ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02059278
Conditions: Primary Open Angle Glaucoma Ocular Hypertension
Keywords: Primary open angle glaucoma Ocular hypertension
Sponsor: Nephron Pharmaceuticals Corporation
Start date: 2014-01-01; Completion date: 2015-01-01
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.

Detailed description:
The objective of this Phase 3 study is to evaluate the efficacy and safety of T-2345 nonpreserved ophthalmic solution (latanoprost 0.005%) in comparison to Xalatan® (latanoprost 0.005%) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH).

This will be a randomized, multicenter, parallel-group, observer-masked study in approximately 380 evaluable subjects treated for 84 days. Subjects will have a history of POAG or OH and elevated intraocular pressure (IOP) and will have been adequately controlled (IOP ≤ 18 mm Hg) on latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks.

Primary efficacy (IOP) will be assessed in the study eye at each visit by Goldmann applanation tonometry at all assessment visits.

Safety will be assessed at each visit by corrected Snellen Visual Acuity, slit lamp examination/anterior chamber cell count and flare and adverse event (AE) collection.

Primary Efficacy Endpoint is the between-group comparison of the mean IOP values at each time point at each of the Day 15, 42, and 84 visits.

Secondary Efficacy Endpoints include:

* Between-group comparison of the mean change from baseline in diurnal IOP measurements at all postbaseline visits.
* Between-group comparison of the mean change from baseline in IOP measurements at all times points at Day 15, Day 42 and Day 84.

Arms: arm 1: T-2345 Ophthalmic Solution dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes) arm 2: Xalatan (Latanoprost 0.005% Ophthalmic Solution) dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)
Interventions: intervention 1: T-2345 intervention 2: Xalatan
Intervention descriptions: intervention 1: T-2345 Ophthalmic Solution intervention 2: Xalatan (latanoprost 0.005% ophthalmic solution)

Protocol documents:
Clinical trial NCT02091362
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2014-03-01; Completion date: 2015-01-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.

Detailed description:

Arms: arm 1: Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods. arm 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.
Interventions: intervention 1: LY2409021 intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered as background therapy.

Protocol documents:
Clinical trial NCT02101281
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Sponsor: Dompé Farmaceutici S.p.A
Start date: 2014-01-20; Completion date: 2015-01-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to assess the efficacy and safety of different doses of rhNGF when administered as eye drops to patients with dry eye.

Detailed description:
This is an open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye

Arms: arm 1: (first planned dose): drop (35 μL) corresponding to 0.70 μg of rhNGF (recombinant human Nerve Growth Factor) was instilled into each eye twice a day (b.i.d.) every 12±2 h for a total daily dose of 2.8 μg (both eyes), for 28 consecutive days. The total dose was 78.4 μg/28 days. arm 2: after completion of Group 1 treatment, one drop (35 μL) corresponding to 0.14 μg of rhNGF (recombinant human Nerve Growth Factor) instilled into each eye b.i.d. every 12±2 h for a total daily dose of 0.56 μg, for 28 consecutive days. Total dose was 15.68 μg/28 days.
Interventions: intervention 1: rhNGF 20 µg/mL intervention 2: rhNGF 4 µg/mL
Intervention descriptions: intervention 1: 1 drop for each eye, twice daily for 28 day intervention 2: 1 drop each eye, twice daily for 28 day

Protocol documents:
Clinical trial NCT02105285
Conditions: Glaucoma Ocular Hypertension
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-04-01; Completion date: 2015-01-01
Enrollment: 193 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.

Detailed description:

Arms: arm 1: Once daily arm 2: Once daily
Interventions: intervention 1: OPC-1085EL ophthalmic solution intervention 2: Carteolol long-acting ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02125734
Conditions: Chronic Obstructive Pulmonary Disease COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2014-04-01; Completion date: 2015-01-01
Enrollment: 88 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium

Detailed description:

Arms: arm 1: QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 arm 2: Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
Interventions: intervention 1: QVA149 intervention 2: Tiotropium
Intervention descriptions: intervention 1: QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day intervention 2: Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

Protocol documents:
Clinical trial NCT02129660
Conditions: Hyperhidrosis
Sponsor: Journey Medical Corporation
Start date: 2014-04-01; Completion date: 2015-01-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Detailed description:
This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.

Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).

Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK blood samples will be taken study subjects.

Arms: arm 1: glycopyrrolate Topical Wipes arm 2: glycopyrrolate Topical Wipes arm 3: glycopyrronium Topical Wipes arm 4: glycopyrronium Topical Wipes arm 5: Vehicle Topical Wipes
Interventions: intervention 1: Dose 1 of glycopyrrolate, 2.0% QD intervention 2: Dose 2 of glycopyrrolate, 3.0% QD intervention 3: Dose 1 of glycopyrronium, 2.5% QD intervention 4: Dose 2 of glycopyrronium, 3.75% QD intervention 5: Vehicle
Intervention descriptions: intervention 1: Dose 1 of glycopyrrolate Topical Wipes intervention 2: Dose 2 of glycopyrrolate Topical Wipes intervention 3: Dose 1 of glycopyrronium Topical Wipes intervention 4: Dose 2 of glycopyrronium Topical Wipes intervention 5: Vehicle Topical Wipes

Protocol documents:
Clinical trial NCT02139124
Conditions: ADHD
Sponsor: Rhodes Pharmaceuticals, L.P.
Start date: 2014-04-01; Completion date: 2015-01-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD

Detailed description:
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adult subjects (18 years of age or older) with ADHD will be randomized to PRC-063 (25, 45, 70 or 100 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.

Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.

Arms: arm 1: Placebo Arm arm 2: PRC-063 25 mg arm 3: PRC-063 45 mg arm 4: PRC-063 70 mg arm 5: PRC-063 100 mg
Interventions: intervention 1: Placebo intervention 2: PRC-063 25 mg intervention 3: PRC-063 45 mg intervention 4: PRC-063 70 mg intervention 5: PRC-063 100 mg
Intervention descriptions: intervention 1: Oral placebo capsule intervention 2: Oral 25 mg capsule - active intervention 3: Oral 45 mg capsule - active intervention 4: Oral 70 mg capsule - active intervention 5: Oral 100 mg capsule - active

Protocol documents:
Clinical trial NCT02140372
Conditions: Healthy
Keywords: colchicine platelet activity neutrophil
Sponsor: NYU Langone Health
Start date: 2014-05-01; Completion date: 2015-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for markers of platelet activity and inflammation.

Detailed description:

Arms: arm 1: Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Interventions: intervention 1: Colchicine
Intervention descriptions: intervention 1: Colchicine 1.2 mg followed by 0.6 mg one hour later

Protocol documents:
Clinical trial NCT02154243
Conditions: Orthostatic Hypotension
Sponsor: Hospital for Special Surgery, New York
Start date: 2014-06-01; Completion date: 2015-01-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Orthostatic hypotension following total hip arthroplasty is known to limit the ability of patients to perform physical therapy (PT) and increase the length of hospital stay and costs. Our goal is to prospectively study the effects of oral midodrine on the signs and symptoms of orthostatic hypotension in 20 patients and the effects of intravenous fluid on the signs of symptoms of orthostatic hypotension in 10 patients. Midodrine will be administered to patients with suspected low SVV, and an intravenous fluid bolus will be administered to patients with low CO. 120 patients will be consented with a view to studying 30 patients who meet the inclusion criteria for orthostatic hypotension. Patients who receive midodrine or the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr, 2 hrs, 3 hrs, and 4 hrs post-intervention. All patients will undergo measurements for blood pressure, arterial augmentation index, and heart rate at baseline (pre-op; holding area) and the time of first PT attempt. Patients will be monitored up to post-operative day 3. The working hypothesis is that midodrine or fluid therapy will significantly raise the mean arterial blood pressure (MAP) by 5 mmHg+ and/or cause a significant change in the Orthostatic Hypotension Questionnaire (characterized by a two-point improvement in symptom score).

Detailed description:

Arms: arm 1: Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\<15 will be given oral midodrine, 10 mg, once. arm 2: Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\>=15 will be given intravenous fluid bolus, 15 cc/kg, once. arm 3: Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
Interventions: intervention 1: Midodrine intervention 2: Intravenous fluid bolus
Intervention descriptions: intervention 1: 10 mg, p.o., once, on day of surgery after first physical therapy session intervention 2: 15 cc/kg, once, on day of surgery after first physical therapy session

Protocol documents:
Clinical trial NCT02155543
Conditions: Healthy Volunteers
Sponsor: Allergan
Start date: 2014-05-01; Completion date: 2015-01-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.

Detailed description:

Arms: arm 1: One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days. arm 2: One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15. arm 3: One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15. arm 4: One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15. arm 5: One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15. arm 6: One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15. arm 7: One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
Interventions: intervention 1: AGN-223575 Formulation A intervention 2: AGN-223575 Formulation B intervention 3: AGN-223575 Formulation C intervention 4: AGN-223575 Vehicle
Intervention descriptions: intervention 1: One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol. intervention 2: One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15. intervention 3: One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15. intervention 4: One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.

Protocol documents:
Clinical trial NCT02163421
Conditions: Healthy
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-06-01; Completion date: 2015-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.

Detailed description:
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to determine its bioavailability, safety, and tolerability in the body with three varying doses of vedolizumab SC compared to people who are administered vedolizumab IV.

The study will enroll approximately 24 non-Japanese patients and 24 Japanese patients. Participants will be randomly assigned to one of the four treatment groups:

* Vedolizumab Intravenous 300 mg
* Vedolizumab Subcutaneous 54 mg
* Vedolizumab Subcutaneous 108 mg
* Vedolizumab Subcutaneous 160 mg

All participants will receive the treatment they are assigned on Day 1 of the study.

This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 196 days. Participants will make 10 visits to the clinic, including one 8 day period of confinement to the clinic, and will be contacted by telephone at Study Day 168 (+/-3), approximately 6 months after dose for a follow-up questionnaire.

Arms: arm 1: Vedolizumab SC, once on Day 1. arm 2: Vedolizumab SC, once on Day 1. arm 3: Vedolizumab SC, once on Day 1. arm 4: Vedolizumab IV, once on Day 1.
Interventions: intervention 1: Vedolizumab SC intervention 2: Vedolizumab IV
Intervention descriptions: intervention 1: Vedolizumab injection, for subcutaneous use (vedolizumab SC) intervention 2: Vedolizumab injection, for intravenous use (vedolizumab IV)

Protocol documents:
Clinical trial NCT02185339
Conditions: Laparoscopic Renal Surgery Laparoscopy Muscle Relaxation
Keywords: Respiratory mechanics Respiratory function test Hemodynamics
Sponsor: Seoul St. Mary's Hospital
Start date: 2014-07-01; Completion date: 2015-01-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.

Detailed description:

Arms: arm 1: For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. arm 2: For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count \>2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.
Interventions: intervention 1: Rocuronium intervention 2: Rocuronium
Intervention descriptions: intervention 1: Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2. intervention 2: Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.

Protocol documents:
Clinical trial NCT02189850
Conditions: Colonoscopy
Keywords: colonoscopy pediatric
Sponsor: Braintree Laboratories
Start date: 2014-06-01; Completion date: 2015-01-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric patients.

Detailed description:

Arms: arm 1: BLI800 oral solution arm 2: BLI800 oral solution
Interventions: intervention 1: BLI800 - Dose 1 intervention 2: BLI800 - Dose 2
Intervention descriptions: intervention 1: BLI800 oral solution intervention 2: BLI800 oral solution

Protocol documents:
Clinical trial NCT02191865
Conditions: Hepatic Insufficiency
Sponsor: Boehringer Ingelheim
Start date: 2014-07-01; Completion date: 2015-01-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.

Detailed description:

Arms: arm 1: Patients with mild hepatic impaired function (Child-Pugh A) arm 2: Patients with moderate hepatic impaired function (Child-Pugh B) arm 3: Healthy control subjects
Interventions: intervention 1: Nintedanib intervention 2: Nintedanib intervention 3: Nintedanib
Intervention descriptions: intervention 1: Soft gelatine capsule intervention 2: Soft gelatine capsule intervention 3: Soft gelatine capsule

Protocol documents: