ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00768430
Conditions: Major Depressive Disorder (MDD) Treatment Resistant Depression (TRD)
Sponsor: Baylor College of Medicine
Start date: 2008-11-01; Completion date: 2012-11-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric and adult patients. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine may have rapid antidepressant properties for patients with severe mood disorders.

In this study we are investigating whether ketamine can have an antidepressant effect compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has not been shown to be an antidepressant, and is therefore acting as an active control in this study.

The study period can last up to 8 weeks, depending on your response to the study medication. There are two required overnight stays in our Research Commons as part of this study.

Detailed description:

Arms: arm 1: Ketamine arm 2: Midazolam
Interventions: intervention 1: Ketamine intervention 2: Midazolam
Intervention descriptions: intervention 1: Single dose .5 mg/kg IV (in the vein) infused over 40 minutes intervention 2: single dose 0.045 mg/kg IV infused over 40 minutes

Protocol documents:
Clinical trial NCT00795210
Conditions: HIV Lipodystrophy
Keywords: HIV lipodystrophy growth hormone growth hormone releasing hormone
Sponsor: Massachusetts General Hospital
Start date: 2009-02-01; Completion date: 2012-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.

Detailed description:
The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period.

Arms: arm 1: Recombinant human growth hormone 6mcg/kg SC once daily arm 2: Recombinant human growth hormone 2mg SC once daily arm 3: Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Interventions: intervention 1: Growth hormone intervention 2: Growth Hormone Releasing Hormone
Intervention descriptions: intervention 1: Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks intervention 2: Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Protocol documents:
Clinical trial NCT00826202
Conditions: Schizophrenia Prodrome
Keywords: schizophrenia d-serine prodrome
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2009-03-01; Completion date: 2012-11-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the safety and efficacy of D-serine as an early intervention treatment for the schizophrenia prodrome condition. This study is a placebo-controlled trial of D-serine in the symptomatic treatment of patients with the schizophrenia prodrome. Seventy two subjects meeting criteria for the schizophrenia prodrome will be included in this study, 24 at each site (Yale, Nathan Kline Institute and Zucker Hillside Hospital). The primary outcome measures will include symptom and neuropsychological measures. The duration of this study is two and a half years.

This research with D-serine holds out the prospect of direct benefit for the patient's current symptoms. Subjects may also benefit from the close monitoring of their symptoms, so that, if schizophrenic psychosis does occur, the psychosis will be recognized and treatment may begin with minimal delay. This study also could be of benefit by suggesting a promising lead in early intervention in the schizophrenic prodrome.

Overall Design Summary. We propose for prodromal patients to be randomized to D-serine vs placebo for 16 weeks. To insure that all subjects have the opportunity to receive D-serine, there will be an optional 16 week cross-over trial on the alternate study medication. No subject will be on D-serine for longer than 16 weeks. Admission criteria, Assessment Procedures, and Study Design will be the same across all sites. The procedures and timeline are shown in Table 1. The procedures and timeline are the same for the initial randomized 16 week trial and the optional cross-over trial on the alternate study medication. If patient's opt for the 16 week treatment on the alternate medication, we will use their assessments from end of initial treatment as baseline for 16 week treatment on alternate medication. Subjects will be seen for two preliminary visits, then once in treatment, subjects will be seen weekly for the first 5 visits then biweekly thereafter. A safety blood and urine collection will be done on day 3 (3 days after the start of study medication). Vital signs and weight, blood draw and urine collection for safety measures, urine pregnancy test and urine for toxicology will be repeated throughout treatment. Adverse effects ratings and symptom assessments will be repeated at each visit. Neuropsychological assessment and optional "Biomarker study" visual, auditory and ERPs tasks will be administered during one of the two preliminary visits then again at study endpoint. Any patients who convert to frank psychosis will be referred/offered immediate treatment.

Detailed description:

Arms: arm 1: 60 mg/kg/day arm 2: None
Interventions: intervention 1: D-serine intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg/kg/day intervention 2: Inert Placebo

Protocol documents:
Clinical trial NCT00847015
Conditions: Bladder Cancer Urinary Bladder
Keywords: Bladder Urinary CISPLATIN GEMCITABINE SU011248 (Sunitinib Malate) 08-159
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-02-01; Completion date: 2012-11-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your tumor before you undergo surgery for your bladder cancer.

Detailed description:

Arms: arm 1: This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Interventions: intervention 1: Sunitinib intervention 2: Gemcitabine intervention 3: cisplatin
Intervention descriptions: intervention 1: Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. intervention 2: Gemcitabine 1,000 mg/m\^2 intervention 3: cisplatin 35 mg/m\^2 will be administered intravenously on days 1 and 8.

Protocol documents:
Clinical trial NCT00909532
Conditions: Cystic Fibrosis
Keywords: Fibrosis Pancreatic Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2009-06-01; Completion date: 2012-11-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.

Detailed description:
This was a phase 3 study in subjects with cystic fibrosis (CF) age 12 years and older who have a G551D-CFTR mutation and percent predicted forced expiratory volumn in 1 second (FEV1) between 40% and 90%.

Based on in vitro studies and pharmacologic, pharmacokinetic (PK), and safety profiles, ivacaftor was selected for clinical development as a possible treatment for patients with CF. Patients with the G551D mutation were the targeted population for this study because ivacaftor is a potentiator of the gating function of the CFTR protein, and the most prevalent mutation with a gating defect in CF is the G551D mutation.

This study was designed to further evaluate the efficacy of ivacaftor in subjects with CF who have a G551D-CFTR gene mutation and to evaluate safety in this population over a longer period than previously studied.

Arms: arm 1: Subjects who received placebo every 12 hours (q12h) for up to 48 weeks. arm 2: Subjects who received 150 mg of ivacaftor q12h for up to 48 weeks.
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: 150-mg tablets given orally q12h for up to 48 weeks intervention 2: Tablet given orally q12h for up to 48 weeks

Protocol documents:
Clinical trial NCT00929864
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2009-10-01; Completion date: 2012-11-01
Enrollment: 869 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abatacept intervention 2: Adalimumab
Intervention descriptions: intervention 1: Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days) intervention 2: Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)

Protocol documents:
Clinical trial NCT00989157
Conditions: Bariatric Surgery
Keywords: Gastric Bypass Duloxetine Cymbalta Pharmacokinetics
Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
Start date: 2009-09-01; Completion date: 2012-11-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.

Detailed description:

Arms: arm 1: All subjects received drug. Single arm.
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: Single dose of 60 mg of duloxetine

Protocol documents:
Clinical trial NCT00996918
Conditions: Alzheimer Disease
Keywords: antibody
Sponsor: Pfizer
Start date: 2009-12-01; Completion date: 2012-11-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Detailed description:

Arms: arm 1: bapineuzumab arm 2: bapineuzumab
Interventions: intervention 1: Bapineuzumab 0.5 mg/kg intervention 2: Bapineuzumab 1.0 m/kg
Intervention descriptions: intervention 1: Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions. intervention 2: I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Protocol documents:
Clinical trial NCT00997932
Conditions: Unplanned Pregnancy
Keywords: levonorgestrel releasing intrauterine device levonorgestrel releasing intrauterine contraception unintended pregnancy prevention postpartum contraception
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-06-01; Completion date: 2012-11-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.

The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.

Detailed description:
This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.

Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.

Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.

Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.

Arms: arm 1: The complete cohort of all women enrolled and stated they wanted an LNG-IUS between 48 and 72 hours of vaginal delivery.
Interventions: intervention 1: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
Intervention descriptions: intervention 1: Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours

Protocol documents:
Clinical trial NCT00998764
Conditions: Alzheimer Disease
Keywords: antibody immunotherapy
Sponsor: Pfizer
Start date: 2009-12-01; Completion date: 2012-11-01
Enrollment: 494 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bapineuzumab 0.5 mg/kg
Intervention descriptions: intervention 1: I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Protocol documents:
Clinical trial NCT01005680
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2012-11-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pemetrexed intervention 2: Gemcitabine intervention 3: Cisplatin
Intervention descriptions: intervention 1: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles intervention 2: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles intervention 3: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles

Protocol documents:
Clinical trial NCT01011673
Conditions: Headache
Keywords: headache tension-type headache
Sponsor: Montefiore Medical Center
Start date: 2009-11-01; Completion date: 2012-11-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.

Detailed description:

Arms: arm 1: Ketorolac 30mg IVSS arm 2: metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
Interventions: intervention 1: Metoclopramide intervention 2: Ketorolac
Intervention descriptions: intervention 1: metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS intervention 2: ketorolac 30mg IVSS

Protocol documents:
Clinical trial NCT01019369
Conditions: Contraception
Keywords: Contraception Medroxyprogesterone 17-acetate Self administration
Sponsor: Carolyn L. Westhoff
Start date: 2010-03-01; Completion date: 2012-11-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.

Detailed description:
Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.

Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.

This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.

Arms: arm 1: Self administration of subcutaneous depot medroxyprogesterone acetate arm 2: Clinic administration (routine care) of DMPA
Interventions: intervention 1: Medroxyprogesterone 17-Acetate intervention 2: Medroxyprogesterone 17-Acetate
Intervention descriptions: intervention 1: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year intervention 2: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

Protocol documents:
Clinical trial NCT01026792
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer Stage IVB Cervical Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2009-12-01; Completion date: 2012-11-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. By blocking this protein cancer cells may stop growing or die.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the efficacy (objective response rate) of temsirolimus given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.

II. To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.

III. To explore the relationship between expression of proteins in the mammalian target of rapamycin (mTOR) pathway in archival tissue samples from patients on this trial and their objective response to therapy.

OUTLINE:

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months (patients with complete response \[CR\], partial response \[PR\], or stable disease \[SD\] only) thereafter.

Arms: arm 1: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Temsirolimus intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents: