Kornimate/medical-research-clean huggingface dataset:
nutritional status of patients victims of haemorragic accidents with antivitamins k

Conditions: Hemorrhagic Accident; Iatrogeny; Denutrition

Summary: bleeding under vitamin k antagonists are a major iatrogenic causes of hospitalization, subject to a fatal outcome in more than one third of cases, mortality is particularly high in cases of serious bleeding, including intracerebral hemorrhage. if the inr measured in these patients are often away from the higher value of the target range, a significant proportion of bleeding were observed for inr between 2 and 3. the study captures the components of the nutritional status of patients on oral anticoagulants, including any micronutrient deficiencies, to determine whether nutritional status is an independent risk factor for bleeding

be included in this study patients under anti-vitamin k supported or followed the emergency department adults. the inclusion visit will be conducted in the emergency department adults clermont-ferrand by an emergency physician or investigator or co-investigator. the protocol will be explained to patients in detail, the information document and consent will be issued for playback, then they will be asked to sign the consent form and participation agreement. case-control study: patients under oral anticoagulant with severe hemorrhagic accident compared with patients without hemorrhagic accident. cases will be matched to controls based on age, sex, and the value of the inr. patients will be divided into two groups: * group 1: cases patient under anti-vitamin k with a serious bleeding event that required treatment in the emergency adults. is considered serious accident requiring the use of a reversion by ppsb (kaskadil ®). * group 2: contols patient under anti-vitamin k with no haemorrhagic manifestations admitted for another reason to emergency adults each case will be paired with two controls

Eligibility criteria:
inclusion criteria: * patients, male or female, aged over 18, under oral anticoagulant therapy with antivitamins k. * inr greater than 1.5, in the therapeutic range or overdose * patient have read, understood and signed the consent form or inclusion emergency consent of the person with confidence * case-control study: patients under oral anticoagulant with severe hemorrhagic accident compared with patients without hemorrhagic accident. cases will be matched to controls based on age, sex, and the value of inr : case: patients victims of serious hemorrhagic accident on vkas, supported emergency adults. will be considered severe hemorrhagic stroke, accidents requiring the use of a reversion by ppsb (kaskadil ®) control : patients on vkas supported the emergency adults for a reason other than bleeding. exclusion criteria: * underage patients * patients who have not read or understood nor signed the consent form or refusal of the reference person. * pregnant women * patients with a pacemaker and / or implantable defibrillator * patients with mechanical valve

Keywords: antivitamin k bleeding haemorrhage nutritional status impedancemetry
ovarian innervation study in patients with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a complex endocrine disorder characterized by hyperandrogenism, insulin resistance, and ovulatory dysfunction. one of the diagnostic criteria for pcos is the presence of polycystic ovaries, which are enlarged ovaries with multiple follicles on ultrasound. however, the mechanisms that lead to the development of polycystic ovaries in pcos are not completely understood. one potential area of investigation is the role of ovarian innervation in the pathophysiology of pcos. therefore, the aim of this study is to evaluate the ovarian innervation in pcos patients through ovarian biopsy sampling.

this is a cross-sectional study that will involve the recruitment of patients diagnosed with pcos. the study will be conducted at a tertiary care center koco gliozheni maternity, faculty of medicine of tirana, department of obstetrics and gynecology with expertise in gynecology and endocrinology and will then be examined with the aid of the department of biology and physiology of the university of perugia. the study protocol will be approved by the institutional ethics committee, and written informed consent will be obtained from all participants.

Eligibility criteria:
inclusion criteria: * diagnosis of pcos based on the rotterdam criteria, * no use of hormonal contraception or medications for at least 3 months prior to the study, * no history of ovarian cancer. exclusion criteria: * history of pelvic inflammatory disease or other pelvic infections, * use of medications that may affect ovarian function or innervation, such as antipsychotics or antidepressants * presence of ovarian cysts \> 5 cm on ultrasound
study evaluating rfix; benefix® in hemophilia b

Conditions: Hemophilia B

Summary: the primary objective of this clinical research study is to assess the safety and efficacy of rfix for a minimum of 6 months in previously treated patients (ptps) with hemophilia b (fix:c ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).


Eligibility criteria:
inclusion criteria: * hemophilia b (fix:c less than 2%) * previous treatment of at least 150 exposure days using any fix product * 12 years of age and older exclusion criteria: * the patient has a currently detectable factor ix inhibitor or a history of inhibitors. (a family history of inhibitors will not exclude the patient) * known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins * patient has a genetic coagulation disorder other than hemophilia b
study to collect samples for mist analysis of zibotentan and bioavailability of zibotentan and dapagliflozin in heatlhy participants

Conditions: Chronic Kidney Disease

Summary: the study will have 2 independent parts: part 1 of the study is intended to collect samples for metabolites in safety testing (mist) analysis after administration of multiple doses of zibotentan. part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapagliflozin after dosing with two different fixed-dose combination (fdc) formulations and dosing with separate formulations of zibotentan and dapagliflozin.

part 1 will be an open-label, non-randomised, single treatment period. a single treatment period during which participants will be resident at the study centre from 2 days before dosing (day -2) until the morning of day 6. part 2 will be an open-label, randomised, 3-period, 3-treatment, cross-over single dose study. participants will be randomised to one of 3 treatment sequences and will receive 3 single-dose study interventions. participants will be resident at the study centre from 2 days before dosing (day -2) until day 3 of the last treatment sequence. participants who were enrolled in part 1 may not be enrolled in part 2.

Eligibility criteria:
inclusion criteria: for inclusion in the study participants should fulfil the following criteria: 1. participants with suitable veins for cannulation or repeated venipuncture. 2. females must have a negative pregnancy test at the screening visit and within 24 hours prior to dosing, must not be lactating and must be of non- childbearing potential 3. male participant must adhere to the contraception methods. 4. have a bmi between 18 and 29.9 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. 5. provision of signed and dated, written informed consent prior to any study specific procedures. exclusion criteria: participants will not enter the study if any of the following exclusion criteria are fulfilled: 1. history or presence of gastrointestinal, hepatic or renal disease or any important disease or disorder. 2. any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention. 3. any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis. 4. any positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody, and human immunodeficiency virus antibody. 5. abnormal vital signs. 6 history of drug abuse or alcohol abuse. 7. history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. 8. participants who are vegans or have medical dietary restrictions. 9. participants tested positive for covid-19 at the time of randomisation or have been previously hospitalised with covid-19 infection.
use of infrared spectroscopy in septic arthritis diagnosis

Conditions: Joint Effusion

Summary: the main objective of this study is to assess the ability of fiber-optic evanescent wave spectroscopy (fews) to discriminate synovial fluids samples of septic arthritis patients from other causes of joint effusion by analyzing ex vivo joint fluid samples collected during routine clinical care.


Eligibility criteria:
inclusion criteria: * patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study * patients over 18 year old, * patients who received information about the protocol and have not expressed opposition to participate. exclusion criteria: * patients opposing the study, * patients aged below 18 year old * protected major (safeguard justice , trusteeship and guardianship) and persons deprived of liberty
tx for child sexual behavior problems

Conditions: Sexual Behavior

Summary: a significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. this project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.


Eligibility criteria:
inclusion criteria: * a caregiver is willing to participate in treatment * a clinically significant t-score on the child sexual behavior inventory * child is between the ages of 5 and 12, inclusive exclusion criteria: * child and/or caregiver iq below 70 * active child and/or caregiver psychosis or suicidal/homicidal ideation * active substance use problems of the caregiver
the effect of a interdisciplinary alcohol cessation intervention

Conditions: Alcohol Use Disorders

Summary: the effect of alcohol interventions seems to be related to the intensity of the interventions. in this study the investigators will assess the effect of a interdisciplinary "booster session" in primary care, given to patients who were admitted to hospitals with alcohol related conditions, and who were given brief intervention before discharge. the booster session is based on a motivational interview.

the study is a randomized clinical trial, and aims to recruit 60 x 2 patients. patients admitted to stavanger university hospital with an alcohol contributed condition, and who has been given a brief alcohol intervention may be recruited. candidates for secondary healthcare related to alcohol misuse will be excluded. the interdisciplinary "booster" session will be given two weeks after discharge, and will be given in the facility of the primary care physician, facilitated by both the physician and an liaison alcohol nurse from stavanger university hospital. the intervention is based on motivational interview technique. the primary outcome will be assessed using the alcohol use disorder identification test-c, six months after discharge. the outcome assessor will be blinded for the intervention. all outcomes will be collected by telephone interview. the study aims to start recruiting candidates in october-november 2010, and will stoop recruiting in december 2012 at the latest. the study was approved by the national ethical comite in august 2011. the results of the study wil be published in international referee based journals.

Eligibility criteria:
inclusion criteria: * admission with an alcohol related disorder exclusion criteria: * lack of ability to give informed consent

Keywords: harmful use hazardous use dependence
a study to evaluate of pm8002 combined with pm1009 in patients with first-line hcc

Conditions: HCC; Liver Cancer

Summary: this study to evaluate the preliminary efficacy, safety and pharmacokinetics of pm8002 combined with pm1009 in patients with first-line hepatocellular carcinoma.

the study is divided into two parts. the first part is a phase ib, single-arm study, which is planned to enroll 3-28 subjects. the second part is a phase ii randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.

Eligibility criteria:
inclusion criteria: 1. voluntary participation in clinical studies; 2. male or female, aged ≥ 18 years; 3. pathologically or clinically confirmed (according to aasld), unresectable locally advanced and/or metastatic hcc; 4. child-pugh liver function score ≤7； 5. no prior systemic therapy for locally advanced or metastatic and/or unresectable hcc； 6. at least 1 measurable lesion ； 7. adequate organ function； 8. ecog score of 0 to 1； 9. life expectancy ≥ 12 weeks; exclusion criteria: 1. pathologically confirmed fibrolamellar hcc, sarcomatoid hcc, cholangiocarcinoma and other components； 2. history of serious allergic diseases； 3. the toxicity of previous anti-tumor therapy has not been alleviated； 4. history of severe cardiovascular diseases within 6 months; 5. current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 6. history of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 7. history of alcohol abuse, psychotropic substance abuse or drug abuse; 8. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome; 9. pregnant or lactating women; 10. other conditions considered unsuitable for this study by the investigator.

Keywords: first line hcc pm1009 pm8002
retrospective assessment of adverse events-related healthcare resource utilization and costs of immune checkpoint inhibitor and targeted therapy for adjuvant treatment of melanoma

Conditions: Melanoma

Summary: this was a retrospective cohort study using the pharmetrics database. the analysis was conducted using the most recent 5 years of data from the database, january 1, 2015, to october 30, 2020. included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy \[io\], or targeted therapy \[tt\] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.


Eligibility criteria:
inclusion criteria * patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period. * patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the national comprehensive cancer network (nccn) guidelines version 2.2020. the first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy. * the first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma. * patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. the index date was the date of first prescription of study drug, io (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib. * at least 18 years of age at the time of adjuvant treatment initiation. * patients with at least 6 months of continuous enrollment prior to the index date. * patients with at least 6 months of continuous enrollment after the index date. * if necessary, there were additional criteria of absence of secondary malignancy (including metastatic site). exclusion criteria * patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period. * patients with chemotherapy or interferon alpha before index date. * patients with pregnancy any time during the study period.
pilot study of haploidentical natural killer cell infusions for poor prognosis non-aml hematologic malignancies

Conditions: Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Juvenile Myelomonocytic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma

Summary: the prognosis of pediatric patients with hematologic malignancies whose disease is primarily refractory or those who experience a chemotherapy resistant bone marrow relapse is extremely poor. when new agents or chemotherapeutic regimens are unable to induce remission in this patient population, hematopoietic stem cell transplant (hsct) is also a poor alternative. thus, in this very high risk group, additional attempts at remission induction with various combinations of chemotherapy alone will unlikely improve outcome and will contribute to overall toxicity. alternative therapies are needed in these patients with chemotherapy resistant disease. immunotherapy with natural killer (nk) cell infusion has the potential to decrease toxicity and induce hematologic remission. nk cells can kill target cells, including leukemia cells, without prior exposure to those cells. in patients undergoing allogeneic hsct, several studies have demonstrated the powerful effect of nk cells against leukemia. furthermore, nk cell infusions in patients with primary refractory or multiple-relapsed leukemia have been shown to be well tolerated and void of graft-versus-host disease effects. in this high risk group, complete leukemic remission has been observed in several of these patients after nk cell infusion. with the current technology available at st. jude, we have developed a procedure to purify nk cells from adult donors. this protocol will assess the safety of chemotherapy and il-2 administration to facilitate transient nk-cell engraftment in research participants who have chemotherapy refractory hematologic malignancies including acute lymphoblastic leukemia, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, or non-hodgkin's lymphoma. in this same cohort, we will also intend to explore the efficacy of nk cells infused in those participants who have chemotherapy refractory disease.

this study will evaluate the persistence, phenotype and function of donor nk cells as well as exploring the efficacy of the infusion in research participants with chemotherapy refractory hematologic malignancies.

Eligibility criteria:
inclusion criteria: * at least two weeks since receipt of last biological therapy, chemotherapy, or radiation therapy. * has a suitable adult family member donor available for nk cell donation. * no current pleural or pericardial effusion. * hiv negative * adequate clinical standing as evidenced by being within multiple renal, hepatic, pulmonary, and neurological required testing parameters. exclusion criteria: * pregnant or lactating

Keywords: nk cell infusion immunotherapy hematologic malignancy miltenyi biotec device haploidentical donor
predictors of cardiovascular outcomes in individuals with different obesity phenotypes

Conditions: Obesity and Obesity-related Medical Conditions

Summary: the aim of this observational study is to identify and evaluate adverse cardiovascular outcomes in metabolically healthy obese individuals in a cohort of 25 to 64 years of age, both men and women. the main questions it aims to answer are: what are the markers of adverse cardiovascular outcomes in metabolically healthy obese individuals?

the study is planned to include 1,600 people of the ryazan city population aged 25-64 years, selected using a three-stage cluster sampling method. participation in the study is voluntary, as evidenced by the signing of informed consent. among them, it is planned to select obese people and conduct phenotyping according to the criteria of the national cholesterol education program adult treatment panel iii (ncep atp iii). it is planned to conduct a survey at all stages of the study. the questionnaire will include the following modules: social status, dietary habits (dietary habits), physical activity, smoking, alcohol consumption, family history, personal history, objective data, laboratory data, data on medical care and disability, quality of life questionnaire. measurement of blood pressure, heart rate, height, weight, waist circumference. laboratory tests: total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glucose, fibrinogen, uric acid, c-reactive protein (by quantitative method). next, it is planned to monitor the examined individuals and collect endpoints for 36 months. the endpoints are: death from any cause, stroke of any etiology, fatal and non-fatal myocardial infarction and coronary artery revascularization, carotid artery surgery. next, it is planned to establish a relationship between the studied indicators and the frequency of adverse outcomes in individuals with different obesity phenotypes.

Eligibility criteria:
inc1. body mass index \>=30 kg/m2 . 2. less than three of the five criteria according to the national cholesterol education program's adult treatment panel iii, ncep/atp iii): * systolic blood pressure \>130 and/or diastolic blood pressure \>85 mmhg, * triglycerides \>1.7 mmol/l, * high density lipoproteins \< 1.03 (men), \< 1.29 (women); * fasting plasma glucose \>=5.6 mmol/l, * waist circumference \>102 cm (men), \>88 cm (women)lusion criteria: exclusion criteria: the presence of * signs of chronic heart failure, * coronary heart disease, * infiltrative or hypertrophic obstructive cardiomyopathy or constrictive pericarditis, * heart disease or valve disease, which can be expected to lead to surgery during the study, * cancer.