ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02185053
Conditions: Alzheimer's Disease
Sponsor: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
Start date: 2014-07-31; Completion date: 2016-07-31
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CPC-201
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02439957
Conditions: Cytomegalovirus Disease Kidney Transplant Infection
Keywords: Cytomegalovirus CMV
Sponsor: Chimerix
Start date: 2015-09-01; Completion date: 2016-07-31
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy.

Detailed description:
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy. The study comprised a screening evaluation period (up to 14 days posttransplant), a treatment period (up to 14 weeks posttransplant), and a posttreatment follow-up period (10 weeks, through Week 24 posttransplant).

Arms: arm 1: 100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily. arm 2: 900 mg valanciclovir (vGCV; two 450 tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
Interventions: intervention 1: Brincidofovir intervention 2: Valganciclovir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02752490
Conditions: Maternal Oxygen Use in Labor
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2016-04-01; Completion date: 2016-07-31
Enrollment: 844 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.

Detailed description:
This is a single-site before and after study comparing the strategy of liberal versus indicated use of maternal oxygen in the first and second stages of labor in the setting of a category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann Hospital in Houston, Texas during the time frame of the study will be included in the study. The study will be conducted over 18 weeks. It will involve two 8 week time periods during which all patients will under either a strategy of liberal administration of oxygen use (current practice) in the "before" portion of the study and indicated administration of oxygen in the "after" portion of the study (new practice). There will be a transition period where training, education, and audit + feedback will be done to prepare for a strategy of indicated administration of oxygen.

Arms: arm 1: Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by the American Congress of Obstetrics and Gynecology (ACOG) at the discretion of the primary nurse or physician arm 2: Administration of maternal oxygen, 100% fraction of inspired oxygen (FiO2) at 10 liters/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
Interventions: intervention 1: Liberal use of maternal oxygen intervention 2: Indicated use of maternal oxygen
Intervention descriptions: intervention 1: Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician intervention 2: Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.

Protocol documents:
Clinical trial NCT00399035
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal Cancer Cediranib RECENTIN
Sponsor: AstraZeneca
Start date: 2006-11-01; Completion date: 2016-08-01
Enrollment: 1254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.

Detailed description:

Arms: arm 1: FOLFOX + placebo Cediranib arm 2: Xelox + placebo Cediranib arm 3: FOLFOX + Cediranib arm 4: XELOX + Cediranib
Interventions: intervention 1: Cediranib intervention 2: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intervention 3: XELOX (Capecitabine and Oxaliplatin) intervention 4: Cediranib Placebo
Intervention descriptions: intervention 1: oral tablet intervention 2: intravenous infusion intervention 3: intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15) intervention 4: oral tablet

Protocol documents:
Clinical trial NCT00547378
Conditions: Urinary Incontinence, Urgency-frequency Overactive Bladder
Keywords: overactive bladder, urinary incontinence, incontinence,Urgency-frequency
Sponsor: MedtronicNeuro
Start date: 2007-10-01; Completion date: 2016-08-01
Enrollment: 571 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are:

1. To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use.
2. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.

Detailed description:
Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities.

Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence.

InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.

InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion.

Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT.

Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.

Arms: arm 1: InterStim Therapy arm 2: Standard Medical Therapy
Interventions: intervention 1: InterStim intervention 2: Standard Medical Therapy
Intervention descriptions: intervention 1: None intervention 2: Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg

Protocol documents:
Clinical trial NCT02517021
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Helsinn Healthcare SA
Start date: 2015-11-01; Completion date: 2016-08-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Detailed description:

Arms: arm 1: Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle arm 2: Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Interventions: intervention 1: Pro-netupitant/Palonosetron intervention 2: Netupitant/Palonosetron intervention 3: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00022516
Conditions: Breast Cancer
Keywords: stage IA breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IB breast cancer estrogen receptor-negative breast cancer progesterone receptor-negative breast cancer triple-negative breast cancer low-dose maintenance chemotherapy stroma angiogenesis
Sponsor: ETOP IBCSG Partners Foundation
Start date: 2000-11-01; Completion date: 2016-08-01
Enrollment: 1086 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.

Detailed description:
PURPOSE:

* Evaluate a low-dose cyclophosphamide and methotrexate chemotherapy-maintenance regimen in early breast cancer.
* Compare the disease-free survival, overall survival, and systemic disease-free survival of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.

OUTLINE:

This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, menopausal status (pre vs post), and approved induction chemotherapy (anthracycline and cyclophosphamide vs other agents). Treatment duration is 12 months of low-dose chemotherapy-maintenance regimen (CM-maintenance) vs no chemotherapy-maintenance regimen (no-CM) following standard adjuvant chemotherapy. Patients are randomized to one of two treatment arms. Patients are followed every 6 months for 5 years, and yearly follow-up thereafter.

Arms: arm 1: No further chemotherapy following standard adjuvant chemotherapy. arm 2: 12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
Interventions: intervention 1: Cyclophosphamide intervention 2: Methotrexate
Intervention descriptions: intervention 1: 50 mg/day orally continuously for 1 year intervention 2: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year

Protocol documents:
Clinical trial NCT00101582
Conditions: Mucositis Solid Tumors Stomatitis Head and Neck Cancer Squamous Cell Carcinoma
Keywords: SCCHN Palifermin Mucositis Oral Cavity Oropharynx Nasopharynx Hypopharynx Larynx Mouth Pain Mouth Sores Radiation Therapy Radiotherapy Radiochemotherapy Concurrent Chemotherapy Xerostomia Stomatitis Mucosa KGF rHuKGF Keratinocyte Growth Factor HNC Head and Neck Cancer Oral Mucositis
Sponsor: Swedish Orphan Biovitrum
Start date: 2005-08-01; Completion date: 2016-08-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).

Detailed description:
This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Arms: arm 1: Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. arm 2: Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
Interventions: intervention 1: Placebo intervention 2: palifermin intervention 3: cisplatin chemotherapy intervention 4: Radiotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43. intervention 4: Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Protocol documents:
Clinical trial NCT00407758
Conditions: Ovarian Cancer Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer
Sponsor: Gynecologic Oncology Group
Start date: 2006-11-01; Completion date: 2016-08-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Enzastaurin 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.

PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
* Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

* Determine the duration of progression-free and overall survival of patients treated with this regimen.
* Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once 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 for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Interventions: intervention 1: enzastaurin hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00559949
Conditions: Recurrent Thyroid Gland Carcinoma Stage I Thyroid Gland Papillary Carcinoma Stage II Thyroid Gland Papillary Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IV Thyroid Gland Papillary Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-12-01; Completion date: 2016-08-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well selumetinib works in treating patients with papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Ascertain the objective response rate (complete response and partial response) in patients with iodine I 131-refractory papillary thyroid cancer treated with selumetinib.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this treatment in these patients. II. Determine the pharmacokinetic profile of this treatment in these patients. III. Determine the progression-free and overall survival of these patients. IV. Assess proxy measures of treatment response (thyroglobulin and PET scan) in patients treated with selumetinib.

IV. Compare relevant laboratory correlates between responders and non-responders.

OUTLINE: This is a multicenter study.

Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

Archived tissue is examined for gene mutations, including RET, BRAF, NTRK, and RAS, by fluorescence in situ hybridization and/or polymerase chain reaction and fluorescence melting curve analysis. Protein expression of ERK and phosphorylated ERK is assessed by immunohistochemical staining.

Blood samples are collected periodically for pharmacokinetic analysis and biomarker assessment (thyroglobulin and antithyroglobulin autoantibodies).

After completion of study therapy, patients are followed periodically for up to 2 years.

Arms: arm 1: Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Selumetinib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary.

Protocol documents:
Clinical trial NCT00659633
Conditions: Pain
Keywords: lidocaine allodynia chronic regional pain syndrome pain
Sponsor: University of Alabama at Birmingham
Start date: 2008-12-01; Completion date: 2016-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Detailed description:
Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Arms: arm 1: Intravenous lidocaine for neuropathic pain
Interventions: intervention 1: lidocaine
Intervention descriptions: intervention 1: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once

Protocol documents:
Clinical trial NCT00720226
Conditions: COPD Emphysema Chronic Bronchitis Smoking
Keywords: COPD emphysema angiotensin receptor blocker
Sponsor: Johns Hopkins University
Start date: 2008-07-01; Completion date: 2016-08-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).

Detailed description:
Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.

Arms: arm 1: Losartan 100 mg daily arm 2: Placebo 1 pill daily
Interventions: intervention 1: Losartan intervention 2: Placebo
Intervention descriptions: intervention 1: Losartan 100 mg daily intervention 2: Placebo pill daily

Protocol documents:
Clinical trial NCT00782288
Conditions: Cystic Fibrosis
Keywords: digitoxin inflammatory markers cytokines gene expression
Sponsor: National Jewish Health
Start date: 2010-08-01; Completion date: 2016-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of digitoxin in serum.

Funding Source-FDA OOPD

Detailed description:
The study will be conducted as a randomized, double blind, placebo-controlled, repeat dosing trial evaluating the effects of 28 days of digitoxin on IL-8 and neutrophil concentrations in induced sputum in subjects with mild to moderate cystic fibrosis lung disease. Twenty-four total patients will be randomized into 3 groups of 8 subjects each (0.05 mg or 0.1 mg digitoxin or a placebo).

Arms: arm 1: low dose 0.05mg digitoxin given once daily for 28 days arm 2: higher dose 0.1mg digitoxin daily for 28 days arm 3: placebo given daily for 28 days
Interventions: intervention 1: digitoxin intervention 2: digitoxin intervention 3: placebo
Intervention descriptions: intervention 1: 0.05mg tabs, once daily for 28 days intervention 2: 0.1mg pills, once daily for 28 days. intervention 3: pill taken once daily for 28 days

Protocol documents: