ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00269399
Conditions: Clostridium Infections Diarrhea
Keywords: Clostridium difficile-associated Diarrhea (CDAD) CDAD C diff
Sponsor: Bausch Health Americas, Inc.
Start date: 2005-12-01; Completion date: 2008-12-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).

Detailed description:
Clostridium difficile is a bacterium that proliferates when normal colonic flora have been altered, most commonly due to antibiotic use. Clostridium difficile is non-invasive and localized to the lumen of the colon. Once established, it produces 2 potent toxins, A and B. The principal reservoir for Clostridium difficile is the hospital environment, with the risk of acquiring Clostridium difficile increasing in direct proportion to the length of hospital stay.

Patients with CDAD typically present with profuse watery or mucoid diarrhea and cramping abdominal pain. Additional symptoms include fever, nausea, anorexia, malaise, and bloody stool. More severe cases may be complicated by dehydration, electrolyte disturbances, ileus, and peritonitis. Systemic manifestations may include prerenal azotemia, sepsis syndrome, and toxic colitis. White blood cell counts (WBCs) also may be markedly elevated with a shift to immature forms. Extreme presentation of fulminant colitis may require a colectomy and even result in death. Symptoms of CDAD may begin a few days after initiation of antibiotic therapy or up to 8 weeks after its discontinuation.

Arms: arm 1: rifaximin 400mg taken 3 times a day arm 2: vancomycin 125mg taken 4 times a day
Interventions: intervention 1: Rifaximin (Xifaxan) intervention 2: Vancomycin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00275301
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder BPD PET olanzapine brain
Sponsor: University of Minnesota
Start date: 2005-12-01; Completion date: 2008-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.

Detailed description:
The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. In an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment.

A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.

Arms: arm 1: Open-label Olanzapine.
Interventions: intervention 1: olanzapine
Intervention descriptions: intervention 1: Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks.

Protocol documents:
Clinical trial NCT00281320
Conditions: Psychosis
Sponsor: Organon and Co
Start date: 2006-02-01; Completion date: 2008-12-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Detailed description:

Arms: arm 1: Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID) arm 2: Dose titration from 5 mg to 10 mg BID
Interventions: intervention 1: Asenapine
Intervention descriptions: intervention 1: Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).

Protocol documents:
Clinical trial NCT00288366
Conditions: Schizophrenia Schizoaffective Disorder Bipolar Disorder
Keywords: schizophrenia schizoaffective disorder bipolar disorder metabolic syndrome
Sponsor: Northwestern University
Start date: 2006-01-01; Completion date: 2008-12-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.

The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.

Detailed description:

Arms: arm 1: aripiprazole (Abilify) arm 2: ziprasidone (Geodon)
Interventions: intervention 1: ziprasidone vs. aripiprazole intervention 2: aripiprazole vs. ziprasidone
Intervention descriptions: intervention 1: ziprasidone vs. aripiprazole dosed according to package insert intervention 2: aripiprazole vs. ziprasidone dosed according to package insert

Protocol documents:
Clinical trial NCT00304161
Conditions: Depressive Disorder Parkinson Disease
Keywords: Depression Parkinson's Disease Atomoxetine
Sponsor: University of Pennsylvania
Start date: 2004-07-01; Completion date: 2008-12-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Detailed description:
Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Arms: arm 1: Participants will receive 40-80mgs of atomoxetine orally once daily. arm 2: Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 40 to 80 mg orally once daily for 8 weeks intervention 2: 40 to 80 mg orally once daily for 8 weeks

Protocol documents:
Clinical trial NCT00307164
Conditions: HIV Infections Lipoatrophy
Keywords: Treatment Experienced Uridine
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2006-09-01; Completion date: 2008-12-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness of uridine supplementation in treating HIV infected individuals on stable ART with lipoatrophy.

Detailed description:
Lipoatrophy is a distressing long-term complication of ART and is associated with decreased quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood. However, past research suggests that mitochondrial toxicity in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues may be responsible for the development of lipoatrophy.

Uridine is a nucleoside that has been shown to be an effective supplement in treating individuals with mitochondrial toxicity. NucleomaxX is a food supplement that consists of mitocnol, a sugar cane extract that has a high content of nucleosides, including uridine. The purpose of this study was to evaluate the effects of uridine supplementation in the form of NucleomaxX on limb fat in HIV-infected individuals receiving stable ART containing stavudine (d4T) or zidovudine (ZDV). In addition, this study evaluated the safety and tolerability of NucleomaxX.

This study lasted for 48 weeks. Participants were randomly assigned to one of two treatment arms, stratified by d4T or ZDV use. Arm A participants received NucleomaxX for uridine, while Arm B participants received a placebo for NucleomaxX. Participants in both arms received their assigned intervention three times per day, every other day, for the duration of the study. There were 8 study visits over the 48-week study duration. Blood collection and a physical exam occurred at all study visits, and participants completed an adherence assessment at most visits. Participants underwent dual energy X-ray absorptiometry scans (DEXA) within 14 days prior to or following the screening visit and at other selected visits. Specific fasting tests for glucose and lipid levels occurred at selected visits. ART was not provided by this study.

Arms: arm 1: Participants received NucleomaxX for 48 weeks arm 2: Participants received NucleomaxX placebo for 48 weeks
Interventions: intervention 1: NucleomaxX intervention 2: NucleomaxX placebo
Intervention descriptions: intervention 1: 36 g sachet taken orally three times daily intervention 2: 36 g placebo sachet taken orally three times daily

Protocol documents:
Clinical trial NCT00319748
Conditions: Breast Cancer Ovarian Cancer Endometrial Cancer Cervical Cancer
Keywords: Breast Ovarian Endometrial Cervical Metastatic 852A IRM Oncology Metastatic Cervical Cancer Metastatic Ovarian Cancer Metastatic Breast Cancer Metastatic Endometrial Cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-04-01; Completion date: 2008-12-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.

Detailed description:
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.

Arms: arm 1: Patients treated with at least one dose - 852A subcutaneous injection. arm 2: Patients who received all 24 doses of 852A per protocol.
Interventions: intervention 1: 852A
Intervention descriptions: intervention 1: 0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.

Protocol documents:
Clinical trial NCT00333359
Conditions: Restless Legs Syndrome
Sponsor: XenoPort, Inc.
Start date: 2006-06-01; Completion date: 2008-12-01
Enrollment: 581 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description:
Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Arms: arm 1: 1200 mg XP13512, orally, once daily for 52 weeks
Interventions: intervention 1: XP13512 (GEn)
Intervention descriptions: intervention 1: 1200 mg XP13512, orally, once daily for 52 weeks

Protocol documents:
Clinical trial NCT00335283
Conditions: Larynx Disease
Sponsor: Vanderbilt University
Start date: 2006-08-01; Completion date: 2008-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.

Detailed description:
Postnasal drip (PND) is a common complaint that brings patients to the attention of their primary care physicians. It is also one of the most common reasons for patients to seek care from otolaryngologists. Traditionally, PND has been considered and treated as a symptom of sinonasal pathology. It has also been shown, along with Gastroesophageal reflux disease (GERD) and asthma, to be a major contributor to the development of chronic cough. PND refractory to treatment aimed at sinonasal disease is sometimes treated with anti-GERD therapy. This treatment modality is based on clinical experience. To date, there are no studies in the literature to support a causal relationship between PND and extraesophageal reflux (EER). In a case control study of patients with and without esophagitis El-Serag et al reported a significant association (odds ratio 1.6, 95%CI 1.4-1.8) between sinusitis and GERD. A later study by Ulualp et al in 11 CT confirmed cases of chronic sinusitis resistant to therapy with conventional sinus therapies they found a significantly higher prevalence of hypopharyngeal acid exposure in the sinusitis group than controls. Recently, in an open label prospective pilot trial, DiBaise et al treated 11 patients with sinusitis and 19 GERD patients with omeprazole 20mg bid for 3-months. 9/11 sinusitis patients were found to have GERD by pH monitoring and there was moderate (25-89%) improvement in the sinus symptoms in the omeprazole treated group. However, there are currently no placebo-controlled trials assessing efficacy of PPI's in patients with PND.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lansoprazole Tablet intervention 2: PH and impedence testing intervention 3: manometry intervention 4: lansoprazole intervention 5: placebo
Intervention descriptions: intervention 1: 40 mg bid x 16 weeks intervention 2: 24 hour ph monitoring intervention 3: done prior to pH probe to measure length of esophagus intervention 4: 40mg bid intervention 5: one tablet bid

Protocol documents:
Clinical trial NCT00345371
Conditions: Methamphetamine
Keywords: methamphetamine addiction
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2006-04-01; Completion date: 2008-12-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

Detailed description:

Arms: arm 1: Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. arm 2: After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Interventions: intervention 1: Topiramate intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00346333
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa, Inherited Retinal Degeneration
Sponsor: National Eye Institute (NEI)
Start date: 2003-07-01; Completion date: 2008-12-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.

Detailed description:
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with mid-peripheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by 60 years if left untreated. Vitamin A palmitate, 15,000 International Units (IU)/d and an omega-3 rich diet have been shown to slow the progression of this condition among adults with the typical forms.(see Archives of Ophthalmology,111:761-772,1993 ; Archives of Ophthalmology 122: 1306-1314, 2004; Archives of Ophthalmology 130(6):701-711,2013).

The present study was a randomized, controlled, double-masked trial with a planned duration of 5 years.Two hundred and forty adults with the typical forms of RP were assigned to either lutein 12mg/d or a control group. Patients in both groups received 15,000 IU/day of vitamin A palmitate in addition to the supplement under study. Participants agreed not to know the contents of the supplement or their group assignment until the end of the trial. The main outcome measurement was the total point score for the 30-2 program of the Humphrey Field analyzer (HFA). In addition,the total point score for the 60-4 program ,the total point score of the 30-2 and 60-4 programs combined, computer-averaged 30-Hz cone Electroretinogram (ERG) amplitude and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were measured annually as secondary endpoints.

Arms: arm 1: Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate arm 2: Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Interventions: intervention 1: Lutein intervention 2: Cornstarch control
Intervention descriptions: intervention 1: 12mg/d intervention 2: Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate

Protocol documents:
Clinical trial NCT00356135
Conditions: Coronary Arteriosclerosis Acute Coronary Syndrome
Sponsor: Eli Lilly and Company
Start date: 2006-07-01; Completion date: 2008-12-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

Detailed description:

Arms: arm 1: Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. arm 2: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. arm 3: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
Interventions: intervention 1: prasugrel 10 mg intervention 2: clopidogrel intervention 3: prasugrel placebo intervention 4: prasugrel 60 mg intervention 5: clopidogrel placebo
Intervention descriptions: intervention 1: 10 mg tablet taken orally intervention 2: 75 mg tablet taken orally intervention 3: oral, as blinding mechanism. intervention 4: 60 mg (six 10-mg tablets) taken orally intervention 5: oral, as blinding mechanism

Protocol documents:
Clinical trial NCT00358644
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia AML Decitabine Dacogen MGI PHARMA, INC.
Sponsor: Eisai Inc.
Start date: 2005-03-01; Completion date: 2008-12-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Decitabine
Intervention descriptions: intervention 1: 20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

Protocol documents: