ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00595556
Conditions: Alcoholism Alcohol Abuse Alcohol Dependence
Keywords: Zonisamide Pharmacotherapy Alcohol dependence anticonvulsant
Sponsor: UConn Health
Start date: 2006-07-01; Completion date: 2009-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.

Detailed description:
Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism.

This is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.

Arms: arm 1: Zonisamide arm 2: placebo
Interventions: intervention 1: zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: flexible dosages of 100-500mg/day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00597818
Conditions: NSAID-induced Gastroduodenal Injury Ulcers Rheumatoid Arthritis Osteoarthritis
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2007-08-01; Completion date: 2009-05-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

Detailed description:

Arms: arm 1: Participants receive matching placebo capsules for 20 months arm 2: Participants receive 18 mcg cobiprostone once daily (QD) for 20 months arm 3: Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months arm 4: Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Interventions: intervention 1: Cobiprostone intervention 2: Placebo intervention 3: Non-steroidal anti-inflammatory drug
Intervention descriptions: intervention 1: 18 mcg cobiprostone capsules for oral administration intervention 2: Matching placebo capsules for oral administration intervention 3: Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Protocol documents:
Clinical trial NCT00599027
Conditions: Allergic Rhinitis Asthma
Sponsor: Organon and Co
Start date: 2008-05-01; Completion date: 2009-05-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.

Detailed description:
The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.

Arms: arm 1: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. arm 2: Placebo nasal spray once daily (two puffs per nostril) in the morning.
Interventions: intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Placebo nasal spray
Intervention descriptions: intervention 1: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. intervention 2: Placebo nasal spray once daily (two puffs per nostril) in the morning.

Protocol documents:
Clinical trial NCT00601250
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2009-05-01
Enrollment: 701 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Detailed description:

Arms: arm 1: Patients receive linagliptin 5 mg tablets once daily arm 2: Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
Interventions: intervention 1: linagliptin intervention 2: linagliptin
Intervention descriptions: intervention 1: Patients receive linagliptin 5 mg tablets once daily intervention 2: Patients receive linagliptin 5 mg tablets once daily

Protocol documents:
Clinical trial NCT00602472
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-02-01; Completion date: 2009-05-01
Enrollment: 1058 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets
Interventions: intervention 1: linagliptin intervention 2: placebo
Intervention descriptions: intervention 1: active intervention 2: placebo to linagliptin 5 mg

Protocol documents:
Clinical trial NCT00603538
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: CP-751,871, Non-small cell lung cancer, Phase 1
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2009-05-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CP-751,871 + carboplatin + paclitaxel
Intervention descriptions: intervention 1: Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.

Protocol documents:
Clinical trial NCT00605033
Conditions: Opiate Dependence Drug Dependence
Sponsor: Indivior Inc.
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.

Detailed description:

Arms: arm 1: Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. arm 2: Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Interventions: intervention 1: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 intervention 2: Subutex, Buprenorphine Hydrochloride, SCH 28444
Intervention descriptions: intervention 1: Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days intervention 2: Subutex sublingual tablet 4-24 mg, daily for 28 days

Protocol documents:
Clinical trial NCT00606489
Conditions: Burns
Sponsor: Cumberland Pharmaceuticals
Start date: 2007-11-01; Completion date: 2009-05-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Caldolor intervention 2: Placebo
Intervention descriptions: intervention 1: 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours intervention 2: Placebo

Protocol documents:
Clinical trial NCT00616902
Conditions: Chronic Kidney Disease (CKD) Stage 5 Hypertrophy, Left Ventricular
Keywords: Zemplar, paricalcitol, PRIMO II
Sponsor: Abbott
Start date: 2009-01-01; Completion date: 2009-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

Detailed description:

Arms: arm 1: Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis arm 2: Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Interventions: intervention 1: paricalcitol injection 4 mcg/mL intervention 2: Placebo Injection 4 mcg/mL
Intervention descriptions: intervention 1: Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis intervention 2: Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis

Protocol documents:
Clinical trial NCT00619073
Conditions: Blood Platelets Clopidogrel
Keywords: blood platelets platelet aggregation inhibitors antiplatelet drugs clopidogrel
Sponsor: University of Massachusetts, Worcester
Start date: 2008-04-01; Completion date: 2009-05-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Clopidogrel is a medication that is used to decrease the ability of platelets to form blood clots.

The theory has been proposed that, in patients with coronary artery disease or stroke, increased platelet function after discontinuation of clopidogrel therapy is associated with an increased clotting risk. However, this theory has never been rigorously tested.

The goal of this research is to determine whether discontinuation of clopidogrel results in increased platelet function.

