cyrilzakka/clinical-trials huggingface dataset:
Community-based Physical Fitness Exercise on the Older Adults' Functional Fitness and Adherence to Physical Activity

Maintaining adequate physical activity (PA) and regularly exercising are very important to promote the good physical and mental health of the elderly. According to the transtheoretical model (TTM) framework, previous research studies have formulated many strategies to promote exercise behaviors, such as incentive strategies, combines municipal resources and links up with the referral of primary care institutions, or including patients in the decision-making process about exercise choices to enable patients to have greater autonomy. In addition, in terms of the strategic aspects of achieving goals, competitive incentives are also an effective strategy. Therefore, this study aims to find out the effects of the community-based physical fitness exercise course, which is given according to TTM, on improving functional fitness and exercise persistence of the older adults.


Eligibility Criteria:
Inclusion Criteria:

* age between 65 to 90 years old
* can stand up from a chair without armrests
* can walk independently for 2 minutes without relying on any mechanical assistance
* no medical issues according to the PAR-Q+ form assessment
* can complete the Senior Fitness Test (SFT)

Exclusion Criteria:

* diagnosed with severe dementia (unable to understand and/or follow verbal commands)
* suffering from stroke, severe hypertension, heart disease, and diabetes
* hip or knee replacement surgery in the past 6 months
* hip fracture
* having undergoing rehabilitation plan
* unable to complete the pre-tests or post-test
Resistance Training Effects on Gut Microbiome and Cardiometabolic Outcomes

The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.

The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* BMI: 25-45 kg/m2
* Sedentary lifestyle
* Consistent diet patterns
* Weight-stable (\<4 kg change over the last 3 mo)
* Willingness to adhere to resistance training protocol and not change diet
* Non-smoker \>1 year or more

Exclusion Criteria:

* Disabilities preventing adherence to resistance training protocol
* Recent start of medications that affect metabolism or appetite
* Antibiotics
* Diabetes
* Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
* Uncontrolled hypertension and blood pressure ≥ 180/110
* Gastrointestinal disease and/or bariatric surgery
* Smoking
* Illicit drug use
* Pregnant or lactating individuals
The Relationship Between Reaction Time and Executive Functions in Female Athletes

The literature shows the positive effects of regular physical activity and sports on executive functions. It is seen that the low reaction times of the athletes increase their success and prevent injuries. However, as a result of the examinations, no studies were found that examined the relationship between the reaction times of the athletes and their executive functions. In this context, it is aimed to examine the relationship between reaction time and executive functions in amateur female athletes who play team sports.

Executive functions are often described as 'higher cognitive processes' that govern other basic cognitive functions. Executive functions include higher-order cognitive abilities such as planning, decision making, problem solving, strategizing, working memory, inhibition, cognitive flexibility, abstraction, and reasoning. It enables individuals to organize their thoughts and actions during goal-directed behavior, to think, to produce ideas, to respond and to control in the face of unexpected situations.

Response time is the time elapsed after the stimulus reaches the body until the first response to these stimuli. It is the time between the first reaction that occurs after the appearance of a sensory, visual or tactile stimulus. Athletes must respond quickly to a ball, the movement of another athlete, or incoming signals to compete successfully and avoid injury. The reaction time depends on the neurophysiological processes in the brain.

In our study, which was planned to evaluate the relationship between reaction time and executive functions in 66 amateur female athletes between the ages of 18-25, who are university football, basketball and volleyball team athletes; The age, body mass index (BMI), sports branch, duration of interest in sports will be recorded in the demographic information form. Hand-eye and foot-eye reaction time of the athletes will be evaluated by BlazePod Reaction Time Determination Test and executive functions will be evaluated with Forward-Backward Number Range test, Stroop test and Tracking A-B test.

Eligibility Criteria:
Inclusion Criteria:

* At least 5 years of sports
* Being an athlete on university sports teams

Exclusion Criteria:

* Athletes with health problems (eg cancer, arthritis, heart disease, lung disease, neurological or psychological illness)
Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.

The goal of this study is to use multimodal MEG/EEG to gain novel insight into the acute effects of THC on neural noise and its interaction with the fast information processing dynamics of the brain's cognition-related functional neural networks.

Eligibility Criteria:
Inclusion Criteria:

* Cannabis use at least once in the past 12 months
* No cannabis use during the course of the study confirmed with negative urine toxicology at screening and on each test day
* Good physical and mental health

Exclusion Criteria:

* Cannabis naïve individuals
* Lifetime or current medical, psychiatric or psychosocial disorders or history that is deemed unsuitable for participation in the study per PI discretion.
* Positive pregnancy test, lactation, or refusal to practice birth control for the duration of the study and for two weeks following completion
* Major current or recent stressors
* Positive urine drug test
* Contraindication for Magnetic Resonance Imaging
* Treatment with psychotropic medication as per discretion of the PI
* IQ less than 80
* Weight exceeding 166kg
* Diagnosis of major psychotic or manic disorder in first-degree relatives.
Tonicity Monitor For Epilepsy and Hypertonic Disorders

Epilepsy is an episodic disorder which can result in recurrent seizures often associated with hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). Hypertonia can often occur before full expression of the seizure and so detection of hypertonia could act as an alarm to epilepsy patients and carers in order to prepare for a seizure event. Secondly, a recording device for seizure frequency and duration is a valuable clinical tool for collecting data for clinicians who manage the disorder in primary and tertiary care. The investigators have developed a portable prototype for hypertonia detection using a non-invasive, muscle activated, sensor that records seizure activity. The investigators now want to test this sensor system in patients identified by Consultant Clinician Custodians within the Wales Epilepsy Research Network (WERN). The Epidetect® prototype has been developed by VIKEL LTD™ in collaboration with WERN - a Welsh Assembly funded network.


Eligibility Criteria:
Inclusion Criteria:

For phase 1 of the trial; - admission to the neurophysiology department at Morriston hospital for in patient video telemetry

For Phase 2 of the trial:

1. For PG-1 and PG-2 the persistence of intractable tonic-clonic epilepsy
2. For PG-3 the clinical suspicion of dissociative seizures
3. For PG-4 the clinical diagnosis of absence epilepsy
4. For CG-1 the absence of neurological, muscular-skeletal disorders
5. Suitable circumstances for informed consent in all instances

Exclusion Criteria:

For Phase 1 of the trial:

- a diagnosis of a movement disorder

For Phase 2 of the trial

1. Where learning difficulties in adult patients or carers prevents informed consent or proper home supervision in PG-2.
2. Where neurological diagnosis is ambiguous or incomplete.
3. Where topical application of the sensors causes discomfort or psychological distress.
The Clinical and Pharmacoeconomic Impact of Rapid Diagnostic Test (Multiplex PCR FilmArray) on Antimicrobial Decision Making Compared to Conventional Decision Making Among Critically Ill Patients

We will show in this study the impact of use the rapid diagnostic method (multiplex PCR filmArray) on clinical and pharmacoeconomic aspects among Critically Ill Patients.

Prospective and retrospective study on 100 patients complaining from sepsis in intensive care unit in International Medical center. Two phase study 50 patients before and 50 patients after use rapid diagnostic test (multiplex PCR filmArray)

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Critically ill patients admitted to ICU, diagnosed as sepsis.

Exclusion Criteria:

* Surviving time less than 48 hours.
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.


Eligibility Criteria:
INCLUSION CRITERIA

To be considered for enrollment in this study, patient must:

* be at least 22 years old
* have cataracts in both eyes
* sign the written informed consent
* be willing and able to comply with examination procedures
* understand, read and write English to complete informed consent and questionnaires
* be available for study follow-up visits EXCLUSION CRITERIA

Patient will not be eligible to take part in the study if:

* currently participating in any other clinical study or have participated in a clinical study during the last 30 days
* have a certain disease/illness, such as poorly controlled diabetes
* have certain ocular conditions, such as uncontrolled pressure in the eye
* taking medication that may affect vision
* pregnant, plan to become pregnant during the study, or are breastfeeding
Virtual Reality-Supported Cardiac Rehabilitation: Psychological, Functional, and Physiological Perspectives

The study aims to evaluate the effectiveness of virtual reality-assisted cardiac rehabilitation compared to conventional cardiac rehabilitation in improving psychological outcomes-depression, stress, anxiety, and kinesiophobia-along with physiological parameters, functional status, physical activity levels, and quality of life in cardiac patients.

This single-blind randomized controlled trial will include 60 participants aged 60 years and older undergoing Phase II CR at the Provincial Specialist Hospital of the Blessed Virgin Mary in Częstochowa, Poland. Participants will be randomly assigned to one of two groups: a conventional CR program or a VR-CR group. Both groups will complete a three-week hospital-based CR program involving structured group exercises, interval cycling, and relaxation sessions. The experimental group will additionally receive eight sessions of immersive VR therapy using the VRTierOne device, consisting of 20-minute sessions twice weekly. These sessions employ interactive and calming virtual environments to promote relaxation and psychological engagement. Outcome measures will be evaluated at baseline (week 0), post-intervention (week 3), and follow-up (week 7). Assessments will include Patient-Reported Outcome Measures for stress, depression, kinesiophobia, and quality of life, physiological metrics (heart rate, blood pressure, metabolic equivalents), HRV, functional capacity (6MWT), and physical activity levels measured using the pedometers.

Eligibility Criteria:
Inclusion Criteria:

* cardiovascular diseases (atherosclerosis, hypertension, coronary artery disease, ischemic heart disease, peripheral artery disease, rheumatic heart disease, deep vein thrombosis, pulmonary embolism, and post-myocardial infraction)
* the second stage of cardiac rehabilitation conducted in outpatient settings

Exclusion Criteria:

* Severe psychiatric disorders (e.g., psychotic symptoms, bipolar disorder)
* initiation of psychiatric treatment or individual psychological therapy during the study period
* current use of antidepressant medications
* cognitive impairments that hinder questionnaire completion, consciousness disorders
* sensory impairments (e.g., severe visual or auditory deficits) that limit interaction with virtual reality.
The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection

The aim of this study was to examine the effect of the Helfer Skin Tapping technique on pain, fear, and anxiety in children who received intramuscular injections.

The research hypotheses are as follows:

H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" during and after the Helfer Skin Tapping technique.

H1: During and after the Helfer Skin Tapping technique, the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" is significantly lower in the intervention group compared to the control group.

In this study, there will be two groups as the intervention (who will receive an intramuscular injection with the Helfer Skin Tapping technique) and the control group (who will receive an intramuscular injection with Routine Technique). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The intramuscular injection will be applied to both the intervention and control groups. The children in the intervention group will receive an intramuscular injection with the Helfer Skin Tapping technique and the control group will receive an intramuscular injection with Routine Technique in the pediatric emergency service. A researcher and a nurse were employed for the intramuscular injection both for the intervention and control groups. A pediatric nurse performed the intramuscular injection for all children and the other researcher helped the children to assess their pain, fear, and anxiety level. Pain, fear, and anxiety in children were evaluated by the children and their parents before, during, 5 minute after the procedure. The intramuscular injection will be performed by the same nurse both in the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 4-10
* The child's application to the Pediatric Emergency Unit
* Parent and child agreeing to participate in the project
* Absence of speech and visual impairment of the child and his parents

Exclusion Criteria:

* The child is not between the ages of 4-10
* The child's application to another department except for the Pediatric Emergency Unit
* Parent and child not agreeing to participate in the project
* Having speech and visual impairment of the child and his parents
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.


Eligibility Criteria:
Primary Inclusion Criteria:

* Health care professional (eg, physician, osteopath, nurse, pharmacist)
* 18 years of age or older
* Enrolled or enrolling in an extended outpatient treatment program for opioid dependence
* Women of childbearing potential must agree to use an approved method of contraception for the duration of the study

Primary Exclusion Criteria:

* Pregnancy and/or lactation
* Evidence of hepatic failure
* Active hepatitis
* Any psychiatric disorder that would compromise ability to complete study requirements
* Recent history of suicidal ideation or attempt
* Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine
* Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children

This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the PEPITES study.

Exclusion Criteria:

* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
* Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.
Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 to 64
* Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
* Sleep difficulties at least 2x per week in the preceding month
* Be on a stable dose of antipsychotic medication
* Symptomatically stable in the last 2 months
* English speaking.

Exclusion Criteria:

* Meet criteria for current alcohol or other substance dependence
* A history of dementia, mental retardation or other neurological disorder
* Not capable of giving informed consent for participation in this study.
* Ongoing pregnancy
* Known sensitivity to zopiclone.
* Insomnia associated with medical disorders likely to impair sleep.
* Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
* Lack of sleep benefit from previous adequate eszopiclone treatment
* History of clinically significant hepatic impairment.
* Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.
A Study of BBI503 in Adult Patients With Advanced Solid Tumors

This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
2. A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
3. ≥ 18 years of age
4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
5. Karnofsky performance status ≥ 70%
6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
7. Females of childbearing potential must have a negative serum pregnancy test
8. Aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 1.5 × upper limit of normal (ULN)
9. Hemoglobin (Hgb) ≥ 10 g/dl
10. Total bilirubin \< or equal to 1.5 × ULN
11. Creatinine \< or equal to 1.5 x ULN or creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
12. Absolute neutrophil count \< or equal to 1.5 x 10\^9/L
13. Platelets ≥ 100 x 10\^9/L
14. Life expectancy ≥ 3 months

Exclusion Criteria:

1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503
2. Surgery within 4 weeks prior to first dose
3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
4. Pregnant or breastfeeding
5. Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection and small intestinal resection)
6. Unable or unwilling to swallow BBI503 capsules daily
7. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements