ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00754546
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: exercise; treadmill; cycle ergometer; breathlessness; leg discomfort
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2008-08-01; Completion date: 2009-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.

Detailed description:
The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak VO2 on the same exercise mode.

At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.

Arms: arm 1: Bronchodilator therapy with arformoterol solution 15 mcg arm 2: Placebo using normal saline
Interventions: intervention 1: Arformoterol tartrate intervention 2: Placebo: Normal Saline intervention 3: Treadmill Exercise intervention 4: Cycle Exercise
Intervention descriptions: intervention 1: 15 mcg in two ml solution administered via nebulizer intervention 2: Normal saline was nebulized. intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00757705
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Extended-Release
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 299 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.

Detailed description:
This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication without the need for titration due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed. Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 24 weeks. Dose adjustment will be done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks. Efficacy will primarily be evaluated by means of Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.

Protocol documents:
Clinical trial NCT00758706
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2008-09-01; Completion date: 2009-05-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

Detailed description:

Arms: arm 1: oral tablet, 75 mg, twice daily during 6 weeks arm 2: Dosing to match AZD1236
Interventions: intervention 1: AZD1236 intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablet, 75 mg, twice daily during 6 weeks intervention 2: Dosing to match AZD1236

Protocol documents:
Clinical trial NCT00762164
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia Statins Ezetimibe
Sponsor: Bronx VA Medical Center
Start date: 2007-03-01; Completion date: 2009-05-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

Detailed description:

Arms: arm 1: Vytorin 10/80 divided into 4 arm 2: Simvastatin 20 milligrams
Interventions: intervention 1: Vytorin intervention 2: Simvastatin
Intervention descriptions: intervention 1: Vytorin 10/80 split into 4 intervention 2: Simvastatin 20 milligrams

Protocol documents:
Clinical trial NCT00770653
Conditions: Diabetes Mellitus Dyslipidemias
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Hyperlipidemias Drug Therapy
Sponsor: Takeda
Start date: 2007-04-01; Completion date: 2009-05-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia.

Detailed description:
Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia, diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased hih-density lipoprotein cholesterol and a predominance of small dense low-density lipoprotein particles. Each of these dyslipidemia features is associated with an increased risk of cardiovascular events.

Pioglitazone and Metformin are established drugs which can be used for the treatment of type 2 diabetes. This study will investigate the effects of treatment with fixed Pioglitazone/Metformin combination therapy of Metformin and Glimepiride in Metformin-pretreated type 2 diabetic patients with dyslipidemia.

Total participation time in this study is anticipated to be approximately 24 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pioglitazone and Metformin intervention 2: Glimepiride and Metformin
Intervention descriptions: intervention 1: Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks. intervention 2: Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Protocol documents:
Clinical trial NCT00777803
Conditions: Glabellar Frown Lines
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2008-11-01; Completion date: 2009-05-01
Enrollment: 381 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.

Detailed description:

Arms: arm 1: IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection. arm 2: OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.
Interventions: intervention 1: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) intervention 2: OnabotulinumtoxinA (Vistabel®)
Intervention descriptions: intervention 1: NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles. intervention 2: OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.

Protocol documents:
Clinical trial NCT00777946
Conditions: Hypertension
Keywords: Aliskiren, Amlodipine, Non-responder to aliskiren
Sponsor: Novartis
Start date: 2008-10-01; Completion date: 2009-05-01
Enrollment: 818 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Detailed description:

Arms: arm 1: Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. arm 2: Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. arm 3: Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
Interventions: intervention 1: Aliskiren 300 mg intervention 2: Aliskiren/Amlodipine 300/5 mg intervention 3: Aliskiren/Amlodipine 300/10 mg intervention 4: Placebo to Aliskiren intervention 5: Placebo to Aliskiren/Amlodipine
Intervention descriptions: intervention 1: Aliskiren 300 mg tablet taken orally once a day with a glass of water. intervention 2: Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. intervention 3: Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. intervention 4: Placebo to Aliskiren tablet taken orally once a day. intervention 5: Placebo to Aliskiren/Amlodipine taken orally once a day.

Protocol documents:
Clinical trial NCT00787254
Conditions: Stomach Ulcer Duodenal Ulcer
Keywords: Curling Ulcer Gastric Ulcer Nonsteroid anti-inflammatory drug Drug Therapy
Sponsor: Takeda
Start date: 2007-04-01; Completion date: 2009-05-01
Enrollment: 366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).

Detailed description:
In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lansoprazole intervention 2: Gefarnate
Intervention descriptions: intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.

Protocol documents:
Clinical trial NCT00787566
Conditions: Chemotherapy-Induced Nausea and Vomiting
Keywords: Highly emetogenic chemotherapy induced nausea and vomiting
Sponsor: Shin Nippon Biomedical Laboratories, Ltd.
Start date: 2008-10-01; Completion date: 2009-05-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy.

Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy.

Detailed description:

Arms: arm 1: 0.5 mg dose, intranasal powder, single spray, administered once arm 2: 1.0 mg dose, intranasal powder, songle spray, administered once arm 3: 2.0 mg dose, intranasal powder, single spray, administered once
Interventions: intervention 1: Intranasal granisetron
Intervention descriptions: intervention 1: 0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

Protocol documents:
Clinical trial NCT00798759
Conditions: Open-angle Glaucoma Ocular Hypertension
Keywords: Open-angle glaucoma Ocular hypertension
Sponsor: Alcon Research
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop self-administered in the study eye(s) once daily at night for 12 weeks arm 2: One drop self-administered in the study eye(s) once daily at night for 12 weeks
Interventions: intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention descriptions: intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.

Protocol documents:
Clinical trial NCT00802893
Conditions: Isolated Systolic Hypertension Endothelial Dysfunction
Keywords: Isolated Systolic Hypertension with Endothelial Dysfunction
Sponsor: Johns Hopkins University
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.

Detailed description:
By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 6R-BH4 intervention 2: Placebo
Intervention descriptions: intervention 1: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period intervention 2: placebo given BID for entire length of study

Protocol documents:
Clinical trial NCT00804973
Conditions: Migraine Headache
Keywords: Migraine Headache
Sponsor: Eli Lilly and Company
Start date: 2008-11-01; Completion date: 2009-05-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: LY2590443 intervention 2: Placebo injection intervention 3: Sumatriptan intervention 4: Placebo capsule
Intervention descriptions: intervention 1: 200 milligrams (mg) as four 50-mg capsules, oral, once intervention 2: saline solution, injection, once intervention 3: 6 milligrams (mg) injection (0.5 milliliter \[mL\] of 12 mg/mL solution), once intervention 4: 4 capsules, once

Protocol documents:
Clinical trial NCT00806260
Conditions: Overweight Obesity
Keywords: Overweight Obesity coordination psychomotor
Sponsor: VIVUS LLC
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.

Detailed description:

Arms: arm 1: Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo arm 2: First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521 arm 3: First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 arm 4: First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
Interventions: intervention 1: VI-0521 intervention 2: Placebo intervention 3: Alcohol intervention 4: alcohol placebo
Intervention descriptions: intervention 1: Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week intervention 2: Placebo daily for 4 weeks intervention 3: None intervention 4: fruit juice

Protocol documents:
Clinical trial NCT00807937
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety Disorder GAD Anxiety
Sponsor: AstraZeneca
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.

Detailed description:

Arms: arm 1: AZD7325 5mg twice daily arm 2: AZD7325 15mg twice daily arm 3: Lorazepam 2mg twice daily arm 4: Placebo
Interventions: intervention 1: AZD7325 intervention 2: AZD7325 intervention 3: Lorazepam intervention 4: Placebo
Intervention descriptions: intervention 1: 4 tablets and 1 capsule taken twice a day for 28 days intervention 2: 4 tablets and 1 capsule taken twice a day for 28 days intervention 3: 4 tablets and 1 capsule taken twice a day for 28 days intervention 4: 4 tablets and 1 capsule taken twice a day for 28 days

Protocol documents:
Clinical trial NCT00809848
Conditions: Ocular Hypertension Glaucoma
Sponsor: Allergan
Start date: 2009-02-01; Completion date: 2009-05-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Detailed description:

Arms: arm 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. arm 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. arm 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. arm 4: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. arm 5: AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Interventions: intervention 1: AGN-210669 ophthalmic solution, 0.075% intervention 2: AGN-210669 ophthalmic solution, 0.05% intervention 3: AGN-210669 ophthalmic solution, 0.025% intervention 4: bimatoprost ophthalmic solution 0.03% intervention 5: AGN-210669 vehicle ophthalmic solution
Intervention descriptions: intervention 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. intervention 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. intervention 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. intervention 4: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. intervention 5: AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Protocol documents:
Clinical trial NCT00820664
Conditions: Postmenopausal Symptoms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium).

Detailed description:

Arms: arm 1: Estrace 2.0 mg tablet arm 2: Estrace 0.5 mg tablet arm 3: Placebo
Interventions: intervention 1: Comparator: Estrace 0.5 mg intervention 2: Comparator: Estrace 2 mg intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: 0.5 mg tablet taken once daily for 28 days intervention 2: 2 mg tablets taken once daily for 28 days. intervention 3: Placebo 0 mg capsule taken once daily for 28 days

Protocol documents: