ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02633527
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Sponsor: Supernus Pharmaceuticals, Inc.
Start date: 2016-02-01; Completion date: 2016-07-25
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Detailed description:
This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).

Arms: arm 1: Placebo, qd, oral capsule arm 2: 100mg SPN-812, qd, oral capsule arm 3: 200mg SPN-812, qd, oral capsule arm 4: 300mg SPN-812, qd, oral capsule arm 5: 400mg SPN-812, qd, oral capsule
Interventions: intervention 1: Placebo intervention 2: 100mg SPN-812 intervention 3: 200mg SPN-812 intervention 4: 300mg SPN-812 intervention 5: 400mg SPN-812
Intervention descriptions: intervention 1: Placebo was administered once daily intervention 2: 100mg SPN-812 was administered once daily and compared to placebo intervention 3: 200mg SPN-812 was administered once daily and compared to placebo intervention 4: 300mg SPN-812 was administered once daily and compared to placebo intervention 5: 400mg SPN-812 was administered once daily and compared to placebo

Protocol documents:
Clinical trial NCT01866423
Conditions: Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer
Sponsor: University of Southern California
Start date: 2013-10-25; Completion date: 2016-07-26
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well orteronel works in treating patients with metastatic hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the relationship between circulating tumor cell (CTC)-based androgen receptor (AR) expression level and \>=-50% prostate-specific antigen (PSA) decline following 12 weeks of therapy with TAK-700 (orteronel).

SECONDARY OBJECTIVES:

I. To assess changes in PSA and CTC levels and time to PSA progression (best response, decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based treatment.

II. To assess measurable disease response and time to radiographic disease progression for castration-resistant prostate cancer (CRPC) with or without prior docetaxel-based treatment.

III. To explore relationships between endocrine and clinical responses.

IV. To confirm the safety of TAK-700 administered without prednisone in patients with metastatic CRPC.

OUTLINE: Patients receive orteronel orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: orteronel intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01298492
Conditions: Crohn's Disease
Keywords: Active Crohn's disease Anti-TNF Refractory Immunosuppressant Refractory
Sponsor: Shire
Start date: 2011-07-01; Completion date: 2016-07-27
Enrollment: 268 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

Detailed description:
The rationale for conducting this open-label extension (OLE) study is primarily to evaluate long term safety of PF 00547659. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. It also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. This is a multi center Phase 2, open label, safety extension study for feeder studies which evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". All subjects entering this study must have discontinued immunosuppressant therapy.

Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks through Week 72. After the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168.

Arms: arm 1: Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008
Interventions: intervention 1: PF-00547659
Intervention descriptions: intervention 1: 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.

Protocol documents:
Clinical trial NCT01786603
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Richard Barohn, MD
Start date: 2013-11-21; Completion date: 2016-07-27
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. Motor neurons are responsible for sending signals to muscles in our bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.

Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics, but the effectiveness of rasagiline for patients with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's disease.

Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration (FDA) and is investigational. Investigational drugs are studied to find out if they are safe and effective in the treatment of diseases or conditions.

By doing this study, researchers hope to learn if rasagiline is safe and slows disease progression in patients with ALS.

Funding Source - FDA OOPD (FDA Orphan Products Division).

Detailed description:
The study is a phase II, double-blind, placebo-controlled, multicenter study of rasagiline 2mg/day. Subjects will be assigned to either active agent or placebo (3:1) for twelve months. Subjects will undergo outpatient evaluations at screening, baseline, and months 1, 2, 4, 6, 8, 10 and 12 and telephone assessments at months 3, 5, 7 and 9. There will be a close-out phone call 30 days post month 12.

Arms: arm 1: Rasagiline 1mg administered orally as a 2mg single dose once daily for 12 months. arm 2: Inactive ingredient equal to 1mg rasagiline 2mg administered as a single dose once daily for 12 months.
Interventions: intervention 1: Rasagiline intervention 2: Placebo
Intervention descriptions: intervention 1: Rasagiline 2mg once a day for 12 months. intervention 2: Placebo (looks like study drug but has no active ingredients) once a day for 12 months.

Protocol documents:
Clinical trial NCT02042183
Conditions: Constipation - Functional
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2013-12-13; Completion date: 2016-07-27
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Detailed description:
Dose administration details:

* Participants with a body weight \<50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID.
* Participants with a body weight \>50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Arms: arm 1: Participants receive lubiprostone twice daily (BID) up to 12 weeks arm 2: Participants receive placebo BID up to 12 weeks
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1 intervention 2: 0 mcg soft capsules of placebo for oral administration

Protocol documents:
Clinical trial NCT02294682
Conditions: Gonorrhea
Keywords: uncomplicated urogenital gonorrhea Bacterial Type II Topoisomerase Inhibitors (BTI) antibiotics GSK2140944 N. gonorrhoeae
Sponsor: GlaxoSmithKline
Start date: 2015-04-15; Completion date: 2016-07-27
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.

Detailed description:

Arms: arm 1: Subjects will receive single oral dose of GSK2140944 1500 mg. arm 2: Subjects will receive single oral dose of GSK2140944 3000 mg.
Interventions: intervention 1: GSK2140944
Intervention descriptions: intervention 1: Immediate release capsules (pink hard gelatin size 00 capsule, with no external marking, filled with slightly agglomerated pale yellowish to grayish yellow powder) containing GSK2140944 500 mg and inactive formulation excipients. GSK2140944 will be administered orally once 1500 mg (3 capsules) or 3000 mg (6 capsules).

Protocol documents:
Clinical trial NCT02477020
Conditions: Schizophrenia
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2015-07-01; Completion date: 2016-07-27
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063 compared with placebo in treatment of acutely exacerbated schizophrenia.

Detailed description:
The drug being tested in this study is called TAK-063. TAK-063 is being tested to treat people who have schizophrenia. This study will look at the different symptoms associated with schizophrenia including cognitive symptoms, personal and social functioning and functional capacity (ability to perform tasks associated with real, everyday life such as household chores, communication, finance, transportation, and planning recreational activities) in people who take TAK-063.

The study enrolled 164 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-063 20 mg
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take the tablets once daily at nighttime. All participants will initially receive TAK-063, 20 mg/day. The dose may be titrated down to 10 mg/day, if intolerable.

The multi-center trial will be conducted in the United States. The overall time to participate in this study is 6 weeks. Participants will be hospitalized until the Week 3 visit. Participants will make 11 visits to the clinic during the treatment and 1 visit during the follow-up.

Arms: arm 1: TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks. Dose may be titrated down to 10 mg/day, if intolerable. arm 2: TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.
Interventions: intervention 1: TAK-063 20 mg intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-063 tablet. intervention 2: TAK-063 matching-placebo tablet.

Protocol documents:
Clinical trial NCT01813422
Conditions: Hypercholesterolemia
Keywords: Cholesterol High Cholesterol Elevated Cholesterol Raised Cholesterol
Sponsor: Amgen
Start date: 2013-04-18; Completion date: 2016-07-29
Enrollment: 970 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

Detailed description:

Arms: arm 1: Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. arm 2: Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT02207309
Conditions: Sarcoma
Keywords: high-risk soft tissue sarcoma pazopanib retroperitoneal soft tissue sarcoma visceral soft tissue sarcoma votrient
Sponsor: Ludwig-Maximilians - University of Munich
Start date: 2015-06-22; Completion date: 2016-07-29
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia.

Detailed description:

Arms: arm 1: 800mg, oral, 24 months arm 2: 800mg, oral, 24 months
Interventions: intervention 1: Pazopanib intervention 2: Placebo (for Pazopanib)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02682823
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2016-03-21; Completion date: 2016-07-29
Enrollment: 91 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.

Detailed description:

Arms: arm 1: CGs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation. arm 2: HCPs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation. arm 3: Participants with RA will perform self-injection of SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation. arm 4: CGs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation. arm 5: HCPs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visit 1 (Day 0) will be performed by the study nurse. Visits 2 and 3 (Days 14 and 28) will be conducted by the HCP for use/performance evaluation.
Interventions: intervention 1: AI-1000 G2 intervention 2: Tocilizumab
Intervention descriptions: intervention 1: Tocilizumab will be administered using the AI-1000 G2. intervention 2: Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

Protocol documents:
Clinical trial NCT02721875
Conditions: Myelodysplastic Syndromes
Sponsor: Boehringer Ingelheim
Start date: 2016-04-28; Completion date: 2016-07-29
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in combination with azacitidine in patients with myelodysplastic syndrome (MDS) after hypomethylating agents (HMA) treatment failure.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Volasertib intervention 2: Volasertib intervention 3: Azacitidine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02364947
Conditions: Alcohol Dependence
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2015-02-09; Completion date: 2016-07-30
Enrollment: 678 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Nalmefene hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: As-needed; tablets, orally intervention 2: As-needed; tablets, orally

Protocol documents:
Clinical trial NCT02465164
Conditions: Cervical Ripening
Sponsor: Henry Ford Health System
Start date: 2015-07-01; Completion date: 2016-07-30
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.

Detailed description:

Arms: arm 1: Control arm 2: Test group
Interventions: intervention 1: Cook catheter intervention 2: Oxytocin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01874665
Conditions: GIST
Keywords: Gastrointestinal Neoplasms Gastrointestinal stromal tumor mesenchymal tumor
Sponsor: Ariad Pharmaceuticals
Start date: 2013-06-05; Completion date: 2016-07-31
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ponatinib in participants with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure of prior tyrosine kinase inhibitor (TKI) therapy.

Detailed description:
This is a non-randomized, open label, multi-center phase 2 study to evaluate the efficacy and safety of ponatinib in participants with metastatic and/or unresectable GIST after failure of prior TKI therapy. Participants whose tumors have an activating mutation in exon 11 of cellular KIT (KIT) will be enrolled into Cohort A. Participants whose tumors have other activating mutations will be enrolled into in Cohort B.

The primary objective is to assess clinical benefit in participants with KIT exon 11-mutant GIST (Cohort A) defined as clinical benefit rate (CBR), which is the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting greater than or equal to (\>=) 16 weeks per modified response evaluation criteria in solid tumors (RECIST 1.1) as a measure of disease control. The secondary objective is to assess clinical benefit in participants with GIST that lacks an activating KIT exon 11 mutation (Cohort B) and in the total participant population. The efficacy assessments are tumor response using RECIST Version 1.1, modified for GIST and assessment of progression-free survival (PFS) and overall survival (OS). The safety assessments include routine physical and laboratory evaluations, electrocardiograms (ECGs), echocardiograms (ECHOs), and adverse event (AE) monitoring. Other assessments include optional 18F fluorodeoxyglucose positron emission tomography (FDG-PET); optional pre- and post-treatment tumor biopsy for pharmacodynamic studies; and pharmacokinetics (PK). It is estimated that accrual will be complete within 1 year; the total estimated duration of the study is 3 years.

Arms: arm 1: Participants with KIT exon 11-mutant GIST. arm 2: Participants with GIST that lack KIT exon 11 mutations (Cohort B).
Interventions: intervention 1: Ponatinib
Intervention descriptions: intervention 1: Ponatinib 45 mg, tablets, orally, once-daily.

Protocol documents: