ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01100268
Conditions: Hoarding Disorder
Keywords: Hoarding
Sponsor: New York State Psychiatric Institute
Start date: 2010-04-01; Completion date: 2011-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.

Detailed description:
Compulsive hoarders perform significantly worse than healthy controls on standard attention tasks. These data suggest that the inability to sustain focus may interfere with hoarders' ability to organize, categorize and make decisions about discarding possessions. Stimulants are first-line treatments for ADHD, improve CPT performance in people with ADHD and enhance school performance in children with ADHD. Extended release formulations, such as methylphenidate ER, are associated with better medication compliance. Together, these data suggest that adjunctive methylphenidate ER might be a novel way to improve attention in compulsive hoarders which might improve hoarding symptoms.

The investigators hypothesis is that adjunctive methylphenidate ER will improve attention in compulsive hoarders aged 18-55. The investigators will also explore the safety of methylphenidate ER administration in compulsive hoarders.

Arms: arm 1: Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Interventions: intervention 1: Methylphenidate ER
Intervention descriptions: intervention 1: Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.

Protocol documents:
Clinical trial NCT01114581
Conditions: Acute Respiratory Infection
Keywords: Acute Respiratory Infection Mucociliary Cough Clearance Guaifenesin
Sponsor: Reckitt Benckiser LLC
Start date: 2010-04-01; Completion date: 2011-04-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.

Detailed description:

Arms: arm 1: Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets arm 2: Given as 2 tablets
Interventions: intervention 1: Mucinex intervention 2: Placebo
Intervention descriptions: intervention 1: Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study intervention 2: Placebo given as 2 tablets

Protocol documents:
Clinical trial NCT01122680
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2011-04-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.

Detailed description:

Arms: arm 1: patients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler arm 2: patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler arm 3: patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler arm 4: patients inhale 2 puffs (dose of 2.5 mcg) once daily in the evening via Respimat inhaler
Interventions: intervention 1: Tiotropium bromide intervention 2: tiotropium bromide intervention 3: tiotropium bromide intervention 4: Placebo
Intervention descriptions: intervention 1: inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg) intervention 2: inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg) intervention 3: inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg) intervention 4: placebo inhalation solution

Protocol documents:
Clinical trial NCT01124617
Conditions: Pain Diabetic Neuropathies Neuralgia Postherpetic Neuralgia
Keywords: Chronic pain Diabetic Neuropathic Pain Neuralgia, Postherpetic Tapentadol hydrochloride extended-release JNS024ER Placebo
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2010-06-01; Completion date: 2011-04-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).

Detailed description:
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), and parallel-group (each group of participant will be treated at the same time) comparison study in Japanese participants with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The duration of study will be 14 weeks. The study consists of 3 parts: Screening (1 Week before study commences on Day 1); Treatment (12 weeks and will include titration period \[from the initiation of the study treatment to determination of the individual's maintenance dose\] and maintenance period \[from completion of the titration period up to12 week\]); and Follow-up (1 Week). Tapentadol hydrochloride ER oral tablet or matching placebo will be administered twice daily for 12 weeks. Efficacy of the participants will primarily be evaluated through Numerical Rating Scale (NRS). Participants' safety will be monitored throughout the study.

Arms: arm 1: Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. arm 2: Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Interventions: intervention 1: Tapentadol intervention 2: Placebo
Intervention descriptions: intervention 1: Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. intervention 2: Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.

Protocol documents:
Clinical trial NCT01129102
Conditions: Dysmenorrhea
Sponsor: Nobelpharma
Start date: 2010-05-01; Completion date: 2011-04-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Detailed description:
The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

Arms: arm 1: Norethisterone 1mg, Ethinyl estradiol 0.02mg arm 2: Norethisterone 1mg, Ethinyl estradiol 0.035mg arm 3: Placebo for NPC-01
Interventions: intervention 1: NPC-01 intervention 2: IKH-01 intervention 3: Placebo
Intervention descriptions: intervention 1: Norethisterone 1mg, Ethinyl estradiol 0.02mg intervention 2: Norethisterone 1mg, Ethinyl estradiol 0.035mg intervention 3: Placebo for NPC-01

Protocol documents:
Clinical trial NCT01135511
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2011-04-01
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: CP-690,550 Eye drops intervention 2: CP-690,550 Eye drops intervention 3: CP-690,550 Eye drops intervention 4: CP-690,550 Eye drops-vehicle intervention 5: Sodium Hyaluronate
Intervention descriptions: intervention 1: Ophthalmic topical solution, low dose, dosed once/day, 8 weeks intervention 2: Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks intervention 3: Ophthalmic topical solution, high dose, dosed once/day, 8 weeks intervention 4: Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks intervention 5: Ophthalmic topical solution, dosed 6 times/day, 8 weeks

Protocol documents:
Clinical trial NCT01161563
Conditions: Prostate Cancer
Keywords: palliative treatment prostate cancer
Sponsor: Watson Pharmaceuticals
Start date: 2010-07-01; Completion date: 2011-04-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

Detailed description:
GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Arms: arm 1: Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. arm 2: Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
Interventions: intervention 1: Triptorelin pamoate intervention 2: Leuprolide acetate
Intervention descriptions: intervention 1: Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock intervention 2: Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Protocol documents:
Clinical trial NCT01167153
Conditions: Hypertension
Keywords: Hypertension Valsartan Amlodipine single pill combination BP control ABPM Hypertensive patients not adequately controlled by mono antihypertensive drugs
Sponsor: Novartis
Start date: 2010-05-01; Completion date: 2011-04-01
Enrollment: 564 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.

Detailed description:

Arms: arm 1: Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. arm 2: Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Interventions: intervention 1: Valsartan/Amlodipine intervention 2: Nifedipine
Intervention descriptions: intervention 1: Valsartan/Amlodipine 80/5mg single pill combination (SPC) intervention 2: Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg

Protocol documents:
Clinical trial NCT01177709
Conditions: Schizophrenia Obesity
Keywords: schizophrenia antipsychotics obesity diabetes
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2008-05-01; Completion date: 2011-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Detailed description:
Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Arms: arm 1: None
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.

Protocol documents:
Clinical trial NCT01178853
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: Kowa Research Institute, Inc.
Start date: 2010-07-01; Completion date: 2011-04-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Warfarin intervention 2: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) intervention 3: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Intervention descriptions: intervention 1: Warfarin 5 mg once daily intervention 2: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) intervention 3: Warfarin 5 mg + Pitavastatin 4mg

Protocol documents:
Clinical trial NCT01183650
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2010-07-01; Completion date: 2011-04-01
Enrollment: 24 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH).

The safety of tadalafil will also be studied.

Detailed description:

Arms: arm 1: 5 mg, administered orally, daily for 10 days
Interventions: intervention 1: Tadalafil
Intervention descriptions: intervention 1: 5 mg, administered orally, daily for 10 days

Protocol documents:
Clinical trial NCT01184859
Conditions: Nocturia
Keywords: nocturia bladder function
Sponsor: Ferring Pharmaceuticals
Start date: 2010-07-01; Completion date: 2011-04-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.

Detailed description:

Arms: arm 1: Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. arm 2: Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. arm 3: Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days. arm 4: Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days. arm 5: Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
Interventions: intervention 1: Desmopressin intervention 2: Placebo
Intervention descriptions: intervention 1: Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration intervention 2: Placebo melt tablet for sublingual administration

Protocol documents:
Clinical trial NCT01189487
Conditions: Pneumonia, Bacterial
Keywords: ampicillin sodium/sulbactam sodium Unasyn-S community acquired pneumonia bacterial pneumonia
Sponsor: Pfizer
Start date: 2010-10-01; Completion date: 2011-04-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.

Detailed description:

Arms: arm 1: ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
Interventions: intervention 1: ampicillin sodium/sulbactam sodium
Intervention descriptions: intervention 1: ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days

Protocol documents:
Clinical trial NCT01190150
Conditions: Menorrhagia
Keywords: Cyclic Heavy Menstrual Bleed Menorraghia
Sponsor: Ferring Pharmaceuticals
Start date: 2010-08-01; Completion date: 2011-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy menstrual bleeding.

Detailed description:

Arms: arm 1: Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8. arm 2: Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
Interventions: intervention 1: tranexamic acid
Intervention descriptions: intervention 1: Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.

Protocol documents:
Clinical trial NCT01193101
Conditions: Hypertension
Keywords: hypertension blood pressure LCZ696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor ARNi Essential hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-01; Completion date: 2011-04-01
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a phase 2 study in patients with essential hypertension.

Detailed description:

Arms: arm 1: LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week. arm 2: LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week. arm 3: LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week. arm 4: Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
Interventions: intervention 1: LCZ696 intervention 2: Placebo
Intervention descriptions: intervention 1: LCZ696 intervention 2: matching placebo to LCZ696

Protocol documents:
Clinical trial NCT01216410
Conditions: Cesarean Delivery
Keywords: Nausea Vomiting
Sponsor: Duke University
Start date: 2008-12-01; Completion date: 2011-04-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.

Detailed description:

Arms: arm 1: Prophylaxis with metoclopramide and phenylephrine infusion. arm 2: Prophylactic phenylephrine infusion and placebo antiemetics arm 3: Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion
Interventions: intervention 1: Metoclopramide intervention 2: Phenylephrine infusion intervention 3: Combination Group
Intervention descriptions: intervention 1: Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion intervention 2: Prophylactic phenylephrine infusion after spinal and placebo antiemetics intervention 3: Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Protocol documents:
Clinical trial NCT01227252
Conditions: Alzheimer's Disease
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2011-04-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LY2886721 intervention 2: Placebo
Intervention descriptions: intervention 1: 5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days intervention 2: Administered orally as capsules, daily for 14 days

Protocol documents:
Clinical trial NCT01229254
Conditions: Atrial Fibrillation Atrial Flutter
Keywords: Betrixaban MK-4448 nonvalvular atrial fibrillation
Sponsor: Portola Pharmaceuticals
Start date: 2010-09-01; Completion date: 2011-04-01
Enrollment: 189 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to optimize drug exposure in the target population.

Detailed description:

Arms: arm 1: Participants on betrixaban 30 mg and concomitant baseline amiodarone arm 2: Participants with lower weights arm 3: Participants with higher weights
Interventions: intervention 1: Amiodarone intervention 2: Betrixaban 60 mg intervention 3: Betrixaban 90 mg intervention 4: Betrixaban 30 mg
Intervention descriptions: intervention 1: Patients on Amiodarone intervention 2: Betrixaban 60 mg once a day with food on Day 0 through Day 25 intervention 3: Betrixaban 90 mg once a day with food on Day 0 through Day 25 intervention 4: Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment.

Protocol documents: