rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX)
Status: Not yet recruiting

This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent form (or assent form as appliable) Aged from 2 to 75 years old Has a new or suspected diagnosis of CTX as defined by an elevated plasma cholestanol concentration (>10 mg/L/>25.7 μmol/L) in conjunction with a clinical presentation consistent with the diseased as assessed by the investigator Has never received treatment with CDCA Has never received treatment with other bile acid products  Exclusion Criteria:  Any medical condition that, in the opinion of the investigator, precludes the participant's participation in the study Presence of known hepatocyte dysfunction or bile ductal abnormalities such as intrahepatic cholestasis, primary biliary cirrhosis or sclerosing cholangitis Inability to adhere to treatment and visit schedule Female participants who are pregnant Female participants who are breast feeding Female participants who are using estrogen-containing compounds and cannot/will not discontinue them for the duration of the study Female participants of childbearing potential who are not using locally approved birth control method(s) or double barrier contraception (ie, condom and diaphragm, condom or diaphragm and spermicidal gel or foam) Taking any of the following medications: bile acid products; inhibitors of bile acid transporters; bile acid binding resins; aluminum-based antacids; coumarin and its derivatives; cholestyramine; ciclosporin; sirolimus; or phenobarbital - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 75 Years - StdAgeList: Child, Adult, Older Adult
Non-invasive Spinal Cord Stimulation After Spinal Cord Injury
Status: Recruiting

Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.

This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Has spinal cord injury, 6 mo or longer since injury Is between 20 and 65 years of age Has difficulty with trunk and/or lower limb function Stable medical condition Non-progressive etiology of spinal injury No ventilatory support  Exclusion Criteria:  Genetic or degenerative etiology of spinal injury Need for ventilatory or other life-sustaining medical support History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Status: Recruiting

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have Type 2 Diabetes (T2D) Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening Are of stable weight for at least 90 days prior to screening Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m^2)  Exclusion Criteria:  Have Type 1 Diabetes (T1D) Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 meter squared (mL/min/1.73 m^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory Have a prior or planned surgical treatment for obesity Have New York Heart Association Functional Classification IV congestive heart failure Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening Have a known clinically significant gastric emptying abnormality Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years Have any lifetime history of a suicide attempt Had chronic or acute pancreatitis Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis
Status: Recruiting

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.  Exclusion Criteria:  A prior solid organ transplant. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening. Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response. Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
Status: Not yet recruiting

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  >= 21 years old Smoke >= 5 cigarettes per day for the past year Willing to use either an EC or NRT Read and speak English Have a smartphone  Exclusion Criteria:  Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation Current use of an EC > 4 days a month Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD) Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia History of cardiac event or distress within the past 3 months Currently pregnant, planning to become pregnant within 6 months, or breastfeeding High blood pressure not controlled by medications Serious angina pectoris or chest pain Stroke within the past three months Known allergy to propylene glycol or vegetable glycerin - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
Search for Olfactory Cells Within the Fetal Ethmoid Epithelium
Status: Not yet recruiting

The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis.

In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base.

The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population.

This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Fetus aged at least 7 weeks of gestation up to 14 weeks + 6 days. Fetus resulting from an in-hospital procedure of voluntary termination of pregnancy, either medicinal or surgical. Fetus whose mother is of legal age and legally responsible. Fetus whose mother has been provided with fair and complete information about the research conducted and has given informed, voluntary, and written consent for the use of fetal products from the voluntary termination of pregnancy procedure she is undergoing. Fetus whose mother has not objected to the utilization of data derived from the research.  Exclusion Criteria:  Fetus macroscopically exhibiting a craniofacial malformation - Gender: All - MinimumAge: 7 Weeks - MaximumAge: 15 Weeks - StdAgeList: Child - StudyPopulation: Fetus aged 7 to 14+6 weeks of gestational age resulting from an in-hospital voluntary termination of pregnancy procedure - SamplingMethod: Non-Probability Sample
Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain
Status: Not yet recruiting

The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patients had CNSLBP with age from 20 to 40 years from both genders. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm. Patients with normal BMI ranges between 18.5:24.9 kg/m2. The study populations must be willing to participate in the study  Exclusion Criteria:  Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II. Psychiatric/mental deficit. Patients who had a previous surgical history (within 6 months) will also excluded. participation in other treatment within the previous 3 month. Pregnancy. History of spinal fracture, tumor, osteoporosis use of medication, such as corticosteroids, anticonvulsants, and anti-inflammatory drugs that may affect the outcome of the study. prior history of adverse effects to physical stimulation therapy. significant physical or mental deficiencies preventing a clear understanding of the study procedure. spinal stenosis, thyroid dysfunctions, obesity, pace-maker. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult
Effect of Chitodex Gel in Tympanoplasty Surgery
Status: Recruiting

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND Are indicated to undergo closure of the perforation via tympanoplasty surgery AND Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND Are 18 years of age or over AND Are able to give written informed consent AND Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op  Exclusion Criteria:  Operative ear is the better or only hearing ear The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination dysfunction during otoscopic and tympanometric examination Known allergy to shellfish or ciprofloxacin antibiotics Pregnant or breastfeeding Hepatitis, HIV or any blood disorders COVID-19 positive patients - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Ethical Attitude and Humanistic Acting Skills of Intensive Care Nurses
Status: Recruiting

Today, rapidly developing technology and changing treatment and care conditions increase the tendency towards ethical values both as an intellectual concept and as a moral guide. The nursing profession, which focuses on people in ethical terms, is also performed by people. This situation brings with it many ethical dilemmas in areas where health care services are provided. In ICUs, long and critical treatments of patients, differences of opinion between the medical team and the institution, non-compliance with patient rights, difficulties in terminal patient care, procedures performed without the patient&#39;s consent, distribution of limited medical resources, unethical attitudes and attitudes of nurse colleagues, Many issues such as long-term exposure to stressors and constant alarm sounds can cause mental distress and negative emotions in intensive care nurses. One of the effective ways to increase the quality of care provided by nurses is humanistic practice ability. The presence of humanistic practice ability provides more realistic, human-centered nursing care, improves the quality of life of patients, and also positively affects health expenditures.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Becoming an intensive care nurse Volunteering to participate in the study  Exclusion Criteria:  Not being an intensive care nurse Not volunteering to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Nurses actively involved in the intensive care unit. - SamplingMethod: Non-Probability Sample
Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
Status: Recruiting

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  De novo adult KTRs  Exclusion Criteria:  Underlying heart disease, defined as aberrant CPET, unstable angina, non-revascularized lesions or life-threatening arrhythmias Uncontrolled hypertension Uncontrolled diabetes, defined as HbA1c ≥ 9% Musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise Multi-organ transplantation Ongoing treatment for malignancies Unable to understand Dutch No access to smartphone and/or computer with internet access Severe pulmonary disease defined as either forced vital capacity (FVC) <50%, one-second value (FEV1) <50%, or a diffusing capacity for carbon monoxide (DLCO) <40% that excludes all serious underlying respiratory disease (pulmonary fibrosis, COPD GOLD II-IV, PAH). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Tolerability of Enteral NAC in Infants
Status: Not yet recruiting

Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology.

This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  122-273 days of life at time of enrollment Confirmed diagnosis of biliary atresia based on intraoperative cholangiogram Able to tolerate oral nutrition and medications and not on continuous tube feeds Anticipated inpatient admission of at least 4 days Legal guardian(s) consent to study enrollment after understanding the risks and investigational nature of the study  Exclusion Criteria:  Gestational age of <32 weeks at birth Inability or contraindication to taking oral nutrition Neonatal intensive care unit admission Short bowel, or other malabsorptive, syndrome Decompensated liver disease (INR > 1.3 despite vitamin K administration) Active respiratory infection Severe concurrent illnesses that would interfere with the conduct and/or results of the study Concurrent participation in another drug trial - HealthyVolunteers: No - Gender: All - MinimumAge: 122 Days - MaximumAge: 273 Days - StdAgeList: Child
Core Endurance in Healthy Young Adults
Status: Recruiting

This study aimed to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time in healthy young adults. The "core" region functions as a connection point between the upper and lower extremities and enables the transfer of force from this region to the extremities. This region is a basic structure where the force required for all movements is generated and transmitted from the proximal segments to the distal segments. "Core" stabilization has a significant impact on limb functionality, and stabilization of the proximal segments is necessary to maintain the mobility and function of the distal segments. To establish a stable base during functional activities, the "core" muscles are activated before the upper and lower extremity muscles. This ensures force production and transfer of resulting forces, thus supporting the mobility of the distal segments. Increasing core stabilization increases force production in the extremities, and control of core strength, balance and movement maximizes upper and lower extremity functions. Any impairment in core stabilization reduces the quality of movement and increases the risk of injury to the upper extremity. Therefore, it has been stated that "core" stabilization has a significant effect on athletic performance and upper extremity functions. There are not enough studies in the literature investigating this effect in healthy young adults. Most existing studies focus on the role of core endurance on athlete performance.

The aim of this study is not only to investigate core endurance levels in healthy young adults but also to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals between the ages of 18-25. Individuals who volunteer to participate in the research. Individuals with normal joint movement.  Exclusion Criteria:  Individuals with orthopedic or neurological diseases. Individuals who have suffered fractures, dislocations, surgeries, etc. in the upper extremities. Individuals with diseases that may affect upper extremity performance Individuals who exercise regularly Individuals who play any musical instrument - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult - StudyPopulation: 104 Healthy young adults - SamplingMethod: Non-Probability Sample