cyrilzakka/clinical-trials huggingface dataset:
Support Group Program in Improving Quality of Life in Underserved Urban Latina Breast Cancer Survivors

This randomized clinical trial studies a support group program in improving quality of life in underserved urban Latina breast cancer survivors. A psychosocial support group program may help reduce distress and improve health-related quality of life in underserved urban Latina breast cancer survivors.

PRIMARY OBJECTIVES:

I. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of health-related quality of life.

II. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of general distress.

SECONDARY OBJECTIVES:

I. A brief qualitative assessment will evaluate the perception of the program among intervention participants using a brief survey.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants attend support group sessions over 1-1.5 hours once weekly for 10 weeks. The sessions include facilitated discussions among participants about the following topics: stress management and emotional coping strategies, nutrition and physical activity, sexuality and body image, medical advocacy, self-care and social support. Participants receive a binder in which the rationale for each topic, techniques learned, and activities completed during each session will be summarized and are shown a Chair-robics digital video disc (DVD).

ARM II: Participants receive one phone call to arrange a follow-up with the promotora, a note acknowledging their participation in the study, and a community resource booklet. Participants are then yoked into one of the 3 intervention groups and asked to attend a 30 minute session similar to Arm I.

Eligibility Criteria:
Inclusion Criteria:

* Latino
* Spanish-speaking
* Diagnosed with breast cancer
* A current resident of either King, Snohomish or Pierce counties in Washington State with the intent of remaining a resident for at least 3 months following study enrollment
* Additionally, at time of enrollment, participants must be post-treatment (with the exception of adjuvant therapy) for their primary cancer and not actively undergoing treatment for a secondary, metastatic, or recurrence of cancer (local or distant)
* There will be no restrictions on time since diagnosis for participants
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children with CAH

An investigation of the safety and efficacy of tildacerfont in participants with CAH.

This is a study to evaluate the safety and efficacy of tildacerfont in participants with Congenital Adrenal Hyperplasia (CAH). Treatment will consist of 4 or 12 weeks of continuous dosing followed by safety follow up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 2+
* Diagnosis of CAH due to 21-hydroxylase deficiency (OHD) and/or elevated 17- hydroxyprogesterone (OHP) requiring ongoing GC replacement since diagnosis
* Stable dose of GC replacement for at least 1 month prior to screening

Exclusion Criteria:

* History of bilateral adrenalectomy or hypopituitarism
* Clinically significant unstable medical conditions, illness, or chronic diseases
* History of active bleeding disorders
* Females who are pregnant or nursing
Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

The primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject (male or female) is \> 60 to \< 79 years of age.
* Subject has Body Mass Index (BMI)\> 20 \< 35.
* Subject is ambulatory with an SPPB score of \> 9.
* Subject agrees to comply with prescribed activity level.

Exclusion Criteria:

* Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study.
* Subject has stated active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
* Subject has stated history of diabetes or fasting glucose value \> 126 mg/dL.
* Subject has stated presence of partial or full artificial limb.
* Subject has stated kidney disease or serum creatinine \> 1.4 mg/dL.
* Subject has evidence of cardiovascular disease assessed during resting or exercise EKG.
* Subject has untreated hypothyroidism with TSH levels greater than 5.5 microUnits/ml.
* Subject has serum glutamate pyruvate transaminase (SGPT) levels greater than two times upper limit of laboratory-designated normal value.
* Subject has a history of allergy to any of the ingredients in the study products.
* Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
* Subject has stated uncontrolled severe diarrhea, nausea or vomiting.

Subject is actively pursuing weight loss.

* Subject is currently taking medications/dietary supplements/substances that could modulate metabolism or weight in the opinion of the principal investigator or physician, e.g. progestational agents, steroids, growth hormone, dronabinol, marijuana, beta-hydroxyl-beta-methylbutyrate (HMB), free amino acid supplements, dietary supplements to aid weight loss. Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma, topical or optical steroids and short-term use (less than two weeks) of Dexamethasone.
* Subject cannot refrain from smoking/discontinue the use of nicotine or tobacco.
* Subject has a stated history of Deep Vein Thrombosis (DVT) or a known hypercoaguable condition.
* Subject cannot discontinue current anticoagulant therapy.
* Subject has refractory anemia with hemoglobin value \< 11.5 g/dL.
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

The present study was a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary endothelial function.

This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content at baseline and again at 6 months following Lp-PLA2 inhibition.

The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years and \< 85 years
* referred to our cardiac catheterization laboratory for coronary vasomotion testing
* are found to have coronary endothelial dysfunction.

Exclusion Criteria:

* these include heart failure
* ejection fraction \< 40%
* unstable angina
* myocardial infarction or angioplasty within 6 months prior to entry into the study
* use of investigational agents within 1 month of entry into the study,
* patients who require treatment with positive inotropic agents other than digoxin during the study
* patients with cerebrovascular accident within 6 months prior to entry the study
* significant endocrine, hepatic or renal, disorders
* local or systemic infectious disease within 4 weeks prior to entry into study
* pregnancy or lactation
* mental instability
* Federal Medical Center inmates
Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in low-income and underserved people living with obesity in Louisiana. The main questions it aims to answer are:

* Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in adults living with obesity in low-income and underserved communities achieve weight loss at 6 months compared to enhanced usual care?
* Will LA-CEAL CONNECT sustain weight loss at 12 months?
* Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months?
* Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in low-income and underserved communities?

Researchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care.

Participants in both arms will:

* Receive health literacy-tailored educational materials and resources for weight loss
* Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements

Participants in the CONNECT intervention arm will also:

* receive health coaching
* self-monitor weight and physical activity using digital technologies
* attend group meetings to identify and increase utilization of community health and wellness resources


Eligibility Criteria:
Inclusion Criteria:

* being 18 to 75 years of age
* living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asian identifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifying participants
* weighing less than 400 pounds
* receiving care from or willing to register at a participating FQHC clinic
* able to understand and speak English
* able to complete the study within the next year (e.g., not planning to move from the area within study period)

Exclusion Criteria:

* having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)
* currently participating in a weight-loss program
* having lost more than 10 pounds in the last 6 months
* being an employee or a family member of an employee of any participating FQHC
* having a disease that can interfere with or be aggravated by exercise or weight loss
Enhancing Immersion in Virtual Reality Based Advanced Life Support Training

Virtual Reality based training modulues have become a part of simulation based medical education and are nowadays used for undergraduate and postgraduate level training of healthcare professionals.In parallel to the advancements in Artificial Intelligence technology voice regotnition has the potential to be used as an interfeace during game play .The aim of this study is whether game interface with Artificial Intelligence based voice regognition may elevate the level of immersion during the use of Virtual Reality based serious gaming for Advanced Cardiac Life Support Training.

Virtual Reality based training modules have become one of the training modalities for simulation based healthcare training and have an important role for the training of healthcare professionals VR based training modules have used hand-held controllers for navigation and interaction with the virtual environment so far. In parallel to the advancements in Artificial Intelligence (AI) and natural language processing (NLP) potential for voice command interfaces, offer an alternative method of control in Virtual Reality applications by providing more intuitive and accessible means of interaction for users.Voice commands, powered by NLP algorithms, enable users to navigate and manipulate virtual environments using natural language and have the potential to reduce the learning curve associated with Virtual Reality controller inputs. Voice interfaces have also the potential to offer accessibility benefits for users with physical disabilities, for whom conventional controllers may be difficult to use\].

Despite the potential advantages, using voice command systems in Virtual Reality gaming has also its limitations like speech recognition accuracy, latency, the system's ability to understand context-specific commands, problems caused by environmental noise, user's accent or speech patterns.

There has been limited research comparing the user performance and user satisfaction of Artificial Intelligence supported voice command interfaces against traditional Virtual Reality controllers. This study aims to compare the two control methods using various metrics like task completion time, participants' exam scores and level of immersion.The hypothesis of this study is that Artificial Intelligence supported voice commands can offer a superior user experience in Virtual Reality gaming by providing a natural form of interaction.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering for the study
* Aged between 20-22 years,
* Being a student in the fourth semester (Spring Semester 2023-2024) of Acibadem Mehmet Ali Aydinlar University Vocational School Anesthesiology Program

Exclusion Criteria:

* No prior Adavanced Cardiac Life Support training,
* History of Virtaul Reality induced motion sickness,
* Medical conditions such as vertigo attacks
* Using medications causing vertigo-like symptoms
Rationalisation of Polypharmacy by the Geriatric Consultation Team

Polypharmacy is a common problem in elderly, leading among others to increased adverse drug events. The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on admission by an adjusted STOPP\*-list in older patients) list could reduce inappropriate prescribing for elderly admitted patients, admitted to non-geriatric departments.

(\* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)

Polypharmacy and (potentially) inappropriate prescribing is highly prevalent in the older population, associated with increase health care expenditures, morbidity and avoidable adverse events .

The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team (GCT) using the RASP (Rationalisation of drugs on admission by an adjusted STOPP-list in older patients) list could reduce inappropriate prescribing for older admitted patients, admitted to non-geriatric departments. The GCT could offer the ideal format to deliver the intervention to a broad older hospitalised population.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to a non-geriatric ward
* 75 years or older
* Dutch speaking
* Consultation by the GCT

Exclusion Criteria:

* End-of-life
* No drugs on admission
Intraoperative Cholangio-Ultrasound in Resective Liver Surgery

Liver surgery should be considered an echo-guided procedure to guarantee conservative but radical resections. The investigators describe a further application of intraoperative ultrasonography (IOUS) for studying the biliary tree during liver surgery with no need for formal cholangiography.

Intraoperative ultrasonography (IOUS) in liver surgery is widely accepted as a fundamental tool for radical and safe hepatectomy \[1\]. New technical improvements of IOUS have been reported in recent years both for tumor characterization and staging \[2\] and for resection guidance \[3-5\]. However, intraoperative cholangiography (IOC) still represents the gold standard for studying the biliary tract anatomy as well as for guiding reconstruction in case of bile duct resection and, moreover, with the advent of living donation it is the standard reference for validating preoperative imaging \[6\]. Conversely, it could be affirmed that IOUS in this sense has no role, if not for guiding intraoperative dilated bile duct drainage \[7\]. Nevertheless, IOC has not negligible costs, it implies the use of x-ray, iodated contrast agents and is time consuming.

Herein is proposed a technique for bile duct exploration by means of intraoperative cholangio-ultrasound (IOCUS) validated on a consecutive series of patients undergoing liver resection.

1. Machi J, Oishi AJ, Furumoto NL, Oishi RH (2004). Intraoperative ultrasound. Surg Clin North Am, 84(4): 1085-111
2. Minagawa M, Makuuchi M, Takayama T, Ohtomo K (2001). Selection criteria for hepatectomy in patients with hepatocellular carcinoma and portal vein tumor thrombus. Ann Surg, 233(3): 379-84
3. Torzilli G, Del Fabbro D, Olivari N, Calliada F, Montorsi M, Makuuchi M (2004). Contrast-enhanced intraoperative ultrasonography during liver surgery. Br J Surg, 91(9): 1165-7
4. Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma (2004). Surg Endosc, 18(1):136-9
5. Torzilli G, Takayama T, Hui AM, Kubota K, Harihara Y, Makuuchi M (1999). A new technical aspect of ultrasound-guided liver surgery. Am J Surg, 178(4): 341-3
6. Lee VS, Krinsky GA, Nazzaro CA, Chang JS, Babb JS, Lin JC, Morgan GR, Teperman LW. Defining intrahepatic biliary anatomy in living liver transplant donor candidates at mangafodipir trisodium-enhanced MR cholangiography versus conventional T2-weighted MR cholangiography. Radiology, 2004; 233(3): 659-66
7. Torzilli G, Makuuchi M, Komatsu Y, Noie T, Abe H, Kobayashi T, Kubota K, Takayama T. US guided biliary drainage during hepatopancreatico-jejunostomy for diffuse bile duct carcinoma. Hepatogastroenterology. 1999; 46(26): 863-6.

Eligibility Criteria:
Inclusion Criteria:

Patients who need:

* clarification of the bile duct anatomy;
* disclosure of eventual intrahepatic bile duct dilation;
* verification of the patency of a sutured bile duct after tumor detachment from a glissonian sheath;
* check of the drainage of a bile duct stump on the liver cut surface prior to bilio-enteric anastomoses.
Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patient With Structural Heart Disease

The aim of this study is to study synergistic effect of eplerenone as Selective aldosterone receptor antagonist with amiodarone compared with amiodarone only in reducing recurrence of atrial fibrillation in patient with structural heart disease

Atrial fibrillation is the most common sustained arrhythmia, with a rising prevalence that substantially increases the risk of stroke and heart failure (1,2), The rate of recurrences without antiarrhythmic treatment is 71%-84%, and it can be reduced to 44%-67% with antiarrhythmic drug therapy(3) Mineralocorticoid receptor blockers (MRBs) are beneficial in systolic HF\[ 4,5,6\]. Specifically, the MRB eplerenone (EPL) has been shown to reduce new onset AF and recurrent AF in HF patients (7). Both angiotensin II and aldosterone elevations may lead to atrial fibrosis and contribute to human AF (8). Experimental results suggest that aldosterone may cause a substrate for atrial fibrosis and AF (9). Aldosterone increases the expression of 11β-hydroxysteroid dehydrogenase type 2 (11b-HSD2) leading to up-regulation of profibrotic mediators and collagen synthesis, which is prevented by MRBs (10).

The European Society of Cardiology (ESC) guidelines identify AF as secondary to Structural heart diseases (SHDs)when a left ventricle (LV) systolic or diastolic dysfunction is demonstrated or LV hypertrophy, valvular disease, and/or other SHDs are documented \[11\].currently, SHD includes: (a) heart failure with reduced ejection fraction (HFrEF, previously severe or moderate LV systolic dysfunction); (b) heart failure with preserved ejection fraction (HFpEF, previously LV diastolic dysfunction); (c) valvular heart disease (VHD) and (d) specific cardiomyopathies, such as hypertrophic cardiomyopathy (HCM) \[12\].

Electrical remodelling is the first mechanism that occurs at the onset of AF and promotes AF through a re-entry-prone substrate. Changes in atrial frequency are determined by changes in the physiology of ion channel activation\[13\] Amiodarone is an antiarrhythmic medication used to treat and prevent a number of types of cardiac dysrhythmias,it blocks the channels that are upregulated by remodelling such as inward-rectifying K1 current (IK1) or by stimulation of the sympathetic nervous system.\[14\]

Eligibility Criteria:
Inclusion Criteria:

- paroxysmal AF who reverted to sinus rhythm either medically or electrically without appropriate secondary cause of primary AF

•AF attack should be documented with ECG

Exclusion Criteria:

* 1-patients are currently on eplerenone or spironolactone 2-hyperkalemia 3-impaired renal function(if CrCl \<50ml/min or serum creatinine\>2 mg/dl) 4-patient on beta blocker and calcium channel blocker (non- dihydropyridine) 5-prosthetic valve 6-severe mitral stenosis 7-thyroid dysfunction 8-WPW 9-severe liver disease 10-persistent or permanent AF 11-pregnancy or breast feeding 12-LV EF\<50% 13-known hypersensitivity or drug reaction to amiodarone 14-acute coronary syndrome 15-refusal of consent
Pain and Quality of Life After Inguinal Hernia Repair

This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.

This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 80 years of age.
* Subject is a candidate for an elective primary inguinal hernia repair.

Exclusion Criteria:

* Subject receiving a bilateral open repair.
* Subject who will have an emergent hernia repair.
* Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks.
* Subject with a history of substance abuse and/or current (within 30 days) narcotic use.
* Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.
* Diabetic subjects requiring insulin.
* Subject with recurrent hernias.
* Subject who will require the use of Exparel during the surgical procedure.
* Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
* Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
* Subject is contraindicated for surgery.
* Subject has a known bleeding or clotting disorder.
* Pregnant or suspect pregnancy.
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
* Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
* Subject unable to comply with the follow-up visit schedule.
* Subject is currently participating in another research study.