ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02025621
Conditions: Coronary Artery Bypass Grafting Mitral Valve Surgery Low Cardiac Output Syndrome
Keywords: coronary artery bypass grafting CABG mitral valve LCOS low cardiac output syndrome levosimendan
Sponsor: Tenax Therapeutics, Inc.
Start date: 2014-07-01; Completion date: 2016-11-01
Enrollment: 882 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).

Detailed description:
This study is being done to evaluate the efficacy of levosimendan compared with placebo in reducing the co-primary endpoints of 30-day composite of all-cause death or use of mechanical assist device (IABP, LVAD or ECMO) or the composite event rate of all-cause death, perioperative MI, need for dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on CPB.

Arms: arm 1: levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours arm 2: placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours
Interventions: intervention 1: Levosimendan intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: matching placebo

Protocol documents:
Clinical trial NCT02031276
Conditions: Crohn Disease
Keywords: ABBV-066 BI 655066 risankizumab
Sponsor: AbbVie
Start date: 2014-02-01; Completion date: 2016-11-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease.

Detailed description:

Arms: arm 1: Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3. arm 2: Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3. arm 3: Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
Interventions: intervention 1: risankizumab IV intervention 2: risankizumab SC intervention 3: Placebo
Intervention descriptions: intervention 1: risankizumab administered by IV infusion intervention 2: risankizumab administered by SC injection intervention 3: Placebo for risankizumab administered by IV infusion

Protocol documents:
Clinical trial NCT02046317
Conditions: Pain
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2011-05-01; Completion date: 2016-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine if there is any difference in the success rate of ultra-sound guided femoral nerve block performed with an echogenic needle versus a standard needle.

Detailed description:
To date, the published information regarding ultrasound guided femoral nerve blocks (FNB) using echo friendly needle is very limited. More so, there is even less information regarding ultrasound guided nerve blocks using echogenic versus standard of care needles.

This study hopes to add to the general knowledge of pain management in the emergency department (ED) setting and provide a unique perspective on ultrasound-guided techniques using echogenic needles to enhance accuracy and success rate of nerve blocks in ED patients.

The study design will have two comparative arms; in both arms we use the same local anesthetic which is Bupivacaine 0.25% with epinephrine; in all cases a total of 15 mL will be injected around the femoral nerve. Once identified with ultrasound, 5 ml will be injected at lateral, medial, and posterior aspect of the nerve. The experimental arm will receive an FNB using an echogenic needle; and the control group will receive an FNB using standard of care needles.

Arms: arm 1: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. arm 2: The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Interventions: intervention 1: Femoral Nerve Block intervention 2: Echogenic needle intervention 3: Standard of care needle intervention 4: Ultrasound
Intervention descriptions: intervention 1: Femoral Nerve Block for isolated femur fractures intervention 2: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. intervention 3: The control group will receive ultrasound-guided femoral nerve block using standard of care needles. intervention 4: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.

The control group will receive ultrasound-guided femoral nerve block using standard of care needles.

Protocol documents:
Clinical trial NCT02074735
Conditions: Alcohol Dependence
Keywords: alcohol dependence alcohol abuse
Sponsor: University of Texas Southwestern Medical Center
Start date: 2014-04-01; Completion date: 2016-11-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if citicoline, as an add-on therapy, will help reduce alcohol use in outpatients with alcohol dependence.

Detailed description:
A total of 62 outpatients with alcohol dependence will be enrolled in a 12-week, randomized, placebo-controlled trial. Participants will be randomized to receive either placebo or citicoline.

Throughout the study, participants will be asked about their alcohol use and any withdrawal or craving symptoms. Depressive symptoms will be measured as well. Cognition and memory will be measured as well with a neurocognitive battery. Blood will be drawn at study start and week 12 to measure liver enzyme levels.

Appointments will be weekly for the entire study. Participants will have a physician follow-up at every study appointment.

Arms: arm 1: Placebo schedule will mimic the schedule of the active comparator citicoline. Placebo will be started at the randomization visit (week 0, mimicking 500 mg/day of citicoline), then increased at week 2 to mimic 1000 mg/day citicoline, then increased to mimic 1500 mg/day of citicoline at week 4, and then increased to mimic 2000 mg/day of citicoline at week 6 until the end of week 12. arm 2: Citicoline will be started at 500 mg/day at the randomization visit (week 0), then increased to 1000 mg/day at week 2, then 1500 mg/day at week 4, and then 2000 mg/day at week 6 until the end of week 12.
Interventions: intervention 1: Placebo intervention 2: Citicoline
Intervention descriptions: intervention 1: Inactive ingredient matching the active comparator in appearance intervention 2: Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.

Protocol documents:
Clinical trial NCT02078180
Conditions: Depression
Sponsor: University of Michigan
Start date: 2014-04-01; Completion date: 2016-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this project are to determine if the bioavailability and release pattern of bupropion HCl products differ and if the genotype of the metabolic enzymes affects the saturation of intestinal enzymes with different dose strengths within one product line. Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER) Office of Generic Drugs improve policy development and review practice in the future for similar products, e.g. extended release oral drug products being metabolized in the gut wall and having multiple strengths.

Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy individuals when they ingest different strengths of bupropion (75-300 mg) with variable release profiles (IR vs XL vs SR) in GI tract.

Working hypothesis: Variation in release rate and mechanism of bupropion formulations in gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract, which will generate different concentration of bupropion and its metabolites in plasma.

Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and pharmacokinetics of bupropion

Working hypothesis: The gain of function of CYP2B6 variants (allele \*4 and \*22) in patients will increase the metabolism of bupropion in the GI tract and liver, reduce both local concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when bupropion is released earlier in GI tract

Detailed description:

Arms: arm 1: One oral dose of generic bupropion IR75 arm 2: One oral dose of generic bupropion IR100 arm 3: One oral dose of generic bupropion SR100 arm 4: One oral dose of generic bupropion SR150 arm 5: One oral dose of generic bupropion XL150 arm 6: One oral dose of generic bupropion XL300
Interventions: intervention 1: generic bupropion
Intervention descriptions: intervention 1: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.

Protocol documents:
Clinical trial NCT02091739
Conditions: Chronic Troublesome Sialorrhea Parkinson's Disease Post-stroke Traumatic Brain Injury
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2014-04-01; Completion date: 2016-11-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.

Detailed description:

Arms: arm 1: * Main period (1 treatment cycle): Subjects to receive 100 Units.
* Extension period (3 treatment cycles): Subjects to receive 100 Units per treatment cycle.
* Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral) arm 2: * Main period (1 treatment cycle): Subjects to receive 75 Units.
* Extension period (3 treatment cycles): Subjects to receive 75 Units per treatment cycle.
* Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral) arm 3: * Main period (1 treatment cycle): Subjects to receive placebo injection.
* Extension period (3 treatment cycles): Subjects will be randomized to receive either 75 or 100 Units IncobotulinumtoxinA per treatment cycle.
* Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)
Interventions: intervention 1: IncobotulinumtoxinA (100 Units) intervention 2: IncobotulinumtoxinA (75 Units) intervention 3: Placebo
Intervention descriptions: intervention 1: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). intervention 2: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). intervention 3: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Protocol documents:
Clinical trial NCT02120261
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Pain Syndrome trigger point injection
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2014-05-01; Completion date: 2016-11-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.

Detailed description:

Arms: arm 1: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. arm 2: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Interventions: intervention 1: Normal Saline intervention 2: Lidocaine Hydrochloride intervention 3: Triamcinolone acetonide
Intervention descriptions: intervention 1: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. intervention 2: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. intervention 3: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.

Protocol documents:
Clinical trial NCT02139306
Conditions: Cystic Fibrosis
Sponsor: PTC Therapeutics
Start date: 2014-08-01; Completion date: 2016-11-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

Detailed description:
This study is to enroll 208 subjects (184 fully evaluable) with nonsense-mutation-mediated CF who are at least 6 years of age and have an forced expiratory volume in 1 second (FEV1) \>= 40% and \<= 90% of predicted. Subjects will be stratified based on age, inhaled antibiotic use, and baseline FEV1, and will be randomized in a 1:1 ratio to receive oral ataluren administered 3 times per day (TID) at respective morning, midday, and evening doses of 10-, 10-, and 20-mg/kg or placebo. Based on the results of a previously conducted study, patients treated with chronic inhaled aminoglycosides (including TOBI) will not be eligible for participation. Spirometry measurement at the screening visit will establish patient eligibility for inclusion based on lung function. FEV1 stability will be assessed during the approximately 4-week screening period, at the conclusion of which patients will be required to demonstrate a relative change in %-predicted FEV1 of less than 15% when compared to the screening value. Assessments will be performed every 8 weeks, depending upon the outcome measure.

Arms: arm 1: Participants received ataluren as oral powder for suspension at the dosages of 10, 10, and 20-mg/kg at morning, midday and evening, respectively for 48 weeks of treatment duration or until treatment discontinuation. arm 2: Participants received matching placebo orally at morning, midday and evening for 48 weeks of treatment duration or until treatment discontinuation.
Interventions: intervention 1: Ataluren (PTC124®) intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Ataluren TID intervention 2: Oral Placebo TID

Protocol documents:
Clinical trial NCT02158572
Conditions: Healthy
Keywords: prevention of pregnancy
Sponsor: Agile Therapeutics
Start date: 2014-08-01; Completion date: 2016-11-01
Enrollment: 2032 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

Detailed description:
AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.

Arms: arm 1: AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)
Interventions: intervention 1: AG200-15
Intervention descriptions: intervention 1: Transdermal contraceptive delivery system

Protocol documents:
Clinical trial NCT02158975
Conditions: Lymphoma, T-Cell
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2014-09-01; Completion date: 2016-11-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately 30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be active in this disease and will improve best objective response.

We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting T-cell-specific transcription factor) expression, which is associated with poor prognosis, and whether GATA-3 expression represents a novel predictive biomarker for MLN9708 sensitivity.

Detailed description:
Up to 25 patients meeting the inclusion and exclusion criteria will be enrolled into this trial in two stages. All enrolled patients will be treated with MLN9708 4 mg PO weekly (days 1, 8, 15 every 28 days) until disease progression or unacceptable toxicity. In the initial stage of the study a total of 11 patients will be enrolled and treated with MLN9708. Should at least 4 patients exhibit a response (CR/CRu, PR), the second stage of 14 patients will open for enrollment. Efficacy will be assessed radiographically, by peripheral blood and bone marrow examination (when indicated), and physical exam every 8 weeks. Safety will be assessed by periodic physical exams, laboratory studies, and adverse events. All patients will have a follow-up visit 35 days (+/-7 days) following the last study drug treatment. Patients with accessible tumor tissue will be asked to undergo a biopsy for a fresh tissue sample for assessment of GATA-3 expression. Archived tissue samples from the initial diagnostic biopsy and the most recent lymphoma biopsy will be obtained in the event a fresh tumor biopsy cannot be obtained. Patients with GATA-3+ TCL and accessible tumor tissue will undergo a tumor biopsy at day 21 (+/- 7 days) of cycle 1. All baseline fresh or archived tissue will undergo central pathology review to confirm the diagnosis of TCL. The rationale for proteasome inhibition in T-cell lymphomas, based on the pre-clinical (and previous phase II) data, is compelling. Therefore, this phase II study will not be restricted to patients with GATA-3 expressing lymphomas.

Arms: arm 1: MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days.
Interventions: intervention 1: MLN9708
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02339584
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: OAG OHT
Sponsor: Alcon Research
Start date: 2015-04-14; Completion date: 2016-11-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the fixed combination (BID) \[Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL eyes drops, suspension\] to the unfixed combination (BID) \[Brinzolamide 10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution\] with respect to intraocular pressure (IOP)-lowering efficacy.

Detailed description:
This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and Month 3. Following washout of any IOP-lowering medication, subjects who meet all inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the specified range during this period will be randomized to Phase II.

Arms: arm 1: Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months arm 2: Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
Interventions: intervention 1: Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension intervention 2: Brinzolamide 10 mg/mL eye drops, suspension intervention 3: Brimonidine 2 mg/mL eye drops, solution intervention 4: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Inactive ingredients used as a placebo for masking purposes

Protocol documents: