cyrilzakka/clinical-trials huggingface dataset:
FDG-PET As an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis

The purpose of this pilot study is to evaluate Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of signing informed consent
* Any solid or hematologic malignancy undergoing treatment with ICI (either as a single agent or in combination with others)
* Ambulatory and able to complete a 2-day high fat and low carbohydrate diet with 18 hours fasting (PET diet), 18F-FDG PET/CT scanning, as well as 13N-ammonia PET-CT myocardial perfusion imaging (part of the routine protocol of the investigation). These two studies will be done as part of the same imaging set.
* Willing to return to Mayo Clinic for ongoing follow-up
* Left ventricular ejection fraction (LVEF) ≥50%
* Cardiac MRI (CMR) without conclusive evidence of inflammation, coronary assessment available (either via cardiac computed tomography angiography, CCTA, or via coronary angiogram) Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

Exclusion Criteria:

* Chest pain
* Fulminant myocarditis requiring steroid therapy
* CMR with definitive evidence of inflammation
* On steroid doses higher than the equivalent of prednisone 1 mg/kg/day for more than 3-5 days at the time of the baseline 18F-FDG PET/CT scanning
* Clinical presentation consistent with acute coronary syndrome (wall motion abnormalities consistent with a specific coronary distribution, coronary angiogram with a culprit lesion identified, patients requiring revascularization either with percutaneous coronary interventions or coronary artery bypass grafting).
* Patients unable to provide informed consent
* Patients unable to complete the diet preparation protocol
* Pregnancy (all women of child-bearing age and potential will have a negative pregnancy test within 48 hours of the PET/CT at screen and 6-month visit)
* Breastfeeding
Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.

Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued:

* To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence
* To assess the impact of the weight loss interventions on quality of life and sleep
* To assess the impact of weight loss on measures of bone health

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal (defined as experiencing at least 12 months without a menstrual period)
* diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation
* completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment
* BMI ≥ 27 kg/m2
* less than 7 servings of alcohol per week
* willing to be randomized into either group
* not planning to move away from the area during the period of study
* non-smoker

Exclusion Criteria:

* serious illness requiring medical treatment
* inability to participate in physical activity due to severe disability
* history of schizophrenia, psychosis or untreated major depression
* unwilling to commute to study site once per week
* failure to provide written informed consent
Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance

Prostate cancer is the most commonly diagnosed cancer in men. However, there is a wide range in prognosis determined by a host of factors. This study will evaluate the feasibility of guiding therapeutic intervention electronically facilitated symptom and disease monitoring in patients being followed on Active Surveillance. Additionally, we will develop a tissue and data resource to support discovery and hypothesis generation to evaluate germline and/or somatic alterations in relation to cancer-specific and overall outcomes..

Primary objectives:

1. Monitor cancer-specific outcomes of men who meet consensus criteria for active surveillance under one of three categories: 1) low or very low-risk prostate cancer, 2) intermediate risk with patient consent, or 3) severe medical comorbidities and high-risk localized prostate cancer or patient desire, despite recommendation

Secondary objectives:

1. Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities.
2. Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction.
3. Develop a tissue and data resource to support discovery and hypothesis generation focused on germline alterations, somatic alterations, and/or the interaction between the two in determining cancer-specific and overall outcomes

Eligibility Criteria:
Inclusion criteria:

1. Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
2. Patient must meet at least one of the following clinical indications for AS: National Comprehensive Cancer Network (NCCN) very low risk or low risk prostate cancer meeting consensus guidelines for AS; NCCN intermediate-risk prostate cancer requesting AS (per patient and clinician shared decision making); or have severe medical comorbidities (defined as CCI estimated 10-year survival \< 50% and agreed by treating clinician) with high- or very high-risk localized prostate cancer.
3. Patients must agree to comply with the surveillance schedule.
4. Patients must be over 18 years of age
5. Written informed consent
6. Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.

Exclusion criteria:

1. Patients are ineligible if they choose not to share their medical data for research purposes.
2. Prior radiation therapy for treatment of the primary tumor.
3. Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol
S8516-S8736-S9125-S9240 Research Study of Genes in Tissue Samples From Patients With B-cell Non-Hodgkin Lymphoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell non-Hodgkin lymphoma.

OBJECTIVES:

* To determine if toxicity following treatment for lymphoma varies according to genetic polymorphisms in oxidative stress-related genes (i.e., SOD2, CAT, GPX1, GSTM1, and GSTP1).
* To assess whether these genetic polymorphisms are associated with progression-free survival and/or overall survival in these patients treated for lymphoma.

OUTLINE: Previously collected samples are used for biomarker analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of aggressive B-cell non-Hodgkin lymphoma

  * Previously treated with curative intent using anthracycline-based therapies
* Previously collected paraffin-embedded diagnostic tissues from clinical trials that were collected as part of SWOG treatment protocols (S8516, S8736, S9125, S9240, and S9349) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients

As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray disc space height measurements as a predictive evaluation method of lumbar disc herniation (LDH) and degeneration in LBP patients in their early 20s.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-25 years
* L-spine X-ray and L-spine MRIs taken within a week of the other test
* Native Korean ethnicity

Exclusion Criteria:

* Scoliosis with a Cobb's angle of ≥20°
* Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)
* Previous spinal surgery
Multifocal Intraocular Lens x Monovision x Hybrid Monovision After Bilateral Cataract Surgery

To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.

The purpose of this study is to evaluate the results in randomized patients that receive bilateral multifocal IOLs, monofocal IOLs with monovision with emmetropia in one eye and 1.50 D of myopia in the other eye, or monofocal IOL in the dominant eye and multifocal IOL in the non-dominant eye, then evaluate visual and refractive outcomes, as well as independence for glasses after bilateral surgery with 1 year of follow up.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral senile cataracts.
* Implantation of IOL in the capsular bag;
* Implants from 10-30 diopter;
* Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery;

Exclusion Criteria:

* Amblyopia;
* Single Eye;
* History of intraocular surgery in the previous year;
* Sequel to prior ocular trauma;
* Important Microphthalmia or aniridia;
* History of damage to the corneal endothelium (chemical burns, herpetic keratitis, corneal guttata);
* Corneal astigmatism \> 1.0 D;
* IOP ≥ 21 mmHg in standard caliper;
* Ocular pathology that affects visual function (uveitis, diabetic retinopathy, age-related macular degeneration, macular dystrophy, retinal detachment, glaucoma, optic neuropathy);
* Pupil \> 5 mm or \< 2 mm under photopic conditions;
* Asymmetrical pupils in the eye or between the eyes;
* Binocular vision absence;
* Any situation that endangers the implant position in the capsular bag (post-traumatic zonular weakness, pseudoexfoliation, for example);
* Patient probably need to laser treatment of the retina;
* Patients whose expectations are unrealistic;
* Patients whose lifestyle involves high expectations of visual acuity (writer, driver, for example);
* Patients at risk of not meeting the clinical follow-up requirements (distance of travel difficulties, for example);
The INSTITUT Study

Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent comorbidity associated with TB. In Benin, the National TB Program systematically provides nutritional support to all persons with TB (PWTB), distributing prepared foods to hospitalized patients and food baskets during outpatient care. In Togo, the PWTB population is similar to that of Benin; however, Togo does not have a systematic program in place to provide nutritional support to these patients.

The investigators will perform a prospective cohort analysis using anonymized TB patient data from the National TB Programs of Benin and Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Participants in Togo who do not receive nutritional support will serve as a control. Unfavorable outcomes in both groups such as treatment failure, death, or relapse will be compared. The results from this study should help to shape TB programs in the future by incorporating nutritional support.

The objectives of this prospective cohort analysis are:

* To estimate the impact of nutritional support on TB treatment outcomes
* To estimate the impact of nutritional support on the nutritional status of persons with TB (PWTB) at the end of treatment.

Pulmonary TB patients who meet eligibility criteria including being diagnosed with a smear-positive (\>/=1+ AFB) and provide informed consent will be enrolled. A projected sample of 1050 participants will be enrolled and followed for approximately 12 months. 700 will be enrolled in Benin and 350 in Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not.

Sputum samples will be collected at baseline and month two to confirm diagnosis and resolution of disease. Chest X-rays will be taken at enrollment, if not available by the TB program, and repeated 6 months following the end of TB treatment to assess for post-TB chronic lung disease. At all visits, surveys will be administered to assess for response to treatment and functional and economic recovery.

Eligibility Criteria:
Inclusion Criteria:

* Drug susceptible, Xpert \[polymerase chain reaction (PCR) test for TB\] positive and/or sputum stain positive for AFB (≥1+)
* Willing to attend follow-up visits and undergo study procedures

Exclusion Criteria:

* Drug resistant TB
* Has received 7 or more days of antimicrobial therapy
* Based on study staff observation, the participant is too sick to enroll. Defined as a score of 4 on the World Health Organization (WHO) Performance assessment.
* Pregnancy at the time of enrollment
* Individuals who are unable to participate in the 6-minute walk test due to pre-existing mobility issues due to disability, trauma, neurological compromise, or cardiopulmonary issues
The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients

This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
* Both males and females will be included.
* In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
* During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
* Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
* Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery

Exclusion Criteria:

* Combined CABG and valve surgery, emergency CABG.
* Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
* Peripheral vascular disease (PVD) affecting the upper limbs.
* Acute coronary syndrome (ACS); acute or recent myocardial infarction.
* Left ventricular ejection fraction ≤30%.
* Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.
* Renal failure, defined as eGFR \< 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).
* Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.
Timing and Intrauterine Insemination in Unexplained Infertility

to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .

IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.

Eligibility Criteria:
Inclusion Criteria:

* Mild male infertility or unexplained infertility

Exclusion Criteria:

* Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block
A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension

The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed. Construct validity will be assessed by the Pearson's correlation coefficient between self-selected community walking speed and the 4-meter walk test. The objective of this multicenter, prospective study is to demonstrate that remote measurement of community walking speed with the Canary canturioTM (CTE) tibial extension is correlated with the fast 4-meter walk test (4mWT).

The primary endpoint is community walking speed, calculated as a mean, remotely captured over the 7 days prior to the patient's regularly scheduled office visit: specifically, the correlation (Pearson correlation coefficient) of community walking speed with the 4mWT.

The secondary endpoints are as follows:

* Correlation coefficient between community walking speed and the Timed Up and Go (TUG) Test
* Completeness of data collection and transmission by the study device
* Correlation coefficient between community walking speed and the Oxford Knee Score
* Correlation coefficient between community walking speed and the Knee Injury and Osteoarthritis Outcome Score Jr (KOOS JR)

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older at the time of surgery
* Patient is scheduled for or has undergone primary total knee arthroplasty using a Persona Personalized Knee System with Canary Tibial Extension (PIQ) TKA implant according to the appropriate surgical technique and IFU.
* Patient must be willing and able to complete the protocol required follow-up
* Patient has participated in the study-related informed consent process
* Patient has a platform-compatible personal computer located in their dwelling with substantially reliable wireless internet access and a USB port

Exclusion Criteria:

* Simultaneous bilateral TKA
* Staged bilateral TKA less than 6 months from indexed procedure
* Patient is a current alcohol or drug abuser
* Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
* Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
* Patient has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint
* Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
* Patient with Neuropathic Arthropathy
* Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
* Patient is undergoing procedures or treatments using ionizing radiation
* Patient has a known or suspected sensitivity to one or more of the implant materials.
* Patients with known orthopaedic lower extremity, spinal and/or neurologic conditions that could affect gait
A Trial of an Oral Nutritional Supplement in Older Hospitalized Patients - NOURISH Study

Evaluate effects of an oral nutritional supplement on healthcare outcomes in older hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 65 years of age.
2. Admitted to hospital with diagnosis of heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
3. Subjective Global Assessment rating of B or C.
4. Length of hospital stay anticipated to be \> 3 days and \< 12 days
5. Able to consume foods and beverages orally.
6. Functionally ambulatory during the 30 days prior to admission.

Exclusion Criteria:

1. Uncontrolled hypertension
2. Diagnosis of diabetes
3. Current active cancer or recently treated cancer
4. Impaired renal function
5. Liver failure, acute Hepatitis, or hepatic encephalopathy
6. Active tuberculosis.
7. HIV
8. Disorder of gastrointestinal tract
9. Autoimmune disorder
10. Intubation, and/or tube or parenteral feeding.
11. Severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
12. Allergy or intolerance to any of the ingredients in the study products.
13. Body mass index of ≥ 40 kg/m2.
14. Resident in a nursing home or other residential facility.
15. Planned surgery during course of the study.