ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01710657
Conditions: Epilepsy Partial Onset Seizures
Keywords: Lacosamide Epilepsy Partial Onset Seizures
Sponsor: UCB Pharma SA
Start date: 2012-09-01; Completion date: 2014-08-01
Enrollment: 548 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

Detailed description:

Arms: arm 1: Matching placebo for 16 weeks. arm 2: Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks. arm 3: Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
Interventions: intervention 1: Lacosamide 50 mg intervention 2: Lacosamide 100 mg intervention 3: Placebo
Intervention descriptions: intervention 1: * Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 50 mg
* Route of Administration: Oral use intervention 2: * Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 100 mg
* Route of Administration: Oral use intervention 3: Matching oral Placebo tablets twice daily for 16 weeks.

Protocol documents:
Clinical trial NCT01731119
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychosis NOS Autistic Disorder Asperger Syndrome Child Development Disorders, Pervasive Bipolar I Disorder Bipolar II Disorder Mood Disorder NOS Severe Major Depression With Psychotic Features Single Episode Major Depression Without Psychotic Symptoms Severe Mood Disorder With Psychotic Features
Keywords: Latuda,lurasidone,antipsychotics,autism, mood, psychosis
Sponsor: University of North Carolina, Chapel Hill
Start date: 2012-12-01; Completion date: 2014-08-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.

Detailed description:
This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes associated with lurasidone treatment. Antipsychotic (AP) naive subjects will start open-label treatment by following a flexible titration schedule. Quasi-antipsychotic naive subjects (less than 4 weeks of total AP treatment) will be started on lurasidone and tapered off the other antipsychotic over an estimated 4 weeks depending on the dose and tolerability of the prior antipsychotic. Other psychoactive medications including antidepressants, benzodiazepines, stimulants, alpha-2 agonists, and mood stabilizers are allowed as long as the dose is not changed, unless it is clinically necessary. Assessments of weight, efficacy, and side effects are conducted at baseline, week 2, week 4, week 8, and week 12. The primary outcome is percent change in weight. The secondary outcomes include psychiatric efficacy measures and side effects.

Arms: arm 1: Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Interventions: intervention 1: Latuda©
Intervention descriptions: intervention 1: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Protocol documents:
Clinical trial NCT01738191
Conditions: Parkinson's Disease Cognitive Impairment
Keywords: Parkinson's disease
Sponsor: Medical University of South Carolina
Start date: 2012-11-01; Completion date: 2014-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and effectiveness of a drug called atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD.

Detailed description:

Arms: arm 1: The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily. arm 2: Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily. intervention 2: None

Protocol documents:
Clinical trial NCT01744730
Conditions: Bacterial Infections Obesity
Keywords: Bacterial infections Obesity pharmacokinetics clindamycin
Sponsor: Phillip Brian Smith
Start date: 2013-06-01; Completion date: 2014-08-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The results of the study will help better understand if children in higher BMI ranges process the medication differently and whether dosing should be adjusted in these children.

Detailed description:
This is a prospective, open-label pharmacokinetic and safety study of multiple doses of IV and oral clindamycin in overweight and obese children ages 2 to 17 years of age. The total study duration is expected to be approximately 24 months; each subject will participate in the study for up to 18 days (screening day; treatment days 1-14 \[may be as short as 2 days\] followed by an observation period of 3 days post discontinuation of clindamycin therapy or after day 17 (on day 18) of therapy in those who are treated with more than 14 days of clindamycin).

Arms: arm 1: Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care. arm 2: Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care. arm 3: Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care. arm 4: Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
Interventions: intervention 1: Clindamycin
Intervention descriptions: intervention 1: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.

Protocol documents:
Clinical trial NCT01745133
Conditions: Psoriasis
Keywords: Olux E foam Sorilux foam
Sponsor: Leon Kircik, M.D.
Start date: 2013-01-01; Completion date: 2014-08-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam may help "maintain" the therapeutic benefit that is achieved with OLUX-E™ Foam in the treatment of moderate plaque psoriasis.

OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation. SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by the FDA for treating plaque psoriasis.

Detailed description:
This is a single-center, investigator-blind study. Approximately 60 qualified subjects will be enrolled into a 2 week treatment phase where they will receive 2 weeks of treatment with Olux E foam. After 2 weeks treatment, subjects with a PGA of 0 or 1 will be re-randomized into maintenance phase.

Subjects that achieve PGA scores of \>2 will be discontinued from the study and will not be randomized. Subjects that achieve PGA scores of 0 or 1 will enter an 8 week maintenance phase where they will be randomized on a 1:1:1 basis to one of the following treatment groups:

* Vehicle foam (BID)
* Sorilux foam (BID)
* Sorilux foam (BID on weekdays) + Olux E foam (BID on weekends)

Subjects will then attend clinic visits at week 6. At week 10 study treatment will be stopped.

The maximum duration of the study is 10 weeks and consists of a Screening/Baseline Visit (Week -0), Re-randomization to maintenance phase visit (Week 2), treatment follow-up visits at Weeks 6, and end of treatment visit at weeks 10.

Arms: arm 1: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks arm 2: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x arm 3: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
Interventions: intervention 1: vehicle foam intervention 2: calcipotriene intervention 3: calcipotriene + clobetasol propionate
Intervention descriptions: intervention 1: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks intervention 2: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks intervention 3: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks

Protocol documents:
Clinical trial NCT01749982
Conditions: Arsenic Metabolites Measured in Urine
Keywords: arsenic Bangladesh choline betaine methylation
Sponsor: Columbia University
Start date: 2012-12-01; Completion date: 2014-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects.

The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.

Detailed description:

Arms: arm 1: Placebo tablets arm 2: Choline bitartrate 700 mg by mouth daily arm 3: Betaine 1000 mg by mouth daily arm 4: Choline bitartrate 700 mg + Betaine 1000 mg daily
Interventions: intervention 1: Placebo intervention 2: Choline bitartrate intervention 3: Betaine intervention 4: Choline bitartrate + Betaine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01750086
Conditions: Postmenopausal Osteoporosis
Keywords: osteoporosis postmenopausal denosumab teriparatide alendronate Forteo® Prolia®
Sponsor: Massachusetts General Hospital
Start date: 2013-01-01; Completion date: 2014-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Detailed description:

Arms: arm 1: Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. arm 2: Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Interventions: intervention 1: Teriparatide 40-mcg subcutaneous injection intervention 2: Denosumab Injection intervention 3: Alendronate Oral Tablet
Intervention descriptions: intervention 1: None intervention 2: One-time Denosumab injection intervention 3: weekly alendronate for 8 weeks

Protocol documents:
Clinical trial NCT01753323
Conditions: Malaria
Keywords: acute malaria, KAF156
Sponsor: Novartis Pharmaceuticals
Start date: 2013-03-01; Completion date: 2014-08-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)

Detailed description:

Arms: arm 1: Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days. arm 2: Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days. arm 3: Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
Interventions: intervention 1: KAF156
Intervention descriptions: intervention 1: KAF156 was supplied as tablets for oral use.

Protocol documents:
Clinical trial NCT01767116
Conditions: Chronic Hepatitis C Infection
Keywords: Interferon-Free Hepatitis C Genotype 1b Chronic Hepatitis C Hepatitis C Virus Hepatitis C Treatment-Naive Paritaprevir Ombitasvir Dasabuvir Viekira PAK Ribavirin
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-12-01; Completion date: 2014-08-01
Enrollment: 419 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

Detailed description:
A randomized, double-blind, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naïve, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Arms: arm 1: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks arm 2: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Placebo for ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Capsule intervention 3: Capsule

Protocol documents:
Clinical trial NCT01768676
Conditions: Erectile Dysfunction
Keywords: healthy male
Sponsor: VIVUS LLC
Start date: 2012-12-01; Completion date: 2014-08-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.

Detailed description:

Arms: arm 1: 100 mg arm 2: placebo
Interventions: intervention 1: avanafil intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg intervention 2: None

Protocol documents:
Clinical trial NCT01783015
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis etanercept methotrexate infliximab adalimumab anti-drug antibody
Sponsor: Pfizer
Start date: 2013-09-01; Completion date: 2014-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

Detailed description:
This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.

Arms: arm 1: Subjects who are mAb ADA positive arm 2: Subjects who are mAb ADA negative arm 3: Subjects who are mAb ADA positive arm 4: Subjects who are mAb ADA negative
Interventions: intervention 1: Etanercept intervention 2: Etanercept intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Etanercept 50 mg once-weekly intervention 2: Etanercept 50 mg once-weekly intervention 3: Etanercept placebo once-weekly intervention 4: Etanercept placebo once-weekly

Protocol documents:
Clinical trial NCT01785472
Conditions: Essential Hypertension
Keywords: Essential hypertension LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2013-04-01; Completion date: 2014-08-01
Enrollment: 1438 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension

Detailed description:

Arms: arm 1: Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. arm 2: Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. arm 3: Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Interventions: intervention 1: LCZ696 intervention 2: Olmesartan intervention 3: Placebo of LCZ696 intervention 4: Placebo of Olmesartan
Intervention descriptions: intervention 1: LCZ696 200 mg tablet intervention 2: Olmesartan 20 mg capsule intervention 3: Placebo tablet of LCZ696 200 mg once daily intervention 4: Placebo capsule of olmesartan 20 mg once daily

Protocol documents:
Clinical trial NCT01796964
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Age-Related Macular Degeneration Wet Exudative AMD Intravitreal injection Retina
Sponsor: Alcon Research
Start date: 2013-03-01; Completion date: 2014-08-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.

Detailed description:
This study consisted of 16 visits (Screening, Baseline \[Day 0\], and 14 post-baseline assessment visits) that occurred at 4-week intervals through Week 56. Enrolled subjects were randomized 1:1 to receive ESBA1008 or EYLEA. All subjects received active intravitreal (IVT) injections at baseline with 2 additional loading doses of the assigned investigational product at 4-week intervals (ie, at Weeks 4 and 8) and then received further injections at 8-weeks intervals at Weeks 16, 24, and 32. Subjects in the ESBA1008 group also received an injection at Week 44, while subjects in the EYLEA group also received injections at Weeks 40 and 48. To maintain the study masking, subjects in the ESBA1008 group received sham injections at Weeks 40 and 48 (when the subjects in the EYLEA group received active injections), while subjects in the EYLEA group received a sham injection at Week 44 (when the subjects in the ESBA1008 group received an active injection). All subjects were followed up to Week 56. Week 40 visit was the end of assessment period for the 8-week treatment cycle.

Arms: arm 1: ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol arm 2: Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
Interventions: intervention 1: ESBA1008 solution intervention 2: Aflibercept
Intervention descriptions: intervention 1: For intravitreal (IVT) injection intervention 2: For intravitreal (IVT) injection

Protocol documents: