ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02279407
Conditions: T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Keywords: omega-3 carboxylic acid
Sponsor: AstraZeneca
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (\>5.5% as measured with magnetic resonance imaging (MRI))

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: Omega-3 carboxylic acids intervention 3: Dapagliflozin intervention 4: Placebo
Intervention descriptions: intervention 1: Placebo matching to Omega-3 carboxylic acids (olive oil) intervention 2: 4 g administered as 4 x 1 g capsules intervention 3: 10 mg administered as 10 mg tablet intervention 4: Placebo matching to dapagliflozin 10 mg

Protocol documents:
Clinical trial NCT02314689
Conditions: Sickle Cell Disease
Sponsor: Suvankar Majumdar
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the maximum tolerated dose, safety and pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in steady-state sickle cell disease.

Detailed description:

Arms: arm 1: IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
Interventions: intervention 1: Intravenous (IV) citrulline
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02319031
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2015-02-01; Completion date: 2015-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

Detailed description:

Arms: arm 1: Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing arm 2: Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Interventions: intervention 1: Daclatasvir intervention 2: Sofosbuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02321462
Conditions: Bowel Cleansing
Keywords: preparation
Sponsor: Ipsen
Start date: 2015-03-01; Completion date: 2015-12-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eziclen intervention 2: Fortrans®
Intervention descriptions: intervention 1: Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy. intervention 2: Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy.

Protocol documents:
Clinical trial NCT02324972
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis Eczema AD AQX-1125 SHIP1
Sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Start date: 2014-12-01; Completion date: 2015-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo on change from baseline in Total Lesion Symptom Score in subjects with mild to moderate atopic dermatitis

Detailed description:
One of the causative factors for the inflammatory response observed in AD is the release of chemokines and other chemoattractant factors followed by recruitment of inflammatory cell subtypes (10). IL-16, a Langerhans cells (LC)-derived chemoattractant cytokine for CD4+ cells, RANTES, monocyte chemotactic protein (MCP-4) and eotaxin are overexpressed in epidermal keratinocytes from AD subjects and may contribute to the chemotaxis of eosinophils, macrophages and Th2-lymphocytes (11).

Since the activation of SHIP1 by AQX-1125 results in the inhibition of inflammatory cell chemotaxis and reduction of pro-inflammatory cytokine synthesis, this study hypothesized that AQX-1125 would improve AD.

Arms: arm 1: 1 x AQX-1125 Capsule daily arm 2: 1 x placebo capsule daily
Interventions: intervention 1: AQX-1125 intervention 2: Placebo
Intervention descriptions: intervention 1: Synthetic SHIP1 activator intervention 2: None

Protocol documents:
Clinical trial NCT02325518
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-angle glaucoma (OAG) Ocular hypertension (OHT) AZORGA® COSOPT®
Sponsor: Alcon, a Novartis Company
Start date: 2014-12-01; Completion date: 2015-12-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

Detailed description:
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.

Arms: arm 1: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. arm 2: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
Interventions: intervention 1: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension intervention 2: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution intervention 3: Subject's habitual PGA monotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02336737
Conditions: Breast Cancer
Keywords: breast cancer sentinel lymph node biopsy
Sponsor: Endomagnetics Inc
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 160 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.

Detailed description:
This is a pivotal, prospective, open label, multicenter, paired comparison of the SentiMag® and SiennaXP® magnetic sentinel node localization system with the standard of care (radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in patients with breast cancer undergoing a sentinel lymph node biopsy. The trial is designed to provide powered evidence that the lymph node detection rate of the SentiMag® and SiennaXP® system is non-inferior to the standard of care in patients with breast cancer.

Arms: arm 1: Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.

Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.
Interventions: intervention 1: SiennaXP intervention 2: Technetium Tc99m Sulfur Colloid intervention 3: Isosulfan blue dye
Intervention descriptions: intervention 1: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe intervention 2: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) intervention 3: Injection of a single dose of isosulfan blue dye

Protocol documents:
Clinical trial NCT02338336
Conditions: Plantar Warts
Sponsor: Nowarta Biopharma Inc
Start date: 2015-02-01; Completion date: 2015-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts

* Clinical Tolerance
* Clinical Recovery
* Evaluate Safety

Detailed description:
Plantar Warts occur on the soles (plantar surface of feet) and can be severely debilitating for patients even for normal walking. The severity and magnitude of the warts can vary, but they are the cause of much pain and discomfort for all age groups. Nowarta 110 has been evaluated for the therapy of plantar warts caused by the HPV virus, (HPV infection). Clinical experience in a totals of 124 patients receiving Nowarta 110 for 5 weeks treatment in multiple clinics overseas has demonstrated the potential of Nowarta110 with absolutely no side effect.

Arms: arm 1: Placebo arm 2: Nowarta110 3 drops administration arm 3: Nowarta110 6 drops administration arm 4: Nowarta110 10 drops administration
Interventions: intervention 1: Nowarta110 intervention 2: Placebo
Intervention descriptions: intervention 1: Nowarta110 contains fig extract as the main drug substance, and colloidal silver is used as a medium for penetration of fig extract into the wart lesion. Liquid for topical administration. intervention 2: Matching placebo liquid for topic administration.

Protocol documents:
Clinical trial NCT02347774
Conditions: COPD Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2015-02-01; Completion date: 2015-12-01
Enrollment: 641 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Detailed description:
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer.

Arms: arm 1: SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer arm 2: SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer arm 3: Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Interventions: intervention 1: SUN-101 50 mcg BID eFlow (CS) nebulizer intervention 2: SUN-101 25 mcg BID eFlow (CS) nebulizer intervention 3: Placebo eFlow (CS) nebulizer
Intervention descriptions: intervention 1: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer intervention 2: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer intervention 3: Placebo BID eFlow (R) Closed System (CS) nebulizer

Protocol documents:
Clinical trial NCT02359877
Conditions: Healthy
Keywords: pegylated interferon beta Volunteers
Sponsor: Biocad
Start date: 2014-07-01; Completion date: 2015-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose administration and multiple estimated therapeutic dose administration of BCD-054.

Detailed description:

Arms: arm 1: Pegylated interferon beta 1a Single doses - 60 mcg, SC/IM Single doses - 120 mcg, SC/IM Single doses - 240 mcg, SC/IM Single doses - 360 mcg, SC/IM Multiple doses - 180 mcg, SC/IM arm 2: interferon beta 1a 44 mcg, SC, 3 times a week for 2 weeks arm 3: interferon beta 1a 30 mcg, IM, once a week for 2 weeks
Interventions: intervention 1: BCD-054 intervention 2: Rebif intervention 3: Avonex
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02361476
Conditions: Psychomotor Agitation
Keywords: Anaesthesia Children Clonidine Sevoflurane Postoperative agitation Prevention Pharmacokinetics Safety
Sponsor: Rigshospitalet, Denmark
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 379 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.

In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.

Detailed description:
BACKGROUND:

Clonidine is widely used off-label in children for several indications such as treatment and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However, the current level of evidence in support of Clonidine treatment for postoperative agitation in children remains limited. In addition, the pharmacokinetic profile of intravenous Clonidine in children is not well characterized for age-groups.

METHODS/DESIGN:

In this prospective multicentre double-blinded randomized clinical trial, the investigators aim to investigate the impact of intravenous (IV) Clonidine administered at the end of surgery, on the incidence and degree of postoperative agitation. Children will be assigned to either the intervention or the placebo group. The allocation will be carried out centrally and stratified based on age and trial-site, with152 patients allocated to each group. In the intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20 minutes before the expected completion of the surgery (as assessed by the surgeon). In the control group; Saline (placebo) is injected in equal quantity during surgery at the same time. The drugs are concealed in identical blinded ampoules.

The primary outcome is postoperative agitation measured on the Watcha scale. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including 30-day follow-up.

Twenty of the patients age 1-2 years and twenty age \>2 years, with a peripheral venous access in place, will be allocated to drug assay sampling; enabling a compartmental PK analysis based on age group, using non-linear mixed effects models.

Arms: arm 1: Clonidine : injection og 3 micg/kg IV during the operation. arm 2: Placebo : injection og equal amount of NaCl IV during the operation.
Interventions: intervention 1: Clonidine intervention 2: Placebo
Intervention descriptions: intervention 1: Injection - during surgery intervention 2: Injection - during surgery

Protocol documents:
Clinical trial NCT02368314
Conditions: Deep Vein Thrombosis
Keywords: Deep vein thrombosis Prophylaxis Sodium enoxaparin
Sponsor: Biocad
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.

Detailed description:
The study will include 116 patients who are planned for hip or knee replacement. Patients will randomized in 2 groups. 1-st group will receive BCD-080 at dose 30 mg every 12 hours during 14 days after surgery, 2-d group will receive Clexane at the same dose. Efficacy assessment will include frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic), symptomatic nonlethal thromboembolia of the pulmonary artery (PATE) and venous thromboembolism death. Safety assessment will include frequency of "big", "small" and other bleedings and frequency of heparin induced thrombocytopenia.The assessment of efficacy and safety parameters will be made during the treatment and follow-up period (till 60 day).

Arms: arm 1: Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery. arm 2: Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Interventions: intervention 1: Sodium Enoxaparine
Intervention descriptions: intervention 1: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).

Protocol documents:
Clinical trial NCT02385318
Conditions: Actinic Keratosis
Sponsor: Padagis LLC
Start date: 2015-02-01; Completion date: 2015-12-01
Enrollment: 519 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.

Detailed description:

Arms: arm 1: Ingenol Mebutate arm 2: Ingenol Mebutate arm 3: Placebo gel
Interventions: intervention 1: Ingenol Mebutate (Perrigo) intervention 2: Ingenol Mebutate (Reference) intervention 3: Placebo gel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_001.pdf: 
 
 
NCT02385318 
 
04-15-2015 













































































































SAP_000.pdf: 
 
 
NCT02385318 
 
04-15-2015
Clinical trial NCT02389881
Conditions: Healthy Volunteers
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-02-01; Completion date: 2015-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.

Detailed description:
The drug being tested in this study is TAK-058, which is under evaluation for the treatment of schizophrenia.

This study will enroll approximately 32 healthy non-elderly and 8 healthy elderly participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Cohort 1 Non-elderly Healthy: TAK-058 25 mg
* Cohort 2 Non-elderly Healthy: TAK-058 75 mg
* Cohort 3 Non-elderly Healthy: TAK-058 150 mg
* Cohort 4 Elderly Healthy: TAK-058 25 mg
* Cohort 5 Non-elderly Healthy: TAK-058 300 mg
* Cohort 1-4 Non Elderly Placebo (dummy inactive solution) - this is an oral solution that looks like the study drug but has no active ingredient.
* Cohort 5 Elderly Placebo This single-center trial will be conducted in the United States. The overall time to participate in this study is 40 days if assigned to Cohort 1 to 4. Participants will be confined to the clinic for 12 days, and will be contacted by telephone 11 and 30 days after last dose of study drug for a follow-up assessment (Days 21 and 40).

The overall time to participate in this study is 14 days if assigned to Cohort 5. Participants will be confined to the clinic for 4 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment (Day 14).

Arms: arm 1: TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. arm 2: TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. arm 3: TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. arm 4: TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants. arm 5: TAK-058 300 mg solution, orally, once daily on Day 1, in non-elderly healthy participants. arm 6: TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants. arm 7: TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
Interventions: intervention 1: TAK-058 intervention 2: TAK-058 Placebo
Intervention descriptions: intervention 1: TAK-058 Solution intervention 2: TAK-058 placebo-matching solution

Protocol documents:
Clinical trial NCT02393547
Conditions: Tobacco Use Disorder Weight Gain
Keywords: obesity
Sponsor: Mayo Clinic
Start date: 2013-09-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be an open label clinical trial with all subjects receiving both lorcaserin and varenicline with a primary aim of reducing post cessation weight gain.

Detailed description:
This will be an open label clinical trial with all subjects receiving both lorcaserin and varenicline. The investigators will obtain preliminary data on the efficacy of lorcaserin (10 mg twice daily) for 12 weeks in 20 adult weight-concerned cigarette smokers with a BMI of 27 to 40 simultaneously receiving 12 weeks of open-label varenicline and a behavioral intervention to assist with stopping smoking. Secondary aims will be weight, waist circumference, and smoking cessation.

Arms: arm 1: Open label all subjects receive both Varenicline and Lorcaserin
Interventions: intervention 1: Varenicline intervention 2: Lorcaserin
Intervention descriptions: intervention 1: All subjects receive Varenicline intervention 2: All subjects receive Lorcaserin

Protocol documents: