ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02047747
Conditions: Brain Cancer
Keywords: Brain Metastasis human epidermal receptor (HER)
Sponsor: David Piccioni, M.D., Ph.D
Start date: 2014-02-01; Completion date: 2016-02-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the disease response, survival, and side effects of an experimental drug called dacomitinib in progressive brain metastases.

Detailed description:
The purpose of this study is to investigate the use of the irreversible pan-ErB kinase inhibitor dacomitinib in the treatment of brain metastases, as measured by radiographic objective response rate.

The rationale of this study is three-fold. First, the use of dacomitinib, an irreversible pan-ErB kinase inhibitor, is to improve the duration of response seen by reversible, EGFR only inhibitors. Inhibition of the multiple ErB kinases may interfere with receptor cross-talk as a method of developing resistance; indeed, patients who have failed erlotinib treatment for systemic disease have seen responses to dacomitinib. The second rationale is to evaluate the pharmacokinetics of the penetration of dacomitinib into the CSF to determine if adequate drug levels reach the CNS, and determine if the current dosing regimen is appropriate. The third rationale is to determine if specific molecular phenotypes preferentially respond to dacomitinib. As part of this study, serum and cerebrospinal fluid will be collected and analyzed both for drug levels and for molecular markers to key elements of the ErB signaling cascade. The objective of the marker analysis to identify a distinct molecular phenotype that may preferentially respond to targeted drug therapy in the future.

Arms: arm 1: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Interventions: intervention 1: Dacomitinib
Intervention descriptions: intervention 1: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.

Protocol documents:
Clinical trial NCT02061540
Conditions: Primary Sclerosing Cholangitis (PSC)
Sponsor: Mirum Pharmaceuticals, Inc.
Start date: 2014-03-01; Completion date: 2016-02-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.

Detailed description:

Arms: arm 1: LUM001 administered orally once each day
Interventions: intervention 1: LUM001
Intervention descriptions: intervention 1: LUM001 oral dose

Protocol documents:
Clinical trial NCT02070302
Conditions: Carpal Tunnel Syndrome
Sponsor: Benjamin Sucher
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be a prospective double blind controlled randomized trial of ten patients diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of medical practices in Arizona. Patients who meet inclusion criteria will be randomly distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned individuals.

Detailed description:
This is a pilot study, to assist with determining appropriate BOTOX® (onabotulinumtoxin A) dosing and injection locations in patients suffering from CTS.

Outcome measures will be obtained at follow-up at 6, 12, and 18 weeks post BOTOX® (onabotulinumtoxin A) injection and post saline injection using the same scales and instruments at baseline, namely Levine scale, JAMAR pinch dynamometer, EDX/NCS and NMUS. These measurements will be used to identify the effectiveness of BOTOX® (onabotulinumtoxin A) in decreasing thenar muscle strength, appropriate BOTOX® (onabotulinumtoxin A) injection dosing, and ability to decrease the inflammation, median nerve dysfunction, edema, symptoms of pain, numbness, and tingling often with associated with CTS.

Arms: arm 1: After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) arm 2: .4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Placebo
Intervention descriptions: intervention 1: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each intervention 2: Placebo (Normal Saline) divided into 2 injections of .4cc each

Protocol documents:
Clinical trial NCT02077140
Conditions: Postoperative Pain
Sponsor: Medtronic Spinal and Biologics
Start date: 2014-02-01; Completion date: 2016-02-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment of acute postoperative pain after subjects undergo bunionectomy.

Detailed description:

Arms: arm 1: Subjects will receive MDT-10013. arm 2: Subjects will receive standard of care.
Interventions: intervention 1: MDT-10013 intervention 2: Standard of care for pain
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02080832
Conditions: Cocaine Dependence
Keywords: substance abuse cocaine impulsivity serotonin MRI
Sponsor: Virginia Commonwealth University
Start date: 2010-02-01; Completion date: 2016-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.

Detailed description:
The Specific Aims of this project are:

Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.

Hypothesis related to Aim 1:

Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.

Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.

Hypothesis related to Aim 2:

Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.

Arms: arm 1: Citalopram (20mg dose) arm 2: None arm 3: Citalopram 40mg dose
Interventions: intervention 1: Citalopram intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg or 40 mg daily for 8 weeks intervention 2: Placebo daily for 8 weeks

Protocol documents:
Clinical trial NCT02087943
Conditions: Dermatitis, Atopic Dermatitis
Keywords: Atopic Dermatitis Atopic Eczema
Sponsor: Amgen
Start date: 2014-06-01; Completion date: 2016-02-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Detailed description:

Arms: arm 1: Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase arm 2: Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase arm 3: Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase arm 4: Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase arm 5: Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.
Interventions: intervention 1: Apremilast intervention 2: Apremilast intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Orally twice a day (BID) intervention 2: Orally twice a day (BID) intervention 3: Orally twice a day (BID) intervention 4: Orally twice a day (BID)

Protocol documents:
Clinical trial NCT02113007
Conditions: Primary Central Nervous System Lymphoma
Keywords: Lymphoma; CNS; rituximab; temozolomide
Sponsor: SCRI Development Innovations, LLC
Start date: 2014-07-01; Completion date: 2016-02-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of high-dose rituximab combined with temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age or older, or in patients 18 years or older who refuse methotrexate-based treatment.

Detailed description:
This is a Phase II, multi-centered, single-arm study. A brief patient lead-in portion will be included to assess safety and feasibility. The first six patients enrolled will be monitored weekly for safety during two treatment cycles (4 weeks) for adverse events to assure there are no unexpected or prohibitive toxicities. If safety signals emerge from this group of patients, the protocol may be discontinued or modified.

Arms: arm 1: Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5
Interventions: intervention 1: Rituximab plus Temozolomide
Intervention descriptions: intervention 1: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Protocol documents:
Clinical trial NCT02121483
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2014-06-01; Completion date: 2016-02-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Patient to receive a high dose of empagliflozin arm 2: Patient to receive a medium dose of empagliflozin arm 3: Patient to receive a low dose of empagliflozin
Interventions: intervention 1: empagliflozin medium dose intervention 2: empagliflozin high dose intervention 3: empagliflozin low dose
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02136498
Conditions: Smoking Cessation Medication Adherence
Keywords: smoking cessation varenicline adherence
Sponsor: Kaiser Permanente
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Detailed description:
Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Arms: arm 1: Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline. arm 2: Participants in the experimental arm received standard cognitive-behavioral self-help materials delivered via a mHealth program + additional personalized support features (automated, tailored advice managing nicotine withdrawal symptoms and medication side-effects \& secure messaging with a cessation counselor; i.e., MyMAP program) + a standard course of varenicline.
Interventions: intervention 1: Varenicline intervention 2: Cognitive-behavioral self-help intervention 3: MyMAP (My Mobile Advice Program)
Intervention descriptions: intervention 1: Standard 12 week course of varenicline, provided in both arms intervention 2: Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone. intervention 3: Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor

Protocol documents:
Clinical trial NCT02157376
Conditions: Stress Ulcer Prophylaxis
Keywords: SUP Upper GI bleeding Seriously ill patients
Sponsor: AstraZeneca
Start date: 2014-07-01; Completion date: 2016-02-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

Detailed description:
Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

Arms: arm 1: iv esomeprazole 30 min intermittent infusions given for maximum 14 days arm 2: iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Interventions: intervention 1: Esomeprazole intervention 2: Cimetidine
Intervention descriptions: intervention 1: iv esomeprazole 30 min intermittent infusions given for maximum 14 days intervention 2: iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Protocol documents:
Clinical trial NCT02203916
Conditions: Hypertension
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-07-01; Completion date: 2016-02-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil versus placebo in Korean adults with essential hypertension.

Detailed description:
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat Korean adults with hypertension. This study will look at changes in blood pressure in people who take azilsartan medoxomil.

The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Azilsartan medoxomil 40 mg
* Azilsartan medoxomil 80 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 two tablets at the same time each day throughout the study.

This multi-centre trial will be conducted in Korea. The overall time to participate in this study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. arm 2: Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. arm 3: Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
Interventions: intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil placebo
Intervention descriptions: intervention 1: Azilsartan medoxomil tablets intervention 2: Azilsartan medoxomil placebo-matching tablets

Protocol documents:
Clinical trial NCT02219932
Conditions: Multiple Sclerosis
Keywords: Fampridine
Sponsor: Biogen
Start date: 2014-09-01; Completion date: 2016-02-01
Enrollment: 646 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period.

The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

Detailed description:

Arms: arm 1: Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks arm 2: Matched placebo 10 mg BID for up to 24 weeks
Interventions: intervention 1: fampridine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Matched placebo

Protocol documents:
Clinical trial NCT02220907
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412 MP-513 TA-7284 Teneligliptin Canagliflozin
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2014-08-01; Completion date: 2016-02-01
Enrollment: 153 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

Detailed description:

Arms: arm 1: Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
Interventions: intervention 1: Teneligliptin/Canagliflozin
Intervention descriptions: intervention 1: Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.

Protocol documents:
Clinical trial NCT02223260
Conditions: Venous Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2014-09-01; Completion date: 2016-02-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

Detailed description:
Purpose:

Arms: arm 1: open label arm with dabigatran oral liquid formulation as single dose
Interventions: intervention 1: dabigatran
Intervention descriptions: intervention 1: Experimental dose chosen based on age and weight

Protocol documents:
Clinical trial NCT02246673
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.

Detailed description:

Arms: arm 1: Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. arm 2: Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. arm 3: Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. arm 4: Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Interventions: intervention 1: RDEA3170 15 mg intervention 2: RDEA3170 10 mg intervention 3: RDEA3170 2.5 intervention 4: RDEA3170 5 mg intervention 5: Febuxostat 40 mg intervention 6: Febuxostat 80 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02267629
Conditions: Obsessive-Compulsive Disorder (OCD)
Keywords: OCD
Sponsor: New York State Psychiatric Institute
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study tests whether GLYX-13 - an experimental drug that acts on a brain receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to a class of medications that target the NMDA brain receptor.

Detailed description:

Arms: arm 1: 10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Interventions: intervention 1: Rapastinel (formerly GLYX-13)
Intervention descriptions: intervention 1: 10 mg/kg IV Rapastinel (formerly GLYX-13)

Protocol documents: