cyrilzakka/clinical-trials huggingface dataset:
Nutritional Screening in Older Individuals

Hospital-based case management programs and home hospitalization services following the risk stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. The objective of these services is to avoid deterioration and hospital admissions or visits to the emergency services by regular follow-up, proactive home visits and support of self-care . The prevalence of malnutrition in patients selected using this model of care is unknown.

The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this high-risk community living population, and to explore risk factors that could identify subgroups of individuals at higher risk.

This study was performed in individuals included in a Case Management (CM) Program lead by the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the hospital with two or more hospital admissions for medical reasons in the previous year are detected by a computerized system and included in the program, an integrated care intervention developed for patients with complex multimorbidity using patient-centred education activities and integrated care interventions, with the support of a Hospital at Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying problems and detecting disease exacerbations. The main aim of this program is to avoid hospital admissions and reduce the number of visits to emergency services

Eligibility Criteria:
Inclusion Criteria:

* Patients included at Case Management Program for complex chronic condition
* Must be able to answer questions on the telephone

Exclusion Criteria:

* Subjects with no telephone,
* Subjects unable to determine their usual weight
* End-of-life clinical situation
Promoting Sleep to Prevent Substance Use in Adolescence

The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.

The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.

The investigators aim to conduct a pilot feasibility randomized controlled trial (RCT) among adolescents (n = 300) who will be randomized to Sleep Fitness (SF) or Sleep Education (SE) to obtain effect size estimates in preparation for a larger scale intervention study. This pilot trial is designed to obtain preliminary data for the following hypotheses:

SF, compared to SE, will produce greater pre-post improvement in sleep after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).

SF, compared to SE, will produce greater pre-post reductions in substance use after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).

SF, compared to SE, will produce greater pre-post improvement on selected mental health outcomes (anxiety, depression) after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).

Eligibility Criteria:
Inclusion and exclusion criteria are considered at the level of schools, classes, and students.

Inclusion Criteria:

* Schools: Only general education high schools, not "newcomer" schools that target immigrants with limited English ability. Our rationale is that we need students to read and understand English well enough to complete our study measures and understand the intervention.
* Classes: After the selection of schools, we will select classes that are representative of the school, insofar as they do not reflect Advanced Placement or remedial classes and utilize similar criteria for admission to the classes (e.g. health, advisory) so that we minimize differences between the classes in the study.
* Students: All participants must receive parental consent, provide their own consent, and must have sufficient English language ability

Exclusion Criteria:

* We propose no exclusion criteria for students who receive parental consent, provide their own assent, and have sufficient English language ability.
Effect of Ginseng on Blood Pressure

To determine the effect of ginseng on blood pressure control.

The effect of ginseng on blood pressure control is controversial, originating from an early 1970s observational study, suggesting that ginseng may adversely effect blood pressure. Despite these early findings, extensive research has since suggested that ginseng may have a positive effect on blood pressure. The current study will help clarify present uncertainty on the effect of ginseng on blood pressure control.

This systematic review and meta-analysis will follow The Cochrane Handbook for Systematic Reviews of Interventions. MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Intervention trials that investigate the effect of ginseng on blood pressure in humans will be included.

Eligibility Criteria:
Inclusion Criteria:

* clinical trials in humans
* randomized treatment allocation
* ≥ 1 month
* suitable control
* viable endpoint data

Exclusion Criteria:

* non-human studies
* non-randomized treatment allocation
* \< 1 month
* lack of a suitable control
* no viable endpoint data
* trials where ginseng is part of a multi-herbal treatment
Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* English language fluency
* Naive to meditation practices (not actively meditating more than one hour per month and/or meditation practice for less than a year in their entire life-time)
* No MRI contra-indications
* Cognitively healthy (no diagnosis of dementia, stroke, developmental disorders, or major systemic diseases that may impact cognitive function)

Exclusion Criteria:

* Below 60 years of age
* Not fluent in English
* Active meditator (meditating more than one hour per month and/or meditation practice for more than a year in their entire life-time).
* Presence of a severe psychiatric (e.g. schizophrenia, bipolar disorder, PTSD), neurological (epilepsy, traumatic brain injury, dementia, multiple sclerosis), or developmental disorder (e.g. autism)
* Systemic disease (e.g. major recent surgeries, cancer)
* Claustrophobia
* Contraindications for MR safety (e.g. metal in body, cochlea implants)
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.

PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed the informed consent process culminating with written informed consent by the subject.
2. Men and women age 18 to 75 years (inclusive)
3. Patients with biopsy proven NASH within the last 3 years
4. Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication for at least 2 months prior to enrollment), impaired fasting glucose or impaired glucose tolerance.
5. HBA1C between 5.5 and 14%.

Exclusion Criteria:

1. Subjects who have undergone surgery within the last 3 months.
2. Subjects who have had a prior gastrointestinal surgery.
3. Subjects with a clinically significant infectious, immune mediated or malignant disease
4. Subjects who are receiving an elemental diet or parenteral nutrition.
5. Subjects who have been treated with any type of immune modulatory drug including steroids or NSAID within the last 4 weeks
6. Subjects who have received either methotrexate or cyclosporine or anti TNF-β (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months.
7. Subjects with a history of coagulopathy.
8. Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
9. Subjects, who will be unavailable for the duration of the trial, are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
10. Subjects who are HIV-positive.
11. Subjects who are HBV-positive
12. Subjects who are HCV-positive.
13. Subjects with active CMV
14. Subjects with anemia (Hb \<10.5 gm/dl).
15. Subjects with thrombocytopenia (platelets \<100K/µl).
16. Subjects with lymphopenia (absolute lymphocyte count \<0.7).
17. Subjects with IgG anti-cardiolipin antibody \>16 IU.
18. Prior exposure to anti-CD3 MAb.
19. Known sensitivity to any ingredients in the study drug
20. Any know autoimmune disease except for the studied disorders.
Evaluating Occupational Stress in Surgeons and Musicians: A Multi-modal Pilot Study Using Wearable EEG, Biomarker Analysis and Validated Questionnaires

To learn about occupational stress among surgeons and musicians by integrating psychological assessments, neurophysiological measures, and biomarkers.

Primary Objectives • To assess the change in occupational stress among surgeons and musicians by measuring physiological and psychological stress markers.

Endpoints:

* Changes in salivary cortisol levels (before and after surgeries for surgeons and live public performances for musicians).
* Changes in State-Trait Anxiety Inventory-Short (STAI-S) scores (administered pre- and post-surgery/performance).

SECONDARY OBJECTIVES AND ENDPOINTS

• Assessing and comparing anxiety and burnout, based on the MBI, STAI-T, M-PAS, and SCAT, in surgeons and musicians

Endpoints:

* Baseline levels of anxiety and burnout measured using the MBI, M-PAS, STAI-T, and SCAT.
* Emotional exhaustion, depersonalization, and personal accomplishment from the MBI in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Professional musicians (i.e., those with academic or orchestral appointments) or MD Anderson Neurosurgeons
* For Musicians only: You will have a musical performance within three months of study enrollment.

For Neurosurgeons only: You will perform a surgical procedure within three months of study enrollment.

Exclusion Criteria:

* Individuals who are unable to provide informed consent
* Individuals diagnosed with severe cognitive impairments, severe psychiatric disorders, or hearing or visual impairments that could affect participation
* Individuals previously enrolled in the study
* Non-English-speaking musicians and/or surgeons
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 to 55 years, inclusive
* Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
* Body Mass Index of 18 to 32 kg/m\^2, inclusive

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to DPP-4 inhibitors or related compounds
* History of allergy or intolerance to metformin or other similar acting agents
* Previous exposure to saxagliptin
* Exposure to metformin within 3 months pervious to study drug administration
* Estimated creatinine clearance of \<80 mL/min using the Cockcroft Gault formula
S8600-S9031-S9333-A, Study of DNA in Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This research trial studies DNA in samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To identify differentially methylated regions (DMRs) associated with overall survival (OS) of acute myeloid leukemia (AML) patients with normal cytogenetics.
* To develop and evaluate in an independent validation set a prognostic score for OS based on the identified DMR.
* To determine whether the prognostic score can group patients into risk groups based on OS.

OUTLINE: Archived blood or bone marrow samples are analyzed for DNA methylation alterations by CHARM array-based genome assay. Each patient's clinical data is also collected.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* De novo acute myeloid leukemia (AML) patients with normal cytogenetics treated with curative therapy who survived at least 28 days after therapy started
* Samples will be taken from the following studies: SWOG-8600, SWOG-9031, SWOG-9333, SWOG-9500, SWOG-S9918, SWOG-S0106, and SWOG-S0112

  * Blood or marrow specimens can be used

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Relative Bioavailability of Pimasertib in Cancer Patients

This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial extension phase).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed solid tumors, either refractory to standard therapy or for which no effective standard therapy is available, with a measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Disease conditions or concomitant medication that may significantly influence the conduct of the trial or an abnormal electrocardiogram (ECG) or blood pressure at Screening as defined in the protocol
* Treatment with strong inhibitors or inducers of cytochrome P450 2C19 (CYP2C19) and CYP3A4 including fruit juices or beverages containing these substances
* History of prior mitogen-activated protein kinase/extracellular signal-regulated kinase (MAPK/ERK) kinase (MEK) inhibitor exposure (including, pimasertib) or progression of disease on MEK inhibitors
* Evidence of a retinal vein occlusion (RVO) on fluorescein angiogram or a history of RVO
* Life expectancy of less than 12 weeks
* Other protocol defined exclusion criteria could apply
ACCESS: AI for pediatriC diabetiC Eye examS Study

The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.

Eligibility Criteria:
Inclusion Criteria:

Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:

* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
* Diagnosis of Type 2 diabetes

Exclusion Criteria:

* Diabetic eye exam within the last 6 months
* Known diabetic retinopathy
Effect of Mango on Gut Microbiota and Metabolic Health

Mango is rich in bioactive compounds such as dietary polyphenols and carotenoids, which may explain its beneficial effect on health. Polyphenols accumulate in the gut where they can positively modulate the microbiota. As gut microbiota may have a strong influence on cardiometabolic health, we hypothesize that mango consumption improves metabolic profile in overweight or obese individuals through beneficial changes in gut microbiota. The study of metagenomics, transcriptomics and metabolomics will be used to validate this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and premenopausal women
* At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference ≥ 80 cm for women and ≥ 94 cm for men
* At least one of the following : TG ≥ 1.35 mmol/L or fasting insulinemia ≥ 42 pmol/L
* Caucasian origin

Exclusion Criteria:

* Nicotine use
* Metabolic disorders or use of medication that may affect parameters measured in the study
* Use of dietary supplements or natural health product that may affect parameters measured in the study
* Use of antibiotics in the last 3 months
* Surgery in the last 3 months or planned during the study timeline
* Alcohol consumption \>2 drinks/day
* Weight change \>5% in the last 3 months
* Mango aversion, allergy or intolerance
* Dietary restrictions (vegetarian, gluten avoidance...)
* Berries consumption \>1 serving/day
* Pregnancy, breastfeeding or pregnancy planned within 3-6 months
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer

RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.

OBJECTIVES:

* Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet.
* Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines.
* Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients.
* Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.
* Arm II: Patients receive a control diet containing the standard amounts of fat and fiber.

PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of the prostate
* Previously untreated and on watchful waiting
* Medically able to receive dietary intervention

PATIENT CHARACTERISTICS:

Age:

* 40 to 80

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially prepared foods

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent luteinizing hormone-releasing hormone agonists (leuprolide or goserelin)
* No concurrent androgen-receptor blocking agents (flutamide or bicalutamide)
* No concurrent testosterone
* No concurrent insulin
* No concurrent finasteride

Radiotherapy:

* Not specified

Surgery:

* No prior orchiectomy

Other:

* No concurrent saw palmetto supplement
Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.


Eligibility Criteria:
Inclusion Criteria:

* Women 15 years of age or older
* First or second pregnancy between 16 and 36 weeks gestation

Exclusion Criteria:

* Pregnancy prior to 16 weeks or after 36 weeks gestation
* Third or later pregnancy;
* Report previous allergic reactions to SP, AS, or unknown antimalarials;
* If the distance to their home is too great or too inaccessible for follow-up;
* Child's father refuses the woman's participation
Effect of Kinesio Taping on Muscle Strength in Quadriceps Femoris

The purpose of this project is to investigate the effect of Kinesio tape on muscle strength of the quadriceps femoris in people with knee pain or symptoms and decreased muscle strength in the quadriceps femoris - a randomized controlled trial.

The aim of the study is to investigate the effect of recoil tape with 0-30% tension, by using one application of Kinesio tape over the muscle fibers of the quadriceps femoris from its origin to its insertion. The participants will be divided into intervention group (taping) and control group (no intervention). Muscle strength test will be performed before and immediately after taping (20-30 minutes) for both groups using hand-held dynamometer measurements (MicroFET 3).

Work is based on the following hypothesis: "Kinesio taping using recoil taping provides increased isometric muscle strength in quadriceps femoris immediately after application".

Eligibility Criteria:
Inclusion Criteria:

* Shoulder problems
* Low muscle strength in quadriceps femoris
* Positive manual recoil-test for the quadriceps femoris

Exclusion Criteria:

* Knee surgery \<3 month
* Pathology in the knee related to tumors, fractures, neurology, rupture of tendons