cyrilzakka/clinical-trials huggingface dataset:
BCAAs, Muscle Protein Synthesis and Glucose Uptake

The present study aims to quantify the insulin sensitivity and the skeletal muscle protein synthetic response to consuming a test drink containing all amino acids or all amino acids except for BCAAs.

Twenty-eight healthy, young volunteers will receive a stable isotope tracer infusion (7.5h) combined with repeated blood and muscle sampling, to measure muscle protein synthesis rate in the postabsorptive state following ingestion of a drink containing all amino acids (n=14) or all amino acids except for BCAAs (n=14).

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18-35 years
* 18.5 \< Body mass index \< 30 kg·m2
* Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes)

Exclusion Criteria:

* Smoking
* Diabetes (Type 1, Type 2, or genetic form of diabetes)
* Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
* Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
* Known allergy to lidocaine
* Regular use of dietary protein and/or amino acid supplements (\>3 times per week)
* Currently involved in a structured progressive resistance training programme (\>3 times per week)
* A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
* Any previous motor disorders or disorders in muscle and/or lipid metabolism
* Presence of an ulcer in the stomach or gut and/or strong history of indigestion
* Known severe kidney problems
* Pregnant or breastfeeding
* Unable to give consent
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).

Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secreting pancreatic neuroendocrine tumor, but other diagnoses such as nesidioblastosis of the pancreatic islets are also possible. Biochemically, EHH is characterized by low glucose concentrations in the presence of inappropriately increased C-peptide (endogenous insulin secretion) and insulin levels. The conventional fasting test is at present the gold standard to document EHH.

Radiolabeled Exenatide for localizing insulinomas in patients with biochemically proven EHH has been evaluated and an exenatide-test in an outpatient setting may be able to replace the fasting test, by an early symptomatic hypoglycemia compared to a prolonged inpatient monitoring.

This study is to investigate the concept of the exenatide test to diagnose EHH.

Eligibility Criteria:
Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:

Inclusion Criteria:

* Informed Consent as documented by signature
* Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations (standardized 72h fasting test).).

Participants as control subjects fulfilling all of the following inclusion criteria are eligible for the study:

Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Possession of the adequate match criteria (age, BMI and gender) to patients with suspicion for an insulinoma

Exclusion Criteria:

* Known hypersensitivity or allergy to Exenatide
* Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
* Calculated creatinine clearance below 40 ml/min
* No signed informed consent
* Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta® or Bydureon®\[= Exenatide\])
* prediabetes or diabetes (HbA1c \> 5.7 %)
* Previous abdominal surgery in the gastrointestinal tract
* Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)
* Any known intolerance to standardized meal (Maizena)
* Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study.
* Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient
Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation

Lactated Ringer(LR) has been extensively used to maintain and replace intravascular volume in a variety of anesthetic procedures. However, the utility of LR in pediatric with hepatic failure undergoing liver transplantation is unclear, because addition of exogenous lactate may increase lactate concentration. In addition,large amounts of normal saline(NS) which does not contain lactate can induce a hyperchloremic metabolic acidosis and have been asociated with adverse effects on kidney injury, coagulation, and death. Accordingly, the investigators performed a double-blinded randomized trial comparing the effects of intraoperative NS or LR on outcomes in pediatric receiving Liver transplantation.


Eligibility Criteria:
Criteria

Inclusion Criteria:

1. Pediatric patients between the age of 3 month and 6 years
2. Scheduled for living donor liver transplantation

Exclusion Criteria:

1. Re-transplantation
2. Combined liver and kidney transplantation
3. Congenital heart disease
4. Refused to participate the study
Multiple Chronic Diseases: the RITH Trial

In this research, investigators pretent to evaluate the effectiveness of clinical, functional, psychological and social impact of an intervention model based on shared care between the Mobile Rehabilitation and Physical therapy team (MRPTT) and nurse case managers of Primary Care in a sample of patients with multiple chronic diseases (comorbidities) and their caregivers. A non-randomised controlled trial.

The Experimental group consisted of patients with multiple chronic diseases referred to services in the province of Almería that comply the inclusion criteria and their caregivers. Outcome measures: sex, age, location, primary caregiver, disabling process, number and type of categories including by multiple pathologies, personal history, assessment (physical and functional), Barthel Index, Lawton and Brody index, risk of falls, Scale Pfeiffer, social support, caregiver burden, hospital readmissions and length, technical aids. Quality of Life (SF-12) and degree of user satisfaction. Regarding the intervention: date of application, date of assessment, objectives, treatment / intervention techniques, number of sessions, staff time spent.

Control Group: Patients with multiple diseases and their caregivers, belonging to health centers or areas where there is no figure nurse case manager or MRPTT. Registration information will consist of the same assessments, questionnaires and scales that are comparable to the experimental and control groups for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple chronic diseases that are referred to the nurse case managers and home rehabilitation.
* Detected in Hospital or Primary Care.
* To provide informed consent to participate in research.

Exclusion Criteria:

* clinical situation of agony;
* No acceptance of treatment by the patient or family
* Refuse to participate in the study
* Lack of cooperation of the patient or caregiver.
PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.

Clinical study in which researchers want to learn more about the safety profile of MESIGYNA used as a medication in routine clinical practice to prevent pregnancy. In order to find this out researchers will collect historic and treatment related data during initial visit and follow-up visits of adult women in reproductive age in the Peruvian population at the outpatient clinic. Mesigyna is a combined injectable birth control medication (norethindrone ethanate (50 mg) and estradiol valerate (5 mg)) for women given monthly.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients,18 to 45 years old with a Mesigyna prescription
* Women for whom the decision to initiate contraception with Mesigyna was made as per investigator's routine practice
* Signed Informed Consent

Exclusion Criteria:

* Women participating in an investigational program with interventions outside of routine clinical practice
* Hypersensitivity to norethisterone enantate or estradiol valerate
Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV.

Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective randomized control clinical trial. Methods: Patients were randomly assigned to two groups: optic capture without AV (Group 1) or in-the-bag implantation with AV (Group 2). The following variables were compared: visual acuity, intraocular pressure, refractive errors, IOL tilt and decentration, lenticular astigmatism, anterior-posterior synechia, inflammatory cell deposits on IOL and post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Children with congenital or developmental cataracts who had cataract surgery and primary IOL implantation at a tertiary care referral institute were included.

Exclusion Criteria:

* Traumatic or uveitic cataract, corneal opacity, iris coloboma, microphthalmia, microcornea, persistent fetal vascularization, congenital glaucoma, and retinopathy of prematurity were all considered exclusion criteria.
Development of AI Model for Uveitis Progression and Prognosis

Uveitis is a recurrent inflammation of the eye that can lead to vision loss with various and complicated etiologies. There are many difficulties in uveitis management due to the requirement of long-term monitoring and treatment. This study intends to establish a longitudinal cohort of uveitis patients to colloect multimodal clinical data including visual acuity, intraocular pressure, anterior segment photography, fundus photography, fluoroscopy and other ophthalmic examinations, and final diagnosis in order to use artificial intelligence and deep learning technology to extract ocular features, explore the association with the progression and prognosis of uveitis and finally establish a disease management model for uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Participants who were diagnosed as uveitis, including the initial stage or relapse, or remission of uveitis.

Exclusion Criteria:

* Participants who cannnot cooperate with ocualr examination.
ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery

The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.

Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.

In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women (ASA I or II)
* Elective cesarean delivery
* Spinal anesthesia
* Term gestation (37 weeks and above)

Exclusion Criteria:

* Multiple gestation
* Known coagulopathy
* Active labour
* Uterine fibroids
* Body mass index \> 45
* Emergency cesarean section
* General anesthesia
* Any contraindication to neuraxial anesthesia
* Cardiopathies
* Known allergies to carbetocin
* Patient refusal
* Placenta previa/Placenta accreta
* Hypertensive disease/Preeclampsia/Eclampsia
* Polyhydramnios
* Previous history of uterine atony or postpartum hemorrhage
* Renal or liver disease
Safety of Splenic Stimulation for RA

This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.

The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.

Eligibility Criteria:
Inclusion Criteria:

* Adult-onset RA of at least six months duration
* Male or female participants, 22-75 years of age
* Active RA
* Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
* Have an appropriate washout from previously used biological DMARDs or JAKi
* A female participant should have no child-bearing potential

Exclusion Criteria:

* Inability to provide informed consent.
* Significant psychiatric disease or substance abuse.
* History of unilateral or bilateral vagotomy.
* Active or latent tuberculosis
* Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B.
* Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
* Previous splenectomy
* Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
* Uncontrolled other inflammatory diseases
* Current/recurrent infections that in the opinion of the PI risk\>benefit.
* History of cancer within the past 5 years, except non-malignant skin cancer.
* Chronic use of morphine or oxicodone
Genetic Contributions to Autism Spectrum Disorders

This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.

Participation generally takes less than 2 hours to complete and travel to Children's Hospital Boston is not required. Participants are asked some questions about their medical and family history. The investigators also request permission to review medical records related to the ASD diagnosis. Finally, the investigators obtain a small blood or saliva sample in order to search for genes that may be important in understanding ASD. The investigators can arrange for the blood draw through a participant's physician or a clinical laboratory and saliva samples can be obtained through the mail. The study questions are answered via telephone or mailed questionnaires. There is no cost to participate.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an Autism Spectrum Disorder (autism, pervasive developmental disorder (PDD), or Asperger's syndrome)
* Age \> 18 months

Exclusion Criteria:

* Do not have the diagnosis of an ASD
* Participation in the "Phenotypic and Genetic Risk Factors in ASD" study at Boston Children's Hospital.
Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT

This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i) Performance scores in normal and severely visually impaired subjects with a clinical diagnosis of retinitis pigmentosa (RP) on MLYMT and MLSDT at multiple luminance levels and (ii) reliability and content validity of MLYMT and MLSDT.

Two assessment visits will be conducted in order to evaluate functional visual performance in severely vision impaired subjects with RP and normally sighted subjects. Two visits will occur at week 0 and week 4 with functional vision assessments occurring at both visits in order to assess visit-to-visit variability. For the MLYMT, navigational vision will be assessed using each eye and binocularly at up to 6 different light levels (range 0.3 to 100 lux). Subjects will also perform the Multi-Luminance Shape Discrimination Test (MLSDT) which assesses near object recognition under different lighting levels. MLYMT and MLSDT performance will be evaluated together with Best Corrected Visual Acuity (BCVA), Visual Field (VF) and responses to visual function questionnaires. Subjects will be assigned to one of two cohorts based on presence or absence of RP in addition to BCVA performance.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Able to comprehend and give informed consent.
3. Able to comply with testing and all protocol tests.
4. Eligible for 1 of 2 cohorts listed below:

Cohort 1: Normally Sighted Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 (as confirmed by ETDRS letter score \> 73) in each eye Cohort 2: Severely Sight Impaired Participants with BCVA no better than logMAR 1.6 in better seeing eye, and worse than LogMAR 1.9 in the worse seeing eye, and a clinical diagnosis of advanced RP

Exclusion Criteria:

1. Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
2. Presence of any condition other than RP Disease that impairs visual acuity or visual fields e.g., visually significant cataract or visual field loss in glaucoma
3. Presence of neurological condition that impairs visual acuity or visual field, e.g., hemianopia secondary to stroke
4. Individuals who refuse or are incapable of performing mobility testing
5. Individuals with retinal prosthesis (such as ARGUS-II)
6. Participation in Nanoscope studies NTXMCO-002 (RESTORE) or NTXMCO-004 (STARLIGHT)
Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.

A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult aged ≥ 19 and \< 55 year-old at screening
* Body mass index (BMI) ≥ 19.0 kg/m2 and \< 27.0 kg/m2 with a body weight ≥ 55 kg at screening.

Exclusion Criteria:

* History or evidence of clinically significant disease
* History of GI disease or surgery that may affect the absorption of a drug
* Laboratory test result which falls into the following values( ALT or AST \> 2 × upper limit of normal (ULN))
* History of regular alcohol consumption exceeding 210 g/week within 6 months
* Daily use of ≥ 20 cigarettes within 6 months
* Has taken any investigational agent within 6 months prior to the first dose of IMP
* Subjects who are considered ineligible to participate in this study at the discretion of the investigator.
A Study on Safety and Efficacy of Propofol in Small Children Under 2 Years of Age

This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.

EMR review of intravenous propofol used in target controlled infusion method in children under 2 years old.

Eligibility Criteria:
Inclusion Criteria:

* Children under 2 years of age
* Children who received intravenous propofol for maintenance of anesthesia

Exclusion Criteria:

* Children who underwent general anesthesia with inhalational anesthetics