cyrilzakka/clinical-trials huggingface dataset:
Empagliflozin and Hepatic Glucose Metabolism

the aim of this study is to examine the role of autonomic nervous system in the increase in hepatic glucose production in response to glucosuria caused by inhibition of renal glucose uptake

Purpose/Objectives: To investigate the effect of empagliflozin, an SGLT2 inhibitor on hepatic glucose production and the role of autonomic nervous system in mediating the increase in hepatic glucose production in response glucosuria Research Design/Plan: the role of autonomic nervous system in the increase in hepatic glucose production caused by empagliflozin will be examined with norepinephrine (NE) turnover in two protocols. The first protocol is cross sectional, in which 36 T2DM patients will receive hepatic glucose production (HGP) and NE turnover will be measured before and after empagliflozin or placebo administration. In protocol 2, diabetic and non-diabetic subjects will receive baseline HGP, NE turnover, hepatic glucose uptake (HGU) and liver fat measurement before at 2 days after the start and 12 weeks after empagliflozin or placebo treatment.

Methods: the following techniques will be employed (1) Measurement of hepatic glucose production with 3H-glucose infusion, with and without glucose clamp, (2) substrate oxidation with indirect calorimetry and plasma ketone/lactate/insulin/glucagon concentrations; (3) Measurement of HGU with Oral-IV double tracer infusion; (4) Measurement of whole body norepinephrine turnover with 3H-norepinephrine infusion; (5) Measurement of heart rate variability; (6) Measurement of liver fat content with 1H-MRS Clinical Relevance: The results of the present studies will help identify the mechanism responsible for the increase in HGP caused by empagliflozin and the increase in ketone production. The first action of the drug ameliorates its clinical efficacy while the second increases the risk of adverse events (ketoacidosis). Identifying the mechanisms underlying these actions will help developing therapeutic strategies which increase the drug clinical efficacy and mitigates its adverse events.

Eligibility Criteria:
Inclusion Criteria:

* eGFR\>60 ml/min healthy volunteers type 2 diabetes patients who otherwise healthy

Exclusion Criteria:

* eGFR \<60 T2DM patients on insulin, GLP-1 RA or SGLT2 treatment Major organ disease type 1 diabetes
Evaluation of Serum Klotho as a Predictor of Progression of Cardiovascular Calcification in Chronic Kidney Disease

This prospective observational study aims to investigate the relationship between CVC and serum Klotho for renal function correction in patients with different CKD stages

In this study, we plan to enroll 400 non-dialysis patients with CKD 2-5 and 300 maintenance hemodialysis patients. Participants will receive coronary artery computed tomography (CT) scanning to detect the extent and the severity of CVC. Follow-up is scheduled at 0, 6, 12, 18, and 24 months and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), total calcium, phosphate, parathyroid hormone (PTH), serum 25(OH) vitamin D, fibroblast growth factor-23 (FGF-23) and coronary artery computed tomography (CT).

The purpose of this study was to clarify the relationship between CVC in patients with different CKD stages and serum Klotho for renal function correction, and to clarify that Klotho can be used as an early biomarker for CVC in patients with CKD, so as to predict the occurrence and progress of CVC.

Eligibility Criteria:
Inclusion Criteria:

1. age over 18 years old, regardless of gender
2. non-dialysis patients with CKD 2-5, or patients with CKD 5 under hemodialysis for more than 3 months

Exclusion Criteria:

1. life expectancy \< 2 years
2. severe complications of heart, lung, liver or brain
3. primary hyperparathyroidism
4. malignant tumor
5. pregnant or breastfeeding
6. contraindications to CT examination
7. unwilling or unable to comply with the research protocol
Keratinocyte Skin Cancer Surgery in the Elderly, Aged 80 Years and Over, is Effective and Safe

As a result of a longer life expectancy and a change in UV exposure, physicians will be facing a growing number of elderly patients with keratinocyte cancer (KC) in fair-skinned populations. The purpose of this study is to better characterize KC surgery in patients over 80 years and older with different comorbid conditions and to investigate the incidence of complications associated with KC surgery.

A retrospective monocentric study of patients aged 80 and older, having surgery for KC in University Hospital of Zurich between January 1, 2022, and December 31, 2022, was conducted. Demographics, comorbidities, current medication, treatment type, tumor characteristics, surgical defect size, repair type and complications within 6 months after surgery were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 80 and older, having surgery for KC in University Hospital of Zurich between January 1, 2022, and December 31, 2022

Exclusion Criteria:

* Presence of a documented rejection.
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.

This FDA post-marketing requirement study will evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) for symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience hepatotoxicity. A liver biopsy will be collected from enrolled patients for central laboratory analysis of macrophage and immune cell profiles to investigate possible mechanisms of the hepatotoxicity. Additionally, 4 blood samples will be collected to evaluate liver function, other relevant safety tests, peripheral immune cells, and for pharmacogenomic testing. Enrolled patients will be followed at least yearly for 10 years to assess long-term risk of hepatic failure.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
* Age ≥18 years old
* Emergence of at least one of the following liver test abnormalities due to TURALIO™ (pexidartinib) exposure:

  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) \>2 × ULN
  * Isolated TBIL \>2 × ULN (excluding patients with Gilbert's syndrome)
  * Isolated AST or ALT \>10 × ULN
  * Alkaline phosphatase (ALP) \>2 x ULN with gamma-glutamyl transferase (GGT) \>2 x ULN
* Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO™ (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program

Exclusion Criteria:

* Not applicable
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.


Eligibility Criteria:
Inclusion Criteria:

* term newborns
* parental informed consent
* inborn infants

Exclusion Criteria:

* major congenital/chromosomal abnormalities
* lack of informed consent
* outborn infants
* Premature infants
Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt

forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises with moderate intensity in the form of walking on electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks. Pulmonary function test was applied by spirometry to assess lung function


Eligibility Criteria:
Inclusion Criteria:

* quarry workers working in the quarries for five years ago at least saver from chest diseases\\\\
* BMI ranged from 25 to 34.9 kg/cm2

Exclusion Criteria:

* Subject with infected chest disease, unstable mental condition and chest cancer patients
* musculoskeletal disease
Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing

In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.

Root canal treatment is a treatment method applied to milk and permanent teeth. The inflamed and necrotic pulp where the root canal is located is cleaned, debrided chemo-mechanically, and finally filled hermetically with a biocompatible material. Necrotic immature teeth lose their restorative and defensive abilities. Since the root canal walls of these teeth are thin and weak, regenerative endodontic procedures are applied more frequently in the treatment of immature teeth to ensure root development and to restore the vitality of the pulp tissue. In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.

Eligibility Criteria:
Inclusion Criteria:• Molars with open apex

* Teeth with apical periodontitis
* Teeth for which prosthetic restoration is not planned
* Patients between the ages of 8-15 who do not have any significant health problems
* Patients who are not accompanied by periodontal problems and have good oral hygiene

Exclusion Criteria:• People with systemic disease and allergic reactions

* Severely damaged teeth
* If the tooth has previously undergone root canal treatment.
* Use of antibiotics, anti-inflammatory and painkillers in the last two weeks
Contribution of the ENT (Ear, Nose, and Throat) Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers

Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Cancer of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, rhinopharynx, salivary glands, facial sinuses, orbital cavity, ear);
* Cancer confirmed by histopathological analysis;
* Therapeutic protocol including radiotherapy.

Exclusion Criteria:

* Any history of radiotherapy of the head and neck
* Synchronous head and neck cancer.
Etiology of Motor Developmental Delay in Children

This study aims to identify the etiology of children with motor developmental delay, in association with the results of magnetic resonance imaging and genetic analysis.

Results of other available assessments including Gross Motor Function Measurements and Bayley Scale of Infant Development, second edition, modified Ashworth Scale, IQ score and developmental language assessments are to be collected.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of motor developmental delay
* available results of functional assessments at ages older than 18 months Functional measures include either GMFM or BSID_II

Exclusion Criteria:

* single domain delay other than motor (e.g., speech delay)
A Phase 2b Study of Zagociguat in Patients With MELAS

PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.

The goal of this clinical trial is to learn about the effectiveness of zagociguat in patients with MELAS. The main questions it aims to answer are:

* Does zagociguat improve fatigue in patients with MELAS?
* Does zagociguat improve cognitive performance in patients with MELAS?
* What is the safety and tolerability profile of zagociguat?

The PRIZM study is evaluating 2 dose levels of zagociguat in a crossover design consisting of two 12-week treatment periods separated by a 4-week washout. Patients will be screened and if eligible, randomly assigned either to receive placebo in period 1 followed by active drug in period 2 OR to receive active drug in period 1 followed by placebo in period 2. Study medication is a once daily oral tablet and will be provided at the clinic and/or shipped to the participant's home. Clinic visits will occur at screening and Week 1 and Week 12 of each treatment period. Visits at Week 4 and Week 8 of both crossover periods will either be in clinic or optionally at the participant's home. Study assessments will be conducted weekly on a phone app and a separate tablet and additional assessments will be conducted during visits. Patients who complete the study will be eligible for an open label extension study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed consent form.
2. 18 to 75 years of age.
3. Diagnosed with MELAS based on the presence of each of the following criteria:

   1. A documented pathogenic variant in a mitochondrial DNA (mtDNA) gene.
   2. History of one or more stroke-like episodes (SLEs) with magnetic resonance imaging (MRI) findings consistent with stroke-like lesions.
4. Scores below normal average on the iDSST and GMLT.
5. Reports fatigue due to MELAS.
6. Can complete at least 1 sit-to-stand in the 30-second test interval.
7. Completes all at-home weekly activities independently during the Screening Period (caregiver may help set up device/app, log-in, etc.).
8. Other criteria per the protocol.

Exclusion Criteria:

1. Systolic blood pressure (BP) 90 mmHg or diastolic BP 60 mmHg.
2. Orthostatic hypotension when measured after standing from a semi-recumbent/supine position.
3. Active cancer significant enough to confound the results of this study.
4. Severe gastrointestinal dysmotility that may impact participation.
5. Recent history (within last 6 months) of platelet dysfunction, hemophilia, von Willebrand disease, coagulation disorder, other bleeding diathesis condition(s), or significant, nontraumatic bleeding episodes.
6. History of spontaneous fracture(s) that in the investigator's opinion represents a safety risk for trial participation.
7. Current use of prohibited medication (reviewed by investigator).
8. Any medical or other condition that the investigator thinks would preclude study participation.
9. Other exclusion criteria per protocol.
Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity

Obesity is a chronic disease that has grown to epidemic proportions in Brazil and throughout the world in recent years. Bariatric surgery has been the most effective method for the treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the longevity and quality of life of patients. The treatment of patients with Class III obesity or higher or Class II with comorbidities is already well established with bariatric surgery being the best option. However, there is no consensus as to the best treatment in cases of Class I or II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures.

The primary objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the outcomes.

This study will be carried out in two institutions. The Kaiser Clinic and Day Hospital and the Faculty of Medicine of ABC. Sixty patients will be randomly selected for treatment by Endospore Endoscopy (ESG) or as controls (only the endoscopist will know which group each patient belongs to). The draw will take place only after upper endoscopy has been carried out to avoid possible contraindications for the procedure due to injuries. Once the criteria for endoscopic evaluation have been met, randomization will be carried out in loco with the patient still sedated. Gastric Endo Sutures will be performed when the patient is randomized for Group I; Group II will be the control group. All patients will be followed up for two years by a multidisciplinary team (endoscopist, surgeon, nutritionist and psychologist). The data will be obtained during the outpatient follow-up at the Hospital Mario Covas and will include demographic (gender, age), clinical (height, weight, BMI, time after procedure, hypertension, diabetes, dyslipidemia, smoking, alcoholism) and operative data (complications).

Preparation to perform the examination/procedure: All exams will be performed with the patients within eight hours. The procedure will begin with the patient in left lateral decubitus position and under general anesthesia performed by an anesthesiologist. Endoscopic suturing will be performed with 2-0 prolene stitches until a tubular-shaped stomach is formed similar to vertical gastrectomy.

Recovery after the procedure: After this procedure and recovery from the anesthesia, all patients will only be discharged in the company of a companion. All patients will be counseled to enter in touch with the physician to report any signs or symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years,
* BMI \> 30 and \< 36 kg/m2, with or without comorbidities,
* BMI \> 36 and \< 40 without comorbidities

Exclusion Criteria:

* Previous gastric surgery
* Taking anticoagulant drugs
* Psychiatric disorders
* Severe esophagitis
Clinical Study Into the Cosmetic Results of Leukosan Adhesive

This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures.

In particular, it tests the long-term cosmetic result after 3 months, the safety and tolerance, as well as the practicality of treatment with Leuksan Adhesive.

An open, randomised, controlled, prospective, single location, clinical study of women of ages between 18 and 60 years within the time span of March 2013 and April 2013.

The medical devices compared were EU (European Union) approved market-ready products with relevant designation according to the legal requirements for medical devices and according to Council guideline 93/42/EWG dated 14th July.

Leukosan Adhesive is a sterile, ultra high viscose adhesive for external skin closure. Due to the skin's moisture, this skin adhesive polymerizes within seconds into a flexible film firmly holding the edges of the wound together and protecting the wound itself.

Premilene DSMP 24, 3/8 needle, thread 3/0 denier was used a a comparison. This suture material was the standard suture material used in the study centre.

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 60
* Undergone laparoscopic operation with 2 mirror image trocar incisions
* Willing to attend examination at clinic at 7-12 days and 10-14 weeks
* Signed agreement by participant

Exclusion Criteria:

* Length of laparoscopic operation more than 2 hours
* Hospitalisation due to complications
* Circumstances leading to difference in trocar incisions
* Existing scar less than 3 cm from the operation point
* Diabetic condition melitis HbA1c\>9mg/d
* Known allergy to tissue adhesive
* Participation in another study within 30 days
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead

This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF \<= 35%) and QRS duration \>= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
* Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment.
* Age 18 or above, or of legal age to give informed consent specific to state and national law.
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol.

Exclusion Criteria:

* A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
* Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
* Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
* Requiring dialysis.
* A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
* Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
* A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
* Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.
* Have a mechanical tricuspid heart valve.