ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00525837
Conditions: Depressive Disorder Smoking
Keywords: varenicline depression anhedonia smoking
Sponsor: Butler Hospital
Start date: 2007-09-01; Completion date: 2008-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications.

Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks.

Medication will be provided free of charge.

Detailed description:
Outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate.

They will receive varenicline dosed according to FDA-approved smoking cessation regime; patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and clinical global improvement self-report scales and clinician global improvement scales at the above time intervals.

Concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs (BP, HR, weight) and tobacco use.

Arms: arm 1: open label varenicline
Interventions: intervention 1: fixed dose varenicline intervention 2: varenicline
Intervention descriptions: intervention 1: varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration. intervention 2: up to 1 mg twice daily

Protocol documents:
Clinical trial NCT00533468
Conditions: Pain
Keywords: pain lumbar puncture neonates infants emergency department topical anesthesia LMX4
Sponsor: State University of New York at Buffalo
Start date: 2007-03-01; Completion date: 2008-03-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Detailed description:
Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.

Arms: arm 1: Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing arm 2: Placebo Cream made on same run at factory but without active Lidocaine 4% drug
Interventions: intervention 1: Lidocaine Cream 4% intervention 2: Placebo
Intervention descriptions: intervention 1: Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure intervention 2: inactive placebo without LMX4

Protocol documents:
Clinical trial NCT00536939
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2008-03-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.

Detailed description:

Arms: arm 1: Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.

Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A). arm 2: Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
Interventions: intervention 1: Enzastaurin intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Placebo
Intervention descriptions: intervention 1: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression intervention 2: 10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression intervention 3: 90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression intervention 4: Oral, daily, until disease progression

Protocol documents:
Clinical trial NCT00548197
Conditions: Intravitreal Bevacizumab Injection Pars Plana Vitrectomy Tractional Retinal Detachment Diabetic Retinopathy
Keywords: Intravitreal Bevacizumab injection Pars plana vitrectomy tractional retinal detachment Diabetic retinopathy
Sponsor: Iran University of Medical Sciences
Start date: 2007-02-01; Completion date: 2008-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.

Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..

In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.

During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.

Detailed description:
Eligibility criteria:

Diabetic tractional retinal detachment-complexity score between 4 and 8

Main outcome measures:

best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)

Arms: arm 1: Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy arm 2: no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy

Protocol documents:
Clinical trial NCT00552786
Conditions: Hearing Loss
Keywords: noise hearing loss temporary threshold shift
Sponsor: National Taiwan University Hospital
Start date: 2007-11-01; Completion date: 2008-03-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent temporary threshold shift in hearing among workers exposed to noise

Detailed description:
Both genetic and environmental factors contribute to noise-induced hearing loss (NIHL). The cellular antioxidant system appears to protect cochlear hair cells from oxidative stress due to noise. Previous animal studies showed protective effects of anti-oxidant medicines against NIHL.The objective of this study is to test the hypothesis that preventive medication of antioxidation is related to susceptibility to NIHL.

The 53 noise-exposed workers from steel industries in Taiwan will be recruited, and divided into N-Acetylcysteine (NAC)(Acetine, 1200mg/day) group and placebo one. The duration of medication is 2 weeks initially. After washout for 2 weeks, the kinds of medications in these 2 groups will be crossover and used for 2 weeks. Firstly, questionnaires interview about noise exposure, smoking, alcohol drinking, drug habit history and calculation of Body Mass Index (BMI) will be done. The following methods would be performed individually after medication. With detailed local examination with otoscope, these subjects receive hearing tests by pure-tone audiometry (PTA) and distortion product otoacoustic emissions (DPOAE) before and after their daily works. The possible confounding factors including background noise, solvent, heavy metals, carbon monoxide and temperature in the workplaces will be assessed. The amount of noise exposure is evaluated by personal dosimeter. Early morning, Blood samples will be collected. Deletion polymorphisms in the Glutathione S-transferase (GST)T1 and GSTM1 genes will be determined. Statistical analysis will be performed to evaluate the relation between intake of anti-oxidant medicine and noise-induced temporal threshold shift (TTS).

The expected results of this study are to determine whether anti-oxidant supplements protect workers from noise-induced TTS.

We anticipate that these human studies might help elucidate the relative importance of anti-oxidant enzymes as risk factors for NIHL.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: N-acetylcysteine (NAC) intervention 2: glucose
Intervention descriptions: intervention 1: 600mg twice daily for 2 weeks intervention 2: 1 gm glucose capsule

Protocol documents:
Clinical trial NCT00554970
Conditions: Asthma
Keywords: Adult Asthmatics
Sponsor: Allergan
Start date: 2007-11-01; Completion date: 2008-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.

Detailed description:

Arms: arm 1: Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol. arm 2: Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol. arm 3: Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol. arm 4: Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
Interventions: intervention 1: MAP0010 low dose intervention 2: MAP0010 high dose intervention 3: Budesonide inhalation suspension 0.25mg intervention 4: Budesonide inhalation suspension 0.5mg
Intervention descriptions: intervention 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol intervention 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol intervention 3: a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol intervention 4: a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol

Protocol documents:
Clinical trial NCT00557349
Conditions: Marginal Ulcers
Keywords: gastric bypass surgery anastomosis, Roux-en-Y Complication, Postoperative
Sponsor: University of Missouri-Columbia
Start date: 2006-11-01; Completion date: 2008-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.

Detailed description:
The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.

Arms: arm 1: 40 mg Omeprazole daily arm 2: 40 mg Famotidine daily
Interventions: intervention 1: Omeprazole intervention 2: Famotidine
Intervention descriptions: intervention 1: 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery. intervention 2: 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.

Protocol documents:
Clinical trial NCT00567593
Conditions: Inflammatory Bowel Disease
Sponsor: James Lewis
Start date: 2007-10-01; Completion date: 2008-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon

Detailed description:
The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression in the absence of pathologic acute and chronic intestinal inflammation.

Arms: arm 1: Rosiglitazone; 8mg tablet once a day for 14 days
Interventions: intervention 1: Rosiglitazone
Intervention descriptions: intervention 1: 8mg tablet once a day for 14 days

Protocol documents:
Clinical trial NCT00571428
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Bronchitis Emphysema
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2007-11-01; Completion date: 2008-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

Detailed description:
This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit. arm 2: Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.
Interventions: intervention 1: Arformoterol Tartrate Inhalation Solution intervention 2: Arformoterol Tartrate Inhalation Solution intervention 3: Placebo
Intervention descriptions: intervention 1: Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID) intervention 2: Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD) intervention 3: Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

Protocol documents:
Clinical trial NCT00573469
Conditions: Crohn's Disease
Keywords: gastrointestinal GI Crohn's disease Japan Japanese
Sponsor: AstraZeneca
Start date: 2006-10-01; Completion date: 2008-03-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.

Detailed description:

Arms: arm 1: D9421-C 9 mg arm 2: D9421-C 15 mg arm 3: Placebo
Interventions: intervention 1: D9421-C, 9mg intervention 2: D9421-C, 15mg intervention 3: Placebo
Intervention descriptions: intervention 1: D9421-C 9 mg was given once daily for 8 weeks. intervention 2: D9421-C 15 mg was given once daily for 8 weeks. intervention 3: D9421-C matching placebo was given once daily for 8 weeks.

Protocol documents:
Clinical trial NCT00574704
Conditions: Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy
Sponsor: Cytos Biotechnology AG
Start date: 2006-09-01; Completion date: 2008-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) intervention 2: House dust mite allergen extract in combination with CYT003-QbG10-placebo intervention 3: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo intervention 4: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Intervention descriptions: intervention 1: subcutaneous injections at 6 visits intervention 2: subcutaneous injections at 6 visits intervention 3: subcutaneous injections at 6 visits intervention 4: subcutaneous injections at 6 visits

Protocol documents:
Clinical trial NCT00576251
Conditions: Ocular Inflammation Associated With Blepharaconjunctivitis
Keywords: Ocular inflammation blepharaconjunctivitis
Sponsor: Alcon Research
Start date: 2007-10-01; Completion date: 2008-03-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis

Detailed description:

Arms: arm 1: Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes arm 2: TOBRADEX 1 drop 4 times daily in both eyes
Interventions: intervention 1: Tobramycin 0.3%/Dexamethasone 0.05% intervention 2: TOBRADEX
Intervention descriptions: intervention 1: Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days intervention 2: TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days

Protocol documents:
Clinical trial NCT00582894
Conditions: Hematological Neoplasms Hematopoietic Stem Cell Transplantation
Keywords: Allogenic stem cell transplant Hematologic diseases
Sponsor: University of Oklahoma
Start date: 2005-02-01; Completion date: 2008-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases

Detailed description:
Primary Endpoints:

1. Engraftment of donor cells
2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival
2. Overall survival

Arms: arm 1: Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Interventions: intervention 1: Busulfex, Fludarabine, ALemtuzumab
Intervention descriptions: intervention 1: Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1

Protocol documents:
Clinical trial NCT00586521
Conditions: Hematologic Disease Hemophilia A
Keywords: Coagulation Disorders
Sponsor: Bayer
Start date: 2006-02-01; Completion date: 2008-03-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.

Detailed description:

Arms: arm 1: On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
Interventions: intervention 1: Kogenate (BAY14-2222)
Intervention descriptions: intervention 1: One group two treatment schedules, first on-demand then switch to prophylaxis

Protocol documents: