ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01111292
Conditions: Colon Carcinoma Dysplasia in Crohn Disease Low Grade Dysplasia in Ulcerative Colitis Rectal Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2014-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot, randomized phase I/II trial studies how well inositol works in preventing colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the effect of myo-inositol (inositol), administered for 3 months, on phospho (P)-beta (B)-catenin staining in areas of low-grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.

SECONDARY OBJECTIVES:

I. To examine the effect of myo-inositol on regression of dysplasia. II. To examine the effect of inositol on p53 and Ki67 staining within remaining dysplasia.

III. To examine the effect of inositol on epithelial apoptosis (cleaved caspase-3) within dysplasia.

IV. To examine the effect of inositol on reductions in mucosal messenger ribonucleic acid (mRNA) levels of monocyte chemotactic protein 1 (MCP1), inducible nitric oxide synthase (iNOS), and cyclooxygenase (Cox)-2.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Beginning within 14 days after colonoscopy, patients receive inositol orally (PO) once daily (QD) on days 1-14 and twice daily (BID) on days 15-90.

ARM II: Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.

After completion of treatment, patients undergo biopsy and colonoscopy with or without mucosal resection.

After completion of study treatment, patients are followed up at 2 weeks.

Arms: arm 1: Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90. arm 2: Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
Interventions: intervention 1: Inositol intervention 2: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT01114360
Conditions: Hypertension
Keywords: Melatonin Hypertension Blood Pressure Cardiovascular Sleep Nighttime Nocturnal Catecholamines Sympathetic Nervous System Endothelial function African American
Sponsor: Emory University
Start date: 2010-03-01; Completion date: 2014-09-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.

Detailed description:
The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.

The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.

Finally, the investigator is looking into changes in vascular biology markers (P-selectin and e-selectin) on melatonin.

Arms: arm 1: African-American subjects with mild to moderate essential hypertension will be given 8mg time release melatonin for 4 weeks. (either before or after placebo exposure). arm 2: African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin)
Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 8 mg time-release melatonin pills, orally, once per night for 4 weeks. intervention 2: Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.

Protocol documents:
Clinical trial NCT01114373
Conditions: Hypertension
Keywords: Melatonin Hypertension Blood Pressure Cardiovascular Sleep Nighttime Nocturnal Catecholamines Sympathetic Nervous System Endothelial Function African American
Sponsor: Emory University
Start date: 2010-06-01; Completion date: 2014-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.

Detailed description:
The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.

The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.

Finally, the investigator is looking into changes in vascular biology markers P-selectin and e-selectin) on Melatonin.

Arms: arm 1: Subjects with mild to moderate essential hypertension will be given 24mg time release melatonin for 4 weeks either before or after exposure to 4 week of placebo with no washout period. arm 2: Subjects with mild to moderate essential hypertension will be given placebo for 4 weeks either before or after exposure to 4 weeks of 24mg daily dose of time release melatonin with no washout period.
Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 24mg of time release melatonin pills (3 x 8mg) to be taken orally at night for 4 weeks. intervention 2: Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.

Protocol documents:
Clinical trial NCT01124006
Conditions: Degenerative Disc Disease
Sponsor: DePuy Spine
Start date: 2010-01-01; Completion date: 2014-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Detailed description:

Arms: arm 1: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. arm 2: Sterile water for injection
Interventions: intervention 1: Intradiscal rhGDF-5 intervention 2: Water for injection
Intervention descriptions: intervention 1: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. intervention 2: Sterile water for injection

Protocol documents:
Clinical trial NCT01140191
Conditions: Leishmaniasis, Cutaneous
Keywords: leishmaniasis cutaneous WR 279,396 paromomycin gentamicin pharmacokinetics safety efficacy military
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2013-09-01; Completion date: 2014-09-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).

Detailed description:
Subjects will be screened over a period of up to 14 days prior to first treatment, and will receive treatment once daily for 20 days. Safety will be assessed by monitoring AEs, lesion site reactions, vital signs, hematology, and blood chemistry parameters.

Complete cure of ulcerated lesions is defined as 100% re-epithelialization or a measurement of ulceration of 0 x 0 mm. non-ulcerated treated lesions will also be measured to monitor total area of exposure of lesions to study drug and will be evaluated for cure (the absence of raised area on the skin).

Follow-up evaluations will be at 28 +2 days, 60 +7 days and 100 +14 days.

Arms: arm 1: All subjects in this one-arm study will receive topical WR 279,396
Interventions: intervention 1: WR 279,396
Intervention descriptions: intervention 1: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days

Protocol documents:
Clinical trial NCT01149538
Conditions: Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Partial Fetal Alcohol Syndrome Alcohol Related Neurodevelopmental Disorder Prenatal Alcohol Exposure
Keywords: FASD FAS Alcohol Prenatal Alcohol
Sponsor: University of Minnesota
Start date: 2010-07-01; Completion date: 2014-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.

Detailed description:

Arms: arm 1: Choline Bitartrate supplementation arm 2: Placebo for choline bitartrate supplementation
Interventions: intervention 1: Choline bitartrate intervention 2: Placebo for choline bitartrate
Intervention descriptions: intervention 1: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix. intervention 2: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.

Protocol documents:
Clinical trial NCT01154673
Conditions: Acute HIV Infection
Sponsor: University of Toronto
Start date: 2011-11-01; Completion date: 2014-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.

Detailed description:
The trial is a prospective, randomized, double-blinded, placebo-controlled study with follow-up to 5 years. Thirty-two individuals presenting with newly diagnosed acute or early HIV-1 infection as described in the inclusion criteria will be enrolled, with sixteen randomized to each arm. Individuals will be randomized to one of two arms: the "Intensive" arm with standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400mg /ritonavir 100mg BID) + Raltegravir + Maraviroc or the "placebo" arm with standard HAART+ Placebo for 48 weeks. Another group of individuals diagnosed with acute or early HIV-1 who elect to forego early treatment will be followed as non-randomized, untreated controls. At week 48, all patients will be informed of study results. If results are positive in the intensive treatment group, the placebo group will be offered to roll-over to the intense treatment arm and followed as an open-label cohort out to five years. Participants may stop treatment at any time and withdraw from the study. If they choose to do so, they will be followed according to the standards employed for all HIV-1 patients at the Maple Leaf clinic. At the five year point, the decision to terminate treatment will be made based on the existing state of the HIV-1 literature at the time.

Arms: arm 1: Patients in this arm will receive the following HAART regimen:

Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID for 96 weeks arm 2: Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) for 48 weeks and then offered open label Raltegravir and Maraviroc after 48 weeks
Interventions: intervention 1: raltegravir intervention 2: maraviroc intervention 3: emtricitabine 200mg /tenofovir 300mg intervention 4: lopinavir 400 mg/ritonavir 100mg
Intervention descriptions: intervention 1: Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART intervention 2: Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART intervention 3: emtricitabine 200mg /tenofovir 300mg QD intervention 4: lopinavir 400 mg/ritonavir 100mg BID

Protocol documents:
Clinical trial NCT01222689
Conditions: Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-11-01; Completion date: 2014-09-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together works in treating patients with locally advanced or metastatic pancreatic cancer that is refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

l. To assess overall survival (as measured by median survival and proportion of patients alive at 24 weeks) in patients with advanced pancreatic cancer who have received one prior line of systemic therapy when treated with the combination of AZD6244 (selumetinib) and erlotinib (erlotinib hydrochloride).

SECONDARY OBJECTIVES:

I. Progression-free survival (median progression-free survival \[PFS\] and proportion of patients with PFS at 12 and 24 weeks).

II. Cancer antigen (CA)19-9 biomarker response (defined as a 50% decline in serum CA19-9 level from baseline in patients with \> 2 x upper limit of normal \[ULN\] CA19-9 measurement).

III. Objective radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

IV. Safety and toxicity profile of the combination of AZ6244 and erlotinib.

OUTLINE:

Patients receive selumetinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2-3 months.

Arms: arm 1: Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: erlotinib hydrochloride intervention 2: selumetinib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01231633
Conditions: Macular Edema Central Retinal Vein Occlusion
Keywords: Macular Edema Central Retinal Vein Occlusion
Sponsor: Long Island Vitreoretinal Consultants
Start date: 2010-09-01; Completion date: 2014-09-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

Detailed description:

Arms: arm 1: Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. arm 2: Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Interventions: intervention 1: Ozurdex intervention 2: Avastin
Intervention descriptions: intervention 1: Ozurdex, 0.7mg dexamethasone intervention 2: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Protocol documents:
Clinical trial NCT01265498
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis (NASH)
Keywords: Farnesoid X Receptor FXR Nonalcoholic fatty liver disease Nonalcoholic steatohepatitis NAFLD NASH obeticholic acid
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2011-03-01; Completion date: 2014-09-01
Enrollment: 283 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS).

Detailed description:
To evaluate whether treatment with obeticholic acid, 25 mg daily for 72 weeks compared to treatment with placebo, improves the severity of nonalcoholic fatty liver disease (NAFLD) as determined from hepatic histology.

Arms: arm 1: obeticholic acid arm 2: Placebo
Interventions: intervention 1: obeticholic acid intervention 2: placebo
Intervention descriptions: intervention 1: 25 mg daily for 72 weeks intervention 2: placebo capsule, 25 mg daily for 72 weeks

Protocol documents:
Clinical trial NCT01267994
Conditions: Sensorineural Hearing Loss Autoimmune Inner Ear Disease
Keywords: Steroid Steroid-Resistant Autoimmune Inner Ear Disease Immune Mediated Hearing Loss Sudden Sensorineural Hearing Loss Meniere's Disease Autoimmune Hearing
Sponsor: Andrea Vambutas
Start date: 2011-06-01; Completion date: 2014-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.

Detailed description:
Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.

Arms: arm 1: Single Arm-Open Label use of Anakinra
Interventions: intervention 1: Anakinra
Intervention descriptions: intervention 1: 100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Protocol documents:
Clinical trial NCT01305252
Conditions: Hypertension, Pulmonary
Sponsor: Stanford University
Start date: 2010-07-01; Completion date: 2014-09-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Study Hypothesis:

Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a traditional "step-up" approach.

The study will evaluate:

1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome at 48 weeks.
2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials in PAH.
3. Utility of longer clinical trial design with the use of combined clinical events as time to clinical worsening surrogate

Detailed description:
This is a 48 week interventional study evaluating the effect of Dual therapy ( Treprostinil inhalations and Tadalafil) versus Mono therapy (Tadalafil). The impact of the therapy on cardiovascular parameters in PAH measured at 24 weeks and event free survival outcome at 48 weeks.

Arms: arm 1: tadalafil 40mg QD(Tadalafil 20 mg QD PO increasing to 40 mg QD as tolerated). arm 2: Treprostinil inhalation QID starting at 3 breaths per inhalation \& gradually increasing to 9 breaths.Each breath provides approximately 6 mcg of treprostinil.Tadalafil 20 mg QD PO increasing to 40 mg QD as tolerated.
Interventions: intervention 1: treprostinil inhalations intervention 2: tadalafil
Intervention descriptions: intervention 1: Treprostinil inhalation QID starting at 3 breaths per inhalation \& gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil. intervention 2: tadalafil 20mg QD PO increasing to 40mg QD as tolerated

Protocol documents:
Clinical trial NCT01348087
Conditions: Fragile X Syndrome
Keywords: Fragile X Syndrome Martin-Bell Syndrome Genetic Diseases X-Linked Escalante's syndrome
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-01; Completion date: 2014-09-01
Enrollment: 148 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212 (NCT01253629).study and patients who have participated in the previous proof-of-concept study CAFQ056A2204 (NCT00718341).

Detailed description:
A 148 patients were enrolled into this treatment extension trial conducted for at least 3 years. This extension trial was terminated after the decision to terminate the AFQ056 development program. The decision was based on the results of two randomized, double blind, placebo controlled phase IIb trials in adult and adolescent FXS patients (CAFQ056A2212 and CAFQ056B2214respectivly), both of which failed to demonstrate efficacy in the FXS population. As this extension trial was terminated, only the primary objective and safety are represented.

Arms: arm 1: All patients initiated treatment with AFQ056 at a starting dose of 25 milligram (mg) twice daily. The dose was titrated from 25mg bid to 50mg bid, 75mg bid and 100mg bid at weekly intervals. Dose adjustments (up- and down titrations) were permitted as needed to manage any tolerability issues and to ensure that patients reach their highest tolerated dose not to exceed 100mg bid.
Interventions: intervention 1: AFQ056
Intervention descriptions: intervention 1: The investigational drug, AFQ056, will be provided as hard gelatin capsules. Two different oral dosage strengths, identical in appearance, will be used.

Protocol documents: