louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03331549: Study on High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population
Official title: Study the High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-ST-segment Elevation Myocardial Infarction
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beckman Coulter, Inc.
First posted: 2017-11-06
Enrollment: 400
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 visiting the Emergency Department of our hospital and have non-traumatic chest pain or other symptoms suggesting acute myocardial infarction will be selected.

Brief summary: The purpose of the study is to establish a high-sensitivity troponin 0h/1h process for the diagnosis of patients suspected of NSTEMI for the Chinese population, obtain the inclusion and exclusion criteria for diagnosis of these patients and compare the new process with the existing diagnosing methods and processes, including the 3h and 6h processes more extensively used at present and the ECG combined with troponin diagnosis, so as to explore a confirmation model suitable for the Chinese population.


Eligibility criteria: Inclusion Criteria:

1. Patients experiencing acute chest pain or angina pectoris symptom within 12 hours before visiting the hospital;
2. Or those experiencing acute chest pain or angina pectoris peak within 12 hours before visiting the hospital.

Exclusion Criteria:

Patients showing ST-segment elevation during ECG and pregnant women.

Primary outcomes:
measure: Diagnosis of non-ST-segment elevation myocardial infarction
timeFrame: After measuring the high-sensitivity troponin level at 1h or 3h
Secondary outcomes:
measure: Cardiovascular events or death
timeFrame: Follow-up for 6 months after diagnosis
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT06302049: Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis
Official title: Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Fatty Liver Disease
Steatohepatitis, Nonalcoholic
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.


Eligibility criteria: Inclusion Criteria:

Both males and females.

* Diabetic and non-diabetic patients.
* Age \>18 years old.
* Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but \<40 kg/ m2.
* Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection.
* Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (\>2 but \<5 times upper limit of normal), hepatic steatosis index (HIS) \>36, HAIR score of 2 or 3.

Exclusion Criteria:

* Patients with a history of hypersensitivity to esomeprazole.
* Patients with BMI ≥ 40 kg/ m2.
* Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates.
* Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine.
* Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency.
* Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
* Patients with cancer or with a history of cancer.
* Patients with cardiovascular diseases.
* Pregnant and lactating females

Primary outcomes:
measure: Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)
timeFrame: Before and after 3 months of the intervention
Secondary outcomes:
measure: Liver function improvement
timeFrame: Before and after 3 months of the intervention
measure: Reduction of oxidative stress
timeFrame: Before and after 3 months of the intervention
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: National Liver Institute
Study officials:
References:
Clinical trial NCT04849949: Black Walnuts and Health
Official title: Acute Consumption of Breakfast Meals With Black Walnut, English Walnuts, or no Nuts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Walnuts are a nutrient dense food, but most health research is on English walnuts (EW). Black walnuts (BW) contain a different antioxidant and fatty acid profile, and more protein, compared to EW. The purpose of the study was to compare postprandial responses following the consumption of 3 breakfast meals containing either butter (control), BW, or EW.

Detailed description: This study was a randomized, double-blind control trial consisting of 3 study visits for 3 different treatments. The treatments were high-fat breakfast muffins containing either butter (control), black walnuts, or English walnuts. The investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit.

Hypothesis: The walnut-containing meals would mitigate post-meal increases in glucose, insulin, triglycerides (TG), and lipid peroxidation while improving all measures of subjective appetite and TAC compared to the traditional meal without nuts.

Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women
* Normal-weight (body mass index = 18-24.9kg/m2)

Exclusion Criteria:

* Allergies to test meal ingredients (gluten, eggs, or nuts)
* Medication/supplement usage
* Chronic disease
* Pregnancy or plans to become pregnant
* Special diets
* Tobacco use

Primary outcomes:
measure: Change in triglycerides (TG) and glucose responses
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in lipid peroxidation
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in total antioxidant capacity
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in insulin
timeFrame: Change from baseline to 3 hours postprandially
Secondary outcomes:
measure: Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in hunger and satiety responses
timeFrame: Change from baseline to 3 hours postprandially
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology
state: Georgia
Study officials:
affiliation: University of Georgia
name: Chad M Paton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04614649: Right Iliac Fossa Treatment-Turkey Audit
Official title: Right Iliac Fossa Treatment-Turkey Audit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Appendicitis
Appendicitis Acute
Keywords: appendicitis
appendectomy
right iliac fossa
abdominal pain
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 3358
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: Patients referred to general surgeons with right iliac fossa pain or suspected appendicitis.

Brief summary: Background:

Acute appendicitis stands out as a frequently encountered surgical emergency. Despite decades of experience and research, the diagnosis remains a formidable challenge, particularly in young females experiencing acute abdominal pain, where the assessment requires consideration of a broader spectrum of potential causes. An overarching concern lies in the risk of over-treatment, leading to an escalation in unnecessary surgeries, known as the negative appendectomy rate (NAR). This elevated NAR is associated with postoperative complications, prolonged hospital stays, and avoidable healthcare expenditures. Despite international guidelines recommending the routine use of risk prediction models for patients with acute abdominal pain, reported NAR values have reached as high as 28.2% in females and 12.1% in males.

Aim:

The primary study aim is to identify optimal risk prediction models for acute RIF pain in Turkey.

The secondary aims are to audit the normal appendicectomy rate, assess whether these scores have similar efficacy in immigrants, and demonstrate nationwide clinical trends to discuss possible improvements.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients referred to general surgeons with right iliac fossa pain or suspected appendicitis.
* All patients who undergo an appendicectomy during the study period.

Exclusion Criteria:

* Previous appendicectomy, right hemicolectomy, or total colectomy.
* Previous abdominal surgery in the last 90 days.
* Pregnancy.
* Patients confirmed with COVID-19.

Primary outcomes:
measure: Best classification performance among 4 appendicitis scoring systems (for Turkish population)
timeFrame: During admission
Secondary outcomes:
measure: Normal Appendicectomy Rate (NAR)
timeFrame: All patients are followed up for 60 days, and data being utilized for NAR calculation is collected within that timeframe.
measure: Best classification performance among 4 appendicitis scoring systems (for immigrant population)
timeFrame: During admission
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Sezai Leventoglu, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01251549: Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
Official title: Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraplegia
Spinal Cord Injuries (SCI)
Keywords: ReWalk
Paraplegia
Spinal Cord Injuries (SCI)
Lead sponsor: ReWalk Robotics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.


Eligibility criteria: Inclusion Criteria:

* Complete cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal Injury Association (ASIA) guidelines
* Male and non-pregnant non-lactating female Age 18-55
* At least 6 months after injury
* Regular use of RGO (Reciprocating Gait Orthosis) or KAFO's (Knee Ankle Foot Orthoses) or able to stand using a standing device (e.g., 'Easy stand')
* Patients must be capable of providing informed consent
* Height of 160 to 190 cm
* Weight of \<100 kg

Exclusion Criteria:

* History of severe neurological injuries other than SCI (Spinal Cord Injuries)(MS (Multiple Sclerosis), CP (Cerebral Palsy), ALS (Amyotrophic Lateral Sclerosis) , TBI (Traumatic Brain Injury) etc)
* Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
* Severe spasticity (Ashworth 4) or uncontrolled clonus
* Unstable spine or unhealed limbs or pelvic fractures
* Heterotopic ossification
* Significant contractures
* Psychiatric or cognitive situations that may interfere with the trial

Primary outcomes:
measure: Safety of use
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy
timeFrame: 3 months
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: Albert Einstein Medical Center, Moss Rehabilitation Center
state: Pennsylvania
city: Como
country: Italy
facility: Ospedale Valduce di Como, Centro Villa Beretta Italy
Study officials:
affiliation: Albert Einstein Medical Center, Moss Rehabilitation Center
name: Alberto Esquenazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289249: Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet
Official title: Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection
Keywords: meropenem
child
bacterial infection
treatment evaluation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Pediatric medical ward.

Brief summary: The object of the study is to investigate whether all included patients receive treatment that is effective against all bacteria that are defined as sensitive to meropenem with the current treatment regimen. Will the investigators findings motivate routine monitoring of plasma concentrations in children receiving meropenem? Up to 50 patients will be included in the study, and all participants are children.


Eligibility criteria: Inclusion Criteria:

* Children aged from 3 months to 18 years that receive treatment with meropenem. Inclusion is independent of how long the patient has been receiving treatment. Children receiving other treatment (except hemodialysis)/other medications can be included.

Exclusion Criteria:

* Children less than three months of age. Patients receiving hemodialysis. Lack of consent.

Primary outcomes:
measure: We will determine how many of the patients in our material that have plasma concentrations of meropenem above 8 mg/l for at least 40% and 75% of the time.
timeFrame: 1 dosing interval (8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo univeristy hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Odd Brørs, Dr Med
role: STUDY_DIRECTOR
affiliation: Oslo univeristy hospital
name: Margrete L Burns, BMed
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Øystein Riise, PhD
role: STUDY_CHAIR
affiliation: Oslo univeristy hospital
name: Tore Abrahamsen, Dr Med
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Gaut Gadeholt, Dr Med
role: STUDY_CHAIR
References:
citation: Ikeda K, Ikawa K, Morikawa N, Miki M, Nishimura S, Kobayashi M. High-performance liquid chromatography with ultraviolet detection for real-time therapeutic drug monitoring of meropenem in plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Sep 1;856(1-2):371-5. doi: 10.1016/j.jchromb.2007.05.043. Epub 2007 Jun 6.
Clinical trial NCT00952549: Facial Yoga Toning Program - A Pilot Study
Official title: Facial Yoga Toning Program - A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Facial Atrophy Related to Age
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the efficacy of a facial yoga exercise program on appearance and to measure patient satisfaction with facial yoga practice.

Detailed description: This is a single center prospective longitudinal pilot study of 27 subjects. The study will include 20 study subjects and 7 controls. Participants in this study will be healthy subjects 18 years and older with mild to moderate facial atrophy without a history of surgical or non-surgical treatment to the area. The study subjects will perform facial yoga and apply sunscreen (Neutrogena Helioplex SPF 55) daily. The controls will apply sunscreen alone daily for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* over age 18 years

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Efficacy of facial yoga toning program on aesthetic appearance
timeFrame: 8 weeks
Secondary outcomes:
measure: subject satisfaction with facial yoga toning program
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Rebecca Tung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Wilma Bergfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06733649: Treatment Education for Perinatal Women and Their Community Support
Official title: Treatment Education for Pre- and Postpartum Women and Their Community Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Dependency
Keywords: opioid dependence
perinatal women
social support
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Perinatal women and the woman's community support will receive one treatment education session.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study evaluates the feasibility and acceptability of a 50 minute treatment education session for perinatal women with opioid use disorder and a community support person. The education session provides correct information about opioid agonist medications and neonatal abstinence syndrome.

Detailed description: Perinatal women with opioid disorder often face criticism by social network members for receiving opioid agonist treatment. Feeling stigmatized by others may impact willingness to start and remain in agonist treatment.

The present study evaluates the feasibility and acceptability of a 50 minute treatment education session for perinatal women who are treated using an agonist medication (methadone or buprenorphine) and community support chosen by the patient.

Study participants will be recruited from perinatal women who receive substance abuse treatment at the Center for Addiction and Pregnancy or Addiction Treatment Services at Johns Hopkins Bayview campus. These women will work with a counselor to select a community support person to bring to the program for the education session.

The session will provide correct information on opioid agonist medications and neonatal abstinence syndrome. This session will follow a structured outline.

Eligibility criteria: Inclusion Criteria:

* perinatal women treated with agonist medication
* interest in study participation
* interest in community support:
* interest in study participation

Exclusion Criteria:

* perinatal women not treated with agonist medication
* not interested in study participation
* not interested in community support:
* not interested in study participation

Primary outcomes:
measure: Percentage of women interested in study participation
timeFrame: Immediately before session 1
measure: Percentage of interested women who bring in community support to the education group
timeFrame: Immediately before session 1
Secondary outcomes:
measure: Knowledge as assessed by survey
timeFrame: Baseline, Immediately after session 1
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Michael Kidorf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00385749: Right Ventricular Defibrillation Lead Select Site Study
Official title: Right Ventricular Defibrillation Lead Select Site Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Congestive
Tachycardia, Ventricular
Keywords: Implanted cardioverter defibrillator
congestive heart failure
right ventricular lead placement
select site pacing
Lead sponsor: Associates in Cardiology, PA
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2006-10-11
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare single coil right ventricular defibrillation leads for implanted cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is hypothesized that RV septal positions are at least as good as apical positions using formally measured defibrillation thresholds(DFTs), and that they may have long term advantages in reducing left ventricular dysfunction.

Detailed description: The new studies "Right Ventricular Lead/Select Site Registry" and "Right Ventricular Lead/Select Site Registry: Acute Study" are studies designed to look at alternate lead locations for defibrillation leads for ICDs. The registry is designed to capture data from patients who have already undergone implant, so as to be able to publish long term data on defibrillation thresholds, pacing thresholds and left ventricular function. This will include both patients from the acute study, and those patients in whom leads have already been placed, and the exact lead location is known. The acute study is designed to directly compare defibrillation thresholds in the apical location versus the interventricular septal location for defibrillation leads. This study involves a direct comparison of two different sites in the same patient; using defined criteria for implant location (see protocol). The acute study is anticipated to enroll 34 patients, but the registry to collect ongoing data will be larger, encompassing previously implanted patients, with an expected sample size of 61 total in the registry for data collection.

Eligibility criteria: Inclusion Criteria:

* Standard indications for ICD placement (AHA/ACC guidelines)

Exclusion Criteria:

* Inability to consent
* age less than 21 years
* inability to participate in study follow-up

Primary outcomes:
measure: Acute defibrillation thresholds
Secondary outcomes:
measure: LV function (LVEF)
measure: pacing thresholds
measure: sensing thresholds
measure: LV diameter
measure: NYHA class
measure: weight
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Holy Cross Hospital of Silver Spring
state: Maryland
Study officials:
affiliation: Holy Cross Hospital of Silver Spring
name: Michael A Lincoln, MD
role: PRINCIPAL_INVESTIGATOR
References: