive Disorders Mental Disorders Nervous System Diseases Central Nervous System Diseases
Sponsor: Pfizer
Start date: 2010-04-01; Completion date: 2010-07-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.

Detailed description:
This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Arms: arm 1: None
Interventions: intervention 1: Dimebon tablet for oral administration
Intervention descriptions: intervention 1: 10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Protocol documents:
Clinical trial NCT01066585
Conditions: Head Lice
Keywords: Head lice Pediculus humanus capitis
Sponsor: Topaz Pharmaceuticals Inc
Start date: 2010-03-01; Completion date: 2010-07-01
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ivermectin Cream intervention 2: vehicle control
Intervention descriptions: intervention 1: Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1 intervention 2: Up to 4 ounces of vehicle control applied to the hair and scalp on day 1

Protocol documents:
Clinical trial NCT01068158
Conditions: Head Lice
Keywords: Head lice infestation Pediculus humanus capitis
Sponsor: Topaz Pharmaceuticals Inc
Start date: 2010-03-01; Completion date: 2010-07-01
Enrollment: 371 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Detailed description:

Arms: arm 1: Up to 4 ounces of topical Ivermectin Cream applied to hair and scalp on day 1 arm 2: Up to 4 ounces of topical control applied to hair and scalp on day 1.
Interventions: intervention 1: 0.5% Ivermectin Cream intervention 2: Placebo control
Intervention descriptions: intervention 1: Up to 4 ounces of 0.5% Ivermectin Cream applied to hair and scalp on day 1. intervention 2: up to 4 ounces of topical vehicle control to head and scalp on day 1.

Protocol documents:
Clinical trial NCT01072149
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD Safety FEV1 Efficacy
Sponsor: GlaxoSmithKline
Start date: 2010-01-01; Completion date: 2010-07-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with placebo. Other objectives are to assess additional efficacy, plus the safety, pharmcodynamics and tolerability of concurrent treatment with Fluticasone Furoate (FF) plus GW642444 when administered at three dose levels for 28 days in subjects with COPD and to assess the steady-state pharmacokinetic profile of Fluticasone Furoatee (FF) and GW642444 at the end of each treatment period.

Detailed description:

Arms: arm 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 3: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 4: placebo
Interventions: intervention 1: Fluticasone Furoate (FF)/GW642444 Inhalation Powder intervention 2: placebo
Intervention descriptions: intervention 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD intervention 2: placebo

Protocol documents:
Clinical trial NCT01072448
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD indacaterol
Sponsor: Novartis
Start date: 2010-01-01; Completion date: 2010-07-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Detailed description:

Arms: arm 1: Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 75 μg intervention 2: Placebo to indacaterol
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Protocol documents:
Clinical trial NCT01078844
Conditions: Autism Asperger's Disorder Pervasive Developmental Disorder NOS
Keywords: Autism Asperger's Disorder Pervasive Developmental Disorder NOS Adult Memantine
Sponsor: Johns Hopkins University
Start date: 2010-02-01; Completion date: 2010-07-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).

Detailed description:

Arms: arm 1: Treatment as usual plus placebo arm 2: Treatment as usual plus memantine
Interventions: intervention 1: memantine intervention 2: Placebo
Intervention descriptions: intervention 1: memantine 5-20 mg daily intervention 2: Look-alike placebo

Protocol documents:
Clinical trial NCT01104558
Conditions: Chronic Heart Failure
Keywords: Bisoprolol Chronic Heart failure
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-12-01; Completion date: 2010-07-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms. But there has been no data reported, about the incidence of beta-adrenergic receptor polymorphism and association with beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects.

Detailed description:
Heart failure impairs the quality of life of an individual and is considered to be the main cause of morbidity and mortality. Prognosis of HF subjects depends on severity, age and sex. Subjects with HF require lifelong treatment. Pharmacological treatment aims to improve both the quality of life and survival of HF subjects.

OBJECTIVES:

Primary objective:

* To analyze the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects

Secondary objective:

* The frequency of polymorphism of beta adrenergic receptor in Korean HF subjects
* To evaluate change from baseline in 6-minute walking test, heart rate (HR), blood pressure (BP), pro B-type natriuretic peptide (BNP) level at week 26 or End of Treatment (EOT)
* To compare frequency and duration of hospitalization due to heart failure

The method involved in this study will be as follows:

* Initial evaluation of HF subjects
* Blood genomic deoxyribonucleic acid (DNA) isolation and collection
* Bisoprolol treatment as add on therapy with standard treatment for HF subject for 6 months
* Genotype of beta adrenergic receptor polymorphism
* Follow up evaluation of treated subjects

Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.

Interventions: intervention 1: Bisoprolol
Intervention descriptions: intervention 1: Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.

Protocol documents:
Clinical trial NCT01111331
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2010-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.

Detailed description:

Arms: arm 1: 1 tablet 25 mg BI 10773 qd for 5 days arm 2: 1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose arm 3: 5 tablets 5 mg warfarin single dose
Interventions: intervention 1: BI 10773 25 mg intervention 2: Warfarin 25 mg intervention 3: BI 10773 25 mg intervention 4: Warfarin
Intervention descriptions: intervention 1: 25 mg BI 10773 qd for 5 days intervention 2: 25 mg Warfarin single dose intervention 3: 25 mg BI 10773 qd for 12 days intervention 4: 25 mg warfarin single dose with and without 50 mg BI 10773

Protocol documents:
Clinical trial NCT01134328
Conditions: Allergic Conjunctivitis
Sponsor: Aciex Therapeutics, Inc.
Start date: 2010-05-01; Completion date: 2010-07-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: AC-150 Combo intervention 2: AC-150A 0.1% intervention 3: AC-150B 0.005% intervention 4: Vehicle
Intervention descriptions: intervention 1: 1 drop in each eye for up to 14 days intervention 2: 1 drop in each eye once per day for up to 14 days intervention 3: 1 drop in each eye once per day for up to 14 days intervention 4: 1 drop in each eye once per day for up to 14 days

Protocol documents:
Clinical trial NCT01139515
Conditions: Healthy
Keywords: pharmacokinetic eletriptan Korean crossover
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-07-01; Completion date: 2010-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.

Detailed description:

Arms: arm 1: 1 X 20 mg eletriptan arm 2: 1 X 40 mg eletriptan arm 3: 2 X 40 mg eletriptan arm 4: 1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose
Interventions: intervention 1: Eletriptan commercial tablet intervention 2: Eletriptan commercial tablet intervention 3: Eletriptan commercial tablet intervention 4: Eletriptan commercial tablet
Intervention descriptions: intervention 1: 20 mg tablet, single dose intervention 2: 40 mg tablet, single dose of 1 X 40 mg intervention 3: 40 mg tablet, single dose of 2 X 40 mg intervention 4: 40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first

Protocol documents:
Clinical trial NCT01150461
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic nonobstructive cardiomyopathy
Sponsor: Massachusetts General Hospital
Start date: 2007-02-01; Completion date: 2010-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether taking losartan helps people with hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart muscle thickening and/or the amount of heart muscle scarring.

Detailed description:
Hypertrophic cardiomyopathy (HCM) is characterized by idiopathic cardiac hypertrophy, heart failure, ischemia even in the absence of epicardial coronary artery disease, and arrhythmias. The pathological features of HCM include hypertrophy and disarray, interstitial fibrosis, and increased arteriolar wall thickness. Hypertrophy and fibrosis are major determinants of morbidity and mortality in hypertrophic cardiomyopathy. Some investigators have demonstrated that interstitial fibrosis and hypertrophy occur secondarily, in response to trophic and mitotic factors in the heart. Therefore, blocking trophic factors may attenuate or potentially reverse hypertrophy and fibrosis in HCM.

Angiotensin II has trophic and profibrotic effects on the heart, and blockade of angiotensin II type I receptors has been shown to attenuate myocardial hypertrophy and fibrosis in acquired cardiac disease in humans and animal models.

We hypothesize that treatment with the selective angiotensin II type receptor antagonist, losartan, will decrease both hypertrophy and fibrosis, improve diastolic function, reduce symptoms, and improve functional status in patients with HCM.

Arms: arm 1: Losartan 50 mg b.i.d. arm 2: Placebo b.i.d.
Interventions: intervention 1: losartan intervention 2: placebo
Intervention descriptions: intervention 1: Losartan 50 mg b.i.d intervention 2: Placebo b.i.d.

Protocol documents:
Clinical trial NCT01151345
Conditions: Healthy
Keywords: diltiazem angiotrofin bioequivalence
Sponsor: Pfizer
Start date: 2010-06-01; Completion date: 2010-07-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.

Detailed description:
Bioequivalence of this particular drug

Arms: arm 1: None
Interventions: intervention 1: TILACEM intervention 2: ANGIOTROFIN
Intervention descriptions: intervention 1: At 08:00 hours on day 1, CIF-BIOTEC personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms. intervention 2: At 08:00 hours on day 1, CIF-BIOTEC Pharmacy personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.

Protocol documents:
Clinical trial NCT01153724
Conditions: Healthy Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2010-07-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BI 1744 intervention 2: Fluconazole
Intervention descriptions: intervention 1: 10 mcg solution for oral inhalation intervention 2: 400 mg capsule

Protocol documents: