ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01385280
Conditions: Estrogen Receptor-positive Breast Cancer Progesterone Receptor Positive Tumor Recurrent Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: University of Arizona
Start date: 2011-02-01; Completion date: 2013-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some clinical experience indicate that it may have the opposite effect on such cells, once they have become resistant to estrogen deprivation. In laboratory models, there is death of the "resistant" population after estradiol treatment, followed by restoration of sensitivity of the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving therapeutic estradiol together with exemestane may kill more tumor cells.

PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating post-menopausal patients with hormone receptor-positive metastatic breast cancer

Detailed description:
OBJECTIVES:

I. To assess feasibility and toxicity associated with estradiol followed by exemestane in the treatment of estrogen receptor positive metastatic breast cancer patients failing prior aromatase inhibitor therapy.

II. Exploratory analysis of bio-correlates which will evaluate the mechanism of action of this treatment combination: changes in serum M-30, a marker of mitochondrial apoptosis; changes in number of circulating tumor cells (CTC); changes in CTC expression of ER, IGF1-R, and M-30.

III. Exploratory analysis of Progression Free Survival (PFS).

OUTLINE: Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.
Interventions: intervention 1: therapeutic estradiol intervention 2: exemestane intervention 3: laboratory biomarker analysis intervention 4: enzyme-linked immunosorbent assay
Intervention descriptions: intervention 1: Given orally (PO) intervention 2: Given PO intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01397422
Conditions: Dyskinesia Levodopa Induced Dyskinesia Parkinson's Disease
Keywords: Levodopa-induced dyskinesia Parkinsonism
Sponsor: Adamas Pharmaceuticals, Inc.
Start date: 2011-07-01; Completion date: 2013-10-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.

Detailed description:

Arms: arm 1: None arm 2: Low dose ADS-5102 (amantadine extended release) arm 3: A mid-dose ADS-5102 (amantadine extended release) arm 4: High dose ADS-5102 (amantadine extended release)
Interventions: intervention 1: ADS-5102 (extended release amantadine HCl)
Intervention descriptions: intervention 1: Oral capsules to be administered once daily at bedtime, for 8 weeks

Protocol documents:
Clinical trial NCT01399866
Conditions: Smoking Cessation
Keywords: D-cycloserine Smoking cues Cognitive remediation physiologic reactivity craving
Sponsor: Massachusetts General Hospital
Start date: 2011-05-01; Completion date: 2013-10-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria, and demonstrate response to cue reactivity at the screening visit, will either be:

* started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which method to use to quit smoking will be based on participant choice as well as taking into account any medical contraindications to either therapy.
* evaluated to confirm abstinence from smoking. Recently abstinent participants referred by a smoking cessation clinic, PCP or self referred must have an expired air CO \< 10 ppm to confirm abstinence.

Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study involves twelve visits and will last approximately ten weeks. For recently abstinent participants referred by a smoking cessation clinic, PCP or self referred, the study involves 7 visits (screening and baseline visit will be merged into one and there is no CBT component) and will last approximately 7 weeks.

Detailed description:

Arms: arm 1: 50 mg capsule,single dose, twice, one week apart, by mouth arm 2: 50 mg capsule,single dose, twice, one week apart, by mouth
Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: 2 single weekly doses, 50 mg capsule intervention 2: None

Protocol documents:
Clinical trial NCT01409031
Conditions: Persistent Pulmonary Hypertension Respiratory Failure
Keywords: newborns respiratory failure pulmonary hypertension treatment
Sponsor: University of Colorado, Denver
Start date: 2011-07-01; Completion date: 2013-10-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether intravenous sildenafil reduces pulmonary artery pressure and improves oxygenation in near-term and term infants with persistent pulmonary hypertension.

Detailed description:
Term infants with respiratory failure and persistent pulmonary hypertension (PPHN) are among the most critically ill infants in the NICU, with significant mortality and morbidity reported even for infants with moderate disease. Currently, management is largely supportive, and includes oxygen, mechanical ventilation (conventional or high frequency ventilation), and exogenous surfactant therapy. Inhaled nitric oxide (iNO) is a pulmonary vasodilator that was approved for the treatment of hypoxic respiratory failure (HRF) and PPHN of the newborn in 1999 based on clinical trials showing a reduction in the need for rescue treatment with extracorporeal membrane oxygenation (ECMO).

One promising therapy to decrease pulmonary arterial pressure and improve oxygenation is sildenafil. Sildenafil is a cGMP-specific phosphodiesterase inhibitor that causes relatively selective pulmonary vasodilation. The use of intravenous (IV) sildenafil was recently FDA approved for use in adults in PPHN. A pilot trial studying dose response and pharmacokinetics in 36 term newborns with PPHN found that IV sildenafil was well tolerated and has the potential to induce marked improvements in oxygenation. The data from this pilot trial provided background to support the dosing regimen for this Phase II trial. We hypothesize that IV sildenafil will acutely reduce pulmonary artery pressure and improve oxygenation in near-term and term infants with PPHN, thus reducing the need for rescue therapy iNO and/or ECMO.

Arms: arm 1: None arm 2: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Interventions: intervention 1: Intravenous Sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days. intervention 2: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.

Protocol documents:
Clinical trial NCT01423253
Conditions: Major Depressive Disorder
Keywords: Depression Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-09-01; Completion date: 2013-10-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.

Detailed description:

Arms: arm 1: Lurasidone 20, 40, or 60 mg/day flexibly dosed
Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed

Protocol documents:
Clinical trial NCT01426438
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2011-11-01; Completion date: 2013-10-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done with people with HIV infection who have low levels of HDL-C. HDL-C is a type of "good" cholesterol. People with low HDL-C have a higher risk of heart disease and may have problems with how their blood vessels relax. The endothelium is the inner lining of all blood vessels, such as arteries and veins. When the endothelium is not working properly, the blood vessels have trouble expanding properly, which contributes to the development of heart and blood vessel disease.

The main purpose of this study is to see if taking either extended-release niacin or fenofibrate for 24 weeks will help blood vessels work better by improving endothelial function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This study will also help determine how safe extended-release niacin and fenofibrate are.

The analysis is an as-treated analysis of participants who completed study treatment and had a week 24 BART scan. Safety analyses include all participants

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Niacin intervention 2: Aspirin intervention 3: Fenofibrate
Intervention descriptions: intervention 1: Extended-release niacin will be given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) intervention 2: Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24. intervention 3: Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks.

Protocol documents:
Clinical trial NCT01435824
Conditions: Healthy
Keywords: healthy adult volunteers comparative bioavailability amoxicillin breast milk Amoxicillin Bioavailability in breast milk
Sponsor: The Hospital for Sick Children
Start date: 2011-06-01; Completion date: 2013-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose to study amoxicillin absorption in a 2-stage program that will progressively produce, for the first time, information leading to pediatric pharmacology recommendations for the administration to children of amoxicillin dissolved in human milk. The investigators study will enroll adult volunteers as number of blood extractions, volume of blood required and subject availability, among other issues, generate a number of ethical and logistical constraints that make it almost impossible to carry such an intensive sampling study in infants.

Detailed description:
As recommended by the Expert Committee on Selection and Use of Essential Medicines, WHO (http://www.who.int/selection\_medicines/committees/en/index.html), oral solid formulations are the preferred forms of medicines for children, especially in developing countries, because of relatively inexpensive and less complicated manufacturing, transporting and storage processes. Whereas solid dosage forms are advantageous in these pharmaceutical logistics, administering solid formulations to infants and children is a challenging issue. Dissolving medicines in water may be acceptable, but safety of drinking water for infants in developing countries and water solubility of the drug itself are major concerns. These challenges are exemplified in the treatment of infectious diseases and diarrhea in infants. Commonly used drugs for infants in low income settings include antibiotics such as amoxicillin. Expert sources have suggested that drug administration in breast milk may be effective. However, little data is currently available to support the recommendation to administer medications dissolved in breast milk to infants.

The second stage of the project will use the information obtained from the first stage, combined with pre-existing data, to define a rational dosing schedule of the target drug dissolved in human milk for young children, using population PK modeling and simulation. This is a study in silico.

Arms: arm 1: Amoxicillin 500 mg was dissolved in 10 ml water and orally administered in a fasting state. arm 2: Amoxicillin 500 mg was dissolved in 10 ml human milk and orally administered in a fasting state.
Interventions: intervention 1: Human milk-dissolved amoxicillin intervention 2: Water-dissolved amoxicillin
Intervention descriptions: intervention 1: An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of breast milk to have 100mL of a 50mg/mL suspension. intervention 2: An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of water to have 100mL of a 50mg/mL suspension.

Protocol documents:
Clinical trial NCT01452529
Conditions: Chronic Low Back Pain
Keywords: Pain Opioid
Sponsor: Purdue Pharma LP
Start date: 2011-10-01; Completion date: 2013-10-01
Enrollment: 905 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Detailed description:

Arms: arm 1: Hydrocodone bitartrate (HYD) once daily (q24h) tablets arm 2: Placebo to match hydrocodone bitartrate once daily tablets
Interventions: intervention 1: Hydrocodone bitartrate q24h film-coated tablets intervention 2: Placebo to match hydrocodone bitartrate q24h tablets
Intervention descriptions: intervention 1: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily intervention 2: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Protocol documents:
Clinical trial NCT01462227
Conditions: Hypoglycemia
Keywords: Hypoglycemia Type 1 diabetes
Sponsor: Yale University
Start date: 2011-08-01; Completion date: 2013-10-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

Detailed description:

Arms: arm 1: Naltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. arm 2: Naltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.
Interventions: intervention 1: Naltrexone High Dose intervention 2: Naltrexone Low Dose
Intervention descriptions: intervention 1: Naltrexone 100mg for two administrations. intervention 2: Naltrexone 50mg for two administrations.

Protocol documents:
Clinical trial NCT01466270
Conditions: Anxiety Disorder Breast Cancer Cognition Disorders Depression Fatigue Sleep Disorders
Keywords: fatigue sleep disorders depression anxiety disorder cognitive/functional effects breast cancer cancer survivor
Sponsor: Wake Forest University Health Sciences
Start date: 2012-07-01; Completion date: 2013-10-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by chemotherapy.

PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive dysfunction after chemotherapy in female breast cancer survivors.

Detailed description:
OBJECTIVES:

Primary

* Determine the feasibility of conducting a randomized placebo-controlled clinical trial for cognitive symptoms in female breast cancer survivors.

Secondary

* Estimate the variability of the clinical outcomes (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36).
* Estimate the within patient correlation over time of the clinical outcomes.
* Obtain preliminary estimates of the effect of donepezil on the primary and secondary outcome variables.
* Correlate the reports of fatigue, sleep disturbance, and mood with measures of cognitive symptoms and neurocognitive test performance.
* Document the severity of cognitive symptoms and functional impairment in female breast cancer survivors who enroll on this pilot study.
* Correlate cognitive symptoms with cognitive test performance.
* Document the toxicities associated with donepezil hydrochloride use.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to menopausal status (pre- vs peri-/post-menopausal) and time since end of chemotherapy (12-36 months vs 36.01-60 months).

Arm I: Patients receive donepezil hydrochloride orally (PO) once daily (QD).

Arm II: Patients receive placebo PO QD.

In both arms treatment continues for 24 weeks.

Patients complete the entire battery of neurocognitive tests and questionnaires (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36) at baseline (pre-treatment), 24 weeks (end of medication), and 36 weeks (end of wash-out).

After completion of therapy, patients are followed at 12 weeks.

Arms: arm 1: Patients receive donepezil hydrochloride PO QD. arm 2: Patients receive placebo PO QD.
Interventions: intervention 1: donepezil hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT01472185
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Sponsor: Gilead Sciences
Start date: 2011-11-01; Completion date: 2013-10-01
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones \[TZDs\] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

Detailed description:

Arms: arm 1: Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen. arm 2: Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.
Interventions: intervention 1: Ranolazine intervention 2: Placebo intervention 3: Diet intervention 4: Exercise
Intervention descriptions: intervention 1: Ranolazine tablets administered orally twice daily. intervention 2: Placebo to match ranolazine administered orally twice daily. intervention 3: Participants are instructed to continue the diet regimen prescribed by their physician. intervention 4: Participants are instructed to continue the exercise regimen prescribed by their physician.

Protocol documents: