ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00551291
Conditions: Myelodysplastic Syndromes
Sponsor: Hoffmann-La Roche
Start date: 2007-08-01; Completion date: 2009-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Interventions: intervention 1: Mycophenolate mofetil intervention 2: Prednisone intervention 3: Erythropoietin Beta
Intervention descriptions: intervention 1: 1 gm twice daily orally until end of study. intervention 2: 10 mg/day orally until end of study. intervention 3: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.

Protocol documents:
Clinical trial NCT00553605
Conditions: Pain
Keywords: Renal Colic Pain Urinary Tract Colic
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2009-06-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.

Detailed description:

Arms: arm 1: Ketoprofen plus placebo parecoxib arm 2: Parecoxib plus placebo ketoprofen
Interventions: intervention 1: Ketoprofen 100mg intervention 2: Parecoxib 40mg
Intervention descriptions: intervention 1: Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection intervention 2: Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period

Protocol documents:
Clinical trial NCT00553787
Conditions: Obesity Type 2 Diabetes
Keywords: Obesity, Type 2 diabetes
Sponsor: VIVUS LLC
Start date: 2007-11-01; Completion date: 2009-06-01
Enrollment: 2487 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Detailed description:

Arms: arm 1: high dose experimental treatment arm 2: mid dose experimental treatment arm 3: Placebo
Interventions: intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: VI-0521
Intervention descriptions: intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: placebo

Protocol documents:
Clinical trial NCT00558467
Conditions: Tourette Syndrome
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2009-06-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pramipexole immediate release (IR) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00564902
Conditions: Age Related Macular Degeneration Cognition Disorders
Keywords: Macular Pigment Optical Density Skin Carotenoids Lipofuscin Photostress (Glare Recovery) Visual Field Progression Contrast Sensitivity Color Vision Cognitive Function
Sponsor: Chrysantis, Inc.
Start date: 2007-11-01; Completion date: 2009-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration.

Detailed description:
To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recovery and National Eye Institute Visual Function Questionnaire 25 scores), but lower risk National Eye Institute (NEI) / Age Related Eye Disease Study (AREDS) characteristics.

Arms: arm 1: 9 mg of Lutein for 12 months arm 2: 3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months arm 3: 3R 3'R Zeaxanthin 8 mg per day during 12 months
Interventions: intervention 1: 3R 3'R Zeaxanthin intervention 2: Lutein intervention 3: Lutein and Zeaxanthin
Intervention descriptions: intervention 1: 8 mg per day during 12 months intervention 2: 9 mg of Lutein during 12 months intervention 3: 8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months

Protocol documents:
Clinical trial NCT00567255
Conditions: Obesity Overweight
Keywords: Obesity
Sponsor: Orexigen Therapeutics, Inc
Start date: 2007-12-01; Completion date: 2009-06-01
Enrollment: 1496 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity.

Detailed description:
Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.

Arms: arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy arm 2: Placebo with ancillary therapy
Interventions: intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day intervention 2: Placebo intervention 3: Ancillary therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Protocol documents:
Clinical trial NCT00576901
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-11-01; Completion date: 2009-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Docetaxel intervention 3: Xeloda
Intervention descriptions: intervention 1: 15mg/kg iv on day 1 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 2000mg/m2 po on days 1-15 of each 3 week cycle

Protocol documents:
Clinical trial NCT00578279
Conditions: Pancreatic Cancer
Sponsor: Indiana University
Start date: 2007-03-01; Completion date: 2009-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.

Hypotheses:

1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)

Detailed description:

Arms: arm 1: subject randomized to 10ml of dehydrated alcohol arm 2: subject randomized to 20ml of dehydrated alcohol
Interventions: intervention 1: dehydrated alcohol
Intervention descriptions: intervention 1: subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure

Protocol documents:
Clinical trial NCT00588536
Conditions: Langerhans Cell Histiocytosis
Keywords: Langerhans Cell Histiocytosis LCH 6-Thioguanine 6-TG Methotrexate MTX 94-132
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 1995-01-01; Completion date: 2009-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).

Detailed description:

Arms: arm 1: MTX, 6-TG, Leucovorin
Interventions: intervention 1: Methotrexate intervention 2: 6-Thioguanine intervention 3: Leucovorin Calcium
Intervention descriptions: intervention 1: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs intervention 2: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose. intervention 3: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)

Protocol documents:
Clinical trial NCT00589914
Conditions: Schizophrenia
Keywords: Schizophrenia long-acting injectable antipsychotic medication
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2007-03-01; Completion date: 2009-06-01
Enrollment: 1221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

Detailed description:
This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection) in adult patients with schizophrenia. The total duration of the study will be approximately 14 weeks. For those patients without source documentation of tolerability to oral (by mouth) risperidone or paliperidone Extended Release (ER) tablets, injectable RISPERDAL CONSTA or paliperidone palmitate, or those patients who were not currently taking another antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment at a dosage of 6 mg/day will be administered for tolerability testing before the first injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL CONSTA). During the DB period, study drug will be administered to patients as an intramuscular (i.m.) injection. Paliperidone palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo) at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day 8), 50 or 100mg eq at V7 (Day 36), and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6 (Day 22), 25 or 37.5mg at V7, and 25, 37.5, or 50mg at V9 will be given as i.m. injections. Patients in the RC group will also take risperidone tablets (1-6 mg/day) at BL for 28 days and be given an injection of PP placebo at BL, V1, V7, and V9.

Arms: arm 1: RISPERDAL CONSTA 25-50 mg eq every 2 weeks arm 2: Paliperidone Palmitate 50-150 mg eq every 4 wks
Interventions: intervention 1: RISPERDAL CONSTA intervention 2: Paliperidone palmitate
Intervention descriptions: intervention 1: RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period. intervention 2: PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.

Protocol documents:
Clinical trial NCT00594945
Conditions: Epilepsy
Sponsor: Jazz Pharmaceuticals
Start date: 2007-12-01; Completion date: 2009-06-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Clonazepam
Intervention descriptions: intervention 1: 1 Dose

Protocol documents:
Clinical trial NCT00599313
Conditions: Metastatic Prostate Cancer
Sponsor: US Oncology Research
Start date: 2007-03-01; Completion date: 2009-06-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.

Detailed description:
The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.

Arms: arm 1: Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: 50 mg/day orally each of Days 1-28 of each 6 week cycle

Protocol documents:
Clinical trial NCT00601107
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: psoriasis psoriasis vulgaris plaque psoriasis chronic plaque psoriasis
Sponsor: Genzyme, a Sanofi Company
Start date: 2008-04-01; Completion date: 2009-06-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation was 28 weeks.

Detailed description:
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group.

Arms: arm 1: Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. arm 2: Doxercalciferol 5 mcg capsules orally once daily up to Week 24. arm 3: Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. arm 4: Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
Interventions: intervention 1: Doxercalciferol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00611403
Conditions: Dry Eye Syndromes
Keywords: LASIK
Sponsor: Allergan
Start date: 2007-12-01; Completion date: 2009-06-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Detailed description:

Arms: arm 1: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) arm 2: Artificial Tears (REFRESH ENDURA®)
Interventions: intervention 1: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) intervention 2: Artificial Tears REFRESH ENDURA®
Intervention descriptions: intervention 1: Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery intervention 2: REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Protocol documents:
Clinical trial NCT00617097
Conditions: Pain Surgical Abortion
Keywords: Pain associated with first trimester surgical abortion
Sponsor: Johns Hopkins University
Start date: 2008-01-01; Completion date: 2009-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.

This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.

The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.

Detailed description:

Arms: arm 1: Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion arm 2: Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
Interventions: intervention 1: lidocaine intervention 2: ketorolac and lidocaine
Intervention descriptions: intervention 1: paracervical block with lidocaine intervention 2: paracervical block with ketorolac and lidocaine

Protocol documents:
Clinical trial NCT00621504
Conditions: Bacterial Pneumonia
Keywords: ceftaroline Community-acquired pneumonia CAP IV (intravenous) Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella spp Multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci Ceftriaxone bacteria ß-lactam beta-lactam antibiotic
Sponsor: Forest Laboratories
Start date: 2008-01-01; Completion date: 2009-06-01
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Detailed description:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

Arms: arm 1: Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism. arm 2: Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Interventions: intervention 1: Ceftaroline fosamil for Injection intervention 2: IV Ceftriaxone intervention 3: Placebo intervention 4: Clarithromycin
Intervention descriptions: intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days intervention 3: Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind intervention 4: In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Protocol documents: