Kornimate/medical-research-clean huggingface dataset:
azacitidine and interferon alfa in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. interferon alfa may interfere with the growth of tumor cells. giving azacitidine together with interferon alfa may be an effective treatment for melanoma. purpose: this phase i trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.

objectives: primary * determine the maximum tolerated dose (mtd) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma. * determine if the mtd of this regimen is biologically active in these patients. * define and describe the toxicities associated with this regimen. secondary * determine, preliminarily, the response in patients treated with this regimen. * describe, preliminarily, the time to progression and overall survival of patients treated with this regimen. outline: this is a dose-escalation study of azacitidine. patients receive azacitidine subcutaneously (sc) once daily on days 1-5 (week 1) followed by interferon alfa-2b sc 3 days a week in weeks 2-4. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: a total of 12 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic melanoma * at least one lesion appropriate for 3 separate punch or core needle biopsies * must have received and failed ≥ 1 prior systemic treatment for metastatic disease patient characteristics: * ecog performance status 0-2 * bilirubin ≤ 1.5 times upper limit of normal (uln) * ast and alt \< 2 times uln * creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 60 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol * no uncontrolled infection * no known hiv positivity * no hepatitis b or hepatitis c infection prior concurrent therapy: * see disease characteristics * at least 3 weeks since prior systemic therapy * more than 4 weeks since prior radiotherapy to target lesions with evidence of progression * no concurrent radiotherapy to target lesions * no concurrent oral or iv corticosteroids * topical creams or ocular steroid drops are allowed

Keywords: recurrent melanoma stage iv melanoma
diagnosis of acute appendicitis, ovary torsion and inflammation, and testicular torsion and inflammation by infrared thermography

Conditions: Abdominal Pain; Testicle Pain

Summary: thermal, or infrared, energy is the part of electromagnetic radiation that an observer perceives as heat. infrared thermography allows us to visualize temperature distribution of the human body and has been used in medical practice since the 1950s. in current study we would like to examine the ability of infrared thermography to detect acute appendicitis, ovary torsion and inflammation, and testicular torsion and inflammation.


Eligibility criteria:
inclusion criteria: * \< 18 years old exclusion criteria: * \> 18 years old

Keywords: children
pulmonary inflammation in covid-19 ards

Conditions: ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19 Acute Respiratory Distress Syndrome

Summary: patients older than 18 years of age, with covid-19 related ards (c-ards) hospitalized in the icu and invasively mechanically ventilated will be included in the study. this is an observational cohort study. after informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a broncho alveolar lavage fluid (balf) sample will be collected. if the patients remain invasively mechanically ventilated a second and third blood and balf sample will be collected every 7-10 days.

the main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the balf of c-ards patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes. the mediators selected have been previously used in ards investigation to attempt prognostic and predictive enrichment. patients hospitalized in the icu following c-ards and requiring invasive mechanical ventilation will be candidates for enrollment. patients enrolled in the study (informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain balf for analysis. a second and third bronchoscopy and sampling of balf will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. a sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). patients will be followed up until hospital discharge. balf samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * covid-19 related ards * hospitalized in icu * invasive mechanical ventilation exclusion criteria: * immunocompromised for previous condition * transplanted patients * known pulmonary bacterial co-infection at the time of admission to the icu * contraindication to the realization of bronchoscopy (itracranial hypertension, severe hypoxaemia with p/f \< 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)

Keywords: ards covid-19 broncho alveolar lavage pulmonary inflammation mechanical ventilation respiratory mechanics
technical assistance for child and adult care food program in family child care home

Conditions: Nutrition Poor; Health Behavior

Summary: this study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. half the providers will be assigned to the nutrition program and the other half will receive a comparison on environmental health.

early care and education (ece) providers play a vital role in ensuring that young children have access to nutritious foods. over 25% of children in ece (1.2 million children) attend family child care homes (fcch). improvements in the child and adult care food program (cacfp) may introduce new barriers for fcch, which have limited meal preparation capacity. limited research has examined foods served by fcch providers, and no group randomized trials have been conducted using a community-based participatory approach in fcch and including an evaluation of intervention costs. goals: 1. determine compliance of menus and meals provided in fcch with cacfp guidelines. 2. determine the effectiveness of a pilot community-based nutrition technical assistance intervention to enhance meeting cacfp best-practices. 3. determine the effectiveness of a statewide community-based nutrition technical assistance intervention to enhance meeting cacfp best-practices. 4. expand university student opportunities for participation in health research. methods: conduct a cross-sectional assessment of a random sample of fcch providers' (n=52) menus and meals served. foods will be evaluated against the cacfp requirements and best-practices. after the cross-sectional examination, providers in the pilot will be randomly assigned to a nutrition technical assistance (n=26) or attention comparison intervention (n=26). following the pilot, trained extension educators will implement both interventions (n=27 intervention, n=27 comparison) in six selected counties, reaching underserved rural and low-income populations. the intervention is based on theoretical foundations and formative interviews, and will consist of two 60-90-minute visits to the fcch and one group class lasting approximately 3 hours.

Eligibility criteria:
inclusion criteria: * family child care home providers within 60 minutes of oklahoma city who participate in the child and adults care food program exclusion criteria: * none

Keywords: early childhood education family child care home food environment
qt interval in patients with pacemaker dependency

Conditions: High Degree AV-block; Left Bundle Branch Block

Summary: the aim of this study is to examine a correction term for an adapted qt interval during ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting for the qt intervals in various pacing conditions.

this investigation aims at determining a possibility to assess the usefulness of various formulae that correct for the different effects of various pacing modes on the qt interval. more specifically, the hypothesis will be tested that applying adequate correction will preserve the predictive power of the qt-interval regarding proarrhythmia in various cardiac pathologies and therapies.

Eligibility criteria:
inclusion criteria: * caucasian race * implanted cardioverter/defibrillator or pacemaker * negative pregnancy test for women of child bearing potential * stable function of the implanted device * stable medical therapy relating to the underlying disease * stable medical therapy of antiarrhythmic drugs and other qt-time changing drugs * no instability of rhythm * x-ray of thorax during device implantation in two levels (ap and ll axis) * written informed consent exclusion criteria: * coronary heart disease and angina pectoris symptoms * patient with acute myocardial infarction or cabg while the last 4 weeks * patient with tachycardia and a rest frequency \>80 bpm * patient with severe pulmonary disease * patient with anaemia * patient with acute infections * patient with severe kidney or liver disease

Keywords: pacemaker icd / crtd corrected qt-interval
non-alcoholic fatty liver disease in women with polycystic ovary syndrome

Conditions: PCOS; NAFLD

Summary: this study was planned to examine the prevalence of vitamin d insufficiency, insulin resistance, non-alcoholic fatty liver disease (nafld), and their relationship with each other and the nutritional status of individuals with polycystic ovary syndrome (pcos) in reproductive age, by evaluating anthropometric, biochemical, and ultrasonographic findings and food consumption frequency data.

a total of 72 female individuals diagnosed with pcos were included in the study. nutritional status, physical activity levels, anthropometric measurements, and biochemical parameters of individuals were examined. a food consumption frequency questionnaire was applied to the individuals. according to the 2003 rotterdam consensus revision, pcos is diagnosed when at least two of the following three conditions are present: polycystic ovaries on ultrasonography, oligomenorrhoea, or anovulation; clinical and/or biochemical symptoms of hyperandrogenemia. testing was done on insulin, lipid profiles, fasting plasma glucose, and liver function. bioelectrical impedance analysis was used to determine body weight and composition. an abdominal ultrasound was used to diagnose nafld.

Eligibility criteria:
inclusion criteria: * female sex * pcos diagnosis * no use of oral contraceptives or any hormone therapy in the last 3 months * no use of vitamin d supplements in the last 3 months * no use of oral antidiabetic drugs in the last 3 months exclusion criteria: * adrenal dysfunction * diabetes mellitus * pregnancy * alcohol consumption * a history of chronic viral hepatitis * autoimmune liver disease * other liver diseases * history of hepatotoxicity * use of antihypertensive, antidiabetic, lipid-lowering drugs

Keywords: polycystic ovary syndrome non-alcoholic fatty liver disease obesity insulin resistance
randomized trial of in.pact admiral® drug coated balloon vs standard pta for the treatment of sfa and proximal popliteal arterial disease

Conditions: Peripheral Arterial Disease (PAD)

Summary: the objective of this study is to evaluate the safety and efficacy of the in.pact admiral® drug coated pta balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) pta balloons. the in.pact admiral, besides the mechanical dilatation effect typical of all pta balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. this drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

the efficacy of the in.pact admiral balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the study. primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on: * the need for re-dilatation of the previously treated vessel segment * an ultrasound examination the safety of the in.pact admiral will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the study. the in.pact sfa trial enrolled in 2 phases: in.pact sfa i and in.pact sfa ii. the 150-patient in.pact sfa i phase is intended to support the second phase in.pact sfa ii ide trial with congruent design and protocol. aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

Eligibility criteria:
general inclusion criteria: * age ≥18 years and ≤85 years * patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an ec approved consent form angiographic inclusion criteria: - target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee) general exclusion criteria: * patient unwilling or unlikely to comply with follow-up schedule * stroke or stemi within 3 months prior enrolment angiographic exclusion criteria: - acute or sub-acute thrombus in the target vessel
telehealth-based chronic disease management for type 2 diabetes

Conditions: Type 2 DM

Summary: this study will be conducted from enrollment until the end of the six-month follow-up period. this study aims to assess the impact of the internet hospital online + offline integrated chronic disease management model on patients with type 2 diabetes mellitus. it will also evaluate the economic impact of the model and identify the characteristics of the appropriate population for the model. finally, it will develop a toolkit to help manage chronic diseases. the study will include 1,636 patients with type 2 diabetes who did not reach the standard of control target of glucose, blood pressure or ldl at the endocrine outpatient clinic and inpatient wards of the third hospital of peking university. we will collect information from participants before the study starts. and the patients will be followed up for 6 months from enrollment. the study management mode included online and offline integrated management in the internet hospital, and routine offline management mode. after completing the enrollment and assessment, we will arrange outpatient follow-up and management according to the current status, doctor's requirements, and study subjects' needs.


Eligibility criteria:
inclusion criteria: * 18-70 years old; * confirmed diagnosis of type 2 diabetes mellitus; * ability to use smartphones to participate in online diagnosis and treatment; * ability of the patient or relatives to assist the patient in self-monitoring of blood glucose; * failure to meet control targets: glycated hemoglobin ≥7. 0%, or ldl-c ≥ 2.6 mmol/l (and ascvd or definite atherosclerosis with stenosis ≥ 1.8 mmol/l), or blood pressure \> 130% and ≥ 1.8 mmol/kg. l), or blood pressure over 130/80 mmhg. exclusion criteria: * mental illness, cognitive dysfunction; * other diseases and complex conditions (untreated tumors, heart disease within 3 months); * acute complications of diabetes, severe hyperglycemia, fasting glucose greater than 16.9 mmol / l, random glucose greater than 20 mmol / l. diabetic ketoacidosis and hypoglycemic coma that are not suitable for online management of diabetes emergencies; * patients with severe chronic complications of diabetes in critical condition (blindness, vision deterioration, new onset of ascvd symptoms); * those who are unsuitable for the study: infection, fracture, trauma, foot ulceration, edema, blindness, cardiovascular emergencies, coma, etc; * those who have not signed the informed consent form.
spy fluorescence imaging systems and indocyanine green to determine the percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries.

Conditions: Cholecystitis

Summary: this is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using spy fluorescence imaging and icg, with each surgery also providing a white light 360 degree images. the primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative spy fluorescence imaging and icg: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older * subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent * subject provides informed consent and signs an approved informed consent document for the study * subject is willing to comply with the protocol and study visit schedule exclusion criteria: * subject is pregnant or lactating * subject has a known allergy or history of adverse reaction to icg, iodine or iodine dyes * subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease * subjects who, in the investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
a study of 5-fuci versus cpt-11 plus cddp versus s-1 alone in advanced gastric cancer

Conditions: Gastric Cancer

Summary: to investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of s-1 compared to continuous infusion of 5-fu in advanced gastric cancer

from the results of our previous phase iii study (jcog9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. this study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of s-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).

Eligibility criteria:
inclusion criteria: 1. unresectable or recurrent histologically proved gastric cancer 2. adequate oral intake 3. age 20 or older and 75 or younger 4. performance status (ecog):0, 1, 2 5. measurable or unmeasurable lesions 6. preserved organ functions 7. no severe medical condition 8. no prior chemotherapy for gastric cancer 9. written informed consent exclusion criteria: 1. patient with marked infection or inflammation 2. patient with severe peritoneal metastasis 3. patient with massive pleural effusion 4. patient with metastasis to cns 5. patient with diarrhea 4 or more times per day 6. patient severe medical condition 7. patient with other concurrent malignancy affecting on survival or adverse events 8. pregnant or nursing patient or with intent to bear baby 9. patient evaluated to be inadequate by a attending doctor 10. patient requiring nutritional support

Keywords: gastric cancer 5-fluorouracil irinotecan cisplatin s-1 advanced or recurrent gastric cancer
investigation of validity and reliability of post-covid-19 functional status scale

Conditions: Covid19

Summary: the new type of coronavirus (sars-cov-2) epidemic puts great pressure on health systems around the world. a large number of people are hospitalized in intensive care units due to acute respiratory distress syndrome due to sars-cov-2. common symptoms seen with sars-cov-2 include fever, cough, and dyspnea, as well as pneumonia, severe acute respiratory distress syndrome, renal failure, and even death. many patients develop mild to moderate disease without pneumonia. the respiratory condition of some patients continues to worsen gradually and develop acute respiratory distress syndrome, which usually requires mechanical ventilation support. exercise capacity and health status of individuals who survived severe acute respiratory distress syndrome are lower than the general population. persistent physical, cognitive, and psychosocial disorders can be seen in people who have survived acute respiratory distress syndrome. given the clinical and radiological heterogeneity of covid-19, it is important to have a simple tool for the disease to monitor the course of symptoms and the impact of symptoms on patients' functional status. klok fa et al. developed the post-covid-19 functional status scale (pcfs). pcfs can be evaluated for functional sequelae after discharge from the hospital, at 4 and 8 weeks after discharge, to directly monitor recovery, and at 6 months. the aim of this study is to investigate the validity and reliability of pcfs in turkish population. research permission to investigate the validity and reliability of pcfs in the turkish population was obtained from the developer of the pcfs.


Eligibility criteria:
inclusion criteria: * clinically stable, * being 18 years of age or older, * having education level at least primary school, * whose local language is turkish, * being discharged after covid-19 * giving consent on a voluntary basis. exclusion criteria: * having an unstable clinical condition, * being stayed in intensive care, * having severe neuromuscular and musculoskeletal problems, * not being able to cooperate to fill questionnaires, * having a cognitive problem, * not being able to read, * not being willing to participate in the study.
translation and validation of the intensive care unit mobility scale (ims)

Conditions: Muscle Weakness; Critical Illness; Mechanical Ventilation Complication; Early Mobilization

Summary: intensive care unit acquired weakness (icuaw) is a common issue in critically ill patients. early mobilization can reduce the occurrence of icuaw. this requires a standardized procedure based on validated scales. one such scale is carol hodgson's icu mobility scale (ims). the subject of the study is the translation of the ims into german and the validation of its reliability and predictive power with regard to various clinical outcomes. furthermore we want to investigate the communication about the mobilisation status of icu-patients between the different medical disciplines that are involved in patient care.


Eligibility criteria:
inclusion criteria: * critically ill adults (age: ≥ 18 years) * expected length of stay in icu \> 24h * ventilation support exclusion criteria: * patients transferred from other icus * patients with pre-existing functional limitations * patients with functional limitations due to the admission diagnosis (e.g. stroke. with hemiparesis)

Keywords: icu-mobility-scale