cyrilzakka/clinical-trials huggingface dataset:
SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

The study team will examine effects of elevated plasma ketones caused by 12-week treatment with an SGLT2i (empagliflozin) treatment in participants with T2DM and HF. The study team will focus on three possible mechanisms of action for these effects and test the following:

(i) Skeletal muscle bioenergetics. Using 31P-MRS, the team will quantitate phosphocreatine \[PCr\], ATP, inorganic phosphate, phosphodiester, and intracellular pH. With 1H-MRS, and will measure intramyocellular lipid content at rest and ATPmax production after exercise. The team will examine the relationships between phosphorous metabolite concentrations, intramyocellular lipid content, and ATP generation before and after 12 weeks of SGLT2 inhibition.

(ii) Cardiopulmonary functional capacity.

(iii) Improvements in Patient-Reported Outcomes (PRO). The Patient-Reported Outcomes Measure Information System (PROMIS) Item Bank v2.0 - Physical Function - Short Form 20a will be used to evaluate self-reported physical function and well-being. This tool is a well-developed and validated method to obtain patient self-reported parameters of health in adults.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
* Age 18-80 years
* BMI 23-38 kg/m2
* Glycated hemoglobin (HbA1c) 5.5-10%
* Blood Pressure (BP) ≤ 145/85 mmHg
* Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
* Stable dose of guideline-directed medications for heart failure and Diabetes
* Stable body weight (±4 pounds) over the last 3 months
* Does not suffer from severe claustrophobia
* No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion Criteria:

* Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
* Pregnancy, lactation or plans to become pregnant
* Allergy/sensitivity to study drugs or their ingredients
* Cancer
* Current drug or alcohol use or dependence
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Intraoperative Methadone for Postoperative Pain Control

To compare patient pain perception and satisfaction as well as opioid-related side effects during inpatient and outpatient care when undergoing bariatric enhanced recovery after surgery protocols with and without methadone.


Eligibility Criteria:
Inclusion Criteria:

• All patients undergoing initial gastric sleeve resection

Exclusion Criteria:

* Age \<18 years or \>60 years
* Patients with BMI \>60
* AHI \> 30 (AHI = Apnea-Hypopnea Index), indicative of severe Obstructive Sleep Apnea (OSA)
* ASA IV or V (American Society of Anesthesiology physical status classification system)
* Patients taking opioids for chronic conditions in the last 10 days preceding the surgery
* Patients currently being treated for chronic opioid addiction
* Patients with severe psychiatric diagnoses
* Allergies to medications used in protocol
A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread

The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
* No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:

  i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
* Life Expectancy ≥ 12 weeks
* Karnofsky Performance Status (KPS) of at least 70%
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
* Males and females must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Active CNS brain metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Inadequately treated adrenal insufficiency
* History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)

Other protocol-defined inclusion/exclusion criteria apply
Virtual Reality Mindfulness Meditation After ACL Reconstruction

To evaluate the effect of virtual reality mindfulness meditation on patients after ACLR, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 1 to 5 years post-ACLR when compared to a virtual reality sham group.

Injury-related fear after anterior cruciate ligament (ACL) injury significantly contributes to decreased return to sport, decreased physical activity engagement, and increased ACL reinjury risk in previously high functioning, physically active individuals. Injury-related fear is also associated with poor jump-landing movement patterns in patients after ACL reconstruction (ACLR). Unfortunately, current rehabilitation practices do not specifically address injury-related fear in patients after ACLR. Virtual reality mindfulness meditation is a mental practice that involves focusing the mind on experiences in the present moment and has been used to address depression, anxiety, and chronic musculoskeletal pain. To evaluate the effect of virtual reality mindfulness meditation on patients after ACLR, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 6 months to 10 years post-ACLR when compared to a virtual reality sham group. Patients in the intervention group will complete 8-weeks of virtual reality mindfulness meditation + an advanced rehabilitation training program. Patients in the sham group will complete 8-weeks of the virtual reality sham + an advanced rehabilitation training program. The central hypothesis is that women 6 months to 10 years post ACLR who undergo virtual reality mindfulness meditation will demonstrate decreased injury-related fear, improved jump-landing movement patterns, and improved brain activity.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 14-25 years
* Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11
* Have poor jump-landing movement quality as measured by the Landing Error Scoring System-Real Time
* Injured their knee playing or training for sports (recreational or organized)
* Right-hand dominant
* 6 months to 10-years post-ACLR
* Demonstrate magnetic resonance imaging (MRI) compliance

Exclusion Criteria:

* Male
* Concussion in the past 3 months
* Presence of metal fragments, pins, plates, or clips, shrapnel, permanent makeup, body piercings that cannot be removed, surgical implants, or orthodontics that cannot be removed
* On any medication that affects the central nervous system
* Any neurological conditions (i.e. epilepsy)
* Claustrophobia
* Under the influence of alcohol or other recreational drugs
* Pregnancy or suspicion of pregnancy
Microbiome Shifts in Adolescent Anorexia Nervosa

The aim of this study is to evaluate the effect of starvation and recovery in adolescent anorexia nervosa patients in regard to microbiome activity and composition and to elucidate potential connections between weight gain, depression and other comorbidities, further to capture hormone levels and inflammation parameters in a longitudinal design.

Anorexia Nervosa (AN) has the highest mortality of all psychiatric disorders. Large part of all patients the disorder becomes chronical. Until now, no (bio-) markers which allow a prognosis of outcome are known. Recently the function of the intestinal microbiome and its effects on food uptake, immunological processes and barrier malfunctions in the intestine is discussed. Especially the concept of the "leaky gut", an adsorption malfunction of the intestinal wall under starvation for antigens may help to explain the low inflammatory response which is commonly found in Anorexia Nervosa subjects and a connection to higher rate of autoimmune diseases by Anorexia Nervosa. Furthermore the presence and quantity of specific bacteria in the intestine seems to be dependent on patient's sex which would contribute to the gender gap of prevalence for Anorexia Nervosa. Stress induced changes of the HPA-axis which are well documented in Anorexia Nervosa patients and often persist even after weight rehabilitation, play an important part for intestinal wall permeability disorders. In the most often used animal model for AN, the Activity-Based Anorexia (ABA) model which combines nutrition restriction and weight loss with hyper activity, a malfunction in intestinal wall permeability was found. Malnutrition and long lasting dieting have a fast and reproducible impact on the intestinal microbiome. Especially animal derived food seems to support proliferation of pro-inflammatory bacteria. A substantial intestinal dysbiosis (reduced alpha-diversity) was found in AN patients which only partly recovered after weight rehabilitation. Reduction in diversity and composition of the microbiome was significantly associated with severity of depressive symptoms in patient, where severity is an indicator for higher level eating pathologies and poorer prognosis. Aim of this longitudinal study is therefore to investigate to interconnections between fecal microbiome and progression of AN, including associations with stress, inflammatory markers and metabolic markers in blood sera as well as clinical parameters such as severity of depression and eating pathologies.

Eligibility Criteria:
Inclusion Criteria:

* Female patients and volunteers between age 12 and 18 at inclusion.
* Written informed consent by Patient/volunteer and caregiver.
* Volunteers with BMI between 10 and 90 percentile of their age group.
* Volunteers without prior eating or mental disorder.

Exclusion Criteria:

* Psychotic disorder(s)
* Personality disorder(s)
* Alcohol and substance abuse
* Prone to self-harming behaviour
* Primary caregiver insufficient German language skills
* Patient/Volunteers IQ lower 85
* Antibiotic treatment within 4 weeks prior to inclusion
Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence

The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).

To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.

Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .

All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Genuine stress urinary incontinence by self report, examination and test
* Urethral hypermobility
* Eligible for all three surgical procedures
* Ambulatory

Exclusion Criteria:

* Pregnancy
* \<12 months post-partum
* Systemic disease and/or drugs known to affect bladder function
* Current chemotherapy or radiation therapy
* Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
* Recent pelvic surgery
* Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree
* Previous pelvic or anti-incontinence surgery
* History of severe abdominopelvic infections
* Known extensive abdominopelvic adhesions
* Detrusor instability and/or intrinsic sphincter dysfunction
* Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
* BMI \>30
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?

The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.


Eligibility Criteria:
Inclusion Criteria:

* bilateral or unilateral transtibial amputation
* at least one year of running experience using running-specific prostheses
* 18-55 years old
* no current problems with their prosthesis or residual limb
* at a K4 Medicare Functional Classification Level

Exclusion Criteria:

* Cardiovascular, pulmonary, or neurological disease or disorder
Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients

Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.


Eligibility Criteria:
Inclusion Criteria:

* adult diabetic outpatients referred for elective colonoscopy

Exclusion Criteria:

* patients \< 18 years of age or \> 75 yrs of age,
* known or suspected pregnancy,
* known or suspected renal failure,
* unstable angina,
* acute coronary syndrome,
* decompensated congestive heart failure,
* decompensated liver failure,
* known or suspected bowel obstruction,
* major psychiatric illness,
* solid organ transplant patients,
* known allergies to PEG-ELS or bisacodyl,
* prior alimentary tract surgery or refusal to consent to the study.
Meshed Vein Graft Patency Trial - VEST

The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.

To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
* Coronary artery with critical stenosis (over 70%)

Exclusion Criteria:

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Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma

To determine if teaching rural children with asthma and their parents about appropriate medication use, asthma triggers unique to a rural setting and increasing access to medical care will result in a decrease in emergency department visits.

Many self-management asthma interventions have demonstrated increase in asthma knowledge, reduced emergency department visits, increased self-efficacy and quality of life. The type of self-management interventions, specifically individualized and interactive educational interventions, have been suggested to have the strongest effect on asthma morbidity. Few studies have tested asthma self-management educational interventions in increasing knowledge, self-efficacy and quality of life in rural pediatric populations. The goal of this study was to test the effectiveness of an asthma educational intervention in improving asthma knowledge in rural children and their parent/caregivers. We hypothesized that an interactive asthma educational intervention would increase parent/caregiver and child asthma knowledge resulting in decreased emergency room visits in rural families of children with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed asthma, attend elementary school in rural county agreeing to participate

Exclusion Criteria: Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD

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Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:

* achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and
* in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.


Eligibility Criteria:
Summary Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Summary Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
Vaccine Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

OBJECTIVES: I. Determine the safety and tolerability of antigen pulsed dendritic cell therapy in patients with metastatic melanoma. II. Perform serial analysis of T cell and B cell function in these patients after this treatment. III. Determine objective response and response duration in these patients after this treatment.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days 1-6, then undergo leukapheresis for 2-3 days, beginning on day 6. Mononuclear cells are selected for CD34+ cells in the laboratory, made into dendritic cells, and then pulsed with MART-1, gp100, tyrosinase, MAGE-3 peptides and flu matrix. These antigen pulsed dendritic cells (ApDCs) are used for vaccinations. Prior to vaccination, ApDCs are mixed with MART-1, gp100, tyrosinase, MAGE-3, and flu matrix. Patients receive this dendritic cell vaccine mixture SQ every 2 weeks for 4 priming doses. Patients receive 4 boost vaccinations SQ at 2 months, 5 months, 9 months, and 15 months following the last priming vaccination. Patients are followed monthly for 2 years.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic melanoma Measurable disease HLA-A2 01 phenotype No active CNS or hepatic metastases

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Normal CD4 and CD8 T cell numbers by flow cytometry Lactic dehydrogenase less than 2 times normal Hepatic: No viral hepatitis Renal: Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive heart failure Pulmonary: No prior asthma Immunologic: Positive intradermal skin test for mumps, histoplasmosis, or streptokinase antigen Immunoglobulin levels normal No prior autoimmune disease (lupus erythematosus, rheumatoid arthritis, or thyroiditis) No allergy to tetanus toxoid or influenza vaccine No sensitivity to E. coli drug preparations Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon At least 8 weeks since prior interleukin-2 Chemotherapy: No more than 3 prior courses of cytotoxic chemotherapy At least 8 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent immunosuppressive agents