ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00558285
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Chronic Obstructive Pulmonary Disease Indacaterol QVA149
Sponsor: Novartis
Start date: 2007-11-01; Completion date: 2008-07-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Detailed description:

Arms: arm 1: Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 2: One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 3: One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 4: One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 5: Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Interventions: intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: glycopyrrolate intervention 4: placebo
Intervention descriptions: intervention 1: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 2: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 3: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 4: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Protocol documents:
Clinical trial NCT00560612
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD Paroxetine Subthreshold
Sponsor: Durham VA Medical Center
Start date: 2006-01-01; Completion date: 2008-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.

Detailed description:
See brief summary

Arms: arm 1: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. arm 2: None
Interventions: intervention 1: Paroxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. intervention 2: Placebo: same as paroxetine (active comparator)

Protocol documents:
Clinical trial NCT00573391
Conditions: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2006-08-01; Completion date: 2008-07-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Detailed description:
A new drug (bortezomib \[VelcadeTM PS-341\]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Arms: arm 1: VTD = Velcade, Thalidomide, and Dexamethasone arm 2: VMD = velcade, melphalan, and dexamethasone
Interventions: intervention 1: Velcade, Thalidomide, and Dexamethasone intervention 2: Velcade, Melphalan, and Dexamethasone
Intervention descriptions: intervention 1: Velcade - Into vein (IV) Days 1, 4, 8, 11

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles

Thalidomide - By Mouth Days 1-28

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles intervention 2: Velcade - Into vein (IV) Days 1, 4, 8, 11

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles

Protocol documents:
Clinical trial NCT00573508
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Sponsor: Astellas Pharma Inc
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 768 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Detailed description:
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.

The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.

Primary efficacy will be based on OAB-q symptom bother score.

Arms: arm 1: Matching placebo tablet taken once daily arm 2: 5mg or 10mg tablet taken once daily
Interventions: intervention 1: Placebo intervention 2: Solifenacin Succinate
Intervention descriptions: intervention 1: Oral Administration intervention 2: Oral Administration

Protocol documents:
Clinical trial NCT00573768
Conditions: Ankle Sprain
Keywords: Ankle, sprain, diclofenac diethylamine
Sponsor: Novartis
Start date: 2007-11-01; Completion date: 2008-07-01
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Diclofenac diethylamine 2.32% gel intervention 2: Placebo intervention 3: Diclofenac diethylamine 2.32% gel / Placebo
Intervention descriptions: intervention 1: Diclofenac diethylamine 2.32% gel twice daily intervention 2: Vehicle 2 times daily intervention 3: Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Protocol documents:
Clinical trial NCT00577655
Conditions: Asthma
Keywords: Pediatric, asthma, albuterol-HFA and Placebo
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Detailed description:

Arms: arm 1: Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. HFA-MDI refers to a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. arm 2: A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")
Interventions: intervention 1: Albuterol intervention 2: Placebo intervention 3: Proventil® HFA
Intervention descriptions: intervention 1: Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days. intervention 2: Placebo HFA MDI four times a day (q.i.d) for 21 days. intervention 3: Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.

Protocol documents:
Clinical trial NCT00585975
Conditions: Cataract Surgery
Sponsor: Bausch & Lomb Incorporated
Start date: 2007-10-01; Completion date: 2008-07-01
Enrollment: 568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of bromfenac ophthalmic solution

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bromfenac ophthalmic solution
Intervention descriptions: intervention 1: sterile opthalmic solution

Protocol documents:
Clinical trial NCT00586495
Conditions: Carcinoma, Renal Cell
Keywords: Sorafenib Nexavar Metastatic RCC Renal Cell Carcinoma Unresectable RCC
Sponsor: Bayer
Start date: 2005-12-01; Completion date: 2008-07-01
Enrollment: 95 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).

Detailed description:

Arms: arm 1: Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally

Protocol documents:
Clinical trial NCT00588640
Conditions: Pain Bladder Cancer Breast Cancer CNS Cancer Colon Cancer Esophageal Cancer Pancreatic Cancer Prostate Cancer Uterine Cancer Head and Neck Cancer Eye Cancer Otorhinolaryngologic Neoplasms
Keywords: Pain HEENT cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2004-10-01; Completion date: 2008-07-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.

Detailed description:

Arms: arm 1: This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours. arm 2: patients receiving around the clock opioid therapy-No patients were accrued to this group arm 3: patients not receiving around the clock opioid therapy.No patients were accrued to this group
Interventions: intervention 1: d-Methadone intervention 2: D-methadone intervention 3: placebo
Intervention descriptions: intervention 1: 8 subjects to receive 40 mg d-Methadone twice a day intervention 2: After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. intervention 3: After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.

Protocol documents:
Clinical trial NCT00614055
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-01-01; Completion date: 2008-07-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec/insulin aspart intervention 3: insulin glargine intervention 4: metformin
Intervention descriptions: intervention 1: Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily intervention 2: Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily intervention 3: Treat-to-target dose titration scheme, injection s.c., once daily intervention 4: Tablets, 1500-2000 mg/day

Protocol documents:
Clinical trial NCT00614926
Conditions: Fatigue
Keywords: Fatigue low energy ALS treatment
Sponsor: New York State Psychiatric Institute
Start date: 2006-06-01; Completion date: 2008-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.

Detailed description:
ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative care, including symptom management, can contribute greatly to improved quality of life. In this context, alleviation of fatigue can help maintain function, extend the duration of time when employment is feasible for those still working, and can enable patients to more fully participate in and enjoy social and recreational activities. Given the prevalence of fatigue in this population, identification of effective treatment is a meaningful goal.

Arms: arm 1: Eligible patients will be treated at baseline through Week 4. Those who choose to continue will have additional in-person visits at Weeks 8 and 12 visits (and Week 16 for those starting modafinil at Week 4). arm 2: Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks. intervention 2: Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.

Protocol documents:
Clinical trial NCT00617188
Conditions: Ovarian Cancer
Keywords: recurrent ovarian epithelial cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2007-06-01; Completion date: 2008-07-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor cells.

PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent ovarian epithelial cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the 90-day clinical benefit (defined as the sum of complete responses, partial responses, and stable disease) in patients with recurrent ovarian epithelial cancer treated with single agent fulvestrant.

Secondary

* To establish the time to termination of treatment (due to all causes including progression and intolerance) for patients treated with this drug.
* To describe the toxicities observed in patients treated with this drug.
* To evaluate the quality of life of patients treated with this drug.
* To determine the effect that prolonged estrogen receptor antagonism has on markers of bone mineral turnover.

OUTLINE: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 of all subsequent courses. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients in continued response at the end of 1 year may continue treatment at the discretion of the treating physician.

Urinary N-telopeptide and serum skeletal-specific alkaline phosphatase are assessed at baseline and at 1, 3, and 6 months during study to determine the influence of estrogen blockade on bone mineral turnover.

Quality of life is assessed at baseline and every 3 months during treatment, and at the end of treatment using The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) cancer questionnaire.

After completion of study treatment, patients are followed at approximately 30 days.

Arms: arm 1: Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
Interventions: intervention 1: Fulvestrant
Intervention descriptions: intervention 1: Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.

Protocol documents:
Clinical trial NCT00619060
Conditions: Healthy
Keywords: skin cancer healthy, no evidence of disease
Sponsor: University of Arizona
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming.

PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.

Detailed description:
OBJECTIVES:

* To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers.
* To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period.

OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.

* Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
* Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.

Arms: arm 1: Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo arm 2: Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
Interventions: intervention 1: Topical Myristyl Nicotinate Cream intervention 2: Placebo
Intervention descriptions: intervention 1: Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks. intervention 2: Participants apply topical placebo to one forearm once daily for 4 weeks.

Protocol documents:
Clinical trial NCT00619801
Conditions: Allergic Rhinitis Chronic Urticaria
Keywords: Xyzal Levocetirizine Allergy Children Seasonal Allergies
Sponsor: UCB Pharma
Start date: 2008-03-01; Completion date: 2008-07-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levocetirizine intervention 2: Placebo
Intervention descriptions: intervention 1: Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks intervention 2: Placebo oral drops (5 drops) dosed twice a day for 2 weeks.

Protocol documents:
Clinical trial NCT00624286
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease COPD indacaterol
Sponsor: Novartis
Start date: 2008-02-01; Completion date: 2008-07-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 150 μg intervention 2: Placebo to indacaterol
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Protocol documents: