ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00661466
Conditions: Pain, Postoperative
Keywords: Gastrointestinal surgery Post operative pain
Sponsor: Innocoll
Start date: 2008-07-24; Completion date: 2009-02-10
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.

Detailed description:
Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision. Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic procedures are performed when warranted, open abdominal surgery is required for certain indications and for more complicated or advanced cases.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes for cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This study will compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant or a plain collagen sponge.

Arms: arm 1: Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. arm 2: Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Interventions: intervention 1: Bupivacaine Collagen Sponge intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: placebo

Protocol documents:
Clinical trial NCT00484198
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Sponsor: Daiichi Sankyo
Start date: 2007-04-23; Completion date: 2009-02-12
Enrollment: 1912 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Detailed description:

Arms: arm 1: None arm 2: Rivoglitazone 1.0 mg arm 3: Rivoglitazone 1.5 mg arm 4: Pioglitazone 45 mg
Interventions: intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Rivoglitazone intervention 4: Rivoglitazone
Intervention descriptions: intervention 1: 45 mg over-encapsulated tablet administered orally, once daily intervention 2: Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule intervention 3: 1.0 mg tablet administered orally, once daily intervention 4: 1.5 mg tablet administered orally, once daily

Protocol documents:
Clinical trial NCT00550420
Conditions: Alzheimer's Disease
Keywords: open-label extension tolerability Alzheimer's disease Rosiglitazone extended-release (XR) safety cognition BRL-049653
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2009-02-12
Enrollment: 331 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed AVA105640. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status

Detailed description:

Arms: arm 1: Rosiglitazone XR
Interventions: intervention 1: Rosiglitazone XR
Intervention descriptions: intervention 1: experimental drug

Protocol documents:
Clinical trial NCT00749411
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD long-acting beta agonist Emphysema Chronic Bronchitis Chronic Obstructive Pulmonary Disease (COPD) bronchodilator long acting muscarinic antagonist
Sponsor: GlaxoSmithKline
Start date: 2008-11-13; Completion date: 2009-02-12
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: GSK233705/GW642444
Intervention descriptions: intervention 1: matching placebo intervention 2: The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.

Protocol documents:
Clinical trial NCT00666406
Conditions: Hemophilia A
Sponsor: Baxalta now part of Shire
Start date: 2008-03-31; Completion date: 2009-02-18
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).

Detailed description:

Arms: arm 1: Advate rAHF-PFM arm 2: Recombinate rAHF
Interventions: intervention 1: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) intervention 2: Recombinant Factor VIII (rAHF)
Intervention descriptions: intervention 1: Infusion of 50 +/- 5 IU/kg bodyweight intervention 2: Infusion of 50 +/- 5 IU/kg bodyweight

Protocol documents:
Clinical trial NCT04574999
Conditions: Vaginal Atrophy
Keywords: Postmenopausal women
Sponsor: Italfarmaco S.A
Start date: 2008-01-25; Completion date: 2009-02-23
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.

Primary objective:

• To evaluate the efficacy of 0.005% Estriol vaginal gel by evaluation of the change in the maturation value of the vaginal epithelium (MV) after 12 weeks of treatment.

Secondary objectives:

* To determine the variation of the vaginal pH, as well as symptoms and signs suggestive of vaginal atrophy after 12 weeks of treatment.
* To study the variation of the MV, pH and symptoms and signs suggestive of vaginal atrophy after an initial observation period of 3 weeks.
* To evaluate the safety of 0.005% Estriol vaginal gel
* To evaluate the acceptability of 0.005% Estriol vaginal gel

Detailed description:
This is a randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.

Eligible patients were randomised in a ratio of 2:1 to 0.005% Estriol vaginal gel : placebo. Each patient was treated for 12 weeks followed by a one-month observational period. The patients attended the study centre at baseline and at 3, 8 and 12 weeks after start of treatment. Vaginal cytology was performed at baseline and at weeks 3 and 12; the vaginal pH and the signs and symptoms of vaginal atrophy were recorded at baseline and after 3 and 12 weeks of treatment. Vital signs, gynaecological exploration and changes in health and concomitant medication were documented at each visit. Transvaginal ultrasound was performed at screening and week 12. The investigators telephoned the patient approximately one month after the final visit to check if the patient had experienced any adverse events since the final visit. Two independent cytopathologists assessed the maturation value of each cytology sample at the end of the study.

Arms: arm 1: 0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week. arm 2: Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Interventions: intervention 1: Estriol intervention 2: Placebo
Intervention descriptions: intervention 1: Gel for vaginal application intervention 2: Gel for vaginal application

Protocol documents:
Clinical trial NCT00258180
Conditions: Diarrhea Gastrointestinal Complications Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: unspecified childhood solid tumor, protocol specific gastrointestinal complications diarrhea
Sponsor: Johns Hopkins University
Start date: 2005-08-15; Completion date: 2009-02-24
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .

PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.

Detailed description:
OBJECTIVES:

Primary

* Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.

Secondary

* Determine the toxic effects of this drug in these patients.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.

After completion of study treatment, patients are followed periodically for up to 1½ years.

PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.

Arms: arm 1: Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
Interventions: intervention 1: filgrastim intervention 2: cyclophosphamide
Intervention descriptions: intervention 1: Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover intervention 2: Administered IV over 1 hour on days 1-4

Protocol documents:
Clinical trial NCT00364923
Conditions: Peripheral T-cell Lymphoma
Keywords: Peripheral T-cell Lymphoma T-cell Lymphoma Lymphoma PDX Pralatrexate Vitamin B12 Folic acid
Sponsor: Acrotech Biopharma Inc.
Start date: 2006-08-01; Completion date: 2009-02-24
Enrollment: 115 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary

• Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)

Secondary

* Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
* Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation

Detailed description:
This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL.

Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.

Interventions: intervention 1: Pralatrexate Injection
Intervention descriptions: intervention 1: Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.

Protocol documents:
Clinical trial NCT00511108
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus (T2DM)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-11; Completion date: 2009-02-24
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Detailed description:

Arms: arm 1: Arm 1: drug arm 2: Arm 2: active comparator arm 3: Arm 3: drug + active comparator arm 4: Arm 4: placebo comparator
Interventions: intervention 1: Comparator: sitagliptin phosphate intervention 2: Comparator: pioglitazone intervention 3: Comparator: placebo to pioglitazone intervention 4: Comparator: placebo to sitagliptin
Intervention descriptions: intervention 1: sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily. intervention 2: pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. intervention 3: pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. intervention 4: sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Protocol documents:
Clinical trial NCT00761215
Conditions: Skin Diseases, Infectious Skin Diseases, Bacterial
Keywords: Skin Infection Complicated Skin and Skin Structure Infection
Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2008-09-17; Completion date: 2009-02-24
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TR-701 200 mg intervention 2: TR-701 300 mg intervention 3: TR-701 400 mg
Intervention descriptions: intervention 1: oral TR-701 200 mg for 5 to 7 days intervention 2: oral TR-701 300 mg for 5 to 7 days intervention 3: TR-701 400 mg for 5 to 7 days

Protocol documents:
Clinical trial NCT00403559
Conditions: Seborrheic Dermatitis
Keywords: seborrheic dermatitis
Sponsor: Dermatology Specialists Research
Start date: 2007-05-07; Completion date: 2009-02-27
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

Detailed description:
This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.

Arms: arm 1: Elidel Cream to be applied twice daily for 4 weeks arm 2: Ketoconazole Cream to be applied twice daily for 4 weeks
Interventions: intervention 1: Elidel intervention 2: Ketoconazole Cream
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00035932
Conditions: HIV Infections
Sponsor: Bristol-Myers Squibb
Start date: 2001-11-01; Completion date: 2009-03-01
Enrollment: 571 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.

Detailed description:

Arms: arm 1: ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study arm 2: ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study arm 3: LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Interventions: intervention 1: Atazanavir + ritonavir + tenofovir + nucleoside intervention 2: Atazanavir + saquinavir + tenofovir + nucleoside intervention 3: Lopinavir/ritonavir + tenofovir + nucleoside
Intervention descriptions: intervention 1: Active Comparator, Capsules, tablets, Oral intervention 2: Active Comparator, Capsules, tablets, Oral intervention 3: Active Comparator, Capsules, tablets, Oral

Protocol documents:
Clinical trial NCT00064701
Conditions: Kidney Transplantation
Keywords: De Novo Kidney Transplant cyclosporine Prograf® mycophenolate mofetil tacrolimus
Sponsor: Astellas Pharma Inc
Start date: 2003-06-01; Completion date: 2009-03-01
Enrollment: 668 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

Detailed description:
This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.

The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.

Arms: arm 1: Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. arm 2: Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. arm 3: Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
Interventions: intervention 1: Tacrolimus Modified Release (MR) intervention 2: Tacrolimus intervention 3: cyclosporine microemulsion intervention 4: mycophenolate mofetil
Intervention descriptions: intervention 1: The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter. intervention 2: The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter. intervention 3: The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter. intervention 4: Oral

Protocol documents:
Clinical trial NCT00113269
Conditions: Kidney Transplantation
Keywords: Treatment Effectiveness Treatment Efficacy Anti-rejection therapy Immunosuppression Therapy, antirejection Renal Transplantation Transplantation, Kidney Transplantation, Renal Grafting, Kidney
Sponsor: Astellas Pharma Inc
Start date: 2005-05-01; Completion date: 2009-03-01
Enrollment: 501 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Detailed description:
A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Arms: arm 1: Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American arm 2: Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American arm 3: Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American arm 4: Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
Interventions: intervention 1: basiliximab intervention 2: rabbit anti-thymocyte globulin intervention 3: tacrolimus intervention 4: alemtuzumab intervention 5: mycophenolate mofetil intervention 6: steroids
Intervention descriptions: intervention 1: IV intervention 2: IV intervention 3: oral intervention 4: Intravenous (IV) intervention 5: oral intervention 6: IV and/or oral

Protocol documents: