ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02493855
Conditions: Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1a
Keywords: Treatment naive HCV Interferon free Hepatitis C Genotype 1a Chronic Hepatitis C Hepatitis C
Sponsor: AbbVie
Start date: 2015-06-01; Completion date: 2016-12-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

Detailed description:

Arms: arm 1: Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. arm 2: Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. arm 3: Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Interventions: intervention 1: Ombitasvir/ABT-450/Ritonavir intervention 2: Dasabuvir intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Ombitasvir/ABT-450/ritonavir combination tablets intervention 2: Dasabuvir tablets intervention 3: Ribavirin tablets

Protocol documents:
Clinical trial NCT02493946
Conditions: Glabellar Lines
Sponsor: Ipsen
Start date: 2015-04-01; Completion date: 2016-12-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the protocol is to demonstrate the safety and the efficacy of a single injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after repeated injections.

Detailed description:
This is a multicentre study conducted in two periods. Subjects will first be enrolled to enter the double blind (DB) period Cycle 1. Subjects who are eligible for retreatment will then be offered to enter open label (OL) Cycles 2 to 5 as DB roll-over subjects. Once recruitment of the DB period is complete, the study will enrol additional BTX-naïve subjects (hereafter referred to as OL de novo subjects) into the OL period Cycle 1. All OL de novo subjects who are eligible for retreatment will also be offered to enter OL Cycles 2 to 5. A total of 580 subjects (180 subjects randomised in the DB period and an additional 400 de novo subjects in the OL period) are planned to complete the study.

Arms: arm 1: Clostridium Botulinum Toxin Type A (BTX A HAC NG), total treatment volume 0.25mL will be divided into 5 injections (0.05mL per injections) injected in 5 pre-defined sites across the glabellar region. A total of 50 Units of BTX-A-HAC NG will be injected/ cycle. arm 2: The total placebo volume 0.25mL will be divided into 5 injections (0.05mL per injections) injected in 5 pre-defined sites across the glabellar region. Administered in Cycle 1 of the double blind phase only.
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02504099
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Infection Early Stage Hepatocellular Carcinoma
Sponsor: AbbVie
Start date: 2015-07-01; Completion date: 2016-12-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

Detailed description:

Arms: arm 1: OBV/PTV/r (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: ombitasvir/paritaprevir/ritonavir intervention 3: ribavirin
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet; ombitasvir coformulated with paritaprevir and ritonavir intervention 3: Tablet

Protocol documents:
Clinical trial NCT02532647
Conditions: Colonoscopy
Sponsor: Paion UK Ltd.
Start date: 2015-11-01; Completion date: 2016-12-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in American Society of Anesthesiologists (ASA) Grade III and IV patients (ASA status evaluated by an anesthesiologist not otherwise involved in the study) undergoing a colonoscopy for diagnostic or therapeutic reasons.

Detailed description:

Arms: arm 1: Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.

Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses arm 2: Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.

Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses arm 3: Placebo administered in double-blind manner.

Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses
Interventions: intervention 1: Remimazolam intervention 2: Midazolam intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02544152
Conditions: Irritable Bowel Syndrome
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2015-02-01; Completion date: 2016-12-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

Detailed description:
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily \[BID\]) in subjects diagnosed with IBS-M/IBS-U.

Arms: arm 1: Participants receive 8 mcg lubiprostone capsules twice daily (BID) arm 2: Participants receive 0 mcg capsules BID
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mcg administered orally twice daily (BID) intervention 2: Matching placebo, 0 mcg administered orally twice daily (BID)

Protocol documents:
Clinical trial NCT02549573
Conditions: Parkinson's Disease Motor Symptoms
Keywords: Motor Symptoms Parkinson's disease Apokyn Apomorphine PD
Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
Start date: 2016-01-01; Completion date: 2016-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if PT intervention will be improved while in the "on" motor state vs. the "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.

Detailed description:
Multicenter, outpatient trial to evaluate PT outcomes in subjects diagnosed with PD and currently using APOKYN. Those subjects who satisfy all eligibility criteria will be randomized to 2 treatment groups:

1. "APO+" (APOKYN treatment before the PT Intervention Visit) and;
2. "APO-" (APOKYN treatment withheld before the PT Intervention Visit).

The study will have:

* Baseline Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic
* APOKYN Response Verification Visit - 1 day
* PT Intervention Visits - for 6 weeks
* End-of-study Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic All subjects will participate in a standardized PT intervention. In both treatment groups, ALL subjects will arrive for the PT Intervention Visit in an "end-of-dose-off" motor state. The "end-of-dose-off" motor state will be achieved by the subject withholding his/her carbidopa/levodopa dose and APOKYN dose for at least 3 hours before the PT Intervention Visit. It is hypothesized that the outcome of PT will be improved when subjects are in the "on" motor state during PT Intervention visits compared with being in the "end-of-dose-off" motor state during PT Intervention visits.

Arms: arm 1: APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit. arm 2: APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.
Interventions: intervention 1: APOKYN intervention 2: Physical Therapy
Intervention descriptions: intervention 1: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit. intervention 2: All subjects will participate in a standardized PT intervention

Protocol documents:
Clinical trial NCT02550795
Conditions: Postoperative Nausea and Vomiting
Sponsor: Gachon University Gil Medical Center
Start date: 2015-09-01; Completion date: 2016-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Detailed description:
Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Arms: arm 1: administration of 0.9% normal saline 10ml arm 2: administration of 0.5ug/kg of dexmedetomidine (5ml) arm 3: administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Interventions: intervention 1: Dexmedetomidine intervention 2: Dexmedetomidine and dexamethasone intervention 3: Control
Intervention descriptions: intervention 1: administration of dexmedetomidine only intervention 2: administration of dexmedetomidine and dexamethasone intervention 3: administration of normal saline

Protocol documents:
Clinical trial NCT02553798
Conditions: Hyperhidrosis
Sponsor: Journey Medical Corporation
Start date: 2015-08-01; Completion date: 2016-12-01
Enrollment: 564 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Detailed description:
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Arms: arm 1: Glycopyrronium Topical Wipes
Interventions: intervention 1: Glycopyrronium Topical Wipes
Intervention descriptions: intervention 1: Glycopyrronium Topical Wipes

Protocol documents:
Clinical trial NCT02558374
Conditions: Open-angle Glaucoma Ocular Hypertension
Sponsor: Aerie Pharmaceuticals
Start date: 2015-09-01; Completion date: 2016-12-01
Enrollment: 708 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

Detailed description:

Arms: arm 1: 1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU) arm 2: 1 drop twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU)
Interventions: intervention 1: AR-13324 Ophthalmic Solution 0.02% intervention 2: Timolol Maleate Ophthalmic Solution 0.5% BID intervention 3: Placebo
Intervention descriptions: intervention 1: 1 drop once daily (QD), PM, OU intervention 2: 1 drop BID, AM/PM, OU intervention 3: 1 drop QD, AM, OU

Protocol documents:
Clinical trial NCT02561585
Conditions: Alopecia Areata
Sponsor: LEO Pharma
Start date: 2016-01-01; Completion date: 2016-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.

Detailed description:
The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.

Arms: arm 1: LEO 124249 ointment 30 mg/g twice daily arm 2: LEO 124249 ointment vehicle twice daily
Interventions: intervention 1: LEO 124249 intervention 2: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02562521
Conditions: Smoking Cessation
Sponsor: Yale University
Start date: 2015-09-01; Completion date: 2016-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate a smoking cessation program for employees at the Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation intervention at the work site.

Detailed description:
The primary aim of this study is to test the effect of a smoking cessation intervention provided to Yale University dining hall employees on smoking quit rates and quit attempts at the end of six weeks of treatment. It is hypothesized that participants from the test site will have higher rates of smoking cessation and quit attempts compared to participants from the control site. In addition, this study will examine the number of participants who enroll in the smoking cessation program who successfully quit smoking at 6 months.

There will be 3 test sites and 3 control sites in this study (broken down into 3 pairs of test/control). Each test site will be matched to on a control site. Self-reported smoking status will be obtained for all participants in the test and control sites at 3 time points (baseline, 6 weeks and 6 months). The study start time for each pair will be delayed by 4-8 weeks for feasibility issues.

Arms: arm 1: The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy \[NRT\] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting. arm 2: Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Interventions: intervention 1: Contingency management intervention 2: Nicotine replacement therapy intervention 3: Varenicline intervention 4: Additional behavioral support
Intervention descriptions: intervention 1: Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking. intervention 2: Participants have the option of using nicotine patch in combination with nicotine gum or lozenge intervention 3: Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative intervention 4: Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support

Protocol documents:
Clinical trial NCT02580240
Conditions: Septic Shock
Keywords: septic shock hydrocortisone mortality
Sponsor: Northern Jiangsu People's Hospital
Start date: 2015-09-01; Completion date: 2016-12-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.

Detailed description:

Arms: arm 1: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. arm 2: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Interventions: intervention 1: Hydrocortisone intervention 2: saline
Intervention descriptions: intervention 1: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). intervention 2: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

Protocol documents:
Clinical trial NCT02582632
Conditions: Hepatitis C Infection Hepatitis C Virus
Keywords: Hepatitis C Virus Interferon-Free Ribavirin-Free Hepatitis C Hepatitis C Genotype 1b
Sponsor: AbbVie
Start date: 2015-11-24; Completion date: 2016-12-01
Enrollment: 166 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

Detailed description:

Arms: arm 1: Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT02600767
Conditions: Malaria
Sponsor: Centers for Disease Control and Prevention
Start date: 2015-12-01; Completion date: 2016-12-01
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions. The results of this efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to evaluate the national policy for treatment of malaria caused by P. falciparum.

Detailed description:
This protocol uses the recommended World Health Organization (WHO) protocol for monitoring antimalarial efficacy. Patients with malaria will receive supervised therapy and will be monitored for 28 days to check for treatment response, both clinically and parasitologically. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. Patients will be asked to come back on Days 2, 3, 7, 14, 21 and 28 for clinical evaluation and blood tests using microscopy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions, this will allow us to determine if the recurrent infection was reinfection or failure or recrudescence. Results of this evaluation will guide treatment policies in Brazil.

Arms: arm 1: Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.
Interventions: intervention 1: Artemether-lumefantrine combination
Intervention descriptions: intervention 1: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.

Protocol documents:
Clinical trial NCT02614131
Conditions: Healthy Alzheimer's Disease Mild Cognitive Impairment
Sponsor: Eli Lilly and Company
Start date: 2015-12-01; Completion date: 2016-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The study will measure how much LY2599666 gets into the bloodstream and how long it takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks. Participants may only enroll in one part.

Detailed description:

Arms: arm 1: LY2599666 given subcutaneously (SC) once. arm 2: Placebo matching LY2599666 given SC once. arm 3: LY2599666 given SC once weekly for 12 weeks (13 doses). arm 4: Placebo given SC once weekly for 12 weeks (13 doses). arm 5: Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks. arm 6: Placebo given IV once weekly or once every 4 weeks for 12 weeks.
Interventions: intervention 1: LY2599666 intervention 2: Solanezumab intervention 3: Placebo SC intervention 4: Placebo IV
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered IV intervention 3: Administered SC intervention 4: Administered IV

Protocol documents: