ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01513967
Conditions: Healthy Volunteers Moderate to Severe Alzheimer Patients
Keywords: Alzheimer, dementia
Sponsor: Regenera Pharma Ltd
Start date: 2012-01-01; Completion date: 2015-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)

Detailed description:
The primary objective of this study is to evaluate the safety and tolerability of RPh201 after single and multiple ascending doses. This study is designed with sufficient time in between dose escalations to allow for an interim analysis of safety and tolerability data as this is considered the safest approach to assess the effects of a compound with an undefined mechanism and therapeutic target.

This protocol is written with some flexibility to accommodate the inherent dynamic nature of Phase I clinical studies. Modifications to the dose, dosing regimen, and/or clinical or laboratory procedures currently outlined below may be required to achieve the scientific goals of the study objectives and/or to ensure appropriate safety monitoring of the study subjects. Interim safety analyses will guide dose escalation/reduction in the trial.

Arms: arm 1: RPh201 single dose (SAD Low Dose ) arm 2: Placebo single dose (SAD Low Dose ) arm 3: RPh201 single dose (SAD Mid Dose ) arm 4: Placebo single dose (SAD Mid Dose ) arm 5: RPh201 single dose (SAD High Dose ) arm 6: Placebo single dose (SAD High Dose ) arm 7: RPh201 multiple dose (MAD Low Dose ) arm 8: Placebo multiple dose (MAD Low Dose ) arm 9: RPh201 multiple dose (MAD Mid Dose ) arm 10: Placebo multiple dose (MAD Mid Dose ) arm 11: RPh201 multiple dose (MAD High Dose ) arm 12: Placebo multiple dose (MAD High Dose )
Interventions: intervention 1: RPh201, botanical drug product intervention 2: Placebo
Intervention descriptions: intervention 1: SC administration at varying doses intervention 2: SC administration at varying doses

Protocol documents:
Clinical trial NCT01564914
Conditions: Glioblastoma Glioblastoma Multiforme
Sponsor: Tracon Pharmaceuticals Inc.
Start date: 2012-05-01; Completion date: 2015-06-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)

Detailed description:
Angiogenesis plays a central role in the progression of solid cancer. TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on proliferating endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. TRC105 has been well tolerated in patients with glioblastoma (GBM) as a single agent. The combination of TRC105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. We hypothesize that TRC105 when administered with bevacizumab will have activity in GBM patients who progress on bevacizumab. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibition by bevacizumab, which could represent a major advance in GBM therapy.

Arms: arm 1: Single arm study
Interventions: intervention 1: TRC105 intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle intervention 2: IV

Protocol documents:
Clinical trial NCT01572727
Conditions: Breast Cancer
Keywords: BKM120 paclitaxel breast cancer metastatic locally advanced PI3K PIK3CA PTEN
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-01; Completion date: 2015-06-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

Detailed description:
Based on the efficacy results at the time of the interim analyses, the DMC recommended stopping the study at Phase II during the interim as it met the protocol pre-specified futility criteria. Consequently, the Phase III portion of the study was not conducted.

Arms: arm 1: Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel. arm 2: Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.
Interventions: intervention 1: Paclitaxel intervention 2: BKM120 matching placebo intervention 3: BKM120
Intervention descriptions: intervention 1: intravenous paclitaxel 80 mg/m2 per week given until progression intervention 2: Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.

Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area. intervention 3: Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.

Protocol documents:
Clinical trial NCT01574326
Conditions: Hyperphosphatemia Chronic Kidney Disease
Keywords: Chronic Kidney Disease Pediatric Sevelamer Carbonate Hyperphosphatemia
Sponsor: Genzyme, a Sanofi Company
Start date: 2012-05-01; Completion date: 2015-06-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

* Evaluate the safety and tolerability of sevelamer carbonate
* Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

Detailed description:
The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.

Arms: arm 1: Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). arm 2: Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
Interventions: intervention 1: Placebo intervention 2: Sevelamer carbonate
Intervention descriptions: intervention 1: Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets intervention 2: 0.8 g sachets of powder for oral suspension or 800 mg tablets

Protocol documents:
Clinical trial NCT01576341
Conditions: Chronic Kidney Disease
Keywords: Epoetin alfa, ESA, HX575, CKD
Sponsor: Sandoz
Start date: 2012-04-01; Completion date: 2015-06-01
Enrollment: 417 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

Detailed description:

Arms: arm 1: Single arm
Interventions: intervention 1: HX575 epoetin alfa (Sandoz)
Intervention descriptions: intervention 1: Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.

Protocol documents:
Clinical trial NCT01585272
Conditions: Alzheimer's Dementia
Keywords: Alzheimer's dementia, AD
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-01; Completion date: 2015-06-01
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase IIIb study is intended to implement a consistent treatment way for switching to Exelon transdermal patch from oral formulation of rivastigmine to stress the importance of (1) advantages of transdermal patch over conventional oral therapies: smooth drug delivery with reduced side effects;(2) encourage treatment compliance in the Alzheimer's dementia setting.

This study is a single-arm, treatment-switched design. Eligible patients, who are under Exelon capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to patch for 48 weeks maintenance treatment. During the maintenance period, the treatment will be initiated with Exelon Patch 4.6 mg/24 hours (Exelon Patch 5 cm\^2) for the first 24 weeks and the dose will be escalated to Exelon Patch 9.5 mg/24 hours (Exelon Patch 10 cm\^2) for another 24 weeks if well tolerated. Visits to assess safety are scheduled at baseline, 3 days, 1 week and 2 weeks after the first treatment switch, every 4 weeks until Week 40, and at the end of study (Week 52). The assessment to address the primary objective will focus on the safety of treatment switching (Week 0\~28); however the safety assessment will be performed during the whole study period.

Detailed description:

Arms: arm 1: Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
Interventions: intervention 1: ENA713
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01590875
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation ablation pulmonary veins adenosine
Sponsor: Medical College of Wisconsin
Start date: 2012-05-01; Completion date: 2015-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

Detailed description:
Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.

Arms: arm 1: 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. arm 2: 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
Interventions: intervention 1: Adenosine arm
Intervention descriptions: intervention 1: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.

Protocol documents:
Clinical trial NCT01590979
Conditions: Atrial Fibrillation New Onset Hemorrhage Prolonged QTc Interval Ventricular Tachycardia Medical Care; Complications, Late Effect of Complications
Keywords: Atrial Fibrillation New Onset Ranolazine CABG valve repair/replacement Cardiac Surgery
Sponsor: Northwell Health
Start date: 2012-04-01; Completion date: 2015-06-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.

Detailed description:
Atrial fibrillation (AF) is a common complication of cardiac surgery. It has been shown that the onset of AF increases in post-operative cardiac surgery population. The rate of AF after coronary artery bypass graft (CABG) procedure range from 10-65% and from 37-50% after valve surgery. Rates of new onset AF are lower for CABG compared to valve procedures. The pathophysiology of post-operative AF is not well elucidated. It has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative AF.

Ranolazine is currently approved as an antianginal drug. The antianginal properties of the drug are due to inhibition of the late inward sodium current. Through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.

Therefore it is important to prevent or minimize the incidence of new onset post-operative AF in post-surgical population.

Arms: arm 1: The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. arm 2: Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: 1000mg, two times a day, 12 hour intervals intervention 2: two times a day, 12 hour intervals

Protocol documents:
Clinical trial NCT01610154
Conditions: Insulin Secretion Insulin Resistance
Keywords: glucagon dipeptidyl peptidase-4 inhibitor
Sponsor: Guangwei Li
Start date: 2012-10-01; Completion date: 2015-06-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.
2. There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (BMI\<25) and overweight (BMI\>25) Chinese type 2 diabetics.
3. The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sitagliptin
Intervention descriptions: intervention 1: Sitagliptin 100 mg QD for 12 weeks

Protocol documents:
Clinical trial NCT01617447
Conditions: Autistic Disorder
Keywords: Autistic Disorder, children and adolescents Aripiprazole Double-blind Randomized children and adolescents
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2012-07-01; Completion date: 2015-06-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder

Detailed description:

Arms: arm 1: administered orally once daily arm 2: administered orally once daily
Interventions: intervention 1: Placebo of Aripiprazole intervention 2: Aripiprazole
Intervention descriptions: intervention 1: administered orally once daily intervention 2: Flexibly dose administered orally once daily

Protocol documents:
Clinical trial NCT01632306
Conditions: Pancreatic Cancer
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2015-06-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.

Detailed description:

Arms: arm 1: LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m\^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum. arm 2: LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle. arm 3: LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m\^2 gemcitabine + 125 mg/m\^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.
Interventions: intervention 1: LY2090314 intervention 2: FOLFOX intervention 3: Gemcitabine intervention 4: Nab-paclitaxel
Intervention descriptions: intervention 1: LY2090314 administered IV intervention 2: FOLFOX administered IV intervention 3: Gemcitabine administered IV intervention 4: Nab-paclitaxel administered IV

Protocol documents:
Clinical trial NCT01648283
Conditions: Healthy Volunteers
Keywords: methadone polymorphisms
Sponsor: Washington University School of Medicine
Start date: 2012-11-01; Completion date: 2015-06-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.

Detailed description:
This investigation determined the influence of CYP2B6 genetic variation, specifically CYP2B6\*6 polymorphism, on clinical methadone plasma concentrations, clearance, and metabolism. The hypothesis was that CYP2B6\*6 heterozygotes or homozygotes would have reduced metabolism and clearance. A secondary objective was to evaluate other less common genotypic variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6\*1/\*1, CYP2B6\*1/\*6 , and CYP2B6\*6/\*6, and also CYP2B6\*4 and CYP2B6\*5 carriers, received single doses of IV and oral methadone. Plasma and urine methadone and metabolite concentrations were determined by tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as plasma metabolite/patent area under the concentration-time curve ratio and metabolite formation clearance.

Arms: arm 1: 1. Intravenous racemic methadone HCl, 6.0 mg bolus
2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511)
Interventions: intervention 1: IV racemic methadone HCl intervention 2: Oral racemic methadone HCl
Intervention descriptions: intervention 1: IV racemic Methadone HC1 6 mg intervention 2: oral d5-methadone HCl 11 mg

Protocol documents:
Clinical trial NCT01651780
Conditions: Severe Aortic Stenosis Transcatheter Aortic Valve Replacement Aortic Valve Replacement
Keywords: Transcatheter aortic valve replacement Aortic valve replacement Severe aortic stenosis
Sponsor: The Medicines Company
Start date: 2012-10-01; Completion date: 2015-06-01
Enrollment: 803 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

Detailed description:

Arms: arm 1: Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram \[mg/kg\]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. arm 2: The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
Interventions: intervention 1: Bivalirudin intervention 2: Unfractionated Heparin
Intervention descriptions: intervention 1: Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion. intervention 2: Unfractionated heparin is an anticoagulant.

Protocol documents: