ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00723801
Conditions: Marfan Syndrome
Keywords: Marfan syndrome Losartan Atenolol Diastolic Function Aortic Stiffness
Sponsor: Brigham and Women's Hospital
Start date: 2007-10-01; Completion date: 2012-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often present, and can be a predictor of aortic dilation and cardiovascular complications. In addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and logical therapeutic targets in adults with Marfan syndrome.

TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic stiffness and improves diastolic function in hypertension, renal disease and hypertrophic cardiomyopathy.

This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and echocardiography for diastolic function will be performed at the beginning and end of treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation will also be performed at 0 and 6 months. We plan to determine whether losartan decreases aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.

Detailed description:
Please See Summary.

Arms: arm 1: Losartan: 100 mg PO QD arm 2: Atenolol: 50 mg PO QD
Interventions: intervention 1: Atenolol intervention 2: Losartan
Intervention descriptions: intervention 1: Atenolol 50mg PO QD intervention 2: Losartan 100mg PO QD

Protocol documents:
Clinical trial NCT00736385
Conditions: Fatty Liver
Keywords: nonalcoholic fatty liver disease
Sponsor: Duke University
Start date: 2009-04-01; Completion date: 2012-12-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if Metformin is safe and useful in the treatment of NAFLD.

Detailed description:
NAFLD is a poorly understood disease which may cause an enlarged liver, abnormal liver test results, and scarring of the liver. It may occur more often in people with obesity, high levels of cholesterol (blood fats), diabetes (high blood sugar), or the insulin resistance syndrome (where a person's body does not respond to the hormone insulin which helps keep blood sugar levels normal). Currently, no effective drug treatment for NAFLD exists. There is increasing evidence that NAFLD may be a condition due to a problem with metabolism (the way your body uses energy). Previous studies have shown that high glucose (sugar) levels may play an important role in the development of fatty liver disease. Medications that decrease your natural glucose level may reduce the amount of fat in the liver and, therefore, might be useful in the treatment of NAFLD. Metformin, a drug approved by the U.S. Food and Drug Administration (FDA) for use in patients with diabetes, has been shown to improve fatty liver in animals and in a small number of human beings.

Arms: arm 1: Metformin XR (extended-release) 2000 mg daily arm 2: Placebo capsule
Interventions: intervention 1: Glucophage (Metformin) intervention 2: Placebo
Intervention descriptions: intervention 1: metformin XR 2000 mg daily for 12 months intervention 2: placebo 2000 mg daily for 12 months

Protocol documents:
Clinical trial NCT00737243
Conditions: Carcinoma
Keywords: Carcinoma of Unknown Primary Site Molecular profiling assay Bevacizumab Erlotinib Paclitaxel Carboplatin
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-08-01; Completion date: 2012-12-01
Enrollment: 289 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.

Detailed description:
The primary objective of the study is evaluate the impact of the molecular assay prediction on the efficacy of therapy for patients with carcinoma of unknown primary site (CUP). Investigators will use tumor profiling results to direct standard, site-specific first-line therapy for patients with CUP.

Arms: arm 1: Paclitaxel, Carboplatin, Bevacizumab and Erlotinib arm 2: Other treatment determined by physician based on molecular profiling assay
Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: Bevacizumab intervention 4: Erlotinib intervention 5: Treatment determined by physician
Intervention descriptions: intervention 1: 175 mg/m2, 1-3 hour IV infusion Day 1 intervention 2: AUC 6.0 IV Day 1 intervention 3: 15 mg/kg IV infusion Day 1 intervention 4: 150 mg PO intervention 5: Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Protocol documents:
Clinical trial NCT00750867
Conditions: Multiple System Atrophy
Keywords: multiple system atrophy, MSA, intravenous immunoglobulin, IVIg
Sponsor: University of Massachusetts, Worcester
Start date: 2008-06-01; Completion date: 2012-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only and does not alter the course of disease.

Although the cause of MSA remains unclear, there is evidence of presence of common neuroinflammatory mechanisms in the MSA brains including activation of microglia and production of toxic cytokines. This research protocol is based on hypothesis that the MSA progression can be altered by blocking the neuroinflammatory activity.

This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains antibodies derived from human plasma which can block the inflammatory responses in the brain that can lead to loss of brain cells.

Detailed description:

Arms: arm 1: Interventions included monthly infusions of intravenous immunoglobulin.
Interventions: intervention 1: intravenous immunoglobulin (IVIg)
Intervention descriptions: intervention 1: The intravenous immunoglobulin (brand Privigen) will be infused intravenously, monthly, 6 times, for 6 months the dose will be 0.4 gram/kg for each infusion.

Protocol documents:
Clinical trial NCT00753688
Conditions: Sarcoma, Soft Tissue
Keywords: metastatic soft-tissue sarcoma pazopanib Soft Tissue Sarcoma placebo
Sponsor: GlaxoSmithKline
Start date: 2008-10-01; Completion date: 2012-12-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

Detailed description:

Arms: arm 1: matching placebo 800 mg once daily orally arm 2: 800 mg once daily orally
Interventions: intervention 1: PAZOPANIB intervention 2: Placebo
Intervention descriptions: intervention 1: 800 mg once daily orally intervention 2: matching placebo 800 mg once daily orally

Protocol documents:
Clinical trial NCT00767520
Conditions: Breast Cancer
Keywords: Advanced Estrogen Receptor Positive Breast Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2009-02-01; Completion date: 2012-12-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Exemestane + Dasatinib intervention 2: Exemestane + Placebo
Intervention descriptions: intervention 1: Tablets, Oral, Exemestane 25 mg + Dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity intervention 2: Tablets, Oral, Exemestane 25 mg + Placebo 100 mg, once daily, until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00775229
Conditions: Trichotillomania
Keywords: hair pulling
Sponsor: University of Chicago
Start date: 2008-08-01; Completion date: 2012-12-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

Detailed description:
The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: Naltrexone arm 2: Placebo
Interventions: intervention 1: Naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: pill, by mouth, 50mg-150mg/day for the duration of the study intervention 2: pill, by mouth, daily

Protocol documents:
Clinical trial NCT00791778
Conditions: Ovarian Neoplasms
Keywords: Peritoneal Neoplasma
Sponsor: Bayer
Start date: 2008-11-01; Completion date: 2012-12-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Detailed description:

Arms: arm 1: Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) arm 2: Participants received 2 matching placebo tablets per oral twice daily
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration. intervention 2: Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.

Protocol documents:
Clinical trial NCT00803010
Conditions: Acute Graft Versus Host Disease
Keywords: Acute Graft Versus Host Disease (aGVHD) GVHD graft-versus-host disease tacrolimus sirolimus methotrexate combination therapy GVHD prophylaxis
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2008-09-01; Completion date: 2012-12-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).

Detailed description:
All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.

Arms: arm 1: Tacrolimus: beginning 3 days before transplant and given for at least 50 days.

Rapamycin: given the day before transplant and continued daily for at least one year. arm 2: Tacrolimus: beginning 3 days before transplant and given for at least 50 days.

Methotrexate: given on days 1, 3, 6 and 11, after transplant.
Interventions: intervention 1: Tacrolimus (TAC) intervention 2: Methotrexate (MTX) intervention 3: Rapamycin (RAPA)
Intervention descriptions: intervention 1: Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3. intervention 2: Methotrexate: administered on day 1 at dose of 15 mg/m\^2, and a dose of 10 mg/m\^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance. intervention 3: Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.

Protocol documents:
Clinical trial NCT00807846
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-09-01; Completion date: 2012-12-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Celecoxib intervention 2: Naproxen
Intervention descriptions: intervention 1: Celecoxib 50 mg or 100 mg PO BID for 6 weeks intervention 2: Naproxen 7.5 mg/kg PO BID \[maximum of 500 mg BID\] for 6 weeks

Protocol documents:
Clinical trial NCT00826228
Conditions: Osteoporosis Bone Loss Spinal Cord Injury
Sponsor: Thomas J. Schnitzer
Start date: 2009-06-01; Completion date: 2012-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.

Detailed description:
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.

Arms: arm 1: None
Interventions: intervention 1: teriparatide intervention 2: weight-bearing
Intervention descriptions: intervention 1: teriparatide 20ug daily sc for 6 months intervention 2: device assisted walking

Protocol documents:
Clinical trial NCT00839982
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Myelodysplastic Syndrome With Isolated Del(5q) Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Myeloid Leukemia
Sponsor: Fred Hutchinson Cancer Center
Start date: 2008-11-01; Completion date: 2012-12-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studied the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) that have relapsed or not responded to treatment.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) of oral clofarabine when given with LDAC (cytarabine) in patients age \>= 60 with previously treated AML or high risk MDS.

SECONDARY OBJECTIVES:

I. To determine the response rate, disease-free survival (DFS), and overall survival (OS) after therapy with oral clofarabine and LDAC for previously treated AML or high-risk MDS.

OUTLINE: This is a phase I, dose-escalation study of clofarabine followed by a phase II study.

Patients receive clofarabine orally (PO) once daily (QD) on days 1-5 and low-dose cytarabine subcutaneously (SC) twice daily (BID) on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.

Arms: arm 1: Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: clofarabine intervention 2: cytarabine
Intervention descriptions: intervention 1: Given PO intervention 2: Given SC

Protocol documents:
Clinical trial NCT00858845
Conditions: Heart Failure
Keywords: Leg Weakness Skeletal Myopathy Sympathetic Nerve Activity
Sponsor: University of California, Los Angeles
Start date: 2008-05-01; Completion date: 2012-12-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
People with heart failure often have weakness in their leg muscles. This study will determine whether the leg weakness is due to very high adrenaline levels and whether the medication clonidine can improve leg weakness.

Detailed description:
Heart failure is a common condition, affecting approximately 5 million people in the United States. People with heart failure are encouraged to exercise and lose weight. However, many people with heart failure develop weakness in their leg muscles, which can make exercise difficult. Increased sympathetic nerve activity, which involves the nerves that carry adrenaline, also occurs in people with heart failure. It is possible that the increased sympathetic nerve activity may actually cause the leg muscle weakness. Clonidine, a medication used to treat high blood pressure, has been found to decrease sympathetic nerve activity. This study will further examine the connection between leg weakness and sympathetic nerve activity. It will also evaluate the effectiveness of clonidine at decreasing leg weakness in people with heart failure. Results from this study may explain why some people with heart failure are unable to exercise and may help to identify ways in which leg strength can be increased.

This study will enroll people with heart failure. Participants will be randomly assigned to wear either a clonidine patch or a placebo patch for 3 months. Participants will wear the patch on their upper arm, and they will replace the patch each week. At study visits at baseline and Month 3, participants will undergo the following procedures:

* Sympathetic nerve activity recording, which will record nerve activity in the lower leg, using small electrodes inserted through the skin
* Muscle biopsy, in which a small piece of muscle tissue will be obtained from participants' legs
* Heart rate and blood pressure measurements
* Arterial baroreceptor measurements, in which the nerves in the body that respond to changes in blood pressure will be examined while participants receive different medications to increase and decrease their blood pressure
* Echocardiography to obtain images of the heart
* Magnetic resonance scan of the leg
* Passive exercise procedure, in which study researchers will conduct an arm exercise with participants

There will be no follow-up visits.

Arms: arm 1: Participants assigned to wear a clonidine patch. arm 2: Participants assigned to wear a matching placebo patch.
Interventions: intervention 1: Clonidine Patch intervention 2: Matching Placebo Patch
Intervention descriptions: intervention 1: A clonidine patch (0.1 mg/week) to be worn for a period of 3 months. intervention 2: A matching placebo patch to be worn for a period of 3 months.

Protocol documents:
Clinical trial NCT00865202
Conditions: Post-operative Delirium
Keywords: delirium surgery operation geriatric complication
Sponsor: University of Colorado, Denver
Start date: 2008-12-01; Completion date: 2012-12-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Post-operative delirium is a common and deleterious complication in elderly patients. The investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. The investigators hypothesize that post-operative supplementation of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study is a double-blinded placebo controlled trial of L-tryptophan supplementation in post-operative ICU patients 60 years and older. The primary outcome measure is the comparison of duration of post-operative delirium in subjects who receive L-tryptophan supplementation versus a similar appearing control.

Detailed description:
The sudy will compare rates and duration of postoperative delirium in groups that receive L-tryptophan supplementation compared to placebo.

Arms: arm 1: L-tryptophan supplementation (1 gram enterally three times per day) starting post-operatively and continuing for a maximum of 9 doses or the time of discharge from ICU (whichever occurs first) arm 2: Similar appearing placebo administered post-operatively (1 enterally three times per day) for a total of nine doses or discharge from ICU (whichever occurs first)
Interventions: intervention 1: L-tryptophan supplementation intervention 2: placebo
Intervention descriptions: intervention 1: L-tryptophan 1 gram enterally TID for a maximum of nine doses or to be discontinued at the time of discharge from the ICU (whichever occurs first) intervention 2: Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)

Protocol documents:
Clinical trial NCT00868192
Conditions: Ovarian Carcinoma Primary Peritoneal Carcinoma
Sponsor: Washington University School of Medicine
Start date: 2008-05-01; Completion date: 2012-12-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months.

Detailed description:
Patients will be treated with pemetrexed 500 mg/m2 IV and Bevacizumab 15 mg/kg IV every 3 weeks.The patient is treated indefinitely until side effects are deemed severe by the investigator or until progression. Disease progression is measured every 6 weeks using RECIST criteria.

Arms: arm 1: Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle

Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
Interventions: intervention 1: Pemetrexed intervention 2: Bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: