cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.

Single-group, open-label, phase I / II clinical trial: Evaluation of the safety of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients.

The proposed study is a single-group, open-label, phase I / II clinical trial in which the patients will be treated with two doses (100 million i.v) of autologous adipose tissue-derived mesenchymal stem cell transplantation.

This study aims to evaluate the safety and efficiency of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients. The inflammaging-patients are who have cytokine increasing (IL6 and TNF alfa)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient, age 40 to 64 years.
2. The inflammatory aging patient as defined in the protocol as TNF alpha or IL6 at the time of screening was higher than the 95% healthy percentile value declared by the test system manufacturer.
3. Have at least 2 of the 3 following diseases:

   * Diabetes type II
   * Dyslipidemia
   * Obesity \[The diagnosis and determination of accompanying diseases (Diabetes, Dyslipidemia, Obesity) will be carried out according to the general guidance of the MOH Vietnam\].
4. Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months.
5. Agree to participate in research and agree to comply with the research examination and evaluation process.

Exclusion Criteria:

1. Patients with a blood-clotting disorder or hemophilia
2. Patients with severe heart failure
3. Acute respiratory pathology at the time of screening
4. Patients with cancer or other acute illness need treatment.
5. Patients with a history of allergy to anesthetics, anesthesia, and antibiotics
6. Patients are planning to participate in another clinical trial while participating in the study
7. There are other conditions or circumstances in which it is difficult for researchers to ensure adherence to treatment in the judgment of researchers.
Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients

Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS.

The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* AIS secondary to a large vessel occlusion
* admitted for endovascular therapy.

Exclusion Criteria:

* Pregnant or breast feeding patient patient under legal protection
* Patient opposition to participate in this study
Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.


Eligibility Criteria:
Inclusion Criteria:

* Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
* 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

* polycystic ovary syndrome (PCOS) patients
* patients with endocrinological diseases or problems
Progressive Resistance Training for Fibromyalgia

Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
* Feminine gender;
* Age between 18 and 65 years;
* Pain between 3 and 8 cm in the Numerical Pain Scale (END);
* Have not changed treatment for fibromyalgia in the past three months;
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Cognitive deficit that does not allow the understanding of the evaluation instruments;
* Other diseases that make it impossible to perform the exercises;
* Physical activity started or changed in the last three months;
* Physical therapy in the last six months;
* In litigation.
Pilot Testing a Patient Safety Display in the Hospital Setting

This is a feasibility pilot study to introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. This intervention, the "Patient Safety Display" will be evaluated in one hospital unit.

This project will introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. A "Patient Safety Display" will be implemented in half of the patient rooms in one hospital unit. The Patient Safety Display will display catheter and pressure injury data pulled real-time from the electronic medical record onto a tablet mounted at the patient bedside.

This is an intervention-control design study that will be conducted with patients and clinicians at Michigan Medicine. The proposed intervention, the Patient Safety Display, will provide clinicians with key catheter and skin information at the bedside when pertinent clinical decisions are being made.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in specific hospital unit of interest or providers caring for patient in that unit

Exclusion Criteria:

* Patients not in unit of interest and providers not caring for patients on that unit
Mindfulness-based Therapeutic Sailing (MBTS) Versus Standard Recreation Therapy Activity (SRT)

This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders.

The specific aims of this investigation are to determine whether:

1. MBTS will result in greater pre- to post-intervention increases in psychological flexibility and state mindfulness than a standard recreation therapy activity (SRT).
2. MBTS participants will experience greater enjoyment of the activity than SRT participants.
3. MBTS will result in greater pre- to post-intervention increases in positive affect and decreases in anxiety as measured as compared to the SRT participants.
4. MBTS participants will exhibit improved outcomes, as compared to the SRT group, in the 3-month post-intervention period.


Eligibility Criteria:
Inclusion Criteria:

* At least one psychiatric or substance use disorder
* At least one Mental Health Service appointment within the previous 12 months

Exclusion Criteria:

* Active psychosis
* Significant cognitive impairment and/or physical impairment that would preclude participation in the activities
* Previous participation in a therapeutic sailing intervention offered by the VA Salt Lake City Health Care System.
The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults

Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited.

This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* • Males and females individuals aged 18-40 years

  * Individuals with a body mass index (BMI) greater than 30 kg/m² and less than 40 kg/m².
  * Individuals medically diagnosed with prediabetes by a physician prior to enrollment in the study as indicated by hemoglobin A1c (HbA1c) levels between 5.7% and 6.4% (American Diabetes Association, 2024), or HOMA-IR score of greater than 1.8.
  * Individuals demonstrating a willingness to follow the dietary protocol
  * Individuals engaging in sedentary physical activity levels

Exclusion Criteria:

* Individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus.

  * Individuals have experienced weight loss of more than 5% in the last three months.
  * Pregnant or lactating women.
  * Individuals undergoing any form of drug treatment.
  * Individuals with a history of major surgery.
  * Individuals have consumed pro-/pre/symbiotic or antibiotics in the past three months.
  * Individuals who engage in any form of regular sports activity.
A Predictive Model for Inadequate Bowel Preparation

We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years undergoing colonoscopy

Exclusion Criteria:

* known or suspected bowel obstruction, stricture or perforation
* compromised swallowing reflex or mental status
* severe chronic renal failure(creatinine clearance \< 30 ml/min)
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* dehydration
* disturbance of electrolytes
* pregnancy or lactation
* hemodynamically unstable
* unable to give informed consent
Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome

Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy. The treatment consists of eight sessions of gut directed hypno therapy during twelve weeks. Effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment.

Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. Firstly, the patients are invited to a meeting with the nurse for information about the study, check for eligibility and to sign the written informed consent. Exclusion criteria that could influence GI symptoms such as organic GI disease, severe psychiatric comorbidity and pregnancy are controlled for. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy. The randomization is organized and performed in blocks by an external unit connected to the University in order to be accurate. The treatment consists of eight sessions of gut directed hypnotherapy during twelve weeks. A standardized protocol is used and is the same both in the group setting as well as in the individual treatment arm. In each group approximately eight patients are included. Every session lasts for one hour. Outcome measures in the study are GI symptom severity, GI-specific anxiety, psychological distress and health related quality of life. These effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment and during the 6 months-, 1 and 2 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* IBS according to Rome III criteria

Exclusion Criteria:

* Organic GI disease
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks

The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

Randomized subjects treated for a qualifying attack were eligible to receive rescue dosing with 1,000 U of C1INH-nf if they did not achieve beginning of substantial relief of the defining symptom within 4 hours after initial treatment with blinded study drug, or if at any time the attack progressed to include airway compromise. A second 1,000 U rescue dose was permitted 60 minutes after the initial rescue dose, if necessary.

The study design also allowed for administration of open-label C1INH-nf for laryngeal angioedema attacks, which were non-randomizable events due to the presence of or potential for airway compromise (immediate 1,000 U dose of C1INH-nf, repeated after 60 minutes, if necessary). In addition, subjects were eligible to receive open-label C1INH-nf (1,000 U single dose) prior to emergency surgical (non-cosmetic) procedures.

A total of 83 subjects were enrolled in the study. Seventy-one (71) subjects experienced qualifying attacks and were randomized to blinded study drug (36 C1INH-nf, 35 placebo); only the 71 randomized subjects were analyzed for efficacy. An additional 12 subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. Of the 35 subjects randomized to placebo, 23 also received C1INH-nf (eg, rescue, open-label). In total, 83 subjects received at least 1 dose of study drug and were analyzed for safety; 71 subjects were exposed to C1INH-nf (59 randomized, 12 open-label only) and 12 subjects were exposed only to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Documented HAE
* Normal C1q level

Exclusion Criteria:

* Low C1q level
* B-cell malignancy
* Presence of anti-C1INH autoantibody
* History of allergic reaction to C1INH or other blood products
* Narcotic addiction
* Current participation in any other investigational drug study or within the past 30 days
* Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
* Pregnancy or lactation
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
Effect Not Imposing COVID-19 Testing Prior to Elective Cataract Surgery

The world health organization declared corona virus disease (COVID19) a pandemic since march 2020. Since then the future landscape of medical practices and procedures is being heavily shaped by the emergence of this pandemic. COVID 19 testing has already standardized within the medical field as doctors wearing scrubs or fitness examination before operation. We are now more than 2 years into COVID-19 pandemic with more than 6 effective vaccines available in the market for public to boost and build up their immunity against the virus. Every 3 to 4 months we hear about a new strain and another wave of the virus attacking the world, therefore healthcare institutions face enormous challenges in balancing patients' needs and simultaneous safety to health care workers.

The Indian council of medical research in June 2020 proposed that testing for Covid-19 for asymptomatic patients coming for elective surgeries should be performed for neurosurgery, ear nose, and throat (ENT) surgery, dental procedures, etc. and for non-surgical interventions like bronchoscopy, upper gastrointestinal endoscopy and dialysis. A role of preoperative testing of Covid-19 for every patient is still controversial especially in asymptomatic healthy patients with not known exposure to a COVID positive patient.

Most patients attending eye out patient department (EOPD) are aged 65y and older are considered at a higher risk for worse outcome in case of COVID-19 infection. Therefore a rethink of a cataract surgery pathway should include preoperative perioperative and postoperative care in order to maintain safety conditions for patients and for healthcare staff.

COVID-19 can infect anyone and result in transmission of infection before the patient become symptomatic or even without ever developing symptoms. Therefore preoperative screening of patients undergoing ophthalmic surgery should be considered.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic adult undergoing cataract surgery

Exclusion Criteria:

* Symptomatic patients (fever, cough lethargy malaise , headache, and aches, sore throat and diarrhoea
Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

This study aims to pilot a world-first intervention, a mental health intervention augmented for children indicated with developmental language disorder (DLD). It serves as a proof-of-concept of how existing observational studies on these topics at the Centre for Research in Child Development (c.f. Tran-Sen; Gibber) can be translated into interventions. Mental health problems here are defined as anxiety type problems of social anxiety, specific phobia, separation anxiety and generalised anxiety. DLD is defined as a marked difficulty in oral language in the absence of biomedical causes (Bishop et al., 2017). This randomised pilot answers three uncertainties in preparation for a future definitive randomised control trial (RCT).

This pilot aims to answer three uncertainties for a future randomised control trial (RCT), namely (1) Is the proposed intervention's efficacy sufficient (2) Are the proposed methods of recruitment sufficient (3) Are the proposed measures of evaluation sufficient Hypotheses: (1) Piloted intervention is sufficient for definitive RCT as 90% confidence intervals contain expected improvement versus treatment-as-usual (2) Piloted recruitment methods are sufficient for definitive RCT as recruitment rate is \>4/month, dropout rate\<25%. (3) Piloted measures are sufficient for definitive RCT as rates of unusable data are \<20% and reliability alpha \>.70.

Eligibility Criteria:
Inclusion Criteria:

* Shows signs of elevated anxiety, fear or stress, as rated on anxiety measures conducted by this study
* Enrolled in Primary 1 to 6 in a Ministry of Education Primary School
* Signs of a language difficulty \[Either one of the following\]

  1. Existing clinical opinion/report of this when child \>5 years old
  2. Score \<10th percentile on language measures conducted by this study

Exclusion Criteria:

* Conditions which exclude Developmental Language Disorder (e.g. Autism, Intellectual Disability, Hearing Impairment, other biomedical conditions).
* Non-anxiety disorder as primary mental health disorder
* Currently receiving treatment for anxiety disorder (e.g. pharmacotherapy or psychotherapy).
Eosinophilic Gastrointestinal Disorders Patient Registry

The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that does not involve medical interventions, but serves as a record of demographics, characteristics of disease and treatment, utilization patterns, quality improvement measures and clinical outcomes. The database is proposed so that epidemiologic research can be performed and current and accurate data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life.


Eligibility Criteria:
Inclusion Criteria:

* male or female participants of any race or ethnicity
* age 0 to 21 years
* diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis

Exclusion Criteria:

* hypereosinophilic syndrome
* non-eosinophilic gastrointestinal or allergic disorder
Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects

Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive patients and to better understand the mechanisms controlling the myogenic tone. Evaluations will be performed through ex vivo studies of peripheral arterioles in human adipose tissue from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the myogenic function in response to progressive blood pressure increases, in order to correlate myogenic function to arterial hypertension and to the molecular mechanisms already identified in the preclinical models.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between 30 and 70 years of age
* Hypertensive patients: Patients with a previous diagnosis of hypertension
* Normotensive patients: subjects without story of hypertension
* Written informed consent

Exclusion Criteria:

* Severe hypertension (eg, systolic \>180 mm Hg, diastolic \>110 mm Hg)
* Manifested or suspected secondary hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, pheochromocytoma)
* History of cardiac complications (previous acute myocardial infarction (AMI), unstabile angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), congestive heart failure (NYHA II-IV))
* Diabetes mellitus
* Renal pathologies (creatinine clearance \< 30 ml/min)
* Severe hepatic dysfunction