ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00719134
Conditions: Episodic Migraine
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2008-09-01; Completion date: 2013-12-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. Relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the RCT.

General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact.

General Hypothesis: The measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.

Detailed description:

Arms: arm 1: Maxalt administration at onset of migraine arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Maxalt intervention 2: placebo pill intervention 3: placebo pills
Intervention descriptions: intervention 1: anti-migraine drug intervention 2: placebo pills intervention 3: placebo pills

Protocol documents:
Clinical trial NCT00727649
Conditions: Fecal Incontinence
Keywords: fecal incontinence adults diarrhea
Sponsor: US Department of Veterans Affairs
Start date: 2008-07-01; Completion date: 2013-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Detailed description:
Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.

Arms: arm 1: Fiber (psyllium) powder arm 2: Loperamide
Interventions: intervention 1: Psyllium powder intervention 2: Loperamide
Intervention descriptions: intervention 1: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) intervention 2: 1 capsule daily for 28 days (weekly adjusted dose)

Protocol documents:
Clinical trial NCT00732160
Conditions: Diabetes Mellitus
Keywords: Glucose Insulin
Sponsor: Vanderbilt University
Start date: 2008-09-01; Completion date: 2013-12-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine the effect of aldosterone on how the body handles glucose (sugar).

Detailed description:
Determine the effect of aldosterone on glucose metabolism in humans.

Arms: arm 1: High Sodium diet- Vehicle infusion then Aldosterone infusion Low Sodium diet- Vehicle infusion then Aldosterone infusion arm 2: High Sodium diet- Aldosterone infusion then Vehicle infusion Low Sodium diet- Aldosterone infusion then Vehicle infusion arm 3: Low Sodium diet- Vehicle infusion then Aldosterone infusion High Sodium diet- Vehicle infusion then Aldosterone infusion arm 4: Low Sodium diet- Aldosterone infusion then Vehicle infusion High Sodium diet- Aldosterone infusion then Vehicle infusion
Interventions: intervention 1: Aldosterone infusion (A) intervention 2: Vehicle Infusion (V) intervention 3: High Sodium Diet (HS) intervention 4: Low Sodium Diet (LS)
Intervention descriptions: intervention 1: Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs) intervention 2: Vehicle infusion for 12.5 hours intervention 3: 160 mmol/d sodium diet for 7 days intervention 4: 20 mmol/d sodium diet for 9 days

Protocol documents:
Clinical trial NCT00768716
Conditions: Pain Fever Hepatotoxicity
Sponsor: Tufts University
Start date: 2008-12-01; Completion date: 2013-12-01
Enrollment: 95 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Although acetaminophen is the most commonly used nonprescription drug in the USA, little is known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The investigators long-term goal is to understand the causes of differences in acetaminophen disposition between people that are the result of genetic variation and ethnicity and may predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this particular study is to measure the rate of elimination of acetaminophen via the 3 main pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans (n=100) and African-Americans (n=100). These rates will then be correlated with selected genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and oxidation in subjects will be significantly correlated with the presence of polymorphisms in the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.

Detailed description:

Arms: arm 1: 2 x 500 mg acetaminophen by mouth once arm 2: 2 x 500 mg acetaminophen by mouth once
Interventions: intervention 1: Acetaminophen
Intervention descriptions: intervention 1: 2 x 500 mg by mouth once

Protocol documents:
Clinical trial NCT00782795
Conditions: Chronic Pancreatitis Insulin Resistance Normal or Mildly Abnormal Stool Fat Levels
Keywords: Chronic pancreatitis Insulin resistance
Sponsor: University of Michigan
Start date: 2008-11-01; Completion date: 2013-12-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or laboratory evidence of chronic pancreatitis.

The goal of the investigators is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.

Detailed description:
The pancreas is a digestive organ that secretes insulin (and other hormones) into the blood for regulating blood sugar (glucose) and digestive enzymes into the intestine for digesting and absorbing nutrients consumed in meals. Chronic pancreatitis is a progressive clinical disease of the pancreas, associated with swelling (inflammation), scarring (fibrosis) and loss of normal functioning tissue. Patients develop diabetes mellitus (elevated blood sugar), malabsorption of nutrients, weight loss and pain. Presently chronic pancreatitis is considered an irreversible condition because the mechanisms responsible for chronic pancreatitis are poorly understood and no therapy is proven. However, recent studies provide important clues that oral medications (Thiazolidinediones) used to treat diabetes mellitus might improve or reverse features of chronic pancreatitis, including elevated sugar or diabetes, reduced secretion of digestive enzymes, and pancreatic swelling and scarring.

Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.

Arms: arm 1: 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. arm 2: 1 sugar pill (placebo) taken once daily for 48 weeks.
Interventions: intervention 1: Pioglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks. intervention 2: None

Protocol documents:
Clinical trial NCT00787644
Conditions: Asthma Obesity
Keywords: Asthma Adipose Tissue Asthmatics Pioglitazone Actos Obesity Exacerbation Fat Overweight Leptin Adiponectin Wheezing Vermont Pulmonary Lung
Sponsor: University of Vermont
Start date: 2009-01-01; Completion date: 2013-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.

Researchers believe this occurs because excess adipose tissue (fat) in the bosy can cause higher-than-normal levels of leptin and lower levels of adiponectin in the blood.

The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.

Detailed description:
Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or placebo (an inactive pill). They will be given study medication to take every day for 12 weeks (3 months).

Participants will complete a number of asthma-related questionnaires and a variety of pulmonary function tests. Participants will undergo physical exams, an electrocardiogram, and blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell counts, glucose levels, BNP hormone levels, and liver function.

To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12 weeks after starting study drug. At these visits many of the pulmonary function tests and questionnaires will be repeated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pioglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months) intervention 2: Matching placebo (inert tablet)

Protocol documents:
Clinical trial NCT00790218
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma Hepatoma HCC
Sponsor: Can-Fite BioPharma
Start date: 2009-02-01; Completion date: 2013-12-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer. Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily basis. Treatment will be assessed for adverse effects and for effects on the tumor.

Detailed description:
This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in 2 phases: a dose-escalation phase, to determine the MTD of CF102 and to evaluate its safety/tolerability, PK, pharmacodynamic, and preliminary clinical activity; and a dose-confirmation phase, which will be a cohort expansion at or below the MTD (ie, the RP2D) of CF102. Subjects will be treated with oral doses of CF102 in consecutive, 28-day cycles. The initial dose of CF102 will be 1 mg twice daily (BID), with subsequent escalations to 5 and 25 mg BID, unless limited by toxicity. Subjects will be evaluated weekly for the first cycle, every 2 weeks for Cycles 2 and 3, and at the end of each subsequent cycle, up to 6 cycles of CF102 treatment. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug.

Arms: arm 1: An open-label trial in 28-day cycles. arm 2: An open-label trial in 28-day cycles. arm 3: An open-label trial in 28-day cycles.
Interventions: intervention 1: CF102
Intervention descriptions: intervention 1: CF102 capsules twice daily by mouth

Protocol documents:
Clinical trial NCT00795288
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid hemorrhage vasospasm cerebral blood flow cerebral metabolism autoregulation statin Vasospasm associated with Subarachnoid hemorrhage
Sponsor: Washington University School of Medicine
Start date: 2008-08-01; Completion date: 2013-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.

Detailed description:
We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Arms: arm 1: Simvastatin, 80 mg/day for 21 days arm 2: Placebo
Interventions: intervention 1: Simvastatin, 80 mg/day for 21 days intervention 2: placebo
Intervention descriptions: intervention 1: Active treatment group intervention 2: Control group

Protocol documents:
Clinical trial NCT00802919
Conditions: Schizophrenia Cigarette Smoking
Keywords: schizophrenia smoking nicotine cognitive deficits nicotinic receptors Cognitive Deficits in Schizophrenia
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2008-09-01; Completion date: 2013-12-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.

Detailed description:
This was a double-blind placebo controlled study of varenicline and matched placebo in patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with antipsychotic medication and were cigarette smokers. Three sites (2 U.S., 1 Israel) were supported by the Stanley grant. A similar independently supported study was conducted in Beijing, China. We were allowed to access these data and combine them for our analysis of results. Subjects at each site participated in a protocol which was approved by their institutional IRB. All subjects signed informed consent.

The study evaluated multiple measures of cigarette smoking, cognitive functions by MATRICS battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and psychiatric symptoms by PANSS (Positive and Negative Symptom Scale), SANS (Schedule For Assessment Of Negative Symptoms), and Calgary Depression scales. Lymphocytes were collected for measurement of epigenetically related mRNA's.

Arms: arm 1: Varenciline 1-2 mg/day arm 2: placebo for varenicline
Interventions: intervention 1: Varenicline intervention 2: Placebo for varenicline
Intervention descriptions: intervention 1: Varenicline 1-2 mg/day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00807586
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Corticosteroid Radiofrequency catheter ablation for atrial fibrillation
Sponsor: Minneapolis Heart Institute Foundation
Start date: 2008-12-01; Completion date: 2013-12-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease inflammation caused by the ablation and thus improve healing and decrease the chance of recurrence of atrial fibrillation.

In this study patients will be randomized to receive intravenous steroids or not immediately following the ablation.

Detailed description:
Atrial fibrillation, a common arrhythmia, is the source of considerable morbidity. Prevalence of atrial fibrillation in adults is 0.5%, increasing to 10% in those patients over the age of seventy five. Numbers are expected to increase nearly 2.5 fold over the next 50 years. Radiofrequency (RF) ablation to cure atrial fibrillation has become an established and effective therapy in the many atrial fibrillation patients. However, approximately 20% return with recurrent atrial fibrillation after ablation.

RF ablation directly targets the substrate for atrial fibrillation, cauterizing cardiac tissue through the application of radiofrequency energy , causing a myocardial lesion which effectively blocks the errant pathway. This process of RF ablation induces an inflammatory effect. As the lesion heals it often enlarges. This may contribute to recurrence of atrial fibrillation after ablation, as well as increased pain. There is some early evidence that a single dose of corticosteroids after ablation may improve the healing process, thus decreasing pain and incidence of recurrent atrial fibrillation.

The aim of the study is to determine the usefulness of a one time dose of solumedrol following radiofrequency ablation for atrial fibrillation..

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Solumedrol intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg, given once within 2 hours of the end of the ablation procedure intervention 2: Normal saline (1.6 cc)

Protocol documents:
Clinical trial NCT00810719
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer stage IV pancreatic cancer
Sponsor: University of California, Davis
Start date: 2009-04-01; Completion date: 2013-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer.

Detailed description:
OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2, downstream signaling molecules, and other molecular markers by immunohistochemistry and RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR, HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and periodically during study for polymorphism analysis and correlative molecular analysis of surrogate endpoint biomarkers.

After completion of study therapy, patients are followed every 3 months.

Arms: arm 1: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Interventions: intervention 1: Erlotinib intervention 2: gemcitabine
Intervention descriptions: intervention 1: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26. intervention 2: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

Protocol documents:
Clinical trial NCT00814502
Conditions: Dementia Alzheimer Disease Dementia, Vascular Sleep Disorders Circadian Dysregulation
Keywords: Alzheimer disease Dementia, vascular Actigraphy Circadian dysregulation Sleep Disorders Circadian rhythm
Sponsor: Massachusetts General Hospital
Start date: 2008-12-01; Completion date: 2013-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of placebo in improving sleep efficiency in people with dementia admitted to the hospital because of their symptoms. You can participate in this study if you have dementia of the Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We will use placebos to see if the study results are due to the study drug or due to other reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription. Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia (trouble falling or staying asleep).

Detailed description:
Sleep patterns normally change with age. Sleep/wake cycles appear to be compromised in people suffering from dementia. Most research involving sleep in dementia has involved community dwelling or nursing home residents. Relatively little is known about the sleep patterns of patients with dementia who develop acute behavioral and psychiatric symptoms and necessitate hospitalization. The relationship between sleep disturbances in these patients and behavioral/psychiatric symptoms is also insufficiently studied. The current study will examine these two sets of data (sleep/wake cycles and clinical symptoms) in a population of elderly subjects with Dementia of the Alzheimer's type (DAT) or vascular dementia (VD) during their hospitalization period. We will compare the sleep outcome measures (primarily sleep efficiency) and clinical outcome measures in subjects treated with Zolpidem CR or Placebo. We will utilize a double-blind, randomized, placebo-controlled design to test our hypothesis that targeting sleep disturbances in hospitalized elderly subjects with DAT or VD leads to improvement in sleep and clinical outcomes.

Arms: arm 1: Subjects randomized to Zolpidem CR arm 2: Subjects randomized to Placebo
Interventions: intervention 1: Zolpidem CR intervention 2: Placebo
Intervention descriptions: intervention 1: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay. intervention 2: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Protocol documents: