ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00077623
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2004-03-01; Completion date: 2005-09-01
Enrollment: 572 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug. arm 2: Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug. arm 3: Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .
Interventions: intervention 1: epoetin alfa or beta intervention 2: methoxy polyethylene glycol-epoetin beta (Mircera) intervention 3: methoxy polyethylene glycol-epoetin beta (Mircera)
Intervention descriptions: intervention 1: iv 3 times weekly, as prescribed intervention 2: 60, 100 or 180 micrograms sc (starting dose) every 2 weeks intervention 3: 60, 100 or 180 micrograms sc (starting dose) every 4 weeks

Protocol documents:
Clinical trial NCT00203216
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2002-09-01; Completion date: 2005-09-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug.

The Jefferson Headache Center has developed this clinical study to evaluate the safety and effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual disturbances).

In addition, the study site will be performing a procedure called Transcranial Magnetic Stimulation (TMS). This procedure measures brain activity because it is thought that people with migraine experience periods of cortical hyperexcitability or over-activity in the brain. This information may help physicians in the future determine which preventive medications will work for which patients.

Detailed description:

Arms: arm 1: Subject titrated open-label study drug to maximally tolerated dose: maximum: 3000 mg. per date. (minimum allowed daily dose to remain in study: 1000)
Interventions: intervention 1: levetiracetam intervention 2: Transcranial Magnetic Stimulation
Intervention descriptions: intervention 1: Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg) intervention 2: None

Protocol documents:
Clinical trial NCT00223262
Conditions: Memory Impairment Due to Corticosteroid Use Hypomania Due to Corticosteroid Use Hippocampal Atrophy Due to Corticosteroid
Sponsor: University of Texas Southwestern Medical Center
Start date: 2002-08-01; Completion date: 2005-09-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.

Detailed description:

Interventions: intervention 1: Lamotrigine (Drug)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00313014
Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain opioid transdermal Butrans
Sponsor: Purdue Pharma LP
Start date: 2004-02-01; Completion date: 2005-09-01
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Interventions: intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: Oxycodone Immediate-Release
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear intervention 3: Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Protocol documents:
Clinical trial NCT00367640
Conditions: Allergy
Keywords: Sublingual immunotherapy Grass pollen tablet Allergic rhinoconjunctivitis
Sponsor: Stallergenes Greer
Start date: 2004-11-01; Completion date: 2005-09-01
Enrollment: 628 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Detailed description:

Arms: arm 1: 100 IR grass pollen allergen extract tablet arm 2: 300 IR grass pollen allergen extract tablet arm 3: 500 IR grass pollen allergen extract tablet arm 4: Placebo tablet
Interventions: intervention 1: 100 IR grass pollen allergen extract tablet intervention 2: 300 IR grass pollen allergen extract tablet intervention 3: 500 IR grass pollen allergen extract tablet intervention 4: Placebo tablet
Intervention descriptions: intervention 1: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 2: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 3: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 4: One sublingual tablet daily during 4 months before pollen season and during pollen season

Protocol documents:
Clinical trial NCT00807235
Conditions: Respiratory Distress Syndrome
Keywords: Lucinactant Nasal continuous positive airway pressure (nCPAP) Respiratory distress syndrome (RDS) Pediatric Premature
Sponsor: Windtree Therapeutics
Start date: 2005-01-01; Completion date: 2005-09-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Detailed description:
Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aerosolized lucinactant intervention 2: Aerosolized lucinactant
Intervention descriptions: intervention 1: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours. intervention 2: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.

Protocol documents:
Clinical trial NCT01182181
Conditions: Healthy
Keywords: Healthy Subjects Bioequivalence
Sponsor: Teva Pharmaceuticals USA
Start date: 2005-08-01; Completion date: 2005-09-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Anastrozole Tablets, 1 mg arm 2: Arimidex® Tablets, 1 mg
Interventions: intervention 1: Anastrozole (Teva Pharmaceuticals USA) intervention 2: Anastrozole (Arimidex®)
Intervention descriptions: intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets

Protocol documents:
Clinical trial NCT02480010
Conditions: Prostate Cancer
Sponsor: Hoffmann-La Roche
Start date: 2003-09-01; Completion date: 2005-09-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

Detailed description:

Arms: arm 1: Participants in Cohort B will receive 1050 mg pertuzumab via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treatment until disease progression or unacceptable toxicity. arm 2: Participants in Cohort A will receive an IV loading dose of 840 milligrams (mg) pertuzumab followed by 420 mg via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treatment until disease progression or unacceptable toxicity.
Interventions: intervention 1: Pertuzumab
Intervention descriptions: intervention 1: Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.

Protocol documents:
Clinical trial NCT02494596
Conditions: Solid Tumor
Sponsor: Hoffmann-La Roche
Start date: 2004-01-01; Completion date: 2005-09-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

Detailed description:

Arms: arm 1: Participants will receive a single 1000-mg/m\^2 dose of oral (PO) capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 1000 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-mg IV infusion. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 2: Participants will receive a single 1250-mg/m\^2 dose of PO capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 1250 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-mg IV infusion. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 3: Participants will receive a single 825-mg/m\^2 dose of PO capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 825 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-mg IV infusion. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.
Interventions: intervention 1: Capecitabine intervention 2: RhuMab 2C4
Intervention descriptions: intervention 1: Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m\^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 1050 mg via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

Protocol documents:
Clinical trial NCT00233389
Conditions: Stomach Ulcer
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2004-04-30; Completion date: 2005-09-09
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study

Detailed description:

Interventions: intervention 1: Rebamipide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00082628
Conditions: HIV Infections Lipodystrophy
Keywords: Growth hormone Serostim® Human Adipose Redistribution Syndrome Human Immunodeficiency Virus lipodystrophy
Sponsor: EMD Serono
Start date: 2004-05-28; Completion date: 2005-09-28
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.

Detailed description:

Arms: arm 1: Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. arm 2: Subjects will receive Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks. arm 3: All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive placebo matched to Serostim® on alternate days for 24 weeks in Period II. arm 4: All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive Serostim® 2 mg on alternate days for 24 weeks in Period II. arm 5: All subjects who will be initially randomized to Placebo arm in Period I continue receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.
Interventions: intervention 1: Placebo intervention 2: Serostim® 4 mg intervention 3: Serostim® 2 mg
Intervention descriptions: intervention 1: Placebo matched to serostim® as subcutaneous injection. intervention 2: Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight. intervention 3: Serostim® 2 mg as subcutaneous injection on alternate days.

Protocol documents:
Clinical trial NCT00755846
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Drug Therapy Diabetes Mellitus, Type II Type 2 Diabetes Mellitus Hyperinsulinism Insulin Resistance
Sponsor: Takeda
Start date: 2005-03-01; Completion date: 2005-10-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.

Detailed description:
Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system.

In response to this problem, Takeda Global Research \& Development Center, Inc. is developing SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Alogliptin intervention 6: Placebo
Intervention descriptions: intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. intervention 5: Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. intervention 6: Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.

Protocol documents:
Clinical trial NCT00055471
Conditions: Prostatic Neoplasms Metastases, Neoplasm
Keywords: prostate cancer Metastatic prostate cancer bone metastases
Sponsor: AstraZeneca
Start date: 2003-06-01; Completion date: 2005-10-01
Enrollment: 22 participants; Allocation: ; Intervention model: 

Brief summary:
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

Detailed description:

Arms: arm 1: 1 x 10 mg oral tablets once daily arm 2: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily arm 3: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
Interventions: intervention 1: ZD4054 10 mg intervention 2: ZD4054 15 mg intervention 3: ZD4054 22.5 mg
Intervention descriptions: intervention 1: 1 x 10 mg oral tablets once daily intervention 2: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily intervention 3: 2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Protocol documents:
Clinical trial NCT00088621
Conditions: Schizophrenia
Keywords: Schizophrenia Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2004-07-01; Completion date: 2005-10-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Detailed description:
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Arms: arm 1: Lurasidone 80mg oral tablet taken once a day
Interventions: intervention 1: Lurasidone 80mg tablet
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00105469
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-07-01; Completion date: 2005-10-01
Enrollment: 743 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

Detailed description:

Arms: arm 1: 1.0% azithromycin in DuraSite arm 2: 0.3% tobramycin
Interventions: intervention 1: AzaSite intervention 2: Tobramycin
Intervention descriptions: intervention 1: AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5. intervention 2: Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

Protocol documents:
Clinical trial NCT00165646
Conditions: Non-erosive Gastroesophageal Reflux Disease
Keywords: non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole
Sponsor: Eisai Co., Ltd.
Start date: 2004-09-01; Completion date: 2005-10-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: E3810 intervention 2: E3810 intervention 3: Placebo
Intervention descriptions: intervention 1: E3810 5mg: once daily orally for 4 weeks intervention 2: E3810 10mg: once daily orally for 4 weeks intervention 3: Placebo: once daily orally for 4 weeks

Protocol documents: