ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00619190
Conditions: Autistic Disorder Asperger Syndrome Autism Spectrum Disorder
Keywords: open label aripiprazole children adolescents autism spectrum disorders
Sponsor: University of North Carolina, Chapel Hill
Start date: 2006-01-01; Completion date: 2012-06-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

Detailed description:
The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.

Arms: arm 1: Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg arm 2: group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
Interventions: intervention 1: aripiprazole
Intervention descriptions: intervention 1: aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months

Protocol documents:
Clinical trial NCT00661453
Conditions: Spinal Muscular Atrophy Type I
Keywords: Spinal Muscular Atrophy SMA Valproic Acid
Sponsor: University of Utah
Start date: 2008-04-01; Completion date: 2012-06-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center trial to test safety and evaluate early treatment intervention with valproic acid and carnitine in moderating SMA symptoms of Type I infants.

Detailed description:
Spinal muscular atrophy (SMA) is a genetic disorder that results in severe muscle weakness. It is one of the most common conditions causing muscle weakness in children. Patients with SMA most often develop weakness as babies or young children. Most people with SMA gradually lose muscle strength and abilities over time. Babies with the severe infantile form of SMA, SMA type I, usually lose abilities and strength quickly over a few weeks or months.

Valproic acid (VPA) is a medicine that has been used for many years to treat patients with epilepsy. Recent research suggests that VPA may be able to upregulate expression of a backup copy of the SMN gene in SMA patient cell lines. In addition, some preliminary data suggests it may prolong survival in animal models of SMA. Because VPA can deplete carnitine in children with SMA Type I, carnitine is added to help prevent possible toxicity.

In this multi-center trial, we will evaluate the effects of VPA/carnitine on infants with SMA type I. A variety of outcome measures, including assessment of safety, will be performed at each study visit to follow the course of the disease. The protocol includes two baseline visits over a period of two weeks, two clinical assessments on medication at 3 and 6 months, and then 6 months additional followup via telephone. Total duration of the study will be approximately 12 months.

Arms: arm 1: All patients will receive VPA and carnitine.
Interventions: intervention 1: Valproic Acid and Levocarnitine
Intervention descriptions: intervention 1: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight

Protocol documents:
Clinical trial NCT00661622
Conditions: Uveal Melanoma Liver Metastases
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2004-10-01; Completion date: 2012-06-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:

* tumor cells will die due to a loss of their blood supply,
* local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and
* a systemic immune response against tumor cells may develop.

Detailed description:
Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization).

Arms: arm 1: Liver embolization treatment with injection of GM-CSF. arm 2: Liver embolization with normal saline injected in place of GM-CSF
Interventions: intervention 1: GM-CSF intervention 2: Embolization
Intervention descriptions: intervention 1: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver. intervention 2: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery

Protocol documents:
Clinical trial NCT00664209
Conditions: Parkinson's Disease Helicobacter Infections Motor Fluctuations
Keywords: Parkinson's disease levodopa Helicobacter pylori
Sponsor: University of California, Los Angeles
Start date: 2008-01-01; Completion date: 2012-06-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.

Detailed description:
Previous investigations have demonstrated that treatment of Helicobacter pylori with antibiotics leads to improved absorption and pharmacokinetics of levodopa. This may potentially benefit patients with Parkinson's disease who have motor fluctuations, specifically excessive "off" time, when their levodopa is not working to control symptoms. We seek to identify the frequency of H. pylori infection in this population using standard lab assays and determine whether eradication with standard triple therapy results in improved clinical response to medication.

Arms: arm 1: These subject receive treatment with active triple therapy followed by treatment with placebo therapy. arm 2: These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
Interventions: intervention 1: clartihromycin, amoxicillin, and omeprazole intervention 2: placebo
Intervention descriptions: intervention 1: clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days intervention 2: placebo therapy

Protocol documents:
Clinical trial NCT00666666
Conditions: Adenocarcinoma of the Prostate Stage IV Prostate Cancer
Keywords: prostate Cancer adenocarcinoma of the prostate stage IV prostate cancer newly diagnosed stage IV prostate cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2009-07-01; Completion date: 2012-06-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving gossypol together with androgen ablation therapy works in treating patients with newly diagnosed metastatic prostate cancer. Gossypol may stop the growth of tumor cells by blocking blood flow to the tumor. Androgens can cause the growth of prostate tumor cells. Luteinizing hormone-releasing hormone agonists and drugs, such as bicalutamide, may lessen the amount of androgens made by the body. Giving gossypol together with androgen ablation therapy may be an effective treatment for prostate cancer

Detailed description:
PRIMARY OBJECTIVE:

I. To determine the percentage of patients with newly diagnosed metastatic prostate cancer who demonstrate undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL) at 7 months when treated with R-(-)-gossypol (AT-101) and androgen ablation therapy.

SECONDARY OBJECTIVES:

I. To determine the safety of this regimen in these patients. II. To determine the percentage of patients with PSA \>= 4.0 ng/mL, overall PSA \< 4.0 ng/mL, and a PSA \>= 0.2 ng/mL but \< 4.0 ng/mL during the first 7 months of therapy.

OUTLINE:

Patients receive R-(-)-gossypol orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive bicalutamide PO QD beginning 6 weeks before the initiation of R-(-)-gossypol and continuing after completion of treatment, at the discretion of the treating physician.

Arms: arm 1: Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
Interventions: intervention 1: AT-101 intervention 2: Bicalutamide intervention 3: LHRH agent
Intervention descriptions: intervention 1: AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle. intervention 2: Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle. intervention 3: An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.

Protocol documents:
Clinical trial NCT00680706
Conditions: Heart Failure Diabetes
Sponsor: Baystate Medical Center
Start date: 2008-01-01; Completion date: 2012-06-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids.

We hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure.

Detailed description:

Arms: arm 1: Receives thiamine arm 2: None
Interventions: intervention 1: Thiamine intervention 2: Placebo
Intervention descriptions: intervention 1: Thiamine (100 mg) in 50 ml D5W, x 2. intervention 2: D5W (50 ml)

Protocol documents:
Clinical trial NCT00718315
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-04-01; Completion date: 2012-06-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: erlotinib [Tarceva] intervention 2: fusidic acid [Verutex] intervention 3: erythromycin [Eritex] intervention 4: Fisiogel
Intervention descriptions: intervention 1: 150mg po daily intervention 2: topical, daily for 30 days. intervention 3: topical, daily for 30 days. intervention 4: topical, daily for 30 days

Protocol documents:
Clinical trial NCT00719901
Conditions: Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2008-07-01; Completion date: 2012-06-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma. Obatoclax and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose and recommended phase II dose of obatoclax mesylate when given in combination with bortezomib in patients with relapsed or refractory multiple myeloma. (Phase I) II. To evaluate the response rate (complete response, partial response, and very good partial response) in patients treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free and overall survival of these patients.

II. To evaluate the incidence of toxicities of this regimen in these patients. III. To explore the utility of genetic markers based on initial evidence that they are predictive of drug responsiveness and/or successful target inhibition.

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

Patients receive obatoclax mesylate IV over 3 hours and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

Arms: arm 1: Patients receive obatoclax mesylate IV over 3 hours and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: obatoclax mesylate intervention 2: bortezomib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00722436
Conditions: Craniosynostosis Bleeding
Keywords: antifibrinolytic, tranexamic acid
Sponsor: University of Pittsburgh
Start date: 2008-07-01; Completion date: 2012-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.

Detailed description:
Surgical procedures for the correction of craniofacial deformities result in unavoidable and significant blood loss in small children and infants. Patients may experience blood losses that exceed one to two blood volumes. In an effort to reduce our transfusion requirements, we have introduced tranexamic acid into our practice. However, the benefit of tranexamic acid in pediatric craniofacial surgery has not yet been reported. We hypothesize that the intraoperative use of tranexamic acid in pediatric patients presenting for craniofacial reconstructions will reduce blood loss and allogeneic transfusion requirements.

This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. An initial dose of 100 mg/kg tranexamic acid (Cyclokapron 100mg/ml) or an equal volume of a placebo will be administered over 15 minutes after the induction of anesthesia and before the skin incision. A maintenance infusion of 10 mg/kg/hr of tranexamic acid or equal volume of a placebo will be started upon completion of the initial dose and will be continued until skin closure. The primary outcome will include the reduction in the total volume of allogeneic erythrocytes.

Arms: arm 1: Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous arm 2: Saline was administered intravenously
Interventions: intervention 1: Tranexamic acid intervention 2: saline
Intervention descriptions: intervention 1: 100 mg/kg load, then 10 mg/kg/hr intervention 2: Placebo

Protocol documents:
Clinical trial NCT00723177
Conditions: Opioid-Related Disorders
Keywords: opioid withdrawal, analgesia
Sponsor: New York State Psychiatric Institute
Start date: 2008-10-01; Completion date: 2012-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.

Detailed description:
Opioid-induced cytokine release and glial activation has been proposed to directly contribute to the affective and physiological aspects of withdrawal. Furthermore, cytokine release following opioid administration has been hypothesized to be a limiting factor in both the duration and magnitude of opioid-induced analgesia. The two primary goals of our study are to assess AV411's ability to 1) reduce the opioid-withdrawal syndrome and 2) increase and prolong the analgesic effects of the mu-opioid agonist, oxycodone. To explore whether AV411 decreases opioid-induced glial cell activation, some participants assigned to the placebo and high dose AV411 groups (n = 6 for each dose condition) will be studied twice with \[11C\]PK11195, a positron emission tomography (PET) radiotracer used to measure the peripheral benzodiazepine receptor (PBR) in the human brain. The PBR is a receptor located on the mitochondria of the microglia and can be used to examine microglial activation in various brain regions.

Arms: arm 1: This group will receive placebo drug arm 2: This group will receive a low dose of AV411 arm 3: This group will receive a high dose of AV411
Interventions: intervention 1: AV411 intervention 2: Placebo (PCB)
Intervention descriptions: intervention 1: Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks intervention 2: Placebo drug will be administered orally twice a day (BID) for two consecutive weeks

Protocol documents:
Clinical trial NCT00732654
Conditions: Milk Allergy
Keywords: Food Allergy Oral Immunotherapy Immunoglobulin E
Sponsor: Johns Hopkins University
Start date: 2008-08-01; Completion date: 2012-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

Detailed description:

Arms: arm 1: These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.

Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years. arm 2: These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years. arm 3: These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
Interventions: intervention 1: Milk Protein Extract Immunotherapy goal of 4mg/day intervention 2: Milk Protein Extract Immunotherapy goal of 7mg/day intervention 3: Milk Powder Immunotherapy goal dose 2000 mg/day intervention 4: Milk Powder Immunotherapy goal dose 1000mg/day
Intervention descriptions: intervention 1: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. intervention 2: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years. intervention 3: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. intervention 4: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Protocol documents: