ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01860586
Conditions: Retinal Detachment Vitreoretinopathy Proliferative
Keywords: pvr rd Proliferative Vitreoretinopathy retinal detachment detachment
Sponsor: Wills Eye
Start date: 2013-06-01; Completion date: 2014-11-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on the rates of recurrent retinal detachment and scar tissue formation.

Detailed description:
Proliferative vitreoretinopathy (PVR) remains the most significant obstacle to successful retinal detachment (RD) repair, accounting for up to 75% of all primary surgical failures. Characterized by the proliferation of cells on the preretinal or subretinal surface, PVR ultimately leads to contraction, foreshortening, and ultimately recurrent detachment of the retina. Several PVR risk factors have been identified, including pre-existing uveitis, large retinal tears, multiple retinal breaks, detachments involving greater than two quadrants of the retina, vitreous hemorrhage, and choroidal detachment. Given the absence of a proven medical therapy for PVR and prior studies establishing VEGF as a potential therapeutic target, further clinical evaluation is warranted. Herein, we report outcomes of a prospective, non-randomized, historical-control pilot study evaluating the effect of serial intrasilicone oil bevacizumab injections on outcomes of PVR-related RD repair.

Arms: arm 1: Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: Bevacizumab (1.25mg/0.05mL) will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.

Protocol documents:
Clinical trial NCT01871532
Conditions: Infertility Monofollicular Development
Keywords: Monofollicular Development Gonal-f® Recombinant Follicle Stimulating Hormone Ovarian hyperstimulation syndrome (OHSS)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2013-07-01; Completion date: 2014-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, multicenter, open-label, comparative and parallel-group study of ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH) treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2 anovulatory subjects who have previously failed to conceive with clomifene treatment.

Detailed description:
Subjects will enter a screening period of up to one month before being randomized at the Baseline Visit, which will occur on Day 1 of the subject's menstrual cycle. Each subject will then receive up to 4 weeks treatment with Gonal-f®. If adequate follicular development (assessed by transvaginal ultrasound) is achieved, the subject will proceed to administration of human chorionic gonadotropin (hCG) within 24-48hrs of last Gonal-f® injection (or according to standard site practice).

Following administration of hCG, subjects will attempt to become pregnant via intercourse or intrauterine insemination. The method of conception will be determined by the subject's requirements and standard practice at the clinic site.

All subjects will be followed up appropriately until confirmation of biochemical pregnancy (hCG + minimum 14 days) and clinical pregnancy (hCG + minimum 42 days, for subjects with positive biochemical pregnancy test).

Arms: arm 1: Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion. arm 2: Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
Interventions: intervention 1: Gonal-f®
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01880437
Conditions: Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
Sponsor: Hoffmann-La Roche
Start date: 2013-09-01; Completion date: 2014-11-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150 mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in combination with cytarabine 20 mg subcutaneously for 10 days.

Anticipated time on study treatment is until disease progression, intolerable toxicity, or patient withdrawal of consent.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: cytarabine intervention 2: vismodegib
Intervention descriptions: intervention 1: Cohort 2: 20 mg sc daily for 10 days starting Day 1, with a possible further cycle of 20 mg sc daily for 5 days starting no earlier than Day 29 intervention 2: Cohorts 1 and 2: 150 mg orally daily

Protocol documents:
Clinical trial NCT01890473
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2013-07-01; Completion date: 2014-11-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

Detailed description:
SC=Subcutaneous

Arms: arm 1: Abatacept 125 mg/syringe subcutaneously through autoinjector, one dose in 71 days arm 2: Abatacept 125 mg/syringe subcutaneously with prefilled syringe, one dose in 71 days
Interventions: intervention 1: Abatacept
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01910116
Conditions: Hand Osteoarthritis
Keywords: osteoarthritis hand Shinbaro GCSB-5
Sponsor: Seoul National University Hospital
Start date: 2013-09-01; Completion date: 2014-11-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.

Detailed description:
Osteoarthritis (OA) as a common musculoskeletal disease affects more than 30% of the elderly population. It frequently involves knees, hips, spines and hands. In hands, the distal and proximal interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. The chronic progressive nature of the disease requires a life-long treatment. The mainstay treatment of hand OA targets pain control. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used. However, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. Further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics.

Shibaro is a mixture of purified oriental herbs consisting of Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex. These herbs have been used for the treatment of diverse inflammatory conditions in Chines traditional medicine. All 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. As such, given the excellent safety profile, anti-inflammatory and analgesic effects, Shinbaro might be ideal in the treatment of OA.

This study will investigate the efficacy and safety of Shinbaro in the treatment of hand OA in a placebo-controlled, randomized, double-blind, multi-center trial.

Arms: arm 1: Placebo 2 capsules, twice daily, for 12 weeks. arm 2: Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks
Interventions: intervention 1: Shinbaro intervention 2: Placebo
Intervention descriptions: intervention 1: GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem intervention 2: The study medication and placebo were identical in appearance.

Protocol documents:
Clinical trial NCT01911442
Conditions: Autism
Keywords: Autism, Lurasidone, Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2013-08-01; Completion date: 2014-11-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Detailed description:
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Arms: arm 1: Lurasidone 20 mg once daily arm 2: Lurasidone 60 mg once daily arm 3: Placebo once daily
Interventions: intervention 1: Lurasidone 20 mg daily intervention 2: Lurasidone intervention 3: Placebo
Intervention descriptions: intervention 1: Lurasidone 20 mg once daily intervention 2: Lurasidone 60 mg once daily intervention 3: Placebo

Protocol documents:
Clinical trial NCT01920893
Conditions: Nasal Polyps
Sponsor: Sanofi
Start date: 2013-08-01; Completion date: 2014-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

* symptoms of sinusitis,
* sinus computed tomography (CT) scan,
* NPS in the sub-group of participants with co-morbid asthma,
* Safety and tolerability.

Detailed description:
Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks.

To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.

Arms: arm 1: Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS). arm 2: Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
Interventions: intervention 1: Placebo (for dupilumab) intervention 2: Dupilumab intervention 3: Mometasone furoate nasal spray
Intervention descriptions: intervention 1: Solution for injection; Subcutaneous injection. intervention 2: Solution for injection; Subcutaneous injection. intervention 3: Nasal spray, 2 actuations in each nostril twice daily.

Protocol documents:
Clinical trial NCT01922050
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2013-10-01; Completion date: 2014-11-01
Enrollment: 320 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Part 1:

To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Detailed description:

Arms: arm 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment arm 2: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment arm 3: Double-Blind, Once-Daily, 2-Day Treatment arm 4: Double-Blind, Once-Daily, 2-Day Treatment arm 5: Double-Blind, Once-Daily, 2-Day Treatment arm 6: Double-Blind, Once-Daily, 2-Day Treatment arm 7: Double-Blind, Once-Daily, 2-Day Treatment arm 8: Double-Blind, Once-Daily, 2-Day Treatment
Interventions: intervention 1: LEO 43204 Formulation 1 intervention 2: LEO 43204 Formulation 2 intervention 3: LEO 43204 Formulation 1 Dose X intervention 4: LEO 43204 Formulation 1 Dose Y intervention 5: LEO 43204 Formulation 2 Dose XX intervention 6: LEO 43204 Formulation 2 Dose YY intervention 7: Placebo Formulation 1 intervention 8: Placebo Formulation 2
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol documents:
Clinical trial NCT01929460
Conditions: Pancreatic Cysts
Sponsor: Kaiser Permanente
Start date: 2014-01-01; Completion date: 2014-11-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.

Detailed description:
With the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered.

A critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (EUS-FNA).

Current guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after the procedure. However, these recommendations are based on limited data from over 15 years ago. More recent retrospective observations suggest equivalent safety when little, or even no antibiotics are given.

Arms: arm 1: Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.

Ciprofloxacin 500mg by mouth twice a day for three days. arm 2: Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration

Oral Placebo, one cap twice a day for three days.
Interventions: intervention 1: Ciprofloxacin intervention 2: Placebo (for ciprofloxacin)
Intervention descriptions: intervention 1: ciprofloxacin oral capsule (one capsule twice a day for 3 days) intervention 2: oral placebo capsule (one capsule twice a day for 3 days)

Protocol documents:
Clinical trial NCT01942161
Conditions: Schizophrenia
Keywords: Schyzophrenia, pediatric patients
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2010-08-01; Completion date: 2014-11-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia

Detailed description:

Arms: arm 1: Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). arm 2: Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. arm 3: Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Interventions: intervention 1: Aripiprazole Low (2 mg/day) intervention 2: Aripiprazole Mid (6 - 12 mg/day) intervention 3: Aripiprazole High (24 - 30 mg/day)
Intervention descriptions: intervention 1: administered 2 mg once daily for 6 weeks intervention 2: administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg intervention 3: administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg

Protocol documents:
Clinical trial NCT01965535
Conditions: HCV Infection
Keywords: Hepatitis C HCV Cirrhosis
Sponsor: Gilead Sciences
Start date: 2013-10-01; Completion date: 2014-11-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA \< the lower limit of quantitation (LLOQ), or achieved HCV RNA \< LLOQ).

Detailed description:

Arms: arm 1: LDV/SOF FDC tablet plus placebo to match RBV for 24 weeks arm 2: Placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by LDV/SOF FDC plus RBV for 12 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV intervention 3: Placebo to match LDV/SOF intervention 4: Placebo to match RBV
Intervention descriptions: intervention 1: LDV/SOF (90/400 mg) FDC tablet administered orally once daily intervention 2: RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) intervention 3: Placebo to match LDV/SOF administered orally once daily intervention 4: Placebo to match RBV administered orally in a divided daily dose

Protocol documents:
Clinical trial NCT01968135
Conditions: Uterine Hemorrhage Contraception
Sponsor: University of Colorado, Denver
Start date: 2013-10-01; Completion date: 2014-11-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive implants who report a bleeding-spotting episode of at least seven days will stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to women receiving 14 days of placebo.

Detailed description:
The ENG contraceptive implant (Implanon/Nexplanon®), is a silicone- free, single rod subdermal contraceptive implant that contains 68 mg of etonogestrel, is approved for use for three years, and is one of the most effective forms of contraception available (1). ENG contraceptive implants are easily inserted and removed (1,2), offer quick return to fertility (2), are cost-effective and cost-saving (3,4) and offer non-contraceptive benefits such as improvement in pain for patients with complaints of dysmenorrhea (5).

Hypothesis: Women using ENG contraceptive implants who report a bleeding-spotting episode of at least seven days will be more likely to stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids compared to women receiving 14 days of placebo.

Arms: arm 1: Placebo Sugar Pill arm 2: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Interventions: intervention 1: Combined Oral Contraceptive Pill intervention 2: Placebo Sugar Pill
Intervention descriptions: intervention 1: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill intervention 2: Placebo Sugar Pill

Protocol documents:
Clinical trial NCT01973231
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-10-01; Completion date: 2014-11-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: lixisenatide
Intervention descriptions: intervention 1: Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day). intervention 2: Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.

Protocol documents:
Clinical trial NCT01977820
Conditions: Phenylketonuria
Keywords: Phenylketonuria Sapropterin Placebo Cognitive Abilities Kuvan®
Sponsor: BioMarin Pharmaceutical
Start date: 2014-02-01; Completion date: 2014-11-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2a multicenter, double-blind, placebo-controlled, randomized, 2-arm pilot trial designed to assess the effect of sapropterin on cognitive abilities in young adults with Phenylketonuria (PKU) over a 26-week treatment period.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sapropterin intervention 2: Placebo
Intervention descriptions: intervention 1: Sapropterin tablets will be administered orally once daily at a dose of 20 milligram per kilogram (mg/kg) during both the 2-Week response test period and 24-Week study period. intervention 2: Sapropterin tablets will be administered orally once daily at a dose of 20 milligram per kilogram (mg/kg) during both the 2-Week response test period and Placebo tablets matching to sapropterin will be administered orally once daily during the 24-Week study period.

Protocol documents: