Kornimate/medical-research-clean huggingface dataset:
promotora navigator - culturally appropriate patient navigator

Conditions: Breast Cancer; Screening Mammography; Community Health Worker

Summary: although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. in the 40-65 year old age range, there is significant disparity in screening mammography utilization in hispanic women compared to their white counterparts. culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. promotoras, culturally appropriate patient navigators for the hispanic community, have been shown to increase screening mammography rates in the hispanic/latino population. however, there is little research exploring the interaction between these lay community health workers and community members. this proposal aims to assess this interaction by measuring the impact of a promotora working with community members in either a group setting or individual setting. understanding this interaction can lead to more effectively designed future community interventions. primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.


Eligibility criteria:
inclusion criteria: * women * identifying as hispanic ethnicity * age 40-64 * tennessee resident exclusion criteria: * personal history of breast cancer * current breast symptoms (palpable mass)
modula-study: modul 10: benefit of crt-therapy in crt-patients with qrs-complex of 120 - 150 ms

Conditions: Heart Failure

Summary: the purpose of this study is to compare the benefit of cardiac resynchronization therapy (crt)-therapy in patients with a qrs-complex of 120-150 ms to patients with a qrs-complex of \> 150 ms.

the objective of this study is to compare the benefit of crt-therapy in patients with a qrs-complex of 120-150 ms to patients with a qrs-complex of \> 150 ms within 12 months. a benefit is defined as change in quality of life and change in physical ability.

Eligibility criteria:
inclusion criteria: * patients with cardiac resynchronization therapy with a defibrillator (crt-d) or cardiac resynchronization therapy pacemakers (crt-p) system * new york heart association (nyha) iii * ejection fraction (ef) below 35% * optimised medical therapy * qrs-complex above 120 ms exclusion criteria: * patients with crt-p and atrial fibrillation
extubation in pediatric patients: proactive or passive?

Conditions: Cough; Tracheal Extubation

Summary: smooth extubation process can reduce the complications in recovery time. this study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation）or removing endotracheal tube directly (proactive tracheal extubation).

this is a randomized, controlled cross-over trial. the hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (pacu). patients aged 3-7 years were randomized into two equal groups: proactive extubation (group a) and passive extubation. at the end of surgery, sevoflurane was turned off and patients all delivered into pacu for recovery. patient was positioned on his or her lateral side. the ventilation was switched to positive airway pressure (cpap) mode once the patients regained spontaneous respiration. after spontaneous breathing turn to regular and sufficient（tidal volume \>6-8 ml/kg, respiratory rate \>10 times per minutes , end tidal carbon dioxide concentration \>7.19 mmhg）, the trachea tube could be removed. in group a, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. in group b, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. after extubation, 2 l/min oxygen was administered with venturi face mask for 10 min in both groups. patients were transported to the ward until they breathed air with a patent airway. the extubation time, recovery characteristics and respiratory complication were recorded.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status aged 3-7 years exclusion criteria: * a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index\>30 kg/m2

Keywords: passive proactive extubation respiratory complication
open label extension study of nct06221852

Conditions: Bipolar I Disorder; Schizoaffective Disorder; Psychosis

Summary: this is a 12-week open-label extension study for participants completing study nct06221852.

in this 12-week single arm open label extension study of nct06221852, the investigators aim to assess the longer term efficacy, safety and tolerability of the ketogenic diet in participants completing the randomized study phase of nct06221852. investigators will assess longer term effects on energy metabolism, insulin resistance and psychiatric symptoms.

Eligibility criteria:
inclusion criteria: * participants who met original entry criteria in, and completed, the randomized 12-week study of nct06221852. exclusion criteria: -no longer meeting original entry criteria from the randomized 12-week study of nct06221852.

Keywords: first episode psychosis ketogenic diet keto brain energy metabolism insulin resistance schizoaffective disorder bipolar disorder magnetic resonance spectroscopy (mrs) redox creatine kinase
nutrigenomics and children obesity: a moderate weight loss intervention study

Conditions: Obesity

Summary: the consumption of diets enriched in proteins (legumes and fish) or antioxidant (fruits and vegetables) could have beneficial effects beyond those of the caloric restriction on biomarkers of the inflammatory and oxidative status. objective: to address the effect of a 10-week dietary intervention aimed to weight loss in obese or overweight children (7-15 aged) on genomics, particularly the changes in the expression of genes related to the inflammatory status and oxidative stress. methodology: 44 navarra children and adolescents of both sexes from pediatric endocrinology services at different hospitals in pamplona will be recruited. the effect of the intensive consumption of different groups of food will be evaluated: legumes and fish ( diets in proteins) and vegetable and fruits (rich diets in antioxidants). before and after the intervention, the following items will be analyzed: (1) the diet of the subjects, (2) body composition and 3 magnitudes related to biological and development parameters, being: (3) lipid and metabolic phenotypic profile; (4) markers of the inflammatory status and oxidative stress, and (5) the genomic profile. the dietary programme will be implemented both in group workshops addresseded to patients and their family, and in individual sessions with the pediatricians and/or registered dieticians. finally, the programme efficacy will be evaluated by the scoreboards integrated in the 5 variables already mentioned.

a longitudinal intervention study in 44 overweight and obese adolescents (23 females and 21 males; mean age 11.5 years) for 10 weeks based on a calorie restricted diet (20-40%) according to obesity degree.

Eligibility criteria:
inclusion criteria: * children between 7 and 15 years * body mass index (bmi) higher to 97 percentile. (cole et al, 2000)\* * cole tj, belizzy mc, flegal km, dietz wh. br med j 2000; 320: 1-6. exclusion criteria: * use of prescription medication * to suffer from any major psychiatry or neurological disease, bulimia nervosa, familiar hypercholesterolemia or any major cardiac, or respiratory metabolic disease.

Keywords: evasyon genoi antioxidants legume fish
anti-angiogenic targeted drugs plus rg3 to improve the efficacy of tace for unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the aim of this study is to compare the efficacy and safety of transcatheter arterial chemoembolization (tace) combined with the anti-angiogenic targeted drugs and ginsenoside rg3 versus tace alone in patients with unresectable barcelona clinic liver cancer (bclc) stage b/c hepatocellular carcinoma (hcc), who has normal liver function and no extrahepatic metastasis.

tace is widely used in patients with unresectable hcc, which has been proved to significantly improve the survival time by the results from some randomized controlled studies and meta-analyses. however, due to the different blood supply characteristics and biological heterogeneity in hcc nodules, the therapeutic effect of tace is limited, and which is still considered as a non-radical treatment. furthermore, vascular embolization by tace may result in hypoxia in tumor tissue, which will induce increased secretion of angiogenic factors such as vascular endothelial growth factor (vegf) and tumor angiogenesis, promote proliferation of residual tumor cells, and enhance tumor invasive and metastasis. accordingly, the effectiveness of tace is still unsatisfying as a single treatment for hcc. both anti-angiogenic targeted drugs and ginsenoside rg3 have showed synergistic effect with tace in patients with unresectable hcc. the purpose of this trial is to evaluate the efficacy and safety of the combination of anti-angiogenic targeted drugs and ginsenoside rg3 plus tace comparing to tace alone in patients with unresectable hcc.

Eligibility criteria:
inclusion criteria: 1. aged 18-75 2. unresectable hcc patients clinically diagnosed or confirmed by histopathology and/or cytology according to guidelines for diagnosis and treatment of primary liver cancer in china (2019 edition); 3. at least one measurable lesion (according to mrecist); 4. bclc stage b or c (china liver cancer staging \[cnlc\] iia, iib and iiia); 5. the maximum diameter of a single lesion ≤10cm; no more than 10 lesions; or combined with portal vein thrombus (pvtt) type i and ii (cheng's classification); 6. child-pugh score \<7; 7. eastern cooperative oncology group (ecog) ps 0-1; exclusion criteria: 1. mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma (hcc-icc) confirmed by pathology; 2. extrahepatic metastasis; 3. previously received hepatectomy, liver transplantation, interventional therapy, ablative therapy and other local therapies for hcc; 4. pvtt type iii/iv (cheng's classification), major hepatic vein invasion or primary to secondary bile duct invasion; 5. a history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding in the past 4 weeks; 6. cardiovascular diseases with significant clinical significance; 7. active infection; 8. other significant clinical and laboratory abnormalities that investigators believe affect safety evaluation.
a study of orelabrutinib plus r-chop in treatment-naïve patients with double expression diffuse large b-cell lymphoma

Conditions: The First Affiliated Hospital of Nanchang University

Summary: this is a multicenter prospective single arm phase ii study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with r-chop in the treatment of treatment-naïve patients with double expression dlbcl.

the patients will be treated with 6/8 cycles of orelabrutinib plus r-chop regimen（21 days per cycle). the primary objective was the complete response rate (crr) at end of induction therapy

Eligibility criteria:
inclusion criteria: * newly diagnosed double expression diffuse large b-cell lymphoma * age 18-70 years * ecog performance status 0-2 * ann arbor stage ii-iv * 8.subjects who in line with the testing standard of the clinical trial laboratory * life expectancy ≥ 3months exclusion criteria: * • systemic lymphoma involved cns. * accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases. * uncontrolled infections (including hbv, hcv, hiv/aids) * subjects who prepared for transplantation * pregnancy or active lactation
the efficacy of red grape seed extract on lipid profile and oxidized low-density lipoprotein (ox-ldl)

Conditions: Hyperlipidemia

Summary: antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic processes. a large number of synthetic and natural antioxidants are known to induce beneficial effects on human health and disease prevention. cardioprotective ability of grape seed extract polyphenols (gsep) was studied in animals and humans. it has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia. in another study, it is suggested that proanthocyanidins, the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of low-density lipoprotein (ldl) and showing an antiatherosclerotic activity. the only human model study designed to evaluate the effect of a standardized formulation of a gsep (leucoselect-phytosome \[lp\]) on the susceptibility of ldl to oxidation in a group of heavy smokers, revealed that the antioxidant potential of gsep may be effective in oxidative stress (smoking); however more investigational data are needed before wider use in clinical settings. based on these observations, the investigators decided to evaluate the effect of gsep in reducing ox-ldl in patients diagnosed with mild hyperlipidemia.


Eligibility criteria:
inclusion criteria: 1. triglyceride \> 150 mg/dl 2. total cholesterol \> 200 mg/dl exclusion criteria: 1. severe hyperlipidemia (triglyceride \> 300 mg/dl,total cholesterol \> 250 mg/dl) 2. usage of antilipid drugs 3. herbivore diet 4. alcoholism 5. heart failure 6. known cases of any malignancy 7. bmi \> 30 kg/m2 8. chronic hepatic diseases 9. smoking 10. chronic renal failure

Keywords: grape seed extract hyperlipidemia
evaluation of a diagnostic enteric card for management of diarrhea

Conditions: Diarrhea

Summary: path is a member of a consortium that is developing a diagnostic enterics card (dec) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality. the pathogens detected on dec include salmonella, campylobacter jejuni, shigella species, and escherichia coli o157:h7. this study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users. it will provide important data on the performance of dec for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.


Eligibility criteria:
inclusion criteria: * have 3 or greater liquid stools in the past 24 hours. * provide written informed consent from at least one parent in the case of children under 18 years of age. * provide written informed consent for those participants above 18 years of age. * provide assent in the case of children 10 years of age or greater. exclusion criteria: * previously enrolled in the study. * parents are unwilling or unable to provide written informed consent. * report using antibiotics in the last 30 days. * adolescent (\<18 years old) parent of a child already enrolled in the study.

Keywords: diarrhea diagnostic pediatric
a trial investigating the effects of semaglutide on ß-cell function in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age: 18-64 years (both inclusive) at the time of signing the informed consent * for subjects with type 2 diabetes: * male and female subjects diagnosed with type 2 diabetes * treated with diet and exercise and/or metformin monotherapy. metformin dose should be unchanged in a period of 30 days prior to screening * body mass index (bmi) between 20.0-35.0 kg/m\^2 (both inclusive) * glycosylated haemoglobin (hba1c) between 6.5-9.0 % (both inclusive) * for healthy control group for graded glucose infusion: * healthy male and female subjects * bmi between 24.0-32.0 kg/m\^2 (both inclusive) * hba1c less than 6.5 % exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner * any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic * use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening * history of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test * history of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
safety assessment of lyxumia (lixisenatide) and sulfonylurea as add-on treatment to basal insulin in uncontrolled patients with type 2 diabetes mellitus who elect to fast during ramadan

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during ramadan fast, of lixisenatide versus sulfonylurea (su). secondary objectives: * to assess effect of lixisenatide versus su on: * changes in glycemic control; * changes in body weight. * to assess overall safety of lixisenatide and su.

the total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-ramadan period + 29-30 days ramadan + 0 4 weeks post-ramadan period). this is a phase 3b study in kingdom of saudi arabia and bangladesh (instead of phase 4 for other countries).

Eligibility criteria:
inclusion criteria : * patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + su (≤50% max allowed dose) ±1 oral antidiabetic (oad) drug. * patients who express the intention to fast during ramadan. * signed informed consent. exclusion criteria: * at the time of screening age \< legal age of majority. * glycated hemoglobin (hba1c) at screening visit: \ 10%. * body mass index (bmi) \<20kg/m\^2. * treatment with basal insulin for less than 6 months prior to screening. * prior antidiabetic medication (basal insulin and oads) not at stable dose (eg, same medication, frequency and \<20% dose change) in the last 8 weeks prior to screening. * previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening. * any discontinuation from a glucagon like peptide-1 receptor agonist (glp-1 ra) due to safety/tolerability issue or lack of efficacy. * patient not willing to perform self-monitored plasma glucose (smpg) as required by protocol and to follow the instructions provided. * type 1, gestational or secondary diabetes. * history of diabetic ketoacidosis. * history of hypoglycemia unawareness. * any medical contraindication for sustained and safe fasting. * pregnant or breast-feeding women. * women of childbearing potential (wocb) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. * known hypersensitivity/intolerance to lixisenatide (lyxumia) or any of its excipients. * all contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective national product labeling. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
tl-895 and krt-232 study in acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this study evaluates tl-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (krt-232), a novel oral small molecule inhibitor of mdm2 for the treatment of adults with flt3 mutated acute myeloid leukemia. participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.


Eligibility criteria:
inclusion criteria: * tp53 wildtype aml * relapsed/refractory to at least one prior therapy, one of which must have included a flt-3 inhibitor * flt3 mutation (flt3-tkd or flt3-itd) * ecog 0-2 * adequate hematologic, hepatic, and renal functions exclusion criteria: * aml subtype 3 * prior treatment with mdm2 antagonist therapies * eligible for hsct

Keywords: aml tp53 flt3+ navtemadlin
effect of dietary fiber on metabolic syndrome, gastrointestinal function, mood and sleep quality in obese people

Conditions: Hypertension; Hyperglycemia; Dyslipidemia; Obesity; Metabolic Syndrome

Summary: metabolic syndrome includes hypertension(high blood pressure), hyperglycemia(high blood suger), dyslipidemia(abnormal blood lipid level) and obesity. the more items that meet metabolic syndrome, the higher the risk of cardiovascular disease and diabetes, and the higher the combined mortality. at present, research reports point out that the occurrence of metabolic syndrome is related to age, obesity, lifestyle and genetics. the lack of sleep may reduce the diversity of intestinal flora, and conversely, if the diversity of intestinal flora can be increased, the quality of sleep may be improved. dietary fiber can improve intestinal microflora and related indexes of metabolic syndrome. although recent studies have demonstrated that dietary fiber will affect obesity, mood and sleep, different kinds of dietary fiber will affect different strains and pro-duce different effects. the effect of resistant starch on metabolic syndrome, mood and sleep of obese people is not very clear. therefore, the objective of this intervention trial was to evaluate the effects of the intake of resistant starch on sleep, mood, changes in body composition and biomarkers in metabolic syndrome.


Eligibility criteria:
inclusion criteria: * obese working popu-lation aged between 30 and 45; * body fat is more than 25% for male and more than 30% for female exclusion criteria: * taking any medicines; * menopausal women; * pregnant woman

Keywords: prebiotic poms psqi indigestible dextrin dietary fiber