Kornimate/medical-research-clean huggingface dataset:
treating acute pancreatitis with dabigatran, a pilot study

Conditions: Acute Pancreatitis

Summary: researchers are studying the safety and efficacy of dabigatran in the treatment of acute pancreatitis.

subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study will be recruited. subjects will be randomized to receive either dabigatran 150mg daily for three days or standard treatment. vital signs, cbc, inflammatory markers and bmp, and bleeding complications will be evaluated daily for the next 7 days of until discharge whichever is sooner.

Eligibility criteria:
inclusion criteria: * acute pancreatitis (presence at least two of three features: typical pain, amylase or lipase \>3 times unl and ap on images) * 18-75 years old * willingness to sign the informed consent * symptom onset within 72 hours exclusion criteria: * under 18 years of age or over 75 years of age * pregnancy or lactating * presence of pseudo aneurysm on ct * predicted severe acute pancreatitis * unwilling or unable to sign the informed consent * had recent surgery or sphincterotomy * active pathological bleeding * concurrent use of anti-coagulation * known serious hypersensitivity reaction to dabigatran * crci \<30ml/min or on dialysis * mechanical prosthetic valves * liver disease * cancer * on chemotherapy or immunosuppressant * persistent alt, ast, akl phos \>2 x uln * active hepatitis c, active hepatitis b, and active hepatitis a * anemia (hemoglobin \<10g/dl) * thrombocytopenia * concomitant use of p-gp inhibitors
addressing weight bias internalization to improve adolescent weight management outcomes: open trial

Conditions: Body Weight; Weight Bias; Weight Stigma; Weight

Summary: weight stigma and weight bias internalization (wbi) are common among adolescents at higher weight statuses. wbi is associated with negative physical and mental health outcomes. the current study aims to test intervention for weight stigma and wbi in conjunction with an evidence-based adolescent weight management program. adolescents (ages 13-17) will participate in a 20-week program tailored to improve wbi and weight-related health behaviors in tandem. primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention.

the overall goal of this project is to examine the impact of intervening on weight bias internalization (wbi) in conjunction with evidence-based adolescent behavioral weight management (bwm) and to assess reduction in key mechanisms of stress resulting from weight stigma (i.e., biological markers of stress and inflammation, dysregulated eating behaviors) and subsequent impact on weight loss interference resulting from wbi. an open trial with 16 adolescents (2 cohorts; 8/group) will be conducted to test initial acceptability and feasibility of the 20-week wbi+bwm intervention in an open trial. quantitative and qualitative feedback concerning acceptability and feasibility will be solicited to refine the intervention. participants are adolescents (ages 13-17 years old) at higher weight status (bmi percentile at or equal to the 95th percentile) will participate in a 20-session weekly intervention focused on weight bias internalization and healthy weight management strategies.

Eligibility criteria:
inclusion criteria: * speak english * 13-17 years of age * bmi at or above \>95th%ile for age and sex * have at least one caregiver available to provide consent and participate in sessions * agree to study participation exclusion criteria: * cognitive impairment or developmental delay impairing participation in a group setting * current participation in a weight management program or recent weight loss of 5% of body weight or more * medical condition known to impact weight or that would otherwise prevent participation
multiple myeloma is a hematologic malignancy characterized by the accumulation of malignant plasma cells in the bone marrow. despite advances in treatment, many patients experience disease relapse. bispecific antibodies offer an innovative therapeutic approach, but approximately 30%-40% of patients

Conditions: Multiple Myeloma (MM)

Summary: this prospective, non-interventional study aims to characterize the molecular and cellular mechanisms underlying the response and resistance of multiple myeloma (mm) patients to bispecific antibodies (bisab) and car-t therapies. conducted at the tel aviv sourasky medical center, the study will enroll up to 200 mm patients aged 18 and older, who are candidates for bisab, car-t, or other mm treatments. bone marrow (4-6 ml) and peripheral blood (15-20 ml) samples will be collected before treatment and at predefined intervals post-treatment, including at disease relapse/progression. the study will analyze plasma cells and the tumor microenvironment (tme) using techniques such as flow cytometry (facs), single-cell rna sequencing, genomic dna sequencing, and elisa to assess soluble bcma levels. key objectives include identifying genetic and protein signatures predictive of treatment response, evaluating specific drug binding, and analyzing interactions between plasma cells and immune cells (e.g., t cells). samples will be processed and stored at the study site, with data coded to ensure patient confidentiality. results will inform personalized treatment strategies for mm patients. the study duration includes 5 years for sample collection, 1 year for data analysis, and up to 20 years for sample storage.

the study protocol outlines a prospective, non-interventional research initiative at tel aviv sourasky medical center to investigate molecular mechanisms of response and resistance to bispecific antibodies (bisab) and car-t therapies in multiple myeloma (mm) patients. led by prof. yael cohen, the study aims to personalize treatment by analyzing bone marrow (4-6 ml) and peripheral blood (15-20 ml) samples from up to 200 mm patients aged 18+, collected pre-treatment and at specific post-treatment intervals (e.g., relapse). key methods include flow cytometry (facs) for drug binding and cell interactions, single-cell rna sequencing and genomic dna sequencing for genetic profiling, and elisa for soluble bcma levels. plasma cells and the tumor microenvironment (tme) will be characterized to identify predictive biomarkers, focusing on genes like bcma, gprc5d, and fcrl5. samples will be processed and stored at the study site for up to 20 years, with strict confidentiality ensured through coding. the study spans 5 years for sample collection, 1 year for analysis, and aims to improve mm treatment outcomes through tailored therapeutic approaches.

Eligibility criteria:
inclusion criteria: diagnosed with multiple myeloma candidate for bisab, car-t, or other myeloma therapy mentally competent and able to sign informed consent exclusion criteria: unable to undergo bone marrow sampling pregnant women minors (\<18), incapacitated, or legally incompetent
a long-term safety study of alks 9072 (also known as alks 9070)

Conditions: Schizophrenia

Summary: this study will evaluate the safety and durability of effect of alks 9072 (also known as alks 9070) during long-term treatment of subjects with stable schizophrenia.


Eligibility criteria:
inclusion criteria: (subjects who participated in alk9072-003) * completed the alk9072-003 day 85 visit * continues to require treatment with an antipsychotic medication (new subjects) * on a stable dose of oral antipsychotic medication * diagnosis of chronic schizophrenia based on diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria that is clinically stable * has been able to achieve outpatient status for more than 3 months prior to screening * body mass index (bmi) of 18.5 to 40.0 kg/m2 (inclusive) * resides in a stable living situation exclusion criteria: (subjects who participated in alk9072-003) * abnormal clinical laboratory, vital sign, or electrocardiogram (ecg) finding during participation in study alk9072-003 that was clinically relevant and related to study drug * missed more than 1 scheduled study visit during participation in study alk9072-003 * has a significant or unstable medical condition that would preclude safe completion of the current study * subject is pregnant or breastfeeding * subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures (new subjects) * history of poor or inadequate clinical response to treatment with aripiprazole * history of treatment resistance * diagnosis of current substance dependence (including alcohol) * pregnant, lactating, or breastfeeding * has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening * currently under involuntary hospitalization * current or expected incarceration additional inclusion/exclusion criteria may apply
rotational thromboelastography study in tranexamic acid and colloid infusion

Conditions: Avascular Necrosis of Femoral Head; Degenerative Arthritis of Hip

Summary: colloid solution is generally used to maintain intravascular volume. it is reported to impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation time and decreasing clot strength. the formed fibrin clot is more vulnerable for fibrinolysis in a case of using colloid. dilution of plasmin in vitro with colloid enhances fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction. tranexamic acid is an antifibrinolytics that competitively inhibits the activation of plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clot. it is used to treat or prevent excessive blood loss during surgery and in other medical conditions. gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic acid. we hypothesized that inhibition of plasmin by tranexamic acid after colloid administration can improve the colloid-induced clot strength impairment.


Eligibility criteria:
inclusion criteria: * patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip * american society of anesthesiologist i or ii exclusion criteria: * patients receiving an intraoperative transfusion * patients receiving thrombin * patients having venous thromboembolism * patients having renal or hepatic disease * patients having coagulopathy * patient having heart failure
canadian scad study

Conditions: Spontaneous Coronary Artery Dissection; SCAD; Fibromuscular Dysplasia

Summary: natural history multicenter, prospective, observational registry with 10-year follow-up

spontaneous coronary artery dissection (scad) is an under-diagnosed and poorly understood condition that frequently affects young women without conventional cardiovascular (cv) risk factors and can result in myocardial infarction (mi), cardiac arrest, and death. this condition has not been adequately studied, and there are no randomized controlled trials to guide treatment. furthermore, scad has been frequently misdiagnosed due to the current "gold-standard" coronary angiography limitations. as such, there are uncertainties with the diagnosis and management of scad patients. therefore, the investigators propose a large prospective multicenter canadian scad study to ascertain the natural history of predisposing arteriopathies and treatment strategy on short and long-term cv outcomes to design future randomized controlled trials. this is a multicenter, prospective, international, observational natural history study with a planned total enrolment of 3,000 patients with scad. the investigators plan to recruit patients from major cardiac catheterization centers across canada and several centers in the united states and internationally. the research team successfully enrolled 750 patients prospectively in the "canadian scad cohort study" from 22 sites in north america. this current study will be an extension of that study, now named the "canadian scad study." it will continue enrolment for a total of 3,000 patients internationally (from \>35 sites). detailed baseline demographics, targeted history for precipitating stressors and predisposing conditions, and investigations for predisposing conditions will be performed during the study. patients will be prospectively followed long-term for up to 10 years for cv events. the study is approved, allowing potential participants to be enrolled using an electronic consent form irrespective of their geographic location and directly communicating with the study team at ubc.

Eligibility criteria:
inclusion criteria: 1. patients admitted with acs (stemi, nstemi or unstable angina) 2. documented scad on a coronary angiogram (including diagnosis with oct or ivus) exclusion criteria: 1. patients where scad is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%

Keywords: fibromuscular displasia (fmd) myocardial infarction myocardial infarction in women non-atherosclerotic coronary artery disease (nacad) myocardial infarction with no obstructive coronary artery disease (minoca) scad spontaneous coronary artery dissection
pilot study of dexmedetomidine sublingual film for the ambulatory treatment of hyperadrenergic autonomic crisis in patients with familial dysautonomia

Conditions: Familial Dysautonomia

Summary: this is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with familial dysautonomia at home. the primary aims are to examine the feasibility of performing a clinical trial using dexmedetomidine at home to terminate autonomic crisis, and refine the interventions and assessments used to evaluate autonomic crisis termination.


Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of familial dysautonomia. * evidence of autonomic crisis, previous treatment with iv dexmedetomidine without significant side effects, and registered medical data within the year preceding the study in our database. * one or more autonomic crises during the last year. * age above 18 years. * the patient has a responsible caretaker to communicate with the medical providers. * provision of signed and dated informed consent form from the patient and responsible caregiver. * able to state willingness to comply with all study procedures and availability for the duration of the study * for males and females of reproductive potential: use condoms for contraception if sexually active. exclusion criteria: * at the consideration of the principal investigator, the caregiver cannot fully understand the protocol or communicate during the crisis with the center. * the patient during the crisis, before taking the medication, has any of the following: * a. oxygen saturation less than 92% on room air or baseline need for oxygen, change from baseline oxygen dependency. * b. respiratory rate \>20 breaths per minute. * c. supine blood pressure ≤ 90/60mmhg * d. febrile illness with temperature \>100.3 f. * e. serological signs of infection (wbc count \>10 g/dl, or crp \>10 mg/l or esr\>20, or above their steady historical baseline levels) in recent (less than one month) studies. * the patient is a female and has a positive pregnancy test. * moca score \<25 points.
allergenic effect of ambrosia in israel

Conditions: Allergy; Ambrosia; Ragweed

Summary: background: respiratory allergic reaction causes great suffering to millions of people worldwide. one of the most known allergen- is the pollen from vegetation, ragweed. genus ambrosia ambrosia belonged to the complex ragweed flowers are pollinated by the wind and the plant's male flowers produce large quantities of small grains of pollen and airborne over long distances and those causes allergic reactions. the plant blooms between june and october, creating a second wave after wave of allergy caused by spring blossoms. this plant originated in north america has invaded many areas in europe and in recent years, taking over large areas in israel, hula valley and northern acre emek hefer for a pen and layers to the south. after ragweed plants are based in particular they spread quickly and invade agricultural fields and significantly reduce the crop. high allergenic ragweed is a health hazard to humans. ragweed plant investigated many aspects of north america and europe in recent decades and extensive literature on ambrosia, but this is the first time ragweed study focuses on israel. working hypothesis and aims: goal of this study is to identify the existence and nature of the sensitivity distribution of ragweed in israel. importance of research: a. ragweed allergen testing and comparing the effect of exposure to plants on the sensitivity of the allergic israeli patients b. the inclusion of ragweed allergen in the diagnostic and therapeutic panel


Eligibility criteria:
inclusion criteria: * respiratory allergic patients exclusion criteria: * non respiratory allergic patients
evaluate the efficacy and safety of shr1459 tablets in patients with primary membranous nephropathy

Conditions: Primary Membranous Nephropathy

Summary: the purpose of this study is to evaluate the efficacy and safety of shr1459 tablets in patients with primary membranous nephropathy.

this study is a phase ii study to evaluate the efficacy and safety of shr1459 tablets in patients with primary membranous nephropathy.

