Kornimate/medical-research-clean huggingface dataset:
summer food service program

Conditions: Pediatric Obesity; Exercise

Summary: this pilot trial is designed to test the acceptability and preliminary efficacy of offering the boks program, an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily, alongside the usda's summer food service program (sfsp) during the summer. eighty children, ages 6-12 years and from low-income households, will be randomized to participate in the boks + sfsp program or to the sfsp alone. we anticipate that the boks program will not only provide increased physical activity for the participants, but that it will help to promote participation in the sfsp given that it will be offered in the same location directly before the sfsp lunches are served.

youth from low-resource communities are disproportionately affected by childhood obesity, independent of race and ethnicity. a time of particular vulnerability for excess weight gain in low-income youth is the summer. findings from three separate low-income populations show that bmi z-scores (bmiz) decrease during the school year and increase during the summer in this population. to address this and aid in national obesity prevention efforts, the institute of medicine and the white house task force on childhood obesity recommend increased access to the summer food service program (sfsp), a federally-funded program that provides a free, healthy lunch meal to youth during the summer. however, participation in the sfsp is low. based on qualitative work with families from low-income communities, this pilot trial is designed to test the acceptability and and preliminary efficacy of the boks program, an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily, when offered alongside the usda's summer food service program during the summer. specifically, 80 children, ages 6-12 years and from low-income households, will be randomized to participate in the boks + sfsp program or to the sfsp alone. to test acceptability of the combined program versus the sfsp alone, we will compare sfsp participation (attendance) across groups. additionally, we will examine physical fitness levels in both groups to determine if participation in the boks program prevents the loss of fitness gains achieved during the school year.

Eligibility criteria:
inclusion criteria: * reside in the low-income, rhode island community where boks program is offered * quality for free meals as part of the nslp, which is equivalent to a family of four having an annual income less than $43,568 in the state of rhode island. * ages 6-12 years * ability of the child to speak, read and write english (for purposes of the focus groups and intervention) * agreement to randomization exclusion criteria: * inability to participate in routine physical activity

Keywords: summer physical activity health disparities
a study to evaluate the pharmacokinetics of pep005 (ingenol mebutate) gel, 0.05%, when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratosis

Conditions: Actinic Keratosis

Summary: this phase ii study is designed to evaluate the pharmacokinetics of pep005 (ingenol mebutate) gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratoses


Eligibility criteria:
inclusion criteria: * male or female; * multiple actinic keratosis (ak) lesions over a 100 cm\^2 area of skin located on the dorsal aspect of one forearm. exclusion criteria: * cosmetic or therapeutic procedures: within 2 weeks and within 2 cm of the selected treatment area(s); * treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system: within 4 weeks; * treatment with 5-fu, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).

Keywords: peplin pep005 actinic keratosis
safety and efficacy study of islets xenotransplantation

Conditions: Type 1 Diabetes

Summary: the neonatal pig islets will be used as donor culturing with our modified culture medium. at the same time the autologous t regulatory cells will be used to induce specific immune tolerance for porcine islets grafts combined the costimulation of t cell activation channel blockers. the treatment for type 1 diabetes will be evaluated the efficacy and safety.


Eligibility criteria:
inclusion criteria: * male and female patients age 18 to 40 years of age; * type 1 diabetes mellitus for at least 5 years; * body weight 40 to 60kg; * ability to provide written informed consent; * manifest signs and symptoms that are severe enough to be incapacitating; * patients with poor diabetes control (hba1c \> 9% ); * patients have diabetes ketoacidosis or hypoglycemia more than once exclusion criteria: * age \ 60 years; * diabetes history \< 5 years; * body weight \> 80 kg; * exogenous insulin requirement \> 1 unit/kg/day; * blood test: hemoglobin male \ normal value (31-43s)10s; * liver dysfunction; * kidney dysfunction; * cardiopulmonary dysfunction; * combined mental illness, cancer, infection, severe trauma, pancreatitis, surgery or other stress situations for patients; gastric ulcer patients, any bleeding disorders, tuberculosis infection and active infection including hepatitis b, hepatitis c, hiv, or john cunningham virus; * serological detection epstein-barr virus (ebv) or cytomegalovirus (cmv)negative; * patient have taken immunosuppressant in recent one year with high incidence of malignancy in three generation; * women not using effective contraception of childbearing age, or planning pregnancy in nearly two years or being pregnant or lactating; * patients can not comply with the research program to complete the diagnosis and treatment; * patients not be passed by ethics committee

Keywords: type1 diabetes porcine islets treg cells immunosuppress xenotransplantation
prognostic value of computed tomography (ct) scan in hemodynamically stable patients with acute symptomatic pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the objectives of the protect study are: * to assess the role of ct pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (pe). * to assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic pe. * to assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic pe. * to assess the role of the pulmonary embolism severity index (pesi) in the risk stratification of hemodynamically stable patients with acute symptomatic pe. * to assess the combined role of ct pulmonary angiography, transthoracic echocardiography, pesi, troponin i and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic pe.


Eligibility criteria:
inclusion criteria: * acute symptomatic pulmonary embolism (pe) confirmed by: * ct pulmonary angiography positive for pe * ventilation/ perfusion lung scan with high likelihood of pe (according to pioped criteria) * v/q ventilation/ perfusion lung scan inconclusive for pe or negative ct pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis. exclusion criteria: * contraindication for ct pulmonary angiography (allergy to iodine contrasts or creatinin clearance \< 30 ml/min). * informed consent not obtained. * pregnancy. * life expectancy of less than 3 months. * hemodynamic unstability defined as sbp \< 90 mm hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation. * thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for pe episode. * participation in another clinical trial for treatment of pe.
dyadic intervention for psychological distress of patients with colorectal cancer and their spouses

Conditions: Colorectal Cancer

Summary: the overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and qol outcomes of patients with colorectal cancer and spouses. the colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.


Eligibility criteria:
inclusion criteria: patients and spouses aged 18 years or older patients diagnosed with colorectal cancer patients scored ≥ 22 points on the kessler psychological distress scale assessment patients and spouses able to read simplified chinese exclusion criteria: psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials
rinitis y sinusitis según la gravedad del asma

Conditions: Asthma

Summary: based on the evidence for the "common pathway" in asthma presentation, our working hypothesis is that asthma severity and lack of control are related to the prevalence and severity of nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal polyps.

primary objective: to assess the prevalence and severity of rhinitis and rhinosinusitis, with or without nasal polyposis, in asthmatic patients depending on severity of their disease. secondary objectives: to assess the impact of nasal and sinusal pathology on asthma control. to correlate asthma severity to rhinitis and rhinosinusitis. to compare the potential association between chronic rhinosinusitis, with and without nasal polyposis, and asthma severity, and to detect radiographic differences, markers of atopy, and pulmonary function.

Eligibility criteria:
inclusion criteria: * patients of both sexes aged 18-70 years attending outpatient clinics diagnosed with asthma at least one year before. gina/gema criteria will be used to diagnose asthma and to rate its severity. exclusion criteria: * illiterate patients; * very severe, disabling comorbidity; * prior non-inflammatory nasosinusal disease
the acute effect of grains of paradise (aframomum melegueta) on ree

Conditions: Obesity

Summary: grains of paradise (aframomumu melegueta) (gp), also known as guinea pepper or alligator pepper, belongs to the zingiberaceae family, which is native to west africa. gp seeds are used as a spice and also have wide-ranging ethnobotanical uses. gp seeds are very rich in non-volatile pungent compounds such as 6-paradol, 6-gingerol, 6-shogaol and related compounds. this feature may equip them with the power to activate the sympathetic nervous system and thereby increase ee, which has been demonstrated in rodents. research suggest that ingestion of gp extract can result in sustained elevation of ee and a consequent reduction in body fat. thus, there is some evidence that gp may have a potential thermogenic effect that could be useful as part of a weight loss treatment. however, there is no information on whether gp has the potential of improving and prolonging the thermogenic effects of bioactives known to elevate fatty acid mobilization and subsequent fat oxidation. this proposal will fill a void in the literature by testing for the first time in healthy, normal weight, human volunteers whether the ingestion of gp in combination with a commercially available complex containing caffeine, green tea, and forskolin has an enhanced acute effect on ree, the largest and most stable component of ee, as well as the ratio of fat:carbohydrate oxidation. this project will provide pilot data to support larger studies such as prospective studies and studies to compare the thermogenic effect with currently available compounds.


Eligibility criteria:
inclusion criteria: * ages 18-65 years * men and women * able to provide written consent in english * a body mass index between 18.5 and 30 kg/m2 exclusion criteria: * current smoker * claustrophobia * use of any prescribed or over-the-counter medication affecting metabolism * suffering from cardiac, hepatic, renal, pulmonary, endocrine or hematological disease * currently pregnant or breastfeeding * consuming more than 300mg of caffeine per day * consuming more than 2 alcoholic beverages per day. * performing more than 3 hrs/week of strenuous exercise * weight loss of more than 5% of body weight over the past 6 months * not willing to abstain from alcohol, caffeine and exercise for 24hr before each test day. * suffering from heartburn or a sensitivity to pungent compounds in foods

Keywords: grains of paradise energy metabolism substrate oxidation
prognostic value of biomarkers associated with endothelial progenitor cells mobilization in acute coronary syndromes

Conditions: Acute Coronary Syndromes

Summary: this prospective study aimed to validate a new prognostic approach of endothelial progenitor cells associated biomarkers in patients with acute coronary syndromes . recruitment is made prospectively by two centers of inter -region south mediterranean,


Eligibility criteria:
inclusion criteria: * acute coronary syndrome (st + \< 12 hours and st- high risk or intermediate risk ),which there is an indication of percutaneous coronary intervention. exclusion criteria: * cancer * chronic inflammatory disease * infectious disease * erythrocyte \<4 g/l * thrombopénia less than 100 000/mm3 ;
isipsmarter: a pilot rct to evaluate a web-based behavioral intervention to reduce sugary beverages among black adults

Conditions: Diet Habit; Sugar-Sweetened Beverages

Summary: the proposed pilot randomized controlled trial (rct) will enroll 24 black adults. the overall goal is to examine the preliminary efficacy of isipsmarter in a 2 group \[isipsmarter vs. static patient education (pe) website\] by 4 assessment (pre, 3-, 6- and 18-month follow-up) design. the generated pilot data will allow us to better understand efficacy and engagement outcomes among black participants. we anticipate trends that isipsmarter will be more efficacious at reducing ssb consumption than a pe website at post assessment.


Eligibility criteria:
inclusion criteria: * english speaking adults, identify as black, \> or equal to 18 years of age, consume \>200 kcals of ssb/day, ability and willingness to access an internet-enabled device at least one time per week and receive sms-based reminder prompts exclusion criteria: * non-english speaking adults, do not identify as black, \<18 years of age, consume \<200 kcals of ssb/day, inability and willingness to access an internet-enabled device at least one time per week and receive sms-based reminder prompts. also, only one person per household is eligible to participate in the trial

Keywords: sugar-sweetened beverages weight health disparities self-monitoring internet intervention e/m health text messaging
[68ga]ga-psma pet/ct in hepatocellular carcinoma: impact of multiparametric dynamic whole-body imaging and kinetic modeling.

Conditions: HCC - Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the use of multiparametric dynamic whole-body \[68ga\]ga-psma pet/ct imaging in newly diagnosed hcc patients or in hcc patients with recent suspicion of refractory, residual, or recurrent disease.


Eligibility criteria:
inclusion criteria: 1. provided written informed consent 2. patient aged ≥ 18 years 3. for cohort a: patient with hcc histologically proven or who meet radiological criteria and are scheduled for biopsy for cohort b: patient with known hcc requiring a new diagnostic imaging workup for suspected refractory, residual or recurrent disease 4. presence of at least one morphological evaluable lesion according to mrecist 1.1 using contrast ct/mri 5. patient must have an ecog (eastern cooperative oncology group) performance status of 0 to 2 6. patient who are child-pugh a 7. patient must have a life expectancy ≥ 6 months as determined by the study investigator 8. patient affiliated to or beneficiary of the national health service 9. consent to practice double-barrier contraception after \[68ga\]ga-psma injection (6 months of contraception for women study participant and their partners, and 3 months for men study participant and their partners) exclusion criteria: 1. known hypersensitivity to psma-11, to any excipient or derivative or to radiographic contrast agents 2. patient requiring emergent surgery for a ruptured / bleeding hcc 3. radioembolization within 3 months prior to inclusion 4. cardiac disease with new york heart association classification of iii or iv 5. any major surgery within 4 weeks before enrollment 6. other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years 7. any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (hiv) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (hba1c) ≥9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study 8. woman who are pregnant or breastfeeding. a serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential 9. patient under guardianship or trusteeship 10. patient under judicial protection

Keywords: 68ga-psma pet/ct hepatocellular carcinoma multiparametric dynamic whole-body imaging
search for predictive markers of efficacy of esas in patients with non-myeloid malignancies or myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes; Anemia; Hemopathies

Summary: anemia is common among cancer patients and the treatment of choice is now erythropoiesis-stimulating agents (esas). however, some patients do not respond to treatment. the purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. first, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. then if it is confirmed by establishing the optimal value of this ratio.

anemia is common among cancer patients and the treatment of choice is now erythropoiesis-stimulating agents (esas). however, some patients do not respond to treatment. thus, only 50-60% of patients with multiple myeloma or non-hodgkin lymphoma respond to esas. the purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. first, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. then if it is confirmed by establishing the optimal value of this ratio.

Eligibility criteria:
inclusion criteria: * patients over 18 * patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome * indication of esas therapy with hb \< 11g/dl exclusion criteria: * uncontrolled hypertension * anemia due to deficiency * pregnant and lactating women * patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion

Keywords: anemia non-myeloid haemopathy myelodysplastic syndrome erythropoiesis stimulating agents predictive markers
national network for cardiovascular genomics: advancing cardiovascular healthcare for hereditary diseases in brazil's unified health system through a multicenter registry

Conditions: Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; Cardiomyopathy Restrictive; Arrhythmogenic Right Ventricular Dysplasia; Non-Compaction Cardiomyopathy; Familial Hypercholesterolemia; Marfan Syndrome; Ehlers-Danlos Syndrome, Vascular Type; Loeys-Dietz Syndrome; Long QT Syndrome; Short Qt Syndrome; Brugada Syndrome; Catecholaminergic Polymorphic Ventricular Tachycardia; Sudden Cardiac Death

Summary: the goal of this observational study is to develop a registry of brazilian patients with hereditary cardiovascular diseases, combining clinical and genomic data. the main questions it aims to answer are: which genes are most commonly affected? what is the frequency of these genetic alterations in our population? participants will be interviewed in routine medical care visits and their dna will be sequenced.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of a hereditary cardiovascular disease according to current clinical guidelines * agree to receive genetic counseling * sign informed consent form * provide the information required in the case report form exclusion criteria: * signature absent from informed consent form * inadequate buccal swab (sample may be collected twice)

Keywords: hereditary cardiovascular diseases whole genome sequencing
psychomotor therapy for very premature infants

Conditions: Premature Infant

Summary: our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. the primary purpose is to determine whether the early psychomotor therapy intervention program improves development and behavior in very preterm infants (vpi) at 24-month corrected age (ca).

vpi \< 30 week of amenorrhea were randomized, in a simple blind controlled trial. the psychomotor development was evaluated according to the bayley scales of infant development-iii (bsid-iii) at 2 years ca. an intermediate point was provided at 9 months ca. pediatric standardized assessments and psychologist semi-directive interviews were conducted. parents also completed a self-administering questionnaire relating to the post-traumatic stress. the intervention consisted on 20 therapy sessions between 2 and 9 months ca, in order to support infants' development, and parent-infant interactions and adjustment. extended description of the protocol, including more technical information (as compared to the brief summary) if desired. do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.

Eligibility criteria:
inclusion criteria: * infants with a gestational age between 24 and 30 weeks. exclusion criteria: * infants with congenital disease, * infants with brain bleeding grade iii-iv, * infants with periventricular leucomalacia, * infants whose mothers had a documented history of physical or mental illness, or drug abuse * infants from non-french -speaking families.

Keywords: neuromotor sequelae cognitive disorders cerebral development psychomotoricity postural management motor coordination parenthood