ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02419547
Conditions: Ventricular Tachycardia
Keywords: Ventricular tachycardia ventricular tachycardia ablation effects of anesthesia on VT induction programed stimulation
Sponsor: Brigham and Women's Hospital
Start date: 2014-07-01; Completion date: 2015-04-26
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is being done to see whether general anesthesia (GA) affects our ability to start ventricular tachycardia (VT) during an VT ablation procedure.

Data collected during this research study will help electrophysiologists and anesthesiologists to make the best decisions about the best anesthetic conditions to use to perform VT ablations.

This research study is a "pilot" study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.

Detailed description:

Arms: arm 1: Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).
Interventions: intervention 1: Versed intervention 2: Fentanyl intervention 3: Propofol intervention 4: Sevoflurane
Intervention descriptions: intervention 1: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia intervention 2: Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia intervention 3: Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia intervention 4: Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia

Protocol documents:
Clinical trial NCT01751776
Conditions: Arthritis, Rheumatoid Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-12-18; Completion date: 2015-04-27
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI 655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after 12 weeks of treatment

Detailed description:

Arms: arm 1: Part 1, Healthy volunteers (HV): Placebo matching BI 655064 80 or 120 milligram (mg) injected subcutaneous on days 1, 8, 15, and 22 (once weekly, for 4 weeks) followed by 6 weeks follow-up period. arm 2: Part 1, Healthy volunteers (HV): Placebo matching BI 655064 180 or 240 mg injected subcutaneous on days 1, 8, 15, and 22 (once weekly, for 4 weeks) followed by 6 weeks (180mg dosing group) or 8 weeks (240mg dosing group) follow-up period. arm 3: Part 1, Healthy volunteers (HV): 80 mg of BI 655064 injected subcutaneous on days 1, 8, 15, and 22 (once weekly, for 4 weeks) followed by 6 weeks follow-up period. arm 4: Part 1, Healthy volunteers (HV): 120 mg of BI 655064 injected subcutaneous on days 1, 8, 15, and 22 (once weekly, for 4 weeks) followed by 6 weeks follow-up period. arm 5: Part 1, Healthy volunteers (HV): 180 mg of BI 655064 injected subcutaneous on days 1, 8, 15, and 22 (once weekly, for 4 weeks) followed by 6 weeks follow-up period. arm 6: Part 1, Healthy volunteers (HV): 240mg of BI 655064 injected subcutaneous on days 1, 8, 15, and 22 (once weekly, for 4 weeks) followed by 8 weeks follow-up period. arm 7: Part 2, patients with Rheumatoid arthritis (RA) who had prior inadequate response to Methotrexat (MTX) therapy: Placebo matching BI 655064 120 milligram (mg) injected subcutaneous on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (once weekly for 12 weeks) followed by 8 weeks follow-up period. arm 8: Part 2, patients with RA who had prior inadequate response to MTX therapy: 120 milligram (mg) of BI 655064 injected subcutaneous on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (once weekly for 12 weeks) followed by 8 weeks follow-up period.
Interventions: intervention 1: Placebo matching BI 655064 intervention 2: BI 655064
Intervention descriptions: intervention 1: Placebo matching BI 655064 injected subcutaneous. intervention 2: BI 655064 injected subcutaneous

Protocol documents:
Clinical trial NCT01959295
Conditions: Herpes Simplex
Sponsor: Maruho Co., Ltd.
Start date: 2013-08-01; Completion date: 2015-04-27
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Detailed description:
A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ASP2151 intervention 2: ASP2151 placebo
Intervention descriptions: intervention 1: 200 mg once daily intervention 2: once daily

Protocol documents:
Clinical trial NCT02059174
Conditions: Type 1 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-02-10; Completion date: 2015-04-27
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The primary hypotheses are that the duration of action, pharmacodynamic profile, and pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.

Detailed description:

Arms: arm 1: MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period arm 2: MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
Interventions: intervention 1: MK-1293 intervention 2: EU-Lantus™ intervention 3: Novolog™
Intervention descriptions: intervention 1: MK-1293 0.4 units/kg administered subcutaneously intervention 2: EU-Lantus™ 0.4 units/kg administered subcutaneously intervention 3: Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in each dosing period to meet basal insulin requirements

Protocol documents:
Clinical trial NCT02320396
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2015-01-09; Completion date: 2015-04-27
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.

Detailed description:
This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.

Arms: arm 1: After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period. arm 2: After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
Interventions: intervention 1: Desloratadine 5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Desloratadine 5 mg tablets intervention 2: Placebo tablets

Protocol documents:
Clinical trial NCT02032173
Conditions: Macular Edema Macular Degeneration Diabetes
Keywords: Ranibizumab Diabetic Macular Edema
Sponsor: Novartis Pharmaceuticals
Start date: 2014-05-19; Completion date: 2015-04-29
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

Detailed description:
This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.

Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 \[Day 0\]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.

The trial was terminated before any patient reached month 12.

Arms: arm 1: Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
Interventions: intervention 1: Ranibizumab 0.5mg
Intervention descriptions: intervention 1: Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Protocol documents:
Clinical trial NCT03162458
Conditions: Acute Upper Respiratory Infections
Sponsor: Materia Medica Holding
Start date: 2015-01-22; Completion date: 2015-04-29
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of the study:

* To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.
* To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Anaferon for children (liquid dosage form) intervention 2: Placebo (liquid dosage form)
Intervention descriptions: intervention 1: 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily. intervention 2: 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.

Protocol documents:
Clinical trial NCT01016483
Conditions: Pancreatic Adenocarcinoma
Keywords: MEK inhibitor cancer pancreatic Adenocarcinoma metastatic chemo-naive phase II
Sponsor: EMD Serono
Start date: 2009-11-30; Completion date: 2015-04-30
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts:

Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic adenocarcinoma.

Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.

Detailed description:

Arms: arm 1: Subjects will receive pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks). arm 2: Subjects will receive pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid - continuous regimen). arm 3: Subjects will receive gemcitabine 1000 mg/m\^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. arm 4: Subjects will receive gemcitabine 1000 mg/m\^2 IV infusion for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally bid - continuous regimen.
Interventions: intervention 1: Pimasertib intervention 2: Gemcitabine intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00080223
Conditions: Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis
Keywords: pulmonary fibrosis respiratory diseases
Sponsor: Genentech, Inc.
Start date: 2003-08-31; Completion date: 2015-04-30
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).

Detailed description:
This study has been designed as a rollover study to collectively include safety data from various previous studies.

In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.

Arms: arm 1: up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
Interventions: intervention 1: Pirfenidone
Intervention descriptions: intervention 1: up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Protocol documents:
Clinical trial NCT00818441
Conditions: Carcinoma, Non-small Cell
Keywords: lung cancer adenocarcinoma HER2
Sponsor: Pfizer
Start date: 2009-03-11; Completion date: 2015-04-30
Enrollment: 119 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (\<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.

Detailed description:

Arms: arm 1: Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC arm 2: Dacomitinib in patients with HER2 mutated or amplified NSCLC
Interventions: intervention 1: Dacomitinib (PF-00299804) intervention 2: Dacomitinib (PF-00299804)
Intervention descriptions: intervention 1: Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose). intervention 2: In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.

Protocol documents:
Clinical trial NCT01586195
Conditions: Malignant Melanoma
Sponsor: Genentech, Inc.
Start date: 2011-10-31; Completion date: 2015-04-30
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E.

Detailed description:

Arms: arm 1: Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.
Interventions: intervention 1: Vemurafenib
Intervention descriptions: intervention 1: Vemurafenib 960 mg BID

Protocol documents:
Clinical trial NCT02128113
Conditions: Corneal Endothelial Cell Loss Ocular Pain Ocular Inflammation Cataract Surgery
Keywords: RTA 408 Cataract surgery Corneal Endothelial Cells omaveloxolone
Sponsor: Biogen
Start date: 2014-05-31; Completion date: 2015-04-30
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.

Detailed description:
Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects.

This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.

Arms: arm 1: A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery arm 2: A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery arm 3: A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Interventions: intervention 1: Vehicle Ophthalmic Solution intervention 2: Omaveloxolone Ophthalmic Suspension 0.5% intervention 3: Omaveloxolone Ophthalmic Suspension 1%
Intervention descriptions: intervention 1: Opthalmic suspension manufactured to mimic RTA 408 suspension intervention 2: 0.5% ophthalmic suspension of RTA 408 intervention 3: 1% ophthalmic suspension of RTA 408

Protocol documents:
Clinical trial NCT02207400
Conditions: Oral Hygiene
Sponsor: GlaxoSmithKline
Start date: 2014-08-25; Completion date: 2015-04-30
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency

Detailed description:
This study will be a single-centre, examiner blind, two treatment, parallel group, stratified (by baseline number of bleeding sites smoking status and bacterial sampling) randomized clinical study. At the screening visit, following provision of written informed consent, eligible participants will be provided with a standard toothpaste and toothbrush for brushing once in at the clinic and for approximately one week use at home until the baseline visit. Participants will be asked to abstain from brushing over a 12 hour period prior to the Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed. Participants will be stratified according to their baseline number of bleeding sites, smoking status and whether selected for bacterial sampling. Participants will be then randomized into one of two treatment groups. After using, their assigned treatment twice daily at home for 6 weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the site with overnight plaque at approximately the same time of day as the Baseline visit if possible. Participants will undergo a full OST examination and the recording of any Adverse Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment. Microbiological samples will be collected on a subset of 50 participants (Determined by first 50 participants randomized).

Arms: arm 1: Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride arm 2: Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride
Interventions: intervention 1: Sodium bicarbonate and sodium fluoride intervention 2: Sodium fluoride
Intervention descriptions: intervention 1: Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride intervention 2: Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride

Protocol documents: