ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01223937
Conditions: Nocturia
Sponsor: Ferring Pharmaceuticals
Start date: 2010-11-01; Completion date: 2011-11-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.

Detailed description:

Arms: arm 1: Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. arm 2: Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
Interventions: intervention 1: Desmopressin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01232790
Conditions: Schizophrenia
Keywords: Schizophrenia working memory N-Acetylcysteine
Sponsor: Yale University
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effects of the amino acid supplement N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons with a diagnosis of schizophrenia.

Detailed description:
Working memory impairment in Schizophrenia is produced by deficiencies of feedback inhibition of glutamate release, due to low cysteine-glutamate antiporter activity. Because of this mechanism, we are interested in whether acute administration of N-Acetylcysteine will improve performance of patients with schizophrenia on a battery of cognitive tasks utilized to test working memory and other cognitive domains, versus placebo. This pilot study will utilize a randomized, double blind, placebo controlled, crossover design.

Arms: arm 1: Group A first receives the commercially available sustained release form of N-acetylcysteine, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days). arm 2: Group B first receives the placebo and then receives a commercially available sustained release form of N-Acetylcysteine. In each arm, the capsules are both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
Interventions: intervention 1: N-Acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: N-acetylcysteine 1200mg bid for 3 days intervention 2: Placebo

Protocol documents:
Clinical trial NCT01240811
Conditions: Genital Tract Mucosal Immunity Genital Tract Microflora
Keywords: intrauterine device IUD levonorgestrel copper CD4 CCR5 microflora
Sponsor: Sharon Achilles
Start date: 2010-11-01; Completion date: 2011-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).

Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.

The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.

Detailed description:

Arms: arm 1: Healthy volunteers not at risk of pregnancy and not using any hormonal contraception. arm 2: Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS. arm 3: Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Interventions: intervention 1: IUD placement intervention 2: Levonorgestrel IUD intervention 3: Copper T380A IUD
Intervention descriptions: intervention 1: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard). intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01241461
Conditions: Cancer
Keywords: Advanced Cancer Metastatic Cancer p70s6 inhibitor
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LY2584702
Intervention descriptions: intervention 1: Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.

Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.

Protocol documents:
Clinical trial NCT01250496
Conditions: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Keywords: regadenoson lexiscan aminophylline SPECT Myocardial Perfusion Imaging pharmacologic stress test
Sponsor: Rush University Medical Center
Start date: 2010-11-01; Completion date: 2011-11-01
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The routine administration of 75 mg of intravenous aminophylline following regadenoson (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce the gastrointestinal (diarrhea and stomach upset) and other side effects related to regadenoson.

Detailed description:
Approximately 250 patients who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a matching inactive placebo (sterile salt water) injection. Participants will be surveyed for gastrointestinal symptoms and other side effects related to regadenoson. The frequency and severity of such side effects will be compared between the two study groups (aminophylline vs. placebo).

Arms: arm 1: 75 mg of intravenous aminophylline. arm 2: Matching normal saline placebo (sterile salt water).
Interventions: intervention 1: Aminophylline intervention 2: Placebo
Intervention descriptions: intervention 1: 75 mg of intravenous aminophylline intervention 2: Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Protocol documents:
Clinical trial NCT01253304
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-11-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition:

* To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function.
* To assess the safety of LY2189265 and any side effects that might be associated with it.

Detailed description:

Arms: arm 1: LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function arm 2: LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A) arm 3: LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) arm 4: LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
Interventions: intervention 1: LY2189265
Intervention descriptions: intervention 1: Subcutaneous (SC) injection

Protocol documents:
Clinical trial NCT01256684
Conditions: Vaginal Atrophy
Keywords: Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
Sponsor: EndoCeutics Inc.
Start date: 2010-12-01; Completion date: 2011-11-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: DHEA intervention 3: DHEA
Intervention descriptions: intervention 1: Placebo vaginal suppository intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 3: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

Protocol documents:
Clinical trial NCT01262352
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2011-01-01; Completion date: 2011-11-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on at least 1 allele.

Detailed description:
Currently, limited objective measures are available to quantify lung function in CF patients with mild lung disease. Lung clearance index (LCI) derived from inert gas multiple-breath washout (MBW) testing hold considerable promise to evaluate early lung disease as studies have detected abnormalities in a high percentage of CF patients with normal spirometry in both infants and children.

This study explored the effect of ivacaftor on LCI and the efficacy of ivacaftor on other clinical and biomarker endpoints of CF lung disease in subjects aged 6 years and older with CF who have the G551D-CFTR mutation on at least 1 allele.

Arms: arm 1: Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2. arm 2: Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Sequence 2.
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: 150 mg tablet, oral use, twice daily every 12 hours (q12h) intervention 2: Tablet, oral use, twice daily every 12 hours (q12h)

Protocol documents:
Clinical trial NCT01265524
Conditions: Heart Failure
Sponsor: Sorbent Therapeutics
Start date: 2011-04-01; Completion date: 2011-11-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.

Detailed description:

Arms: arm 1: Investigational drug: 15 g CLP per day given as capsules arm 2: Placebo, capsules
Interventions: intervention 1: CLP intervention 2: Placebo
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents:
Clinical trial NCT01266876
Conditions: Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2011-01-01; Completion date: 2011-11-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH)

Detailed description:

Arms: arm 1: Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 2: Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 3: Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 4: Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 5: Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Interventions: intervention 1: Alirocumab intervention 2: Placebo
Intervention descriptions: intervention 1: Alirocumab two SC injections in the abdomen only. intervention 2: Placebo two SC injections in the abdomen only.

Protocol documents:
Clinical trial NCT01283581
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Sponsor: Melinta Therapeutics, Inc.
Start date: 2011-01-01; Completion date: 2011-11-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials

Detailed description:

Arms: arm 1: 300 mg IV (intravenous) every 12 hours for 5-14 days arm 2: 15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas arm 3: 600 mg IV every 12 hours for 5-14 days
Interventions: intervention 1: Delafloxacin intervention 2: Linezolid intervention 3: Vancomycin
Intervention descriptions: intervention 1: 300mg IV every 12 hours for 5-14 days intervention 2: 600mg IV every 12 hours for 5-14 days intervention 3: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days

Protocol documents:
Clinical trial NCT01294787
Conditions: COPD
Keywords: COPD QVA149 tiotropium exercise exercise tolerance combination bronchodilator moderate to severe COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2011-02-01; Completion date: 2011-11-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: QVA149 delivered once daily via single-dose dry powder inhaler. arm 2: Placebo, delivered once daily via single-dose dry powder inhaler. arm 3: Tiotropium delivered once daily via HandiHaler® device.
Interventions: intervention 1: indacaterol and glycopyrronium bromide (QVA149) intervention 2: placebo intervention 3: tiotropium
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01298219
Conditions: Opioid-induced Bowel Dysfunction
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2010-12-01; Completion date: 2011-11-01
Enrollment: 439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Detailed description:

Arms: arm 1: 24 mcg capsules twice daily (BID) arm 2: 0 mcg capsules twice daily (BID)
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg administered orally twice daily (BID) intervention 2: Matching placebo, 0 mcg administered orally twice daily (BID)

Protocol documents:
Clinical trial NCT01298752
Conditions: Inflammation Pain Cataract
Sponsor: Bausch & Lomb Incorporated
Start date: 2011-02-01; Completion date: 2011-11-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Detailed description:

Arms: arm 1: Mapracorat ophthalmic suspension arm 2: Vehicle of mapracorat ophthalmic suspension
Interventions: intervention 1: Mapracorat intervention 2: Vehicle
Intervention descriptions: intervention 1: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. intervention 2: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.

Protocol documents:
Clinical trial NCT01301274
Conditions: Hyponatremia
Keywords: hyponatremia maintenance solutions pediatrics
Sponsor: Hospital General de Niños Pedro de Elizalde
Start date: 2011-02-01; Completion date: 2011-11-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.

Detailed description:
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.

However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.

It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.

More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.

It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.

There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.

Arms: arm 1: Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. arm 2: Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
Interventions: intervention 1: hypotonic intervention 2: isotonic
Intervention descriptions: intervention 1: 0.45% NaCl/5% dextrose IV maintenance fluids intervention 2: 0.9% NaCl/5% dextrose IV maintenance fluids

Protocol documents:
Clinical trial NCT01306292
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension Right heart Catheterization
Sponsor: Bracco Diagnostics, Inc
Start date: 2011-04-01; Completion date: 2011-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.

Detailed description:
Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections in randomized order during right heart catheterization: one administration of SonoVue and one administration of placebo, either SonoVue followed by Placebo or Placebo followed by SonoVue. The purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following IV administration of SonoVue versus any effects following IV administration of the same volume of placebo.

Arms: arm 1: Ultrasound contrast agent under development arm 2: normal saline 0.9% for injection used as the comparator
Interventions: intervention 1: SonoVue intervention 2: Placebo
Intervention descriptions: intervention 1: dose of 4.8 mL administered intravenously one time intervention 2: Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)

Protocol documents:
Clinical trial NCT01336972
Conditions: Autosomal Dominant Polycystic Kidney Disease
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-10-01; Completion date: 2011-11-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the trial was to determine the short-term effects of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal function.

Detailed description:
Renal function was assessed during screening with the estimated glomerular filtration rate (eGFR), which was calculated with the 4-variable modification of diet in renal disease (MDRD) equation using a minimum of 2 creatinine measurements. The eGFR values were used to categorize participants into 1 of 3 mutually exclusive strata (\> 60 \[Group A\], 30 to 60 \[Group B\], and \< 30 \[Group C\] mL/min/1.73 m\^2). Each of the 3 groups received the same tolvaptan treatment.

During the 3-week treatment period, participants were up-titrated on a weekly basis from 45/15 mg to 60/30 mg to 90/30 mg (AM and PM \[8 hours later\] split-dose) to the maximally tolerated dose. The 3-week treatment period was followed by a 3-week post-treatment period during which no study medication was administered.

The effects of the highest tolerated split-dose of tolvaptan on renal hemodynamics and pharmacokinetic and pharmacodynamic parameters were assessed throughout the 6 weeks of the study. The reversibility of changes during the post-treatment period after withdrawal of the drug was determined and the acute transitory effects on kidney volume were also explored.

Arms: arm 1: Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM \[8 hours later\]) to the maximally tolerated dose. arm 2: Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM \[8 hours later\]) to the maximally tolerated dose. arm 3: Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM \[8 hours later\]) to the maximally tolerated dose.
Interventions: intervention 1: Tolvaptan
Intervention descriptions: intervention 1: Tolvaptan was supplied as 15 and 30 mg tablets.

Protocol documents: