Kornimate/medical-research-clean huggingface dataset:
familial aggregation of stress response

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to perform data analyses on the familial aggregation of the stress response as it relates to hypertension.

background: given recent advances in the analyses of genetic epidemiologic data, the database presented a unique opportunity to address timely issues pertinent to the contribution of genetic and environmental factors to individual differences in cardiovascular reactivity. design narrative: secondary data analyses were performed on family data obtained in an ongoing hypertension genetic study conducted at the university of utah with roger r. williams as principal investigator. the available data represented one of the largest studies of cardiovascular reactivity among genetically related individuals. during 1981-83, a total of 2,548 subjects, members of 98 extended families (multiple generations and multiple nuclear families) participated in an extensive cardiovascular examination and were assessed on a comprehensive battery of cardiovascular tests. annual follow-up questionnaires obtained information about the onset of hypertension and new medication prescribed. in 1991-92, a follow-up exam was conducted on 1,500 subjects. the data analysis attempted to confirm or refute hypotheses postulating a reactivity-hypertension association; investigated whether there was a sex limitation in the genetic and environmental determinants of reactivity; explored genotype-by-age interactions in the control of reactivity;and determined whether there was shared genetic and/or environmental variance between reactivity and other recognized cardiovascular risk factors such as obesity or lipids. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
music therapy intervention to reduce caregiver distress at the end of life

Conditions: Quality of Life; Stress; Anxiety; Depression

Summary: this is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.

caregivers are at high risk for stress, poor quality of life (qol), and burnout. as a patient nears death, common themes for caregivers include anxiety and emotional distress from impending death, anticipatory grief, and acceptance of loss, which negatively impact the caregiver qol. investigators propose to conduct a pilot project to investigate music therapy impact on caregiver distress for caregivers of imminently dying hospitalized patients referred to hospice. upon enrollment, caregivers will be provided a music therapy intervention with legacy-building components, and will be asked to complete 3 brief questionnaires on distress and quality of life before and after the music therapy to assess their response to the intervention. the overall aim is to reduce caregiver distress and optimize qol.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. self-identified caregiver 3. english-speaking exclusion criteria: 1. unable to provide consent

Keywords: hospice palliative care integrative medicine music therapy inpatient caregiver
a culturally tailored lifestyle intervention to prevent diabetes in south asians

Conditions: Diabetes; Obesity

Summary: the south asian community, people with origins in india, pakistan, bangladesh, maldives, nepal, sri lanka, or bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. this study will test the feasibility and community acceptability of a culturally appropriate lifestyle intervention for the prevention of diabetes in the south asian community. the outcomes of this project could be used to plan larger interventions to prevent diabetes in south asians, a rapidly growing segment of the us population.


Eligibility criteria:
inclusion criteria: * self-identified as being of south asian origin * live in or near atlanta, georgia * bmi greater than 22 kg/m2 calculated from standardized weight and height measurements (a bmi of greater than 22 kg/m2 is indicative of overweight in the south asian population) * a confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.) * no prior diabetes diagnosis (physician diagnosis or on diabetes medication) * a high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening) * fasting glucose of 100-125 mg/dl (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dl (impaired glucose tolerance), measured at baseline visit * no history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant exclusion criteria: * capillary glucose less than 120 * fasting glucose less than 100 mg/dl or greater than 125 mg/dl or 2 hour post-load glucose less than 140 mg/dl or greater than 199 mg/dl * age less than 25 years * bmi less than 22 kg/m2 * pregnancy * history of heart disease or diabetes (other than gestational diabetes) * current functional difficulties * severe lung disease or cancer * failure to pass cardiovascular stress test

Keywords: diabetes obesity pre-diabetes south asian
nuvaring vs. oral contraceptive pills (ocp) for in-vitro fertilization (ivf) pre-treatment

Conditions: Infertility; In-vitro Fertilization

Summary: the newly designed contraceptive ring, nuvaring has a lower total steroid dose, and medications are delivered locally. it has been proven to be as safe and effective as the combined ocp in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. it is hypothesized that nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to coh for ivf.


Eligibility criteria:
inclusion criteria: * patients less than 38 years of age. * healthy women starting their first ivf/icsi cycle. * no contraindication to combined oral contraceptive (coc) use. appendix 1 * consent to randomization. exclusion criteria: * any contraindication to coc use. * hypersensitivity to nuva ring or any of its components. * language barrier to consent.
a phase 3 randomized, double-blind placebo controlled, multi-regional trial to evaluate the efficacy and safety of gt0918 for the treatment of mild to moderate covid-19 male patients

Conditions: COVID-19

Summary: the purpose of this study is to assess the efficacy and safety of proxalutamide (gt0918) in male outpatients with mild to moderate covid-19 disease

the subjects in the experimental group will receive gt0918 (200mg oral once-daily (qd) for 14 consecutive days) in addition to supportive treatment. the subjects in the control group will receive placebo (200mg oral once-daily (qd) for 14 consecutive days) in addition to supportive treatment.

Eligibility criteria:
inclusion criteria: 1. adult males age ≥18 years of age at the time of randomization 2. are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate covid-19 patients to be hospitalised, such as covid-19 patients in mainland china) 3. the subject's first positive sars-cov-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization 4. subjects with adequate liver and renal function 5. agree to the collection of nasopharyngeal swabs and venous blood 6. the participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol exclusion criteria: 1. have spo2 ≤ 93% on room air at sea level or pao2/fio2 \< 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute 2. has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to covid-19 or requires treatment with supplemental oxygen 3. have known allergies to any of the components used in the formulation of the study drug or placebo 4. suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo 5. have any co-morbidity anticipated to require surgery within \<7 days, or that is considered life threatening within 30 days 6. have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose 7. prior, current, or planned future use of any of the following treatments at screening: covid-19 convalescent plasma, mabs against sars-cov-2, ivig (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening 8. are investigator site personnel directly affiliated with this study 9. have received an investigational intervention for sars-cov-2 prophylaxis within 30 days prior to randomization

Keywords: covid-19
a study to assess the safety and efficacy of asp1941 in combination with dipeptidyl peptidase-4 (dpp-4) inhibitor in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to evaluate long-term safety and efficacy after concomitant administration of asp1941 and dpp-4 inhibitor in japanese patients with type 2 diabetes mellitus.

this is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on a dpp-4 inhibitor alone. dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients receiving with dpp-4 inhibitor mono-therapy for at least 4 weeks * hba1c value between 6.5 and 9.5% * body mass index (bmi) 20.0 - 45.0 kg/m2 exclusion criteria: * type 1 diabetes mellitus patients * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300mg/g) * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: dipeptidyl peptidase-4 inhibitor asp1941 dpp-4 inhibitor long-term safety diabetes mellitus
a study evaluating safety and efficacy of biod 531 compared to humalog® mix 75/25 in subjects with type 2 diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of biod-531 compared to humalog®mix 75/25 in patients with type 2 diabetes.

biod-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. the purpose of this trial is to evaluate glucose control and safety of biod-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.

Eligibility criteria:
inclusion criteria: * established clinical diagnosis of type 2 diabetes, consistent with ada classification criteria for 6 months or longer. * body mass index 27 - 45 kg/square meter, inclusive. * screening hba1c between 7.5 and 11.0%, inclusive. * up to two injections per day of u-100 basal (nph, glargine, or detemir), pre-mixed, or self-mixed basal/prandial insulins or insulin analogs at stable total daily doses between 40 -200 units/day, inclusive, for ≥ 3 months prior to screening. exclusion criteria: * regular use of humulin®r u-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening. * history of bariatric surgery. * subject has had one or more severe hypoglycemic episodes associated with seizure, coma, or unconsciousness within the past 6 months. * history of known hypersensitivity to any of the components in the study medication. * new york heart association (nyha) class iii or iv functional capacity, unstable angina pectoris, myocardial infarction, severe peripheral vascular disease, ischemic strokes or transient ischemic attacks within 6 months of screening. * systolic blood pressure ≥ 180 mmhg or sitting diastolic blood pressure ≥ 100 mmhg confirmed on repeat during screening visit.
study to evaluate the efficacy and safety of dwp14012 on maintaining healing in subjects with healed erosive esophagitis

Conditions: Healed Erosive Esophagitis

Summary: this study aims to demonstrate the noninferiority of dwp14012 to lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of dwp14012 in patients with healed erosive esophagitis confirmed on egd after medication treatment.


Eligibility criteria:
inclusion criteria: 1. male and female adults aged 19 to 75 years, at the date the written informed consent form is signed 2. subjects with erosive esophagitis (la grade a-d) confirmed on egd within 12 weeks from visit 2 (randomization day) 3. subjects with healed erosive esophagitis (no mucosal break observed according to la classification) confirmed on egd performed within 10 days before visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (ppi, p-cab, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis exclusion criteria: 1. subjects who have barrett's esophagus (\> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon egd screening 2. subjects who have inflammatory bowel disease (crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (ibs), primary esophageal motility, or pancreatitis. 3. subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system 4. subjects who have had a malignant tumor in the last 5 years 5. subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (a low dose of aspirin \[100 mg/day\] which has been administered for prophylactic purpose before study entry is allowed) 6. subjects who cannot stop the existing erosive esophagitis treatment being taken
study of demographic and dietary profile in patients with ulcerative colitis in upper egypt

Conditions: Diet in Ulcerative Colitis Patients

Summary: diet is known to play role in the complex etiology of uc.patient with uc tend to adapt unguided dietary habits without the guidance of a dietician or physician (dejong,m.j 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give correct dietary advice to uc patients(haskkey,n et al 2017).


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis diagnosed by clinical endoscopic and histopathological methods exclusion criteria: - patients with any co morbidity ( htn,dm,primary sclerosing cholangitis, as those patients need some restrictions of diet which may affect the prognosis of the disease)
metformin and insulin to pancreatic cancer related diabetes (type 3c)

Conditions: Pancretic Cancer; Diabete Mellitus

Summary: about 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. the consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. new-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer. pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. high glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of metformin and insulin on regulating blood glucose in type 3c diabetes.


Eligibility criteria:
inclusion criteria: * signed informed content obtained prior to treatment * age ≥ 18 years and ≤ 80 years * eastern cooperative oncology group (ecog) performance status 0-2 * patients must have histologically confirmed pancreatic adenocarcinoma * history of diabetes mellitus, or newly diagnosed diabetes mellitus according to the american diabetes association criteria * the expected survival after surgery ≥ 3 months exclusion criteria: * active second primary malignancy or history of second primary malignancy * patients who have received any form of anti-tumor therapy including surgery, chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy * inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc * pregnant or nursing women * patients who are unwilling or unable to comply with study procedures

Keywords: blood glucose metformin insulin
febuxostat for tumor lysis syndrome prevention in hematologic malignancies

Conditions: Tumor Lysis Syndrome

Summary: the purpose of this study is to determine whether febuxostat is superior to allopurinol in the prevention of tumor lysis syndrome (tls) in patients with hematological malignancies at intermediate or high risk of tls (according to cairo-bishop classification) who undergo chemotherapy

this study is designed as a randomised, double-blind, active-controlled, parallel-group study to be conducted in approximately 80 sites. approximately 340 male or female patients aged 18 or older suffering from hematologic malignancies (de novo patients or relapsing patients) at intermediate to high risk of tls and scheduled for receiving the first cycle of cytotoxic chemotherapy, regardless of the line of treatment, will be randomized in this study. eligible patients (as per screening visit) will be randomly allocated in a 1:1 ratio to febuxostat or allopurinol. the double-blind treatment period starts two days prior to the planned beginning of chemotherapy and continues for 7 to 9 consecutive days, according to investigator judgment and on the basis of the actual duration of chemotherapy regimen administered to the patient. along the study treatment, uric acid levels, creatinine levels, laboratory tls/clinical tls and adverse events represent the major clinical findings to be monitored on a daily basis. overall the study encompasses 10 to 11 planned visits at site, including screening, randomisation, on treatment and final follow up visits.

Eligibility criteria:
inclusion criteria: * patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies at intermediate or high risk of tls (according to the tls risk stratification, cairo m et al, british journal of haematology, 2010)candidate to allopurinol treatment or have no access to rasburicase * eastern cooperative oncology group (ecog) performance status of 0 to 3 * life expectancy \> 1 month exclusion criteria: * patients known to be hypersensitive to febuxostat or allopurinol or to any of the components of the formulations * patients with sua levels ≥ 10 mg/dl at randomization * patients receiving febuxostat, allopurinol or any other urate lowering therapy (e.g. rasburicase, probenecid) within 30 days prior to randomization * patients with severe renal and/or hepatic insufficiency * patients with diagnosis of ltls or ctls at randomization

Keywords: febuxostat, tumor lysis syndrome, leukemia, lymphoma
study on the diagnostic efficacy of icl selection and prediction depth model based on eye images

Conditions: Posterior Chamber Phakic Intraocular Lens; Vault; Deep Neural Network; Myopia; Anterior Chamber Angle

Summary: to evaluate the diagnostic efficacy of deep learning network model in implantable collamer lens selection and prediction in a multicenter cross-sectional study

posterior chamber intraocular lens implantation is an main choice for myopia correction. implantable collamer lens (icl) is currently the most widely used, and the official reference index is mainly based on biological parameters obtained from eye images. the parameter acquisition and selection of icl design are often controversial, forcing the doctors to synthesize multiple modal data, making the optimization of icl formula being a focus of attention in refractive surgery. this research aimed to build an image-based icl prediction algorithm to assist human physicians in decision-making and improve the accuracy, safety and predictability of icl implantation.

Eligibility criteria:
inclusion criteria: 1. aged 18-45 years ; 2. myopia, with or without astigmatism, annual diopter change ≤ 0.50 d for 2 consecutive years ; 3. anterior chamber depth ≥ 2.80 mm ; 4. corneal endothelial cell count ≥ 2000 / mm2, stable cell morphology ; 5. there were no other ocular diseases that significantly affected vision and / or systemic organic lesions that affected surgical recovery. exclusion criteria: 1. there were no other ocular diseases that significantly affected vision and / or systemic organic lesions that affected surgical recovery; 2. have a history of corneal refractive surgery or intraocular surgery ; 3. corneal endothelial cell count is low ; 4. those with systemic diseases ; 5. lactating or pregnant women.

Keywords: posterior chamber phakic intraocular lens vault deep neural network
evaluation of the cerebral oxygenation with near infrared spectrophotometry (nirs) at the hypernatremic dehydration in newborn

Conditions: HYPERNATREMIA

Summary: the aim of the study is to evaluate cerebral oxygenation with near infrared spectrophotometry (nirs) at the hypernatremic dehydration in newborns.


Eligibility criteria:
inclusion criteria: * gestation week \> 37 ve na \>150 mg/dl * dehydration exclusion criteria: * sepsis * intracranial haemorrhagia * congenital cardiac diseases

Keywords: cerebral oxygenation hypernatremi̇a newborn na values
development of an urticaria control test

Conditions: Chronic Urticaria

Summary: the aim of the project is to develop a patient reported outcome instrument to assess disease control in chronic urticaria patients (urticaria control test - uct) of age 12 and older.


Eligibility criteria:
inclusion criteria: all patients suffering from chronic forms of urticaria are eligible

Keywords: urticaria, patient reported outcome