ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00468299
Conditions: Early Pregnancy Failure Miscarriage Fetal Demise Anembryonic Pregnancy
Keywords: early pregnancy failure mifepristone misoprostol buccal miscarriage fetal demise anembryonic progesterone
Sponsor: Boston University
Start date: 2007-04-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there will be no difference in time to complete miscarriage between the two groups.

Detailed description:
The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated efficacy at one week. We have found that many women do not want to wait for one week for an outcome of their medical treatment, and want resolution sooner. This has hampered the widespread utilization of medical therapy in our institution.

We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to demonstrate the relative efficacy of two medication regimens for treatment of EPF by performing a randomized trial. One regimen will be 800μg buccal misoprostol alone and the other regimen will be 200mg mifepristone, orally, in addition to 800μg buccal misoprostol, simultaneously. The primary outcome will be complete abortion rates 24hours after medication administration. We hypothesize that mifepristone will not improve complete abortion rates at 24hrs.

Secondary outcomes include rates of abortion by medical treatment at one week, the indications for surgical intervention, relationship of progesterone levels and type of pregnancy failure to outcomes in the two groups. Another secondary objective is to assess satisfaction with the treatment process at the conclusion of pregnancy termination, and 3 weeks after the beginning of the process.

The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but buccal use is increasing. We will use buccal misoprostol, which is widely used at our institution. We will assess the efficacy of this route of administration as well as assess patient acceptability of this method.

Arms: arm 1: Women in this arm receive placebo and misoprostol 800 mcg buccally arm 2: Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally
Interventions: intervention 1: Misoprostol and placebo intervention 2: Mifepristone and misoprostol
Intervention descriptions: intervention 1: Women in this group receive 800 mcg misoprostol plus a placebo intervention 2: This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally

Protocol documents:
Clinical trial NCT00472446
Conditions: Thyroidectomy
Keywords: Surgery Thyroid gland cervical block Pain, Postoperative
Sponsor: Cantonal Hospital of St. Gallen
Start date: 2006-01-01; Completion date: 2008-12-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).

The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.

Detailed description:

Arms: arm 1: bilateral superficial cervical block, placed before surgery (just before skin incision) arm 2: placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision) arm 3: bilateral superficial cervical block, placed after surgery (just after skin closure) arm 4: placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)
Interventions: intervention 1: bilateral superficial cervical block intervention 2: placebo bilateral superficial cervical block
Intervention descriptions: intervention 1: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side. intervention 2: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.

Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.

Protocol documents:
Clinical trial NCT00481195
Conditions: Bipolar I Depression
Sponsor: Cephalon
Start date: 2007-06-01; Completion date: 2008-12-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day \[2 tablets\]) was allowed. The dosage could not be increased after it was decreased. intervention 2: Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.

Protocol documents:
Clinical trial NCT00486031
Conditions: Inflammatory Bowel Disease Ulcerative Colitis
Keywords: IBD UC Ulcerative Colitis Inflammatory Bowel Disease
Sponsor: Bausch Health Americas, Inc.
Start date: 2006-10-01; Completion date: 2008-12-01
Enrollment: 443 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Detailed description:
The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Arms: arm 1: None
Interventions: intervention 1: Balsalazide Disodium
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00487825
Conditions: Rheumatoid Arthritis
Keywords: ACR20, ACR50, ACZ885 (anti-interleukin-1beta monoclonal antibody), rheumatoid arthritis, methotrexate
Sponsor: Novartis
Start date: 2007-03-01; Completion date: 2008-12-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

Detailed description:

Arms: arm 1: Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. MTX was given as variable dosing regimen of 7.5 mg-15 mg weekly. arm 2: Methotrexate (MTX) was given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
Interventions: intervention 1: Canakinumab (investigational) intervention 2: Placebo intervention 3: Methotrexate (MTX)
Intervention descriptions: intervention 1: Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 2: Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 3: Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.

Protocol documents:
Clinical trial NCT00491400
Conditions: Diabetes Mellitus Metabolic Syndrome
Keywords: endothelium obesity diabetes mellitus dyslipidemia
Sponsor: Boston University
Start date: 2005-09-01; Completion date: 2008-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome.

Detailed description:
The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. The study is a double blind, placebo controlled, crossover study with the order of treatment randomized. Patients will receive each treatment for 8 weeks with a 1 week rest period between treatment periods. Endothelial function will be tested using non-invasive techniques before and after each treatments. A total of 40 subjects with diabetes or the metabolic syndrome will be enrolled at Boston Medical Center.

Arms: arm 1: Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second arm 2: Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second
Interventions: intervention 1: Fenofibrate intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 140 mg/day for 8 weeks intervention 2: 20 mg/day for 8 weeks

Protocol documents:
Clinical trial NCT00491764
Conditions: Onychomycosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-01; Completion date: 2008-12-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis.

Detailed description:

Arms: arm 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. arm 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. arm 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. arm 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. arm 5: Terbinafine 250 mg QD for 12 weeks. arm 6: Placebo for 24 weeks.
Interventions: intervention 1: SCH 56592 intervention 2: SCH 56592 intervention 3: SCH 56592 intervention 4: SCH 56592 intervention 5: Terbinafine intervention 6: Placebo
Intervention descriptions: intervention 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. intervention 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. intervention 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. intervention 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. intervention 5: Terbinafine 250 mg QD for 12 weeks. intervention 6: Placebo for 24 weeks.

Protocol documents:
Clinical trial NCT00492622
Conditions: Gastroparesis Gastroesophageal Reflux Disease
Keywords: Gastroparesis Gastroesophageal reflux disease heartburn
Sponsor: University of Louisville
Start date: 2007-06-01; Completion date: 2008-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Detailed description:
Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot.

Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.

Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.

Arms: arm 1: subjects receive immediate release omeprazole for 7 days then delayed release for 7 days arm 2: subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
Interventions: intervention 1: Immediate-release omeprazole intervention 2: Delayed-release omeprazole
Intervention descriptions: intervention 1: Immediate-release omeprazole 40 mg qam for 7 days intervention 2: Delayed-release omeprazole 40 mg qam for 7 days

Protocol documents:
Clinical trial NCT00493974
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease COPD Exacerbation Anti-leukotriene Length of Stay LOS
Sponsor: University of Minnesota
Start date: 2007-03-01; Completion date: 2008-12-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.

Detailed description:
COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. COPD is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Treatment usually includes inhaled bronchodilator or steroid medications that work by relaxing the muscles around the lung airways and reducing inflammation. Zileuton, a medication that is used to prevent asthma symptoms, may be beneficial in treating people who experience COPD exacerbations. Zileuton works by blocking the formation of substances that cause inflammation, fluid retention, and constriction in the lungs. The purpose of this study is to evaluate the effectiveness of zileuton at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation.

This study will enroll adults who are admitted to the hospital due to severe COPD symptoms. Participants will be randomly assigned to receive either zileuton or placebo four times a day for up to 14 days. While in the hospital, lung function testing and urine collection will occur. Study visits will occur at Days 14 and 30, and will include lung function testing, a medical history review, and a study drug adverse effects review.

Arms: arm 1: Zileuton (Zyflo, 600 mg 4 times a day) arm 2: Placebo
Interventions: intervention 1: Zileuton intervention 2: Placebo
Intervention descriptions: intervention 1: Zyflo tablets, 600 mg, 4 times a day intervention 2: Placebo 4 x daily

Protocol documents:
Clinical trial NCT00502996
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2008-12-01
Enrollment: 246 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
Interventions: intervention 1: Methotrexate intervention 2: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: \>=15 mg po/week intervention 2: 1g iv on days 1 and 15

Protocol documents:
Clinical trial NCT00505687
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro®
Sponsor: UCB Pharma
Start date: 2005-02-01; Completion date: 2008-12-01
Enrollment: 186 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Detailed description:
This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Arms: arm 1: Rotigotine
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

The maximum rotigotine dose allowed is 16 mg/24 hours.

Protocol documents:
Clinical trial NCT00506662
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-07-01; Completion date: 2008-12-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

Detailed description:
Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.

Arms: arm 1: Individually adjusted dose of insulin detemir once daily arm 2: Individually adjusted dose of insulin NPH once daily
Interventions: intervention 1: insulin detemir intervention 2: insulin NPH
Intervention descriptions: intervention 1: Treat-to-target, s.c. (under the skin) injection, once daily intervention 2: Treat-to-target, s.c. (under the skin) injection, once daily

Protocol documents:
Clinical trial NCT00511134
Conditions: Insomnia Nicotine Dependence
Keywords: insomnia nicotine dependence smoking smoking cessation zyban
Sponsor: Yale University
Start date: 2007-04-01; Completion date: 2008-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objectives:

The primary objective of this study is to determine the efficacy of eszopiclone at treating sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking cessation.

Sleep disturbances are a significant problem for smokers who are trying to quit smoking. Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents used to aid smoking cessation (e.g., pharmacotherapies) may disrupt sleep. Lunesta (eszopiclone) is a medication that has been approved by the FDA to treat insomnia. Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine withdrawal-related symptoms of sleep disturbance.

This study will be 7 weeks duration. All participants will begin taking Zyban at the beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2. Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the target quit date at the beginning of week 2. All subjects will receive eight (8) weekly sessions of brief individual supportive smoking cessation counseling.

Hypothesis:

It is hypothesized that significantly fewer sleep problems will be reported by participants taking Lunesta as compared to placebo. Specifically, it is expected that participants taking Lunesta will report less difficulty falling and staying asleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.

Detailed description:

Arms: arm 1: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks) arm 2: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks)
Interventions: intervention 1: Eszopiclone intervention 2: Bupropion
Intervention descriptions: intervention 1: eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule intervention 2: bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.

Protocol documents: