ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02006706
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2006-08-10; Completion date: 2007-11-23
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: methotrexate intervention 3: methylprednisolone
Intervention descriptions: intervention 1: 1000 mg iv Days 1 and 15 intervention 2: 10 - 25 mg/week intervention 3: iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

Protocol documents:
Clinical trial NCT00252382
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung Squamous Cell Large Cell Adenocarcinoma Carcinoma Cancer
Sponsor: Sunesis Pharmaceuticals
Start date: 2005-12-27; Completion date: 2007-11-29
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.

Detailed description:
Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Arms: arm 1: Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)
Interventions: intervention 1: SNS-595 Injection
Intervention descriptions: intervention 1: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.

Protocol documents:
Clinical trial NCT00132678
Conditions: Bipolar Disorder
Keywords: Mood episodes Bipolar 1 disorder Intramuscular Injectable risperidone safety and efficacy
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2005-02-01; Completion date: 2007-12-01
Enrollment: 559 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

Detailed description:
RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) placebo-controlled study to explore the safety and effectiveness of RISPERDAL CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder. This study includes 5 periods: a screening period lasting up to 1 week; an open-label RISPERDAL (oral risperidone) treatment period lasting 3 weeks; an open-label RISPERDAL CONSTA stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with RISPERDAL CONSTA lasting 8 weeks. Efficacy will be assessed using the Young Mania Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions - Severity (CGI-S) scale, Medical Outcomes Study Short Form 36 (SF-36), and the Personal and Social Performance (PSP) scale. Safety will be evaluated throughout the study and includes assessment of adverse events, clinical laboratory tests (including hematology, serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms (ECGs), vital signs (pulse and blood pressure), physical examination, body mass index (BMI), and the Extrapyramidal Symptom Rating Scale (ESRS). Oral risperidone (flexible dosage) 1 to 6 mg/day for the first 3 weeks. Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients receiving placebo during DB-period)

Arms: arm 1: Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks arm 2: Placebo Matching placebo intramuscular (IM) injection every 2 weeks
Interventions: intervention 1: Risperdal Consta intervention 2: Placebo
Intervention descriptions: intervention 1: 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks intervention 2: Matching placebo intramuscular (IM) injection every 2 weeks

Protocol documents:
Clinical trial NCT00145509
Conditions: Bipolar Disorder
Sponsor: Organon and Co
Start date: 2005-08-01; Completion date: 2007-12-01
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.

Detailed description:

Arms: arm 1: Asenapine arm 2: Placebo
Interventions: intervention 1: Asenapine intervention 2: Placebo
Intervention descriptions: intervention 1: Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks intervention 2: Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

Protocol documents:
Clinical trial NCT00191113
Conditions: Turner Syndrome
Keywords: syndrome Turner Turner's height growth growth hormone somatropin short stature short hearing glucose metabolism
Sponsor: Eli Lilly and Company
Start date: 1989-02-01; Completion date: 2007-12-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

Detailed description:
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry.

Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity \< 2 cm per year and a bone age of 14 years or greater.

Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997.

Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study.

Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.

Arms: arm 1: Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). arm 2: Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
Interventions: intervention 1: Somatropin intervention 2: Ethinyl estradiol intervention 3: Medroxyprogesterone acetate
Intervention descriptions: intervention 1: 0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height). intervention 2: escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met. intervention 3: 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.

Protocol documents:
Clinical trial NCT00227305
Conditions: Schizophrenia Bipolar I Disorder
Keywords: Schizophrenia Bipolar I Disorder
Sponsor: AstraZeneca
Start date: 2004-08-01; Completion date: 2007-12-01
Enrollment: 381 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

Detailed description:

Interventions: intervention 1: quetiapine fumarate
Intervention descriptions: intervention 1: Oral dosing, flexible dosing

Protocol documents:
Clinical trial NCT00230178
Conditions: Tumor Lysis Syndrome Cancer Hyperuricemia
Keywords: Hyperuricemia Tumor lysis syndrome Leukemia Lymphoma Myelodysplastic Syndromes Solid tumor cancers Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only) Tumor lysis syndrome (cancer patients only)
Sponsor: Sanofi
Start date: 2004-04-01; Completion date: 2007-12-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-center, open-label, parallel group study with three arms:

* Rasburicase alone
* Rasburicase followed by Allopurinol
* Allopurinol alone

The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Detailed description:
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Arms: arm 1: Rasburicase alone given as a single agent for 5 days arm 2: Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) arm 3: Oral allopurinol alone given as a single agent for 5 days
Interventions: intervention 1: Rasburicase (SR29142) intervention 2: Allopurinol
Intervention descriptions: intervention 1: 30-min IV infusion intervention 2: Oral administration

Protocol documents:
Clinical trial NCT00422513
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-03-01; Completion date: 2007-12-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: 120-360 micrograms (iv) monthly, starting dose arm 2: As prescribed, (iv), 3 times weekly
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: 120-360 micrograms intravenous (iv) monthly, starting dose intervention 2: As prescribed, iv, 3 times weekly

Protocol documents:
Clinical trial NCT00423657
Conditions: Bacterial Infections
Keywords: Abscess Antibacterial Antibiotic Antimicrobial Bacterial infection, skin Ceftaroline Ceftaroline acetate Cellulitis Cephalosporin Complicated skin and skin structure infection (cSSSI) cSSSI Intravenous Methicillin-resistant Staphylococcus Aureus (MRSA) PPI-0903 Prodrug Skin disease, bacterial Skin infection Staphylococcal skin infection Staphylococcus aureus Streptococcal skin infection Surgical site infection TAK-599
Sponsor: Forest Laboratories
Start date: 2007-03-01; Completion date: 2007-12-01
Enrollment: 680 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 complicated skin infections in adults.

Detailed description:
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Arms: arm 1: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. arm 2: Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
Interventions: intervention 1: ceftaroline intervention 2: vancomycin plus aztreonam intervention 3: Placebo
Intervention descriptions: intervention 1: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days intervention 2: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. intervention 3: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Protocol documents:
Clinical trial NCT00035815
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis ALS progressive weakness insulin-like growth factor-1 IGF-I Myotrophin
Sponsor: Mayo Clinic
Start date: 2003-06-01; Completion date: 2007-12-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.

Detailed description:
The objective of this trial was to determine whether IGF-1 (MyotrophinTM) slows progression of weakness in amyotrophic lateral sclerosis (ALS). Three hundred thirty patients with ALS from 20 medical centers participated in this double blind, placebo-controlled two-year study. Half the patients received IGF-1 and the other half received placebo. The drug will be administered twice a day.

ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous system and shows protection of motor neurons in animal models and cell culture systems. It is thought to block cell death pathways and promote muscle re-innervation and axonal growth and regeneration.

Arms: arm 1: Insulin like growth factor, type 1 will be given 0.05 mg per kg body weight subcutaneously twice daily arm 2: Placebo arm
Interventions: intervention 1: Insulin like growth factor, type 1 intervention 2: Placebo
Intervention descriptions: intervention 1: 0.05 mg per kg body weight given subcutaneously twice daily intervention 2: The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.

Protocol documents:
Clinical trial NCT00056498
Conditions: Schizophrenia
Sponsor: University of Maryland, Baltimore
Start date: 2001-12-01; Completion date: 2007-12-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

Detailed description:
Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy.

Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.

Arms: arm 1: Participants assigned to risperidone arm 2: Participants assigned to placebo
Interventions: intervention 1: Placebo intervention 2: Risperdal
Intervention descriptions: intervention 1: Placebo capsule daily for 16 weeks intervention 2: Risperdal 4 mg per day for 16 weeks

Protocol documents:
Clinical trial NCT00098059
Conditions: Herpes Simplex
Keywords: herpes simplex cold sores fever blisters children Famvir famciclovir
Sponsor: Novartis Pharmaceuticals
Start date: 2005-02-01; Completion date: 2007-12-01
Enrollment: 74 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

Detailed description:

Arms: arm 1: single-arm
Interventions: intervention 1: Famciclovir
Intervention descriptions: intervention 1: Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

Protocol documents:
Clinical trial NCT00108524
Conditions: Diabetes Mellitus Obesity
Keywords: anti-obesity agents diet therapy diet, reducing obesity overweight risk factors weight loss
Sponsor: US Department of Veterans Affairs
Start date: 2004-07-01; Completion date: 2007-12-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Detailed description:
Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.

Arms: arm 1: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. arm 2: Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.
Interventions: intervention 1: Low carbohydrate ketogenic diet intervention 2: Orlistat intervention 3: Low-fat diet
Intervention descriptions: intervention 1: A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat. intervention 2: In addition to the low fat diet, Orlistat is taken 3 times daily. intervention 3: Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

Protocol documents:
Clinical trial NCT00132873
Conditions: Narcolepsy
Keywords: Narcolepsy Cataplexy
Sponsor: Jazz Pharmaceuticals
Start date: 2004-10-01; Completion date: 2007-12-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Detailed description:
This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Interventions: intervention 1: Xyrem (sodium oxybate) oral solution
Intervention descriptions: intervention 1: Xyrem (sodium oxybate) oral solution

Protocol documents:
Clinical trial NCT00141219
Conditions: Diabetic Neuropathies Neuralgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2005-12-01; Completion date: 2007-12-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: 150-600mg/day, BID intervention 2: Placebo

Protocol documents: