louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06053333: Social Determinants of Health in Hepatobiliary Cancer Patients
Official title: Social Determinants of Health in Hepatobiliary Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Hepatobiliary Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-09-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with hepatobiliary cancers

Brief summary: This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To characterize the social determinants of health - and specifically travel-limiting access to cancer care but also other issues, such as trouble in finding childcare, joblessness, and limited education - among SEA Americans with hepatobiliary cancers, exposure risk including aflatoxin and viral hepatitis among other exposures.

OUTLINE: This is an observational study.

Patients complete a questionnaire, undergo blood, urine, and buccal swab sample collection and have their medical records reviewed on study. Patients also undergo collection of clinically archived tissue samples on study.

Eligibility criteria: Inclusion Criteria:

* Patients 18+ year of age with hepatobiliary cancers

Exclusion Criteria:

* Patients under 18 years of age

Primary outcomes:
measure: Percentage of patients reporting transportation barriers that affect medical care
timeFrame: Baseline; up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Nguyen H. Tran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608433: Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function
Official title: Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteer Study
HPA
Cortisol Deficiency
Adrenal Insufficiency
Keywords: Hypothalamo-pituitary-adrenal axis
Healthy volunteers
Glucagon-like peptide-1 receptor agonists
GLP-1 receptor agnoists
semaglutide
adrenal insufficiency
HPA axis
adrenal function testing
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study aims to investigate the effects of a single dose of the glucagon-like 1 receptor agonist semaglutdie/Rybelsus on the hypothalamo-pituitary-adrenal axis, thus cortisol levels and other stresshormones in healthy males.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 18-60 years
* BMI 18.5-30 kg/m2
* No regular medication

Exclusion Criteria:

* participation in a trial with investigational drugs within 30 days
* vigorous physical exercise within 24 hours before the study participation
* alcohol intake within 24 hours before the study participation
* a history of intake of glucocorticoids or GLP-1 RA within the last 8 weeks.
* Known allergy towards GLP-1 RA

Primary outcomes:
measure: Change in serum cortisol after Rybelsus vs. Placebo
timeFrame: within 210 minutes after the intake of the study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References:
Clinical trial NCT05409833: Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population
Official title: Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population (CarPoS Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transthyretin Amyloidosis
Carpal Tunnel Syndrome
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: Centro de Investigação em Tecnologias e Serviços de Saúde
name: Rede de Investigação em Saúde
First posted: 2022-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ≥60 years old submitted to hand surgery

Brief summary: Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. The main aims of this project are the characterization of the association between idiopathic carpal tunnel syndrome and transthyretin amyloidosis and its evaluation as a predictive factor of cardiac amyloidosis


Eligibility criteria: Inclusion Criteria:

. Patients aged ≥ 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications.

Exclusion Criteria:

. Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.

Primary outcomes:
measure: Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old
timeFrame: 24 months
Secondary outcomes:
measure: Association between synovial transthyretin amyloidosis with carpal tunnel syndrome
timeFrame: 24 months
measure: Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário São João
city: Porto
country: Portugal
facility: Faculty of Medicine (FMUP)
Study officials:
affiliation: Universidade do Porto
name: Elisabete Martins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385733: Inspiratory Muscle Training in Pulmonary Hypertension
Official title: The Effects of Inspiratory Muscle Training on Exercise Capacity, Physical Activity and Quality of Life in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
inspiratory muscle training
functional capacity
physical activity
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Biruni University
First posted: 2017-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.

Detailed description: Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences, pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction. Aerobic exercise programs in patients with pulmonary hypertension are reported to result in improved exercise capacity and endurance of the patients, improvement in WHO functional class and quality of life, increased peak workload and increased peripheral muscle function. In recent years, few studies have investigated the efficacy of inspiratory muscle training in patients with PH.The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Pulmonary Hypertension,
* NYHA functional class I-IV
* MIP pressure \<80 cm h2O

Exclusion Criteria:

* COPD
* Conditions which can limit the assessments
* Insufficient cooperation

Primary outcomes:
measure: mouth pressures
timeFrame: 10 minutes
Secondary outcomes:
measure: International Physical Activity Questionnaire-Short Form
timeFrame: 10 minutes
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: 15 minutes
measure: Activity monitoring (Sense wear® Armband)
timeFrame: 3 days
measure: 6 minute walking test
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Goksen Kuran Aslan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000233: Alternate Day Buprenorphine Administration, Phase X - 15
Official title: Alternate Day Buprenorphine Administration, Phase X
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 34
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how subjects will make changes in the amount of medication received when given a monetary alternative to buprenorphine.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Opioid withdrawal
measure: Subjective dose estimate
measure: Drug effect characteristics: ARCI
measure: Money choice
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petry, Bickel (in press) Buprenorphine self-administration in buprenorphine-maintained, opioid-dependent outpatients: Effects of an alternate reinforcer. Psychopharmacology. Petry, Bickel (in press) Buprenorphine self-administration in buprenorphine-maintained, opioid-dependent outpatients: Effects of an alternate reinforcer. Psychopharmacology
citation: Antoniotti C, Germani MM, Rossini D, Lonardi S, Pietrantonio F, Santini D, Marmorino F, Allegrini G, Daniel F, Raimondi A, Borelli B, Zaniboni A, Conca V, Abraham J, Spetzler D, Maiello E, Boccaccino A, Passardi A, Giordano M, Tamburini E, Korn MW, Masi G, Cremolini C. FOLFOXIRI and bevacizumab in patients with early-onset metastatic colorectal cancer. A pooled analysis of TRIBE and TRIBE2 studies. Eur J Cancer. 2022 May;167:23-31. doi: 10.1016/j.ejca.2022.02.031. Epub 2022 Mar 30.
Clinical trial NCT01687933: The Effect of Virtual Reality Glasses on Labor Pain
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Labor Pain
Anxiety
Keywords: Labor pain
Virtual reality
the first stage of labor
Pain relief
Simulator
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are different medicinal and non medicinal methods to control labor pain. Today, much attention has been on non medicinal methods because of limitations and complications of medical procedures. Virtual reality is a new and promising method of diversion of mind that may have an impact on labor pain. This study was conducted to determine the effect of virtual reality on the first stage of labor pain.


Eligibility criteria: Inclusion Criteria:

* Iranian
* low risk pregnancy
* primipara

Exclusion Criteria:

* vision or ear disorders
* History of motion sickness or headaches
* psychological disease or Addiction

Primary outcomes:
measure: pain and anxiety
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07003633: Preoperative Analgesia: The Effectiveness of the PENG Block in Patients With Hip Fractures
Official title: Preoperative Analgesia: The Effect of the Pericapsular Nerve Group (PENG) Block Administered Preoperatively in Patients With Hip Fractures on Preoperative Analgesic Efficacy, Early Postoperative Discharge, Mortality, and Morbidity.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fracture Surgeries
Keywords: Analgesia
PENG block
Hip Fracture
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to provide effective preoperative analgesia in patients undergoing surgical procedures due to hip fractures by administering a pericapsular nerve group (PENG) block under ultrasound guidance. This approach seeks to increase patient satisfaction, reduce analgesic requirements, enable earlier discharge, and decrease morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hip farcture surgery

Exclusion Criteria:

* Chronic analgesics consumption
* Patients contraindicated for neuraxial anesthesia
* Alcohol and drug addiction
* Allergies to local anesthetics and opioids
* Patients who refuses to participate in the study

Primary outcomes:
measure: Preoperative Pain Scores and Opioid Consumption
timeFrame: 24 hours preoperatively
Secondary outcomes:
measure: Discharge Time
timeFrame: From surgery to discharge up to 30 days
measure: Postoperative Mortality and Morbidity
timeFrame: 30 days after surgery
measure: Opioid Consumption
timeFrame: 24 hours preoperatively
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Universtiy Training and Research Hospital
Study officials:
References:
Clinical trial NCT05334433: Child Behavior After Local Anesthetic Injection Using Needless Systems
Official title: Assessment of Child Behavior and Soft Tissue Reaction After Local Anesthetic Injection Using Needle Versus Needless Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique


Eligibility criteria: Inclusion Criteria:

* According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
* Children who are medically fit.
* Children who are capable of interacting on a mental level.
* Children between the ages of 6 to 8.
* First dental visit.

Exclusion Criteria:

* Children who struggle with behavioral control (uncooperative).
* Children who have a history of allergic reaction to local anesthetic drugs.
* Parental rejection for participation.

Primary outcomes:
measure: Child behavior (Feeling pain during injection) (Binary Yes/No)
timeFrame: During injection (Immediate) (No follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University, Cairo, Egypt
Study officials:
References:
Clinical trial NCT02127333: Role of Oxygen for Vascular Dysfunction
Official title: Role of Acute and Chronic Hypoxemia for Vascular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Dysfunction
FMD
IMT
Microcirculation
Oxygen Pressure
Carbon Dioxide Pressure
Oxygen Saturation
Forced Expiratory Volume After 1 Second
Keywords: chronic obstructive pulmonary disease
Coronary artery disease
Endothelial function
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 38
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CAD patients with or without COPD; healthy volunteers

Brief summary: Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for vascular function. For this purpose we measure capillary oxygen concentration and vascular.

Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood flow and laser doppler perfusion imaging.

We hypothesize that hypoxemia leads to impaired vascular function.


Eligibility criteria: Inclusion Criteria:

* stable coronary artery disease
* stable chronic obstructive pulmonary disease

Exclusion Criteria:

* acute myocardial infarction within 30 days
* acute exacerbated COPD within 30 days
* acute infections
* severe acute or chronic renal failure
* severe heart failure
* atrial fibrillation
* severe cardiac arrhythmia
* hypotension
* active malignant disease
* active rheumatic disease
* pulmonary hypertension with vasoactive therapy

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery
timeFrame: Baseline
Secondary outcomes:
measure: Forearm blood flow
timeFrame: Baseline
measure: Laser doppler perfusion
timeFrame: Baseline
measure: Intima-media thickness of the brachial artery
timeFrame: Baseline
measure: Fractional diameter change of the brachial artery
timeFrame: Baseline
measure: Endothelium-independent vasodilation of the brachial artery
timeFrame: Baseline
Other outcomes:
measure: Plasma nitrite concentration
timeFrame: Baseline
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicineine
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03426033: Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin
Official title: Phase 1, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Elevated Lipoprotein(a)
Cardiovascular Diseases
Lead sponsor: Akcea Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.


Eligibility criteria: Inclusion Criteria:

* Motivated and available for duration of study and willing to adhere to protocol
* Males who are unable to procreate or agree to contraception throughout study
* Females who are postmenopausal or surgically sterile
* BMI between 18.5 and 30 kg/m2
* Weighing greater than or equal to 50kg
* Normal lab results
* No known diseases or significant findings on physical exam

Exclusion Criteria:

* Females of childbearing potential
* Reactions/infection at injection site
* Hypersensitivity to any drugs or similar drugs to those used in the study
* Conditions or disease that may interfere with study drug
* Any significant diseases
* Known history or familial history of bleeding disorders
* Drug dependency or abuse
* Illness within 28 days
* Previous exposure to other investigational drug within 28 days
* Blood donations within 28 days

Primary outcomes:
measure: The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
timeFrame: Each day for days 1-10 and 15-45
Secondary outcomes:
measure: The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.
timeFrame: 45 days
measure: Prothrombin Time will be measured by testing blood samples at each individual time point.
timeFrame: Each day for days 1-7 and 15-21
measure: International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.
timeFrame: Each day for days 1-7 and 15-21
measure: Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.
timeFrame: Each day for days 1-7 and 15-21
measure: The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
timeFrame: Each day for days 1-10 and 15-45
Other outcomes:
Locations:
city: Mount Royal
country: Canada
facility: Clinical Site
state: Quebec
Study officials:
References: