cyrilzakka/clinical-trials huggingface dataset:
Optimizing Body Composition for Function in Older Adults

The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.

In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These participants will be randomized into one of 4 groups:

Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and pioglitazone/Actos™

The specific aims of the pilot are:

1. In both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training.
2. In both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group.
3. Assess the feasibility of the recruitment, assessment and intervention strategies
4. To estimate adherence to the weight loss, exercise training, and drug interventions;
5. In this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study.
6. To obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.

Eligibility Criteria:
Inclusion Criteria:

* Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short physical performance battery score 3-10

Exclusion Criteria:

* Diabetes, weight \> 136 kg, Medical condition that limits exercise participation, Congestive heart failure, abnormal kidney function, higher ALT than normal, currently involved in a weight loss or exercise program, current smoking, alcohol or drug abuse, taking anti-inflammatory steroids, taking protein supplements, taking PPAR-gamma agonist, edema, anemia
FINGER; Finland-Germany Myocardial Infarction Study

The purpose of this observational study is to find characteristics and risk stratification methods for identification of subjects who have increased risk of death, especially sudden cardiac death, after acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myocardial infarction
* Consent to the study
The Effect of Metformin on Breast Cancer Patients

Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients.

Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.

This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
2. Female Age between 18- 65 years.
3. Written informed consent.

Exclusion Criteria:

1. Known hypersensitivity reaction to Metformin.
2. Intolerable Metformin GI complaints.
3. Patients at risk of lactic acidosis.
4. Diabetic breast cancer patients.
5. Body Mass Index \< 18.5 (underweight breast cancer patients).
6. Renal impairment, eGFR \<45 mL/min/1.73 m².
Cancer Genetic Testing in Ethnic Populations

This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.

SECONDARY OBJECTIVES:

I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:

Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel testing.

Ib. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network \[NCCN\]) based approach for genetic evaluation.

OUTLINE:

Patients undergo collection of blood or saliva sample for genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age
* Individuals diagnosed with any solid tumor cancer including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary; and presenting to Mayo Clinic (MC Arizona or MC Florida) for clinical management/treatment; and patients receive genetic testing as described above
* Self-identified as being from various ethnic populations including Hispanic/Latino, Native American/Alaskan, African American (including of African descent), Asian and other European populations
* Blood collection is feasible (health, access and/or tolerability) for requested blood sample(s)
* Individuals have agreed to participate and signed the study informed consent form

Exclusion Criteria:

* Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic and available for review by the research coordinator at time of consent
* Past or current history of hematological cancer (including leukemias, multiple myeloma)
* All bone marrow transplants
The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient undergoing oesophagectomy with laparoscopy and thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA score 1 to 3
* oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy

Exclusion Criteria:

* pregnancy
* Uncooperative patient
* patient refusal
* Coagulopathy
* allergy to local anesthetic
* Psychological Disorders
* Failure to install the epidural or paravertebral catheter. The patient will therefore be excluded secondarily but will be able to benefit from an alternative technique for the management of his pain.
* Sepsis
* Skin infection at the puncture site
* Allergy to local anesthetics
* Esophagectomy with cervical surgical time
* Patient with chronic pain EVA\> 4 before surgery.
Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease

The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

SECONDARY OBJECTIVE

* Evaluate the improvement for Depression which is one of the Nonmotor symptoms
* Evaluate the improvement of clinical symptoms between two groups
* Evaluate the improvement of Quality of Life between two groups

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease patients in accordance with UK Queensquare Brain Bank
* modified Hoehn \& Yahr stage \<3
* Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.

Exclusion Criteria:

* K-MMSE\<24
* History of drug-induced Parkinsonism
* secondary parkinsonism
* History of schizophrenia or hallucination
* Requirement of treatment with anti-depressants due to depressive disorder
* Pregnant and/or breeding women
* Renal inadequacy
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate

Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

The ablation strategy for patients with atrial fibrillation (AF) and concomitant atrial substrate (e.g. low-voltage areas; LVA) is a matter of controversy.

Results of studies investigating the impact of LVA may have been confounded by PV-to-left-atrial (LA) reconnection due to non-durable ablation. Therefore, the true contribution of LA-LVA to AF recurrences remains unknown.

Meanwhile, new ablation technologies such as the HeartLight™ laser balloon (LB) ablation system providing near complete chronic PVI rates have been developed.

Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic atrial fibrillation
* Left atrial size \<50mm
* Left ventricular ejection fraction \<45%
* Patient is able to provide informed consent

Exclusion Criteria:

* Contraindications for PVI
* Previous PVI attempts
* Inability to be treated with oral anticoagulation
* Presence of intracardiac thrombi
* Pregnancy
* Participation in other clinical studies
* Unwilling to follow the study protocol and to attend follow-up visits
Validity and Reliability of the Smart Speed Device

The Smart Speed device developed at Zafer Teknopark in Turkey was developed to objectively assess reaction time. The aim of this study was to evaluate the validity and reliability of the Smart Speed device in comparison with BlazePod and Nelson Reaction Test.

The capacity to perceive, analyze, and react to a signal is referred to as reaction time. Reaction time is influenced by many factors such as visual and auditory factors. It is also influenced by individual factors such as age, gender, body mass index, attention and fatigue. Having reaction time within normal limits is very important for maintaining activities of daily living. BlazePod is a valid and reliable device for the assessment of reaction time. The Nelson Reaction test is also a valid and reliable test frequently used in the clinic for the assessment of reaction time due to its simple and rapid application. The Smart Speed device developed at Zafer Teknopark in Turkey was developed to objectively assess reaction time. The aim of this study was to evaluate the validity and reliability of the Smart Speed device in comparison with BlazePod and Nelson Reaction Test.

Eligibility Criteria:
Inclusion Criteria:

* Without having systemic disease
* To be able to speak Turkish language

Exclusion Criteria:

* Having a problem that affects physical performance
Nicotine Patch - Bioequivalence Study

The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject aged 18 to 45 years (inclusive)
* Current Smoker of \>or = 5 and \< or = to 15 cigarettes/day
* Fagerström score \< or =5 at selection
* Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion Criteria:

* Presence of any significant medical findings or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or safety assessment of a transdermal patch
The ENDOCARDITIS AUMC Data Collection

The investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients.

The aim of this study is to examine the differences between patients with and without endocarditis who undergo cardiothoracic (valve) surgery. In addition, the investigators will look at the differences between endocarditis patients who undergo surgery, and those who are treated conservatively. The investigators will look at incidence and degree of perioperative coagulation abnormalities, as well as transfusion and coagulation factor requirements, heparin resistance, bleeding scores, predictive endocarditis mortality scores, vasopressor-inotrope scores, and relate these where possible to the pathogen causing IE. The investigators will also look at perioperative complications, in particular, thromboembolic events and mortality at 30 and 90 days, and at 1 year.

These outcomes may help optimise perioperative care for high-risk endocarditis patients, and in particular those undergoing valve surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Dutch or English speaking
* All patients with infective endocarditis admitted to Amsterdam UMC in the study period
* All patients with infective endocarditis scheduled for cardiac valve surgery compared to a matched cohort of patients scheduled for similar surgery due to non-infectious indication in Amsterdam UMC in the same period

Exclusion Criteria:

* Previous history of coagulation disorders
Impact of Massage Therapy on the Quality of Life of Hospice Patients

This is a pilot study to evaluate the impact of massage therapy in hospice patients.

As an integrative therapy, there is growing evidence that massage therapy can be an effective therapeutic tool for relief of pain and non-pain symptoms in hospice and palliative care patients. Massage therapy can provide comfort, relaxation, and improve quality of life for patients. The primary aim of the study is to gather data on the effects of complementary massage therapy on patient's symptoms and quality of life. The study goal is to improve patient symptoms of pain, anxiety, depression, and quality of life through the use of massage therapy provided to hospice patients. Questionnaires would be utilized before and after each massage intervention and would quantify symptom and quality of life levels.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Clinically determined by hospice staff to be appropriate for massage therapy (ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being)
3. Place of residence within 30 minutes of downtown Rochester
4. Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

Exclusion Criteria:

1. Patients ineligible for massage therapy due to complexity of medical care including complex wound and multiple drains
Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
* Body mass index (weight \[kg\]/height squared \[m2\]) of no more than 30
* Males and females between 12 and 17 years of age, inclusive

Exclusion Criteria:

* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
* Past or current history of epilepsy or seizure disorder
* Critically ill or unstable patients
A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma

The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for larynx cancer. The standard of care treatment will include chemotherapy and radiation for 7 weeks.

This study is an open label, single arm study which will enroll patients with locally advanced squamous cell carcinomas of the larynx. Positive tumor PDL1 expression by IHC will not be required for enrollment.

All patients with receive Pembrolizumab and cisplatin in combination with radiation. Pembrolizumab 200 mg flat dose given Q21 days will begin 3 weeks prior to initiation of chemoradiation and continued through the 21-day cycle until completion of chemoradiation. Cisplatin will be given 100 mg/m2 every 21 days during radiation as per standard of care.

Pembrolizumab has well defined toxicities as single agent and has non-overlapping mechanisms of action with cisplatin and radiation. The safety of these agents used in combination has not been previously described, therefore the study will begin with a safety run-in phase 1 followed by the phase II design. See statistical section for details.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven, previously untreated stage III or IV squamous cell carcinoma of the larynx, Primary tumor stage (T2, T3) and nodal stage (N0, N1, N2, N3).
* Measurable disease based on RECIST 1.1.
* Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
* Anticipated survival minimum of 12 months.
* Adequate labs

Exclusion Criteria:

* Patients with T1 primary tumor or T4 large volume tumor that has resulted in larynx dysfunction at baseline (for example tumor largely penetrating into base of tongue and resulting in inability to swallow at baseline)
* Prior radiation therapy to the larynx area or involved neck.
* Distant metastasis
* Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).

The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-vessel revascularization \[TVR\]) at 1 year after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 19 years of age
* Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* ST-elevation myocardial infarction
* Severe renal dysfunction (eGFR \<30 ml/min/1.73 m2 or serum creatinine level \>1.5 mg/dl), unless patient is on renal replacement therapy.
* Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) \< 30%
* Life expectancy \< 1 year for any non-cardiac or cardiac causes
* Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
* Unwillingness or inability to comply with the procedures described in this protocol
Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors

Majority of breast cancer survivors are overweight or obese at time of diagnosis, putting them at increased risk for insulin resistance and Type 2 Diabetes Mellitus (T2DM). Women with insulin resistance at time of breast cancer diagnosis often have larger tumors, later stages of cancer and worse prognosis. Additionally, chemotherapy often leads to increases in insulin resistance and cognitive impairment. Many cancer survivors experience memory and brain function decline following chemotherapy that can last for years, and insulin resistance may contribute to worse cognitive outcomes in cancer survivors. Omega-3 polyunsaturated fatty acids (PUFAs) are anti-inflammatory nutrients that may help reduce insulin resistance and negative cognitive outcomes from cancer treatments. The purpose of this observational study with cross-sectional design is to investigate the relationship of omega-3 PUFAs with insulin resistance and cognitive function in obese breast cancer survivors. Due to the global pandemic caused by the coronavirus disease of 2019 (COVID-19), this study will be conducted entirely remotely using electronic data collection and remote finger-stick blood sample collection. The study will aim to enroll 80 racially and ethnically diverse female breast cancer survivors (age 45-75) who are postmenopausal, and 1 to 4 years post breast cancer diagnosis. Participants will complete study questionnaires online, and some cognitive tests will be completed through zoom sessions with trained study personnel. Participants will be mailed kits with thorough instructions to complete fingerstick blood sample collections and mail them back to the research lab. Upon receipt of blood samples and completion of all study questionnaires, participation will be complete.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer diagnosis
* Between 1-4 years post-breast cancer diagnosis
* Postmenopausal (at least 1 year post-menses)
* Ability to access and use internet resources, including Zoom video calls
* English speaking

Exclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Unwillingness to complete finger prick for blood collection