ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02251717
Conditions: Hepatitis C Virus Infection
Keywords: renal transplant
Sponsor: Gilead Sciences
Start date: 2014-10-14; Completion date: 2016-06-16
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

Detailed description:

Arms: arm 1: Participants will receive LDV/SOF FDC for 12 weeks. arm 2: Participants will receive LDV/SOF FDC for 24 weeks.
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily

Protocol documents:
Clinical trial NCT01585766
Conditions: Multiple Sclerosis, Relapsing Forms
Keywords: MAb, B cell, depletion, RMS
Sponsor: MedImmune LLC
Start date: 2012-04-24; Completion date: 2016-06-20
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).

Detailed description:
This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.

Arms: arm 1: Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. arm 2: Participants received SC injection of 60 mg MEDI-551 on Day 1. arm 3: Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. arm 4: Participants received SC injection of 300 mg MEDI-551 on Day 1. arm 5: Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. arm 6: Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1.
Interventions: intervention 1: MEDI-551 30 MG-IV intervention 2: MEDI-551 60 MG-SC intervention 3: PLACEBO-IV-SC intervention 4: MEDI-551 100 MG-IV intervention 5: MEDI-551 300 MG-SC intervention 6: MEDI-551 600 MG-IV
Intervention descriptions: intervention 1: Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. intervention 2: Participants received SC injection of 60 mg MEDI-551 on Day 1. intervention 3: Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1 intervention 4: Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. intervention 5: Participants received SC injection of 300 mg MEDI-551 on Day 1. intervention 6: Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.

Protocol documents:
Clinical trial NCT00323063
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer male breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2006-05-01; Completion date: 2016-06-20
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared to gemcitabine alone in treating patients with previously treated locally advanced or metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare time to progression in patients with previously treated locally advanced or metastatic breast cancer treated with gemcitabine hydrochloride with vs without imatinib mesylate.

Secondary

* Compare the efficacy of these regimens in these patients.
* Compare the overall survival of patients treated with these regimens.
* Compare the safety and tolerability of these regimens in these patients.

OUTLINE: This is a multicenter, open-label, randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
* Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.

In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Arms: arm 1: Patients receive gemcitabine hydrochloride IV on days 3 and 10. arm 2: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
Interventions: intervention 1: gemcitabine hydrochloride intervention 2: imatinib mesylate
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally

Protocol documents:
Clinical trial NCT01183780
Conditions: Colorectal Cancer
Keywords: second line metastatic colorectal cancer FOLFIRI ramucirumab CRC mCRC
Sponsor: Eli Lilly and Company
Start date: 2010-12-02; Completion date: 2016-06-20
Enrollment: 1072 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ramucirumab intervention 2: Placebo intervention 3: Irinotecan intervention 4: Folinic Acid intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: 8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 2: Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 3: 180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 4: 400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 5: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Protocol documents:
Clinical trial NCT02119650
Conditions: NSCLC (Non-small Cell Lung Carcinoma)
Keywords: Non small cell lung cancer
Sponsor: Incyte Corporation
Start date: 2014-02-11; Completion date: 2016-06-21
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.

Detailed description:
The study consisted of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 participants each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in participants with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Participants in the safety run-in received open-label ruxolitinib and pemetrexed and cisplatin.

In the second part of the study, participants enrolled and randomized and received pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered was determined from the data produced in the safety run-in phase.

Treatment consisted of repeating 21-day cycles. Participants received infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo was self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, was allowed for participants eligible for maintenance therapy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ruxolitinib intervention 2: Placebo intervention 3: Pemetrexed intervention 4: Cisplatin
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID)) intervention 2: 5 mg matching placebo tablets to be administered by mouth intervention 3: 500 mg/m\^2 administered as an intravenous infusion over 10 minutes intervention 4: 75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion

Protocol documents:
Clinical trial NCT02446015
Conditions: Dry Eye Syndrome
Sponsor: Alcon Research
Start date: 2015-06-19; Completion date: 2016-06-21
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

Detailed description:
This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Arms: arm 1: SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days arm 2: SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
Interventions: intervention 1: SYSTANE® ULTRA Lubricant Eye Drops
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02483975
Conditions: Asthma
Keywords: Fluticasone Furoate Asthma HPA axis Children Inhaled corticosteroid
Sponsor: GlaxoSmithKline
Start date: 2015-10-09; Completion date: 2016-06-21
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Inhaled corticosteroids (ICS) have a number of known class effects including hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been established, it is important to assess the risk of suppression in children so as to establish whether this medicine can be safely used in this young population. This study aims to evaluate the effect of inhaled FF on the HPA axis of children 5-11 years of age (inclusive) with persistent asthma compared with placebo. Approximately 143 subjects will be enrolled. Subjects will enter a 7 to 14 day run-in period on oral montelukast 4 milligrams (mg) (5 year old subjects) or 5 mg (6-11 year old subjects) once daily. Eligible subjects will be randomized to receive once-daily FF inhalation powder 50 micrograms (mcg) or once-daily placebo inhalation powder in the morning via the ELLIPTA™ inhaler for 42 days. Subjects will continue to receive open label montelukast during the treatment period. All subjects will be provided albuterol/salbutamol inhalation aerosol, to use as needed to treat acute asthma symptoms throughout the study.

ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.

Detailed description:

Arms: arm 1: Subjects will receive by oral inhalation FF 50 mcg once daily in the morning via ELLIPTA for 42 days. Subjects will continue to receive oral montelukast once daily in the evening and may use albuterol/salbutamol inhalation aerosol as needed. arm 2: Subjects will receive by oral inhalation placebo once daily in the morning via ELLIPTA for 42 days. Subjects will continue to receive oral montelukast once daily in the evening and may use albuterol/salbutamol inhalation aerosol as needed.
Interventions: intervention 1: FF intervention 2: Placebo intervention 3: Montelukast intervention 4: Albuterol/Salbutamol
Intervention descriptions: intervention 1: FF will be provided as a dry powder inhaler with 30 doses per device, each containing 50 mcg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA. intervention 2: Placebo will be provided as dry powder inhaler with 30 doses per device, each containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA. intervention 3: Montelukast will be provided as 4 mg and 5 mg chewable tablets. intervention 4: Albuterol/Salbutamol will be provided as inhalation aerosol.

Protocol documents:
Clinical trial NCT02480712
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2015-07-01; Completion date: 2016-06-22
Enrollment: 107 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

Detailed description:

Arms: arm 1: Participants will receive SOF/VEL for 12 weeks
Interventions: intervention 1: SOF/VEL
Intervention descriptions: intervention 1: 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily

Protocol documents:
Clinical trial NCT02594644
Conditions: Keratosis, Actinic
Sponsor: University of California, Davis
Start date: 2014-11-06; Completion date: 2016-06-22
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Detailed description:
The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Arms: arm 1: 10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. arm 2: 20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Interventions: intervention 1: Microneedle Roller intervention 2: Aminolevulinic Acid intervention 3: Blue Light
Intervention descriptions: intervention 1: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length. intervention 2: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA intervention 3: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Protocol documents:
Clinical trial NCT02604160
Conditions: Chronic Kidney Disease
Sponsor: Eli Lilly and Company
Start date: 2015-11-17; Completion date: 2016-06-22
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593.

The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body.

The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.

Detailed description:

Arms: arm 1: Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A. arm 2: 0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.
Interventions: intervention 1: LY3113593 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by slow intravenous (IV) infusion. intervention 2: Administered by slow intravenous (IV) infusion.

Protocol documents:
Clinical trial NCT02614547
Conditions: Severe Postpartum Depression
Sponsor: Sage Therapeutics
Start date: 2015-12-15; Completion date: 2016-06-22
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.

Detailed description:

Arms: arm 1: Participants received infusion rates of placebo matched to SAGE-547. arm 2: Participants received a 4-hour dose titration of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Interventions: intervention 1: SAGE-547 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as intravenous infusion. intervention 2: Administered as intravenous infusion.

Protocol documents:
Clinical trial NCT02138838
Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric
Sponsor: Amgen
Start date: 2014-11-07; Completion date: 2016-06-23
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

Detailed description:
This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to \< 12 and 12 to \< 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.

Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.

Arms: arm 1: Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. arm 2: In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Interventions: intervention 1: Cinacalcet HCl intervention 2: Standard of Care
Intervention descriptions: intervention 1: Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets. intervention 2: Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Protocol documents:
Clinical trial NCT01649271
Conditions: Breast Neoplasms Stomach Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2012-07-23; Completion date: 2016-06-23
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.

Detailed description:

Arms: arm 1: afatinib escalating dose with 3-weekly trastuzumab arm 2: afatinib at MTD dose with weekly trastuzumab arm 3: afatinib at MTD level with 3-weekly trastuzumab
Interventions: intervention 1: Herceptin intervention 2: afatinib intervention 3: trastuzumab intervention 4: Herceptin intervention 5: afatinib intervention 6: afatinib
Intervention descriptions: intervention 1: 3-weekly intervention 2: at MTD level intervention 3: 3-weekly intervention 4: weekly intervention 5: at MTD level intervention 6: escalating dose

Protocol documents: