ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00299104
Conditions: Rheumatoid Arthritis
Keywords: Rituxan MTX RA IMAGE WA17047
Sponsor: Genentech, Inc.
Start date: 2006-01-01; Completion date: 2013-07-01
Enrollment: 755 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.

Detailed description:

Arms: arm 1: Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6 arm 2: Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6 arm 3: Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.

From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
Interventions: intervention 1: folate intervention 2: methotrexate intervention 3: methylprednisolone intervention 4: placebo intervention 5: rituximab
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Oral or parenteral repeating dose intervention 3: Intravenous repeating dose intervention 4: Intravenous repeating dose intervention 5: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00374322
Conditions: Neoplasms, Breast
Keywords: Breast Cancer ErbB2-overexpressing early-stage breast cancer adjuvant
Sponsor: GlaxoSmithKline
Start date: 2006-08-01; Completion date: 2013-07-01
Enrollment: 3166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

Detailed description:

Arms: arm 1: 6 tablets daily for 12 months arm 2: Lapatinib 1500 mg (6 tablets) daily for 12 months
Interventions: intervention 1: lapatinib intervention 2: placebo
Intervention descriptions: intervention 1: Lapatinib 1500 mg (6 tablets) daily for 12 months intervention 2: 6 tablets daily for 12 months

Protocol documents:
Clinical trial NCT00434642
Conditions: Ovarian Cancer
Keywords: Avastin Ovarian carcinoma Peritoneal carcinoma Peritoneal cancer Fallopian tube cancer Fallopian tube carcinoma OCEANS
Sponsor: Genentech, Inc.
Start date: 2007-04-01; Completion date: 2013-07-01
Enrollment: 484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

Detailed description:

Arms: arm 1: Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study. arm 2: Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
Interventions: intervention 1: Carboplatin intervention 2: Gemcitabine intervention 3: Bevacizumab intervention 4: Placebo
Intervention descriptions: intervention 1: Carboplatin was provided as commercially available drug. intervention 2: Gemcitabine was provided as commercially available drug. intervention 3: Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL \[25 mg/mL\]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP. intervention 4: Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Protocol documents:
Clinical trial NCT00514943
Conditions: Head and Neck Neoplasms Carcinoma, Squamous Cell
Sponsor: Boehringer Ingelheim
Start date: 2007-08-01; Completion date: 2013-07-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.

Detailed description:

Arms: arm 1: once daily taken orally arm 2: once every week by intravenous injection
Interventions: intervention 1: BIBW 2992 intervention 2: Cetuximab
Intervention descriptions: intervention 1: experimental drug taken once daily orally intervention 2: active comparator administered weekly intravenously

Protocol documents:
Clinical trial NCT00537940
Conditions: Epilepsy Partial Seizure Disorder Epilepsies, Partial Complex Partial Seizure Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-02-01; Completion date: 2013-07-01
Enrollment: 482 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Gabapentin
Intervention descriptions: intervention 1: 150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects intervention 2: 300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects

Protocol documents:
Clinical trial NCT00975195
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-02-01; Completion date: 2013-07-01
Enrollment: 2488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

Detailed description:

Arms: arm 1: fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate arm 2: fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Interventions: intervention 1: tiotropium inhalation intervention 2: salmeterol xinafoate intervention 3: fluticasone propionate intervention 4: placebo matched for fluticasone propionate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01358578
Conditions: Chronic Plaque Psoriasis
Keywords: Psoriasis, inflammatory skin disease, scaly patches Psoriasis inflammatory skin disease
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-01; Completion date: 2013-07-01
Enrollment: 1306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Detailed description:

Arms: arm 1: AIN457 150mg arm 2: AIN457 300mg arm 3: Placebo arm 4: Etanercept arm 5: Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase arm 6: Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
Interventions: intervention 1: Placebo intervention 2: secukinumab (AIN457) intervention 3: etanercept
Intervention descriptions: intervention 1: Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept intervention 2: secukinumab (AIN457) 150mg or 300mg subcutaneous intervention 3: etanercept 50mg subcutaneous

Protocol documents:
Clinical trial NCT01453387
Conditions: Advanced Solid Tumor
Keywords: MEK inhibitor Solid Tumor Phase I
Sponsor: EMD Serono
Start date: 2011-09-01; Completion date: 2013-07-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to test the experimental drug, MSC2015103B at different dose levels and on different treatment schedules, to see whether it is safe and can be tolerated when given to subjects once a day one day per week over a 21-day period or once a day three times per week over a 21-day period. The investigators would also like to find out how MSC2015103B is broken down by the body.

Additional purposes of the trial are to assess side effects of MSC2015103B and to find out whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to explore pharmacokinetics.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MSC2015103B intervention 2: MSC2015103B
Intervention descriptions: intervention 1: Schedule 1: MSC2015103B will be administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD establishment. Starting dose will be 150 microgram (mcg), which will be escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently. intervention 2: Schedule 2: MSC2015103B will be administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose will be 150 mcg, and will be escalated to 200 mcg subsequently.

Protocol documents:
Clinical trial NCT00089583
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: antiretroviral therapy pediatrics AGENERASE amprenavir fosamprenavir HIV Infection ritonavir protease inhibitor LEXIVA
Sponsor: ViiV Healthcare
Start date: 2004-07-01; Completion date: 2013-07-01
Enrollment: 110 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .

Detailed description:
A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of GW433908/Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18 years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to \<6 years old

Arms: arm 1: Cohort 1B - 2 - less than 6yrs old (FPV/RTV BID) Cohort 2 - 6 to less than 12 yrs old (FPV/RTV BID) Cohort 3 - 12 - 18 yrs old (FPV/RTV BID) Cohort 4 - 2 - 18 yrs (FPV/RTV BID) arm 2: Cohort 1A - 2 - less than 6yrs old (FPV BID)
Interventions: intervention 1: LEXIVA (GW433908) intervention 2: Ritonavir
Intervention descriptions: intervention 1: Fosamprenavir suspension or tablet bid intervention 2: Ritonavir solution bid

Protocol documents:
Clinical trial NCT00226239
Conditions: Cancer
Keywords: head neck
Sponsor: University of Pittsburgh
Start date: 2005-10-01; Completion date: 2013-07-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.

Detailed description:
This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.

The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.

Arms: arm 1: Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)
Interventions: intervention 1: Docetaxel intervention 2: Cisplatin intervention 3: Cetuximab intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: Docetaxel 75 mg/m\^2 IV over 1 hour, day 1 intervention 2: Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion. intervention 3: Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3). intervention 4: Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.

Protocol documents:
Clinical trial NCT00233948
Conditions: Adult Liposarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: City of Hope Medical Center
Start date: 2006-03-01; Completion date: 2013-07-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from spreading.

PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma.

Detailed description:
OBJECTIVES:

I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.

II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single agent and to describe the toxicities at each does studied.

III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and progression free survival in patients with liposarcoma treated with nelfinavir.

V. To evaluate the expression and activity of certain proteins in the tumors of patients entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1, p21, NFkB (NFkappaB), caspase 3).

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: nelfinavir mesylate intervention 2: biopsy intervention 3: laboratory biomarker analysis intervention 4: pharmacological study intervention 5: gene expression analysis intervention 6: western blotting intervention 7: reverse transcriptase-polymerase chain reaction intervention 8: immunoenzyme technique
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies

Protocol documents:
Clinical trial NCT00248651
Conditions: Dyspepsia and Other Specified Disorders of Function of Stomach
Keywords: Bloating Early Fullness Nausea Upper Abdominal Discomfort dyspepsia stomach pain stomach discomfort
Sponsor: Mayo Clinic
Start date: 2006-10-01; Completion date: 2013-07-01
Enrollment: 292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often interfere with school and work, and weight loss may occur due to dietary restrictions.

The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia.

Detailed description:
The aims of this study were to:

1. Determine whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The investigators also planned to determine if antidepressant therapy reduces disability, improves quality of life and influences clinical response over 6 months after ceasing medication.
2. Determine if gastric emptying (motor dysfunction) and the nutrient drink test (a test that assesses gastric hypersensitivity and/or gastric accommodation) is altered by antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors (SSRI), and whether subgroups with altered physiology are associated with treatment outcome.

Arms: arm 1: Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding. arm 2: Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks. arm 3: Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
Interventions: intervention 1: Amitriptyline intervention 2: Escitalopram intervention 3: Placebo
Intervention descriptions: intervention 1: 25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs. intervention 2: 10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs. intervention 3: Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.

Protocol documents:
Clinical trial NCT00262223
Conditions: Stress Disorders, Post-Traumatic Alcohol Abuse Substance-Related Disorders
Keywords: Co-morbid alcohol dependence and PTSD Alcohol and other drug use disorders Treatment outcome
Sponsor: New York State Psychiatric Institute
Start date: 2006-05-01; Completion date: 2013-07-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This treatment intervention trial is designed for men and women with either alcohol misuse (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive behavioral treatment intervention called "Seeking Safety" + Medication ("Zoloft") or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment.

Detailed description:
The impetus for the current study is to contribute to the development of effective treatments targeted for men and women with either alcohol misuse (e.g., hazardous or binge drinking) or alcohol use disorders (e.g. alcohol abuse or alcohol dependence) and comorbid PTSD. Research findings have shown that these individuals have poorer treatment outcomes and show more severe symptoms than treatment seeking alcohol-misusing or alcohol dependent participants without PTSD. The aim of this study is to replicate and expand on 1) pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for individuals with comorbid substance use disorders and PTSD, "Seeking Safety" 2) preliminary results on the effectiveness of the antidepressant sertraline ("Zoloft") for a dually diagnosed population and 3) the examination of the effectiveness of these interventions over either treatment alone. We are comparing "Seeking Safety" alone to "Seeking Safety" in combination with the antidepressant medication sertraline ("Zoloft") in terms of their effectiveness in reducing alcohol use and PTSD symptoms. Participants will be randomly assigned to one of two treatments (Seeking Safety + Med or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment. Secondary aims of the study include exploring potential differences between alcoholic subtypes on treatment outcomes; impact of combined treatment on treatment participation and global psychiatric symptoms; differences in the time course and order of changes in alcohol and drug use and PTSD symptoms by condition.

Arms: arm 1: Seeking Safety + Sertraline arm 2: Seeking Safety + Placebo;
Interventions: intervention 1: Seeking Safety intervention 2: Sertraline intervention 3: Pill placebo
Intervention descriptions: intervention 1: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders intervention 2: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type intervention 3: None

Protocol documents: