ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00983645
Conditions: Renal Transplant Rejection
Keywords: Kidney Transplantation Immunosuppression
Sponsor: Loma Linda University
Start date: 2004-10-01; Completion date: 2013-03-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.

Detailed description:
This study aims to include Hispanics who have undergone a renal transplant to determine the specific outcome after renal transplantation, assuming that ethnic groups require different immunosuppressant regimens. Trough levels in transplant recipients determine the dosing requirements for Tacrolimus and Cyclosproine. It has been recently found, however, that testing cyclosporine levels in the blood 2 hours after taking cyclosporine is more effective in dosing cyclosprine for renal transplant patients than trough levels. The specific study aims include comparing the cyclosporine monitoring in patients with trough and C2 levels, and adjusting immunosuppression based on C2 levels.

Arms: arm 1: Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants arm 2: Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Interventions: intervention 1: Prograf intervention 2: Neoral
Intervention descriptions: intervention 1: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID intervention 2: Cyclosporine (Neoral) starting dose 3mg/kg PO BID

Protocol documents:
Clinical trial NCT00989911
Conditions: Congenital Heart Disease
Keywords: Single ventricle congenital heart disease
Sponsor: University of California, Los Angeles
Start date: 2010-05-01; Completion date: 2013-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.

Detailed description:
Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.

Arms: arm 1: Bosentan
Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.

Protocol documents:
Clinical trial NCT00990106
Conditions: Stress Disorders, Post-Traumatic Combat Disorders Sleep Disorders
Keywords: posttraumatic stress disorder PTSD nightmares prazosin sleep disturbance combat trauma
Sponsor: Seattle Institute for Biomedical and Clinical Research
Start date: 2009-09-01; Completion date: 2013-03-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether prazosin will:

* reduce the incidence of nightmares and sleep disturbance
* increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.

Detailed description:
This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the treatment of PTSD trauma-related nightmares, sleep disturbance, global function and sense of well-being, and other clinical features and comorbidities of PTSD. Participants will be 210 OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or psychotherapy will be maintained constant. Randomization will be stratified by site and use of an antidepressant.

Arms: arm 1: prazosin Pfizer Minipress

oral capsules

Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. arm 2: placebo

oral capsules

Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.
Interventions: intervention 1: prazosin hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually. intervention 2: placebo

Protocol documents:
Clinical trial NCT01008904
Conditions: Breast Cancer Cancer Survivor Hot Flashes Unspecified Adult Solid Tumor, Protocol Specific
Keywords: cancer survivor hot flashes breast cancer unspecified adult solid tumor, protocol specific
Sponsor: Virginia Commonwealth University
Start date: 2009-07-01; Completion date: 2013-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.

PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.

Secondary

* To evaluate the effect of magnesium oxide on overall quality of life.
* To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses.

OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium oxide twice daily in weeks 4 and 5.

Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment. Patients also complete quality-of-life, symptom, and self-assessment questionnaires at baseline, once weekly during treatment, and at the completion of treatment.

After completion of study treatment, patients are followed up for at least 30 days.

Arms: arm 1: Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Interventions: intervention 1: magnesium oxide intervention 2: questionnaire administration intervention 3: quality-of-life assessment
Intervention descriptions: intervention 1: Given PO intervention 2: Ancillary studies intervention 3: Ancillary studies

Protocol documents:
Clinical trial NCT01021215
Conditions: Tobacco Use Disorder
Keywords: Cancer Prevention Smoking-related lung disease Smoking Celecoxib Celebrex Zileuton Zyflo CR Prevention
Sponsor: National Cancer Institute (NCI)
Start date: 2010-05-01; Completion date: 2013-03-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether short-term administration of zileuton, a 5-lipoxygenase (5-LO) inhibitor, in current smokers will suppress the formation of urinary leukotriene E4 (LTE4) and shunt arachidonic acid into the cyclooxygenase (COX) pathway, resulting in elevated urinary prostaglandin E-metabolite (PGE-M).

SECONDARY OBJECTIVES:

I. To determine whether short-term co-administration of celecoxib, a selective COX-2 inhibitor, and zileuton suppresses levels of both urinary LTE4 and PGE-M in current smokers.

II. To evaluate the association between baseline levels of urinary LTE4 and magnitude of the arachidonic acid shunt induced by zileuton.

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

ARM I: Patients receive zileuton orally (PO) twice daily (BID) on days 1-6.

ARM II: Patients receive zileuton as in Arm I and celecoxib PO BID on days 1-6.

Arms: arm 1: Zileuton 1200 mg twice orally twice a day on days 1-6. arm 2: Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
Interventions: intervention 1: Zileuton intervention 2: Celecoxib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: 1200 mg twice daily given orally (PO) for 6 days intervention 2: 200 mg twice daily given orally for 6 days intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01031810
Conditions: Major Depressive Disorder
Keywords: Treatment Resistant depression Major Depression MDD Depression
Sponsor: New York State Psychiatric Institute
Start date: 2009-11-01; Completion date: 2013-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A) levels are elevated in patients with treatment-resistant major depression, and to explore whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI) medication in this population.

Detailed description:
While Major Depressive Disorder (MDD) is prevalent and disabling, compelling recent data from the Sequenced Treatment Alternatives to Relieve Depression (STAR\*D) study indicate that only about half of patients attain remission from MDD, even after multiple antidepressant medication trials. Further, no biomarker has been validated which can select an effective treatment for such patients, presenting critical unmet intellectual and clinical challenges. The recent landmark finding of an markedly elevated level of monoamine oxidase A (MAO-A) in the brains of depressed patients with MDD compared to controls, using positron emission tomography (PET) with a positron-emitting carbon isotope, (carbon 11 \[11C\]) labeled monoamine oxidase inhibitor (MAOI), has provided an unparalleled opportunity to address these challenges. It has long been known that MAOIs are effective for some patients with treatment-resistant MDD, although their side effect profile makes them highly unacceptable both to patients and physicians, severely curtailing their utility.

This study seeks to: 1) replicate this study using PET scans in 20 subjects with MDD but extending it to patients with treatment-resistant depression (TRD). (Results from these participants with be compared to those from 10 non-depressed controls; 2) explore the correlation of the brain MAO-A level biomarker to treatment outcome by treating the 20 PET-imaged TRD patients with an MAOI, hypothesizing that their MAOI response will be related to their level of MAO-A. Brain MAO-A is an ideal candidate biomarker for this study since it appears to be significantly abnormally elevated in MDD, yet it has a broad range of values even among depressed patients. Most importantly, the MAO-A biomarker is known to be the single pharmacologic target of the treatment, making it appear likely that outcome with MAOI treatment will be related to MAO-A.

Arms: arm 1: patients will receive treatment with tranylcypromine
Interventions: intervention 1: tranylcypromine
Intervention descriptions: intervention 1: MAO-Inhibitor 60mg-120mg

Protocol documents:
Clinical trial NCT01039688
Conditions: Arthritis, Rheumatoid
Keywords: oral JAK inhibitor MTX DMARD clinical trial joint diseases autoimmune diseases anti-Inflammatory agents rheumatic diseases
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2013-03-01
Enrollment: 956 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Disease-modifying antirheumatic drug
Intervention descriptions: intervention 1: Oral tablets administered at a dose of 5 mg BID for 24 months intervention 2: Oral tablets administered at a dose of 10 mg BID for 24 months intervention 3: Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months

Protocol documents:
Clinical trial NCT01075152
Conditions: Cryptococcal Meningitis HIV Infections AIDS
Keywords: cryptococcal meningitis cryptococcus cryptococcosis HIV AIDS strategy
Sponsor: University of Minnesota
Start date: 2010-11-01; Completion date: 2013-03-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

Detailed description:
After 7-11 days of amphotericin B therapy, subjects will be randomized in a 1:1 allocation to:

* Early initiation of ART (Experimental Group) = ART initiated within 48 hours after study entry, OR
* Standard initiation of ART (Control Group) = ART at \>=4 weeks after study entry

HIV therapy will be with efavirenz plus nucleoside backbone per national guidelines for first line therapy.

Arms: arm 1: HIV therapy initiated at 7-13 days of cryptococcal meningitis diagnosis. HIV therapy consisting of a nucleoside with lamivudine and efavirenz. arm 2: HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week).

HIV therapy consisting of a nucleoside with lamivudine and efavirenz.
Interventions: intervention 1: efavirenz intervention 2: nucleoside
Intervention descriptions: intervention 1: Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis. intervention 2: Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.

Protocol documents:
Clinical trial NCT01077401
Conditions: Diabetic Macular Edema
Keywords: Diabetic edema DME
Sponsor: Johns Hopkins University
Start date: 2010-02-01; Completion date: 2013-03-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema (DME).

Detailed description:

Arms: arm 1: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. arm 2: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Interventions: intervention 1: Ranibizumab intervention 2: ranibizumab
Intervention descriptions: intervention 1: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. intervention 2: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Protocol documents:
Clinical trial NCT01095666
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2013-03-01
Enrollment: 1484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Metformin intervention 4: Dapagliflozin Placebo intervention 5: Pioglitazone
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, Once daily, 24 weeks intervention 2: Tablets, Oral, 10 mg, Once daily, 24 weeks intervention 3: Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks intervention 4: Tablets, Oral, 0 mg, Once daily, 24 weeks intervention 5: Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Protocol documents:
Clinical trial NCT01101867
Conditions: Diabetes Admitting Hospital Non-critically Ill
Keywords: diabetes glucose hospital
Sponsor: Kathleen Dungan
Start date: 2010-06-01; Completion date: 2013-03-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Detailed description:
The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Arms: arm 1: aspart dose determined based upon carbohydrate intake. arm 2: fixed meal dose of aspart (based upon weight or total daily insulin dose)
Interventions: intervention 1: Aspart fixed dose intervention 2: Aspart flexible dose
Intervention descriptions: intervention 1: fixed dose intervention 2: dose based upon carbohydrate intake and total daily requirements

Protocol documents:
Clinical trial NCT01114737
Conditions: Phenylketonuria
Keywords: Phenylketonuria PKU Kuvan Sapropterin dihydrochloride Neuropsychiatric disorder ADHD
Sponsor: BioMarin Pharmaceutical
Start date: 2010-08-01; Completion date: 2013-03-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blind, placebo-controlled, randomized study is designed to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU.

Detailed description:
Phenylketonuria (PKU) results from deficient phenylalanine hydroxylase (PAH) activity and leads to toxic phenylalanine (Phe) accumulation in patients with PKU causing mental retardation, microcephaly, delayed speech, seizures, psychiatric symptoms and behavioral abnormalities. Although for most PKU patients early initiation of dietary treatment prevents severe complications, discontinuation of dietary restrictions at an early age is associated with poor cognitive development and neuropsychiatric disorders are present even in early-treated and well controlled PKU patients.

This study, PKU-016, will be conducted in PKU patients to evaluate the therapeutic effects of sapropterin dihydrochloride on the symptoms of attention deficit hyperactivity disorder (ADHD), depression, and anxiety.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sapropterin dihydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). intervention 2: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.

Protocol documents:
Clinical trial NCT01121666
Conditions: Infertility
Keywords: Assisted reproductive treatment Superovulation Follitropin alfa r-hFSH AFOLIA
Sponsor: Finox AG
Start date: 2010-06-01; Completion date: 2013-03-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Follitropin alfa
Intervention descriptions: intervention 1: 150IU per day subcutaneously for a maximum of 16 days

Protocol documents:
Clinical trial NCT01127763
Conditions: Breast Cancer
Keywords: metastatic breast cancer
Sponsor: NYU Langone Health
Start date: 2010-06-01; Completion date: 2013-03-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study investigates the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer.

Detailed description:
The primary objective of this study was to determine clinical benefit rate (CBR) i.e.complete remission (CR) + partial remission (PR) + stable disease (SD) lasting ≥ 6 months, and the toxicity of RAD001 /carboplatin in women with metastatic triple-negative breast cancer. Treatment consisted of intravenous carboplatin at area under the plasma concentration-time curve (AUC) 6, later decreased to AUC 5, and subsequently to AUC 4 every 3 weeks with daily 5mg RAD001.

Arms: arm 1: Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
Interventions: intervention 1: RAD001 intervention 2: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01135914
Conditions: Diabetic Macular Edema
Keywords: DME visual impairment diabetes macular edema diabetic macular edema ranibizumab laser photocoagulation retinopathy retina
Sponsor: Novartis Pharmaceuticals
Start date: 2010-07-01; Completion date: 2013-03-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.

Detailed description:

Arms: arm 1: Participants received ranibizumab intravitreal injection and laser photocoagulation treatments arm 2: Participants received ranibizumab intravitreal injection therapy only arm 3: Participants received Laser photocoagulation therapy only
Interventions: intervention 1: ranibizumab intervention 2: Laser
Intervention descriptions: intervention 1: Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms. intervention 2: Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.

Protocol documents: