cyrilzakka/clinical-trials huggingface dataset:
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.

This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet.

Depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.

Exclusion Criteria:

1. ASA 4 or 5
2. Diagnosis of chronic pain
3. Daily chronic opioid use (over 3 months of continuous opioid use).
4. Inability to communicate pain scores or need for analgesia.
5. Infection at the site of block placement
6. Age under 18 years old or greater than 75 years old
7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)
8. Intolerance/allergy to local anesthetics
9. Weight \<50 kg
10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
12. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Anesthetic Efficacy of X-tip Intraosseous Injection

* Hypothesis:

  * X-tip intraosseous is an effective supplementary injection in mandibular hot teeth as well as Periodontal Ligament (PDL) injection
* Purposes:

  * Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar Nerve Block
* Methods and Materials:

  * forty patients with mandibular hot molar or second premolar which had not been anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected for this study

* Randomization:

  * All patients will be randomly divided into two groups as follows:

    1. X-tip intraosseous injection will be used as supplementary
    2. PDL injection will be used as supplementary
* Anesthetic evaluation:

  * For anesthetic evaluation we will use Visual Analog Scale (VAS)

Eligibility Criteria:
Inclusion Criteria:

* Mandibular Molars and second premolars with Acute Irreversible Pulpitis
* None of the teeth selected should have been anesthetized following 3.6 ml Lidocaine block injection

Exclusion Criteria:

* Unhealthy patients
* Teeth which were anesthetized following 3.6 ml nerve block injection
* Patients who did not have any signs of lip anesthesia following 3.6 ml injection
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).

The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for weight reduction in obese patients. This study will determine the feasibility of using BIB in the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the efficacy of the BIB in improving histology of NASH in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 21-65 years of age,
* Had histological evidence of NASH,
* Had a BMI of greater than 27kg/m2, and
* Had failed at least 6 month trial of medical therapy for weight reduction.

Exclusion Criteria:

* Patients with any organic disease of the upper GI tract,
* Were receiving anti-inflammatory drugs,
* Anticoagulants or steroids, or
* Had a history of alcoholism or drug addiction. A hiatus hernia of \> 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of BIB.
The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

Primary sarcopenia is used to describe aging and progressed with the physiologic decline. Secondary sarcopenia is associated many chronic disease, including acquired immune deficiency syndrome, cancer, chronic heart failure, chronic lung disease, liver cirrhosis, chronic kidney disease and rheumatoid arthritis. In the past, nutrition status is evaluated by body mass index, mid-upper -arm circumference and serum albumin. Bioelectrical impedance analysis is also a common method to measured body composition, but bioelectrical impedance analysis will be affected by tissue edema and ascites. In contrast, cross-section imaging, such as computed tomography and magnetic resonance can analyzed abdominal muscle and fat accurately.

Since computed tomography and magnetic resonance imaging can evaluate the severity of polycystic liver and kidney disease. Investigators can use cross section imaging at 3rd lumber level to separate skeletal muscle and fat tissue. Previous studies showed the quantity and quality of abdominal muscle are important prognostic factor after liver transplantation. Besides, chronic kidney disease and receiving renal placement therapy lead protein catabolism and make patients with end stage renal disease have sarcopenia. Finally, patients with polycystic liver and kidney disease have organomegaly, which causes abdominal distention and poor appetite. Therefore, the aim of this study is to observe the association between skeletal muscle mass and the severity of disease and to study whether change in hepatic and renal volumes is associated with change in muscle mass.

The imaging study (CT or MRI) will be performed within one month before the procedure to measure total kidney volume and psoas muscle area.

The procedure will use transcatheter embolization to renal artery. The follow-up imaging study will be performed six months after the procedure to measure total kidney volume and psoas muscle area..

Eligibility Criteria:
Inclusion Criteria:

* Polycystic related disease with medical images (CT or MRI) diagnosed
* Aged over 20 years

Exclusion Criteria:

* Lack of Bio-exam or medical images
* Pregnancy
Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation

Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Undergoing primary orthotopic liver transplantation

Exclusion Criteria:

* Redo orthotopic transplantation
* Acute or fulminant liver failure
* Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy
* Patients with an abnormal preoperative stress test (EF \<55%, areas of prior infarct, ongoing ischemia)
Registry for Perioperative Data in Patients Undergoing Cardiac Surgery

The purpose of this registry is to obtain perioperative data in patients undergoing cardiac surgery and find out relations between the data and investigate several causes affecting postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery

Exclusion Criteria:

* refused to participate
The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults

Cardiovascular diseases (CVD), primarily heart disease and stroke, are the leading causes of death and prescription drug use in Canada. Research on certain dietary supplements looks promising as a way to help reduce CVD risk factors. Studies show that supplementation of certain nutrients such as antioxidants, amino acids, electrolytes, vitamins and minerals may effectively reduce cardiovascular risk factors. The dietary supplement CardioFlex Q10, which is high in the aforementioned components, was developed to help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.

The overall objective of this study is to determine if 90 days of supplementing with CardioFlex Q10 can reduce CVD risk factors in adults, independent of other dietary or physical activity changes.

The purpose of this study is to determine whether or not daily supplementation with the dietary supplement CardioFlex Q10 for 90 days can reduce cardiovascular risk factors in healthy adults. The health markers that will be tested include the participant's waist circumference, body weight, body mass index (BMI), atherosclerosis risk factors (blood pressure, plethysmogram (PTG) wave form, heart rate variability, accelerated plethysmograph (APG) type (biological age of arteries)), and blood work including total plasma lipid profile (total cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (TGs)), kidney and liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST), Lactate dehydrogenase (LDH), Blood Urea Nitrogen (BUN), creatinine), and inflammatory and endothelial function biomarkers (C-reactive protein (CRP), Interleukin-6 (IL-6), soluble intercellular cell adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1) ).

All health markers will be tested the day before starting the study and the day after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-65
* An accelerated plethysmograph (APG) type (biological age of arteries) of D, E, F or G and/or a high density lipoprotein (HDL) to total cholesterol (TC) ratio of ≤24 percent

Exclusion Criteria:

* Have used prescription cholesterol or blood pressure medication in the last 3 months
* Perform more then 150 minutes of moderate to rigorous activity per week
* Pregnant or planning on getting pregnant during the study period
Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama

The purpose of this study is to adapt and evaluate a combination intervention that includes: (1) a data-driven approach to directed community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART (antiretroviral therapy)Start program, all in Mobile County Health Department (MCHD) jurisdictions in Alabama.

Aim 1. Adapt and integrate COAST-AL using a pre-implementation formative assessment guided by the CFIR. In-depth interviews and clinic observations with community clinic providers, clinic administrators, and MCHD and Alabama Department of Public Health (ADPH) officials will inform targeted Community-based testing, linkage through Project Connect, and Rapid Start into existing work flows (inner setting, process), identify opportunities to use publicly available data to inform testing outreach (outer setting), and explore provider attitudes towards Rapid Start (individuals).

Aim 2. Assess the clinical and implementation effectiveness of COAST-AL in six AL counties served by MCHD. Using RE-AIM, the investigators will evaluate the effects of COAST-AL on clinical and implementation outcomes on progress towards EHE goals. The primary clinical effectiveness outcome is days to viral suppression (VS) for new HIV diagnoses. The primary implementation outcome is the proportion of Zip Code Tabulation Areas with at least 15% of adult population tested for HIV (Reach).

Aim 3. Utilize a community-academic partnership to identify implementation strategies to support maintenance and future dissemination of COAST-AL. Using interviews, concept mapping, and nominal group techniques to inform implementation mapping, the investigators will work collaboratively with local and state health department stakeholders to identify and prioritize implementation strategies to sustain and implement COAST-AL in other health departments across AL and rural EHE(Ending the Epidemic)-focus states.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1 \& 3:
* Fit into one of the following categories:

  1) MCHD leadership, 2) ADPH leadership, 3) clinic administrators, 4) outreach testing specialists, 5) linkage coordinators and community health workers, 6) physicians, 7) nurses, 8) counselors all working at HIV care facilities in the six MCHD jurisdiction counties.
* Over the age of 18 years old.

AIM 2: (IDIs)

* Over the age of 13 years old
* Tested for HIV in MCHD jurisdiction from time of COASTAL implementation to 36 months post-implementation start date.

Exclusion Criteria:

* Exclusion criteria include unwillingness or inability to provide informed consent.
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing

The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 years
* Stable Tibial fracture recommended for surgical intervention

Exclusion Criteria:

* Patients not meeting inclusion criteria
* Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)
* Previously non-ambulatory patients
* Delayed presentation of fracture (\>4 weeks)
* Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability
* Patients with an achieve infection or wound at the surgical site
* Any previous ligament or fracture surgery on the index site
* Inflammatory rheumatic disease or other rheumatic disease-
* Immune compromised patients (hepatitis, HIV, etc.)
* Unwilling or unable to participate or follow study protocol
Effectiveness of Community-Based Physiotherapy Versus General Practice

Summary: (Objectives and methodology of the project) AIM: To evaluate the clinical effectiveness of Community physiotherapy intervention on chronic diseases (heart disease, chronic obstructive pulmonary disease, back pain, mechanical neck pain, fibromyalgia, osteoarthritis lower limbs, neurological and cancer survivors) and a group of healthy patients cardiovascular risk factors. DESIGN: Randomized, controlled, prospective study. SUBJECTS OF STUDY: Patients with chronic disease go to the Local Sports Torremolinos Center INTERVENTION: Establishment of a control group that give you some advice education care (brief advice) and a group common experimental multimodal program of 12 weeks therapeutic exercise with health education (brief advice). It will follow up complete with ratings pre and post intervention to both groups and follow up at 6 and 12 months for long-term effect through specific questionnaires for each subgroup chronic disease and pain score (visual scale analog), quality of life (EuroQol-5D) and state health general (Short-Form 12, SF-12) VARIABLES: The intervention physical therapy Community. Result: Specific questionnaires for each subgroup, pain (Visual analogue scale), quality of life (EuroQoL) and general health status (SF-12). DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome (Chi square, Student t, ANOVA, Mann-Whitney, Wilcoxon, by type and normal variables). Likewise, establish measures of effect size in main outcome variables, by reduction relative risk, absolute risk and odds ratio with their respective confidence intervals.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria will be severe cuts of the disease based on functionality and not the dysfunction indicates the severity level higher 20% of the specific questionnaire for each subgroup

Exclusion Criteria:

* Common exclusion criteria for subgroups:

"Rejection of the patient to take part in the survey

* Processes of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures "Cognitive impairment of any etiology Presence of unstable angina, arrhythmia, unstable, failure of cardiac valvular "Severe hypertension (systolic\> 200 or diastolic\> 120)
* Depressed systolic function at rest (EF less than 50%)
* Evidence of exercise-induced ischemia
* Evidence of exercise-induced arrhythmias.
* Stenotic coronary lesions greater than 50%. Exercise intolerance, or physical activity any cause.
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer

RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.

OBJECTIVES:

* Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer.
* Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes.
* Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years.

Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven stage I, invasive breast cancer
* Hormone receptor status:

  * Estrogen receptor positive
  * Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age:

* 65 to 80

Sex:

* Female

Menopausal status:

* Postmenopausal

Performance status:

* Not specified

Life Expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No serious disease that would preclude surgery
* No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* Not specified
The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation

Post stroke hemiplegia patient have shoulder subluxation in affected side. The investigators use functional electrical stimulation in posterior deltoid and supraspinatus for prevention and treatment. But the investigators hypothesis self triggered myoelectric stimulation system has more effective for shoulder subluxation. The purpose of this study is to compare post-stroke shoulder subluxation treatment FES and triggered FES.


Eligibility Criteria:
Inclusion Criteria:

1. Within 3months after stroke
2. 1st stroke patients with hemiplegic shoulder subluxation which is measured above one finger breadth by physical examination
3. Shoulder abduction strength is above P- grade (MMT)
4. Male or female, ≥ 20 years of age
5. Written informed consent has beed obtained
6. Patients who understand purpose of this study and conform with intervention process

Exclusion Criteria:

1. Quadriplegia or double hemiplegia
2. History of injury, surgery, etc. of U/E and upper chest area
3. person who implanted metalic device(ex. pacemaker, vagus nerve stimulator)
4. patients who have lower motor neuron lesion
5. person who have difficulty using electrode due to skin problem such as skin ulcer or open wound
6. who have seizure or epilepsy history
7. Female who are pregnant
WECARE: A Behavioral Intervention for Dementia Caregivers

This study aims to pilot test a culturally tailored behavioral intervention called "WECARE" to enhance caregiving mastery and improve psychosocial wellbeing of Chinese American family caregivers of persons with Alzheimer's Disease and related dementia.

The investigators propose to test a culturally tailored mHealth behavioral intervention to enhance caregiving mastery and improve psychosocial wellbeing among Chinese American family caregivers of persons living with Alzheimer's Disease and related dementia. This intervention, Wellness Enhancement for Caregivers (WECARE), will be delivered via WeChat, a social media app highly popular among Chinese Americans. About 45 participants will be recruited for the pilot test. Participants will complete a baseline survey, receive 7-week WECARE program on their WeChat accounts, complete a follow-up survey 12 weeks after the baseline, and then a qualitative interview on Zoom.

Eligibility Criteria:
Inclusion Criteria:

1. 21 years or older,
2. self-identified as Chinese or Chinese American,
3. speak and read Chinese (Mandarin or Cantonese),
4. own a smartphone and use WeChat,
5. living in Washington DC metropolitan, and
6. currently care for a family member with ADRD and provide care for at least 10 hours a week.

Exclusion Criteria:

1. do not read or speak Chinese,
2. care-recipient is in hospice care or have a life expectancy less than 6 months,
3. signs of severe intellectual deficits or psychotic disorders, or
4. unable to provide informed consent.
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)

To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer


Eligibility Criteria:
Inclusion criteria :

* Inoperable breast cancer
* Recurrent breast cancer

Exclusion criteria :

* Corresponding to contraindication of eribulin mesylate
* Not applicable to indications of eribulin mesylate
* Not applicable to aggravation or recurrence of breast cancer in patients who have previously been treated with anthracycline and/or taxane antitumor drugs