cyrilzakka/clinical-trials huggingface dataset:
Heart Failure and Regional Specific Exercise Training Stimulus

The aim of this study is to determine whether heart failure patients can tolerate a four-weeks of a new exercise training regimen that targets peripheral tissues (Regional Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic capacity and strength in healthy subjects aged 70+years who were at risk for losing functional independence.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 55 and 90
* Diagnosed with heart failure (NYHA class II-III)
* Receiving optimal medical therapy
* Sedentary (≤ 30 min/wk structured physical activity)
* Peak VO2 between 10 and 30 mL/kg/min.

Exclusion Criteria:

* Oxygen dependent
* Recent medications changes (within 3 months)
* Fixed-rate pacemakers
* Uncontrolled hypertension
* Type I diabetes
* Organ transplant
* Bariatric surgery
* Renal failure (stage 4 or 5)
A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004).

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.


Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
* Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
* Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
* High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
* M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous)
* Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
* Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

Exclusion Criteria:

* Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization.
* Has residual thrombus post nephrectomy in the vena renalis or vena cava.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Received prior treatment with a cancer vaccine.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has a history of brain or bone metastatic lesions.
* Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* History of allogeneic tissue/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications
HIV Indicator Diseases in Hospital and Primary Care

Patients are frequently evaluated by physicians for medical work-up of HIV indicator conditions in hospital and in primary care at the general practitioner. Testing for HIV is indicated with HIV indicator disorder but often omitted in clinical work-up. Besides the fact that HIV testing is forgotten, there are other reasons such as an underestimation of the risk of HIV in the event of indicator disorders, stigma and difficulties in discussing the test with a patient. Also and more relevant for primary care than for the hospital, practical challenges can exist for a patient to go to a laboratory, or costs are a hurdle.

This project focuses on improving HIV indicator condition driven testing in different settings of the HIV epidemic, initially in the Netherlands as low HIV prevalence setting followed by an assessment of its benefit in different international settings. A specific focus will also be on the Rotterdam area in the Netherlands which has a high prevalence of undiagnosed HIV in the Netherlands. The ultimate aim is to decrease the number of undiagnosed HIV in populations, improve the 90-90-90 HIV cascade of care goals particularly its first pillar, and to help supporting the UNAIDS goal to end HIV/AIDS


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an HIV indicator conditions.

Exclusion Criteria:

* Below 18 years of age
* Recent HIV test (\< 12 months, except for mononucleosis-like disease and STDs)
Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring

A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic heart failure.
* Ejection fraction equal to or below 40%.
* New York Heart Association (NYHA) class II to class III.
* Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure.

Exclusion Criteria:

* Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney).
* Currently in an investigational device or drug study.
* Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.
White Light Scanning to Aid Body Contouring: A Pilot Project

A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.

A 3-D digital body camera that employs non-intrusive white light phase profilometry and 24 coordinated charge-coupled cameras scans and produces a "point cloud" image of the subject. The result of the two-minute scan process is an accurate three-dimensional body model of the subject, consisting of over 1.2 million surface points. The point cloud is compressed to provide programmable measurement extraction profiles (MEP's) that automatically extracts linear and circumferential measurements. Subjects are scanned and anthropometrically measured pre-operatively, and at 3, 6 and 9 months post-op.

Eligibility Criteria:
Inclusion Criteria:

* All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.

Exclusion Criteria:

* Pregnant, nursing,or have a history of epilepsy.
* Individuals under 18 years old;
* Problems reading or understanding spoken instructions;
* Are in jail or in a "locked ward";
* Are a student or an employee of EVMS; or
* Are chemically-dependent.
Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)

This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single followed by multiple dose, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact of STX-100 on gene and protein expression for αvβ6 related and TGF-β-inducible genes (including tubulointerstitial injury, epithelial function, and IF/TA related genes) in renal transplant patients with biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult patients, 18 (or the legal age of consent) to 65 years old, male or female.
* eGFR ≥ 25 ml/min (Cockcroft-Gault formula).
* Six to 60 months post renal transplant at the initiation of screening.
* Qualifying renal biopsy obtained within 8 weeks prior to randomization with histologic evidence of ≥ Grade 2 IF/TA (Banff score) without morphologic evidence of a treatable etiology (e.g., BK virus nephropathy, chronic obstruction).
* Adequate bone marrow and liver function
* Weight between 40-110 kg.
* Female patients must be surgically sterile, postmenopausal (minimum 1 year without menses and verified by follicular-stimulating hormone \[FSH\] levels), or agree to use contraception from the time of signing the informed consent form through 16 weeks following the last injection of study medication. Male patients must also agree to use birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through 16 weeks following the last injection of study medication.

Exclusion Criteria:

* Recipient of a multi-organ transplant.
* History of T-cell mediated rejection (TCMR) within 3 months prior to randomization.
* Patients who are receiving high dose corticosteroids at the time of screening.
* Histologic evidence of acute TCMR (≥ Banff Grade 1A) on a qualifying renal biopsy for this study. Patients with 'borderline' changes (Banff criteria) on a qualifying renal biopsy are eligible for this study if the Principal Investigator believes treatment for TCMR is not warranted.
* Prior or current histologic evidence of polyomavirus BK virus nephropathy.
* Any histologic finding on the qualifying renal biopsy that the Investigator believes warrants modifying the patient's current therapy.
* Evidence of active tissue invasive cytomegalovirus or Epstein-Barr virus infection.
* History of malignancy, including carcinoma or post-transplant lymphoproliferative disorder.
* History of chronic pulmonary disease or smoker within the past 5 years or more than 15 pack-years exposure.
* Serious local infection or systemic infection within 3 months prior to screening.
* Surgery within 3 months prior to Day 1 (other than minor cosmetic surgery, minor dental procedures, or percutaneous kidney transplant biopsy).
* Positive test for HBsAg, HCV, or HIV antibody at screening.
* Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month prior to dosing.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Heart Disease

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of congestive heart failure and angina

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of congestive heart failure and angina. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Congestive Heart Failure or Angina
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion

This is prospective cohort study in subjects with a planned percutaneous coronary intervention (PCI) of their chronic total occlusion (CTO). The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO. The study is designed to enroll 50 subjects with CTO in the span of 3 years. There will be a 6-month assessment of the outcomes of death and cardiovascular death. As the study includes FDA approved tests, there will be no safety endpoint per se, however there will be a mechanism for monitoring adverse events as will be described in detail.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 21 years
* seen at University of Chicago Medical center with a planned PCI of a single CTO vessel
* must have either stable angina or angina equivalent
* must have a CTO with a clear donor vessel supplying most of the collaterals.

Exclusion Criteria:

* subjects with a pacemaker or implantable cardioverter defibrillator
* contraindication to cardiac MRI, adenosine, heparin, or nitroglycerin
* cardiac transplantation
* Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2, given the risk of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF) associated with iodinated and gadolinium-based contrast agents, respectively, in patients with significant renal dysfunction
* Women who may potentially be pregnant will receive a pregnancy test and be excluded if pregnant
* Vulnerable populations such as children, college students, prisoners, non-English speakers, and those with diminished decision-making capacity
* Inability or refusal to consent for the study.
Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

Three arm study comparing three novel contact lens solutions.


Eligibility Criteria:
Inclusion:

* Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
* Stable correction is defined as longer than six months.
* Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

* Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
* Any systemic or ocular disease that could affect contact lens wear.
* Women who are pregnant or lactating.
MAST - Magnesium for Sickle Cell Acute Crisis in Children

The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.

Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.

In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.

Eligibility Criteria:
Inclusion Criteria:

* Known sickle cell disease
* Previous painful crisis resulting in an Emergency Department(ED) visit
* Current visit with a chief complaint of pain
* Age 4 years - 18 years
* Staff ED decides to admit to the hospital
* Staff ED decides to start an intravenous line

Exclusion Criteria:

* Fever (\>38.5C) during the 24 hours prior to visit at triage
* Patients transfused within 90 days of study entry
* Patients with known renal disease
* Patients with known heart block or myocardial damage
* Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
* Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours
* Patients or parents unable to communicate in English
* Known pregnancy
* Known allergy to Magnesium
* Admission to the ICU
* Enrolment to the study in the last 30 days
Neurofeedback Intervention for Reading Deficits in Subacute Stroke

The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.


Eligibility Criteria:
Inclusion Criteria:

* First-ever left-hemisphere stroke \< 3 months prior to study recruitment or healthy volunteer
* Age: 18 - 80 years old
* Fluent and literate in English prior to stroke
* Reading deficits, defined as \>3 errors on the Paragraphs test (subtests VIII, IX) of the Reading Comprehension Battery for Aphasia-2nd ed. (RCBA-2) in keeping with the healthy control accuracy criterion of 86-100% correct.

Exclusion Criteria:

* Inability to consent or complete study tasks
* Inability to undergo MRI (e.g., pregnancy, non-MRI compatible implants, claustrophobia)
* A history of prior neurological disease (e.g., brain tumor, Alzheimer's disease)
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer

Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.

This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments.

The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed invasive breast carcinoma
2. Stage II or III
3. ECOG performance status of 0 or 1
4. Age 18-80

Exclusion Criteria:

1. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.
2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.
3. Infection requiring systemic treatment.
4. Active double cancer (however, the following are not excluded: (1) Completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Other cancers that have not recurred for more than 5 years).
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Aged 18 or above
* Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
* Documented PD-L1 expression by PD-L1 IHC per local report.
* Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
* Part C and Part D: No prior I/O treatment for metastatic NSCLC.
* Part E: No prior treatment for metastatic NSCLC.
* ECOG performance status of 0 or 1 at enrolment.
* Life expectancy of ≥ 12 weeks at enrolment.
* Have at least 1 measurable lesion per RECIST v1.1.
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
* Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
* Previous treatment with an anti-TIGIT therapy
* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
* Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
* Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).

Treatment with one previous systemic chemotherapy will be allowed.

* Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
* Symptomatic central nervous system (CNS) metastasis.
* Thromboembolic event within 3 months prior to enrolment.
* Other invasive malignancy within 2 years prior to screening.