ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02034162
Conditions: Helminth Infections
Keywords: Helminth infections Helminths Pediatric Preschool aged School aged Mebendazole Vermox Placebo
Sponsor: Janssen Research & Development, LLC
Start date: 2014-12-01; Completion date: 2015-09-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.

Detailed description:
This will be a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), multi-center, parallel-group study (each group of participants will be treated at the same time) to evaluate the efficacy and safety of mebendazole (a drug currently being investigated for Helminth gastrointestinal infections) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in children (including pre-school and school-aged children) with Helminth infections. The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and a post-treatment (or follow-up) phase. A pharmacokinetic (explores what a drug does to the body) open-label substudy (asks a separate research question from the parent study while using the same participant population but does not contribute to the parent study's objectives) will be included in the parent study to measure the level of mebendazole in the blood. Safety assessments will be performed throughout the study. Each participant will take part in the study for approximately 30 days.

Arms: arm 1: Mebendazole will be administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) and in an open-label manner at Visit 4 (Day 21). arm 2: Matching placebo will be administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1).
Interventions: intervention 1: Mebendazole intervention 2: Placebo
Intervention descriptions: intervention 1: Mebendazole will be administered as a single-dose 500 mg chewable tablet. For children 1 year to \<36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child. intervention 2: Matching placebo will be administered as a single-dose chewable tablet. For children 1 year to \<36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.

Protocol documents:
Clinical trial NCT02034708
Conditions: Primary Brain Tumor
Keywords: Primary brain tumor
Sponsor: Guerbet
Start date: 2014-06-01; Completion date: 2015-09-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment).

270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between.

Each patient will, therefore, receive two MRI during his/her participation in the study.

The two arms consist in :

* Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI.
* Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI.

Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.

MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.

Detailed description:

Arms: arm 1: Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI arm 2: Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI
Interventions: intervention 1: Dotarem® intervention 2: Gadovist®/Gadavist®
Intervention descriptions: intervention 1: Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. intervention 2: Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.

Protocol documents:
Clinical trial NCT02035748
Conditions: Vitreomacular Traction Vitreomacular Adhesion
Keywords: Vitreomacular traction Symptomatic vitreomacular adhesion Ocriplasmin JETREA
Sponsor: Alcon Research
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 628 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.

Detailed description:
After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).

Arms: arm 1: Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
Interventions: intervention 1: Ocriplasmin
Intervention descriptions: intervention 1: 0.5 mg/0.2 mL solution for injection

Protocol documents:
Clinical trial NCT02057523
Conditions: Proteinuria Transplant Glomerulopathy
Sponsor: University of Illinois at Chicago
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.

Detailed description:

Arms: arm 1: Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.
Interventions: intervention 1: Acthar
Intervention descriptions: intervention 1: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

Protocol documents:
Clinical trial NCT02061358
Conditions: Viral Infection
Keywords: Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral RNA Virus Infections Virus Diseases Pharmaceutical Solutions Pharmacologic Actions Therapeutic Uses
Sponsor: Emergent BioSolutions
Start date: 2014-07-01; Completion date: 2015-09-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

Detailed description:
The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus. There are four DENV serotypes. Infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. Immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV infections per year distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.

Arms: arm 1: Subjects receiving UV-4B 3 mg oral solution or placebo arm 2: Subjects receiving UV-4B 10 mg oral solution or placebo arm 3: Subjects receiving UV-4B 30 mg oral solution or placebo arm 4: Subjects receiving UV-4B 90 mg oral solution or placebo arm 5: Subjects receiving UV-4B 180 mg oral solution or placebo arm 6: Subjects receiving UV-4B 360 mg oral solution or placebo arm 7: Subjects receiving UV-4B 720 mg oral solution or placebo arm 8: Subjects receiving UV-4B 1000 mg oral solution or placebo
Interventions: intervention 1: UV-4B 3 mg intervention 2: UV-4B 10 mg intervention 3: UV-4B 30 mg intervention 4: UV-4B 90 mg intervention 5: UV-4B 180 mg intervention 6: UV-4B 360 mg intervention 7: UV-4B 720 mg intervention 8: UV-4B 1000 mg intervention 9: Placebo
Intervention descriptions: intervention 1: Oral solution, single dose intervention 2: Oral solution, single dose intervention 3: Oral solution, single dose intervention 4: Oral solution, single dose intervention 5: Oral solution, single dose intervention 6: Oral solution, single dose intervention 7: Oral solution, single dose intervention 8: Oral solution, single dose intervention 9: Oral solution, single dose

Protocol documents:
Clinical trial NCT02062645
Conditions: Essential Hypertension
Keywords: essential hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-01; Completion date: 2015-09-01
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.

Detailed description:

Arms: arm 1: All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks.
Interventions: intervention 1: amlodipine/valsartan
Intervention descriptions: intervention 1: Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg

Protocol documents:
Clinical trial NCT02064166
Conditions: Parkinson Disease Multiple System Atrophy
Keywords: Parkinson disease Multiple system atrophy Intranasal Insulin
Sponsor: Peter Novak
Start date: 2014-02-01; Completion date: 2015-09-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. There is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and memory in healthy and cognitively impaired non-diabetic adults.

The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects.

This proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of PD and MSA.

The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of the cognitive scale ratings.

Detailed description:

Arms: arm 1: 40 IU of intranasal insulin daily arm 2: Placebo arm using intranasal normal saline
Interventions: intervention 1: Intranasal Insulin
Intervention descriptions: intervention 1: 1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
2. placebo arm: normal saline, daily, intranasally, for 4 weeks.

Protocol documents:
Clinical trial NCT02095158
Conditions: Erythema Rosacea
Sponsor: Allergan
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 440 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.

Detailed description:

Arms: arm 1: Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
Interventions: intervention 1: Oxymetazoline HCL Cream 1.0%
Intervention descriptions: intervention 1: Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.

Protocol documents:
Clinical trial NCT02107898
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2014-03-01; Completion date: 2015-09-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters.
* To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment.
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetics of alirocumab.

Detailed description:
Total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks).

Arms: arm 1: Placebo (for alirocumab) every two weeks (Q2W) added to stable lipid-modifying therapy (LMT). arm 2: Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels above pre-specified threshold at Week 8 as defined in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012 i.e.

* ≥100 mg/dL (2.59 mmol/L) in heFH participants or in non-familial hypercholesterolemia (non-FH) participants who had a history of documented coronary heart disease (CHD)
* ≥120 mg/dL (3.10 mmol/L) in non-FH participants who had a history of documented diseases or other risk factors as categorized in primary prevention category III
Interventions: intervention 1: Placebo (for alirocumab) intervention 2: Alirocumab intervention 3: Lipid-Modifying Therapy (LMT)
Intervention descriptions: intervention 1: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector. intervention 2: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector. intervention 3: Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.

Protocol documents:
Clinical trial NCT02111096
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The intent of this study is to assess the safety of LY2409021 in participants with Type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. The study treatment is expected to last 12 months (52 weeks).

Detailed description:

Arms: arm 1: 20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician. arm 2: 100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician. arm 3: Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Interventions: intervention 1: LY2409021 intervention 2: Sitagliptin intervention 3: Placebo intervention 4: Metformin intervention 5: Sulfonylurea
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally

Protocol documents:
Clinical trial NCT02111603
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Sponsor: Mayo Clinic
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.

Detailed description:
This study will evaluate whether Colesevelam, a bile acid sequestrant, is able to reduce fecal bile acids and improve bowel function in patients with IBS-diarrhea and Mayo's HPLC method can demonstrate a response to the Colesevelam.

The study design will be a single center, unblinded, single dose trial to study the ability to identify the effect of taking 1875 mg (3 tablets \[625 mg/tablet\]) of Colesevelam orally twice daily for ten days on fasting serum 7alphaC4 and total 48 hour fecal bile acid excretion. Stool and fasting serum samples will be collected predose and during final 48 hours' dosing for assessment. Participants will also fill out an 8-day stool diary assessing frequency, consistency, ease of passage of bowel movements before and during treatment with Colesevelam.

Arms: arm 1: 1875 mg of Colesevelam orally twice daily for 10 days
Interventions: intervention 1: Colesevelam
Intervention descriptions: intervention 1: Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days

Protocol documents:
Clinical trial NCT02120664
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

Detailed description:

Arms: arm 1: Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie \[mCi\]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB. arm 2: Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
Interventions: intervention 1: Florbetapir (18F) intervention 2: 11C-PiB
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02123134
Conditions: Moderate to Severe Convexity of Submental Fat Safety Efficacy
Sponsor: Kythera Biopharmaceuticals
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.

Detailed description:

Arms: arm 1: Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. arm 2: Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Interventions: intervention 1: ATX-101 intervention 2: Placebo
Intervention descriptions: intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. intervention 2: Phosphate buffered saline placebo for injection

Protocol documents:
Clinical trial NCT02149342
Conditions: Actinic Keratoses
Keywords: Actinic keratoses Daylight-PDT Hexylaminolaevulinate HAL Methylaminolaevulinate MAL Hyperspectral imaging
Sponsor: Joint Authority for Päijät-Häme Social and Health Care
Start date: 2014-05-01; Completion date: 2015-09-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.

Detailed description:
Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded.

Arms: arm 1: 0.2% HAL (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and MAL (Metvix, Galderma) used in a randomized split-face design
Interventions: intervention 1: Hexylaminolaevulinate cream intervention 2: Methylaminolaevulinate cream
Intervention descriptions: intervention 1: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014) intervention 2: MAL 16% is used as photosensitizer for daylight-PDT

Protocol documents: