ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02742987
Conditions: Coronary Artery Disease Diabetes Mellitus
Sponsor: Campus Bio-Medico University
Start date: 2014-03-01; Completion date: 2015-06-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: Ticagrelor 90 mg twice daily + standard medical therapy arm 2: Clopidogrel 150 mg once daily + standard medical therapy
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel intervention 3: Standard medical therapy
Intervention descriptions: intervention 1: Ticagrelor 90 mg twice daily intervention 2: Clopidogrel 150 mg once daily intervention 3: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions

Protocol documents:
Clinical trial NCT02774343
Conditions: Cocaine Use Disorder Alcohol Use Disorder
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2012-08-01; Completion date: 2015-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine whether a medication called pioglitazone (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients.

Detailed description:

Arms: arm 1: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. arm 2: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.
Interventions: intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Therapy intervention 4: Contingency Management
Intervention descriptions: intervention 1: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued. intervention 2: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study. intervention 3: Cognitive-behavioral therapy 1 hour per week intervention 4: Prize-based contingency management for attendance

Protocol documents:
Clinical trial NCT02236611
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD inhaler ease of use glycopyrronium umeclidinium novel dry powder inhaler long-acting muscarinic antagonist inhaler errors
Sponsor: GlaxoSmithKline
Start date: 2014-09-26; Completion date: 2015-06-02
Enrollment: 1036 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily \[QD\]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD) administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). The total duration of subject participation in the study will be approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced expiratory volume in one second) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of open-label study medication at Visits 3 to 7.

BREEZHALER is a registered trademark of Novartis AG.

Detailed description:

Arms: arm 1: Randomized subjects will receive umeclidinium inhalation powder 62.5 mcg, once daily over a period of 12 weeks via a nDPI. Subjects will be instructed to take one dose each morning. arm 2: Randomized subjects will receive glycopyrronium 44 mcg, once daily over a period of 12 weeks via a BREEZHALER inhaler. Subjects will be instructed to take one dose each morning.
Interventions: intervention 1: Umeclidinium intervention 2: Glycopyrronium
Intervention descriptions: intervention 1: Umeclidinium 62.5 mcg will be available as dry inhalation powder to be taken using a nDPI intervention 2: Glycopyrronium bromide will be available as inhalation capsules, 44 mcg per capsule, taken using BREEZHALER inhalers

Protocol documents:
Clinical trial NCT01580813
Conditions: Type 2 Diabetes
Keywords: diabetes exercise cardiovascular heart insulin sensitivity
Sponsor: University of Colorado, Denver
Start date: 2011-06-01; Completion date: 2015-06-05
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.

Detailed description:

Arms: arm 1: Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi arm 2: Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit
Interventions: intervention 1: Acipimox intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit. intervention 2: Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.

Protocol documents:
Clinical trial NCT02285504
Conditions: Postpartum Depression
Keywords: Postpartum depression
Sponsor: Sage Therapeutics
Start date: 2015-01-07; Completion date: 2015-06-05
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).

Detailed description:

Arms: arm 1: Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms per kilogram per hour \[mcg/kg/hr\] \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).
Interventions: intervention 1: SAGE-547
Intervention descriptions: intervention 1: Intravenous injection

Protocol documents:
Clinical trial NCT02179892
Conditions: Pain
Keywords: anesthesia surgery pain
Sponsor: Colette Curtis MD
Start date: 2014-07-01; Completion date: 2015-06-06
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.

The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group

Detailed description:
Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.

Arms: arm 1: Bupivacaine Extended-Release Liposome Injection (Exparel)will be administered via TAP block procedure arm 2: Bupivacaine and Dexamethasone Injection will be administered via TAP block procedure.
Interventions: intervention 1: Bupivacaine Extended-Release Liposome Injection (Exparel) intervention 2: Bupivacaine and Dexamethasone Injection intervention 3: IV Acetaminophen intervention 4: Oral Acetaminophen
Intervention descriptions: intervention 1: 266mg/30mL of Exparel will be injected via unilateral TAP block intervention 2: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block. intervention 3: Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses. intervention 4: Oral acetaminophen 650 mg every 6 hours.

Protocol documents:
Clinical trial NCT01686568
Conditions: Insulin Resistance
Sponsor: Mayo Clinic
Start date: 2012-12-21; Completion date: 2015-06-08
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.

Detailed description:
Dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil, prevent insulin resistance in rodents, but data in humans is ambiguous. No existing studies have systematically evaluated the influence of n-3 PUFAs on insulin sensitivity and beta cell function in insulin resistant, non-diabetic humans. The Investigators hypothesize that 6 months of oral supplementation of purified EPA/DHA (3.9g/day) will significantly improve hepatic and peripheral insulin sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals. Based on recent work in mice, the investigators also hypothesize that EPA/DHA will increase the content and function of mitochondria in skeletal muscle, measured using a combination of in vivo and in vitro methods. Overall, the investigators hypothesize that EPA+DHA supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant humans, and this improvement will be associated with mitochondrial biogenesis and attenuated lipid accumulation in skeletal muscle and liver.

A sub-study was added in which participants receiving dietary omega-3 fatty acids or placebo supplements underwent abdominal subcutaneous adipose tissue biopsies to measure the content of total, pro- (M1) and anti- (M2) inflammatory macrophages (immunohistochemistry), crown-like structures (immunohistochemistry), and senescent cells (β-galactosidase staining), as well as a two-step euglycemic, pancreatic clamp with a stable-isotope labeled precursor ((U-13C)palmitate) infusion to determine the insulin concentration needed to suppress palmitate flux by 50% (IC50(palmitate)f).

Arms: arm 1: Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months. arm 2: Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
Interventions: intervention 1: Omega-3 intervention 2: placebo
Intervention descriptions: intervention 1: Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months. intervention 2: None

Protocol documents:
Clinical trial NCT01993940
Conditions: Opioid-induced Constipation
Keywords: Opioid-induced Constipation
Sponsor: Shionogi
Start date: 2013-11-04; Completion date: 2015-06-09
Enrollment: 553 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

Detailed description:

Arms: arm 1: Participants received 0.2 mg naldemedine orally once daily for 12 weeks. arm 2: Participants received matching placebo orally once daily for 12 weeks.
Interventions: intervention 1: Naldemedine intervention 2: Placebo
Intervention descriptions: intervention 1: Naldemedine 0.2 mg tablet taken orally once a day intervention 2: Placebo tablet taken orally once a day

Protocol documents:
Clinical trial NCT01951625
Conditions: Heart Failure
Keywords: Worsening Heart Failure Heart Failure with Reduced Ejection Fraction
Sponsor: Bayer
Start date: 2013-11-29; Completion date: 2015-06-09
Enrollment: 456 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

Detailed description:

Arms: arm 1: 2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks arm 2: 2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration) arm 3: 2.5 mg orally once daily for 12 weeks (with sham titrations) arm 4: 1.25 mg orally once daily for 12 weeks (with sham titrations) arm 5: Orally once daily for 12 weeks (with sham titrations)
Interventions: intervention 1: Vericiguat (BAY1021189) (1.25 mg) intervention 2: Vericiguat (BAY1021189) (5 mg) intervention 3: Placebo
Intervention descriptions: intervention 1: 1.25 mg BAY1021189 tablets intervention 2: 5 mg BAY1021189 tablets intervention 3: None

Protocol documents:
Clinical trial NCT01831765
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2013-08-26; Completion date: 2015-06-11
Enrollment: 1290 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Faster-acting insulin aspart intervention 2: insulin detemir intervention 3: insulin aspart intervention 4: Faster-acting insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal. intervention 2: Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily. intervention 3: Injected subcutaneously (s.c., under the skin), dose individually adjusted. intervention 4: Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.

Protocol documents:
Clinical trial NCT01464788
Conditions: Ischemic Stroke
Keywords: stroke Argatroban thrombin-inhibition thrombolysis anticoagulation
Sponsor: Andrew D. Barreto, MD
Start date: 2011-10-01; Completion date: 2015-06-11
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized controlled clinical trial to estimate overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA who are randomized to also receive either low-dose Argatroban, high-dose Argatroban or neither.

Detailed description:
Recombinant tissue plasminogen activator (rt-PA), the only proven treatment for acute ischemic stroke, fails to reperfuse brain in most patients with large thrombi. In our Phase 2a low-dose safety study (n=65), the two drugs appeared safe when delivered concomitantly and recanalization rates were greater than historical controls. This study will provide evidence-based hypotheses and data needed to design a larger definitive trial.

The purpose of this trial is to estimate overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA who are randomized to also receive either low-dose Argatroban, high-dose Argatroban or neither.

Arms: arm 1: 100 micrograms/kilogram bolus, followed by 1 microgram/kilogram/minute IV infusion for 48 hours

and

rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour arm 2: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours

and

rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour arm 3: rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
Interventions: intervention 1: Low Dose Argatroban intervention 2: High Dose Argatroban intervention 3: rt-PA (alteplase)
Intervention descriptions: intervention 1: 100 micrograms/kilogram bolus, followed by 1 microgram/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour intervention 2: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour intervention 3: rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour

Protocol documents:
Clinical trial NCT01927757
Conditions: Moderate to Severe Rheumatoid Arthritis
Keywords: rheumatoid arthritis etanercept arthritis adalimumab failure to respond loss of response to adalimumab ACR20 methotrexate Swollen joints tender joints
Sponsor: Amgen
Start date: 2013-05-06; Completion date: 2015-06-11
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.

Detailed description:

Arms: arm 1: Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks
Interventions: intervention 1: Etanercept intervention 2: Methotrexate
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Background methotrexate at least 15 mg weekly

Protocol documents:
Clinical trial NCT01107964
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome Recent Diagnosis of Dry Eye Syndrome
Sponsor: Milton S. Hershey Medical Center
Start date: 2010-07-01; Completion date: 2015-06-15
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Oral Omega-3-acid ethyl esters intervention 2: Placebo corn oil capsule
Intervention descriptions: intervention 1: 1 gram capsule by mouth four times daily for 45 days intervention 2: 1 gram by mouth 4 times daily for 45 days

Protocol documents:
Clinical trial NCT01907854
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-12-02; Completion date: 2015-06-15
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: sitagliptin intervention 3: placebo intervention 4: placebo
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 subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day) intervention 2: 100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day) intervention 3: Sitagliptin placebo tablets once-daily intervention 4: Sitagliptin placebo tablets once-daily

Protocol documents: