louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01270594: A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
Official title: A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: William S. Middleton Memorial Veterans Hospital
name: American Society of Health-System Pharmacists
First posted: 2011-01-05
Enrollment: 97
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler adherence in veterans with COPD who have demonstrated poor inhaler adherence through pharmacy refill records?

Veterans who receive who receive daily maintenance inhalers from the William S Middleton Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80% over the previous six months will be invited to participate in the study. This study will randomize 100 participants to a usual care arm or a pharmacist counseling intervention. Final data collection will be six months after randomization to determine if both self-reported and refill record adherence has changed.


Eligibility criteria: Inclusion Criteria:

* Male and female veterans established with the William S. Middleton Memorial Veterans Hospital and associated Community Based Outpatient Clinics
* Fill their inhaled COPD medications with the VHA
* A diagnosis of COPD and an active prescription for a twice daily long-acting beta-agonist and/or long-acting anticholinergic with or without a prescription for inhaled corticosteroids for at least 4 months.
* Non-adherence to at least one COPD medication, a medication possession ratio of less than 80% or over 120% via the pharmacy refill records.

Exclusion Criteria:

* Patients with a diagnosis or electronic medical record note regarding significant hearing impairment.
* Patients with a diagnosis regarding cognitive deficit and activated power of attorney.
* Patients who use daily nebulization instead of inhalers for maintenance medication.

Primary outcomes:
measure: Adherence to daily inhaled COPD medications
timeFrame: Previous six months
Secondary outcomes:
measure: COPD exacerbations
timeFrame: Previous six months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW-Madison School of Pharmacy
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital
name: Arthur Schuna, RPh MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02392494: Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Official title: A Single Rising Dose Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MK-1075 in HCV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.

Detailed description: Per protocol, panels may be omitted if the objectives of the study are met in preceding panels.

Eligibility criteria: Inclusion Criteria:

* Male or female of non-child bearing potential
* In good health other than HCV genotype (GT) 1 infection

Exclusion Criteria:

* Is mentally incapacitated or legally institutionalized
* Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer
* Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)
* Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening
* Consumes \>2 alcoholic beverages a day or uses illegal drugs
* Has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
* Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy

Primary outcomes:
measure: Percentage of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to Study Day 14
measure: Percentage of Participants Who Discontinued Study Due to an AE
timeFrame: Up to Study Day 14
measure: Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075
timeFrame: Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01764594: Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Official title: A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Diseases
Autoimmune Diseases
Lupus Erythematosus, Systemic
Skin and Connective Tissue Diseases
Connective Tissue Disease
Keywords: Lupus
SLE
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2013-01-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.


Eligibility criteria: Inclusion Criteria:

* Patients with Systemic Lupus Erythematosus (SLE)

Exclusion Criteria:

* Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE)
* History of chronic, recurrent, or recent severe infection
* Significant hematologic abnormalities
* History of cancer, heart failure, renal disease, liver disease or other serious illness

Primary outcomes:
measure: Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
timeFrame: 0 - 28 Weeks
measure: Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study
timeFrame: 0 - 28 Weeks
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 0 - 28 Weeks
measure: Predose plasma concentration (Ctrough)
timeFrame: 0 - 28 Weeks
measure: Area under the concentration-time curve over the dosing interval (AUCτ)
timeFrame: 0 - 28 Weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: 102
city: Leuven
country: Belgium
facility: 101
city: Plovidv
country: Bulgaria
facility: 203
city: Sofia
country: Bulgaria
facility: 201
city: Sofia
country: Bulgaria
facility: 202
city: Berlin
country: Germany
facility: 301
city: Erlangen
country: Germany
facility: 303
city: Frankfurt
country: Germany
facility: 305
city: Greifswald
country: Germany
facility: 306
city: Hannover
country: Germany
facility: 304
city: Kiel
country: Germany
facility: 302
city: Krakow
country: Poland
facility: 501
city: Wroclaw
country: Poland
facility: 503
city: Bucharest
country: Romania
facility: 601
city: Cluj
country: Romania
facility: 602
city: Moscow
country: Russian Federation
facility: 701
city: Yaroslavl
country: Russian Federation
facility: 702
city: Hospitalet Del Llobregat
country: Spain
facility: 401
city: Santiago de Compostela
country: Spain
facility: 402
city: Sevilla
country: Spain
facility: 404
city: Sevilla
country: Spain
facility: 405
Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00385294: Role of B2 Adrenergic Receptors in Labor Pain
Official title: Role of B2 Adrenergic Receptors in Labor Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Pain Threshold
Labour Pain
Keywords: Genetic
pain
obstetrical
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2006-10-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nuliparous women anticipating NSVD

Brief summary: The study aims to understand why labor is more painful for some women compared to others. The study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child.

Detailed description: Other than parity, and infant size, the etiology of the great variability in labor pain us unknown. Previous studies have demonstrated that baseline pain sensitivity is related to postoperative pain and narcotic requirement. We hypothesize that baseline pain sensitivity is related to pain in labor. The study will determine baseline sensitivity to heat, cold and pressure as measurement of pain sensitivity. Furthermore, b2 adrenergic genotype has recently been identified as a potential determinant of pain sensitivity. The investigators will determine whether B2 receptor haplotype is an independent predictor of pain experienced in labor.

Eligibility criteria: Inclusion Criteria:

* nulliparous women
* Third trimester of pregnancy on enrollment

Exclusion Criteria:

* Chronic Pain
* Pain medication utilization
* Large for gestational age baby
* Small for gestational age baby
* Systemic illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Pamela D. Flood, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liang DY, Liao G, Wang J, Usuka J, Guo Y, Peltz G, Clark JD. A genetic analysis of opioid-induced hyperalgesia in mice. Anesthesiology. 2006 May;104(5):1054-62. doi: 10.1097/00000542-200605000-00023.
citation: Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.
Clinical trial NCT05088694: The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.
Official title: The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Norm, Social
Literacy
Resistance Skills
Beliefs About Consequences
Decision Making Skills
Empathy
Tolerance
Open Mindedness
Active Citizenship
Anti-extremism
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Researcher from UNC Greensboro have partnered with Prevention Strategies and key stakeholders from the Kingdom of Bahrain to conduct a study using the innovative, engineering-inspired methodological approach, the Multiphase Optimization Strategy (MOST), to optimize and evaluate the Peaceful Coexistence and Anti-Extremism middle and high school curricula. No other curriculum targeting tolerance and/or extremism has been optimized using the state-of-the-art MOST methodology. The overall goal of the project is that the optimized versions of Peaceful Coexistence and Anti-Extremism curricula will be used across the Kingdom of Bahrain and translated for use in other countries to combat the spread of extremism and intolerance. Additionally, the D.A.R.E. keepin' it REAL (kiR) and D.A.R.E. myPlaybook high school programs will be evaluated as part of the Peaceful Coexistence and Anti-Extremism evaluation.


Eligibility criteria: Inclusion Criteria:

* Public or private Bahraini middle or high school students.
* In addition to the main evaluation questions, the following groups will also be included to make programmatic improvements.
* Parents of above mentioned middle or high school students.
* D.A.R.E. Officers teaching middle school and high school D.A.R.E. in Bahrain.

Exclusion Criteria:

* None

Primary outcomes:
measure: Norms about intolerance
timeFrame: immediately post intervention
measure: Dignity
timeFrame: immediately post intervention
measure: Plurality
timeFrame: immediately post intervention
measure: Beliefs about consequences
timeFrame: immediately post intervention
measure: Source literacy
timeFrame: immediately post intervention
measure: Resistance skills
timeFrame: immediately post intervention
measure: Decision making
timeFrame: immediately post intervention
measure: Empathy
timeFrame: immediately post intervention
measure: Tolerance of different opinions and behaviors of others
timeFrame: immediately post intervention
measure: Open Mindedness to differing opinions
timeFrame: immediately post intervention
measure: Non-Violent Conflict Resolution
timeFrame: immediately post intervention
measure: Community values
timeFrame: immediately post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: UNC Greensboro
state: North Carolina
Study officials:
References:
Clinical trial NCT06785194: Revive Toric RWE Study
Official title: Samfilcon B Custom Toric Lens Real-World Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2025-01-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population at study site locations

Brief summary: This is a post-market observational clinical investigation. The objective of this observational study is to evaluate the visual performance and HCP satisfaction of REVIVE samfilcon B custom toric contact lenses.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the ICF is signed
2. Have the capacity to read, understand, and provide written voluntary informed consent
3. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
4. Have no active ocular disease or allergic conjunctivitis
5. Not be using any topical ocular medications
6. Be willing and able to follow instructions
7. Have signed a statement of informed consent
8. Be an experienced soft contact lens wearer (have previously used soft contact lenses)
9. Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device

Exclusion Criteria:

1. Is participating in another research study
2. Is considered by the Investigator to not be a suitable candidate for participation
3. Is not eligible for treatment with the study lens per the IFU (contraindicated)
4. Has had previous ocular surgery
5. Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance

Primary outcomes:
measure: Investigator overall satisfaction as assessed by the Investigator Survey
timeFrame: Assessed 14 days ± 3 days after the final dispensing/refinement visit
Secondary outcomes:
Other outcomes:
Locations:
city: Orange Park
country: United States
facility: Site 101
state: Florida
city: Orange Park
country: United States
facility: Site 102
state: Florida
city: Canton
country: United States
facility: Site 103
state: Georgia
Study officials:
References:
Clinical trial NCT01959594: A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
Official title: Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: multiple doses
pharmacokinetics
safety
tolerability
healthy volunteers
steady state
cognitive impairment associated with schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Primary outcomes:
measure: Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS.
timeFrame: 0-15 days
measure: Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,
timeFrame: 0-15 days
measure: CogState at followup
timeFrame: 22-25 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01663194: Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction
Official title: Observational Study of N/L Ratio in Patients With STEMI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevated Myocardial Infarction
Keywords: N/L ratio, STEMI, primary PCI, Long-term mortality
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 1034
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI patients who were admitted within 6 hours from symptom onset and who underwent primary PCI were prospectively included in this study

Brief summary: Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with adverse outcomes among patients with coronary artery disease, its role during the acute phase of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This study sought to investigate the association of the pre-procedural N/L ratio within-hospital and long-term outcomes among STEMI patients undergoing primary percutaneous coronary intervention (PCI).

Detailed description: Inflammation plays a role in the initiation and progression of the atherosclerotic process. Due to a growing recognition of its role, recent studies have focused on inflammatory markers and their association with outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Recently, our single center study demonstrated that preprocedural neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L ratio in long-term outcomes among patients with STEMI; however, they evaluated the association between long-term mortality and in-hospital N/L ratio, they were single-center studies and they evaluated a relatively small study population.

In the present multicenter experience, the investigators aimed to investigate the association of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with STEMI undergoing primary PCI.

Eligibility criteria: Inclusion Criteria:

ST elevated myocardial infarction

Exclusion Criteria:

Treatment with fibrinolytic drugs in the previous 24 hours Active infection Previously documented history of a systemic inflammatory process Known malignancy End-stage liver disease Renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University school of medicine
Study officials:
affiliation: Erciyes University school of medicine
name: Mahmut Akpek, MD
role: STUDY_DIRECTOR
References: