ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01066871
Conditions: Isolated Cartilage Injury of the Knee
Keywords: Knee cartilage injury fibroblast growth factor 18 FGF18
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2010-03-01; Completion date: 2013-04-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Several people all over the world suffer from cartilage injuries in the knee. Symptoms include pain, joint swelling, and loss of function. Without repair, cartilage injury may ultimately lead to osteoarthritis (OA). Natural healing is poor, and to date treatment is available only for deep cartilage defects involving also the underlying bone. A promising candidate for drug treatment of cartilage injury is sprifermin (AS902330), a recombinant form of the human fibroblast growth factor (FGF) 18.

So far, the drug has been used in subjects with different stages of knee OA in two ongoing studies without emerging safety issues following single and multiple intra-articular injections of ascending doses. However, OA represents late-stage cartilage injury, where repair might be difficult due to diffuse damage, reduced responsiveness of the cartilage, and/or the involvement of other joint structures.

This clinical trial is meant to provide the proof of concept and to identify an efficacious dose of sprifermin (AS902330) for the treatment of adult subjects with acute cartilage injuries of the knee. The first subject for this trial was treated on the 19th of April 2010.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Sprifermin (AS902330) 10 mcg intervention 2: Sprifermin (AS902330) 30 mcg intervention 3: Sprifermin (AS902330) 100 mcg intervention 4: Placebo
Intervention descriptions: intervention 1: Sprifermin (AS902330) will be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks. intervention 2: Sprifermin (AS902330) will be administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks. intervention 3: Sprifermin (AS902330) will be administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks. intervention 4: Placebo matched to sprifermin (AS902330) will be administered as intra-articular injection once every week for 3 consecutive weeks.

Protocol documents:
Clinical trial NCT01252355
Conditions: Multiple Sclerosis Relapse
Sponsor: Sanofi
Start date: 2011-01-01; Completion date: 2013-04-01
Enrollment: 534 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

* Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:

  * Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
  * Disability progression
  * Burden of disease and disease progression as measured by brain MRI
* Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
* Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
* Assess associations between variations in genes and clinical outcomes (safety and efficacy)
* Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
* Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

Detailed description:
The study period per patient was expected to be between 56 and 160 weeks depending on when the patient was randomized and this included the following:

* a screening period up to 4 weeks,
* a treatment period expected to be between 48 and 152 weeks,
* 4-week post rapid elimination follow-up period.

Patients were to continue on treatment until a fixed common end date which was approximately 48 weeks after randomization of the last patient.

For those patients who completed the treatment period, a long term extension study of approximately 1 year (including teriflunomide alone) was initially planned to be proposed.

Arms: arm 1: Teriflunomide 7 milligram (mg) once a day concomitantly with IFN-beta therapy. arm 2: Teriflunomide 14 mg once a day concomitantly with IFN-beta therapy. arm 3: Placebo (for teriflunomide) once a day concomitantly with IFN-beta therapy.
Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Interferon-beta (IFN-beta)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration intervention 3: Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled.

Administration according to the package insert.

Protocol documents:
Clinical trial NCT01298531
Conditions: Axial Spondyloarthritis
Keywords: Etanercept Axial Spondyloarthritis NSAIDs sparing effect
Sponsor: Pfizer
Start date: 2011-05-01; Completion date: 2013-04-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.

Detailed description:

Arms: arm 1: Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks. arm 2: Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
Interventions: intervention 1: etanercept intervention 2: etanercept intervention 3: placebo
Intervention descriptions: intervention 1: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks. intervention 2: etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo. intervention 3: placebo subcutaneous (SC) injections once weekly for 8 weeks.

Protocol documents:
Clinical trial NCT01309737
Conditions: Psoriasis
Keywords: Xeljanz tofacitinib Jak-inhibitor oral treatment chronic severe moderate Pruritus Itch DLQI treatment safety efficacy CP-690,550 Plaque Psoriasis Psoriasis Vulgaris
Sponsor: Pfizer
Start date: 2011-03-01; Completion date: 2013-04-01
Enrollment: 960 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo/CP-690,550 intervention 4: Placebo/CP-690,550
Intervention descriptions: intervention 1: 10 mg oral BID, Continuous treatment for 52 Weeks intervention 2: 5 mg oral BID, Continuous treatment for 52 Weeks intervention 3: 0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo) intervention 4: 0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

Protocol documents:
Clinical trial NCT01464190
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: PA21 Phosphate Binder
Sponsor: Vifor Pharma
Start date: 2011-09-01; Completion date: 2013-04-01
Enrollment: 659 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PA21 (2.5 g tablet containing 500 mg iron) intervention 2: Sevelamer carbonate
Intervention descriptions: intervention 1: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). intervention 2: Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Protocol documents:
Clinical trial NCT01706536
Conditions: COPD
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2012-10-01; Completion date: 2013-04-01
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).

Arms: arm 1: EP-101 Placebo AM + EP-101 Placebo PM arm 2: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM arm 3: EP-101 25 mcg AM + EP-101 25 mcg PM arm 4: EP-101 50 mcg AM + EP-101 50 mcg PM arm 5: EP-101 100 mcg AM + EP-101 100 mcg PM
Interventions: intervention 1: Placebo intervention 2: EP-101 12.5 mcg intervention 3: EP-101 25 mcg intervention 4: EP-101 50 mcg intervention 5: EP-101 100 mcg
Intervention descriptions: intervention 1: EP-101 Placebo AM + EP-101 Placebo PM intervention 2: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM intervention 3: EP-101 25 mcg AM + EP-101 25 mcg PM intervention 4: EP-101 50 mcg AM + EP-101 50 mcg PM intervention 5: EP-101 100 mcg AM + EP-101 100 mcg PM

Protocol documents:
Clinical trial NCT00131911
Conditions: Gastrinoma Glucagonoma Insulinoma Metastatic Gastrointestinal Carcinoid Tumor Neuroendocrine Tumor Pancreatic Polypeptide Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma Somatostatinoma WDHA Syndrome
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2013-04-01
Enrollment: 93 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival.

OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated tumor). Each Group was independently evaluated for all study endpoints.

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

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

Arms: arm 1: Patients receive 400 mg oral sorafenib twice daily on days 1-28. arm 2: Patients receive 400 mg oral sorafenib twice daily on days 1-28.
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: 400 mg given orally

Protocol documents:
Clinical trial NCT00201825
Conditions: Lung Cancer Non-Small-Cell Lung Carcinoma
Keywords: Previously Untreated Advanced
Sponsor: Tony Bekaii-Saab
Start date: 2004-12-01; Completion date: 2013-04-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.

Detailed description:
Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition. Docetaxel is also approved for second line treatment of metastatic NSCLC. Research indicates that capecitabine, in combination with docetaxel, has efficacy against NSCLC. Capecitabine appears to have anti-cancer activity through several enzymes. This drug is metabolized in the body to another agent called 5-FU. During this conversion process, 5-FU requires thymidine phosphorylase (TP), a cellular characteristic associated with tumor growth. There are higher levels of TP expression in tumors as compared to normal tissue. The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine. This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC.

Purpose: This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC. Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies.

Treatment: Patients in this study will receive docetaxel and capecitabine. Docetaxel will be administered through intravenous infusions. Capecitabine will be provided through oral pills. A four-week period constitutes one cycle. Docetaxel will be given weekly for three weeks followed by one week of rest. Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Arms: arm 1: None
Interventions: intervention 1: Capecitabine intervention 2: Docetaxel
Intervention descriptions: intervention 1: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. intervention 2: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.

Protocol documents:
Clinical trial NCT00234039
Conditions: Bladder Cancer
Keywords: recurrent bladder cancer stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder
Sponsor: SWOG Cancer Research Network
Start date: 2006-11-01; Completion date: 2013-04-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder may kill more tumor cells.

PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).

Detailed description:
OBJECTIVES:

* Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete response rate, in patients with recurrent superficial transitional cell carcinoma of the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin (BCG).
* Determine the recurrence-free, worsening-free, progression-free, and overall survival of patients treated with this drug.
* Evaluate the toxicity of this drug in these patients.
* Correlate, preliminarily, expression levels of genes or genetic polymorphisms involved in the gemcitabine pathway and angiogenesis with clinical toxicity, response, and relapse-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive gemcitabine intravesically once a week for 6 weeks (weeks 1-6) in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response proceed to maintenance therapy at week 14.
* Maintenance therapy: Patients receive gemcitabine intravesically once in weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 6-12 months.

Arms: arm 1: None
Interventions: intervention 1: gemcitabine hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00353496
Conditions: Endocrine Tumors
Keywords: Non functioning entero-pancreatic tumours
Sponsor: Ipsen
Start date: 2006-06-01; Completion date: 2013-04-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: lanreotide (Autogel formulation) intervention 2: Placebo
Intervention descriptions: intervention 1: 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. intervention 2: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Protocol documents:
Clinical trial NCT00470054
Conditions: Extensive Stage Small Cell Lung Cancer Limited Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-04-01; Completion date: 2013-04-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.

SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.

III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.

Arms: arm 1: Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00493649
Conditions: Breast Cancer
Sponsor: US Oncology Research
Start date: 2007-06-01; Completion date: 2013-04-01
Enrollment: 493 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.

Detailed description:

Arms: arm 1: On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel (Taxotere) 75 mg/m2 IV (over 1 hour), plus cyclophosphamide (Cytoxan) 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter.
Interventions: intervention 1: Taxotere intervention 2: Cytoxan intervention 3: Herceptin
Intervention descriptions: intervention 1: On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years. intervention 2: On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years. intervention 3: On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.

Protocol documents: