cyrilzakka/clinical-trials huggingface dataset:
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.

This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Lifestyle-limiting claudication or rest pain.
* Subject (or their legal guardian) has read, understood and provided written informed consent.
* At least 21 years of age.
* Quality of life questionnaires completed.
* Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
* If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure.
* If applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure.
* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test.
* Projected life expectancy of greater than three years.
* The ability to comply with protocol.
* Angiographic and Lesion Requirements meets protocol criteria.

Exclusion Criteria:

* Untreated flow-limiting aortoiliac occlusive disease.
* Any previous stenting or surgery in the target vessel.
* Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
* Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
* Femoral or popliteal aneurysm.
* Non-atherosclerotic disease resulting in occlusion.
* Tibial artery disease requiring treatment.
* Prior ipsilateral femoral artery bypass.
* Severe medical comorbidities.
* Popliteal artery vascular access at any time during procedure.
* Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention.
* Serum creatinine \> 2.5 mg/dL within 45 days prior to study procedure.
* Major distal amputation.
* Septicemia.
* Any previously known coagulation disorder.
* Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
* Contraindication to anticoagulation or antiplatelet therapy.
* Known allergies to stent/stent-graft components.
* History of prior life-threatening reaction to contrast agent.
* Currently participating in another clinical research trial.
* Current peritoneal or hemodialysis.
Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles

The aim of the first year of this three-year plan is to analyze and compare the muscle quality of lower limb muscle (microcirculation, muscle performance and mechanical characteristics) and maximal aerobic exercise capacity in treadmill exercise tests for diabetic and non-diabetic cases. The hypotheses are:1) the muscle quality of lower limb muscle and maximal aerobic exercise capacity are different between participate with diabetic and non-diabetic, 2) the effect of the three-month aerobic exercise intervention or home exercise on the characteristics of the muscle quality are different , and 3) intrinsic factors (such as age, BMI, and HDL) and characteristics of specific FTO genes are influenced the training outcomes.

Participants with diabetes will attend an 12-week aerobic exercise intervention or home exercise if the exercise test result of the maximum rate of oxygen consumption is fair or poor. Assessments will be taken before and after the training program, which including muscle strength, stiffness, quality, microcirculation and exercise capacity. Comparisons between the pre-training and post-training condition will be made for each groups. And the assessments also compare with the healthy control group.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes group: 1) Age between 30-70 years of old, 2) type 2 diabetes.
* Healthy control group: 1) Age between 30-70 years of old, 2) without diabetes

Exclusion Criteria:

* history of moderate-severe somatic or autonomic neuropathy, cardiovascular disease, preproliferative or proliferative retinopathy, and chronic renal failure
* unable to perform the programs or assessments
* other systematic diseases
TAP Block in Laparoscopic Cholecystectomy.

Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.

A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.

Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.

Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.

Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.

Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient refusal
* Patients with a history of cardiac, or respiratory diseases ( \>ASA III).
* Patients with allergy to amide local anesthetics or medication included in the study.
* Infection at the needle insertion site.
* Pregnancy
* BMI \>35
* Drug abusers
68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism

To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype

This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.

Eligibility Criteria:
Inclusion Criteria:

1. PA diagnosis confirmed by at least one confirmatory test
2. willingness to undergo AVS and surgery
3. informed consent to participate in the study.

Exclusion Criteria:

1. PA patients who met guideline criteria for bypassing AVS \[i.e. younger than 35 years old, with typical APA characteristics (plasma aldosterone \>300pg/ml, plasma renin \< 2·5mIU/l, serum potassium \<3·5mmol/l, CT indicated unilateral 1cm low-density adenoma);
2. failed adrenal vein cannulation during AVS;
3. Subtyping diagnosis was inconclusive based on AVS results (e.g. aldosterone/cortisol ratio in bilateral adrenal veins lower than the peripheral vein, or missing data);
4. pregnant or lactating women;
5. patients with a history of uncontrolled malignant tumor;
6. concurrent Cushing's syndrome \[including mild autonomous cortisol secretion: cortisol after 1mg dexamethasone suppression test (DST)\>138 nmol/l or cortisol after 2mg DST \>50 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)\<10pg/ml;
7. diagnosis of familial hyperaldosteronism;
8. imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
9. unsuitable for surgery, such as heart failure with New York Heart Association (NYHA) class III or IV, severe anemia (Hemoglobin\<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate\<30ml/min/m;
10. alcohol or drug abuse and mental disorders.
Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery

SPRINT PNS System will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (TKA) who meet eligibility criteria and consistent with established coverage policy. SPRINT PNS System will be implanted for 60 days. At the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. If pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old
* Underwent a primary or revision unilateral TKA
* Completed all CHOIR questionnaires before and after TKA surgery
* Persistent postsurgical knee pain ≥ 5 of 10 during ambulation as demonstrated on the CHOIR assessment.
* Must meet the definition of chronic pain.

  1. Pain that continues or is expected to continue for longer than 3 months from its initial onset or
  2. Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or
  3. Pain requiring opioid use beyond 30 days.

Exclusion Criteria:

* Patients with a pre-operative history of moderate to high dose use of opioids (≥ 50 morphine milligram equivalents (MME) average per day)
* Patients taking opioids for reasons other than pain in knee that underwent TKA
* Patients with arthrofibrosis or indicated for manipulation under anesthesia
* BMI \>35
* Uncontrolled Diabetes Mellitus Types I or II, indicated by an HbA1c \>7.0% within the last 3 months
* Vulnerable population (e.g. pregnant women, prisoners, minors, or employees)
* Deep brain stimulation (DBS) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the SPRINT stimulator's current pathway.
* Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage in affected leg, pain caused by knee implant requiring revision, compromised immune system) as determined by the Investigator
* Workers Compensation
Study of Adjuvant ONO-4538 With Resected Gastric Cancer

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed adenocarcinoma of the stomach
* Patients without a remnant cancer (R0) who have undergone gastrectomy
* Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

* Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
* Multiple primary cancers
* A current or past history of severe hypersensitivity to any other antibody products
* Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease
Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism

The objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. All meals will be prepared in a metabolic kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25 healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL cholesterol and cholesterol excretion will be improved on the high phytosterol diet even though macronutrient composition, mineral intake and fiber consumption are similar.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race or ethnicity between 18 to 80 years of age, inclusive;
* Body mass index between 20-35 kg/m2;
* LDL-cholesterol between 100-189 mg/dL based on the average of duplicate screening measures. If the two LDL-C levels differ by more than 30 mg/dL, a third test will be scheduled with all three results averaged;
* Free of chronic disease;
* Willing to eat only the foods that are provided by the Center during the diet periods;
* Willing to consume no more than 1 alcoholic drink per day.
* Willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days;
* Willing to drink no more than 5 cups of caffeine-containing beverages a day.

Exclusion Criteria:

* Age \< 18 or \> 80 years;
* Based on duplicate screening laboratory values: 1) LDL-C \> or = 190 mg/dL; 2) TG \> or = 250 mg/dL; 3) blood pressure \> or = 160 mm Hg systolic or 95 mm Hg diastolic;
* Documented presence of atherosclerotic disease;
* Diabetes mellitus;
* Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease;
* Body mass index \> 35;
* For women, pregnancy, breast feeding or postpartum \< 6 months;
* For women, peri-menopausal;
* History of drug or alcohol abuse;
* History of depression or mental illness requiring treatment or medication within the last 6 months;
* Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
* Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids;
* Lifestyle or schedule incompatible with the study protocol;
* Planned continued use of dietary supplements through the study trial;
* Taking any lipid-lowering, or other medications known to affect blood cholesterol
Analysis of Human ALS Tissues and Registry of ALS Patients

Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive, terminal condition of muscle weakness that is associated with degeneration of neurons in the spinal cord and brain. This devastating disorder afflicts people in the prime of their lives. At the present time, there are no cures for this disorder, and current treatments are marginal at best. Despite years of intensive research, a fundamental understanding of this disease is still lacking. There is a need to identify both reliable markers of disease progression and effective treatments. The goal of this research is to bring a greater understanding of ALS patients closer to the research studies that can lead to new hypotheses and approaches.

Patients will be approached during in-person or phone/online appointments and asked their consent to enter information and results from their physical examinations, electrodiagnostic testing, and other testing done as a standard of care and into a database to monitor disease progression and use them for research purposes. Also, the patients will be asked for consent to undergo a MRI scan.

In a second informed consent form, patients will be enrolled to perform a rapid postmortem autopsy and have the tissue banked for research purposes. It is important to keep the consents separate because some patients may not consent to this postmortem study, but would consent to the premortem studies.

The information gained from the premortem studies will be used during the postmortem examination to select tissue for further processing. Tissue from different regions, including brain, spinal cord, nerve and muscle will be processed in parallel for cellular and molecular analyses that include histology, immunostaining, in situ hybridization, protein, RNA, and small molecule analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Established diagnosis of ALS
* Able and willing to give written informed consent and must authorize release and use of protected health information

Exclusion Criteria:

* Patients below the age of 18
* No diagnosis of ALS
An Observational Pilot Study to Test a Smartwatch-based EMA Method During Exercise With Breast Cancer Survivors

The goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called "PHITbit."


Eligibility Criteria:
Inclusion Criteria:

* Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer.
* Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during the assessment period.
* Willing to wear the ActiGraph monitor during the assessment period.
* Willing to wear the study issued Fitbit Versa 3 smartwatch during the assessment period.
* Access to internet to complete REDCap survey assessments.

Exclusion Criteria:

* Non-English speaking/not able to read English.
* Evidence of major contraindications for exercise per the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+.
* Currently pregnant.
* History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium).
* Evidence of moderate-severe depressive symptoms (indicated by a score ≥ 10 on Patient Health Questionnaire-8). -Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6- item cognitive screener).
* Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE-AID screener.
Effects of Volleyball Intervention on Health-related Fitness in Primary School Students

The goal of this study is to find out if doing a 16-week volleyball program integrated in physical education classes at school can make primary school students stronger, faster, and have better endurance. The study also wants to see whether the program can lead to changes in the students' body weight, body fat, and muscle mass.

Eighty-eight healthy primary school students (mean age 13.3 years) were randomized to a TGfU volleyball intervention group (VG) or a control group (CG). CG participants attended three regular physical education (PE) classes per week, while VG participants attended two regular PE classes and a TGfU volleyball intervention that was implemented in the third PE class. The main part of each volleyball intervention session was based on the "Teaching Games for Understanding" (TGfU) model. This approach emphasizes the development of fundamental skills and tactical understanding of the game by utilizing modified games, such as small-sided games and mini-volleyball. By using this method, participants are able to increase their interaction with the ball and engage in moderate-to-vigorous gameplay intensity more frequently. The primary study outcomes were assessed before and after the 16-week intervention for both VG and CG participants. The main hypothesis is that implementation of the TGfU volleyball intervention in the physical education curriculum will lead to greater improvement in body composition and physical fitness outcomes among seventh-grade primary school students compared to those who receive traditional physical education classes, demonstrating that this intervention can be an effective method for reducing adiposity and promoting physical fitness levels among adolescents.

Eligibility Criteria:
Inclusion Criteria:

* seventh grade primary school students
* were not exempt from participating in physical education classes
* did not have any health conditions (pediatric disease, orthopedic conditions, injuries, respiratory or cardiovascular disease)
* voluntary participation
* obtained informed consent from parents or legal guardians

Exclusion Criteria:

* exempted from participating in physical education classes
* currently participating in other interventions
* the presence of acute or chronic infectious disease
* the presence of injury
* not able to attend all intervention sessions
* not obtaining informed consent from parents or legal guardians
* do not want to participate voluntary
Iyengar Yoga for Prolonged Grief Disorder

Experiencing the death of a loved one is inevitable for older adults. Before the coronavirus disease 2019 (COVID-19) pandemic, over 2.5 million people died annually in the United States, including 52,000 in Wisconsin alone, and COVID-19 has added to this toll. Each person who dies leaves an average of five grieving people behind. Most grieving older adults are resilient and recover their pre-loss functioning within one year. However, in about 10%, acute grief becomes protracted and debilitating, leading to the development of prolonged grief disorder (PGD), a clinically diagnosable mental health condition. PGD in older adults increases the risk for poorer medical, mental health, and cognitive outcomes; lower quality of life; disability; premature mortality; and suicide. Despite the magnitude of this problem, the neurobiology of PGD in older adults is poorly understood. By using Iyengar Yoga (IY) as a probe for PGD neurobiology, this pilot project aims to address this critical gap.

Our goal is to conduct a pilot study to examine in PGD the modulating effects of 10-week IY on circulating endocannabinoid and emotion processing brain circuit, and the associations between biological changes and clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than or equal to 40 years of age
* Bereavement \>6 months
* Score greater than or equal to 25 on the Inventory of Complicated Grief (ICG)
* Presence of PGD (subsyndromal and syndromal)
* Adequate visual and auditory acuity

Exclusion Criteria:

* Delirium/unstable medical conditions
* Lifetime history of neurological illnesses: seizures, stroke, dementia of any etiology, severe head injury, brain tumor or surgery
* Serious back, joint or neck injuries within the past 3 months
* Currently practicing yoga
* Gross structural abnormalities on T1-weighted images
* Lifetime history of the following psychiatric disorders: bipolar or psychotic disorders, including psychotic depression
* Current alcohol/drug abuse or dependence
* Magnetic resonance imaging (MRI) contraindications
* Acute suicidality
Promoting Weight-Loss in African American Cancer Survivors in the Deep South

This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.

This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* African American breast, colon, or prostate cancer survivor (Index Participant)
* Family member (support person) of African American breast, colon, or prostate cancer survivor (Family Member Participant)
* Live, work, or attend school in target county
* BMI \>= 25 kg/m2

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next year
* Known major medical or psychological condition known to influence body weight
* Uncontrolled hypertension (BP \> 160 mmHg systolic or \>100 mmHg diastolic)
* medicated or poorly controlled diabetes (glucose \> 126) Cardiovascular event in the preceding 12 months
* History of gastric bypass or bariatric surgery
* History of psychiatric hospitalization in past 2 years
* History of substance abuse or eating disorder
* Any other condition by which a medical professional has suggested diet modification, physical activity and/or weight reduction would be contraindicated