ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01674647
Conditions: Atrial Fibrillation
Keywords: rivaroxaban oral anticoagulant nonvalvular atrial fibrillation cardioversion stroke transient ischemic attack thromboembolism cardiovascular event
Sponsor: Bayer
Start date: 2012-10-01; Completion date: 2014-01-01
Enrollment: 1504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

Detailed description:

Arms: arm 1: A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion. arm 2: A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Vitamin K antagonist (VKA)
Intervention descriptions: intervention 1: Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study intervention 2: VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards

Protocol documents:
Clinical trial NCT01682720
Conditions: Hepatitis C
Keywords: HCV Genotype 2 Genotype 3
Sponsor: Gilead Sciences
Start date: 2012-09-01; Completion date: 2014-01-01
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. arm 2: Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. arm 3: SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Placebo to match SOF intervention 4: Placebo to match RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Placebo to match SOF administered orally once daily intervention 4: Placebo to match RBV administered orally in a divided daily dose

Protocol documents:
Clinical trial NCT01703286
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2014-01-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.

Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.

Detailed description:

Arms: arm 1: given once daily over 28 days arm 2: given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days arm 3: given once daily over 28 days
Interventions: intervention 1: Placebo intervention 2: Linagliptin intervention 3: Placebo intervention 4: Placebo intervention 5: Placebo intervention 6: Glimepiride
Intervention descriptions: intervention 1: Placebo matching Glimepiride intervention 2: given once daily for 28 days intervention 3: Placebo matching Linagliptin intervention 4: Placebo matching Linagliptin intervention 5: Placebo matching Glimepiride intervention 6: 1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)

Protocol documents:
Clinical trial NCT01726517
Conditions: Chronic Hepatitis C Virus
Keywords: HCV genotype 1 (GT-1) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Treatment-Naïve Protease Inhibitors PI
Sponsor: Gilead Sciences
Start date: 2012-10-01; Completion date: 2014-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Detailed description:

Arms: arm 1: Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks. arm 2: Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks. arm 3: Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks. arm 4: Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor \[PI\]+pegylated interferon \[PEG\]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks. arm 5: Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01742208
Conditions: Type 1 Diabetes Mellitus
Sponsor: Lexicon Pharmaceuticals
Start date: 2013-02-01; Completion date: 2014-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

Detailed description:

Arms: arm 1: Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. arm 2: Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration. arm 3: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
Interventions: intervention 1: Sotagliflozin intervention 2: Placebo intervention 3: Sotagliflozin
Intervention descriptions: intervention 1: Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups. intervention 2: Participants received placebo-matching sotagliflozin tablets once daily for 29 days. intervention 3: Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.

Protocol documents:
Clinical trial NCT01744496
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease Rotigotine Chronic Pain Nonmotor symptoms
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2012-11-01; Completion date: 2014-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.

Detailed description:

Arms: arm 1: Rotigotine Transdermal Patches arm 2: Placebo Transdermal Patches
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Patches will contain 4 mg / 24 h (20 cm\^2), 6 mg/ 24 h (30 cm\^2), or 8 mg /24 h (40 cm\^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days. intervention 2: Placebo patches match the size of active patches 20 cm\^2, 30 cm\^2, or 40 cm\^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

Protocol documents:
Clinical trial NCT01749501
Conditions: Respiratory Distress Syndrome
Sponsor: Martin Espinosa, MD
Start date: 2011-01-01; Completion date: 2014-01-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.

Detailed description:
The investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. The study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. Demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. Each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. The investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study.

The response of paralysis, onset and duration will be assessed clinically. Onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. Duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone

Arms: arm 1: 0.6 mg/kg once arm 2: Placebo
Interventions: intervention 1: Rocuronium intervention 2: Placebo
Intervention descriptions: intervention 1: 0.6 mg/Kg once intervention 2: Normal saline same amt as 0.6mg/kg of study drug

Protocol documents:
Clinical trial NCT01777217
Conditions: Over-Active Bladder
Keywords: Urination Disorder Overactive Bladder Prostate Cancer Radiation Vesicare
Sponsor: Advanced Research Network
Start date: 2013-02-01; Completion date: 2014-01-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

Detailed description:
This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.

Arms: arm 1: Solifenacin succinate, 5mg or 10 mg once daily arm 2: Drug: Placebo oral
Interventions: intervention 1: Solifenacin succinate intervention 2: Placebo
Intervention descriptions: intervention 1: IGRT with VESIcare intervention 2: IGRT with placebo

Protocol documents:
Clinical trial NCT01782859
Conditions: Total Hip Replacement
Sponsor: Hospital for Special Surgery, New York
Start date: 2012-10-01; Completion date: 2014-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.

Detailed description:

Arms: arm 1: Control group arm 2: Steroid group will receive the following:

1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
Interventions: intervention 1: Prednisone intervention 2: Hydrocortisone intervention 3: Placebo (for Prednisone)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01787383
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis Ingenol mebutate gel
Sponsor: LEO Pharma
Start date: 2013-02-01; Completion date: 2014-01-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ingenol mebutate gel 0.05 % intervention 2: Ingenol mebutate gel 0.015 %
Intervention descriptions: intervention 1: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially intervention 2: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially

Protocol documents:
Clinical trial NCT01810302
Conditions: Cerebral Vasospasm
Keywords: Vasospasm Subarachnoid hemorrhage Aneurysmal subarachnoid hemorrhage Nicardipine Intrathecal SAH aSAH
Sponsor: University of Florida
Start date: 2013-08-01; Completion date: 2014-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.

Detailed description:
Subarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000 Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50 to 75% of patients, and this is attributed to secondary ischemia in approximately 30% of patients. This delayed cerebral ischemia has been attributed to the anatomic narrowing of arteries in the cerebral vasculature which occurs following SAH.

Because of this relationship between cerebral vasospasm, cerebral ischemia, and poor outcome, there has been significant effort to establish treatments that decrease the incidence of vasospasm after SAH. Currently, medications and hemodynamic maneuvers are used as standard of care for the treatment of vasospasm and to improve outcome after SAH.

The calcium channel blocker, nimodipine, is one of the few treatments for vasospasm that has been shown to be of proven benefit. Nicardipine is another calcium channel blocker that has been evaluated in several studies via an intravenous administration route. These studies did show significant improvements in symptomatic and angiographic vasospasm, although a benefit in outcome was not seen. However, the intravenous administration of nicardipine was associated with significant systemic side effects that may have affected outcome including hypotension, pulmonary edema, and azotemia.

The administration of nicardipine via an intrathecal route avoids the systemic complications associated with intravenous dosing since the direct cerebrospinal fluid dosing is much lower. The result is that the systemic concentration will remain low avoiding systemic side effects, and central nervous system concentration will remain high. We propose that this difference may improve outcomes while minimizing complication related effects on patient outcomes.

Arms: arm 1: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10. arm 2: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Interventions: intervention 1: Nicardipine hydrochloride intervention 2: Preservative-free normal saline
Intervention descriptions: intervention 1: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10. intervention 2: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.

Protocol documents:
Clinical trial NCT01812707
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2013-03-01; Completion date: 2014-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.

Secondary Objectives:

* To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo
* To evaluate the safety and tolerability of alirocumab
* To evaluate the development of anti-alirocumab antibodies
* To evaluate the pharmacokinetics of alirocumab

Detailed description:
The duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8-week follow-up period.

Arms: arm 1: Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose. arm 2: Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 3: Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 4: Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Two SC injections in the abdomen only intervention 2: Two subcutaneous (SC) injections in the abdomen only

Route of administration: subcutaneous injection (1 mL) in the abdomen intervention 3: Orally once daily at a stable dose of 5 to 20 mg as background therapy

Route of administration: oral administration in the evening

Protocol documents: