ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00845845
Conditions: Nonalcoholic Steatohepatitis (NASH) Hepatic Steatosis
Keywords: Non-alcoholic steatohepatitis Omega-3 fatty acids MRI NASH
Sponsor: University of Illinois at Chicago
Start date: 2006-03-01; Completion date: 2010-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).

Detailed description:

Arms: arm 1: Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks arm 2: Participants receive daily placebo and dietary counseling for 24 weeks
Interventions: intervention 1: Omega-3-acid ethyl esters (Lovaza) intervention 2: Placebo
Intervention descriptions: intervention 1: 4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks. intervention 2: Daily placebo with dietary counseling for 24 weeks.

Protocol documents:
Clinical trial NCT00857233
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Sponsor: H. Lundbeck A/S
Start date: 2004-06-01; Completion date: 2010-10-01
Enrollment: 297 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.

Detailed description:
Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.

The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158.

In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.

Arms: arm 1: None
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: 20 mg oral tablets once daily

Protocol documents:
Clinical trial NCT00860938
Conditions: COPD
Keywords: Inhaled corticosteroids COPD mannitol
Sponsor: Cantonal Hosptal, Baselland
Start date: 2007-04-01; Completion date: 2010-10-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.

Detailed description:
In patients with chronic obstructive pulmonary disease (COPD), the treatment with inhaled corticosteroids (ICS) is controversial. Preliminary results of our recent pilot study in 30 COPD patients showed for the first time, that ICS response mey be predicted by a bronchoprovocation challenge test with mannitol. However, this finding needs to be proven in a placebo-controlled trial. For this cohort study, 100 corticosteroid-naive, non reversible (FEV1) patients with COPD will be recruited. Spirometry before and after bronchodilation will be measured at study entry and at four weeks run-in (only tiotropium) and at three month of treatment with tiotropium and ICS or placebo. Quality of life (St. George Respiratory Quality of Life Questionnaire) and exacerbation rate of COPD will be assessed. Measurement of exhaled nitric oxide and mannitol challenge will be performed at study entry and at 1 and 4 month. Primary endpoint will be improvement in FEV1 in each group (positive and negative mannitol challenge) after 3 months follow up. Secondary endpoints will be the difference in dose-response-curve in the mannitol challenge, exacerbation rate and change in quality of life after three month follow-up.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Budesonide
Intervention descriptions: intervention 1: After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo

Protocol documents:
Clinical trial NCT00862121
Conditions: Crohn´s Disease
Sponsor: Ferring Pharmaceuticals
Start date: 2009-04-01; Completion date: 2010-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.

Detailed description:

Arms: arm 1: Mesalazine (Mesalamine) 2 g sachet; 6 g daily arm 2: Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
Interventions: intervention 1: Pentasa intervention 2: Placebo
Intervention descriptions: intervention 1: 6 g/day orally, 2 g in the morning and 4 g in the evening intervention 2: 6 g/day orally, 2 g in the morning and 4 g in the evening

Protocol documents:
Clinical trial NCT00872001
Conditions: Coronary Artery Bypass Myocardial Infarction Ventricular Dysfunction, Left Stroke Cardiopulmonary Bypass
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-01; Completion date: 2010-10-01
Enrollment: 3080 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.

Detailed description:

Arms: arm 1: Acadesine intravenous (IV) infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB) arm 2: Normal saline, IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
Interventions: intervention 1: Acadesine intervention 2: Normal Saline
Intervention descriptions: intervention 1: Acadesine 42 mg/kg diluted in normal saline to a total of 500 mL, delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 0.1 mg/kg/min (translating into 1.2 mL/min for a 500 mL solution). In addition, a 5 µg/mL cardioplegia solution of acadesine will be administered, and acadesine will be added to the priming solution (5 µg/mL) in the heart lung machine during CPB. intervention 2: Normal saline, 500 mL delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 1.2 mL/min for a 500 mL solution. In addition, standard cardioplegia solution with added normal saline will be administered, and placebo (normal saline) will also be added to the heart lung machine priming solution.

Protocol documents:
Clinical trial NCT00876694
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2010-10-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

Detailed description:

Arms: arm 1: Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. arm 2: Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
Interventions: intervention 1: Indacaterol 300 µg intervention 2: Salmeterol 50 µg
Intervention descriptions: intervention 1: Indacaterol 300 µg once daily (od) via SDDPI intervention 2: Salmeterol 50 µg twice daily (bid) via Diskus®

Protocol documents:
Clinical trial NCT00882713
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2009-02-01; Completion date: 2010-10-01
Enrollment: 202 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

Detailed description:

Arms: arm 1: Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.\[Mircera\]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)

Protocol documents:
Clinical trial NCT00895817
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic esophagitis acid reflux
Sponsor: Walter Reed Army Medical Center
Start date: 2008-04-01; Completion date: 2010-10-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (\> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.

The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Swallowed fluticasone intervention 2: Esomeprazole
Intervention descriptions: intervention 1: 440 µg twice daily for 8 weeks intervention 2: 40 mg once daily for 8 weeks

Protocol documents:
Clinical trial NCT00908076
Conditions: Parkinson's Disease
Keywords: constipation Parkinson's disease
Sponsor: Baylor College of Medicine
Start date: 2009-02-01; Completion date: 2010-10-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.

Detailed description:
Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasized. Problematic symptoms include varying degrees of dementia, psychosis, diminished assertiveness and confidence, general fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder, and a common yet difficult to define sense of "not feeling well".

A commonly missed symptom in Parkinson's patients is constipation. Constipation can be difficult to treat with current medications available and many are ineffective. Levodopa and dopamine agonists drugs are useful for motor symptoms in Parkinson's Disease but have no effect on constipation. Laxatives and enemas provide limited relief with bothersome side effects. Even fewer drugs have been studied targeting the constipation problem specifically in the Parkinson's Disease population. Lubiprostone (AMITIZA) is a new medication that has been studied in the general population for the treatment of chronic constipation. It has been shown to be a safe and effective medication with few side effects. Lubiprostone has not yet been studied in the Parkinson's Disease population. We hope to show that this medication can be safe and effective for constipation in PD patients as well.

Arms: arm 1: Amitiza arm 2: Matching Placebo
Interventions: intervention 1: LUBIPROSTONE
Intervention descriptions: intervention 1: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.

Protocol documents:
Clinical trial NCT00912093
Conditions: Hereditary Angioedema
Keywords: HAE Type I HAE Type II HAE
Sponsor: Shire
Start date: 2009-07-16; Completion date: 2010-10-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).

Detailed description:
This Phase III study consisted of two parts: A controlled phase and an open label extension (OLE) phase.

The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy and safety of icatibant compared with placebo for the first treated cutaneous and/or abdominal attack.

Patients with moderate to severe abdominal or cutaneous attacks were randomized to receive a single, blinded, subcutaneous injection of icatibant (30 mg) or placebo. After a protocol amendment, patients with mild to moderate laryngeal HAE attacks were also randomized to receive a single, blinded subcutaneous injection of icatibant (30 mg) or placebo in order to obtain blinded, controlled efficacy and safety data for this subset of subjects. Patients experiencing severe laryngeal attacks (post-amendment) or mild to severe laryngeal attacks (pre-amendment) were to receive open-label icatibant.

After treatment of the first attack in the controlled phase, patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the study was discontinued or the product was commercially available.

Arms: arm 1: Single subcutaneous injection of matching placebo arm 2: Single subcutaneous injection of icatibant, 30 mg
Interventions: intervention 1: Icatibant intervention 2: Placebo
Intervention descriptions: intervention 1: Single subcutaneous injection of icatibant, 30 mg intervention 2: Single subcutaneous injection of matching placebo

Protocol documents:
Clinical trial NCT00914186
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis Pruritus
Sponsor: Taisho Pharmaceutical R&D Inc.
Start date: 2009-06-01; Completion date: 2010-10-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.

Detailed description:
(none provided)

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: TS022 intervention 2: Vehicle
Intervention descriptions: intervention 1: Lotion intervention 2: Lotion

Protocol documents:
Clinical trial NCT00949533
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2009-08-01; Completion date: 2010-10-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.

Detailed description:

Arms: arm 1: Oseltamivir capsule will be administered orally at a dose of 75 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter \[mg/mL\]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. arm 2: Oseltamivir capsule will be administered orally at a dose of 150 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
Interventions: intervention 1: Oseltamivir
Intervention descriptions: intervention 1: Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days

Protocol documents:
Clinical trial NCT00956254
Conditions: Mucositis Pain Unspecified Adult Solid Tumor, Protocol Specific
Keywords: mucositis unspecified adult solid tumor, protocol specific pain
Sponsor: INSYS Therapeutics Inc
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis.

Detailed description:
RATIONALE: One dose of fentanyl sublingual spray may be effective in relieving pain in opioid-tolerant cancer patients.

PURPOSE: This phase III trial is studying the side effects of fentanyl sublingual spray and to see how well it works in treating opioid-tolerant cancer patients with or without oral mucositis.

OBJECTIVES:

Primary

* To compare the absorption/distribution kinetics of a single dose of fentanyl sublingual spray in opioid-tolerant cancer patients with or without oral mucositis.
* To evaluate the safety and tolerability of this regimen.

OUTLINE: This is a multicenter study.

Patients fast for at least 8 hours before and at least 4 hours after and no water is allowed for at least 1 hour before and at least 1 hour after study drug administration. Patients receive a single dose of fentanyl sublingual spray while in an upright position in clinical care recliners or beds, and remain in an upright posture for at least 4 hours after administration. Patients are instructed not to swallow for at least 5 minutes after administration and not to expectorate the drug.

After study drug administration, 10 blood samples are collected over a 12-hour period for pharmacokinetic and other analyses.

Arms: arm 1: Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Interventions: intervention 1: Fentanyl sublingual spray
Intervention descriptions: intervention 1: Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.

Protocol documents:
Clinical trial NCT00960076
Conditions: Type 2 Diabetes
Keywords: T2DM Metformin A1c
Sponsor: AstraZeneca
Start date: 2009-08-01; Completion date: 2010-10-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

Detailed description:

Arms: arm 1: Saxagliptin arm 2: Metformin Extended Release
Interventions: intervention 1: Saxagliptin intervention 2: Metformin XR intervention 3: Metformin XR
Intervention descriptions: intervention 1: 5mg oral tablet once daily intervention 2: 500mg oral tablet once daily intervention 3: 750mg, 2 tablets once daily

Protocol documents:
Clinical trial NCT00965562
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome PMS calcium
Sponsor: Donaghue Medical Research Foundation
Start date: 2000-09-01; Completion date: 2010-10-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.

Detailed description:
This is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the Yale site into treatment. Participants will be screened at various collaborating ob-gyn centers for possible PMS symptoms, and direct referrals from the community will also be accepted. Subject participation length is about 7 months with 6 scheduled study visits.

Methodology: After successfully completing the screening and qualification phase, participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind treatment. Participants will be evaluated monthly during the randomization phase for adverse events, concurrent medication, and primary and secondary efficacy variables.

.

Arms: arm 1: Fluoxetine arm 2: Calcium arm 3: None
Interventions: intervention 1: Fluoxetine intervention 2: Calcium intervention 3: Placebo
Intervention descriptions: intervention 1: Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium. intervention 2: 1200 mg of calcium to be taken for 5 menstrual cycles. intervention 3: For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.

Protocol documents: