rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
TGRX-326 Pharmacokinetic Drug Interaction
Status: Recruiting

This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  healthy subject; male or female Age between 18 and 45 (inclusive) body mass index (BMI) between 19.0 and 26.0 (inclusive) agree to consent able to communicate with investigator well and complete the study according to study protocol  Exclusion Criteria:  abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.) any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody prolongation in QT interval use of substance that affects CYP3A4 enzyme activity with 30 days before screening use of any drug within 14 days of test article administration use of any investigational drug or participation of any clinical study within 3 months before screening vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period history of cardiovascular diseases history of mental conditions including depression, aggressive behaviours, epilepsy, etc. history of major surgery within 6 months before screen, or have unhealed surgical wounds. any clinically significant conditions that investigator believes could affect study outcomes history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of > 0.0 mg/dl at screening history of substance abuse, or positive drug results at screening history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice positive pregnancy test results, or pregnant/breast-feeding females history of unprotected sexual activities within 1 month before screening have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study any reasons that is deemed unsuitable for study participation as determined by investigator - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
taVNS Application Timing During Robotic Sensorimotor Task
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.

Main Questions it Aims to Answer:

How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?

Participants Will:

Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.

Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.

Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.

Comparison Group:

Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy participants above 18 years of age and able to provide informed consent and understand the study requirements  Exclusion Criteria:  Individuals with major untreated depression, major cognitive and/or communication deficits, and major comprehension and/or memory deficits that may interfere with the informed consent process, task-specific practice, or communication of adverse events will be excluded from the study. Neurological conditions such as epilepsy, participation in any other research trial, pregnancy, use of implanted electrical devices, and use of medication or procedure that interferes with vagal functions. Pregnancy or trying to get pregnant. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics
Status: Recruiting

Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.

This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1) Clinical diagnosis of carotid stenosis.  Exclusion Criteria:  Vascular stenosis with vascular malformations. Aneurysm. Severe heart, liver, or kidney disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults aged between 18 and 80 years old - SamplingMethod: Non-Probability Sample
Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
Status: Not yet recruiting

Objectives

Main objective:

Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain

Secondary objectives:

Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants from 18 to 65 years old Sign informed consent  Exclusion Criteria:  Diagnosed diseases at the time of the study. Severe previous psychiatric conditions. Medical contraindications that prevent the use of non-invasive neuromodulation therapy. Having exercised in the hours prior to the NESA treatment. Having consumed coffee or tobacco in the hours prior to the treatment. Minors. Individuals who have previously received any type of neuromodulation treatment. Cancer. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Comparison of Constraint Induced Movement Therapy and Mirror Therapy
Status: Recruiting

Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Medically diagnosed with Hemiplegic CP Age ranges btween3-12 years Hemiplegic CP with motor disability No major contractures of upper limb muscle Both genders were included Able to follow command No orthopedic surgery during the previous six months(8)  Exclusion Criteria:  Functional limb Patients with contracture Patient with sensory,cognitive and perceptual disorders Patient with seizures Patient with orthopedic surgery - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 12 Years - StdAgeList: Child
Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes
Status: Not yet recruiting

A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed Resides in the United States Endorses better concentration or cognitive function (fewer feelings of brain fog) as a primary desire Has the opportunity for at least 20% improvement in their primary health outcome Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study  Exclusion Criteria:  Report being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid US shipping address and mobile phone number Reports current enrollment in another clinical trial Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety lak Reports a diagnosis or cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) Lack of reliable daily access to the internet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 105 Years - StdAgeList: Adult, Older Adult
FCI in Post-operative Low Grade Gliomas
Status: Recruiting

The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.

The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with post operative low-grade glioma. Capacity to give informed consent. Capacity to co-operate with the scanning procedures and duration. Age 16 and above. Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner. Participants who meet the safety criteria for undergoing an MRI scan. Participants must be mobile enough to be positioned onto the FCI scanner couch.  Exclusion Criteria:  MRI-incompatible conditions, as detected in the MRI safety screening form. Restrictions to mobility that would prevent the correct positioning in the scanner by trained research radiographer (e.g., severe kyphosis). Participants who are unable to give fully informed consent. Women who are pregnant. Participants who are unable to understand or communicate in English. Patients who suffer from claustrophobia. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult
Intraocular Lens Implant Registry Study
Status: Recruiting

The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity  Exclusion Criteria:  Dementia Pregnancy Breastfeeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who receive an intraocular lens are offered to participate in the study. - SamplingMethod: Non-Probability Sample
KEEP Connecting Kin
Status: Recruiting

The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informal kinship caregivers in Oregon are defined as relatives or fictive kin who are caring for children between the ages of 4 to 18 years outside of the child welfare system with no birth/step parent living in the home.  Exclusion Criteria:  Informal kinship caregivers in Oregon who have previously participated in a KEEP or KEEP-CK group, or have a partner living in their home who has previously participated in a KEEP or KEEP-CK group. Focal child is not between the ages of 4-18 years at the baseline assessment. Focal child has been adopted by the kinship parent at the baseline assessment. Focal child is not living with the kinship caregiver full time (e.g., babysitting/weekends/vacations) at the baseline assessment. Focal child is in child welfare at the baseline assessment. Focal child is living with the kinship caregiver in a certified foster home at the baseline assessment. Focal child has a developmental disability or delay that impairs their ability to be responsive to the parenting content of KEEP-CK. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy
Status: Recruiting

This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment.

Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice?
Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Danish speaking Diagnosed with stage 3 malignant melanoma Eligible for adjuvant immunotherapy  Exclusion Criteria:  Metastatic disease Mental impairment - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients diagnosed with malignant melanoma who at about to receive adjuvant therapy with immunotherapy or targeted therapy - SamplingMethod: Non-Probability Sample
Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study
Status: Recruiting

Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .

Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .

Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  all patients with symptomatizing BPH who have a prostate volume > 60 gm and indicated for surgical treatment.  Exclusion Criteria:  patients with small fibrotic prostates, high PSA (not co-inciding with BPH), neurogenic bladder. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 50 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)
Status: Recruiting

The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.

The main questions it aims to answer are:

Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
Is the WELT-ED safe for use in the target population without causing adverse effects?

Participants will:

Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged between 19 and 65 years Diagnosed with an eating disorder according to ICD-10.  F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified)  Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening. Able to use a mobile application (app) on a smartphone without difficulty. After receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent.  Exclusion Criteria:  Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder. Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass). Have a BMI less than 17 kg/m^2 or more than 40 kg/m^2 at the time of screening. Diagnosed with a major psychiatric disorder according to the MINI. Have a past or current diagnosis of schizophrenia or bipolar disorder. At risk of suicide (C-SSRS score of 4 or higher) or have attempted suicide in the past 2 weeks. Have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months. Pregnant or planning to become pregnant during the trial period. Participated in another clinical trial within 4 weeks prior to screening. Have a history of alcohol or substance abuse. Considered by the investigator to be unsuitable for participation in this clinical trial for any other reason. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Noise, Oxidative Stress and Cardiovascular System
Status: Not yet recruiting

Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 18-65 both genders good self-reported health  Exclusion Criteria:  diabetes mellitus arterial hypertension or other cardiovascular diseases kidney diseases pregnancy malignant diseases mental diseases - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All persons who visit the Nutrition Counselling Unit of the Institute of Hygiene and Medical Ecology, located at the Faculty of Medicine, University of Belgrade will be eligible to participate in the study. The study population will include 75 participants with normal weight and 75 overweight/obese participants who meet the inclusion criteria for the survey. Participants will be informed of the protocol and sign an informed consent form. - SamplingMethod: Non-Probability Sample