ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01586975
Conditions: Stroke Myocardial Infarctions
Sponsor: Northwestern University
Start date: 2007-07-01; Completion date: 2011-12-01
Enrollment: 93 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.

Detailed description:
Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.

Arms: arm 1: Clopidogrel 75 mg daily arm 2: open-label Aspirin 81 mg daily arm 3: open-label Aspirin over 300 mg daily
Interventions: intervention 1: Clopidogrel intervention 2: Aspirin 81 mg intervention 3: Aspirin >300 mg
Intervention descriptions: intervention 1: Clopidogrel 75 mg QD intervention 2: Aspirin 81mg QD intervention 3: Aspirin \>300 mg QD

Protocol documents:
Clinical trial NCT01588470
Conditions: Type 2 Diabetes Coronary Heart Disease
Keywords: diastolic function mitochondria pioglitazone pericardial fat
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2006-06-01; Completion date: 2011-12-01
Enrollment: 130 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the existence of heart abnormalities in patients with diabetes and the effect of pioglitazone in correcting these abnormalities.

Detailed description:
PRIMARY OBJECTIVES

1. To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.
2. To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects.
3. To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects.
4. To examine the effect of pioglitazone on myocardial insulin sensitivity, pericardial fat content, and cardiac function.

SECONDARY OBJECTIVES To examine the relationships between myocardial insulin sensitivity, pericardial fat content, and cardiac function.

Arms: arm 1: Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone
Interventions: intervention 1: pioglitazone
Intervention descriptions: intervention 1: 45 mg per day for 6 months

Protocol documents:
Clinical trial NCT01635439
Conditions: Labor Pain
Sponsor: Ain Shams University
Start date: 2010-12-01; Completion date: 2011-12-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).

Detailed description:
A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.

Arms: arm 1: Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h. arm 2: PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Interventions: intervention 1: Propess intervention 2: Prostin E2
Intervention descriptions: intervention 1: The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation. intervention 2: 3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.

Protocol documents:
Clinical trial NCT01875159
Conditions: Hypoxia
Keywords: Prematurity Apnea of prematurity Intermittent hypoxia
Sponsor: American SIDS Institute
Start date: 2010-07-01; Completion date: 2011-12-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.

Detailed description:
Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

Arms: arm 1: Caffeine citrate 6 mg/kg/day arm 2: Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
Interventions: intervention 1: Caffeine citrate 6 mg/kg/day
Intervention descriptions: intervention 1: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.

Protocol documents:
Clinical trial NCT02138006
Conditions: Coronary Heart Disease Stroke Renal Failure
Sponsor: Karolinska Institutet
Start date: 1982-09-01; Completion date: 2011-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

Detailed description:
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.

In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.

Arms: arm 1: Intensive insulin treatment arm 2: Standard insulin treatment
Interventions: intervention 1: Intensive insulin treatment intervention 2: Standard insulin treatment
Intervention descriptions: intervention 1: Mealtime insulin (Actrapid) Basal insulin (Monotard) intervention 2: Insulin Mixtard

Protocol documents:
Clinical trial NCT02304926
Conditions: Dyslipidemia
Keywords: Dyslipidemia Simvastatin Ezetimibe Lipid profile Inflammation Oxidative stress Endothelial function
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with statins and ezetimibe generally constituting the medication of choice. By acting at different levels, the combination of these drugs allows the therapeutic objective to be achieved. However, it is not known how these drugs qualitatively affect the composition of lipoprotein subfractions, which differ in size and atherogenic potential. The investigators set out to evaluate this effect as well as their effects on inflammatory, oxidative stress and endothelial function parameters.

Detailed description:
The study consisted of a randomised parallel trial and took place during a period of 2 months. A total of 42 hyperlipidemic patients were randomly assigned to one of 2 groups: one received simvastatin (40 mg/day) and the other received ezetimibe (10 mg/day) for 4 weeks, after which both groups were administered combined therapy for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Arms: arm 1: Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated. arm 2: Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Interventions: intervention 1: Simvastatin intervention 2: Ezetimibe intervention 3: Simvastatin + Ezetimibe
Intervention descriptions: intervention 1: simvastatin (40 mg/day) for 4 weeks intervention 2: ezetimibe (10 mg/day) for 4 weeks intervention 3: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period

Protocol documents:
Clinical trial NCT02572609
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-11-01; Completion date: 2011-12-01
Enrollment:  participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation), manufactured by Bolder Arzneimittel GmbH \& Co. KG to Boehringer Ingelheim compared to ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ambroxol hydrochloride soft pastille intervention 2: Mucosolvan ® adult syrup
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02903238
Conditions: Pain Osteoarthritis
Keywords: placebo pain osteoarthritis
Sponsor: Northwestern University
Start date: 2011-07-01; Completion date: 2011-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.

Detailed description:
In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo

At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.

Arms: arm 1: placebo capsule
Interventions: intervention 1: Duloxetine intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time intervention 2: Lactose capsule

Protocol documents:
Clinical trial NCT01439373
Conditions: Hepatitis C, Chronic
Keywords: chronic hepatitis C NS5A inhibitor ribavirin pegylated interferon GSK2336805
Sponsor: GlaxoSmithKline
Start date: 2011-07-07; Completion date: 2011-12-05
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with chronic hepatitis C (CHC).

Detailed description:
HCV infection is a major public health problem globally and a leading cause of chronic liver disease. New medications are needed that are better tolerated and offer a greater chance of achieving sustained viral clearance compared to currently available therapy. GSK2336805 is a HCV NS5A inhibitor being developed for the treatment of subjects with CHC. This Phase II, double blind, randomized, placebo-controlled study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with CHC. Subjects will be randomly allocated on a 2:1 basis to GSK2336805 or matching placebo and will be stratified by IL28B status and HCV viral genotype (genotype 1 or 4). The study consists of 2 parts. In Part 1, GSK2336805 or matching placebo will be given as single-dose monotherapy (Day 1). In Part 2, GSK2336805 or matching placebo will be co-administered with peginterferon alfa-2a and ribavirin through 4 weeks of treatment (Days 2 to 28). After completion of Part 2, GSK2336805/matching placebo will be discontinued and subjects will be offered continued standard-of-care anti-HCV therapy.

Arms: arm 1: Study Part 1 arm 2: Study Part 1 arm 3: Study Part 2 arm 4: Study Part 2
Interventions: intervention 1: GSK2336805 intervention 2: Pegylated interferon alfa-2a intervention 3: Ribavirin intervention 4: GSK2336805 Matching Placebo
Intervention descriptions: intervention 1: Active Investigational Drug intervention 2: Standard of Care drug intervention 3: Standard of Care drug intervention 4: Placebo of Investigational Drug

Protocol documents:
Clinical trial NCT01250977
Conditions: Smoking
Keywords: Non-treatment seeking smokers, reporting consumption of at least 10 cigarettes per day for at least the past 6 months
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2011-01-11; Completion date: 2011-12-06
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept) for side effects and effects on smoking behavior and performance on neurocognitive tasks in a population of dependent smokers.

Detailed description:
Nicotine dependence is a major public health problem and currently available treatments are ineffective for the majority of smokers. Thus, there is a need to develop and test novel medications to assist smokers to quit smoking. This pilot feasibility study examined: (1) tolerability and medication adherence, and (2) the effects of donepezil versus placebo on smoking behavior and cognitive performance in non-treatment seeking smokers. We predicted that 4 weeks of donepezil would improve working memory at the highest task difficulty level and sustained attention. Because participants in this study were not trying to quit, change in smoking behavior was a secondary outcome.

Arms: arm 1: Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days. arm 2: Participants are instructed to take one 5mg pill (donepezil HCL \[Aricept®\]) every night before going to bed with a glass of water for 28 days.
Interventions: intervention 1: Donepezil intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01097616
Conditions: Primary Insomnia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-05; Completion date: 2011-12-07
Enrollment: 1023 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.

Detailed description:

Arms: arm 1: Drug arm 2: Drug arm 3: Placebo Comparator
Interventions: intervention 1: Suvorexant High Dose (HD) intervention 2: Suvorexant Low Dose (LD) intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: Suvorexant 40 mg + placebo matching suvorexant 20 mg for participants \<65 years old; Suvorexant 30 mg + placebo matching suvorexant 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week double-blind (DB) Run-out (RO) following the TRT/EXT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime. intervention 2: Suvorexant 20 mg + placebo matching suvorexant 40 mg for participants \<65 years old; Suvorexant 15 mg + placebo matching suvorexant 30 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week DB RO following the TRT/EXT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime. intervention 3: Matching placebos to suvorexant 40 mg and 20 mg for participants \<65 years old; matching placebos to suvorexant 30 mg and 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Placebo is a third treatment arm for comparison to the two active (suvorexant) treatment arms during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week DB RO following the TRT/EXT phase, participants in this study arm continue to receive placebo. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.

Protocol documents:
Clinical trial NCT00581009
Conditions: Major Depressive Disorder Bipolar Disorder
Keywords: Sleep deprivation antidepressant depression chronobiological
Sponsor: University of California, Irvine
Start date: 2001-05-30; Completion date: 2011-12-09
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.

Detailed description:

Arms: arm 1: chronobiological augmentation group arm 2: medication only group arm 3: None
Interventions: intervention 1: chronobiological augmentation intervention 2: sertraline, lithium intervention 3: one night of sleep deprivation and two FDG PET scans
Intervention descriptions: intervention 1: Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days intervention 2: Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.

Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks. intervention 3: MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.

Protocol documents:
Clinical trial NCT01005459
Conditions: Labor Pain
Keywords: labor pain combined spinal epidural labor analgesia CSE analgesia labor analgesia
Sponsor: Wake Forest University
Start date: 2009-08-01; Completion date: 2011-12-12
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tetracaine intervention 2: Bupivacaine
Intervention descriptions: intervention 1: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain. intervention 2: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Protocol documents: