ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01181531
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperthyroidism Hemodialysis Parathyroid PARADIGM
Sponsor: Amgen
Start date: 2010-10-01; Completion date: 2012-08-14
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Traditional Vitamin D Therapy intervention 2: Cinacalcet
Intervention descriptions: intervention 1: Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling. intervention 2: Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.

Protocol documents:
Clinical trial NCT01443403
Conditions: Opioid-induced Constipation
Keywords: Opioid Therapy Non-Malignant Chronic Pain Opioid-Induced Constipation
Sponsor: Shionogi
Start date: 2011-08-17; Completion date: 2012-08-22
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.

Detailed description:

Arms: arm 1: Participants received placebo orally once daily for 28 days. arm 2: Participants received 0.1 mg naldemedine orally once daily for 28 days. arm 3: Participants received 0.2 mg naldemedine orally once daily for 28 days. arm 4: Participants received 0.4 mg naldemedine orally once daily for 28 days.
Interventions: intervention 1: Placebo intervention 2: Naldemedine
Intervention descriptions: intervention 1: Matching placebo tablets administered orally once a day. intervention 2: Naldemedine tablets administered orally once a day.

Protocol documents:
Clinical trial NCT01512667
Conditions: Renal Insufficiency
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-01-17; Completion date: 2012-08-22
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.

Detailed description:

Arms: arm 1: Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency. arm 2: Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Interventions: intervention 1: MK-0822
Intervention descriptions: intervention 1: A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.

Protocol documents:
Clinical trial NCT01519778
Conditions: Major Cutaneous Abscess Cellulitis Erysipelas
Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-02-15; Completion date: 2012-08-27
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Detailed description:
This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.

Arms: arm 1: None
Interventions: intervention 1: TR701 FA
Intervention descriptions: intervention 1: 1 tablet 200 mg once daily

Protocol documents:
Clinical trial NCT01328002
Conditions: Primary Fibromyalgia
Keywords: Fibromyalgia Pediatric Fibromyalgia Adolescent Fibromyalgia milnacipran Savella loss of therapeutic response Forest Research Institute Pain Fatigue Serotonin Norepinephrine Reuptake Inhibitors Randomized Withdrawal
Sponsor: Forest Laboratories
Start date: 2011-04-30; Completion date: 2012-08-31
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Detailed description:
* 8 weeks open-label treatment period with milnacipran.
* Followed by randomization to 8-weeks double blind treatment period for eligible patients

Arms: arm 1: oral administration, twice daily dosing arm 2: oral administration, twice daily dosing
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study.

Oral administration, twice daily dosing intervention 2: matching placebo tablets daily

Protocol documents:
Clinical trial NCT00389441
Conditions: Thyroid Neoplasms
Keywords: VEGFR inhibitor tyrosine kinase inhibitor anti-angiogenic carcinoma papillary follicular medullary anaplastic
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2012-09-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

Detailed description:
Additional study details: assess safety and efficacy

Arms: arm 1: None
Interventions: intervention 1: AG-013736
Intervention descriptions: intervention 1: AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Protocol documents:
Clinical trial NCT00473382
Conditions: Diabetes Mellitus Macular Edema
Keywords: Lucentis DME Diabetes Vision loss
Sponsor: Genentech, Inc.
Start date: 2007-06-01; Completion date: 2012-09-01
Enrollment: 382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473330 (Protocol ID FVF4170g).

The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.

Detailed description:
This study is composed of 3 phases: (1) A 24-month controlled treatment period (monthly treatment with ranibizumab 0.3 mg, ranibizumab 0.5 mg, or sham injection) followed by (2) a 12-month treatment period in which patients randomized to the sham group who had not discontinued from treatment (still masked) could choose to receive monthly ranibizumab 0.5 mg while the 2 ranibizumab treatment groups continued on the same treatment they received in the first 2 years. Patients who had not discontinued treatment by Month 36 were eligible to continue treatment with ranibizumab 0.5 mg as needed (pro re nata, PRN) in (3) an extension phase of the study for up to 2 more years, resulting in up to 5 years possible total treatment time for some patients.

As per the protocol, Genentech terminated the study approximately 30 days after approval of ranibizumab for diabetic macular edema in the United States.

Arms: arm 1: Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. arm 2: Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. arm 3: Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months.
Interventions: intervention 1: Ranibizumab intervention 2: Sham injection
Intervention descriptions: intervention 1: Sterile solution for intravitreal injection. intervention 2: None

Protocol documents:
Clinical trial NCT00596830
Conditions: Carcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung
Keywords: IGF-1R inhibitor Non-small-cell lung carcinoma CP-751 871
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2012-09-01
Enrollment: 681 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Detailed description:
The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 \[figitumumab\] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

Arms: arm 1: Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.' arm 2: Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
Interventions: intervention 1: CP-751,871 (Figitumumab) intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Carboplatin intervention 5: Paclitaxel
Intervention descriptions: intervention 1: CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles. intervention 2: Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles. intervention 3: Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles. intervention 4: Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles. intervention 5: Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.

Protocol documents:
Clinical trial NCT00658515
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Start date: 2008-04-01; Completion date: 2012-09-01
Enrollment: 15871 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dalcetrapib (RO4607381) intervention 2: Evidence-based medical care for Acute Coronary Syndrome intervention 3: Placebo
Intervention descriptions: intervention 1: 600mg po daily intervention 2: As prescribed intervention 3: po daily

Protocol documents:
Clinical trial NCT01323790
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain Opioid-Induced Constipation
Sponsor: AstraZeneca
Start date: 2011-03-01; Completion date: 2012-09-01
Enrollment: 700 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

Detailed description:

Arms: arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment
Interventions: intervention 1: NKTR-118 intervention 2: NKTR-118 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg oral tablet once daily intervention 2: 25 mg oral tablet once daily intervention 3: Placebo to NKTR-118

Protocol documents:
Clinical trial NCT01395524
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain Opioid-Induced Constipation.
Sponsor: AstraZeneca
Start date: 2011-07-01; Completion date: 2012-09-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: NKTR-118 intervention 2: NKTR-118 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg oral tablet once daily intervention 2: 25 mg oral tablet once daily intervention 3: Oral tablet intake once daily

Protocol documents:
Clinical trial NCT01566149
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2012-03-01; Completion date: 2012-09-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \& adolescents.

Detailed description:

Arms: arm 1: Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks arm 2: Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Interventions: intervention 1: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI intervention 2: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Intervention descriptions: intervention 1: Two oral inhalations per dose intervention 2: Two oral inhalations per dose

Protocol documents:
Clinical trial NCT00006392
Conditions: Prostate Cancer
Keywords: prostate cancer
Sponsor: SWOG Cancer Research Network
Start date: 2001-07-01; Completion date: 2012-09-01
Enrollment: 35533 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.

Detailed description:
OBJECTIVES:

* Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
* Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
* Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.

Arms: arm 1: vitamin E and selenium placebo daily for 7-12 years arm 2: selenium and vitamin E placebo daily for 7-12 years arm 3: vitamin E and selenium placebo daily for 7-12 years arm 4: vitamine E placebo and selenium placebo daily for 7-12 years
Interventions: intervention 1: Vitamin E intervention 2: Selenium intervention 3: Vitamin E placebo intervention 4: selenium placebo
Intervention descriptions: intervention 1: 400 IU daily by mouth for 7-12 years intervention 2: 200 mcg daily for 7-12 years intervention 3: daily for 7-12 years intervention 4: daily for 7-12 years

Protocol documents:
Clinical trial NCT00081263
Conditions: Cervical Carcinoma Cervical Intraepithelial Neoplasia Grade 2/3 Stage 0 Cervical Cancer
Sponsor: Gynecologic Oncology Group
Start date: 2005-06-01; Completion date: 2012-09-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the efficacy of celecoxib to induce complete remission (or partial regression to cervical intraepithelial neoplasia (CIN) 1) of CIN 2/3 or CIN 3 as evaluated in the post-treatment excisional biopsy.

II. To determine the toxicity of celecoxib (400 mg once daily) as assessed by Common Terminology Criteria for Adverse Events in this patient population of women with CIN 2/3 or CIN 3.

SECONDARY OBJECTIVES:

I. To assess whether treatment with celecoxib changes the number of quadrants containing acetowhite lesions as determined through colposcopic examination.

II. To determine the efficacy of celecoxib treatment in changing human papillomavirus (HPV) viral load in cervical cells.

III. To examine the association of histologic response; HPV viral load; lesion size; proliferation index (marker of proliferation Ki-67 \[Ki67\]), apoptosis index (terminal deoxynucleotidyl transferase (TdT)-mediated dUTP nick end labelin \[TUNEL\] assay), angiogenesis (vascular endothelial growth factor \[VEGF\]), and cyclooxygenase-2 (COX-2) in tissue; the amount of VEGF and basic fibroblast growth factor (bFGF) in serum before and after treatment; and the amount of celecoxib present in serum during treatment. Cervical cytology karyometry will be assessed as a potential marker for regression IV. To determine the feasibility of digital imaging, web-based review of histopathology in a Gynecologic Oncology Group (GOG) study.

V. To compare the diagnoses of the web-based review of histopathology with the diagnoses of GOG's standard procedure.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral celecoxib once daily for 14-18 weeks.

ARM II: Patients receive oral placebo once daily for 14-18 weeks.

Arms: arm 1: Patients receive oral celecoxib once daily for 14-18 weeks. arm 2: Patients receive oral placebo once daily for 14-18 weeks.
Interventions: intervention 1: Celecoxib intervention 2: Laboratory Biomarker Analysis intervention 3: Placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Given orally

Protocol documents:
Clinical trial NCT00109707
Conditions: Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) Hypereosinophilic Syndrome Systemic Mastocytosis
Keywords: CML in blast crisis CML in chronic phase CML in accelerated phase Gleevec resistance Gleevec intolerant Gleevec and CML imatinib resistance imatinib intolerant Hypereosinophilic Syndrome Systemic Mastocytosis Chronic eosinophilic syndrome Philadelphia chromosome positive acute lymphoblastic leukemia HES CEL CML SM Ph+ ALL refractory to standard therapy Ph+ALL relapsed AMN107A
Sponsor: Novartis Pharmaceuticals
Start date: 2005-04-01; Completion date: 2012-09-01
Enrollment: 507 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions:

Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)

Group A - Imatinib failure only (arms 2, 3 and 4)

* imatinib-resistant or intolerant CML - Chronic Phase (CP)
* imatinib-resistant or intolerant CML - Accelerated Phase (AP)
* imatinib-resistant or intolerant CML - Blast Crisis (BC)

Group B - Imatinib and other TKI failure (arms 2, 3 and 4)

* imatinib-resistant or intolerant CML - Chronic Phase (CP)
* imatinib-resistant or intolerant CML - Accelerated Phase (AP)
* imatinib-resistant or intolerant CML - Blast Crisis (BC)

Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)

Systemic mastocytosis (Sm) (arm 6)

Detailed description:

Arms: arm 1: Imatinib-resistant / intolerant PH+ CML-CP patients arm 2: Imatinib-resistant / intolerant PH+ CML-AP patients arm 3: Imatinib-resistant / intolerant PH+ CML-CP patients
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: None

Protocol documents: