cyrilzakka/clinical-trials huggingface dataset:
Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

The project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. Novel endoscopic methods based on the principles of bariatric surgery are also highly effective. No direct randomized comparison of both types of treatment has been performed to date and the mechanisms of action of both procedures are still only partially clarified. The aim of the project is to perform a randomized trial comparing efficacy and safety of three treatment options in patients with obesity: laparoscopic sleeve gastrectomy, endoscopic gastric plication and conservative treatment. A further aim is to characterize the influence of the three treatments on subclinical inflammation, gut microbiota composition and changes of gastrointestinal hormones. The results of the project will describe the efficacy and safety of these procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Eligibility Criteria:
Inclusion Criteria:

1. BMI \> 35 kg/m2
2. For patients with type 2 diabetes - stable antidiabetic medication \> 1 month
3. Age 18-60 years

Exclusion Criteria:

1. Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
2. Prior gastrointestinal (GIT) surgery interfering with study procedure
3. Severe gastroesophageal reflux, severe GIT motility disorder
4. Active malignancy
5. Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
6. Acute liver or kidney failure
7. Transplantation of insulin producing tissue
8. Gravidity or lactation
9. Mental disorder
10. Inability to sign informed consent
11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure

6. Acute liver or kidney failure 7. Transplantation of insulin producing tissue 8. Gravidity or lactation 9. Mental disorder 10. Inability to sign informed consent 11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure
A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial Disease

The primary objective of this study is to assess the safety of vatiquinone in participants with inherited mitochondrial disease who had prior exposure to vatiquinone in a PTC/BioElectron sponsored (previously Edison) clinical study or treatment plan.

The study will continue until vatiquinone becomes commercially available or the program is terminated.


Eligibility Criteria:
Inclusion Criteria:

* Participants with inherited mitochondrial disease including Leigh syndrome, Alpers syndrome, mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), myoclonic epilepsy with ragged-red fibers (MERRF), pontocerebellar hypoplasia type 6 (PCH6), or other mitochondrial disease who participated in a previous vatiquinone clinical study or treatment plan.
* Women of childbearing potential must have a negative pregnancy test at screening/baseline and agree to abstinence or the use of at least 1 of the highly effective forms of contraception as specified in the protocol (with a failure rate of \<1% per year when used consistently and correctly). Highly effective contraception or abstinence must be continued for the duration of the study, and for up to 30 days after the last dose of study drug.
* Fertile men who are sexually active with women of childbearing potential and who have not had a vasectomy, must agree to use a barrier method of birth control during the study and for up to 30 days after the last dose of study drug.

Exclusion Criteria:

* Current participation in any other interventional study.
* Pregnancy or breast feeding.
AVF Volume Blood Flow Reduction in HD Patients

Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Cardio-fistular recirculation (CFR) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. Additionally, CFR is one of the few easily modifiable risk factors through surgical reduction of AVF volume blood flow (Qa).

The study aimed to evaluate the extent of involution of heart structural and functional changes following Qa reduction in patients with heart failure and CFR \> 25%.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* age \> 18 years
* CKD 5D
* Native arteriovenous fistula or vascular graft
* Heart failure with preserved CO (NYHA I-IV )
* Cardio-fistula recirculation ≥ 25%
* eKt/V \> 1.2
* Absence of arrhythmias (except grade I AV block)
* Absence of valvular disease (except mitral regurgitation I-II)
* Arteriovenous fistula blood flow reduction surgery

Exclusion Criteria:

* Death
* Kidney transplantation
* Conversion of vascular access to central venous catheter
* Withdrawal of informed consent
Transfer of Non-technical Skills From Simulation to Clinical Practice

Since 1988, simulation has been proposed as a teaching tool in Anesthesia. The simulation environment allows to teach learners non-technical skills which are a combination of cognitive, social, and personal resources complementary to procedural skills that contribute to an efficient and safe performance.

Non-technical skills traditionally used in Anesthesia are task management, situational awareness, teamwork and decision making. They can be indirectly measured with validated scales (e.g. Anesthesia Non-Technical Skills (ANTS) system). In addition to these basic skills, specific skills such as Anesthesia Crisis Resource Management (ACRM) are required when the patient presents a critical clinical situation.

Simulation, as proposed by Gaba, was initially practiced in centers specifically designed for this purpose. More recently, we have proposed the model of in situ simulation, i.e. in the usual workplace with the usual work team, as another option for the practice of simulation.

There are many theories about the transfer of learning. Transfer can be defined as what remains of the completed training that the learner actually uses, i.e. the final real effect.

Nevertheless, almost 30 years after the introduction of simulation in the training of anesthesiologists, data demonstrating the interest of this teaching in terms of transfer of learning of non-technical skills to clinical practice or benefits for patients are rare.

The main objective of this study is to evaluate the transfer of non-technical skills taught in a training program including in situ simulation to clinical practice by anesthesiology residents.


Eligibility Criteria:
Inclusion Criteria:

- Internship in the ambulatory surgery unit

Exclusion Criteria:

- Refusal to participate
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia

The purpose of this observational study is to evaluate the prostatic arterial embolization (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the treatment of symptomatic benign prostatic hyperplasia (BPH).

EmboProstate is an observational study that collects data of patients with benign prostatic hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The study evaluates the efficacy and safety of the microspheres for prostatic arterial embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be enrolled in this study. If eligible patients are recruited, they will undergo the prostate artery embolization procedure in our radiology department. Once the catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused by BPH. Within one week after PAE as well as after one, three and six months post-procedure an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* male
* adults \> 40 years old
* severe symptomatic BPH with IPSS \> 18 and/or QoL \> 3 or maximum urinary flow rate (Qmax) ≤ 15 ml/sec or transurethral catheter for retention
* no improvement after or intolerance of medical treatment for at least six months
* prostatic volume \> 30 cm³

Exclusion Criteria:

* female
* less than 40 years old
* eGFR \< 45 ml/min \* m²
* suspicion of prostatic malignancy
* prostatic malignancy
* acute prostatitis or cystitis
* hydronephrosis
* bladder stone or bladder diverticulum
* urethral stenosis
* major surgery within 4 weeks prior to the screening visit
* active clinically serious infection
* progressive arteriosclerosis
* contraindications against angiography
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.

The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient will be available for all visits
* Patients suffer from non-cancerous chronic pain according to HAS criteria
* Patient not having taking opioids in previous 2 months
* Patient indicated for prescription of opioids (oxycodone, codeine or tramadol) or patient not responding to first line treatment

Exclusion Criteria:

* The subject is participating in an category I interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* The patient is likely to procreate and does not use an effective method of contraception (contraceptive ring, surgical contraception, implant, patch, contraceptive pill, male and female condoms, IUD)
* There is a contra-indication for opioid use
* Patient with an addiction risk (score ≥ 8 on ORT scale).
A RCT Evaluating an Online Intervention in Increasing Pneumococcal Vaccination Among Older Adults

To evaluate the relative efficacy of an online intervention based on the Trans-theoretical Model delivered by a fully-automated Chatbot with natural language processing functions versus a control in promoting pneumococcal vaccination uptake among Hong Kong people aged ≥65 years. A total of 374 participants will be randomized evenly to either the intervention group or the control group. Participants in the intervention group will receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3. Participants in the control group will receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3. All participants will be followed up 6 and 12 months after completion of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥65 years
* having Hong Kong ID
* Chinese speaking
* have not received any penumococcal vaccination
* willing to be followed up by telephone
* having a smartphone
* able to send and read text/voice messages via smartphone.

Exclusion Criteria:

* blindness or deafness
* not able to communicate with others effectively
* with known contradictions of pneumococcal vaccination
* having been diagnosed with major psychiatric illness
* scored ≤16 in the validated telephone version of the Cantonese Mini-mental State Examination (T-CMMSE).
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804

There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55.
* No evidence of active or latent TB.
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence, including abnormal clinical laboratory parameters, eg, liver enzyme elevations, or a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy) or any active GI disease (including any relevant surgery).
* Any current and clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3. A clinically significant skin lesion is defined as Grade 1 (mild) for rash and pruritus, and Grade 2 (moderate) or above for all other lesions (see Short Name description in CTCAE for specific description of lesion).
* Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer

The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain.

Participants will:

* Be randomly assigned to one of two available groups (virtual reality or standard of care)
* Participations will only be during one chemotherapy session.
* Those assigned to virtual reality:

  * The research team will provide a virtual reality
  * The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns.
  * Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes
* Those assigned to the standard of care:

  * The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.

In recent decades, new cancer cases have consistently risen. Participants diagnosed with cancer commonly face psychological symptoms including distress, anxiety, and depression in addition to physical symptoms (i.e., pain). Importantly, these symptoms might be exacerbated during chemotherapy sessions. New innovative technological strategies have been under development to control the symptoms and improve quality of life. Immersive virtual reality (VR) is a simulated experience that enables participants to interact with an artificial three-dimensional visual and auditory environment. VR could be an innovative intervention to relieve psychological symptoms associated with chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Biopsy proven diagnosis of Cancer (any stage or type).
* Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis.
* Must have the ability to understand and the willingness to sign a written informed consent document
* Followed by a medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic.
* Ability to read and write in English or Spanish.

Exclusion Criteria:

* Age \<18 years.
* No prior history of Cancer.
* Prior medical history of severe motion sickness.
* Prior medical history of seizures
* Pregnancy.
* Unable or unwilling to participate in the immersive Virtual Reality study at the Maroone Cancer Center
A Cross-Functional, Population-Representative, Web-Based, Epidemiologic Study to Estimate the Prevalence and Burden of Nocturia Due to Nocturnal Polyuria in the US

To estimate the prevalence of nocturia due to nocturnal polyuria (NP) in the US and describe the demographic and clinical characteristics as well as the burden of illness in participants with nocturia due to NP.


Eligibility Criteria:
Inclusion Criteria:

* At least 30 years of age;
* Willing to provide informed consent;
* Able to read US-English or Spanish
* Able to use a computer and access the internet.

Exclusion Criteria:

* Symptomatic acute urinary tract infection (UTI) (experiencing symptoms such as pain or burning when you urinate, strong and frequent urge to urinate, or cloudy, bloody, or strong-smelling urine);
* Currently pregnant or ≤12 months postpartum;
* Recent surgery in the last \<6 months;
* Current lifestyle that leads to irregular or atypical circadian patterns (e.g. employed in overnight shift work)
* Prior YouGov survey participation in past two weeks
The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria.

Urticaria is a chronic allergic inflammatory disorder. Genetic and environmental factors, such as exposure to allergens and microbes, have a detrimental role in the development of chronic urticaria. Vitamin D also has an important role in urticaria. Lower sera vitamin D level was observed in patients that developed urticaria. Vitamin D binding protein (DBP) bound to vitamin D and regulated its metabolites in the circulation. Moreover, vitamin D receptors (VDR) have been identified on nearly all cells of the immune system. It may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut.

The investigators plan to design a double-blind trial to evaluate the role of human microbiome and vitamin D in the development of urticaria. We will enroll children with chronic urticaria (CU) and age and gender matched healthy children,and collected their venous blood and microbiome samples of nasal and anal swab. Then, CU subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. After six months of follow-up, their blood, nasal cavity, and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.

The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of CU, and design a microbiota-related preventive and treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Experimental group: patients with chronic spontaneous urticaria under the age of 18 .
2. Control group: healthy children under the age of 18 (eg, healthy siblings of sick children).

Exclusion Criteria:

1. Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month.
2. Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.
Nail Bed Repair With or Without Nail Bed Coverage

A randomized clinical trial conducted at Patel hospital, Karachi, from March 2024 to February 2025, to evaluate infection in patients undergoing nailbed repair with and without nailbed coverage, with minimum follow up for one month post operative.

Background:

The fingernail serves as a protective barrier for the dorsal fingertip while also enhancing its aesthetic appeal. Fingertip injuries account for approximately two-thirds of pediatric hand injuries, with nail bed injuries comprising 15% to 24% of these cases. In the United Kingdom, 96% of surgeons routinely remove the nail plate, repair the nail bed, and reposition the nail plate onto the nail bed. The rationale for repositioning includes protecting the repair, reducing infection risk, minimizing pain during dressing changes, and preventing adhesions by supporting the nail fold. When the autologous nail is unavailable, alternatives such as silver foil is used.

Objective:

This study aims to evaluate the risk of surgical site infection after nail bed repair with and without nail bed coverage.

Methods:

This is a two-arm randomized clinical trial enrolling 152 patients (76 in each group) over a 12-month period from March 2024 to February 2025. Patients undergoing nail bed repair will be randomized into two groups-one receiving nail bed coverage (repositioned nail or substitute) and the other without coverage. The primary outcome is the incidence of surgical site infection. Secondary outcomes include pain during dressing changes and cosmetic results.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all age groups and genders,
* Presented to the emergency or outpatient department within 48 hours of injury,
* Provided written informed consent (or had consent given by a parent/guardian in the case of minors),
* Injury to a single finger,
* Fractures that do not involve an open wound or require fixation.

Exclusion Criteria:

* Infected injuries,
* Underlying nail diseases,
* Pre-existing deformities in the injured or contralateral finger,
* Distal phalanx fractures requiring fixation,
* Amputations,
* Partial or complete loss of the nail bed requiring reconstruction,
* Multiple nail bed injuries,
* Known allergies to prescribed postoperative medications.