ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02378935
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2015-02-17; Completion date: 2016-04-12
Enrollment: 205 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) arm 2: VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis) arm 3: VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) arm 4: VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) arm 5: VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis) arm 6: VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis) arm 7: VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis) arm 8: GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis) arm 9: GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis) arm 10: VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
Interventions: intervention 1: VOX intervention 2: SOF/VEL intervention 3: RBV
Intervention descriptions: intervention 1: 100 mg tablet(s) administered orally once daily with food intervention 2: 400/100 mg FDC tablet administered orally once daily with food intervention 3: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01416181
Conditions: Secondary Progressive Multiple Sclerosis
Keywords: Natalizumab secondary multiple sclerosis MS SPMS Tysabri
Sponsor: Biogen
Start date: 2011-09-13; Completion date: 2016-04-13
Enrollment: 889 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.

Detailed description:

Arms: arm 1: In Part 1 participants were randomized to receive 300 mg of natalizumab intravenously (IV) every 4 weeks for 96 weeks. In Part 2 participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks. arm 2: In Part 1 participants were randomized to receive placebo IV every 4 weeks for 96 weeks. In Part 2 participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
Interventions: intervention 1: natalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as specified in the treatment arm intervention 2: Matched placebo in part 1

Protocol documents:
Clinical trial NCT02024932
Conditions: Spinal and Bulbar Muscular Atrophy
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-04; Completion date: 2016-04-13
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).

Detailed description:

Arms: arm 1: Participants received single doses of 0.01 mg/kg BVS857 intravenously (i.v.) on day 1, 0.01 mg/kg BVS857 subcutaneously (s.c.) on day 15, 0.03 mg/kg BVS857 s.c. on day 29, 0.06 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. arm 2: Participants received single doses of 0.03 mg/kg BVS857 i.v on day 1, 0.03 mg/kg BVS857 s.c. on day 15, 0.06 mg/kg BVS857 s.c. on day 29, 0.10 mg/kg BVS857 s.c. on day 43 and 0.10 mg/kg BVS857 s.c. on day 57. (BVS857 concentrations differed on days 43 and 57.) arm 3: Participants received single doses of matching placebo i.v. on day 1 and matching placebo s.c. on days 15, 29, 43 and 57. arm 4: Participants received 0.1 mg/kg BVS857 i.v. weekly for 12 weeks. arm 5: Participants received 0.06 mg/kg (maximum 6 mg) BVS857 i.v. weekly for 12 weeks. arm 6: Participants received matching placebo i.v. to BVS857 weekly for 12 weeks.
Interventions: intervention 1: BVS857 intervention 2: Placebo
Intervention descriptions: intervention 1: BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c.. intervention 2: Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..

Protocol documents:
Clinical trial NCT02653872
Conditions: Healthy Subjects
Keywords: Non-randomized Verapamil Itraconazole Diltiazem Safety Tolerability Pharmacokinetics
Sponsor: AstraZeneca
Start date: 2016-01-22; Completion date: 2016-04-13
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 1, non-randomized, fixed sequence, 3-period, drug-drug interaction study to assess the pharmacokinetics (PK) of AZD7986 in healthy subjects when administered alone and in combination with multiple doses of verapamil and itraconazole or diltiazem

Detailed description:
This study will be an open-label, non-randomised, fixed sequence, 3-period study conducted at a single study centre to assess the PK of AZD7986 in healthy subjects when administered alone and in combination with multiple doses of verapamil and itraconazole or diltiazem. An adaptive design with an interim analysis of the PK data from Periods 1 and 2 will be used to determine which of itraconazole or diltiazem will be administered in combination with AZD7986 in Period 3.

Treatments to be administered in a fixed order separated by a washout period:

period 1 - single AZD7986 (25 mg) on Day 1 (1 hour before food), washout 7 days period 2 - verapamil (240 mg extended release formulation) daily 1 hour before food (Day 1 to 10) and a single dose of AZD7986 (25 mg) 1 hour before food (Day 5), washout period 14 days period 3 - subject to interim pharmacokinetic analysis of AZD7986 alone compared with AZD7986 and verapamil combined, either itraconazole (200 mg, oral solution formulation 10mg/mL) administered twice on Day 1 and daily on days 2 to 11 (1 hour before food) plus AZD7986 (25mg) single dose on Day 6 (1 hour before food); or diltiazem (360 mg, extended release formulation) on Days 1 to 13 (1 hour before food) plus AZD7986 (25 mg) 1 hour before food on Day 8.

Arms: arm 1: AZD7986 (15 mg/mL) 25 mg dosage administered alone arm 2: Daily administration of verapamil (240 mg, extended release formulation) on Days 1 to 10 plus administration of single dose AZD7986 (25 mg) on Day 5 arm 3: Itraconazole (200 mg, oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily Days 2 to 11 plus single dose AZD7986 (25 mg, tbc) on Day 6 arm 4: Diltiazem (360 mg, extended release formulation) administered Days 1 to 13 plus single dose AZD7986 (25 mg) on Day 8
Interventions: intervention 1: AZD7986 intervention 2: Verapamil intervention 3: Itraconazole intervention 4: Diltiazem
Intervention descriptions: intervention 1: Oral solution, single dose, dilution from concentrate intervention 2: Extended release tablet for oral use intervention 3: Oral solution intervention 4: Extended release capsule

Protocol documents:
Clinical trial NCT02343159
Conditions: Multiple Sclerosis
Sponsor: Biogen
Start date: 2015-02-28; Completion date: 2016-04-15
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD reader (a "standard" cap) and no patient counseling intervention (standard of care, Arm 1) at Month 12.

The secondary objectives of this study in this study population are: to determine if data display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the addition of patient counseling intervention based on MEMS data (Arm 3), or data display from a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6 and 12 for all arms; to assess the association between adherence and patient- reported outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.

Detailed description:

Arms: arm 1: A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study. arm 2: A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study. arm 3: A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
Interventions: intervention 1: dimethyl fumarate intervention 2: Medication Event Monitoring System (MEMS) intervention 3: Adherence counseling
Intervention descriptions: intervention 1: 120 mg and 240 mg delayed release capsules intervention 2: The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container intervention 3: A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)

Protocol documents:
Clinical trial NCT01760954
Conditions: Endometriosis
Keywords: Endometriosis associated pain Elagolix Gonadotropin-Releasing Hormone Antagonist Dysmenorrhea (DYS) Non-Menstrual Pelvic Pain (NMPP)
Sponsor: AbbVie
Start date: 2012-12-28; Completion date: 2016-04-15
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.

Detailed description:
This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.

Arms: arm 1: Participants received elagolix 150 mg tablets once a day (QD) for 6 months. arm 2: Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.
Interventions: intervention 1: Elagolix
Intervention descriptions: intervention 1: Elagolix tablets administered orally

Protocol documents:
Clinical trial NCT02645253
Conditions: Asthma Chronic Obstructive Pulmonary Disease COPD
Keywords: Safety Pharmacokinetics Pharmacodynamics Glucocorticoid receptor modulator Healthy male subjects
Sponsor: AstraZeneca
Start date: 2016-01-12; Completion date: 2016-04-17
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)

Detailed description:
This is a phase I, randomized, single-blind, placebo controlled, sequential-group design study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594 after single and multiple ascending doses given once daily by inhalation in healthy male Japanese subjects, compared with placebo

Arms: arm 1: AZD7594 inhalation powder (200 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) arm 2: AZD7594 inhalation powder (400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) arm 3: 1600 μg AZD7594 inhalation powder (4 x 400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) arm 4: 400 μg AZD7594 pressurized inhalation suspension (2 x 200 μg inhalations) or placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)
Interventions: intervention 1: AZD7594 inhalation powder (200 μg) intervention 2: AZD7594 inhalation powder (400 μg) intervention 3: AZD7594 pressurized inhalation suspension (200 μg) intervention 4: AZD7594 placebo inhalation powder intervention 5: AZD7594 placebo pressurized inhalation suspension
Intervention descriptions: intervention 1: 200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI) intervention 2: Cohort 2: 400 μg AZD7594 inhalation powder via multi-dose DPI Cohort 3: 1600 μg (4 x 400 μg inhalations) AZD7594 inhalation powder via multi-dose DPI intervention 3: 400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI) intervention 4: AZD7594 placebo inhalation powder via multi-dose DPI intervention 5: AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

Protocol documents:
Clinical trial NCT01835158
Conditions: Clear Cell Renal Cell Carcinoma Metastatic Kidney Carcinoma Stage III Renal Cell Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7
Sponsor: National Cancer Institute (NCI)
Start date: 2013-07-08; Completion date: 2016-04-18
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine if patients with renal cancer treated with cabozantinib (cabozantinib-s-malate) will have improved progression-free survival compared to patients treated with sunitinib (sunitinib malate).

SECONDARY OBJECTIVES:

I. To determine whether the response rate of patients with renal cancer treated with cabozantinib will be higher when compared with patients treated with sunitinib.

II. To determine whether patients with renal cancer treated with cabozantinib will have an improved overall survival when compared with patients treated with sunitinib.

TERTIARY OBJECTIVES:

I. To determine whether renal cancer patients with high MET expression by immunohistochemistry (IHC) have improvement in progression-free survival compared to patients with low MET expression on both arms of this study.

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

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Arms: arm 1: Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cabozantinib S-malate intervention 2: Laboratory Biomarker Analysis intervention 3: Sunitinib Malate
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT02066402
Conditions: Bacterial Infections
Sponsor: Bayer
Start date: 2014-03-04; Completion date: 2016-04-18
Enrollment: 598 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.

Detailed description:
Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.

ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid

Arms: arm 1: Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo. arm 2: Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days.
Interventions: intervention 1: Tedizolid (BAY119-2631) intervention 2: Placebo Tedizolid (BAY119-2631) intervention 3: Linezolid intervention 4: Placebo Linezolid
Intervention descriptions: intervention 1: 50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days intervention 2: 50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days intervention 3: 50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days intervention 4: 50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days

Protocol documents:
Clinical trial NCT02301936
Conditions: Hepatitis C Virus Infection
Keywords: Sickle Cell Disease Gilead Hepatitis C
Sponsor: Gilead Sciences
Start date: 2015-03-02; Completion date: 2016-04-18
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).

Detailed description:

Arms: arm 1: Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks. arm 2: Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: 90/400 mg fixed dose combination (FDC) tablet administered orally once daily

Protocol documents:
Clinical trial NCT02290873
Conditions: Colonoscopy
Sponsor: Paion UK Ltd.
Start date: 2015-03-30; Completion date: 2016-04-19
Enrollment: 461 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.

Detailed description:

Arms: arm 1: Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses arm 2: Inactive control arm

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses arm 3: Midazolam iv 1.75 mg\* for sedation induction and 1.0 mg\* for sedation maintenance.

\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
Interventions: intervention 1: Remimazolam intervention 2: Midazolam intervention 3: Placebo
Intervention descriptions: intervention 1: For induction and maintenance of sedation intervention 2: For induction of maintenance and sedation intervention 3: Inactive control arm

Protocol documents: