rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Status: Not yet recruiting

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnoses of Congenital Heart Disease Age 18+ ACHD level of structural complexity II or III Recent (<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF < 60% Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by > 5% in the last 6 months or less. Must be able to complete neurocognitive assessments on a handheld computer.  Exclusion Criteria:  Diagnosed with Diabetes Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022). Previous therapy with Jardiance at <4 weeks Glomerular Filtration Rate <20 Pregnancy, breastfeeding, or planning to become pregnant in the coming year History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1) Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease, Gaucher disease, Tay-Sachs disease, Mucolipidosis IV, Niemann-Pick disease, Type A mitochondrial disease, Metabolic disorders related to glucose metabolism - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Sufentanil on the Postoperative Pain
Status: Not yet recruiting

This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who undergo elective robot-assisted nephrectomy surgery American Society of Anesthesiologists grade 1,2,3 Age > 18 years old  Exclusion Criteria:  Refuse to participate to the study Allergic history of opioid chronic pain opioid user before surgery MAO inhibitor user Severe respiratory insufficiency - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children
Status: Not yet recruiting

Sleep disorder in autism children is common and it affects the physical, behavior and mental health. There is lack of comprehensive management program/module to treat the sleep disorders in children with ASD. Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present. Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders, so as to improve the behavioral outcomes as well. This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged 4-10 years with diagnosis of ASD and ICSD based sleep disorder At-least 6 months of behavioral therapy and follow-up at AIIMS  Exclusion Criteria:  Refractory epilepsy Secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis ASD with metabolic disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 10 Years - StdAgeList: Child
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
Status: Not yet recruiting

Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Male; - Ages 25 and 60; - Diagnosis of oligospermia; - With sexual partner; - Indication of drug treatment with steroid hormones, precursors or analogues.  Exclusion Criteria:  - Severe oligospermia - Anatomical change - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues; - BMI 35; - Participant who presents liver enzyme and creatinine values above the upper limit of normality; - History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone; - Hypersensitivity to any ingredient present in the formulation; - Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety; - Proven infertility of the partner; - History of genetic disorder; - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk; - Active cancer at the discretion of the Investigator; - Participants with pregnant and breastfeeding partners; - Cycling and horse riding more than 3 hours per week; - Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism; - Smoking greater than half a pack per day or equivalent. - HealthyVolunteers: No - Gender: Male - MinimumAge: 25 Years - MaximumAge: 60 Years - StdAgeList: Adult
Dexamethasone and Pregnancy: Maternal Effects
Status: Not yet recruiting

This study will analyze obstetric, endocrine and metabolic follow-up data in women treated with DEX. It will reveal the prevalence and importance of weight gain, insomnia, edema, stretch marks, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up to 3 months after pregnancy, with the aim of improving the management of these women and preventing comorbidities.

A few studies suggest problems in women treated with DEX during pregnancy. However, all these studies are retrospective, based on self-questionnaires, and have not evaluated all pregnancy outcomes. Moreover, it would appear that a third of women treated with DEX no longer wish to resume the treatment (8). Compliance with treatment is strongly linked to its efficacy. It is therefore important to start investigating the pregnancy outcomes of women treated with DEX. This project is relevant because it has the potential to improve current clinical practice and recommendations related to this treatment, and thus have a direct impact on future patient care. The results of this study will guide us in the management of women presenting an indication for prenatal DEX treatment, and will help to inform the Order of November 15, 2022.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Femme majeure (âge ≥ 18 ans)  Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS :  Mutation sévère du gène CYP21A2 chez chacun des parents Fœtus féminin Grossesse unique Ayant commencé un traitement anténatal par DEX depuis au moins 24h  Exclusion Criteria:  Contraindication to dexamethasone treatment Objection to use of data Persons under legal protection (curatorship, guardianship), court-appointed guardians - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia - SamplingMethod: Non-Probability Sample
A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
Status: Not yet recruiting

This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female, ≥ 18 and ≤ 70 years old at the time of screening BMI ≥ 32 and ≤ 40 kg/m² at screening  Exclusion Criteria:  Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol) Participants who have had an increase or decrease in body weight more than 5% within the last 3 months Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months Use of any drug treatment that affects gastric pH Use of any drug treatment that affects gastrointestinal motility Diagnosis or treatment of any symptomatic or structural abnormality of the GI tract or active disease within 12 months Clinically significant symptoms (as determined by the Investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
Status: Not yet recruiting

This study aims to evaluate the effectiveness of neuromuscular electrical stimulation with superimposed voluntary contraction (NMES+ group) compared to NMES without voluntary contraction (NMES group) during the initial month of rehabilitation post anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group. Both groups will follow an identical rehabilitation regimen in the first month after surgery, which includes interventions for symptom management, inflammation control, edema reduction, improved joint motion range, and restoration of muscle function.

All participants will undergo identical assessment protocols at four time points: pre-surgery evaluation, and assessments at 2, 15, and 30 days post-ACLR. The primary outcome of the study is the maximal isometric strength of knee extensors. Secondary outcomes encompass thigh muscle atrophy, self-reported functional impairments, knee pain, knee edema, joint range of motion, and quadriceps activation status.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.  Exclusion Criteria:  Failure to attend the pre-surgery assessment session; Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study; Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)
Status: Recruiting

This is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. If eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  21-50 years old Heavy drinkers (consuming more than 4 drinks/day or more than 14 drinks/week for men, or more than 3 drinks/day or more than 7 drinks/week for women) Regular users of legal-market flower cannabis (at least 2x/week in past 3 months) report simultaneously using alcohol and legal-market flower cannabis at least once per month in the past 3 months English speakers.  Exclusion Criteria:  Daily tobacco users Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD) Females cannot be pregnant, breastfeeding or trying to become pregnant Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders, 5) Current use of psychotropic (except anti-depressants) Report illicit drug use in past 60-days or fail drug screen on the day of the study appointment Major medical condition contraindicating alcohol and/or cannabis consumption. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 50 Years - StdAgeList: Adult
Subcutaneous Administration of MD-18 in Healthy Subjects
Status: Not yet recruiting

A Single Center, Single Dose, Double-blind, Randomized, Placebo-controlled Dose-Escalating Study to Evaluate Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in healthy subjects.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects aged 18-70 years, both genders.  Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:  Absence of clinically significant illness or surgery within the preceding 12 weeks. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease. Male subjects with female partners of childbearing potential must agree to utilize an approved contraceptive during the study. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use contraception during the study. Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal). Body mass index (BMI) of 18.5-39.9 kg/m2  Exclusion Criteria:  History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen. Note: use of Cannabinoids for medical purposes is allowed. Pregnant or breastfeeding within six months of screening assessment. Substantial changes in eating habits or exercise routine within the preceding three months. Evidence of eating disorders. >5% weight change in the past three months. Bariatric surgery within the past five years. Significant renal impairment glomerular filtration rate (GFR) <60 milligram/milliliter/1.73m2). Liver function tests (i.e., alanine aminotransferase, Aspartate Amino Transferase, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression). Use of drugs approved for the treatment of obesity. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests. A baseline prolongation of ventricular activation and recovery interval after repeated measurements of >450 millisecond; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). Participation in an investigational drug trial within three months prior to dosing in the present study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Influence of Sodium Intake in spondyLoarthriTes
Status: Recruiting

The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)  Exclusion Criteria:  catient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists. current treatment with an anti-IL-17A agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-IL23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old. patients on systemic corticosteroids with corticosteroid therapy > 10 mg prednisone equivalent pregnant woman - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Relationship Between Respiratory Muscle Strength, Balance, Trunk Control, Functional Capacity in Stroke Patients
Status: Recruiting

The purpose of this study; To determine the relationship between respiratory muscle strength, balance, trunk control, functional capacity and motor functions in stroke patients and compare them with healthy individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Stroke individuals over the age of 18  Exclusion Criteria:  Patients with another neurological problem (Parkinson, Multiple sclerosis, etc.) that will affect functionality and balance other than stroke Patients with orthopedic problems (short limbs, spine and lower extremity surgery) with pulmonary disease Patients with cooperation and communication problems - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Stroke individuals over the age of 18 and healthy individuals who are followed up with a diagnosis of ischemic or hemorrhagic stroke and who apply to Kırıkkale University Faculty of Medicine Physical Medicine and Rehabilitation clinic will be included in our study.  Socio-demographic characteristics of all individuals (age, height, body weight, body mass index, exercise and smoking habits, dominant side, lesion side, stroke type and onset, comorbid conditions, fall history, etc.) will be recorded. - SamplingMethod: Probability Sample
Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy
Status: Recruiting

The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  GMFCS 4 or 5 with spastic cerebral palsy children Volunteering to participate in the study  Exclusion Criteria:  Botulinum toxinA injection in the last 3 months Surgical intervention involving the musculoskeletal system in the last 6 months Having an invasive medical pump (baclofen, insulin, etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 12 Years - StdAgeList: Child
rTMS-enhanced Psychotherapy for Borderline Personality Disorder
Status: Recruiting

This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section) minimum age 16, informed consent of the patient informed consent of patient's legal representative in case of patients under age 18  Exclusion Criteria:  neurological disorder comorbid affective disorder or schizophrenia-related disorder intelligence quotient<70 contraindications for MRI measurement contraindication for rTMS treatment pregnancy - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: cisgender female - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult
Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students
Status: Not yet recruiting

Approximately 60% of males and 40% of females do not meet current fluid intake recommendations, which is associated with adverse health consequences such as obesity, diabetes, and chronic kidney disease. Newer technologies have been designed to promote fluid intake. "Smart Water Bottles" use mHealth technology to capture fluid intake behaviors automatically and provide cues to encourage fluid consumption. Studies using Smart Water Bottles have helped some individuals increase fluid intake to help reduce kidney stone formation. However, limited research has assessed the efficacy of this technology on improving fluid intake in college students. College is a time with the potential to form healthy habits that carry into adulthood. Previous work has also identified daily changes in morning urine color, thirst perception, and body mass, as simple, inexpensive indicators of daily fluctuations in water balance. Tracking changes in these metrics has the potential to provide participants with evidence of adequate or inadequate fluid consumption. Thus, the combination of prompting from a smart water bottle, as well as daily self-monitoring changes in hydration status, may encourage college students to increase daily fluid consumption.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must report currently drinking less than the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (<2.5 L per day for males; <2.0 L per day for females). Has access to a cell phone which can download the app associated with the Smart Water Bottle.  Exclusion Criteria:  Currently trying to gain or lose weight Have had surgery of the digestive tract Currently taking diuretics (e.g., Thiazide, Loop diuretics or potassium-sparing diuretics) Currently taking centrally-acting medications (e.g., anesthetics, anticonvulsants, central nervous system stimulants/amphetamines, muscle relaxants) Report currently consuming at least the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (>= 2.5 L per day for males, >=2.0 L per day for females). Currently pregnant (females) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult