ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00546728
Conditions: Impaired Glucose Tolerance
Sponsor: St. Paul Heart Clinic
Start date: 2007-10-01; Completion date: 2011-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.

Detailed description:

Arms: arm 1: Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily. arm 2: Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Interventions: intervention 1: Exenatide intervention 2: Metformin
Intervention descriptions: intervention 1: exenatide 10 mcg twice daily intervention 2: metformin 500 twice daily

Protocol documents:
Clinical trial NCT00567398
Conditions: ESRD Diabetes
Keywords: ESRD Diabetes CAPD APD
Sponsor: Vantive Health LLC
Start date: 2008-04-01; Completion date: 2011-07-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

Detailed description:

Arms: arm 1: Dianeal only arm 2: Physioneal, Extraneal, Nutrineal
Interventions: intervention 1: Dianeal intervention 2: Physioneal intervention 3: Extraneal intervention 4: Nutrineal
Intervention descriptions: intervention 1: Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose) intervention 2: Physioneal 40 or Physioneal 35 intervention 3: Extraneal - 7.5% Icodextrin intervention 4: Nutrineal - 1.1% Amino Acids

Protocol documents:
Clinical trial NCT00567489
Conditions: ESRD Diabetes CAPD APD
Keywords: ESRD Diabetes CAPD APD
Sponsor: Vantive Health LLC
Start date: 2008-01-01; Completion date: 2011-07-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

Detailed description:
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.

Arms: arm 1: Dianeal only arm 2: PEN solutions: Nutrineal, Extraneal, and Physioneal
Interventions: intervention 1: Physioneal intervention 2: Dianeal intervention 3: Extraneal intervention 4: Nutrineal
Intervention descriptions: intervention 1: Physioneal 40 or Physioneal 35 intervention 2: Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose) intervention 3: 7.5% Icodextrin intervention 4: Amino Acids 1.1%

Protocol documents:
Clinical trial NCT00589303
Conditions: Atrial Fibrillation Heart Failure
Keywords: Atrial Fibrillation Heart Failure AV Node ablation Cardiac pacemaker Antiarrhythmic drug
Sponsor: Mayo Clinic
Start date: 2007-12-01; Completion date: 2011-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).

Detailed description:
Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated this strategy is highly effective in controlling symptoms among patients who have failed numerous drug therapy. Quality of life is improved while hospital admission and office visits are reduced.

Pilot Study Design

* All patients will be 1:1 randomized to standard-care drug therapy (American College of Cardiology/American Heart Association Guideline, 2006) or AV node ablation and pacemaker therapy
* For patients randomized to AVN ablation, there will be a 1:1 sub-randomization to conventional right ventricular apex pacing or cardiac resynchronization therapy (biventricular pacing)
* All patients will be followed at 2 and 6 months from the time of randomization in the pilot study.
* A total of 60 patients from 5-15 clinical sites will be enrolled during an active recruiting period of 12 months for the pilot study.

Arms: arm 1: FDA approved rate and rhythm control drugs arm 2: AV Node ablation and device implant
Interventions: intervention 1: FDA approved rate and rhythm control drugs intervention 2: AV Node ablation and device implant
Intervention descriptions: intervention 1: Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.

Rate Control:

Beta-Blocker:

* metoprolol
* atenolol
* carvedilol

Calcium Channel Blocker:

* verapamil
* diltiazem

Rhythm Control:

* procainamide
* quinidine
* disopyramide
* propafenone
* flecainide
* sotalol
* dofetilide
* amiodarone intervention 2: Pacing Systems:

* Enpusle Premarket Approval Number (PMA#) P980035
* EnRhythm PMA# P980035
* Adapta PMA# P980035

Cardiac Resynchronization Therapy (CRT) Pacing Systems:

\- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031

Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:

* EnTrust PMA# P980016
* Virtuoso PMA# P980016

ICD CRT Pacing Systems:

* InSync Maximo PMA# P980016
* InSync Sentry PMA# P890003
* Concerto PMA# P980016

Protocol documents:
Clinical trial NCT00592904
Conditions: Neuralgia
Keywords: Neuralgia neuropathy
Sponsor: Eisai Inc.
Start date: 2008-01-01; Completion date: 2011-07-01
Enrollment: 262 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E2007
Intervention descriptions: intervention 1: Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).

Protocol documents:
Clinical trial NCT00605280
Conditions: Macular Edema Associated With Diabetes Mellitus
Keywords: randomized sham-controlled multicenter macular edema
Sponsor: Pfizer
Start date: 2005-09-01; Completion date: 2011-07-01
Enrollment: 317 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Standard of Care intervention 2: Macugen
Intervention descriptions: intervention 1: Clinicians decision to use optional laser therapy. intervention 2: Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.

Protocol documents:
Clinical trial NCT00606580
Conditions: Cutaneous Leishmaniasis
Keywords: cutaneous leishmaniasis, topical treatment, Tunisia
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2008-01-01; Completion date: 2011-07-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.

Detailed description:
This is an efficacy study to test the ability of WR 279,396 topical cream to treat uncomplicated cutaneous leishmaniasis caused primarily by Leishmania major in adults and children in Tunisia where the disease in endemic. A total of 375 volunteers will be randomized to the three arms described above to determine product efficacy. Safety data in all three arms will also be collected.

Arms: arm 1: WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) arm 2: Paromomycin Alone topical cream (15% paromomycin topical cream) arm 3: The cream base without the addition of paromomycin or gentamicin
Interventions: intervention 1: WR 279,396 topical cream intervention 2: Paromomycin Alone topical cream intervention 3: Vehicle placebo cream
Intervention descriptions: intervention 1: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. intervention 2: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. intervention 3: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.

Protocol documents:
Clinical trial NCT00609622
Conditions: Colorectal Neoplasms
Keywords: metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2011-07-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

Detailed description:
The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.

Arms: arm 1: Treatment arm A - sunitinib plus mFOLFOX6 arm 2: Treatment arm B - bevacizumab plus mFOLFOX6
Interventions: intervention 1: sunitinib intervention 2: mFOLFOX6 intervention 3: bevacizumab intervention 4: mFOLFOX6
Intervention descriptions: intervention 1: Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2). intervention 2: FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle intervention 3: Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks. intervention 4: FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Protocol documents:
Clinical trial NCT00626743
Conditions: Hypertension
Sponsor: SK Chemicals Co., Ltd.
Start date: 2008-05-01; Completion date: 2011-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

Detailed description:

Arms: arm 1: Active Drug arm 2: Tablet which has the same appearance and taste but doesn't contain active ingredient
Interventions: intervention 1: SK3530 100mg, Placebo, Amlodipine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00636649
Conditions: Night Eating Syndrome
Keywords: Eating disorder
Sponsor: Duke University
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.

Detailed description:

Arms: arm 1: Escitalopram arm 2: Placebo
Interventions: intervention 1: Escitalopram intervention 2: Placebo
Intervention descriptions: intervention 1: 10-20 mg intervention 2: Placebo

Protocol documents:
Clinical trial NCT00656656
Conditions: Pemphigus
Keywords: pemphigus rituximab immunoadsorption dexamethasone treatment management
Sponsor: University of Luebeck
Start date: 2008-01-01; Completion date: 2011-07-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
Intervention descriptions: intervention 1: Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks

Rituximab: 1000 mg i.v. given twice at a 2-week interval

Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks

Azathioprine: 2.5 mg/kg body weight daily p.o.

Protocol documents:
Clinical trial NCT00659438
Conditions: Prostate Cancer
Sponsor: Genzyme, a Sanofi Company
Start date: 2008-02-01; Completion date: 2011-07-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.

Detailed description:

Arms: arm 1: Bicalutamide 150mg + ZD6474 300mg arm 2: Bicalutamide 150mg + placebo
Interventions: intervention 1: ZD6474 (Vandetanib) intervention 2: Bicalutamide intervention 3: Placebo
Intervention descriptions: intervention 1: 300mg orally, once daily intervention 2: 150mg orally, once daily intervention 3: orally, once daily

Protocol documents:
Clinical trial NCT00661778
Conditions: Non-small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-07-01; Completion date: 2011-07-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Detailed description:

Arms: arm 1: Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Interventions: intervention 1: Bevacizumab intervention 2: Cisplatin intervention 3: Docetaxel
Intervention descriptions: intervention 1: Bevacizumab was supplied as a sterile liquid in glass vials. intervention 2: Bevacizumab was supplied as a sterile liquid in glass vials. intervention 3: Bevacizumab was supplied as a sterile liquid in glass vials.

Protocol documents:
Clinical trial NCT00661960
Conditions: HIV Infections AIDS
Keywords: HIV Positive AIDS Antiretroviral Therapy Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution treatment experienced
Sponsor: University of California, Davis
Start date: 2008-03-01; Completion date: 2011-07-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV medications.

Detailed description:
While the world-wide AIDS epidemic continues to impact millions of individuals, effective anti-HIV medications have substantially reduced morbidity and mortality for those patients able to adhere to combination regimens. Despite improved survival, durable virologic suppression, and increases in peripheral CD4+T-cell counts in patients receiving potent antiretroviral therapy (ART), immune reconstitution remains incomplete as measured by a number of additional surrogate markers. Perhaps critically important among areas of apparent incomplete immune recovery is the gastrointestinal-associated lymphoid tissue (GALT), where CD4+T-cells repopulate very slowly, if at all. Raltegravir is a new ART agent from a novel class of HIV inhibitors, integrase inhibitors, that results in rapid suppression of HIV and recovery of peripheral CD4+T-cells. This project proposes to examine whether volunteers receiving raltegravir recover GALT immune cells more completely than those taking comparator ART.

Arms: arm 1: HIV Negative volunteers arm 2: HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications arm 3: HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
Interventions: intervention 1: raltegravir intervention 2: efavirenz
Intervention descriptions: intervention 1: 400mg tablet twice daily by mouth for nine months intervention 2: 600mg capsule once daily by mouth without regard to food

Protocol documents: