ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00535613
Conditions: Emergence Agitation
Sponsor: University of Wisconsin, Madison
Start date: 2007-08-01; Completion date: 2010-12-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic.

Detailed description:
Emergence agitation is defined as a mental disturbance during the recovery from general anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It manifests in children as some combination of restlessness, moaning, inconsolable crying, involuntary physical activity, and thrashing about. This puts patients at risk of injuring themselves or their caregivers, causing bleeding or disruption of their surgical repair, and pulling out IVs and drains. It can be difficult to maintain necessary vital sign monitoring in these agitated patients, and constant one-on-one nursing is often required. When emergence agitation occurs, all members of the healthcare team, and the parents report dissatisfaction with the quality of the child's recovery from anesthesia.

Propofol is a commonly used intravenous anesthetic agent. Studies have compared continuous infusions of intravenous propofol versus inhalational sevoflurane for the maintenance of anesthesia. These have shown a significant decrease in the incidence of emergence agitation in the patients who received the propofol infusions. This proposed study will investigate the effects of a single bolus dose of propofol at the conclusion of a sevoflurane inhalational anesthetic.

Arms: arm 1: propofol arm 2: no propofol
Interventions: intervention 1: Propofol
Intervention descriptions: intervention 1: IV, single bolus at completion of anesthetic, 0.1 ml/kg

Protocol documents:
Clinical trial NCT00537511
Conditions: Carcinoma, Small Cell
Sponsor: Celgene
Start date: 2008-02-01; Completion date: 2010-12-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.

Detailed description:

Arms: arm 1: Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Interventions: intervention 1: Pomalidomide intervention 2: Cisplatin intervention 3: Etoposide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00545233
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period. arm 2: Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin [Copegus] intervention 3: Pioglitazone
Intervention descriptions: intervention 1: 180 micrograms subcutaneous weekly for 48 weeks intervention 2: 1000-1600 mg day orally for 48 weeks. intervention 3: 30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.

Protocol documents:
Clinical trial NCT00548470
Conditions: Schizophrenia Tobacco Use Disorder Nicotine Dependance
Keywords: schizophrenia varenicline cognition cigarette smoking
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2007-06-01; Completion date: 2010-12-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).

Detailed description:

Arms: arm 1: open label varenicline 2mg/day
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: Varenicline 1-2 mg/day

Protocol documents:
Clinical trial NCT00550862
Conditions: Liver Cirrhosis, Biliary
Keywords: PBC, Primary Biliary Cirrhosis, Liver,
Sponsor: Intercept Pharmaceuticals
Start date: 2007-10-01; Completion date: 2010-12-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

Detailed description:
None provided

Arms: arm 1: INT-747 10 mg once daily in combination with URSO for 12 weeks. arm 2: INT-747 25 mg once daily in combination with URSO for 12 weeks. arm 3: INT-747 50 mg once daily in combination with URSO for 12 weeks. arm 4: Placebo once daily in combination with URSO for 12 weeks.
Interventions: intervention 1: INT-747 intervention 2: Ursodeoxycholic Acid (URSO) intervention 3: Placebo
Intervention descriptions: intervention 1: Once a day (QD) by mouth (PO) intervention 2: Stable dose for at least 6 months prior to screening. Dose as prescribed by physician. intervention 3: Placebo

Protocol documents:
Clinical trial NCT00553735
Conditions: Dry Eye
Keywords: Dry Eye Graft versus Host Disease GVHD
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2007-08-01; Completion date: 2010-12-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.

Detailed description:
The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.

Arms: arm 1: If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)

The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score. arm 2: If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)

The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Interventions: intervention 1: Cyclosporine A 0.05% intervention 2: Arificial Tear
Intervention descriptions: intervention 1: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months. intervention 2: Artificial Tear - three times a day for 18 months.

Protocol documents:
Clinical trial NCT00553969
Conditions: Pre-hypertension
Keywords: cardiovascular disease prevention
Sponsor: University of Minnesota
Start date: 2007-11-01; Completion date: 2010-12-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.

Detailed description:
* This study will compare the effect of Coreg CR and lisinopril, separately and together, on Rasmussen Disease Score in a controlled study with an inactive substance (placebo).
* Study patients will have pre-hypertensive (slightly elevated) blood pressures not requiring therapy.
* Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. Angiotensin is a chemical that is made by the body continuously. Angiotensin narrows blood vessels and thereby maintains (elevates) blood pressure. When the enzyme is blocked by lisinopril, angiotensin cannot be converted into its active form. As a result, blood pressure is lowered. Lisinopril is a drug that has been approved for use by the U.S. Food and Drug Administration (FDA) and health authorities for the treatment of high blood pressure and heart failure.
* Coreg CR is a once-a-day heart medication that is part of a class of drugs known as beta-blockers. Beta-blockers prevent beta-adrenergic substances such as adrenaline from activating parts of the nervous system, including the heart. Beta-blockers therefore relieve stress on the heart by slowing heart beat, decreasing the force of heart muscle contractions, and reducing blood pressure. Coreg has also been approved by the FDA for the treatment of hypertension and various other cardiovascular conditions.
* It is possible that the beta blocker could increase the benefits of the ACE inhibitor by inhibiting renin production, which is an important step in angiotensin production. These two drugs may act together to provide even more protection to blood vessels and the heart.

Arms: arm 1: Coreg CR + lisinopril arm 2: Coreg CR + placebo arm 3: lisinopril + placebo arm 4: placebo + placebo
Interventions: intervention 1: carvedilol phosphate intervention 2: lisinopril intervention 3: carvedilol phosphate and lisinopril intervention 4: placebo and placebo
Intervention descriptions: intervention 1: Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months intervention 2: tablets, 10mg once daily for 1 month, 20mg once daily for 8 months intervention 3: carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months intervention 4: capsule once daily for 9 months; dosage unknown

Protocol documents:
Clinical trial NCT00560404
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-04-01; Completion date: 2010-12-01
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms sc monthly (starting dose) intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00576381
Conditions: Tetrology of Fallot Heart Ventricle Hypoplastic Left Heart
Keywords: Precedex Open Heart Surgery Dexmedetomidine Sedation
Sponsor: Athena Zuppa
Start date: 2006-04-01; Completion date: 2010-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

Detailed description:
This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

Arms: arm 1: Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion

Protocol documents:
Clinical trial NCT00579280
Conditions: Bipolar Disorder Panic Disorder Generalized Anxiety Disorder
Keywords: Randomized Double-Blind Placebo-Controlled Quetiapine DivalproexSodiumER Bipolar Anxiety Panic GAD
Sponsor: University of South Florida
Start date: 2007-07-01; Completion date: 2010-12-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Detailed description:
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of quetiapine SR monotherapy compared to divalproex sodium ER monotherapy in outpatient subjects with a lifetime bipolar I, II, or not otherwsise specified (NOS) disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 180 subjects will be randomized to obtain 90 subjects who complete the 8-week trial (30 completers per treatment group). This calculation is based on drop out rates in a similar patient population carried out by this group of collaborators. Subjects will be randomized to quetiapine SR or divalproex sodium ER or placebo in a 1:1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of extrapyramidal side effects (EPS). Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.

Arms: arm 1: Quetiapine SR (Quetiapine Sustained Release) arm 2: Divalproex Sodium ER (Divalproex Sodium Extended Release) arm 3: placebo
Interventions: intervention 1: quetiapine SR intervention 2: divalproex sodium ER intervention 3: placebo
Intervention descriptions: intervention 1: flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks intervention 2: Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks intervention 3: placebo

Protocol documents:
Clinical trial NCT00582972
Conditions: Osteoporosis Achlorhydria GERD Hip Fracture
Keywords: Calcium Absorption Fractional Calcium Absorption Omeprazole Stable Calcium Isotopes Proton Pump Inhibitor Intestinal Absorption of Calcium
Sponsor: University of Wisconsin, Madison
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

Detailed description:
Existing literature makes it unclear whether proton pump inhibitor therapy truly decreases intestinal calcium absorption. Up to 25 postmenopausal women will participate in this study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. The secondary outcomes include the change in urine n-telopeptide.

We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo three calcium absorption studies. The first 2 studies will determine the monthly variation in calcium absorption, while the 3rd study will occur after taking 40 mg of omeprazole daily for 30 days. Women will present to the research unit in the early morning and receive an oral and intravenous calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During the first stay, we will measure each subject's gastric pH by collecting gastric fluid from a temporary nasogastric tube. In consenting subjects we will collect one tube of blood, isolate its DNA.

Arms: arm 1: Subjects will receive omeprazole 40 mg daily for 30 days
Interventions: intervention 1: Omeprazole
Intervention descriptions: intervention 1: 40 mg po qAM one-half hour before breakfast for 30 days

Protocol documents:
Clinical trial NCT00589628
Conditions: Chronic Uveitis
Keywords: Childhood Uveitis
Sponsor: Egla C. Rabinovich
Start date: 2007-09-01; Completion date: 2010-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Participant responses will be measured at at four to eight week intervals for up to ten months.

Detailed description:
Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period. Initial to final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact test, depending on numbers available. Predictors of response will be examined by logistic regression.

Arms: arm 1: 5mg/kg/dose of infliximab IV every 4 weeks for 9 doses arm 2: 10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.
Interventions: intervention 1: infliximab intervention 2: infliximab
Intervention descriptions: intervention 1: 5mg/kg/dose IV at 4 week intervals intervention 2: 10mg/kg/dose IV at 4 week intervals

Protocol documents:
Clinical trial NCT00590161
Conditions: Nonalcoholic Steatohepatitis
Keywords: Fatty Liver Nonalcoholic fatty liver disease (NALFD) NAFLD Nonalcoholic steatohepatitis (NASH) NASH pentoxifylline
Sponsor: Case Western Reserve University
Start date: 2006-12-01; Completion date: 2010-12-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year will result in improvement of biochemical parameters of liver disease and hepatic histology. The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and levels of cytokines in patients with NASH.

Detailed description:

Arms: arm 1: Pentoxifylline (PTX) 400 mg by mouth (PO) three times daily (TID) arm 2: Placebo three times daily (TID)
Interventions: intervention 1: pentoxifylline (PTX) intervention 2: placebo
Intervention descriptions: intervention 1: 400 mg PO tid intervention 2: placebo tid

Protocol documents: