Kornimate/medical-research-clean huggingface dataset:
the intraoperative physiologic changes of patients under hyperthermic intraperitoneal chemotherapy (hipec) cytoreductive surgery; prospective observational study

Conditions: Peritoneal Surface Malignancies

Summary: the most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (hipec), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. it is widely known that hipec entails severe physiological changes and precautions during anesthesia. however, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during hipec cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. the investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during hipec cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for hipec cytoreductive surgeries.


Eligibility criteria:
inclusion criteria: * adult patients 20 years of age or older who will undergo hipec cytoreductive surgery at the colon and rectal surgery department of our hospital exclusion criteria: * cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.
diet and health in adults with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the prevalence of us adults with metabolic syndrome (mets) is over 34%, impacting nearly 35% of all adults and 50% of those aged 60 years or older. mets is characterized as a combination of underlying risk factors that when, occurring together, increase the risk for chronic diseases such as type 2 diabetes mellitus (t2dm), cardiovascular disease, stroke, and certain types of cancer, resulting in an 1.6-fold increase in mortality. according the american heart association, health risks associated with metabolic syndrome can be significantly reduced by reducing body weight and eating a diet that is rich in whole grains, fruits, and vegetables. potatoes (e.g. skin-on white potatoes) are an excellent source of potassium, vitamin c, and vitamin b6 and a good source of magnesium and dietary fiber. in addition, the potato has greater dry matter and protein per unit growing area compared with cereals. despite this, consumers tend to believe that potatoes are high in calories and in fat compared with other carbohydrate sources such as rice or pasta, an incorrect assumption since a potato has negligible fat and a low energy density similar to legumes. data from short-term nutrition intervention trials, suggest that potatoes consumed as part of a low-glycemic load meal can play a role in the prevention or treatment of mets. however, the impact of long-term potato consumption on cardiometabolic risk factors associated with mets is not known. therefore, there is a critical need to determine if regular (\> 4 times per week) potato consumption can improve cardiometabolic health in individuals with mets.


Eligibility criteria:
inclusion criteria: * resides in northwest arkansas * age 18+ years * metabolic syndrome (characterized by participant having three or more of the following measurements: abdominal obesity, triglyceride level over 150 mg/dl, hdl cholesterol \ 100 mg/dl) * all ethnicities * female and male * currently consuming a high glycemic load diet exclusion criteria: * food allergies * dietary restrictions (e.g. vegetarian, vegan, etc.) * trying to lose weight in last 3 months * prescription medications related to heart disease or type 2 diabetes * fear of needles
locally advanced or metastatic pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: multiple centers, uncontrolled, open-label, non-randomized single-arm study

to evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving gsl treatment, primary objective: overall tumor response rate (by recist criteria) secondary objectives: disease control rate (objective response rate + stable disease ≧ 16 weeks) time to tumor progression progression-free survival overall survival clinical benefit response quality of life safety profile biomarker of pancreatic cancer

Eligibility criteria:
inclusion criteria: 1. patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas. 2. patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination. 3. patients have no history of prior chemotherapy for metastatic pancreatic cancer. patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible. 4. patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. 5. baseline ecog performance status is 2. 6. patients have life expectancy of at least 12 weeks. 7. patients have age 70 years. 8. patients have adequate organ function. 9. patients with biliary obstruction which is adequate drained before enrollment are eligible. 10. patients agree to have an indwelling venous catheter implanted. 11. women or men of reproductive potential should agree to use an effective contraceptive method. 12. all patients must be informed of the investigational nature of this study and must sign written informed consents. exclusion criteria: 1. patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. 2. patients with metastatic lesion in central nervous system. 3. patients with active infection. 4. patients with active cardiopulmonary disease or history of ischemic heart disease. 5. patients who have peripheral neuropathy \> grade i of any etiology. 6. patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator. 7. patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.

Keywords: in elderly patients
clinical test for transtek glass body analyzer

Conditions: Weight; Body Fat Disorder; Bone Mass

Summary: the clinical protocol of the clinical testing of this device: 1. objective of the test: to verify the functions and efficiency of devices. 2. test methods and procedures: comparison test. 3. dut: transtek glass body analyzer, model: gbf-830, gbf-835, gbf-950, and sa-15. 4. comparison device: scaleman body fat scales, fs-148bw1 (predicate device). 5. study endpoints: transtek devices and the predicate device are substantial equivalence. 6. statistical methodology used: description of statistical methods. 7. result: efficiencies of transtek devices and predicate device are in the same level.

hospital information the data was collected by west china medical college clinical investigator team at wuhou district hospital, no. 9 tongzilin road, wuhou district, chengdu 610041, p. r. china. investigator: catharine zhang, nurse a; vivian luo, nurse b; dr. james zhu, sponsor. contact dr. james zhu tel: +86 1330 8036568 used equipments dut (device under test): transtek glass body analyzer, gbf-830, gbf-835, gbf-950, and sa-15. reference device: scaleman body fat scales, fs-148bw1 (predicate device). test protocol 1. test purpose: the aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by dut and reference device. note: gbf-835 has not total body water, bone mass, and muscle mass functions. so it just collects weight and body fat data. 2. target subject: the subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. patient's population analysis is bellow. 3. test procedures 1) record the name, age, gender, and height of each subject. 2) let subject seated calmly for two minutes before test, dry the feet. 3) use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value. 4) for each subject, repeat 3) to get 3 pairs measurements. 5) repeat step 1) to 4) for every device (dut: gbf-830, gbf-835, gbf-950, and sa-15; and reference device: fs-148bw1). 6) repeat step 1) to 5) for each subject. 5. note: 1. no motion and speaking are allowed during the measurement. 2. all dut use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency. 3. test environment: temperature: 20±1℃; relative humidity: 40\~50%.

Eligibility criteria:
inclusion criteria: * male,female exclusion criteria: * below 18 years old

Keywords: weight body fat total body water bone mass muscle mass
automated identification of psychogenic nonepileptic seizures

Conditions: Convulsion, Non-Epileptic

Summary: a retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures

this is a validation study of a post-processing method intended to identify psychogenic nonepileptic seizures by analysis of surface electromyographic (semg) artifact previously recorded during routine video-electroencephalographic (veeg) monitoring

Eligibility criteria:
inclusion criteria: a subject will be eligible for inclusion in this study if the following criteria apply. * subject was previously admitted to the medical university of south carolina for inpatient veeg monitoring in the musc epilepsy monitoring unit and at least one pnes was recorded during that admission. * male or female between the ages of 2-99 * can understand and sign written informed consent, or will have a parent or a legally authorized representative (lar) who can do so, prior to the performance of any study assessments exclusion criteria: * no exclusion criteria have been established for this study.
probiotic on type 2 diabetes and chronic obstruction pulmonary disease

Conditions: Type 2 Diabetes; Chronic Obstructive Pulmonary Disease

Summary: this trial is a randomized, double-blind, parallel placebo clinical trial, the purpose of which is to investigate whether the adjuvant therapy of using probiotics during the treatment of diabetic patients can decrease blood sugar levels significantly in comparison with placebo, and observe if the reduced lung function could be recovered in patients with type 2 diabetes (t2dm) and chronic obstructive pulmonary disease (copd) simultaneously.


Eligibility criteria:
inclusion criteria: * subjects are between 50-85 years old, and clinical diagnosis of t2dm (hba1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dl or oral glucose tolerance test 2-hour plasma glucose ≥ 200 mg/dl). * patients with stable pulmonary obstruction (pulmonary function fev1/fvc \<0.7) with symptoms of pulmonary obstruction. * subjects can cooperate with the collection of experimental specimens and return for regular visits. * the patient or family members have signed the informed consent form. * the patient must receive adjuvant treatment with probiotic for 12 weeks. exclusion criteria: * the patient or caregiver is unable to follow the physician's instructions for the trial, including the completed symptom assessment form and compliance with medication. * the patient has a history of related allergic reactions, or the use of other highly sensitive or contraindicated drugs (allergy to antibiotics or antipyretics). * the patient have taken oral immunosuppressive drugs, intravenous steroids or t cell inhibitor ointments within the past 2 weeks. * the patient has consumed probiotic-related products (including drops, lozenges, capsules, powder and yogurt) within the past 1 month. * the patient received high doses of steroids within the past 1 month. * the patient with active infection or severe pulmonary disease (eg, tuberculosis, bronchiectasis, or fibrosis). * the patient is receiving treatment for a major disease or congenital disease. * the patient is not suitable to participate in the trial as assessed by the professional physician.

Keywords: diabetes mellitus chronic obstructive pulmonary disease gut microbiota probiotics
assess use of 18f-fluciclovine for patients with large brain metastases treated with staged stereotactic radiosurgery

Conditions: Brain Metastases, Adult; Brain Metastases; Brain Cancer

Summary: the spread of cancer to the brain is referred to as brain metastases. brain metastases are a common complication of cancer. this study is being done to determine whether the use of a new imaging agent, 18f-fluciclovine, is able to detect which patients are responding to radiation therapy. in addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.


Eligibility criteria:
inclusion criteria: 1. male or female, age ≥18 years 2. performance status, eastern cooperative oncology group 0-2 3. confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter 4. plan for ssrs per the treating team 5. for women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required 6. for females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18f-fluciclovine positron emission tomography/computerized tomography exclusion criteria: 1. prior anaphylactic reaction to 18f-fluciclovine 2. evidence of leptomeningeal disease 3. prior whole-brain radiation therapy 4. contraindication to mri (e.g., due to safety reasons, such as presence of a pacemaker) 5. females pregnant at the expected time of 18f-fluciclovine administration 6. females who are expecting to be breastfeeding at the time of 18f-fluciclovine and unwilling to stop breast-feeding for 24 hours. temporary cessation of breastfeeding 24 hours after the time of imaging is allowed 7. major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Keywords: brain brain metastases brain metastases, adult brain cancer stereotactic radiosurgery
carmustine plus o(6)-benzylguanine in treating patients with recurrent or progressive gliomas of the brain

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of carmustine plus o(6)-benzylguanine in treating patients who have recurrent or progressive gliomas of the brain.

objectives: i. determine the maximum tolerated dose of carmustine when administered following o6-benzylguanine in patients with recurrent, persistent, or progressive cerebral anaplastic gliomas. ii. characterize the toxic effects associated with this treatment regimen in these patients. iii. observe patients for clinical antitumor response when treated with this regimen. outline: patients are stratified according to prior nitrosourea administration (yes or no). (prior nitrosoureas stratum closed) an initial cohort of 3 patients per stratum is treated with intravenous o6-benzylguanine followed approximately 1 hour later by intravenous carmustine every 6 weeks. additional cohorts of 3-6 patients are treated with escalating doses of carmustine until dose limiting toxicity (dlt) is observed. the maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dlt. courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 24-56 patients (12-28 per stratum) will be accrued in 12 months.

Eligibility criteria:
disease characteristics: histologically proven recurrent, persistent, or progressive glioblastoma multiforme or anaplastic astrocytoma diagnosed by biopsy/resection evaluable residual disease by mri or ct scan patient characteristics: age: 18 and over performance status: karnofsky 60-100% life expectancy: not specified hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: sgot no greater than 2.5 times upper limit of normal bilirubin within normal limits renal: creatinine no greater than 1.5 mg/dl or creatinine clearance greater than 60 ml/min bun no greater than 25 mg/dl pulmonary: dlco greater than 80% predicted other: not pregnant or nursing fertile patients must use effective contraceptive method during and for 2 months after study prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks since prior nitrosourea, procarbazine, or mitomycin) and recovered endocrine therapy: concurrent corticosteroid therapy must be stable for at least 1 week prior to study, if clinically possible radiotherapy: at least 4 weeks since prior radiotherapy and recovered surgery: not specified

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma
study of pembrolizumab treatment after cyad-101 with folfox preconditioning in metastatic colorectal cancer

Conditions: Unresectable Metastatic Colorectal Cancer

Summary: the purpose of the cyad-101-002 study is to assess the safety and clinical activity of cyad-101 in patients with unresectable metastatic colorectal cancer administered concurrently with folfox chemotherapy, followed by pembrolizumab treatment.

this study aims to provide insight into whether cyad-101 administration concurrently with folfox chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer

Eligibility criteria:
key inclusion criteria: 1. histologically proven metastatic adenocarcinoma of the colon or rectum. 1. confirmed metastatic unresectable adenocarcinoma of the colon or the rectum. 2. confirmed non-microsatellite instability high (non-msi-h)/mismatch-repair proficient (pmmr) tumor status 3. unequivocal and measurable disease by response evaluation criteria in solid tumors (recist version 1.1). 4. recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include folfox chemotherapy 5. the patient is due to receive folfox chemotherapy 6. neurotoxicity less than or equal to common terminology criteria for adverse events (ctcae) grade 1 from previous chemotherapy. 2. eastern cooperative oncology group (ecog) performance status 0 or 1. 3. adequate organ, hepatic, renal, pulmonary and cardiac functions 4. tumor biopsy at screening key exclusion criteria: 1. any other investigational agent or device within 4 weeks of the first study treatment administration. 2. any anticancer agent within 4 weeks of the first study treatment administration 3. filgrastim (granulocyte-colony-stimulating factor \[g-csf\]) or similar growth factors within 7 days of the first study treatment administration 4. prior therapy with an anti-pd-1, anti-pd-l1, or anti pd-l2 agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor 5. prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration 6. major surgery within 4 weeks before the planned day for the first study treatment administration 7. a live vaccine within 30 days prior to the planned day for the first study treatment administration 8. uncontrolled intercurrent illness or serious uncontrolled medical disorder 9. patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.
a post marketing safety study of sitagliptin phosphate/metformin hydrochloride (janumet®) (mk-0431a-235)

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (hcl) (janumet®) from endocrinologists, diabetologists, internists, and general practitioners.


Eligibility criteria:
inclusion criteria: * must be taking sitagliptin phosphate/metformin hcl (janumet®) for the treatment of type 2 diabetes mellitus * treating physician must agree to provide information regarding the participant's treatment
the psychological impact of covid-19 outbreak on covid-19 survivors and their families

Conditions: Mental Health Wellness 1

Summary: patients with covid-19 diagnoses are treated under isolation in hospitals and with high-stress level. currently, there is little information on the mental health implications of exposure amongst covid-19 survivors and their family members. research exploring the psychological impact amongst survivors of exposure to covid-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of covid-19. this study aims to assess the psychological impact of the covid-19 outbreak on covid-19 survivors and their family members.

since the 2019 coronavirus disease (covid-19) was first reported, it has been rapidly transmitted and has aroused enormous global attention. infected patients may develop severe and even fatal respiratory symptoms such as acute respiratory distress syndrome (ards) and acute respiratory failure, ending up in intensive care. patients with covid-19 diagnoses are treated under isolation in hospitals and with high-stress level. the stress and psychological impact on patients were also correlated significantly with several adverse psychological effects, such as fatigue, fear of social contact, poor sleep, loneliness, and depressed mood. the psychological impact of covid-19 may also evolve and last for a prolonged period after discharge from the hospital. however, there is currently little information on the mental health implications of exposure amongst covid-19 survivors and their family members. research exploring the psychological impact amongst survivors of exposure to covid-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of covid-19. this study aims to assess the psychological impact of the covid-19 outbreak on covid-19 survivors and their family members.

Eligibility criteria:
inclusion criteria: * covid-19 survivors (i.e., diagnosed with covid-19 and discharged from the hospital) and/or a family member of a covid-19 survivor; * aged 18 years or above; * no medical diagnosis of psychiatric illness exclusion criteria: • refusal to give consent

Keywords: stress anxiety depression families
a clinical trial study to evaluate efficacy and safety of atorvastatin in korean patients with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.


Eligibility criteria:
inclusion criteria: * age 20 \~ 79 * people who have not reached ldl-c targeted level in accordance with the guidelines for hyperlipidemia management released by korean society of lipidology and atherosclerosis * in case of female participants taking combination hrt or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.