Detailed description:
In this study, we will address the question: does discontinuation of clopidogrel result in platelet hyperreactivity? We will perform a double-blind, placebo-controlled, crossover study in normal subjects, in whom platelet reactivity will be measured before clopidogrel or placebo, during clopidogrel or placebo, and at various time points after discontinuation of clopidogrel or placebo. The dose of clopidogrel will be the standard, FDA-approved dose: 75 mg daily. All subjects will be treated with aspirin 81 mg daily throughout the 57 days of study assessment in both the clopidogrel arm and the placebo arm, because the clinically relevant question is: in patients who remain on aspirin, does discontinuation of clopidogrel result in platelet hyperreactivity?

Arms: arm 1: The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days. arm 2: The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
Interventions: intervention 1: clopidogrel + aspirin intervention 2: placebo intervention 3: Aspirin
Intervention descriptions: intervention 1: Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days. intervention 2: Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days. intervention 3: Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.

Protocol documents:
Clinical trial NCT00621140
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-02-01; Completion date: 2009-05-01
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate efficacy, safety and tolerability of BI 1356 versus placebo

Detailed description:

Arms: arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets
Interventions: intervention 1: linagliptin intervention 2: placebo
Intervention descriptions: intervention 1: active intervention 2: placebo

Protocol documents:
Clinical trial NCT00634114
Conditions: Reflux Esophagitis
Keywords: Reflux Esophagitis
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2009-05-01
Enrollment: 540 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.

Detailed description:

Arms: arm 1: Esomeprazole and Omeprazole arm 2: Esomeprazole
Interventions: intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Omeprazole
Intervention descriptions: intervention 1: 10mg once daily oral administration intervention 2: 20mg once daily oral administration intervention 3: 10mg once daily oral administration

Protocol documents:
Clinical trial NCT00642356
Conditions: Parkinson's Disease
Keywords: Idiopathic Parkinson's disease carbidopa/levodopa/entacapone non-motor symptoms motor-symptoms
Sponsor: Novartis
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa
Intervention descriptions: intervention 1: Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. intervention 2: Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.

Protocol documents:
Clinical trial NCT00645853
Conditions: Persistent or Permanent Nonvalvular Atrial Fibrillation
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2009-05-01
Enrollment: 523 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD0837 intervention 2: VKA INR 2-3
Intervention descriptions: intervention 1: Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od intervention 2: Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Protocol documents:
Clinical trial NCT00650078
Conditions: Rheumatoid Arthritis
Keywords: Signs and Symptoms Autoimmune Diseases Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Predniso(lo)ne
Sponsor: Amgen
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Modified Release (MR) prednisone 5 mg arm 2: None
Interventions: intervention 1: MR prednisone intervention 2: Placebo
Intervention descriptions: intervention 1: 1 x 5 mg daily intervention 2: 1x daily

Protocol documents:
Clinical trial NCT00655083
Conditions: Infantile Colic Infantile Functional Gastrointestinal Disorders
Keywords: Infantile colic Abdominal Cramps Colicky Pain Functional gastrointestinal disorders
Sponsor: Menarini Group
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.

Detailed description:
This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.

Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.

Arms: arm 1: Nepadutant 0.1 mg/kg arm 2: Nepadutant 0.5 mg/kg
Interventions: intervention 1: Nepadutant intervention 2: Nepadutant
Intervention descriptions: intervention 1: 0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) intervention 2: 0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)

Protocol documents:
Clinical trial NCT00658723
Conditions: Hemostasis
Sponsor: Ethicon, Inc.
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Detailed description:

Arms: arm 1: None arm 2: SURGICEL™ Absorbable Hemostat
Interventions: intervention 1: Fibrin Pad intervention 2: SURGICEL™
Intervention descriptions: intervention 1: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). intervention 2: Absorbable hemostat

Protocol documents:
Clinical trial NCT00667992
Conditions: Asthma
Keywords: Asthma hyperreactivity
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2009-05-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.

Detailed description:

Arms: arm 1: Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks arm 2: Budesonide HFA 400 mcg twice daily for 2 weeks arm 3: Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks arm 4: Budesonide CFC 400 mcg twice daily for 2 weeks
Interventions: intervention 1: Budesonide HFA intervention 2: Budesonide CFC
Intervention descriptions: intervention 1: standard daily inhaled dose intervention 2: standard daily inhaled dose

Protocol documents:
Clinical trial NCT00669396
Conditions: Pregnancy
Keywords: contraception emergency contraception pregnancy prevention after unprotected intercourse
Sponsor: University of Utah
Start date: 2008-04-01; Completion date: 2009-05-01
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

Detailed description:
This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.

Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Arms: arm 1: IUD arm 2: Oral levonorgestrel
Interventions: intervention 1: Copper T380 IUD intervention 2: levonorgestrel
Intervention descriptions: intervention 1: Copper T380 IUD intervention 2: 1.5 mg

Protocol documents: