ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02109042
Conditions: Osteoporosis, Postmenopausal
Sponsor: Eli Lilly and Company
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected.

This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug.

There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

Detailed description:

Arms: arm 1: Weekly SC injections of blosozumab for 6 weeks.
Interventions: intervention 1: Blosozumab
Intervention descriptions: intervention 1: Administered subcutaneously

Protocol documents:
Clinical trial NCT02109497
Conditions: Healthy Volunteers
Sponsor: Prana Biotechnology Limited
Start date: 2014-05-01; Completion date: 2014-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.

Detailed description:
This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day 1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be collected during after each dose of the study drugs, along with safety monitoring assessments.

Arms: arm 1: Single dose of caffeine 100 mg administered
Interventions: intervention 1: PBT2
Intervention descriptions: intervention 1: PBT2 250 mg administered

Protocol documents:
Clinical trial NCT02121509
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-05-01; Completion date: 2014-07-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.

Detailed description:

Arms: arm 1: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition arm 2: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition arm 3: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition arm 4: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition
Interventions: intervention 1: Linagliptin intervention 2: Linagliptin/Metformin ER FDC intervention 3: Metformin ER
Intervention descriptions: intervention 1: 1 x Linagliptin tablet intervention 2: 2 x Linagliptin/Metformin ER FDC tablet intervention 3: 3 x Metformin ER tablets

Protocol documents:
Clinical trial NCT02121860
Conditions: Hepatic Impairment Liver Diseases Digestive System Diseases
Keywords: Hepatic Impairment Pharmacokinetics Pharmacodynamics
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.

Detailed description:

Arms: arm 1: All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556 arm 2: All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556 arm 3: All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556 arm 4: All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556
Interventions: intervention 1: IDN-6556
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02135016
Conditions: Target Controlled Infusion (TCI) Thoracic Epidural Anesthesia Block Level Gastrointestinal Surgery
Keywords: effect-site concentration propofol thoracic epidural anesthesia
Sponsor: First Hospital of China Medical University
Start date: 2014-04-01; Completion date: 2014-07-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction.

Detailed description:

Arms: arm 1: epidural anesthesia with 1% lidocaine 10ml before propofol TCI arm 2: epidural anesthesia with 2% lidocaine 5ml before propofol TCI arm 3: epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Interventions: intervention 1: 1% lidocaine intervention 2: 2% lidocaine intervention 3: 0.9% normal saline
Intervention descriptions: intervention 1: epidural anesthesia with 1% lidocaine 10ml before propofol TCI intervention 2: epidural anesthesia with 2% lidocaine 5ml before propofol TCI intervention 3: epidural anesthesia with 0.9% normal saline 5ml before propofol TCI

Protocol documents:
Clinical trial NCT02159352
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2014-06-01; Completion date: 2014-07-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.

Detailed description:

Arms: arm 1: Treatment A: Daclatasvir oral tablet on specific days

Treatment B: Daclatasvir tablet and Darunavir Tablet/Ritonavir capsule orally on specific days arm 2: Treatment C: Daclatasvir oral tablet on specific days

Treatment D: Daclatasvir tablet and Lopinavir/Ritonavir tablet orally on specific days
Interventions: intervention 1: Daclatasvir intervention 2: Darunavir intervention 3: Ritonavir intervention 4: Lopinavir/Ritonavir
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02249728
Conditions: Healthy Volunteers
Sponsor: Prana Biotechnology Limited
Start date: 2014-06-01; Completion date: 2014-07-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.

Detailed description:

Arms: arm 1: IV PBT2 microtracer and oral PBT2 single dose arm 2: oral 14C PBT2
Interventions: intervention 1: IV PBT2 microtracer and oral PBT2 single dose intervention 2: oral 14C-PBT2
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02506881
Conditions: Healthy
Keywords: darbepoetin alfa pharmacokinetics pharmacodynamics healthy volunteers
Sponsor: Biocad
Start date: 2013-03-01; Completion date: 2014-07-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval of at least 25 days.

Detailed description:

Arms: arm 1: Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg. arm 2: Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg. arm 3: Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg. arm 4: Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
Interventions: intervention 1: Darbepoetin alfa
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02766244
Conditions: Burns
Sponsor: Texas Tech University Health Sciences Center
Start date: 2014-01-01; Completion date: 2014-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Three patients were recruited for assessment of ICG fluorescence in burns.

Detailed description:
The early determination of healing potential in indeterminate thickness burns may be difficult to establish by visual inspection alone, even for experienced burn practitioners. This case series explores the use of indocyanine green (ICG) fluorescence using portable bedside assessment as a potential tool for early determination of burn depth. Three subjects with indeterminate thickness burns had daily perfusion assessment using ICG fluorescence assessment using the SPY machine (SPY®, Lifecell Corp., NJ, USA) in addition to standard burn care. The fluorescence was quantified as a percentage of the perfusion of intact skin, and areas of hypo and hyper-perfusion were indicated. The burn surgeon, blinded to the ICG results, made a clinical determination of the need for skin grafting or discharge. The perfusion in areas of differing depth of burn were compared over the entire study period to determine both the magnitude of difference, and the point in the time course of healing when these changes became evident.

Arms: arm 1: Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
Interventions: intervention 1: ICG/SPY intervention 2: Antibiotic Ointment
Intervention descriptions: intervention 1: indocyanine green fluorescence imaging intervention 2: Antibiotic ointment

Protocol documents:
Clinical trial NCT01656395
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-08-23; Completion date: 2014-07-08
Enrollment: 576 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second \[FEV1\]). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; and (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12 weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in the average change from baseline in FEV1 over the last 6 weeks of the 12-week active-treatment period.

Detailed description:

Arms: arm 1: Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks arm 2: Participants receive MK-1029 30 mg tablets QD for 12 weeks arm 3: Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks arm 4: Participants will receive MK-1029 150 mg tablets QD for 12 weeks arm 5: Participants will receive Montelukast 10 mg tablets QD for 12 weeks arm 6: Participants will receive Placebo tablets QD for 12 weeks arm 7: Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD. arm 8: Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD
Interventions: intervention 1: MK-1029 intervention 2: Montelukast 10 mg intervention 3: Placebo
Intervention descriptions: intervention 1: MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization. intervention 2: Parts I-II: Participants will receive Montelukast 10 mg tablets QD intervention 3: Parts I-II: Participants will receive Placebo tablets QD

Protocol documents:
Clinical trial NCT00976911
Conditions: Ovarian Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-10-29; Completion date: 2014-07-09
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m\^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks \[q3w\]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. arm 2: Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
Interventions: intervention 1: Bevacizumab intervention 2: liposomal doxorubicin intervention 3: paclitaxel intervention 4: topotecan
Intervention descriptions: intervention 1: 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks intervention 2: 40mg/m2 iv every 4 weeks intervention 3: 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle intervention 4: 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle

Protocol documents:
Clinical trial NCT01723514
Conditions: Migraine
Keywords: Migraine
Sponsor: Amgen
Start date: 2012-11-14; Completion date: 2014-07-10
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.

Detailed description:

Arms: arm 1: Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57. arm 2: Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.
Interventions: intervention 1: Erenumab 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 NCT01697800
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-09-01; Completion date: 2014-07-14
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year survival estimates of approximately 50%, and is associated with a high rate of systemic immune impairment as well as evasion of a tumor specific immune response. Preclinical and clinical data have shown that phosphodiesterase 5 (PDE5) inhibitors (tadalafil) can be used to augment immune function in HNSCC patients through inhibition of the cancer-induced myeloid derived suppressor cells (MDSCs).

A multi site phase II, randomized, prospective, biomarker endpoint trial to determine optimum timing and design of PDE5 antitumor immunotherapy (tadalafil) in conjunction with conventional therapy for HNSCC.

40 patients with biopsy proven HNSCC will be randomized to receive tadalafil (n=25) or placebo (n=15) for at least 10-14 days before starting conventional therapy and continuing until 90 days after completion of conventional therapy. Tumor-specific T cell responses will be assessed using HNSCC cell lines, in blood collected before initiation of tadalafil/placebo and at 60 and 90 days after completion of conventional therapy. Number and function of MDSC and Treg cells will be assessed before and at 60 and 90 days after completion of conventional therapy. Prevnar 13® vaccine will be administered 10-14 days after commencing tadalafil/placebo (before conventional therapy begins) and again at 60 days after completion of conventional therapy. Vaccine-specific responses assessed at 60 and 90 days post-conventional therapy will be used to measure the ability of tadalafil to augment immune response to vaccine.

Detailed description:

Arms: arm 1: Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment arm 2: Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02246920
Conditions: Seasonal Allergic Rhinitis
Keywords: Bioequivalence Allergic Rhinitis
Sponsor: Teva Pharmaceuticals USA
Start date: 2014-03-01; Completion date: 2014-07-14
Enrollment: 1474 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be tested for superiority against a placebo nasal spray.

Detailed description:

Arms: arm 1: Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days arm 2: Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days arm 3: Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Interventions: intervention 1: Fluticasone propionate intervention 2: Flonase® intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mcg/actuation Nasal Spray intervention 2: 50 mcg/actuation Nasal Spray intervention 3: Inactive Nasal Spray

Protocol documents:
Clinical trial NCT01021748
Conditions: Locally Advanced or Metastatic Solid Tumors
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-11-23; Completion date: 2014-07-16
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the safety and tolerability of combination therapy with MK-2206 and AZD6244 (selumetinib) and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) for this drug combination in the treatment of participants with locally advanced or metastatic solid tumors. Preliminary efficacy data will also be collected.

The primary hypotheses for this study are that: 1) the Dose-limiting Toxicities (DLTs) observed in participants with locally advanced or metastatic solid tumors after administration of combination therapy with MK-2206 and AZD6244 will be dose-dependent and allow for identification of the MTD, and 2) oral administration of combination therapy with MK-2206 and AZD6244 to participants with advanced solid tumors will be generally well-tolerated.

Detailed description:

Arms: arm 1: Participants receive MK-2206 45 mg oral tablets once every other day (QOD) PLUS AZD6244 75 mg oral capsules once daily (QD) starting on Day 1 of each 28-day cycle. arm 2: Participants receive MK-2206 45 mg oral tablets QOD PLUS AZD6244 75 mg oral capsules twice daily (BID) starting on Day 1 of each 28-day cycle. arm 3: Participants receive MK-2206 90 mg oral tablets once weekly (QW) PLUS AZD6244 50 mg oral capsules BID starting on Day 1 of each 28-day cycle. arm 4: Participants receive MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules QD starting on Day 1 of each 28-day cycle. arm 5: Participants receive MK-2206 90 mg oral tablets QW PLUS AZD6244 75 mg oral capsules BID starting on Day 1 of each 28-day cycle. arm 6: Participants receive MK-2206 90 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle. arm 7: Participants receive MK-2206 90 mg oral tablets QW PLUS AZD6244 150 mg oral capsules QD starting on Day 1 of each 28-day cycle. arm 8: Participants receive MK-2206 100 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle. arm 9: Participants receive MK-2206 135 mg oral tablets QW PLUS AZD6244 100 mg oral capsules QD starting on Day 1 of each 28-day cycle.
Interventions: intervention 1: MK-2206 intervention 2: AZD6244
Intervention descriptions: intervention 1: Oral tablets intervention 2: Oral capsules

Protocol documents: