ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01703065
Conditions: Adenocarcinoma of the Prostate Castration-resistant Prostate Cancer Recurrent Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer
Keywords: Prostate cancer Bone metastases
Sponsor: University of Washington
Start date: 2013-06-18; Completion date: 2015-09-18
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
Primary Outcome Measure:

1. Change in urinary N-telopeptide (uNTX) from baseline to after 6 weeks of treatment with cabozantinib in men with non-metastatic CRPC.

   Secondary Outcome Measures:
2. Changes in serum markers of bone metabolism from baseline to after 6 weeks of treatment with cabozantinib. Markers of bone metabolism in blood include bone specific alkaline phosphatase, alkaline phosphatase, LDH.
3. Changes in biomarker expression in bone biopsy samples. To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.

OUTLINE:

Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Arms: arm 1: Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. arm 2: Non-Metastatic CRPC patients to receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cabozantinib
Intervention descriptions: intervention 1: Given orally once a day

Protocol documents:
Clinical trial NCT02460497
Conditions: Female Pattern Hair Loss, Androgenic Alopecia
Sponsor: Galderma R&D
Start date: 2015-05-27; Completion date: 2015-09-19
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the effect of Minoxidil 2% Solution and Botanical Hair Solution Regimen in women with thinning hair and female pattern hair loss/androgenic alopecia (Ludwig I and II).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Treatment: Minoxidil 2% / Botanical Hair Solution for Women
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT04218799
Conditions: Human Microbiome
Keywords: intranasal mupirocin topical chlorhexidine
Sponsor: University of Maryland, Baltimore
Start date: 2014-08-12; Completion date: 2015-09-22
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Intranasal Mupirocin and Topical Chlorhexidine
Intervention descriptions: intervention 1: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.

Protocol documents:
Clinical trial NCT01290029
Conditions: Chronic Kidney Disease Hyperparathyroidism, Secondary Secondary Hyperparathyroidism
Keywords: pediatric CKD dialysis paediatric
Sponsor: Amgen
Start date: 2011-01-25; Completion date: 2015-09-23
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.

Detailed description:

Arms: arm 1: Participants received a single, oral dose of 0.25 mg/kg cinacalcet.
Interventions: intervention 1: Cinacalcet
Intervention descriptions: intervention 1: Single, oral dose of 0.25 mg/kg cinacalcet

Protocol documents:
Clinical trial NCT01611155
Conditions: Peripheral Neuropathy
Sponsor: Mayo Clinic
Start date: 2012-02-17; Completion date: 2015-09-23
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)

Detailed description:
PRIMARY OBJECTIVES:

I. To explore whether venlafaxine can prevent or ameliorate chronic, cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX).

SECONDARY OBJECTIVES:

I. To explore whether venlafaxine can ameliorate acute neuropathy associated with oxaliplatin.

TERTIARY OBJECTIVES:

I. To explore whether venlafaxine can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity.

II. To explore whether venlafaxine causes adverse events in this setting. III. To explore whether the neuropathy data provided by the Rydel-Seiffer graduated tuning fork is consistent with patient-reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN) and whether this tool might cause different results in patients receiving venlafaxine versus placebo.

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

ARM I: Patients receive venlafaxine orally (PO) twice daily (BID) beginning on day 1 of and continuing through completion of FOLFOX.

ARM II: Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.

After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 18 months.

Arms: arm 1: Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX. arm 2: Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Interventions: intervention 1: venlafaxine intervention 2: placebo intervention 3: questionnaire administration intervention 4: quality-of-life assessment
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Ancillary studies

Protocol documents:
Clinical trial NCT01106898
Conditions: Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer
Sponsor: University of Nebraska
Start date: 2010-03-24; Completion date: 2015-09-28
Enrollment: 112 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well giving cyclophosphamide and paclitaxel with or without trastuzumab works in treating patients with stage I-II breast cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy, such as trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the toxicities and ability to complete the planned treatment of a dose-dense regimen of cyclophosphamide and paclitaxel with or without trastuzumab in patients with newly diagnosed stage I-II breast cancer.

II. To estimate recurrence free survival of a dose-dense regimen of cyclophosphamide and paclitaxel with or without trastuzumab in patients with newly diagnosed stage I-II breast cancer.

OUTLINE:

SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide intravenously (IV) over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY (human epidermal growth factor receptor 2 \[Her-2\] neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 3 years.

Arms: arm 1: SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cyclophosphamide intervention 2: paclitaxel intervention 3: trastuzumab intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01620528
Conditions: Endometriosis
Keywords: Gonadotropin-Releasing Hormone Antagonist Endometriosis associated pain Dysmenorrhea (DYS) Non-Menstrual Pelvic Pain (NMPP) Elagolix
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-05-22; Completion date: 2015-09-28
Enrollment: 872 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

Detailed description:
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.

Arms: arm 1: Elagolix 150 mg once daily (QD) for the 6-month Treatment Period arm 2: Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period arm 3: Placebo BID for the 6-month Treatment Period
Interventions: intervention 1: elagolix intervention 2: placebo
Intervention descriptions: intervention 1: oral tablet intervention 2: oral tablet

Protocol documents:
Clinical trial NCT02402452
Conditions: HCV Infection
Sponsor: Gilead Sciences
Start date: 2015-05-05; Completion date: 2015-09-28
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.

Detailed description:

Arms: arm 1: Participants will receive a single dose of voxilaprevir on Day 1. arm 2: Participants will receive a single dose of voxilaprevir on Day 1.
Interventions: intervention 1: Voxilaprevir
Intervention descriptions: intervention 1: 100 mg tablet administered orally

Protocol documents:
Clinical trial NCT02262130
Conditions: Solar Urticaria
Keywords: Omalizumab Efficacy Safety
Sponsor: Centre Hospitalier Universitaire de Besancon
Start date: 2014-09-30; Completion date: 2015-09-29
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.

Detailed description:
This is an open-labelled multicentric phase II study testing the efficacy and the safety of omalizumab 300 mg (W0, W4 and W8) in patients affected with severe and refractory solar urticaria.

Arms: arm 1: Omalizumab 300 mg W0, W4 and W8
Interventions: intervention 1: Omalizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01749904
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Intraocular pressure
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-01-31; Completion date: 2015-09-30
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.

Detailed description:

Arms: arm 1: BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s). arm 2: Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Interventions: intervention 1: BOL-303259-X intervention 2: Timolol intervention 3: BOL-303259-X
Intervention descriptions: intervention 1: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6). intervention 2: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6) intervention 3: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)

Protocol documents:
Clinical trial NCT01784523
Conditions: Antiphospholipid Syndrome
Keywords: antiphospholipid autoantibodies antiphospholipid positive
Sponsor: Hospital for Special Surgery, New York
Start date: 2013-02-01; Completion date: 2015-09-30
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.

Detailed description:
Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.

This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.

Arms: arm 1: patients randomized to standard treatment will not receive hydroxychloroquine. arm 2: Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.
Interventions: intervention 1: Hydroxychloroquine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01870921
Conditions: Acute Coronary Syndrome
Sponsor: AstraZeneca
Start date: 2013-06-26; Completion date: 2015-09-30
Enrollment: 2004 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome

Detailed description:

Arms: arm 1: 90 mg/tablet, 1 tablet bid
Interventions: intervention 1: Ticagrelor
Intervention descriptions: intervention 1: 90mg/tablet, 1 tablet bid

Protocol documents:
Clinical trial NCT00853658
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure Cardiovascular death CHF hospitalization morbi-mortality trial outcome study endpoint driven plasma renin activity renin angiotensin aldosterone system direct renin inhibitors BNP KCCQ eGFR (NYHA class II to IV) with elevated BNP and reduced LVEF
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2015-10-01
Enrollment: 7064 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.

Detailed description:

Arms: arm 1: Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally. arm 2: Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally. arm 3: Enalapril monotherapy -10 mg film-coated tablet and administered orally.
Interventions: intervention 1: Enalapril intervention 2: Aliskiren
Intervention descriptions: intervention 1: Enalapril 10 mg film-coated tablet and administered orally. intervention 2: Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.

Protocol documents:
Clinical trial NCT01364090
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C treatment injection drug users or receiving opiate substitution therapy
Sponsor: Kirby Institute
Start date: 2012-06-01; Completion date: 2015-10-01
Enrollment: 93 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.

Detailed description:
The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.

Arms: arm 1: Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). arm 2: Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).
Interventions: intervention 1: Pegylated interferon alfa 2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. intervention 2: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Protocol documents:
Clinical trial NCT01371721
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Depression
Sponsor: Pfizer
Start date: 2012-02-01; Completion date: 2015-10-01
Enrollment: 269 participants; Allocation: ; Intervention model: 

Brief summary:
This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: DVS SR
Intervention descriptions: intervention 1: Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

Protocol documents:
Clinical trial NCT01494506
Conditions: Metastatic Pancreatic Cancer
Keywords: Pancreatic cancer MM-398 PEP02 Metastatic pancreatic cancer Gemcitabine refractory pancreatic cancer Second line pancreatic cancer treatment Pancreatic cancer post gemcitabine therapy
Sponsor: Merrimack Pharmaceuticals
Start date: 2011-11-01; Completion date: 2015-10-01
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

Detailed description:

Arms: arm 1: MM-398 120 mg/m2 Q3W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 120 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 100 mg/ m2 of irinotecan free base. arm 2: 5 Fluorouracil and Leucovorin IV arm 3: MM-398 80 mg/m2, 5-FU and Leucovorin Q2W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 80 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 70 mg/ m2 of irinotecan free base.
Interventions: intervention 1: MM-398 intervention 2: 5 Fluorouracil intervention 3: Leucovorin
Intervention descriptions: intervention 1: Arm A: MM-398 120 mg/m2 IV Q3W

Arm C: MM-398 80mg/m2 IV Q2W intervention 2: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks

Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks intervention 3: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks

Arm C: Leucovorin 400 mg/m2 IV every 2 weeks

Protocol documents: