Kornimate/medical-research-clean huggingface dataset:
monitoring subjects with fluid-management issues in the home environment

Conditions: Heart Failure; Hypertension

Summary: this study is designed to validate ease-of-use for the cova monitoring system, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.

the study has the following objectives: objective 1: investigate ease-of-use associated with the cova monitoring system: determine if subjects could use the test device on a daily basis, and if the components of this system (sensor, gateway, web-based system) were indeed operational objective 2: determine if daily application of the sensor's adhesive electrodes resulted in any skin irritation objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device

Eligibility criteria:
inclusion criteria: * subject is between 21 (twenty-one) and 90 (ninety) years of age at screening. * subject will have a current prescription for a diuretic medication. * subject and/or legally authorized person/representative is willing to undergo the informed consent process prior to enrollment in the study. * subject is a candidate for this study based on the pi's opinion and knowledge of the subject's condition. exclusion criteria: * subject is participating in another clinical study that may affect the results of either study. * subject is unable or not willing to wear electrode patches as required. * subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches. * subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. * subject is considered by the pi to be medically unsuitable for study participation.

Keywords: heart failure impedance fluids
a study of ramucirumab (ly3009806) plus medi4736 in participants with advanced gastrointestinal or thoracic malignancies

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Non-Small Cell Lung Cancer; Hepatocellular Carcinoma

Summary: the main purpose of this study is to evaluate the safety of ramucirumab plus medi4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (gej) adenocarcinoma, non-small cell lung cancer (nsclc), or hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * measurable metastatic disease or locally advanced and unresectable disease * has histopathologically confirmed gastric or gej adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy * has histopathologically confirmed nonsquamous or squamous nsclc with documented disease progression after 1-3 prior lines of systemic therapy * has histopathologically or cytologically confirmed hcc, child-pugh class a, with documented disease progression during or after discontinuation of sorafenib therapy, or intolerance of sorafenib therapy, and an α-fetoprotein (afp) ≥ 1.5x upper limit of normal * availability of tumor tissue for biomarker analysis * has an eastern cooperative oncology group performance status of 0 or 1 * has adequate organ function exclusion criteria: * has known brain metastases * has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years * history of allogeneic organ transplant * has active or prior documented autoimmune disease within the past 24 months * has human immunodeficiency virus (hiv) infection or acquired immunodeficiency syndrome (aids)-related illness, or a history of immunodeficiency * has active hepatitis b or hepatitis c infection, or co-infection with both hepatitis b and c virus * for gastric/gej and nsclc participants, has chronic hepatitis b or hepatitis c infection. (for hcc participants, those with chronic hepatitis b virus \[hbv\] infection with a negative hbv deoxyribonucleic acid \[dna\] test and who are on antiviral therapy, and those with chronic hepatitis c virus \[hcv\] infection are eligible) * has a history of interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis, non-infections pneumonitis, radiation-induced or drug-induced pneumonitis * has received any previous systemic therapy targeting programmed death (pd) 1 or pd-ligand 1/2 signaling pathways, and other immune checkpoint inhibitors * have received previous systemic therapy with ramucirumab

Keywords: metastatic advanced immuno-oncology vascular endothelial growth factor (vegf) angiogenesis pd-1 pd-l1
validation of a test for fetal malformations

Conditions: Fetal Anomaly

Summary: the investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose. the study aims at determining the performance parameters (specificity, sensibility, positive predictive value (ppn), negative predictive value (npv), etc.) of the test and its applicability. to do this, the investigators will use the serum samples of the patients enrolled in new zealand in the scope study (www.scopestudy.net), an international study conducted between years 2004-2008.

the test has been developed in a case-control study. in this clinical trial the investigators will test it in a large cohort that is likely to resemble a real population. the purpose of validation is to see if the test is able to recognize the few malformed fetuses in the entire population and especially its specificity in real conditions. in addition, the investigators will check whether particular maternal conditions (such as preeclampsia, gestational diabetes, etc.) or fetal conditions (small for gestational age, large for gestational age, etc.) affect the test results.

Eligibility criteria:
inclusion criteria were the ones designed by scope study: - nulliparous women, with a singleton pregnancy, between 14wks, 0 days and 16wks, 6 days gestation who give informed consent to participate in scope. exclusion criteria were the ones designed by scope study: * unsure of last menstrual period (lmp) * unwilling to have ultrasound scan at ≤20 weeks * ≥3 miscarriages * ≥3 terminations * essential hypertension treated pre-pregnancy * moderate-severe hypertension at booking ≥160/100 mmhg * diabetes * renal disease * systemic lupus erythematosus * anti-phospholipid syndrome * sickle cell disease * hiv positive * major uterine anomaly * cervical suture * knife cone biopsy * ruptured membranes now * long term steroids * treatment low-dose aspirin * treatment calcium (\>1g/24h) * treatment eicosapentanoic acid (fish oil) * treatment vitamin c ≥1000 mg \& vit e ≥400 iu * treatment heparin/low molecular weight heparin
late sequelae of bronchopulmonary dysplasia

Conditions: Lung Diseases; Bronchopulmonary Dysplasia

Summary: to measure the cardiopulmonary function in individuals who developed bronchopulmonary dysplasia (bpd) at stanford university medical center from 1964-1973 and to determine the factors associated with the presence of cardiopulmonary function abnormalities in these adolescents and young adults.

background: eleven to 22 percent of prematurely born human infants with respiratory distress syndrome (rds) treated with artificial ventilation and supplemental oxygen therapy, develop a severe chronic lung disease called bronchopulmonary dysplasia. while many children who had bpd are asymptomatic by three years of age, some can have respiratory symptoms and abnormal pulmonary function tests at nine years of age. the hypothesis tested in this study is that abnormalities of pulmonary function seen in infants with bpd can persist into adolescence, even in asymptomatic children and young adults. design narrative: a detailed interval pulmonary history was taken. pulmonary abnormalities were determined by pulmonary angiography and lateral chest x-ray and pulmonary function tests for small airway obstruction, reversible bronchial hyperreactivity, distribution of ventilation, air trapping and hyperinflation, residual interstitial disease or edema, vascular bed loss, and gas exchange. right and left ventricular hypertrophy were evaluated by electrocardiogram. elevated right ventricular pressure was estimated by echocardiography with doppler ultrasound. the atopic status of the children was determined. other abnormalities, including growth retardation, developmental delay, hearing loss, retrolental fibroplasia, and neurologic disability seen in bpd were assessed by history and physical examination.

Eligibility criteria:
no eligibility criteria
coagulation factors alterations in patients undergoing complex thoraco-abdominal aortic aneurysm repair

Conditions: Thoraco-abdominal Aortic Aneurysm Repair; Coagulation Factors Alterations; Platelet Activation

Summary: this study will evaluate the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.

endovascular aneurysm repair of abdominal aorta activates a significant inflammation reaction and has an impact on coagulation. platelet activation seems to have a major role in this prothrombotic and hypercoagulable state. in complex thoraco-abdominal aortic aneurysm repair the implants are more complexed and the duration of operation longer. the main hypothesis is that all the above have a greater impact on platelet activation and coagulation alterations. the aim of this study is the evaluation of the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in university hospital of larissa, after informed consent will be included. exclusion criteria: * refuse to participate * prior surgery within 3 months * asa ps \> 3 * known medical history of thrombophilia or functional platelet dysfunction
results from a french temporary utilization authorization of first-line acute myeloid leukemia (aml) patients ineligible for intensive chemotherapy (ic), treated with venetoclax azacitidine

Conditions: AML, Adult

Summary: following the results of the phase 1b and the phase 3 studies, venetoclax/azacitidine (ven/aza) was available in france for newly diagnosed aml patients ineligible-ic patients through the early access program the so-called atu program. venetoclax (ven) has been available in france through the atu since feb 2021 and through the current post-atu schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. between february 15, 2021, and june 30, 2021, 285 requests for atu were made to the pharmaceutical company (abbvie) and led to the initiation of treatment of more than 230 patients. at the end of atu period, all these 230 atu patients continued to be treated by ven/aza as part of the current post-atu period. healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. early access to treatment in france is close to real-life setting condition.


Eligibility criteria:
inclusion criteria: * adult patients * treatment with ven-aza for newly diagnosed aml and ineligible to intensive chemotherapy * treatment in the named-patients program (atu) exclusion criteria: * treatment with ven-aza for previously treated aml * prior treatment for preexisting hematological malignancies other that aml, including aza is not an exclusion criteria * hydroxycarbamide given for aml is not an exclusion criteria * aza started before ven for aml is not an exclusion criteria * opposition to data collection
efficacy and safety of famciclovir 1-day treatment compared to 3-day treatment with valacyclovir in adults with recurrent genital herpes

Conditions: Genital Herpes

Summary: this study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).


Eligibility criteria:
inclusion criteria: * at least 18 years old * history of at least 4 recurrences of genital herpes in the preceding 12 months * lesions located on the external genitalia or anogenital region * willing to discontinue suppressive treatment * documented positive herpes simplex virus (hsv) * general good health, and history of normal renal function exclusion criteria: * women of childbearing potential not using approved form of contraceptive * pregnant or nursing women * history of hypersensitivity to famciclovir, valacyclovir, or acyclovir * known to be immunosuppressed * known to have renal dysfunction * receiving anti-herpes therapy * known to have other genital tract disorders * known to have condition which could interfere with drug absorption additional protocol-defined inclusion/exclusion criteria may apply.

Keywords: herpes simplex genital herpes famciclovir valacyclovir recurrent genital herpes
needs assessment of long-term care for psychiatric patients

Conditions: Mental Disorders

Summary: the quantity and quality of inpatient services for persons with psychiatric illness have been enhanced in the last two decades. following the enforcement of nationwide health insurance and the physically and mentally disabled citizens protection act, the financial pressure of medical care for psychiatric patients is relieved, and actions related to the protection of patients' human rights have been taken. nonetheless, problems related to psychiatric illness are not limited to symptoms. patients' daily functions are affected and it causes continuous pressure on the family. currently, psychiatric care places more emphasis on inpatient services. once the patient is discharged from the hospital, related psychiatric services are not widely available, which leads to symptom exacerbation, repeated hospital admissions, increased burden to the family, etc. a provision of continuous long-term care that meets the various needs of psychiatric patients is a critical issue in current psychiatric care. based on a three-phase needs assessment model, the purpose of the study is to evaluate the needs of long-term care for psychiatric patients. the first phase will identify the current status of needs from the perspectives of patients and the family, psychiatric professionals, and the system. the second phase will identify the goals of long-term care for psychiatric patients. the goals will be identified by a nominal group, composed of experts related to the field of psychiatric long-term care. the third phase will determine the objectives of long-term care services for psychiatric patients. that is to determine the proper contents of long-term care services for the patients based on the goals identified in the previous phase. the three-phase needs assessment will be carried out in a two-year period. the results of the study will provide important information to the future planning of long-term care for psychiatric patients.

first, the participants were informed about how to fill in the self-report survey questionnaire. then the participants began to complete the questionnaire. after finishing it, the participants gave the questionnaire back to the examiner.

Eligibility criteria:
inclusion criteria: * psychiatric patient * must be able to read chinese * caregivers of psychiatric patients

Keywords: psychiatrists
effect of epbd in ercp on the prognosis of patients with choledocholithiasis complicated with duodenal papillary diverticula

Conditions: Periampullary Diverticula

Summary: the investigators hypothesized that nipple balloon dilatation could make ercp more successful and reduce postoperative complications and mortality. so the investigators design this experiment on this assumption.

the incidence of periampullary diverticula in patients with choledocholithiasis is very high at 47.1%. a large number of literatures refered that duodenal papillary diverticulum is a high risk factor for postoperative complications and recurrence of choledocholithiasis . till now, there have been no randomized controlled trials to explore the effect of nipple balloon dilatation (eplbd) on the treatment and prognosis of patients with choledocholithiasis complicated with periampullary diverticula (found during ercp).

Eligibility criteria:
inclusion criteria: 1. patients with choledocholithiasis. 2. during ercp, the patient was diagnosed as choledocholithiasis combined with duodenal papillary diverticulum. 3. ages 16 to 75. 4. choledocholithiasis no larger than 1.5 cm exclusion criteria: 1. patients with duodenal papillary tumor. 2. pregnant. 3. patients with gastrointestinal duct obstruction endoscopy who cannot be operated and who have endoscopic contraindications. 4. patients with duodenoscopy contraindications. 5. patients with severe pancreatitis and other serious diseases.

Keywords: epbd
study to evaluate the safety, pharmacokinetics, and pharmacodynamics of bms-686117 in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of bms-686117


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve) * fasting plasma glucose: 126 - 240 mg/dl * hemoglobin a1c: 6 - 10% * estimated crcl ≥ 60 ml/min * alt ≤ 1.5 x uln and total bilirubin ≤ 2 x uln * stable and well controlled hypertension and/or dyslipidemia * concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks exclusion criteria: * women of childbearing potential * symptomatic diabetes with polyuria and/or polydipsia * history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome * history of renal disease including diabetic nephropathy
comparison of remineralisation efficacy of mi paste plus® and remin pro® for white spot lesions in primary teeth

Conditions: White Spot Lesion

Summary: the present study aimed to compare the remineralisation capacity of white spot enamel lesions between two commercially available tooth pastes (remin pro and mi paste plus), applied at home twice a day on the anterior upper primary teeth by the patient and parents.

objective: to evaluate and compare the clinical efficacy of remin pro® and mi paste plus® for the remineralisation of white spot lesions (wsl) on the enamel of primary teeth. methods: the selected design for this study was a randomised double-blind clinical trial based on consort guidelines. patients with at least one upper anterior primary tooth with a wsl on the enamel surface, with units of fluorescence (uf) ranged from 11-20 (evaluated with diagnodent) were included in the study. patients were randomly assigned to receive either the twice-daily at-home topical application of remin pro® or mi paste plus® (both as experimental pastes) or colgate total® (as control paste). the degree of remineralisation was quantified by the change in the number of uf from the baseline evaluation and at days 10 and 21. the difference between groups was statistically evaluated using ancova and anova techniques.

Eligibility criteria:
inclusion criteria: * young paediatric patients with at least one upper anterior primary tooth exhibiting one or several wsl on the smooth enamel surface. * attending the paediatric dentistry postgraduate program's clinic * enamel lesions with units of fluorescence (uf) ranging from 11-20 as determined by diagnodent * signed informed consent exclusion criteria: * history of hypersensitivity to any of the compounds of the pastes * enamel hypoplasia * compromising systemic diseases

Keywords: primary teeth enamel remineralisation
comparative bioavailability study of synerx and verelan pm 300 mg verapamil hcl er capsules under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to determine the bioequivalency of synerx pharma verapamil extended release capsules.

the purpose of this study is to determine if synerx pharma verapamil hcl er capsules are bioequivalent to verelan pm capsules in healthy volunteers under food effect conditions.

Eligibility criteria:
inclusion criteria: healthy adult male or female volunteers, 18-55 years of age. subjects will be continuous non-smokers for at least 3 months prior to the first dose. weighing at least 60 kg for males and 52 kg for females and within the normal range according to accepted normal values of the body mass index chart (18.00 -28.00 kg/m2). medically healthy subjects with clinically normal laboratory profiles, vital signs and ecgs. absence of any exclusion criteria during history, physical, or laboratory evaluation. confirmation that all female subjects are not pregnant by a certified, validated pregnancy test. females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be an acceptable birth control method postmenopausal women with amenorrhea for at least 2 years will be eligible. give voluntary written informed consent to participate in the study. exclusion criteria: history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. in addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to verapamil, other calcium ion influx inhibitors or any other component of the product formulations; idiosyncratic reaction to acetaminophen; malabsorption within the past year; recurrent headaches or migraines. presence of a medical condition requiring regular treatment with prescription drugs. tests giving reasonable suspicion of a disease that would contraindicate taking an investigational drug or that might affect the interpretation of the results of the study. female subjects who are pregnant or lactating. subjects who tested positive at screening for hiv, hbsag or hcv. positive test results for drugs of abuse or alcohol. subjects whose sitting blood pressure is less than 110/60 mmhg at screening or 100/55 mmhg prior to dosing in each period. subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each period. subjects whose pr interval is \>190 msec at screening and \>200 msec prior to dosing in each period. subjects whose qtc interval is \>450 msec at screening and prior to dosing in each period. subjects who have used any drugs or substances known to be strong inducers and/or inhibitors of cyp enzymes within 28 days prior to the first dose. subjects who have been on a special diet during the 28 days prior to the first dose and throughout the study. subjects who donated 50 to 499 ml of blood within 30 days and more than 499 ml within 56 days prior to the first dose.