ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02203331
Conditions: Endometriosis
Sponsor: Bayer
Start date: 2014-10-16; Completion date: 2016-10-24
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain

Detailed description:

Arms: arm 1: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection arm 2: Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection arm 3: Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection arm 4: Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection arm 5: Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection arm 6: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Interventions: intervention 1: Placebo intervention 2: Levonorgestrel intervention 3: Anastrozole intervention 4: Lupron / Leuprolide acetate
Intervention descriptions: intervention 1: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection intervention 2: Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection intervention 3: Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection intervention 4: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection

Protocol documents:
Clinical trial NCT02679729
Conditions: Cystic Fibrosis
Keywords: inhaled dose intravenous dose healthy subjects safety tolerability pharmacokinetics AZD5634 jet nebulizer
Sponsor: AstraZeneca
Start date: 2016-02-11; Completion date: 2016-10-24
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects

Detailed description:
This study is a Phase I, FIH, randomized, single-blinded (study center staff remain blinded during the dosing phase of the study), placebo-controlled, single ascending dose, sequential dose group study in healthy male subjects and/or female subjects of non-childbearing potential at a single study center to assess AZD5634 following inhaled and intravenous dose administration

Arms: arm 1: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 2: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 3: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 4: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 5: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 6: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 7: Subjects will inhale single doses of AZD5634 or placebo under fasted conditions and will rinse his/her mouth with approximately 100 mL (up to 240 mL) of water which must be swallowed arm 8: Subjects will receive a single dose of IV AZD5634 and after a washout period of 14 days the same subjects will receive a single dose of inhaled AZD5634
Interventions: intervention 1: AZD5634 for inhalation intervention 2: AZD5634 for infusion intervention 3: Placebo
Intervention descriptions: intervention 1: Solution, citrate buffer, saline nebulizer solution; strength 0.1 - 5 mg/g; administered by jet nebulizer intervention 2: Solution, citrate buffer, saline solution for infusion; strength 0.013 mg/mL intervention 3: inactive substance

Protocol documents:
Clinical trial NCT03447353
Conditions: Driving Behavior
Keywords: driving Xanax Norco simulation
Sponsor: Timothy L. Brown
Start date: 2016-06-14; Completion date: 2016-10-25
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies.

This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.

Detailed description:
This study uses EEG, EKG, computerized assessment, blood sampling, and driving simulation.

Individuals recruited will be normal, healthy individuals not currently taking the study drugs. The study will involve five visits, a screening visit as well as four dosing visits. The dosing visits will have a clean (double placebo) and three drugged visits (Xanax and Norco placebo, Xanax placebo and Norco, Xanax and Norco). The screening visit will last about two hours and will include drug and pregnancy testing as well as screening for physical/psychological health. Each of the dosing visits will last approximately five to six hours and will include sleep and food intake surveys, being dosed with study drugs or placebos, AMP assessments, a simulator drive, and wellness surveys. There will also be 4 mL blood sampling before dosing, before driving, and after driving.

Arms: arm 1: Subject receives two tablets, both containing placebo arm 2: Subject receives two tablets, one containing Xanax and one containing Norco arm 3: Subject receives two tablets, one containing Xanax and one containing placebo arm 4: Subject receives two tablets, one containing Norco and one containing placebo
Interventions: intervention 1: Xanax 1Mg Tablet intervention 2: Norco 10Mg-325Mg Tablet intervention 3: Placebo Oral Tablet
Intervention descriptions: intervention 1: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco intervention 2: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam intervention 3: Single dose on two of the four study visits, double dose on one of the four study visits

Protocol documents:
Clinical trial NCT02071082
Conditions: HIV HBV
Keywords: HIV HBV Coinfection
Sponsor: Gilead Sciences
Start date: 2014-02-25; Completion date: 2016-10-26
Enrollment: 79 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults.

Participants will be enrolled into two cohorts:

* Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive
* Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed

Detailed description:

Arms: arm 1: HIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks. arm 2: HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
Interventions: intervention 1: E/C/F/TAF
Intervention descriptions: intervention 1: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Protocol documents:
Clinical trial NCT02678923
Conditions: Acute Coronary Syndrome
Sponsor: The Medicines Company
Start date: 2015-12-03; Completion date: 2016-10-26
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be a proof-of-concept, placebo-controlled, double-blind, randomized trial in participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy, pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5 infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.

Detailed description:

Arms: arm 1: 20 mg/kg of MDCO-216 administered intravenously (IV) as a 360 milliliter (mL) infusion over 2 hours on Days 1, 8, 15, 22, and 29 arm 2: 360 mL of placebo (0.9% sodium chloride \[NaCl\] solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29
Interventions: intervention 1: MDCO-216 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01172938
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis Psoriasis Arthritis inflammation skin condition inflammatory cells apremilast CC-10004 phosphodiesterase type 4
Sponsor: Amgen
Start date: 2010-06-02; Completion date: 2016-10-27
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Detailed description:
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Arms: arm 1: 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase arm 2: 30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily arm 3: Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16 arm 4: Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.
Interventions: intervention 1: Apremilast 20mg intervention 2: Apremilast 30mg intervention 3: Placebo + 20 mg Apremilast intervention 4: Placebo + 30 mg Apremilast
Intervention descriptions: intervention 1: Apremilast 20 mg twice daily, orally intervention 2: Apremilast 30 mg twice daily, orally intervention 3: Placebo + 20 mg Apremilast intervention 4: Placebo + 30 mg Apremilast

Protocol documents:
Clinical trial NCT01553058
Conditions: Psoriasis Cardiovascular Disease
Keywords: Psoriasis Cardiovascular Disease FDG/PET-CT NB-UVB Phototherapy Vascular Inflammation Lipid Biomarkers
Sponsor: University of Pennsylvania
Start date: 2012-07-01; Completion date: 2016-10-27
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis.

This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.

This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis.

Detailed description:

Arms: arm 1: Injection of the active drug Humira. arm 2: Injection of placebo in place of active Humira injection. arm 3: NB-UVB Phototherapy 3 times per week, no other intervention.
Interventions: intervention 1: Adalimumab (Humira) intervention 2: Placebo Injection intervention 3: NB-UVB phototherapy
Intervention descriptions: intervention 1: Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule. intervention 2: Placebo injection will be given according to the same dose and schedule as the active comparator. intervention 3: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.

Protocol documents:
Clinical trial NCT01636687
Conditions: Plaque-type Psoriasis
Keywords: Psoriasis Moderate to Severe Plaque-type Psoriasis Skin condition skin disease itching condition psoriasis vulgaris relapsing/remitting psoriasis immune-mediated systemic disease skin lesions red skin lesions scaly patches papules plaques itching
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-17; Completion date: 2016-10-27
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Detailed description:

Arms: arm 1: Subjects who were in placebo at Week 52 cannot continue in the extension treatment period arm 2: After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period. arm 3: After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.
Interventions: intervention 1: Placebo intervention 2: Secukinumab 150mg intervention 3: Secukinumab 300mg
Intervention descriptions: intervention 1: 2 injections of placebo to secukinumab 150mg per dose intervention 2: Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered intervention 3: Secukinumab 300mg (2 injections of 150mg secukinumab per dose)

Protocol documents:
Clinical trial NCT01866592
Conditions: Psoriasis Cardiovascular Disease
Keywords: Psoriasis Cardiovascular Disease Vascular Inflammation Lipid Biomarkers Metabolic biomarkers FDG-PET/CT
Sponsor: University of Pennsylvania
Start date: 2013-04-01; Completion date: 2016-10-27
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.

Detailed description:

Arms: arm 1: Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.
Interventions: intervention 1: Adalimumab
Intervention descriptions: intervention 1: Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Protocol documents:
Clinical trial NCT01979952
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2013-11-26; Completion date: 2016-10-27
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.

Detailed description:

Arms: arm 1: 150 mg twice daily arm 2: twice daily dosing
Interventions: intervention 1: Matching Placebo intervention 2: Nintedanib
Intervention descriptions: intervention 1: twice daily dosing intervention 2: gelating capsule

Protocol documents:
Clinical trial NCT02035553
Conditions: Alzheimer's Disease Psychosis
Sponsor: ACADIA Pharmaceuticals Inc.
Start date: 2013-11-01; Completion date: 2016-10-27
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with Alzheimer's disease psychosis.

Detailed description:

Arms: arm 1: Placebo, two tablets, once daily by mouth arm 2: Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
Interventions: intervention 1: Pimavanserin tartrate intervention 2: Placebo
Intervention descriptions: intervention 1: Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin) intervention 2: Placebo, two tablets, once daily by mouth

Protocol documents:
Clinical trial NCT02277093
Conditions: Colorectal Cancer
Sponsor: Washington University School of Medicine
Start date: 2015-09-22; Completion date: 2016-10-27
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators propose to assess the efficacy, progression-free survival, and adverse events of pacritinib in patients with refractory colorectal cancer.

Detailed description:

Arms: arm 1: * Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)
* Pacritinib should be take at approximately the same times every day with a glass of water, with or without food
Interventions: intervention 1: Pacritinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02287818
Conditions: Gout
Sponsor: TWi Biotechnology, Inc.
Start date: 2014-12-01; Completion date: 2016-10-27
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.

Detailed description:
AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism of action of AC-201 includes the inhibition of the production and activity of caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in the kidney. The goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key role in mediating this inflammatory response.

Arms: arm 1: Placebo plus Febuxostat arm 2: AC-201 CR tablet plus Febuxostat
Interventions: intervention 1: Placebo intervention 2: AC-201 intervention 3: Febuxostat
Intervention descriptions: intervention 1: Placebo twice daily from Day 1 to Week 12 intervention 2: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12 intervention 3: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL

Protocol documents: