cyrilzakka/clinical-trials huggingface dataset:
Biobank for African American Prostate Cancer Research in Florida

The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among men of African Ancestry in Florida and; b) to examine whether smoking increases the aggressiveness of prostate cancer using several biological approaches.

Investigators plan to contact African American prostate cancer patients regarding participation. This project has 3 main components. Eligible patients may choose to participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.

This project will create the first state-wide data and biospecimen bank for men of African ancestry with prostate cancer. The sampling strategy and size of the study population ensure that the cohorts is representative, enhancing validity of studies based on this resource. In addition, there are no data on the role of smoking in African American prostate cancer. The approach to share the resource with Florida prostate cancer researchers is innovative and possible because the four annual prostate cancer symposiums organized by Moffitt has unified many Florida prostate cancer researchers who are now well connected and actively collaborating, as evidenced by publications and funded projects among participants.

Eligibility Criteria:
Inclusion Criteria:

* The initial recruitment of cases will be done with 3 mailings: the first to introduce the study to the participant from Florida Cancer Data System (FCDS) of the Florida Department of Health and ask them to complete the eligibility form and contact information update form; a second mailing to those who are determined to be eligible for the study to obtain the Informed Consent Form and the Baseline survey; and a third mailing to those who completed the survey to obtain a saliva sample and medical release form for tissue.
* Histologically biopsy confirmed, primary prostate cancer, diagnosed between January 2013 and December 2015
* African American or Black; Hispanic Black; Afro-Caribbean
* Are at least 20 years old
* Are a resident of Florida
* Additional criteria may apply

Exclusion Criteria:

* Does not meet Inclusion Criteria
The Effects of Restricted Dietary of AGEs on the Glycemic Control, Oxidative Stress and Inflammation

To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy diet and no changing in physical activity pattern.Parameters related to metabolic syndrome, anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the end of the study.

Metabolic syndrome (MS) is a cluster of cardiovascular risk factor abnormalities associated with increased risk of type 2 diabetes mellitus, cardiovascular disease, and all-cause mortality. Non-enzymatic glycation plays an important role in the development of physiological and pathophysiological processes such as aging, diabetes, atherosclerosis, and chronic renal failure. Preventing glycation can minimize diabetic complications. Advanced glycation end products (AGEs) are formed endogenously when the carbonyl groups of reducing sugars nonenzymatically react with the free amino groups on proteins. AGEs are generated in vivo as a normal consequence of metabolism, but their formation is accelerated under conditions of hyperglycemia, hyperlipidemia and increased oxidative stress. It can also form in food processing and the variety and the amount of dietary AGEs (dAGE) depend on food nutrients, the heating used in food processing, pH conditions, presence of some metal ions (Cu++, Fe++) and water content. In this study 2 groups of metabolic syndrome patients(22 in each group) will receive same low calorie diet and one of the groups plus restricted dietary AGEs according to the international references.Along 8 weeks the investigators will talk to each patient by phone and every months the participants will come and the investigators will take anthropocentric measurements and the recommendations for diets will review. The three-day 24-hour recall food questionnaire will take at first,middle and the end of program.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report

Exclusion Criteria:

* history of allergy
* clinically diagnosed renal, pituitary, thyroid, infections and inflammations, cancer and using of insulin, using multivitamin mineral and vitamin B6 suplements.
* Using any
* history of cancers.
* pregnancy, lactation.
A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.


Eligibility Criteria:
Inclusion Criteria:

* Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab
* Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
* Eastern Cooperative Oncology Group (ECOG) 0-1

Exclusion Criteria:

* History of uveal melanoma
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
* Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
Outcome of Radiation Therapy in Operated Gastric Cancer

* Study tolerability and toxicity of radiotherapy with or without chemotherapy for operated gastric cancer.
* Evaluate the efficacy of adjuvant radiotherapy with or without chemotherapy as regarding local control and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Age of the patient; ≥18 and ≤75 years.
* Histologically proven gastric or gastroesophageal adenocarcinoma.
* Pt received adjuvant Radiotherapy with or without chemotherapy with any protocol.

Exclusion Criteria:

* Patient \>75 years\&\<18 years.
* Histologically types other than adenocarcinoma .
* Metastatic patients (M1).
* Pt didn't recive radiotherapy.
Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer

This is a multi-center, stratified and single-blinded Phase 2 study of neoadjuvant immunotherapy in combination with the antiGDF15 antibody visugromab (CTL-002) for the treatment of subjects with MIBC set to undergo radical Cystectomy (RC)/Re-TURBT who cannot receive or refuse to receive cisplatin-based chemotherapy.


Eligibility Criteria:
Main Inclusion Criteria:

* Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
* Male or female aged ≥ 18 years.
* Histopathologically confirmed urothelial carcinoma.
* Clinical Stage T2-T4aN0M0 MIBC.
* Ineligible for cisplatin therapy per modified Galsky criteria or refuses cisplatin-based chemotherapy.
* Eligible for radical Cystectomy.
* Pretreatment tumor material from transurethral resection of the bladder tumor (TURBT) must be available.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Adequate organ function (bone marrow, hepatic, renal function and coagulation).

Main Exclusion Criteria:

* Pregnant or breastfeeding.
* Received prior radiotherapy on the bladder tumor.
* Received a partial cystectomy.
* Any prior systemic anti-cancer therapy including investigational agents and immunotherapy.
* Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (NYHA) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time \< 6 months prior to Screening or presence of uncontrolled heart failure NYHA Grade III or higher.
* Left ventricular ejection fraction (LVEF) \< 50% measured by echocardiogram or MUGA.
* QTcF ≥ 470 ms regardless of sex.
* Any active autoimmune requiring systemic immunosuppressive treatments.
* Any history of non-infectious pneumonitis \< 6 months prior to Screening.
* Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present \< 6 months prior to Screening.
* History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (\< 6 months prior to Screening).
Ultrasound Assessment During Exercise

This study evaluates the ability of the transverse abdominis (TrA) to contract during and after two different types of exercise - either sling based exercise or traditional core stability exercise. The TrA is measured by real time ultrasound imaging. The investigators hypothesized that the sling based exercise would activate the TrA to a greater degree and that there would be a greater activation after the exercise.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain with stabilization classification

Exclusion Criteria:

* Fractures, neurological condition
Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

Prostate cancer has been the most common neoplastic disease in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. While, as many as 47% of the ultra-sound guided biopsies may be false negative and biopsies carry a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This study will enroll 150 men with previous negative biopsies and clinical suspicion of prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal examination (DRE) or patients in active surveillance due to low risk prostate carcinoma. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS guided biopsy based on MRI findings will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Language spoken: Finnish or Swedish
* Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
* Previous diagnosis of prostate carcinoma and patient on active surveillance
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Language spoken: Finnish or Swedish
* Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
* Previous diagnosis of prostate carcinoma and patient on active surveillance
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
Well-Mama Community Doula Navigator Study

This study will develop and test an intervention, called the Well-Mama intervention, which includes the use of a checklist by Community Doula Navigators to support pregnant women. Participants will be randomized to either receive standard perinatal care or standard perinatal care plus the Well-Mama intervention.

Black, Indigenous, and People of Color (BIPOC) women experience profound maternal health disparities in the US, including rising rates of maternal mortality and severe maternal morbidity. This study will develop a Well-Mama intervention for pregnant and postpartum BIPOC women, centered around Community Doula Navigators conducting in-person and telehealth check-ins on 5 priority areas (mental health, cardiovascular symptoms, safety, opioid/substance abuse, and social support), supplemented with virtual support groups and labor support. The investigators will conduct a randomized trial to test whether the Well-Mama intervention increases BIPOC women's receipt of prenatal and postpartum care.

Eligibility Criteria:
Inclusion Criteria:

1) Pregnant individuals that are age 15-49 years; (2) uninsured or have public insurance (i.e., Medicaid); (3) singleton pregnancy \<32 weeks gestation; and (4) not cognitively impaired

Exclusion Criteria:

Already receiving/enrolled in another perinatal care program beyond standard care, such as group prenatal care, maternity home, or employing their own doula
DOAC Versus VKA After Cardiac Surgery

Postoperative management of oral anticoagulation is a frequent preoccupation in cardiac surgery, concerning about half of patients. Vitamin K antagonists are often recommended but their management is not easy due to the high dose-response patient variability. Pharmacologically more stable, direct oral anticoagulants have similar efficiency in preventing thromboembolic complications while they decrease the risk of bleeding in certain patient populations. The objective of study is to assess the safety and efficacy of direct oral anticoagulants in the postoperative period of cardiac surgical procedures.

This study will be composed by 2 groups of 103 participants, patients undergoing cardiac surgery and needing oral anticoagulation in the early postoperative period.

The control group will receive vitamin K antagonist and the study group will receive direct oral anticoagulant. The investigators will call back each participants at 3 months to report the ischemic and bleeding complications during this period and evaluated the quality of life of the oral anticoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery, with or without cardiopulmonary bypass
* Indication of postoperative oral anticoagulation: preoperative (atrial fibrillation/flutter of idiopathic venous thromboembolism disease), intraoperative (bioprosthetic mitral valve replacement/mitral valve repair or bioprosthetic tricuspid valve repair), postoperative (de novo persistent more than 24 hours or recurrent atrial fibrillation/flutter, venous thromboembolism)

Exclusion Criteria:

* mechanical valvular prostheses or ventricular assist devices
* morbidly obesity (body mass index ≥ 40 kg/m²), prior biliopancreatic diversion or sleeve gastrectomy
* perioperative dysphagia needing naso-enteric tube or jejunostomy
* antiretroviral of antifungal oral therapy
* perioperative recent (less than 2 weeks) stroke
* perioperative severe renal failure (clearance of creatinine under 30 mL/min or dialysis)
* perioperative severe hepatic failure (elevated alanine aminotransferase more than 3 times the superior limit of normal range or cirrhosis)
* perioperative recent (less than 3 months) heparin-induced thrombocytopenia
Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part a

This Study will comprehensively evaluate a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.

A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used

This study will evaluate Jaspr's patient-facing tablet-based application (app) during suicide-related ED visits. The app guides patients in completing the Suicide Status Interview, which comprise of an evidence-based Collaborative Assessment \& Management of Suicidality (CAMS) certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety planning, and lethal means safety counseling. It also offers access to a menu of "Comfort and Skills" modules that teaches patients behavioral skills to effectively manage imminent distress, while shared stories offer a library of professionally produced, racially and culturally diverse, inspirational videos of people with suicide-centered lived experience.

Subjects who interact with Jaspr can continue to access their safety plan, comfort and coping skills exercises, and the video library via Jaspr at Home (JAH) mobile application; a summary of the self-administered risk assessment is shared with the clinical team directly through the patient electronic medical record to help guide the treatment plan.

Part A of the study will be an individual, patient-level Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. All subjects will complete a baseline assessment prior to random assignment to one of the the two study conditions. All subjects will receive follow-up phone calls for 12 months after enrollment at weeks 6, 12, 24, 36, and 52. These calls will assess suicide related outcomes and healthcare utilization. In addition, the Massachusetts Department of Public Health (MA DPH) death registry will be reviewed, and each subject's electronic health record will be reviewed.

Part B of the study will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes.

This ClinicalTrials.gov record will cover only Part A. Part B is summarized in a separate entry.

Eligibility Criteria:
Inclusion Criteria:

* Positive for suicide risk on the Patient Safety Screener in the ED (active suicidal ideation int the past 2 weeks, or suicidal attempt in the past 6 months)
* Cognitively and emotionally capable of consent and engaging in Jaspr app.
* Reads English at 6th grade level.
* Reliable telephone access.
* Owns a smart phone
* Lives in Massachusetts

Exclusion Criteria:

* Prisoners or in state custody
* Adults unable to consent
* Patient \<18 yeas
* Enrolled subjects during the 12 month follow-up period
Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema

The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.

The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.

In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
* Volume difference between affected and healthy arm ≥ 10%
* Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.
* Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria:

* Stage I lymphedema or located in several places.
* Patients for whom compression is contraindicated.
* Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.
* Motor and sensitive neurological deficiency / psychiatric or addictive disorders
* Pregnant or breastfeeding patient
* Patient intolerant to MOBIDERM Autofit or known allergies to the components used.
* Participation to any other clinical study which has an impact on the different endpoints
* Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.