Kornimate/medical-research-clean huggingface dataset:
effect of conjugated linoleic acid supplement on body composition

Conditions: Obesity

Summary: the purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gcla, or 6.4g cla daily for twelve weeks. changes in body composition, weight, and clinical laboratory values are compared between the three groups.

sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g cla, or 3) 6.4 g cla groups and supplemented for 12 weeks. body fat mass (bfm) and lean body mass will be determined by dexa at baseline and twelve weeks during the intervention. in addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. the effect of cla supplementation on weight, waist and hip measurements, and bmi will also be determined at 12 weeks. plasma cla and pill counts will be measured as an indication of compliance. several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of cla-rich foods, energy, micronutrients and antioxidants.

Eligibility criteria:
inclusion criteria: * bmi between 30 and 35 kg/m2 exclusion criteria: * history of chronic disease * food allergies or intolerances * drug therapy for diagnosed disease or lipid-lowering * use of weight-lowering medication or diet * use of tobacco products * current or planned pregnancy * use of cla supplement in previous 3 months * current substance abuse * abnormal clinical laboratory values

Keywords: conjugated linoleic acid obesity body composition body fat mass lean body mass
early intervention with non-ablative fractional laser to reduce cutaneous scarring

Conditions: Cicatrix

Summary: to investigate intervention with early application of non-ablative laser to prevent scarring in the skin

to intervene in scar formation at three different time-points

Eligibility criteria:
inclusion criteria: * good health * men * skin type 2-3 * non-smokers * presenting full medical record exclusion criteria: * active skin disease in test area * resent uv-exposure in test area * history of keloid * current or resent cancer * uncontrolled systemical disease
international social network intervention

Conditions: Behavior

Summary: this grant involves 24 social networks of young men who have sex with men, roma, and young high-risk heterosexual adult men and women living in hungary, bulgaria and russia.

for over 4 years, our international collaborative research team has carried out a social network hiv prevention intervention trial with community populations of young men who have sex with men (ymsm), disadvantaged ethnic minority roma (gypsies), and high-risk heterosexual adult (yha) women and men in hungary, bulgaria and russia. eastern europe has seen a sharp increase in hiv incidence, and social network interventions are high in cultural relevance because post-communist populations have a long history of trusting and relying upon their personal networks more than their governments. across the three countries represented in our research during the past funding period, we enrolled social networks of ymsm, roma, and yhas. this study will renew our international collaboration to extend this network intervention approach. our study, to date, has worked with very small independent friendship groups (usually composed of 5-6 people) as "egocentric" social networks.

Eligibility criteria:
inclusion criteria:members of a friendship group will be eligible for enrollment if they are of legal age to independently consent to participate in this study. in its review and approval of this protocol, the irb at botkinhospital, st. petersburg, russia verified and confirmed in writing to us that the age of research participation consent is 15. in its review and approval of this protocol, the irb at the health and social development foundation determined that the age of research participation consent in bulgaria is 16. in hungary, the irb at the institute of sociology at the hungarian academy of sciences determined that the age of independent consent to participate in this study is 14. - exclusion criteria:individuals will be excluded from enrollment into the study if they are below the age for providing independent consent or are not capable of providing informed consent based on impairment due to the presence of sever psychopatology, substance use, or similar conditions observed at the time of informed consent. social networks will be excluded from the study if: (1) more than 33% of named network members do not agree to participate; (2) fewer than 50% of members report occurrence of unprotected intercourse during the past 3 months at baseline; or (3) more than 10% of a network's members are also members of another network enrolled in the study. -
modality of pain management in ambulatory tonsillectomy surgery in adults

Conditions: Tonsillar Disorder

Summary: no sforl recommendation for adult ambulatory tonsillectomy. this study would allow the establishment of an ambulatory management during an adult tonsillectomy. this would allow a return home from j0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.


Eligibility criteria:
inclusion criteria: * programmed tonsillectomy surgery exclusion criteria: * congenital or acquired hemostasis disorder * indication of uvulo-bike-pharyngo-plasty * contraindication to the use of one of the protocol molecules including pregnancy * allergy to analgesic treatments used in the study * ongoing analgesic treatment that cannot be interrupted
molecular diagnostics of bacterial infections and antibiotic resistance in blood samples and rectal swabs using advanced ngs sequencing methods

Conditions: Resistance Bacterial

Summary: this is an experimental study without drug and device, non-profit, on biological samples stored at the tropica biobank of the ditm. the aim of the project is to verify the performance of ngs-based assays, which can be used in the field of microbiology. the clinical evaluation investigations of ngs technology will be conducted on an adequate number of clinical blood samples and rectal swabs. the analyzes will be compared with the standard microbiology methods used in the ditm diagnostic routine.


Eligibility criteria:
inclusion criteria: * samples of patients for whom blood culture and multi drug resistant (mdr) surveillance tests were carried out in rectal swabs at the irccs sacro cuore don calabria hospital * samples for which the information and consent to the conservation of biological samples for research purposes has been signed at the tropica biobank or * samples for which, after all reasonable efforts, it was not possible to obtain the signature of the information and consent to the conservation of biological samples for research purposes at the tropica biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness). exclusion criteria: * absence of data relating to positivity or negativity to the germs of interest * absence of stored residual material
symbicort in airway predominant chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the main objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (copd) phenotype will be more effective than using these treatments in patients with loss of lung tissue. symbicort plus ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with airway predominant copd.

subjects from the copdgene study who have airway-predominant copd on chest ct scan will be enrolled; a total of 40 subjects is planned. subjects will all have background ipratropium-albuterol administered four times daily. subjects will be randomized to receive budesonide (180 ug twice daily) or formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks. the main objective is to explore novel outcomes: blood biomarkers and chest ct scan. outcomes include lung function, walk distance, respiratory disease-specific health status, and expiratory chest ct scan gas trapping as an exploratory outcome. the primary outcome measure will be fev1 pre-bronchodilator 12 hours after the last dose of study medication at the end of 12 weeks of treatment. fev1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of budesonide and budesonide/formoterol

Eligibility criteria:
inclusion criteria: 1. copd gold stage 2 and 3 (post-bronchodilator fev1 35-80% predicted and fev1/fvc \<0.7 at the time of enrollment in copdgene) by spirometry. 2. less than 15% of the lung \<-950 hounsfield units on copdgene high-resolution inspiratorychest ct scan (i.e. no evidence of significant emphysema) 3. greater than 10% gas trapping on copdgene expiratory ct scan (i.e. evidence of small airway disease). 4. no history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid. 5. body weight \<100 kg (low dose ct scans in subject with increased boyd weight can not be reliably analyzed). exclusion criteria: 1. exacerbation of copd or other respiratory illness requiring antibiotics within the past 8 weeks. 2. previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications. 3. symptomatic, untreated benign prostate hypertrophy. 4. allergy to peanuts. 5. glaucoma

Keywords: copd
comparative evaluation of the effectiveness of diclofenac sodium versus vitamin d on myofascial pain

Conditions: Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint

Summary: it has been reported in the literature that there is a significant relationship between bruxism and low serum vitamin d levels. it was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin d supplementation on symptoms in individuals with myofascial pain and vitamin d deficiency.

in the current literature, it has been reported that there is a significant relationship between teeth grinding and low serum vitamin d levels. vitamin d has been shown to play an important role in the musculoskeletal and cardiovascular systems, as well as in the control of calcium and phosphate metabolism and in maintaining adequate blood levels of these minerals. vitamin d deficiency has been associated with poor physical performance and low muscle strength. there are also studies to understand the relationship between tmj disorders and vitamin d level (serum 25(oh) d). these studies reported a relationship between the presence of tmj disorder and vitamin d deficiency. nsaids are a large group of drugs that inhibit cyclooxygenases and thus prevent the formation of prostaglandins. traditionally, it has been the most commonly prescribed group of medications for pain in the orofacial area. it is recommended to use these drugs regularly for at least 2 weeks to achieve an anti-inflammatory effect in individuals with tmj disorders. it was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin d supplementation on symptoms in individuals with myofascial pain and vitamin d deficiency.

Eligibility criteria:
inclusion criteria: * vitamin d deficiency, * myofascial pain complaint, * chronic pain, * no missing teeth, * absence of open bite and/or crossbite. exclusion criteria: * individuals who have undergone interventional or surgical procedures related to the temporomandibular joint, * temporomandibular joint pathology, * pregnancy or breastfeeding, * individuals who do not come for postoperative checks, * using different medications other than those recommended, * allergy to study drugs and materials to be used

Keywords: temporomandibular joint vitamin d myofascial pain sodium diclofenac
safety and tolerability evaluation study of bvac-b in patients with her2/neu(human epithelial growth factor receptor 2) positive gastric cancer after failure to standard care

Conditions: Stomach Neoplasms

Summary: bvac-b is immunotherapeutic vaccine using b-cell and monocytes as antigen presenting cell. this study is open-label, accelerated titration, multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of bvac-b in patients with progressive or recurrent her2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.


Eligibility criteria:
inclusion criteria: * progressive or recurrent her2/neu positive(ihc 1+≥) gastric cancer * received 1 or more chemotherapy or radiotherapy as prior therapy for progressive or recurrent tumor lesion * at least 1 measurable lesion according to recist(ver 1.1) * ages above 19 * ecog performance status between 0 to 2 * patients meets the blood test standards in the screening test * patients meets the blood chemistry test standards in the screening test * patients who has agreed to a medically accepted contraceptive in this clinical trial * patients at least six months or more of survival can be expected * patients decided to participate in this clinical trial and signed written informed consent exclusion criteria: * histopathology is a neuroendocrine or small cell carcinoma * history of brain metastasis or signs of brain metastasis * clinical diagnosis of hepatitis c or hepatitis b * clinical diagnosis of human immunodeficiency virus (hiv) * history of hiv infection * patients with heart failure, coronary artery disease(cad) or myocardial infarction in 6 month prior to screening. (lvef is lower than 50% in screening visit) * administered the drug for other clinical trials within 4weeks before participate in this trial * administered any vaccines within 4weeks before participate in this trial (4 weeks for live vaccine, 2 weeks for other inactivated vaccine) * administered the granulocytes concentrates within 3 months before the screening visit * received chemotherapy or radiation therapy within 2 weeks before the 1st administration of investigational drug(bvac-b) * received following formulation within 1 months before the screening visit : chronic steroids(more than 5 days), immunosuppressant or immunomodulatory agents. g-csf * patients who have participated in the clinical trial of a immunotherapeutic vaccine within 1 year or immunotherapy within 3 months before the screening visit * patients who is pregnant or breast-feeding * patients who researchers has determined that participation in the clinical trial is inappropriate * suspected to have other progressive cancer or malignant tumor needs treatment in 3 years. completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma, cervical intraepithelial neoplasia are not included

Keywords: her2/neu ihc 1+ bvac cellid b-cell monocyte immunotherapeutic vaccine breast cancer colorectal cancer pancreatic cancer
translational analysis in longitudinal series of ovarian cancer organoids

Conditions: Organoids; Epithelial Ovarian Cancer

Summary: this is a longitudinal observational phase ii, single center, single arm study on the reliability of high grade serous ovarian carcinoma organoids obtained from primary debulking surgery (pds)+adjuvant chemotherapy and neoadjuvant chemotherapy + interval debulking surgery (nact+ids) cases as model for the patients' response to treatments. since organoids represent a model system comparable to patient-derived xenografts, the investigators tested the null hypothesis that the possibility of correctly identifying the drug-sensitivity could improve from 80%, as assessed by xenografts to at least 95%. the first step was planned to include 7 patients; if 5 or more patients do not respond, the trial will be terminated. if the trial goes on to the second stage, a total of 43 patients will be studied. considering a patient dropout of approximately 10%, the study was planned to enroll at least 48 patients.

in this project, the investigators propose to employ the patients-derived organoid technology to test hgsoc organoids obtained from pds+adjuvant chemotherapy and nact+ids cases to predict patients' response to treatments; moreover, the investigators aim to study genomic and phenotypic evolution of hgsoc organoids from pds+adjuvant chemotherapy and nact+ids patients undergoing relapse. finally, the investigators intend to investigate splicing-targeting technologies as new potential therapeutic treatments to increase vulnerability of hgsocs. figo stage iiic or iv ovarian, fallopian tube, or primary peritoneal cancer patients will be included if disease at metastatic sites is supposed to be completely resectable and they will be triaged for staging laparoscopy to obtain histologic diagnosis and to provide the tumor load assessment through the laparoscopic score. if pds is chosen, open cytoreduction will be performed at the same time and bioptic tissue will be collected for organoids; otherwise, women will be submitted to nact followed by ids and tissue for organoids will be collected from both staging lps biopsy (pre-) and subsequent surgery (post-nact). part of each surgical specimen will be used to obtain organoids, whereas part will be frozen for direct comparative analysis of the original tumor. 1-6 organoids from each patient will be prepared from pds or nact-ids patients (pre- and post-nact) and blood samples will also be collected to purify extracellular circulating rna (crnas).

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years 2. estimated life expectancy of at least 4 weeks 3. performance status (ps) according to eastern cooperative oncology group (ecog) \< 2 4. adequate bone marrow, respiratory, hepatic, cardiologic medullary and renal function (creatinine clearance \< 60 ml/min according to cockroft formula) 5. histologic diagnose of epithelial ovarian cancer at frozen section and laparoscopic score ≥ 8 or ≤ 12 (considered htl) with no evidence of mesenteric retraction exclusion criteria: 1. pregnancy or breast-feeding 2. history of concomitant or previous malignancy in the last 5 years
clinical frailty scale validation in patients scheduled for vascular surgery

Conditions: Vascular Diseases

Summary: major vascular operations put the body under stress. we are trying to find out if the general health of a patient and the stress resulting from surgery can lead to the development of complications after surgery as well as increase the length of time spent in hospital. there is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty.


Eligibility criteria:
inclusion criteria: patients attending vascular pre assessment clinic age \> 60 - exclusion criteria: refusal or inability to provide informed consent. patients under 60 years of age. patients not undergoing a vascular procedure. -
efficacy, safety and tolerability of afq056 in patients with huntington's disease in reducing chorea

Conditions: Huntington's Disease; Chorea

Summary: this study will assess the efficacy, safety and tolerability of afq056 when added to optimize standard therapy in patients that have huntington's disease in reducing chorea.


Eligibility criteria:
inclusion criteria: * huntington's disease (based on dna testing polyq \>36) with a uhdrs maximal chorea score of \>10 * patient with concomitant huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization * female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception exclusion criteria: * patients with marked cognitive impairment (mmse less than 18), with presence of psychosis and/or confusional states * patients with a history or presence of renal impairment and/or liver disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: huntington's disease chorea dyskinesia
high school football and adult health

Conditions: Health Impairment; Pain; Obesity

Summary: the primary aim of the study is to determine the effect of playing high school football on self-rated health in late adulthood. this is an observational study that will use data from the wisconsin longitudinal study, a longitudinal cohort of high school graduates from 1957, to compare graduates who played high school football with comparable graduates who did not play football on self-rated health, pain, functional ability, and weight at the age of 65 years.

data will be used from the wisconsin longitudinal study (wls), a long-term study of a random sample of 10,317 men and women who graduated from wisconsin high schools in 1957 to determine the association between participation in high-school football and self-rated health, pain, and obesity in late adulthood. the wls is an optimal observational dataset to answer these hypotheses. wls captures early-life exposures that are important predictors of health and well-being in later life such parental socioeconomic status, occupation, and education level, family structure, and race. it also captures whether study participants participated in high school football and contains detailed measurements of their health in adulthood. wls provides a robust and longitudinal dataset, overcoming the limitations of prior cross-sectional studies, to compare the health in later adulthood of those who played high school football to those who did not, after carefully controlling for a potential confounders a matched observational study will be conducted, in which football players and controls will be divided into smaller subgroups which are relatively homogeneous along a range of baseline covariates. the outcomes will be compared within each matched set, after adjusting for residual imbalances in the distribution of these baseline covariates between the football players and controls.

Eligibility criteria:
inclusion criteria: • male exclusion criteria: * no yearbook information available to determine football playing status * sports participation in yearbook was not recorded under senior photo or in an index * played a high contact sport other than football (e.g. hockey)

Keywords: health football pain obesity