rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
LBNP Tolerance With Skin Warming After Exercise Cold Stress
Status: Recruiting

Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 and 40 years old free of known disease and illness Speak English Systolic blood pressure <140mmHg Diastolic blood pressure <90 mmHg  Exclusion Criteria:  Currently pregnant or breast feeding Individuals with diagnosed with cardiac, respiratory, neurological and/or metabolic illness or disease. Currently taking prescribed or over the counter medications known to influence the cardiovascular, pulmonary, renal and/or central nervous system. Current use of tobacco or nicotine products Any physical limitations that impede completion of the tests, such as exercise tests will also be an exclusion criteria. Body mass< 80 pounds body weight Appendectomy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
Status: Not yet recruiting

The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:

Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.
Establish a monitoring and early warning system for secondary infections.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Agree to participate in this study and sign the informed consent form; Be of any gender and aged 18-70 years old; No life-threatening underlying diseases and complications during the perioperative period. Undergo liver transplantation within 24 hours.  Exclusion Criteria:  1.Patients deemed unsuitable by the investigator to participate in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Liver transplant recipients - SamplingMethod: Non-Probability Sample
A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection
Status: Not yet recruiting

The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:

Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.
Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hospitalized patients with viral hepatitis cirrhosis agreed to participate in the study and signed an informed consent form; Any gender and age between 18-70 years old; HBsAg positivity lasting more than 6 months; have clinical manifestations of hepatic decompensation and portal hypertension, laboratory test results, liver imaging or endoscopy and other comprehensive diagnosis of definite cirrhosis.  Exclusion Criteria:  Patients with other non-hepatophilic causes of cirrhosis; Patients who, in the opinion of the investigator, are not suitable for participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with hepatic virus-caused cirrhosis - SamplingMethod: Non-Probability Sample
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
Status: Recruiting

The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).

These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pathologically confirmed diagnosis of primary endometrial cancer (endometrioid, clear cell, serous, mixed, any grade) FIGO stage IA-IB Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis available - Availability of preoperative MRI scans in dicom (.dcm) format Availability of preoperative US images in dicom (.dcm) format Availability of preoperative CT-scan images in dicom (.dcm) format (optional) Available clinical information (e.g. baseline information, surgery, adjuvant therapy, median follow up period 24 months)  Exclusion Criteria:  Metastatic cancer to the uterus (not primary EC) Uterine sarcoma Conservative surgery FIGO stage > II Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis not available Patients without available MRI, US or CT-scan images on digital media Clinical information not available or incomplete Any other malignancy in the previous 5 years or synchronous Patients aged under 18 years - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients
Status: Not yet recruiting

The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:

Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.
Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.
Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.

Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines (2021 edition); Aged 18 years and above; PCE predicted ASCVD risk of 5% - <7.5%; Those with a predicted survival time of >1 year; No plans to leave the depth in the next 3 months; Voluntary participation in this study and signing the informed consent.  Exclusion Criteria:  Those with a past history of CVD; Those with HIV-related neurocognitive disorders and various serious opportunistic infections; Those with diabetes mellitus; Known nut allergy; Planning to become pregnant within 6 months; Are on lipid-lowering therapy or using any interfering medications or diets; Are participating in other HIV-related or dietary intervention-related scientific research programs. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients.
Status: Recruiting

The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.

In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Written informed consent prior to study participation Adult patients (≥ 18 years)  Patients scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve/coronary artery bypass graft (CABG) or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) one of the following additional risk factors:  a high perioperative risk profile, defined as predicted operative mortality of ≥ 8% (European System for Cardiac Operative Risk Evaluation, EuroSCORE II). Age >70 Clinical Frailty Score 4 or more Urgent surgery (defined as to be performed within 24-48 hours after admission) Left ventricular ejection fraction <35%  Exclusion Criteria:  Known hypersensitivity to fish oil (FO)/ fish products or egg protein Pregnancy or lactation period Previous history of atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia Inability or unwillingness of individual to give written informed consent Not expected to survive an additional 48 hours from screening evaluation Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" (DNR) acceptable) Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma Patients receiving and extracorporeal mechanical assist device (e.g. extracorporal life support systems [ECLS], or intra-aortic ballon pump [IABP]) or for advanced heart failure therapies (e.g. platelet aggregation inhibitors [TAH], ventricular assist devices [VAD]) Enrolment in anyinterventional trial within the last 30 days Already receiving FO-containing medical nutrition products Severe malnutrition (as defined by the BMI<18.5) Severe liver dysfunction defined by Child Pugh Class C. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR < 30ml/min)1 Known severe coagulation disorder - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Echography Study_Anthropometric Measurements
Status: Not yet recruiting

This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.

In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.

Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female, 2 to 70 years old, inclusive In stable health, as determined by medical history and physical examination at screening (ie, any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during assessments, so that in the opinion of the investigator or designee there will not be any impact on the ability of the subject to participate in the study) For the adult population, body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m2 at screening BMI = weight (kg)/(height [m])2 Willing and able to provide written informed consent and assent (as appropriate) prior to initiation of study procedures Subjects must be able to communicate effectively with the study staff and to understand study instructions (not applicable for toddlers and preschoolers)  Exclusion Criteria:  Any skin or muscular condition, such as eczema, scars, infections, moles, or tattoos at the site of measurements Allergy to ultrasound gel Any other condition or prior therapy that, in the investigator or designee's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures Is an employee or authorized representative of CROSSJECT SA or ICON plc Adult under guardianship or subject incarcerated - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 2 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult
Improvement of Women's Health After Allogeneic Stem Cell Transplantation
Status: Not yet recruiting

The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All women aged 18 and over who will receive a first allogeneic HSCT (bone marrow, peripheral blood stem cells from a related, unrelated (including cord blood) or haploidentical donor) at the CIUSSS-EMTL. Recruitment will begin when the project receives ethical approval. Recruitment period will be of 2 to 3 years.  Exclusion Criteria:  Those who receive a second HSCT allograft. Those who receive an autologous transplant. Inability to give informed consent. Unable to communicate in French or English. Any other reason which, according to the investigators, makes it preferable for a patient not to participate. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: All women aged 18 and over who will receive a first allogeneic HSCT - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Allotransplanted women who receive a first allogeneic stem cell transplant. - SamplingMethod: Non-Probability Sample
Self-hypnosis Training for Chronic Pain Management
Status: Recruiting

Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.

The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.

Adverse events: none expected.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria were to have participated in the past year in the self-hypnosis training program and to agree to take part in these research interviews. be 18 years of age or older; have received one of the above diagnoses, confirmed by medical record review or physician confirmation; report pain that has been present for at least 3 months; have a pain intensity over the last 24 hours (24h pain) of at least 4 on a Numerical Rating Scale (NRS) from 0 to 10 at baseline; be able to read, speak and understand French; have Internet access and be able to participate in a telepractice intervention group and complete online questionnaires.  Exclusion Criteria:  have deafness and/or severe cognitive impairment that may impair communication; have current or recent psychiatric instability (e.g., active suicidal ideation, active delusional or psychotic thoughts) that could interfere with participation, as assessed by a clinical psychologist. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
Status: Not yet recruiting

This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.

The aims of the study are:

Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).

Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.

Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden.

Eligibility:
- EligibilityCriteria: Patient Inclusion Criteria:  Age ≥50 years of age; Self-identified as Black/African American; Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit; Able to communicate in English; and Has an informal caregiver (family member or close friend willing to participate in the study for 6 months.  Caregiver Inclusion Criteria:  Willing to attend 4, one-hour sessions with the study participant; Willing to support the study participant for study duration (6 months); and Willing to complete brief baseline, 3- and 6-month assessments.  Patient/Caregiver Exclusion Criteria:  Mental confusion at screening assessment suggesting significant dementia; Alcohol or drug abuse/dependency at screening assessment; Active psychosis or acute mental disorder at screening assessment; and Life expectancy <6 months at screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult
Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD
Status: Not yet recruiting

Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with chronic Graft-Versus-Host Disease (cGVHD) treated at Virgen del Rocío University Hospital will be invited to participate in the trial (n=108), under the following eligibility criteria: Inclusion criteria: Adult (18 years or older); Underwent allogeneic hematopoietic stem cell transplantation (alloHSCT) diagnosed with cGVHD; No medical contraindication for moderate or high-intensity exercise; Proficiency in the Spanish language; Have access to the internet.  Exclusion Criteria:  Unable to perform initial or final physical assessments; Having serious pre-existing conditions before the oncological diagnosis or diseases that are not or poorly controlled; Not signing or delivering the informed consent on the indicated date. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy
Status: Recruiting

This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults > 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy Treatment naive adult acute myeloid leukemia patients  Exclusion Criteria:  Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded Patients who are pregnant or breast-feeding - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy. - SamplingMethod: Non-Probability Sample