Kornimate/medical-research-clean huggingface dataset:
ex-vivo expanded γδ t-lymphocytes (omnimmune®) in patients with acute myeloid leukaemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: this study investigates the potential curative properties of gamma delta t-cells obtained from a blood-related donor of an aml patient.

this is an open-label, safety and efficacy, escalating dose, single arm study on 9 adult subjects (3 cohorts) and 3+3 design will be used. hla typed patients and potential blood-related donors will be screened for comorbidities. suitably matched or haploidentical family donors will be selected according to protocol specified criteria and institutional guidelines of participating site.

Eligibility criteria:
inclusion criteria: 1. history of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow) 2. relapsed or refractory aml 1. aml relapse after intensive chemotherapy or 2. aml relapse after allogeneic hct or 3. aml progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) or 4. no response to at least 4 cycles of low intensity therapy 5. aml refractory to 2 cycles of induction chemotherapy 3. presence of \> 5% of blasts in bone marrow or peripheral blood smear 4. patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic haematopoietic cell transplantation (hct) 5. considered suitable for lymphodepleting chemotherapy 6. age 18 years up to the age of 70 (≤ 70) 7. life expectancy of at least 3 months 8. karnofsky performance status ≥ 50% 9. available related hla-haploidentical or hla-matched donor 10. ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ t cells product infusion. maintenance replacement steroid is allowed. 11. patient able to understand and sign written informed consent exclusion criteria: 1. uncontrolled infections 2. renal insufficiency: creatinine \> 180 μmol/l or on dialysis 3. heart failure: ef \< 40% 4. respiratory insufficiency: oxygen therapy required at inclusion in the study 5. significant liver impairment: bilirubin \> 50 μmol/l, ast or alt \> 4 times normal upper limit 6. treatment with bisphosphonates (2 months before start) 7. active autoimmune disease or gvhd 8. pregnant or breastfeeding 9. patient of fertile age not using two-barrier method of birth control.

Keywords: gamma delta t lymphocytes
analysis of inflammatory reactions observed in bronchoalveolar lavages (bals)

Conditions: Lung Cancer

Summary: immunological toxicities associated with immune checkpoint inhibitor (ici) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. some of these events are severe and occur in 15-20% of patients treated with programmed death 1 (pd-1) antibodies. the study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of icis on cells of the immune system, outside the tumor microenvironment. diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti pd-(l)1; either for bronchial cancer, melanoma or any other type of cancer. patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (bal) performed during bronchial fibroscopy as part of their routine care. these analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ici toxicity.


Eligibility criteria:
inclusion criteria: * adult subject (≥ 18 years old) * patient having consented to the research group 1: * patient with cancer who was treated with immunotherapy * appearance of ct lung abnormalities during immunotherapy, not related to cancer * with high suspicion of infiltrative lung disease: * pneumopathy (ctcae version 5 classification). * patients requiring bronchial fibroscopy with bal groups 2: * patient with lung cancer with peripheral tumor * requires surgical pulmonary lobectomy in the operating room exclusion criteria: * patient treated or having been treated in the last 2 months with corticosteroid therapy * patient treated with immunosuppressant and/or cyclophosphamide, and/or anti-tnf α in the last 12 months * absence of consent * patient under curatorship, guardianship or safeguard of justice * pregnant woman * group 1: * patient with respiratory failure groups 2: * patient with lung cancer with proximal or endobronchial tumor * patients requiring bilobectomy or pneumonectomy * patient who has been treated with immunotherapy

Keywords: anti pd-(l)1 diffuse infiltrative lung disease
a clinical trial for azvudine in the treatment of novel coronavirus pneumonia (covid-19）

Conditions: COVID-19

Summary: to evaluate the efficacy and safety of azvudine in treatment of covid-19


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, gender not limited; 2. laboratory (rt-pcr) confirmed covid-19; 3. the time from the first positive nucleic acid test to randomization does not exceed more than 4 days; 4. informed consent has been signed. exclusion criteria: 1. known or suspected allergies to the components of azivudine tablets; 2. according to the latest version of the national health and medical commission diagnostic criteria of covid-19, patients with severe novel coronavirus pneumonia was confirmed; 3. severe liver disease (tbil\>=2 times normal upper limit; altast\>=5 times normal upper limit); 4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 ml/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis; 5. subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally; 6. subjectsis currently receiving anti-hiv treatment; 7. women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial; 8. participating in other clinical trials or using experimental drugs, except traditional chinese medicine; 9. other conditions that not appropriate to be enrolled into this study based on investigator's advise.
once-a-day tacrolimus conversion study: the onetac trial

Conditions: Heart Failure

Summary: this study investigates the use of tacrolimus extended release in stable patients who have undergone a heart transplant. all patients will receive the study medication free of charge for the 1 year duration of the study.

tacrolimus has been extensively studied in solid organ transplantation. it is fda approved for heart transplant recipients as a twice a day formulation (prograf brand name, as well as generic formulations). a modified release formulation is available and fda approved for kidney transplant recipients (astagraf, astellas pharmaceutical), but is not approved for heart transplant patients. in this study the investigators will study 100 patients who are stable on twice a day tacrolimus and convert these subjects to once a day modified release tacrolimus. the investigators will observe these patients for 1 year following the switch and assess safety and efficacy in a heart transplant population.

Eligibility criteria:
inclusion criteria: * adult, age 18 or higher * heart transplant recipient at least 365 days post-transplant at time of study screening * informed consent available * willingness to return for study visits, clinically indicated bloodwork * on tacrolimus-based chronic immunosuppression. * self-identified ethnic group is provided exclusion criteria: * prior heart or solid organ transplant * less than 365 days post-transplant at study screening * receiving cyclosporine based immunosuppression or calcineurin inhibitor free regimen * concurrent kidney or other solid organ * inability to provide informed consent * more than 15 years post-transplant

Keywords: immunosuppression
the diagnostic value of shear wave elastography

Conditions: Thyroid Nodule

Summary: background: the main goal when diagnosing thyroid nodules, is to differentiate the few malignant from the overwhelming background of benign nodules. currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic thyroid surgery is necessary. therefore, there is a need to develope the diagnostic tools for pre-operative diagnostic work-up of thyroid nodules. the study will investigate a novel ultrasonographic technique called shear wave elastography (swe) in the pre-operative evaluation of thyroid nodules. aim: to evaluate the diagnostic value of swe in the pre-operative diagnosis of thyroid nodules in a tertiary surgical center. perspectives: an optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.


Eligibility criteria:
inclusion criteria: * nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery exclusion criteria: * not undergoing thyroid surgery
optimiser registry - a prospective cohort study to describe the optimal management and outcomes of patients presenting with acute myocardial infarction

Conditions: Myocardial Infarction; Myocardial Ischemia; STEMI; NSTEMI

Summary: the purpose of the optimiser registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with ami and are treated with pci as well as prospectively collect the clinical outcome data. outcomes will be compared in different clinical subgroups. the impact of pci in ami in general as well as cardiovascular outcomes after ami will be assessed.

* to assess procedural success and clinical outcomes among persons with ami, who undergo pci and/ or cabg for ami (stemi or nstemi) 1. periprocedural outcomes/ complications, which will be analyzed, represent: final result (e.g. timi flow), stent expansion, dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. short and long-term clinical outcomes of interest including: new ami, unstable angina (ua), stent-/scaffold thrombosis, target lesion failure, target vessel revascularization, ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * to describe procedural and clinical performance of various balloon, stent and scaffold devices implanted in patients presenting with ami during the afore mentioned period * to study the impact of different devices and strategies used for lesion preparation and pci optimization strategies among patients undergoing pci * to describe early and late angiographic and oct-findings among coronary artery disease in patients with ami treated with various metallic stent and scaffold devices * to assess possible predictors for coronary stent implantation or device failure * to evaluate the impact of different antithrombotic regimens on patient clinical outcomes * to study procedural and clinical outcomes among cad patients requiring hemodynamic support using mechanical devices. * to describe economic implications (cost-effectiveness) of various interventional treatments for cad.

Eligibility criteria:
inclusion criteria: * subject \>18 years of age * individuals who are newly diagnosed with ami or have been diagnosed with ami (stemi or nstemi) within the last 5 years (since 2016). * subjects must be willing to sign a patient informed consent (pic) or a patient ́s relative/ proxy are willing to provide pic or patients have signed the general consent (gk). exclusion criteria: * patient unwilling or unable to provide informed consent * patients with no acs/ami (e.g. takotsubo cardiomyopathy, acute heart failure not related to ami)
active and passive cervical flexion-rotation tests

Conditions: Cervicogenic Headaches

Summary: motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. a test involving flexing and rotating the neck has been found useful to diagnose this type of headache. this observational study investigates this neck motion test when performed actively by the patient and passively by the examiner, then compares the results of motion attained.


Eligibility criteria:
inclusion criteria: * one-sided headaches * headaches caused by neck movement or sustained head positioning * neck, shoulder, or arm pain * intermittent headaches at least one headache per week for greater than 2 months * headaches of moderate intensity exclusion criteria: * a diagnosis of rheumatoid arthritis * current pregnancy * international headache society criteria for other headache forms (such as tension or migraine) * cervical radiculopathy * treatment for headaches by a physical therapist, chiropractor, massage therapist, or osteopath in the past month * positive test for vertebral artery insufficiency or cranial-vertebral ligament instability

Keywords: headache diagnosis flexion rotation test range of motion upper cervical
balloon vs. self expanding transcatheter valve for degenerated bioprosthesis

Conditions: Valve Heart Disease

Summary: transcatheter aortic valve implantation (tavi) serves a growing spectrum of patients with symptomatic severe aortic stenosis (as). approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. tavi has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. the median time since index surgical aortic valve replacement (savr) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. tavi in this setting has proven to have equally favorable results as in native aortic valves7. balloon expandable8 and self-expanding9 transcatheter heart valves (thv) can be used in a degenerated bioprosthesis and each have specific assets and limitations. tavi in a failed bioprosthesis can cause coronary obstruction, thv migration, paravalvular leakage and prosthesis patient mismatch. the sapien-3 / ultra and evolut r/pro are the 2 most commonly used thv platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. objective: to compare tavi with evolut r/pro vs. sapien-3 / ultra in terms of device success. study design: international multi-center randomized study with 1:1 randomization to tavi with sapien-3 / ultra or evolut r/pro. study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral tavi by heart-team consensus. investigational intervention: transfemoral tavi with sapien-3 / ultra or evolut r/pro main study parameters/endpoints: 1. primary endpoint is device success at 30 days defined by * absence of procedural mortality and * correct positioning of a single prosthetic heart valve into the proper anatomical location and * intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient \< 20 mmhg or peak velocity \< 3 m/s, and no moderate or severe prosthetic valve regurgitation). severe prosthesis patient mismatch is defined by effective orifice area (eoai) ≤0.65 cm2/m2 2. safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.


Eligibility criteria:
inclusion criteria: * age ≥ 65 years * failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral tavi with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector ct). * written informed consent exclusion criteria: * not eligible for transfemoral tavi with sapien-3 / ultra and evolut r/pro * multi-valve defects requiring intervention * clinically unstable and/or inotropic/vasopressor /mechanical support. * known mural thrombus in the left ventricle * presence of a mechanical aortic valve * history of recent (within 1 month) stroke or tia
safety and immunogenicity study of live attenuated vaccine against varicella without gelatin

Conditions: Chickenpox; Zoster

Summary: the purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，geometric mean titer (gmt) between groups of live attenuated varicella vaccine without gelatin.

observational objectives: to describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday. to describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

Eligibility criteria:
inclusion criteria: * parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent * participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months * participant is aged ≥ 1 year to ≤ 12 years * body temperature ≤ 37.0℃ * participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster exclusion criteria: * known allergy to any constituent of the vaccine * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction * known bleeding disorder * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * participation in any other interventional clinical trial * an acute illness with or without fever (temperature \> 37.0℃) in the latest week preceding enrollment in the trial * inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study * reported clearly the infection of the upper respiratory tract with 6 months * clinical manifestation of metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Keywords: varicella vaccine gelatin
transcutaneous electric nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy

Conditions: Pain

Summary: this study evaluates pain relief during extracorporeal shock-wave lithotripsy by using transcutaneous electrical nerve stimulation (tens) and comparing it with fentanyl which is a narcotic analgesic. half of the participants will receive a primary fentanyl dose together with tens application, another half will receive a primary fentanyl dose. all patients will receive fentanyl increments if they still complained of pain.

the ideal anesthesia technique for eswl must provide good analgesia, sufficient sedation, and rapid recovery with minimal side effects. opioids are commonly used analgesics during eswl. fentanyl is a potent synthetic narcotic, which has rapid onset and a short duration of action, it offers an acceptable analgesia during eswl but has a noticeable respiratory depression. transcutaneous electrical nerve stimulation (tens) is a method in which low voltage electrical impulses transmit through electrodes attached to the skin over a painful area. it is usually used to relieve a variety of painful conditions. a tens unit contains electrical signal generator, a battery in addition to a set of electrodes. the tens is small, programmable and the generator can deliver stimuli with different current intensities, pulse rates and pulse width. the mechanism of analgesia by tens has been explained by many theories. the gate control theory by melzack and wall, stated that "when an electrical current is applied to a painful area, transmission of pain through small diameter fibers is inhibited by the activity of the large diameter, fast-conducting proprioceptive sensory fibers, closing the gate to the pain perception to the brain". another mechanism suggested is activation of descending inhibitory pathway, via release of endogenous opioids.

Eligibility criteria:
inclusion criteria: * patients scheduled for extracorporeal shock-wave lithotripsy (eswl), having a solitary renal stone 6 - 15 mm. * age18 to 75 years old. * asa physical status i -ii. * bmi of 25- 30. exclusion criteria: * patients with bleeding and coagulation disorder. * hypertension. * pregnancy, * patient with demand pacemaker. * dermatological lesions at the site of eswl e.g. eczema or dermatitis. * drug or alcohol addiction.

Keywords: extracorporeal shock-wave lithotripsy, pain relief during extracorporeal shock-wave lithotripsy fentanyl transcutaneous electrical nerve stimulation
effects of antidepressant on postsynaptic signal transduction in serotonergic system of depressed patients

Conditions: Depression

Summary: the purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration, or represent the clinical status of depressed patients.

the purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

Eligibility criteria:
inclusion criteria: 1. met the diagnostic and statistical manual of the american psychiatric association (dsm-iv) criteria for mdd from the department of psychiatry, sungkyunkwan university, seoul, south korea. 2. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by dsm-iii/iv criteria, at least 2 years after first episode onset, and agreement to informed consents exclusion criteria: * pregnancy * significant medical conditions * abnormal laboratory baseline values * unstable psychiatric features (e.g, suicidal attempt) * history of alcohol or drug dependence, seizure, neurological illness, or concomitant axis i psychiatric disorder

Keywords: antidepressant response signal transduction lymphocyte biomarkers depressed patients antidepressant drug adverse reaction
perfect project - part 1 - study 2

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products. we hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.


Eligibility criteria:
inclusion criteria: * normoglycemic (\<5.6 mmol/l) and normotensive (systolic blood pressure \<140 mm hg and diastolic blood pressure below \< 90 mm hg) * bmi of 18.5-29.9 kg/m2 exclusion criteria: * restrained eaters * regularly skip breakfast * smokers * competitive sports or athletic training at a high intensity * those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year. * those unable to walk for an hour continuously