Eligibility criteria:
inclusion criteria: 1. diagnosis of primary membranous nephropathy based on renal biopsy before or during screening 2. have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator) 3. pla2r-ab titer ≥20ru/ml at screening 4. 24-hour urinary protein ≥ 3.5g/d at screening 5. have egfr ≥ 60 ml/min/1.73 m2 (based on ckd-epi formula) at screening exclusion criteria: 1. any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy 2. existence of clinically significant infection within 1 month before screening, 3. severe or not well controlled other complications 4. abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators 5. alt \> 2 times uln and/or ast \> 2 times uln and/or bilirubin \>2 times uln at screening 6. subject has evidence of active, latent, or inadequately treated infection with mycobacterium tuberculosis 7. positive of hepatitis b surface antigen, hepatitis c antibody, hiv antibody or syphilis antibody at screening;
study of psychological defense mechanisms used by liver transplant patients

Conditions: Liver Diseases

Summary: organ transplantation has a special place in the medical field. it symbolizes a medicine whose limits always seem to be repelled. because transplantation is unusual, it places people in front of outstanding issues which he has to cope with his personality and history. factors involved in the psychology of patient presenting with graft are past and present psychic functioning, object relations, experience of transplantation itself and quality of social environment. before or after graft defense mechanisms can be so intense that they can make the patient unable to overcome the graft. yet as a pathological mechanism that denial was considered beneficial provided it is short. the aim of this study is to evaluate on psychopathological influence of psychological defense mechanisms used by liver transplant patients on their somatic psychological and social outcome.

the objective is to measure the influence of variations of psychological defense mechanisms. the investigators want to measure the influence of personal history of patients, causal disease pre-existing, conditions of graft's realization, structure of patient's social environment (family or institutional); and wish to identify which of those elements can be protective or vulnerability factors with a view to allow adequate support (especially for patients who had multiple poor prognostic factors) the investigators will study pre-transplant psychological defense mechanisms of the subjects using the bond defense style questionnaire and structure of personality using the scid ii personality scale. they will evaluate post-transplant patient outcomes on clinical and social developments with dsq 88 and general health questionnaire (ghq 28) to six months, twelve months and five years after transplantation. meanwhile, they will address each time you visit the data on consumption, misuse and alcohol dependence using the audit questionnaire (alcohol use disorders identification test). the hypothesis is that the defense mechanisms, their variations and personality of the patients are both vulnerability factors as protective factors in different phases of the graft. identification should allow to optimize care and improve overall health. results of this research could make it possible to determine the factors used in liaison psychiatry in the long term to ensure an adequate medical and psychiatric support to transplant patients.

Eligibility criteria:
inclusion criteria: * adult patients between 18 and 65 years old * liver disease requiring a liver transplantation * registered on the waiting transplant list in the university hospital of lille exclusion criteria: * fulminant hepatitis * mental incapacity

Keywords: liver transplant patients hepatic transplantation
vildagliptin in new onset diabetes after transplantation

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine whether monotherapy with vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed new onset diabetes after transplantation (nodat).

development of new onset diabetes mellitus after transplantation (nodat) also called post-transplant diabetes mellitus (ptdm) increases the risk of cardiovascular disease and poor short term clinical outcomes. there is currently no doubt about the fact that nodat is a condition that needs medical attention and treatment. although most centers follow treatment regimens for dm type ii prospective data about their effectiveness in nodat are lacking. little information exists in kidney transplantation regarding conventional glucose-lowering therapies, either oral hypoglycemic agents or traditional insulin regimens. the aim of this study was to evaluate whether a monotherapy with vildagliptin improve glycemic control and to assess the safety in kidney transplanted patients with newly diagnosed nodat.

Eligibility criteria:
inclusion criteria: • newly diagnosed nodat defined by pathologic ogtt (2h, 75mg glucose): glucose ≥ 200mg/dl * renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of triple therapy with tacrolimus or cyclosporine a, mycophenolate mofetil or azathioprine, and prednisone. * stable graft function for more than 6 months post transplant. * informed consent of the patient exclusion criteria: * patients with prior history of type 1 or type 2 diabetes * body mass index (bmi) \> 40 * pregnancy * severe renal impairment (gfr \< 30 ml/min./1.73 m2) * severe liver impairment * severe blood glucose elevation with the need for therapy with insulin or hba1c \>8.5%

Keywords: diabetes kidney transplantation new onset diabetes mellitus after transplantation