cyrilzakka/clinical-trials huggingface dataset:
Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in HFpEF Patients Treated With ARNI

Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan.

The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials.

Eligibility Criteria:
Inclusion Criteria:

* left ventricular ejection fraction ≥50%；
* with the symptoms and/or signs of heart failure；
* BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
* at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.

Exclusion Criteria:

* LVEF less than 45% at any time;
* severe infection;
* ACS;
* pregnancy;
* eGFR \<30 mL/min/1.73 m2, etc.
The Effect of Probiotics on Chronic Kidney Disease

Probiotics could attenuate renal function deterioration in CKD patients.

Chronic kidney disease (CKD) is a global health issue that has a substantial impact on affected individuals. Chronic inflammation, which is widely seen in CKD including long-term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk. Inflammatory markers such as C-reactive protein, IL-6, IL-18, and TNF-α, are elevated in dialysis patients and can predict cardiovascular event and all-cause mortality. Endotoxin is bacterial lipopolysaccharide, and makes up the outer membrane of Gram-negative bacteria. Endotoxin is also an important source and also a marker of inflammation in CKD.

The natural intestinal microbiota is altered in CKD patients as an increase in aerobic bacteria such as E. coli and a decrease in anaerobic bacteria such as Bifidobacterium. Dysbiosis might contribute to the chronic inflammatory state in dialysis patients through endotoxemia, induction of the pro-inflammatory cytokine, and production of uremic toxins through fermentation of protein in the large intestine. Probiotics containing Bifidobacterium species and Lactobacilli species could benefit the host by inhibiting the growth or epithelial invasion of pathogenic bacteria, enhancing the intestinal barrier function, and regulating the immune system.

Probiotics could suppress proinflammatory cytokines, such as TNF-α and IL-6 . In addition, probiotics could improve renal function parameters in uremic rats and significantly lower levels of blood urea nitrogen in stage 3 and 4 CKD patients. The aim of the present study is to evaluate:

1. Whether probiotics could retard the decline of renal function?
2. Whether probiotics could change microbiota?
3. Whether probiotics could reduce the serum levels of endotoxin and cytokines (TNF-α, IL-6, and IL-18)?
4. Whether probiotics could improve the gastrointestinal symptoms in CKD patients?

Estimated glomerular filtration rate, stool microbiota, serum cytokines and endotoxin, and gastrointestinal symptoms of stage 3-5 patients are measured before and after intervention. The Wilcoxon signed-rank and Wilcoxon rank-sum tests were used to compare intra- and intergroup differences for continuous variables, as appropriate. A p value less than 0.05 was considered significant.

Eligibility Criteria:
Healthy volunteers:

The criteria for healthy volunteers were: no hypertension (Blood pressure\<140/90mmHg), no diabetes (Glucose AC 70\~100mg/dl), no hyperlipidemia (Cholesterol Total 130\~200mg/dL、Triglyceride\<150mg/dL), no urinary protein (-) and normal renal function (eGFR\>90), after signing the consent form, the stool samples will be collected.

CKD patients:

Inclusion Criteria:

‧Stage 3-5 CKD patients, at least 20 years of age and regular follow-up for at least 6 months prior to enrollment.

Exclusion Criteria:

* Pregnancy.
* On immunosuppressive therapy.
* Active infectious condition.
* Acute kidney injury.
* Consuming other forms of probiotics.
* Taking antibiotics within 30 days prior to enrollment.
HRAD-Vascular Access

The perioperative setting is a common site of pediatric anxiety and distress. Perioperative anxiety in pediatric patients can result in uncooperative behavior, poor postoperative outcomes, and trauma. Given the fast-paced nature of the perioperative environment, many anxiety measures are too time consuming for clinical implementation prior to surgery. Pediatric anesthesiologists need reliable and efficient assessment tools to quickly measure childhood distress to target prophylactic and therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria:

* participants who is undergoing vascular access

Exclusion Criteria:

* Clinically unstable
Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

To investigate whether the DHEA supplementation could improve mitochondrial quality in poor ovarian responders

Women who underwent in vitro fertilization (IVF) treatment participated, including normal ovarian responders (NORs) and poor ovarian responders (PORs). PORs were assigned to receive DHEA supplementation or not before the IVF cycle. For all patients, cumulus cells (CCs) were obtained after oocyte retrieval. In the CCs, mRNA expression of mitochondria-related genes was measured. To compare the mRNA expression of mitochondria-related genes in the CCs among the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Poor ovarian responders met the Bologna criteria, having at least two of the three following features: (1) advanced maternal age (≥ 40 years) or any other risk factor for POR, (2) a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and (3) an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle counts (AFC) \< 5 or anti-Müllerian hormone (AMH) \< 1 ng/mL in this study.
* Normal ovarian responders met the following criteria: (1) AFCs ≥ 5 or AMH ≥ 1 ng/mL and (2) the number of retrieved oocytes was between 5 and 15.

Exclusion Criteria:

* previous oophorectomy
* exposure to cytotoxic or pelvic irradiation for malignancy
* positive screening for recurrent pregnancy loss (chromosome mapping, antinuclear antibodies, extractable nuclear antigens, antiphospholipid antibodies, thrombophilic screening)
* any other sensitizing or ovarian stimulating therapy during the previous 3 months
Effects of Ultraviolet B Exposure Using a Ultraviolet Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults

Vitamin D regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. Its primary source is Ultraviolet B radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. This study explores using a daily Ultraviolet B Light Emitting Diodes device to improve vitamin D levels while assessing the potential for skin inflammation.


Eligibility Criteria:
Inclusion Criteria:

Age ranges 19-65 years Healthy participants Patients who are willing or able to follow the doctor's instructions Fully understand the purpose and procedure of this clinical trial

Exclusion Criteria:

Participants excluded those who have any kind of disease Lactating and pregnant women Physical disabilities that could interfere with participation, a history of depression, or other psychiatric conditions
Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation

Whether teaching leadership with a short debriefing has a positive influence on the performance of cardiopulmonary resuscitation remains largely unknown. The investigators will assess the sustained efficacy of a short leadership debriefing compared to a technical debriefing in a high fidelity simulated cardiopulmonary resuscitation.

Context:

Whether the performance of cardiopulmonary resuscitation can be positively influenced by teaching leadership with a short debriefing remains largely unknown

Objective:

To test the hypothesis that (1) leadership instruction are effective and (2) improved leadership results in better performance in a high fidelity simulated cardiopulmonary resuscitation.

Design:

Prospective, randomized-controlled superiority trial

Setting:

Simulator Center of the University Hospital Basel in Switzerland

Patients or Other Participants:

237 volunteer medical students in teams of 3

Intervention:

During a baseline visit, the medical students participate in a video-taped simulated witnessed cardiac arrest. Participants are randomized to receive thereafter a short video-assisted debriefing focusing either on correct positions of arms and shoulders (technical debriefing) or on leadership and communication to enhance team coordination (leadership debriefing). A follow-up simulation is conducted after 4 months. Leadership utterances, technical skills and the resuscitation performance of the teams are compared based on videotapes coded by two independent researchers.

Main Outcome Measures:

The primary outcomes for this study are the amount of hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation was started. Secondary endpoints are the effectiveness of the technical and leadership instructions, respectively.

Eligibility Criteria:
Inclusion Criteria:

* volunteer medical students

Exclusion Criteria:

* no informed consent
Compassion and Metacognition in Schizotypal Personality

The purpose of this study is to assess the safety and efficacy of a newly developed psychotherapy for schizotypal personality disorder. This new form of psychotherapy integrates compassion focused therapy and metacognitively oriented psychotherapy.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a psychological assessment so as to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to new integrative psychotherapy or treatment as usual (cognitive behavioral therapy plus standard psychopharmacological treatment). One month after the conclusion of the two forms of treatment (both lasting 6 months), patients will have access to the final follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

- Being diagnosed with Schizotypal Personality Disorder at SCID-5-AMPD

Exclusion Criteria:

* Being under psychotherapy or psychopahrnacological treatment
* Being diagnosed with schizophrenia and other psychotic disorders
* Being diagnosed with bipolar disorder
* Being diagnosed with intelletual disability
* Being diagnosed with any neurological disases
Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

The prevalence of overweight children has increased dramatically over the last decade, and many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a naturally occurring dietary fatty acid, has shown promising results in reducing body fat among adults, and we propose to test the efficacy of CLA supplementation on body fat accretion in 6 to 10 year old children who are overweight or at risk of overweight.


Eligibility Criteria:
Inclusion Criteria:

* age 6 to 10 years
* body mass index greater than 85th percentile
* Tanner stage I

Exclusion Criteria:

* medical condition
* dairy allergy
Cycling Study With the Axonics System

A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.

After consent is provided, the required visits are at Baseline, Day 0, 1-Month, and 3-Month. At the follow-up visits, a bladder diary is reviewed, symptoms are assessed, the PGI-I questionnaire is completed, and cyclic stimulation hours may be changed.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who are ≥ 21 years at the time of consent
2. Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled)
3. Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent
4. UUI episodes:

   1. For currently implanted participants (Group A), they must be considered therapy responders with a \>50% reduction in UUI episodes (based on their original baseline diaries) and satisfied with their SNM therapy
   2. For de novo candidates (Group B), they must have completed a successful PNE documented with a \>50% reduction in UUI episodes on a 3-day diary (a diary must exist within a medical record or equivalent)
5. Willing and capable of providing informed consent
6. Agrees to return to the site for all study visits
7. Fluent (able to speak and read) in English

Exclusion Criteria:

1. Any participant that the study Investigator deems to be a poor candidate who is unable to complete a 72-hour bladder diary or will be non-compliant for study visits
2. Diagnosis of urinary retention
3. Surgical treatment for stress incontinence (e.g. sling, Burch), and/or pelvic organ prolapse in the past 3 months or recommended or planned within 3 months from the time of consent
4. Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent
5. Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
6. Current symptomatic urinary tract infection (UTI)
7. A patient who early discontinued from the ARTISTRY registry
8. A female with a positive urine pregnancy test
9. A female who is breastfeeding
Role of Indomethacin in Difficult Embryo Transfer.

the aim of the study is to assess the role of indomethacin in cases of difficult embryo transfer in intracytoplasmic sperm injection cycles.

It is a prospective randomized study in which 200 women undergoing ICSI( intracytoplasmic sperm injection) and fulfilling the inclusion criteria(Difficult mock embryo transfer on day of ovum pick up ,Women's age 20-38 yaears,Early follicular FSH ≤10 IU/l ,Tubal, male infertility, unexplained factors of infertility.) will be recruited.

All patients will received long stimulation protocol ;down regulation will be achieved by administration of triptorelin0.1 mg(decapeptyl 0.1 mg, Ferring, Malmo, sweden) S.C daily from day 21 of the cycle preceding the stimulation cycle till the day of hCG administration.,down regulation will be checked day 2 of stimulation cycle by checking serum E2˂50 pg/ml, endometrial thickness ˂ 5mm and quiescent both ovaries.

When down regulation is achieved stimulation is commenced using hmG(Menogon, ferring pharmaceuticals, Germany) 225 IU daily intramuscular injection, Serial trans-vaginal ultrasound to assess follicular growth and serum E2 are done starting on day 6 of the cycle and onward, with adjustments of gonadotropin dose and monitoring frequency based on patient response.

Once 3 or more leading follicles reached≥18mm hCG 10000 IU (Pregnyl; NV Organon) will be administrated IM.

Ovum pick up will be done 34-36 hours following hCG administration with ultrasound guidance under general anesthesia.after that mock embryo transfer will be done using labotec embryo transfer catheter and women in which any degree of difficulty according to Tomas et al. 2002 criteria will be recruited in the study and divided randomly into two groups according to computer generated random cards ;group A (n=100): will receive indomethacin 100 mg rectal supp(KAHIRA PHARMA\&CHEM,IND,CO.CAIRO-EGYPT) 1-2 hours before embryo transfer, group B (n=100) will not receive any medications before embryo transfer.

Embryo transfer of 2 embryos will be done by the same technique in lithotomy position with full bladder under ultrasound guidance 2-3 days after ovum pick up depending on the number and quality of available embryos using labotec catheter (Labotec, Gottingen Germanny).

Luteal phase will be achieved Using progesterone vaginal pessaries (Cyclogest, Alpharma, UK) 400 mg twice daily from the day of egg collection till the day of the pregnancy test and continued till 12 week gestation if pregnancy is documented.

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients undergoing ICSI cycle with difficult mock transfer done on day of day of ovum pick up

Exclusion Criteria:

* repeated ICSI failure
* Easy mock embryo transfer on day of ovum pick up
* Early follicular FSH \>10 IU/l
* Past history of allergy to NSAID.
* Past history of asthma, peptic ulcer disease or inflammatory bowel disease. Endometrial pathology
Acupuncture and Dry Needling in Peripheral Acute Fatigue Reduction

Introduction: Neuromuscular fatigue is defined when the muscle becomes incapable of generating muscle power or strength after exercise or long repetitive activities. As well as, the inability to maintain optimum performance and generate maximum voluntary contractions during a physical exercise. When performing physical activity, the body's metabolic response increases proportionally to exercise to satisfy the demands of the human physiological. Part of the energy accumulated during exercise is lost to the environment in the form of heat and another part is maintained internally through the physiological control for thermoregulation. In addition, the muscle generates an electric signal important to determine its status regarding power and fatigue.

Objective: To investigate the reduction of acute peripheral fatigue induced by isometric contractions from acupuncture and dry needling techniques, compared to absolute rest.

Methods: This is a cross-sectional study and experimental study, with descriptive, analytical and quantitative approach. It follows the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The volunteers will be gathered according to the eligibility criteria, and randomly divided in 3 groups: the control group (G1), the volunteers who will remain in prolonged rest; the acupuncture group (G2), in which volunteers will receive six needles in six acupoints in the non-dominant upper limb and the dry needling group (G3), in which the volunteers will receive application of six needles arranged in the non-dominant biceps brachialis.


Eligibility Criteria:
Inclusion Criteria:

* Male individuals, aged between 18 and 40 years and who are not practicing regular physical activity (sedentary lifestyle).

Exclusion Criteria:

* Are using food supplementation;
* Have joint or bone lesions on the limb to be studied;
* Have problems of metabolic order;
* Use of hormone therapy;
* Have had caffeine in the two hours before the study;
* Have ulceration or wounds in the electrode application region for electromyography;
* Show absence of myofascial trigger points in areas of dry needling technique;
* Body Mass Index below normal values or higher than overweight.
Research and Characterization of New Genes Involved in Intellectual Disability

Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is identified only in 30 to 60% of cases.

The purpose of this study is to indentify genes involved in ID with new genetics tools (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.


Eligibility Criteria:
Inclusion Criteria:

* for the patients: Clinical diagnosis of intellectual disbility
* for the unaffected sibs: to be aged at least 3 years
* informed consent

Exclusion Criteria:

* absence of informed consent
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications

The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours.
* No contra-indication for intra-operative volume controlled mechanical ventilation
* Flat supine surgeries without expected positional adjustments
* American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Use of Nitrous Oxide
* BMI \> 40
* Ventilation through Nasal intubation or Tracheostomy
* Preexisting sore throat, coughing, nausea/vomiting
* Recent history of upper respiratory infection
* Pregnancy
* Expected to be kept intubated after surgery completion
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation

Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 70 years old;
* Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
* intact skin where the product will be applied
* Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Personal history of atopy;
* History of sensitisation and irritability to topical products;
* Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
* Use of new drugs and/or cosmetics during the experiment;
* Skin reactivity;
* Previous participation in a study with the same product under test;
* Volunteers who have congenital or acquired known immunodeficiency;
* Relevant medical history or current evidence of alcohol or other drugs abuse;
* Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
* Sponsor's employees involved in the study, or close family member of an employee involved in the study;