rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Stress-motivated Alcohol Use as a Value-based Decision-making Process
Status: Recruiting

The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question[s] it aims to answer are:

Does psychological stress affect the decision to consume (more) alcohol?
How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Drinking alcohol at least once a week Consuming 4 (female) or 5 (male) drinks in one occasion at least once a month  Exclusion Criteria:  Currently pregnant or trying to become pregnant Past or current diagnosis of an anxiety disorder, such as Generalized Anxiety Disorder or Post-Traumatic Stress Disorder Past or current treatment for alcohol use Past or current medical condition that contraindicates alcohol use Past or current reaction to alcohol that contraindicates alcohol use Past or current medication that contraindicates alcohol use - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
Scalp Block -Craniotomi
Status: Recruiting

Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.

In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who underwent craniotomy under elective conditions ASA I-III 18-75 years old GCS >13  Exclusion Criteria:  GCS <13 Emergency surgery Presence of contraindications to the LA agents used in this study Chronic use of opioids Psychiatric disorders Presence of infection at the injection site Uncontrolled intracranial hypertension Chronic hypertension, Coronary artery disease, arrhythmia, Coagulopathy, Patients who have previously undergone craniotomy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Erector Spinae Block -Dexmedetomidine
Status: Recruiting

Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.

Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Written informed consent; 18-75 years old ASA Physical Status 1-3; Patients planned for lumbar disc surgery  Exclusion Criteria:  Rejection during registration Request for dismissal from employment Inability to give informed consent Emergency surgery Bleeding diathesis Chronic use of opioids Psychiatric disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
CommunityRx-Cardiovascular Disease
Status: Not yet recruiting

The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:

• What is the effectiveness of community resource information on patient self-efficacy to use community resources?

Participants will be given:

A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
Access to a community resource navigator for support with using the HealtheRx upon request
2 text messages with reminders about the HealtheRx and access to the community resource navigator

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patient African American age 2 or older  Have at least one cardiometabolic condition:  Overweight (BMI greater than or equal to 25 kg/m^2); Obesity (BMI greater than or equal to 30 kg/m^2); ICD-9 or 10 diagnostic code for overweight or obesity Adult prehypertension (SBP 120 to 129 and DBP greater than 80 mmHg); Adult hypertension (SBP greater than or equal to130 or DBP = 80 mmHg); Pediatric Prehypertension (SBP or DBP greater than or equal to 90th but <95th percentile) Pediatric Hypertension (SBP or DBP greater than or equal to 95th percentile); ICD-9 or 10 diagnostic code for hypertension Adult and Pediatric Prediabetes (Fasting glucose 100-125 mg/dL or OGTT 140-199 mg/dL) Adult and Pediatric Diabetes (FPG greater than or equal to126 mg/dL (7.0 mmol/L) or OGTT greater than or equal to 200 mg/dL (11.1mmol/L) or HgbA1C greater than or equal to 6.5); ICD-9 or 10 diagnostic code for diabetes, pre-diabetes or elevated glucose, or gestational diabetes; Adult and Pediatric Total cholesterol (>200mg/dL; LDL >130mg/dL; HDL < 35 mg/dL; TG greater than or equal to150mg/dL); ICD-9 or 10 diagnostic code for hyperlipidemia  Exclusion Criteria:  Unable to read, speak or understand English Unable to receive text message or email communications Living in the same household as someone already enrolled in the CRx-CVD study Adults with limited life expectancy (e.g., advanced cancer, end stage liver disease, hospice) Adults receiving treatment for cancer Adults living in skilled nursing facilities Dementia/other significant cognitive impairment - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - StdAgeList: Child, Adult, Older Adult
Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback
Status: Recruiting

The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ischaemic or hemorrhagic lesion in one hemisphere only (right or left hemiplegia/hemiparesis) Presence of unilateral spatial neglect confirmed by neuropsychological examination Mini Mental State Examination > 23 The patient must be able to maintain a sitting position and rotate his head Onset acute event no later than 180 days from the date of enrollment  Exclusion Criteria:  Multiple or bilateral lesions Presence of visual difficulties Right neglect with associated aphasic deficit (in comprehension) Mini Mental State Examination < 23 Presence of degenerative pathologies, tumors, or other comorbid pathologies Epilepsy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
Status: Not yet recruiting

This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.

Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

Eligibility:
- EligibilityCriteria: Inclusion:  Adult caregivers will be eligible if they:  Are English speaking. Have a child who is 1-10 years of age with SCD (any genotype) who has been prescribed hydroxyurea for at least 180 days prior to enrollment. Note: Caregivers who have multiple children meeting criteria will only be able to enroll once.  Adolescents (>11 years at enrollment) are eligible if they:  Are English speaking. Are 11-25 years of age. Have a diagnosis of SCD (any genotype) and have been prescribed hydroxyurea for at least 180 days prior to enrollment.  Exclusion:  Adolescents and caregivers of younger children who participated in the previous VDOT study will be excluded. Adolescents and caregivers of younger children receiving multiple SCD modifying treatments (e.g., chronic transfusions or L-glutamine) will be excluded.  Randomization: enrolled subjects will be eligible for randomization if they open their electronic adherence monitoring device at home at least once during the run-in period. - HealthyVolunteers: No - Gender: All - MinimumAge: 11 Years - StdAgeList: Child, Adult, Older Adult
Hepcidin After Intravenous Iron Treatment
Status: Not yet recruiting

The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  informed consent as documented by signature iron-deficiency (serum ferritin <30ng/ml) female gender premenopausal age >18 years body mass index (BMI) in normal range (18-25 kg/m²) the participant is linguistically and cognitively able to understand the study procedure  Exclusion Criteria:  anaemia (hemoglobin <117g/l) allergy or contraindications for iron infusions anamnestic current pregnancy breastfeeding chronic inflammatory diseases (e.g. colitis) liver disease (alanine transaminase (ALT) >35 U/l) increased C-reactive protein (CRP) (>5mg/l) intake of dietary supplements containing iron (last 7 days) - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: iron deficient non-anemic women - SamplingMethod: Non-Probability Sample
Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos)
Status: Recruiting

The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject's written informed consent obtained prior to any study related procedure; Male and female adults aged ≥ 18 and ≤ 75; Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive; Non-smokers or ex-smokers who smoked < 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking > 1 year (6 months for e-cigarettes) prior to screening; Diagnosis of asthma: physician-diagnosed asthma for at least 6 months and with diagnosis before the age of 50 years; Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine > 500-1000 μg and > 1000 μg respectively, or estimated clinical comparable dose). Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.  Exclusion Criteria:  History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment; Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation); Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction
Status: Not yet recruiting

There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patient must be able willing and able to provide informed consent. The investigators wil enroll males between >30 and <70 years of age who have ED based on IIEF scores (score between 16 and 25.) with patients suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.  The patient has been in a stable relationship for over 3 months prior to enrollment with a minimum of 2 sexual attempts per month for at least one month prior to enrollment.  A1C level ≤ 7% within 1 month prior to enrollment.  Exclusion Criteria:  Participating in another study within the past three months that may interfere with the results or conclusions of this study, under judicial protection (prison or custody), adult under guardianship, or patient refuses to sign the consent.  History of radical prostatectomy or extensive pelvic surgery, past radiation therapy of the pelvic region within 12 months prior to enrolment, recovering from any cancer within 12 months prior to enrollment.  Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator, psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.  Anatomical malformation of the penis, including Peyronie's disease.  A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.  The patient is taking blood thinners and has an international normalized ratio (INR) >3.  Received shockwave treatment at least 6 months before enrollment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 30 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension
Status: Recruiting

The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:

If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
If the changes in lipid profile are in a dose-response manner

Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug  Exclusion Criteria:  Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- - Hypothyroidism Having previously suffered a myocardial infarction or stroke Pharmacological treatment with insulin, sulfonylureas, protease inhibitors Chronic gastrointestinal disease Pregnancy or intention to become pregnant during the study period. Breastfeeding Allergy or intolerance to garlic High alcohol consumption (>14 units per week) Smokers - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery
Status: Not yet recruiting

The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Males and Females ages over 18 years Patients who undergo ankle arthroscopic surgery Patients who are able to read and give informed consent on their own behalf  Exclusion Criteria:  Patients with any known cardiac diseases Uncontrolled hypertension (> 180/110 mmHg) Revision case Younger than 18 years of age Pregnant women - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.
Status: Recruiting

The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Increased homocysteine level above 15 µmol/l; Increased LDL level >=1.4 mmol/l.; Absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study;  Exclusion Criteria:  Individual intolerance to the components of the substance; Pregnancy or breastfeeding; Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year); Taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism
Status: Not yet recruiting

This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1 TPOAb levels > 300 IU/mL  Exclusion Criteria:  Age < 18 years and >85 Pregnant or breastfeeding woman Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury
Status: Not yet recruiting

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient has been diagnosed with traumatic brain injury Patient has self-identified as planning to enroll in an observational clinical trial Patient is a minimum of 18 years or older  Exclusion Criteria:  Pregnant or nursing patients Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Quantity of participants in traumatic brain injury study who sustain participation until study completion - SamplingMethod: Probability Sample