Kornimate/medical-research-clean huggingface dataset:
exercise and prevention of syncope: expose

Conditions: Syncope

Summary: the purpose of this study is to determine whether eight weeks of exercise performed at an intensity of approximately 65% vo2max will improve symptoms associated with fainting (vasovagal syncope).

background: vasovagal syncope affects 20-30% of the population, and for those who faint recurrently it causes a significant reduction in the quality of life. although significant progress has been made in the past 15 years in our understanding of its diagnosis and prognosis, our therapeutic attempts often end in failure. many patients who have been diagnosed with vasovagal syncope have a reduced orthostatic tolerance. improved orthostatic tolerance has been achieved through exercise in a number of studies on healthy individuals. however, its efficacy as a means of treatment for those with vasovagal syncope has not been thoroughly explored. comparison: subjects will be randomized to one of two groups: an exercise group or control. the exercise group will be asked to train at a target of approximately 65% of their maximum exercise capacity (vo2max) for 8 weeks/3 times per week. the control group will be asked to perform a series of neck rotation exercises. orthostatic tolerance will be examined in both groups pre and post intervention.

Eligibility criteria:
inclusion criteria: a diagnosis of vasovagal syncope as the cause of loss of consciousness, \>1 lifetime syncope spell preceding enrolment, \>-3 points on the s3 score for structurally normal hearts, \>18 yrs of age with informed consent - exclusion criteria: subjects with a negative physical activity readiness questionnaire (parq), those who are unable to provide informed consent, those with a vo2max \>55ml/kg/min, those who exercise more than 30 minutes per day, 3 times per week, other causes of syncope, individuals with valvular, coronary, myocardial, or conductive abnormality, significant arrhythmia, hypertrophic cardiomyopathy, permanent pacemaker, seizure disorder, heart failure, major chronic cardiovascular disease, or renal dysfunction. -

Keywords: exercise total peripheral resistance venoconstriction blood volume expansion orthostatic tolerance
biomarkers of antidepressant resistance

Conditions: Depression

Summary: according to the who, major depressive disorders have become the second worldwide cause of disability. treatment, long-term medication, leads to frequent resistance (up to 40%). establishing a cerebral molecular signature of depression is not feasible in humans (need for cerebral samples). the alternative is to use peripheral biological samples (blood, urine, saliva). metabolomic is the integrated and quantitative study of all the metabolites of a biological system. this aims to define the metabolic status of an organism for a particular condition. metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.) and are detected by: * liquid or gas chromatography coupled to mass spectrometry (lc-ms, gc-ms), * proton nuclear magnetic resonance (1 h-nmr). the biomarkers resulting from these studies have become important diagnostic criteria, measured objectively and evaluated as indicators of a normal or pathological state, or even predictors of treatment efficacy. this approach allows the discovery of biomarkers that best describe the status of a disease for better understanding and are usable in a context of individualized medicine, with effects on clinical practice and management.


Eligibility criteria:
inclusion criteria: * between 18-60 years-old * major depressive disorder, confirmed by mini international neuropsychiatric interview (mini) * no bipolar disorder or schizophrenia, confirmed by mini * no neurological dementia disease * able to perform olfactive tests, i.e. no anosmia and/or allergy to odors * score madrs (montgomery asbergdepression rating scale) \>20 * no antidepressant treatment during 14 days before inclusion * informed written consent * affiliation to a social security system exclusion criteria: * patient who don't want any antidepressant treatment for this depressive episode * legal incapacity and/or any circumstances making the person unable to understand the trial features, purposes or consequences * participating to drug clinical study or in exclusion period of clinical study because of previous participation * pregnant woman

Keywords: depression antidepressant resistance
identifying msi status from ctdna in chinese patients with refractory advanced solid tumors

Conditions: Solid Tumor

Summary: this is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor dna in chinese patients with refractory advanced solid tumors.

this study is conducted in chinese patients with advanced refractory metastatic solid tumors. a total of 8-10 ml of blood will be collected from eligible patients and used for extracting circulating tumor dna. blood-msi status will be tested based on spanom technique developed by 3d medicines inc. shanghai, china. patients are encouraged to provide tissues collected from progressive disease for tissue-msi testing (not required for inclusion).

Eligibility criteria:
inclusion criteria: 1. male or female, age≥18 years old. 2. confirmed malignant solid tumor by histopathology or cytopathology. 3. colorectal cancer: progression after second-line therapy. non-colorectal cancer: progression after first-line therapy. 4. time duration from the last time of anti-cancer treatment to blood sample collection for msi testing ≥ two weeks or five times half-life period of anti-cancer drugs 5. signed the informed consent with name and time. exclusion criteria: 1. hematological malignancy 2. patients who received immuotherapies. 3. patients who received blood transfusion within one month before blood collection. 4. pregnancy.

Keywords: solid tumor china msi ctdna
study for the treatment of ulcerative colitis with adacolumn

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the adacolumn apheresis system to treat the signs and symptoms of ulcerative colitis.

trial features: * non-drug therapy * most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as asacol (mesalamine), pentasa (mesalamine), colazal (balsalazide disodium) and dipentum (olsalazine sodium) throughout the study components of the study: * study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments * physical exams, laboratory tests and disease assessments conducted at no charge to the patient * 2:1 randomization (treatment:sham)

Eligibility criteria:
key inclusion criteria: * moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge * adequate peripheral venous access to allow for completion of the apheresis treatments * receiving one or more of the following medical therapies: \*sulfasalazine, \*mesalamine and other 5-asa agents, \*prednisone or 6-mercaptopurine or azathioprine or have not received the above medical therapies due to intolerance or demonstrated non-response * agree to participate in the required follow-up visits * able to complete a diary * signed written informed consent document and authorization for use of protected health information key exclusion criteria: * evidence of toxic megacolon * major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks * proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis * requiring in-patient hospitalization * a history of allergic reaction to heparin or heparin-induced thrombocytopenia * a history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures * a history of severe cardiovascular or peripheral arterial diseases * a history of cerebral vascular diseases * liver diseases * renal insufficiency * insulin-dependent type i or type ii diabetes * known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment * any hypercoagulable disorder * known infection with hepatitis b or c, or hiv * severe anemia * leukopenia or granulocytopenia * evidence of current systemic infection * malignancy * pregnant, lactating or planning to become pregnant during the course of the investigational study * used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic

Keywords: ulcerative colitis, apheresis
the anifrolumab prim program

Conditions: Systemic Lupus Erythematosus

Summary: pregnancy and infant outcomes in anifrolumab exposed pregnancies using pregnancy outcomes intensive monitoring (prim) data: the anifrolumab prim program

the anifrolumab prim program is a supplementary program which utilizes enhanced collection of secondary data from reported anifrolumab-exposed pregnancies collected as part of astrazeneca's pv system. initial information about the exposed pregnancy will be collected through the pregnancy report submitted by anifrolumab treated patients or hcps to the astrazeneca pv database. pregnancy outcome information will be collected in close proximity to the planned delivery. additional follow-up and outcome information will be collected 12 months after delivery. for pv reports of exposed pregnancies that have already had a pregnancy outcome at the time of initial report (retrospective cases), initial characteristics, pregnancy outcome, and any available infant health information will be collected at the time of the initial report. targeted follow-up checklists and guidance documents will ensure that pv data collected for anifrolumab-exposed pregnancies are as complete as possible and have been mapped for pre-specified analytic variables that will be used to evaluate the safety of anifrolumab exposure for pregnancy and infant outcomes.

Eligibility criteria:
inclusion criteria: * currently or recently (within 1 year of pregnancy outcome) pregnant * exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception exclusion criteria: * pregnancy cases that have been enrolled in the prospective pregnancy registry (d3461r00051), those reported prior to the start of the prim program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab prim study.

Keywords: chronic autoimmune disease immunosuppressants corticosteroids human monoclonal antibody (igg1ƙ mab) post marketing requirements (pmr) study pregnancy systemic lupus erythematosus
association of acupuncture and cupping in advanced knee osteoarthritis

Conditions: Knee Osteoarthritis; Pain, Chronic

Summary: given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the institute of orthopedics and traumatology outpatient clinic of the university of são paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.

120 patients with indications for surgical knee treatment from iot-hcfmusp will be invited to participate in the project. inclusion applications and those who agree to sign a free and informed consent form (ic) will be included. during the period of inclusion of patients, will be clarified regarding the application and evaluation methods that will be used through consultation and initial medical evaluation. then, the included patients are randomized into four existing groups: group a - acupuncture sham + cupping sham; group b - sham acupuncture + real cupping; group c - real acupuncture + sham cupping; group d - real acupuncture + real cupping.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of knee osteoarthritis * womac-pain greater than or equal to 15 points. exclusion criteria: * advanced degenerative central neuropathy (parkinson's, alzheimer's) * diabetic peripheral neuropathy * stroke sequela * history of digestive bleeding * chronic renal failure * renal failure * heart failure * fibromyalgia * rheumatoid arthritis * sle * severe depression * psychiatric disorders * concomitance with hip arthritis

Keywords: acupuncture cupping osteoarthritis pain
establishing first trimester markers for the identification of high risk twin

Conditions: Small for Gestational Age (Disorder); Pre-Eclampsia

Summary: the purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.


Eligibility criteria:
inclusion criteria: * pregnant women from 11 -14 weeks of gestation exclusion criteria: * nuchal thickness above 3 mm, * chronic hypertension, * thrombophilia, * diabetes
primary culture of residual specimens obtained from aspiration of hepatic tumor to predict the prognosis of the patients

Conditions: Hepatocellular Carcinoma

Summary: the aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into barcelona clinic liver cancer (bclc) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (hcc) patients.

a total of at least 150 patients will be included and followed for at least one year. the proliferative speeds of cultured cells will be classified into (a) rapid proliferation of hcc cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (cafs), (b) rapid proliferation of cafs alone, and (c) slow proliferation three groups. the definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day \> two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day \> 70% growth area of the 25 cm flask. the graphpad prism software version 4.03 (graphpad software, inc., la jolla, ca, usa) is applied for statistical analysis. influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. the statistical significance is defined as p \< 0.05.

Eligibility criteria:
inclusion criteria: 1. patients are proven to have hcc based on fine-needle aspiration of the tumor. 2. patient have residual specimens obtained from fine-needle aspiration of the tumor. 3. patients agree to participate this study after fully explanation. exclusion criteria: 1. patients are not proven to have hcc based on fine-needle aspiration of the tumor. 2. patient do not have residual specimens obtained from fine-needle aspiration of the tumor. 3. patients do not agree to participate this study after fully explanation.

Keywords: hepatocellular carcinoma primary culture fine-needle aspiration cancer-associated fibroblast
an open label extension study in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to evaluate the safety and tolerability of ly2127399 administered as subcutaneous injections for 48 weeks in participants with rheumatoid arthritis


Eligibility criteria:
inclusion criteria: * have given written informed consent * women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation * have participated in either study h9b-mc-bcdg (nct00689728) or study h9b-mc-bcdh (nct00785928) exclusion criteria: * have had, during study h9b-mc-bcdg (nct00689728) or study h9b-mc-bcdh (nct00785928), any safety event, \[including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (ae) that caused discontinuation from treatment\] that in the opinion of the investigator poses an unacceptable risk to participation in the study. * have received, during study h9b-mc-bcdg (nct00689728) or study h9b-mc-bcdh (nct00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (dmards), or live vaccines. * enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.

Keywords: arthritis
reversibility of diastolic disfunction in septic shock

Conditions: Diastolic Dysfunction; Septic Shock

Summary: objectives: to study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the icu with a diagnosis of septic shock, in terms of mortality (icu and hospital) and mortality at 90 days. 2.4. secondary objectives: a) incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock. b) incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used. c) incidence and reversibility of right ventricular systolic dysfunction.


Eligibility criteria:
inclusion criteria: * patients admitted to the icu with diagnosis of septic shock, and stay longer than 48h exclusion criteria: * no echocardiographic window * fatal prognosis with do not resuscitate orders at admission * previous history of ischemic cardiomyopathy * valvular prosthesis * advanced degree of valvular disorder * advanced degree of pericardial effusion
correlation between cognitive functions and mri in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in mri of multiple sclerosis patients.

recent literature suggests that multiple sclerosis is accompanied by significant deficits in cognitive performance. the origin of these cognitive deficits is not known, since the severity of cognitive deficits was not found to be correlated with disease parameters such as duration, lesion load or disease intensity as measured on standard scales (e.g. edss). the research hypothesis we plan to test is that the individual intensity of cognitive deficits is correlated with degeneration of specific neuronal structures related to cognitive performance, such as the hippocampus and prefrontal cortex. to test this hypothesis, we plan to perform volumetric measurements of such regions on mri scans obtained from ms patients during the course of their clinical evaluation, and attempt to correlate those with the results of neuropsychological tests performed by the same subjects around the time of mri scanning.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple sclerosis * age 18-65 exclusion criteria: * another brain disease * stroke * brain trauma * neurosurgery

Keywords: multiple sclerosis memory cognitive deficits mri hippocampus prefrontal cortex
emergency linkage to outpatient psychiatric services

Conditions: Emergency Services, Psychiatric

Summary: the purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. this randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.

there are subgroups of patients who only seek care in emergency settings. an effective strategy to link that group to ambulatory care involves extending contact with psychiatric emergency services beyond the initial hospital-based visit. the "window of opportunity" to promote successful treatment linkage is brief. this is a study of a novel treatment format that seeks to expand the concept of the emergency contact, the study patients method of entering the mental health system of care, and by doing this, enhance retention in prescribed outpatient care. the effects of the intervention on patient symptoms and mental health service use will be examined.

Eligibility criteria:
inclusion criteria: * english and spanish-speaking adult patients (18-and above) presenting to the psychiatric emergency service who rate a "1" or higher on the spectrum of suicidal behavior of pfeffer screening scale, and who have outpatient followup organized by comprehensive psychiatric emergency program staff through hospital outpatient psychiatric services are eligible for inclusion. exclusion criteria: * subjects less than 18 years old, those rated as not suicidal in the emergency department, subjects with mental retardation/developmental delay, and subjects who have community psychiatric treatment that they elect to continue in lieu of hospital outpatient psychiatric services referral are ineligible.

Keywords: mental health services suicide suicide ideation
study of out of specification for tisagenlecleucel

Conditions: B-cell Acute Lymphoblastic Leukemia; Diffuse Large B-cell Lymphoma

Summary: this study will evaluate the safety of tisagenlecleucel that is out of specification( oos) for release as commercial product. specifically, this study will evaluate the safety of ctl019 in the patients treated within the approved label by japan health authority in part 2. only for part 1, in addition to safety, key efficacy of ctl019 will also be evaluated.

this is a single-arm, open-label, multicenter, interventional phase iiib study in pediatric/young adult patients with relapsed/refractory (r/r) b-cell acute lymphoblastic leukemia (pall) and adult patients with r/r large b-cell lymphoma (lbcl) including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high-grade b cell lymphoma, and dlbcl arising from follicular lymphoma for part 1 and and r/r all and r/r non-hodgkin's lymphomas (nhl) for part 2 patients whose final manufactured tisagenlecleucel patient-specific batch does not meet the approved local commercial release specifications are eligible for inclusion. each case will be individually assessed and approved by the novartis manufacturing facility and the novartis global medical team (including patient safety). following a single infusion of ctl019, the patient will be followed for 3 months for part 1, and 1 day for part 2.

Eligibility criteria:
key inclusion criteria: * signed informed consent/assent must be obtained for this study prior to participation in the study. * patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications. * not excluded from commercial manufacturing under the health authority-approved tisagenlecleucel prescribing information for their respective country/region. * oos material has not been deemed to pose an undue safety risk to the patient. * patient is suffering from a serious or life-threatening disease or condition. * repeat leukapheresis is not clinically appropriate per the investigator assessment. key exclusion criteria: for part 1, patients meeting any of the following criteria are not eligible for inclusion in this study: * human immunodeficience virus (hiv) positive patients. * patients with active replication of hepatitis b virus (hbv) or hepatitis c virus (hcv). * patients with primary central nervous system (cns) lymphoma. * history of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel. * uncontrolled active infection or inflammation. * any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment. * pregnant or nursing (lactating) women. for part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of ctl019.

Keywords: out of specification tisagenlecleucel acute lymphoblastic leukemia large b-cell lymphoma relapsed/refractory pediatric young adult patients