cyrilzakka/clinical-trials huggingface dataset:
Role of Aging and Individual Variation in Exercise Training Responsiveness

The primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (Parent trial: STRRIDE-PD; NCT00962962). This feasibility pilot study will enroll up to 8 participants to complete a 6-month aerobic exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who completed participation in the STRRIDE-PD trial (NCT00962962)
* Body Mass Index (BMI) \> 18 and \< 45 kg/m2
* Stable dose (≥1 month) of any cardiometabolic medications

Exclusion Criteria:

* Poor vein access
* Current use of tobacco or any nicotine products, including e-cigarettes
* Insulin-dependent diabetes
* Active untreated hyper or hypothyroidism with thyroid stimulating hormone (TSH) concentrations \< 1.5 or \> 10.0 uIU/mL
* Systemic inflammatory or connective tissue disease, chronic infectious disease, chronic pulmonary disease or symptomatic cardiovascular disease with positive functional study by ECG or imaging
* Current, actively treated malignancy other than dermatologic conditions
* Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
* Relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension, significant anemia, important electrolyte imbalance, and hyperthyroidism
* Modified testing contraindications: acute myocardial infarction (MI) within six months; resting hypertension with systolic or diastolic blood pressures \>160/90 mmHg
* Unable to safely participate in an exercise program per study protocol per PI discretion
* Planned, intentional weight loss during study
Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

This pilot clinical trial studies the side effects and best dose of apigenin in increasing health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound that may have anti-cancer activities. Eating a celery-based diet may help in prevention and treatment of inflammatory diseases including cancer.

PRIMARY OBJECTIVES; I. To determine the feasibility of apigenin oral supplementation using a specially formulated celery-banana bread.

II. To determine the safety and tolerability of apigenin supplementation.

OUTLINE: This is a dose-escalation study.

Patients consume one serving of lower dose apigenin celery-banana bread daily on days 1-7, and then consume one serving of higher dose apigenin celery-banana bread on days 8-14. Patients undergo blood sample collection on day 1 prior to and 6 hours after bread ingestion, on day 8 prior to and 6 hours after ingestion of bread, and on day 15 (or endpoint). Patients also provide a baseline urine sample and then 24-hour urine samples on days 1, 7, 8, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be followed in Stefanie Spielman Comprehensive Breast Center (SSCBC) High Risk Breast Clinic
* No known allergy to ingredients of banana bread preparation (eggs, almonds and other nuts since the celery also has almond powder)
* Must be \> 1 year from pregnancy, lactation or chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Ability to give informed consent
* Participate in the specified study visits and laboratory testing including three (20 mL) blood draws and three 24 hour urine collections

Exclusion Criteria:

* Concurrent malignancy or metastatic malignancy of any kind
* Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
* Current and past history of hypertension
* Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study
* Pregnant or nursing women
* Concurrent use of tamoxifen, raloxifene, or any of the aromatase inhibitors
Contingency Management for Chronic Recidivist Alcohol-Dependent Patients

The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients.

This study evaluates the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients. 116 alcohol-dependent patients who have received 4 or more alcohol detoxifications in a calendar year will be randomly assigned to one of two 6-month treatment conditions: standard case management treatment, or standard case management treatment plus CM. In the CM condition, patients earn the chance to win prizes by submitting negative breath samples and by complying with steps toward treatment goals, such as attending outpatient substance abuse treatment services, attending appointments with low income housing programs, or complying with outpatient psychiatric treatment. Treatment services received, alcohol and drug use, psychosocial functioning, and HIV risk behaviors will be measured pre-treatment and at months 1, 3, and 6 (post-treatment), and at follow-ups scheduled for 9, 12, and 18 months after intake.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* Four or more inpatient alcohol detoxifications in the previous 12 months
* current diagnosis of DSM-IV alcohol dependence

Exclusion Criteria:

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Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.

Children requiring inpatient rehabilitation treatment following acquired brain injury (ABI) are at risk for poor engagement in rehabilitative therapies. A within subject crossover design will be used to determine whether involving dogs in physical and occupational therapies while receiving inpatient rehabilitation improves patient engagement, how involving dogs improves engagement, and identify who is most likely to benefit. This project addresses the critical need to establish an evidence base for animal-assisted therapies in pediatric rehabilitation, incorporates innovative methods, and has the potential to lead to improved clinical care for children and adolescents receiving intensive rehabilitation following ABI.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, etc).
* Consent: The family must provide informed consent by parents or legal guardians.
* Assent: The child/adolescent must provide a signature indicating assent to participate in the study.
* Age at the time of screening: 4-21 years old
* Sex: includes both males and females
* Responsiveness: Rancho score greater than 2 at the time of enrollment (as noted in the medical chart).

Exclusion Criteria:

* Allergies: Patient has a significant allergy to dogs
* Fear: Patient has a significant fear of dogs
* Disease: Participant is on contact precautions or has a communicable disease that may pose a risk to the dog or dog handler or has a compromised immune system where interacting with the dog and/or handler would be of significant risk to the patient.
* Medical History: History of developmental delay prior to ABI.
* Behavioral History: Participant or family has a history of animal abuse or cruelty.
* Responsiveness: Rancho score of 2 or less
Identification of Interscalene Brachial Plexus on Ultrasonography Using a Deep Neural Network

The purpose of the study is to develop and validate an algorithm based on deep neural networks (DNNs) to identify interscalene brachial plexus on ultrasonography automatically.

The investigators plan to develop a deep learning-based network to automatically identify interscalene brachial nerves on ultrasound images. The trained model will be validated on an independent dataset. The performance of the network will also be compared against practicing anesthesiologists.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class I or II
* scheduled for elective surgery

Exclusion Criteria:

* skin lesion or infection of neck
* any known peripheral neuropathy
* brachial nerve plexus injury
* previous injury or operation on neck
* pregnancy
* allergic to ultrasound gel
"A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum

The main goal of the pectus multicenter outcomes study is to document the utility of PEx repair in improving health and quality of life and to test the prevailing belief that the two predominant surgical procedures currently in use for PEx repair are essentially equivalent in terms of long-term outcomes.

We believe the uncertainty about the impact of PEx on cardiopulmonary function is due to part to the fact that the previous studies have not measured the physiological parameters mostly likely affected by the defect. A protocol to test this was developed. Thus, we propose to use these measures as well as conventional output of progressive exercise test to examine cardiopulmonary function before and after surgical repair of PEx within the context of the original study.


Eligibility Criteria:
Inclusion Criteria:Haller index by thoracic computed tomography (CT) scan of 3.2 or greater, has decided to have surgery to repair PEx, Written informed consent obtained from the parent or guardian of the subject,or, fro subjects 18-21 years, from the subject him(her)self, and assent of the child.

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Exclusion Criteria:Pectus carinatum, Poland's syndrome or other comlex chest wall anomaly,Previous repair of PEx by any technique, Previous thoracic surgery, Congenital heart disease, Bleeding dyscrasia, History of major anesthetic risk factors such as malignant hyperthermia, Pregnancy, Surgical repair to be performed with bar other than stainless steel.

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Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy and in Normal People

Find if the retinal function is affected in both the nonsevere and the severe stage of Graves' ophthalmopathy (GO) by comparing the retinal oxygen saturation of GO patients with that of normal people.

Graves'ophthalmopathy (GO), also called thyroid-associated ophthalmopathy, is often mild and self-limiting, and probably declining in frequency, with only 3-5% of cases posing a threat to eyesight, remaining a pathogenetic enigma and a therapeutic dilemma. In its nonsevere expression, the symptoms and signs include Photophobia, Foreign body sensation, Eyelid retraction, increased intraocular pressure, Lagophthalmos, and Mild diplopia. In its severe expression, it is a disfiguring and invalidating disease with the optic nerve damaged. However, in this study, we want to find if the retinal vessels is affected in the early stage of the disease through observing the oxygen saturation of the retinal vessels and compare it with that of the normal people.

Eligibility Criteria:
Inclusion Criteria for GO patients:

1. conforms to the diagnosis of Graves' ophthalmopathy;
2. age \> 18;
3. volunteered to participate in this research, and sign the informed consent.

Inclusion Criteria for Control group:

1. age \> 18;
2. diopter within + / - 3D;
3. volunteered to participate in this research, and sign the informed consent.

Exclusion Criteria for GO patients:

1. Fundus could not be seen clearly;
2. pregnant and lactating women;
3. could not tolerate the examination.

Exclusion Criteria for Control group:

1. with severe systemic disease and cause eye lesions;
2. have history of eye disease, ocular trauma and eye surgery impacting on visual function;
3. pregnant and lactating women;
4. could not tolerate the examination.
A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product

To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.

This study is designed to assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan. Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-inf and Cmax ratio are within the 80-125% interval for log-transformed values.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult, aged between 20 to 40 years old.
2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.
3. The normal range of the body mass index should between 18.5 and 25.
4. Normal laboratory determinations results including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.
5. Normal hematology results including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
6. Normal urinalysis results including: glucose, protein, RBC, WBC, epith, casts and bacteria.
7. Female subject who is:

   * using adequate contraception since last menstruation and no plan for conception during the study.
   * non-lactating.
   * has negative pregnancy test (urine) within 14 days prior to the study.
8. Informed consent form signed.

Exclusion Criteria:

1. A history of drug or alcohol abuse during the past 24 weeks.
2. Sensitivity to analogous drug.
3. A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
5. Planed vaccination during the time course of the study.
6. Participation of any clinical investigation during the last 60 days.
7. Regular use of any medication during the last 4 weeks.
8. Single use of any medication during the last 2 weeks.
9. Blood donation of more than 250 mL within the past 12 weeks.
10. Individuals are judged by the investigator or co-investigator to be undesirable as subjects.
Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women

Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds of all austrian women suffering from depression or anxiety disorders are over 45 years old. The serotonergic system, partially regulated by the steroid hormones estrogen and progesterone, plays a major role in the pathogenesis and treatment of these illnesses. To examine the effect of the hormone replacement therapy on the serotonergic system, twenty-four postmenopausal women will be measured using positron emission tomography (PET). The volunteers will participate in two PET scans. The first PET scan will be performed right before the hormone treatment starts, the second PET scan about 8 weeks after daily treatment with (1) a combination of estrogen and progesterone or (2) estrogen and placebo. This imaging study hypothesizes that the expression of the main inhibiting serotonergic receptor (the serotonin-1A receptor) will be altered by the hormone therapy. The results of the study might lead to new strategies in the treatment of psychiatric illnesses during and after the menopausal transition.


Eligibility Criteria:
Inclusion Criteria

* Postmenopausal females (over 14 months of amenorrhoea)
* Age 50 - 65 years
* Signed informed consent form
* Consent not to participate in PET or SPECT studies with an added equivalence dose of over 15 mSv within 10 years following the final assessment of the participant in this study

Exclusion criteria

* Steroid hormone treatment within 6 months prior to the inclusion
* Current substance abuse
* History of any malign illness
* Any implant or stainless steel graft
* Concomitant neurological illness
* Concomitant psychiatric disorder except anxiety disorders or depression
* Treatment with a psychotropic agent targeting serotonin-1A and serotonin-2A receptors or the serotonin transporter such as buspirone, pindolol or SSRIs
* Clinically relevant abnormalities in the general physical examination and the routine laboratory screening
* Concomitant major illness, especially: liver disease, disorders of the endocrine system, osteoporosis (when treated with vitamine D), any clinically relevant vascular or heart diseases
* One of the following gynaecological diseases: ovariectomy, hysterectomy, endometriosis, cervical smear test: PAP \> II
* Failures to comply with the study protocol or to follow the instructions of the investigating team
* Investigations using PET or SPECT within 10 years prior to the inclusion
Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation

It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.

Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 21 years - ASA I or II.
* Patient's willingness to participate in this study.
* Availability for 4-month follow-up.
* Absence of active periodontal disease.
* Single tooth replacement is needed with simultaneous contour augmentation.
* Available pre-operative CBCT study.
* Extraction of tooth at least 8 weeks prior to planned implant therapy.

Exclusion Criteria:

* Pregnancy at the screening visit.
* Smoking more than 10 cig/day.
* Active infection at the site of surgery (teeth involved).
* Multiple missing teeth adjacent to each other (long span edentulous area).
* Vertical bone defect less than 2mm (intra surgical assessment)
The Use of CT to Identify Damaged Heart Muscle in Patients Undergoing Ventricular Tachycardia Ablation.

Patients with ventricular tachycardia (VT) undergo catheter ablation. During the ablation procedure, the heart is mapped to determine areas of heart muscle damage. The heart scarring areas are often the source of the VT. Delayed enhancement CT has recently been used to determine areas of scarring . This study is to determine if the areas of damaged heart muscle mapped with the delayed enhancement CT correlate with the same areas that are determined during the catheter ablation.

Catheter ablation of ventricular tachycardia (VT) is performed in patients who have recurrent VT despite the use of other therapies. Electroanatomic mapping of the left ventricular myocardium is performed as part of these procedures to define the arrhythmogenic substrate for subsequent ablation. We hypothesize that delayed enhancement multi-detector computed tomography (MDCT) will identify areas of myocardial scarring or fibrosis that correlate with findings of voltage mapping in patients with a prior myocardial infarction who are undergoing VT ablation. We will perform a pilot study involving 10 patients with coronary artery disease scheduled for VT ablation to determine the ability of delayed enhancement MDCT to identify arrhythmogenic substrates in these patients, when compared with electroanatomic mapping. All patients will undergo a standard of care 64-slice MDCT study, followed 5 minutes later by the research delayed enhancement acquisition. We will evaluate the relationship between hyperenhanced myocardium, as detected by delayed enhancement MDCT, and abnormal myocardium detected on voltage mapping, defined as areas of myocardium with \< 0.5 mV signal amplitude. Studies will be performed on the new Siemens 64-slice dual source CT scanner, which reduces radiation exposure from the scan by 33-50%. This study will generate preliminary data which will be used for subsequent NIH/AHA grant applications or industry sponsored trials.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Prior myocardial infarction
* Scheduled for CT scan \< 1 week prior to VT ablation for ventricular arrythmia

Exclusion Criteria:

* Serum creatinine \> 1.8 mg/dL
* Contrast dye allergy
* Atrial fibrillation
* Unable to lie flat for the duration of image acquistion (15-20 minutes)
* Clinical instability at time of CT study acquisition
* Women of childbearing potential
* Personal or social problems that might prevent compliance with the study
Radial Artery Puncture Hemostasis Study

RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization.

A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices.

Follow-up of the subject will take place 60 days after the index procedure.


Eligibility Criteria:
Inclusion Criteria:

* Coronary angiogram planned from a radial artery approach
* Use of 5, 6 or 7 French sheaths

Exclusion Criteria:

* Radial artery diameter \<1.8 mm as measured via ultrasound
* Established peripheral arterial disease
* Known autoimmune illness
* Hemodynamic instability
* Pregnant or nursing
* Condition following resuscitation
Dance and Diabetes/Prediabetes Self-Management

The Dance for Diabetes program was designed as a community service project for the North Carolina Albert Schweitzer Fellowship. The purpose of this research is to evaluate the effectiveness of the project and its impact on participants. This study will assess whether a group dance workshop along with diabetes education can help people with diabetes and prediabetes.

This is a pilot study that will be testing whether or not a group dance workshop is useful and effective. If it is, the study team will refine the workshop model and do additional dance classes in the future. This research study will involve attending a dance workshop once a week for 2 months using an online, video-conferencing computer application. Participants will also receive information about exercise and how to manage their diabetes. Participants will receive a phone call every week during the 2 months to assess their experience. Study participants will also be asked to complete surveys at the beginning and end of the 2-month session, as well as 1 month and 2 months after the classes end.

Eligibility Criteria:
Inclusion Criteria:

* adults proficient in English with diabetes or prediabetes
* subjects who have an established healthcare provider

Exclusion Criteria:

* known cardiovascular disease (acute coronary syndrome, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, and peripheral arterial disease) for the last 6 months
* unwilling or unable to partake in light to moderate level of dance physical activity for 1 hour because of physical impairment (e.g. wheelchair, amputation)