ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02418468
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, FEV1, indacaterol
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-28; Completion date: 2016-04-19
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B.

This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus:

1. Indacaterol 150ug or
2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.

Detailed description:

Arms: arm 1: Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) arm 2: Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Interventions: intervention 1: Indacaterol intervention 2: Placebo
Intervention descriptions: intervention 1: Indacaterol 150µg capsules for inhalation daily intervention 2: Matching placebo indacaterol capsules for inhalation daily

Protocol documents:
Clinical trial NCT02424578
Conditions: Pain, Postoperative
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2015-05-01; Completion date: 2016-04-19
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.

Detailed description:

Arms: arm 1: Diclofenac Capsules low dose three times daily for up to three days arm 2: Diclofenac Capsules high dose three times daily for up to three days
Interventions: intervention 1: Diclofenac Capsules low dose intervention 2: Diclofenac Capsules high dose
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02186171
Conditions: Osteoporosis in Men
Keywords: Osteoporosis in men
Sponsor: Amgen
Start date: 2014-06-16; Completion date: 2016-04-20
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.

Detailed description:

Arms: arm 1: Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. arm 2: Participants received placebo subcutaneous injections once a month for 12 months.
Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month. intervention 2: Administered by subcutaneous injection once a month.

Protocol documents:
Clinical trial NCT02257957
Conditions: Dry Eye Sjogren Syndrome
Sponsor: Universidad Nacional de Colombia
Start date: 2014-11-30; Completion date: 2016-04-20
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Detailed description:
Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Arms: arm 1: 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 arm 2: 15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90
Interventions: intervention 1: PRP injection intervention 2: Standard care Hyaluronic acid eye drops
Intervention descriptions: intervention 1: None intervention 2: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90

Protocol documents:
Clinical trial NCT02076399
Conditions: Immune Thrombocytopenic Purpura
Keywords: Persistent Immune Thrombocytopenic Purpura Chronic Immune Thrombocytopenic Purpura
Sponsor: Rigel Pharmaceuticals
Start date: 2014-07-14; Completion date: 2016-04-21
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Detailed description:

Arms: arm 1: Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability. arm 2: Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Interventions: intervention 1: Fostamatinib disodium intervention 2: Placebo
Intervention descriptions: intervention 1: Fostamatinib (100 mg PO bid or 150 mg PO bid) intervention 2: Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Protocol documents:
Clinical trial NCT01371708
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Depression
Sponsor: Pfizer
Start date: 2012-02-02; Completion date: 2016-04-22
Enrollment: 283 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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 NCT02350569
Conditions: Hepatitis C Virus Infection
Keywords: liver transplant hepatitis C Gilead Communicable Diseases Infection Liver Diseases RNA Virus Infections
Sponsor: Gilead Sciences
Start date: 2015-05-22; Completion date: 2016-04-22
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.

Detailed description:

Arms: arm 1: Participants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant.
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally

Protocol documents:
Clinical trial NCT02412098
Conditions: Long QT Syndrome
Keywords: Hepatic Impairment
Sponsor: Gilead Sciences
Start date: 2015-03-19; Completion date: 2016-04-22
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral eleclazine and its metabolite, GS-623134, in participants with normal and impaired hepatic function. Participants in the healthy control group will be matched to participants with impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).

Detailed description:

Arms: arm 1: Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). arm 2: Participants with severe hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). arm 3: Participants with mild hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).
Interventions: intervention 1: Eleclazine
Intervention descriptions: intervention 1: Eleclazine tablets administered orally

Protocol documents:
Clinical trial NCT02277691
Conditions: Essential Hypertension
Keywords: Pharmacological therapy Drug Therapy
Sponsor: Takeda
Start date: 2014-11-07; Completion date: 2016-04-25
Enrollment: 341 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of long-term administration of TAK-536, amlodipine (AML), and hydrochlorothiazide (HCTZ) in participants with essential hypertension.

Detailed description:
The drug being tested in this study is called TAK-536TCH. TAK-536TCH is being tested to treat people who have essential hypertension. The study looked at effectiveness and long-term safety of TAK-536TCH in people who took TAK-536CCB in addition to standard care.

The study enrolled 341 patients. Participants received:

* TAK-536CCB (as TAK-536/AML, 20 mg/5 mg) in run-in period,
* TAK-536TCH (as TAK-536/ AML/HCTZ, 20 mg/5 mg/12.5 mg) in treatment period
* TAK-536CCB and HCTZ 12.5 mg in treatment period

All participants were asked to take tablets at the same time each day throughout the study.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 56 weeks (4 weeks run-in period and 52 weeks treatment period). Participants made multiple visits to the clinic during the study.

Arms: arm 1: For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.

For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg orally, once daily, before or after breakfast.
Interventions: intervention 1: TAK-536TCH tablet intervention 2: TAK-536CCB tablet intervention 3: HCTZ 12.5 mg tablet
Intervention descriptions: intervention 1: TAK-536TCH tablets intervention 2: TAK-536CCB tablets intervention 3: HCTZ tablets

Protocol documents:
Clinical trial NCT02294734
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: functional respiratory capacity High-resolution computed tomography GSK2269557 acute exacerbation of COPD lung capacity
Sponsor: GlaxoSmithKline
Start date: 2015-03-31; Completion date: 2016-04-25
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks including screening, treatment period and a follow up visit. Subjects will receive once daily study treatment administration starting on Day 1. Study is planned to recruit approximately 120 subjects such that approximately 100 subjects complete the study.

Detailed description:

Arms: arm 1: Participants will receive 2 inhalation of GSK2269557 dry powder once daily via DISKUS™ 'device' (DISKUS is a trademark of the GSK group of companies) arm 2: Participants will receive 2 inhalation matching placebo dry powder once daily via DISKUS 'device'
Interventions: intervention 1: GSK2269557 intervention 2: Placebo
Intervention descriptions: intervention 1: Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily intervention 2: Dry powder for inhalation via DISKUS 'device'

Protocol documents:
Clinical trial NCT02009761
Conditions: Purpura, Thrombocytopenic, Idiopathic
Sponsor: Boehringer Ingelheim
Start date: 2013-12-18; Completion date: 2016-04-26
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.

Detailed description:

Arms: arm 1: The patients were administered 120 mg BI 655064 solution for subcutaneous injection q1w (once a week) subcutaneously for 4 weeks.

Patients who showed an increase in platelet count above or equal to 100 x 10\^9/L continued treatment with 120 mg BI 655064 solution for subcutaneous injection q1w for additional 8 weeks, followed by 12 weeks of follow-up.

Patients whose platelet count stayed below 100 x 10\^9/L continued treatment for 2 weeks with 180 mg BI 655064 solution for subcutaneous injection q1w followed by 120 mg BI 655064 solution for subcutaneous injection q1w for additional 6 weeks, followed by 12 weeks of follow-up.
Interventions: intervention 1: BI 655064
Intervention descriptions: intervention 1: subcutaneous injection

Protocol documents:
Clinical trial NCT02261467
Conditions: Forehead Rhytides Glabellar Rhytides
Sponsor: Allergan
Start date: 2014-10-21; Completion date: 2016-04-26
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

Detailed description:

Arms: arm 1: OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. arm 2: Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
Interventions: intervention 1: OnabotulinumtoxinA intervention 2: Normal Saline
Intervention descriptions: intervention 1: OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments. intervention 2: Placebo (normal saline) injected into the protocol-specified areas on Day 1.

Protocol documents:
Clinical trial NCT01006369
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2009-05-01; Completion date: 2016-04-27
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Hydroxychloroquine may help chemotherapy and bevacizumab work better and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* To assess the progression-free survival (PFS) of patients with metastatic colorectal carcinoma treated with hydroxychloroquine in combination with capecitabine, oxaliplatin, and bevacizumab and to compare this to a previously reported median PFS of 7.9 months.

Secondary

* To measure the overall response rate.
* To measure the duration of response for responding patients.
* To measure the disease-control rate (complete response, partial response, or stable disease for at least 2 courses).
* To document the safety and feasibility of this regimen in these patients.
* To develop surrogate biomarkers for autophagy detection in patient tissue specimens and to characterize the effects of hydroxychloroquine on autophagy in patients in vivo.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive oral capecitabine twice daily on days 1-15 and oral hydroxychloroquine twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Peripheral blood and tumor tissue samples may be collected for biomarker and other laboratory studies.

After completion of study treatment, patients are followed up for 1 year.

Arms: arm 1: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one.

Drug: hydroxychloroquine hydroxychloroquine 200 mg po BID daily arm 2: Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days.

Drug: hydroxychloroquine hydroxychloroquine 200 mg po BID daily
Interventions: intervention 1: hydroxychloroquine
Intervention descriptions: intervention 1: hydroxychloroquine 200 mg po BID daily

Protocol documents:
Clinical trial NCT02468557
Conditions: Previously Untreated Pancreatic Ductal Adenocarcinoma Relapsed/Refractory Pancreatic Ductal Adenocarcinoma
Sponsor: Gilead Sciences
Start date: 2015-07-30; Completion date: 2016-04-27
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety of single agent idelalisib and to evaluate safety and define the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma.

Detailed description:

Arms: arm 1: Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks. arm 2: Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + nab-paclitaxel. arm 3: Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + mFOLFOX6.
Interventions: intervention 1: Idelalisib intervention 2: Nab-paclitaxel intervention 3: mFOLFOX6
Intervention descriptions: intervention 1: Tablets administered orally twice daily intervention 2: 125 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle intervention 3: mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m\^2) or racemic leucovorin 400 mg/m\^2, oxaliplatin 85 mg/m\^2, bolus 5-fluorouracil 400 mg/m\^2, and a 46 hour infusion of 5-fluorouracil 2, 400 mg/m\^2.

Protocol documents:
Clinical trial NCT02767271
Conditions: Tinea Pedis Tinea Cruris
Sponsor: Bausch Health Americas, Inc.
Start date: 2015-12-02; Completion date: 2016-04-27
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (\<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.

Detailed description:

Arms: arm 1: Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the ankles. arm 2: Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the groin, thighs, and abdomen.
Interventions: intervention 1: Luliconazole Cream 1%
Intervention descriptions: intervention 1: Luliconazole cream will be applied topically per schedule specified in the arms.

Protocol documents:
Clinical trial NCT02988882
Conditions: Chronic Allergic Conjunctivitis
Sponsor: Ocular Therapeutix, Inc.
Start date: 2015-06-01; Completion date: 2016-04-27
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Detailed description:

Arms: arm 1: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use arm 2: PV (placebo drug delivery vehicle)
Interventions: intervention 1: Dexamethasone intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: