Kornimate/medical-research-clean huggingface dataset:
car - γ δ t cells in the treatment of relapsed and refractory cd7 positive t cell-derived malignant tumors

Conditions: CAR; Malignant Tumors

Summary: this is a study on the clinical application of chimeric antigen receptor modified γδ t cells (car - γδ t cells) in relapsed and refractory cd7 positive t cell-derived malignant tumors.the main purpose of this study was to evaluate the efficacy of car - γ δ t cell infusion in patients with relapsed and refractory cd7 positive t cell-derived malignancies.

γδt cells are known as "a great candidate for car-t cells". although they only account for 2% - 5% of all t cells in our body, they are a natural killer. cd7 is recognized as a sensitive marker of t-all, and its expression level on t-all cells is opposite to cd3: compared with normal t cells, the expression level of cd7 on t-all cells is significantly increased (p \< 0.001), while the expression level of cd3 on t-all cells is significantly decreased (p \< 0.001). at the same time, cd7 expression is absent in about 10% of normal t cells, and these cd7 negative t cells have the ability of normal t cells to express cytokines. therefore, cd7 has become a potential target for the treatment of t-all because of its specificity and safety.

Eligibility criteria:
inclusion criteria: 1. the patients must be patients with relapsed or refractory cd7 positive t cell-derived malignancies, who have at least one course of standard regimen chemotherapy and one course of salvage regimen chemotherapy and have poor effect; 2. researchers believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation; 3. patients should have indicators for detection or evaluation of disease, including detection of minimal residual disease (mrd) by immunophenotyping, cytogenetics or pcr; 4. they are 14-70 years old, regardless of gender or race; 5. physical condition: ecog score 0-2; 6. cardiac function: left ventricular ejection fraction greater than or equal to 40%; 7. the expected survival time was \> 12 weeks; 8. serum creatinine (cr) ≤ 1.5 × uln (upper limit of normal value), alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 × uln, total bilirubin ≤ 1.5 × uln; 9. patients have self-knowledge ability and can sign informed consent; 10. the guardian of the child patient agreed to sign the informed consent. exclusion criteria: 1. pregnant or lactating women; 2. uncontrolled infection; 3. active hbv or hcv infection; 4. people living with hiv; 5. less than 100 days after allogeneic hematopoietic stem cell transplantation; 6. patients with acute gvhd or chronic gvhd after allogeneic hematopoietic transplantation; 7. patients receiving gvhd treatment.

Keywords: cd7 positive t-cell γδt
effect of hammam experience on general health and perceived well-being

Conditions: Chronic Stress; Wellness; General Health

Summary: the main objective of this study is to analyze the effect of a hammam experience, a massage experience and a placebo in a healthy general population on their general health and perception of well-being, assessed with biophysiological, physical and psychoemotional markers, and its impact on chronic stress. our hypothesis is that the hammam experience will produce a more favorable acute (just after the experience) and subacute (24 hours after the experience) response on the study variables than the other interventions with at least a moderate effect size.


Eligibility criteria:
inclusion criteria: * men and women (50%) 25-65 years old * no metabolic risk. * resident in the province of granada. * socio-economic level: medium-high * experience in self-care * spanish level c2 exclusion criteria: * pregnancy * participation in treatments and relaxation techniques or taking medication (anxiolytics) frequently (≥ 1 per week) in the last 12 months * medical situations limiting participation in the study: acute musculoskeletal pathologies (fractures, wounds, etc.) or local inflammatory processes, diagnosed psychiatric disease, vascular diseases (thrombosis), contagious diseases, fever, thermoregulation problems, incontinence, craniocerebral trauma or infarction (\< 6 months), thermal allergies, hypertension, or any uncontrolled systemic disease).

Keywords: hamman balneotherapy massage chronic stress general health wellness
inspiris resilia durability registry

Conditions: Aortic Valve Stenosis

Summary: prospective, open-label, multicenter, european registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical avr with the inspiris resilia aortic valve™.

the inspiris resilia aortic valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. the tissue is created by treating bovine pericardial tissue with edwards integrity preservation. it incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation. the novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard perimount valve in an ovine model. in this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-crf at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5. the required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. it was estimated, from commence trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to varc-2) is around 0.915. the following table illustrates 95% cis at different levels of risk: sample size observed freedom from event 95%ci 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250 20% of registry sites will be monitored with 100% source data verification

Eligibility criteria:
inclusion criteria: 1. age 18 to 60 years inclusive 2. subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation 3. subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery 4. subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up 5. subject provides written informed consent prior to the procedure exclusion criteria: 1. active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 2. previous aortic valve replacement 3. valve implantation is not possible in accordance with the device ifu 4. subject has a life expectancy ≤ 12 months for any reason intraoperative exclusion criteria: 1. valve implantation is not possible in accordance with the device ifu

Keywords: heart valve diseases heart diseases cardiovascular diseases surgical valve
hip protector for prevention of hip fracture

Conditions: Hip Fracture

Summary: this study aims to evaluate the efficacy of the investigators psu hip protector for prevention of fracture in elderly.the eligible patients include those with previous diagnosed as unilateral hip fracture. they will be randomized into 2 groups;psu hip protector and no protector. the patients will be instructed to wear the protector fulltime.the inceidence of hip fracture will be compared between both group at the end of 1 year.


Eligibility criteria:
inclusion criteria: * patients with previous diagnosed as unilateral hip fracture exclusion criteria: * poor communicative ability * cannot independently ambulate * local skin problem at trocahnteric area

Keywords: hip fracture back support
cardiac rehabilitation and frailty physical training program in elderly patients after open heart surgery

Conditions: Frailty Syndrome

Summary: the aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation.

the clinical trial will be performed during patient rehabilitation. all examination of the patient will be performed before rehabilitation and at the end of rehabilitation. total subjects will spend 20 days in rehabilitation. all subjects who will have frailty syndrome will be assigned to one of three groups: control, intervention group-1 or intervention group-2.

Eligibility criteria:
inclusion criteria: * patient's agreement to participate in the study, * age 65 years and older, * patients admitted to cr after open heart surgery, * patients with frailty (edmonton frailty scale ≥4) * 6-minute walk distance (6-mwd) ≥150 meters and walking without mobility aid. exclusion criteria: * patient's disagreement to participate in the study * exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive, vision, linguistic deficits, chronic heart failure class iv, anemia, wound healing disturbance or other various acute conditions that may limit active participation in physical therapy programs.

Keywords: evaluate the impact of physical therapy tools for functional capacity, fear of falls, motivation, quality of life after open heart surgery and frailty
reducing delirium after cardiac surgery: a multifaceted approach of perioperative care

Conditions: Delirium; Cardiac Disease

Summary: the objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. this proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.

the proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.

Eligibility criteria:
inclusion criteria: * age ≥60 years, undergoing high risk cardiac surgery, signed informed consent. exclusion criteria: * patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.

Keywords: delirium cardiac surgery postoperative sedation
risk and importance of peroperative nasal hemorrhage in the treatment of lacrimal duct obstruction in young children

Conditions: Lacrimal Duct Obstruction

Summary: the aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (master ka) in the treatment of naso lacrimal duct obstruction (nldo). in the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes. a lower risk of hemorrhage could lead to a change in the anesthetic procedure. the gold standard in nldo is the use of an orotracheal intubation. it could then be replaced by the use of an orolaryngeal mask. a forthcoming study will evaluate the results of this anesthetic change.


Eligibility criteria:
inclusion criteria: * \< 6 years of age * unilateral lacrimal duct obstruction with programmed surgery * surgery scheduled wih a "pushed" mono-canaliculonasal intubation * no opposition of parents for he participation of their child exclusion criteria: * coagulation disorder * previous history of nasolacrimal intubation (homo or contra-lateral) * non covered by health insurance
fibrinogen early in severe trauma study

Conditions: Trauma; Haemorrhage; Coagulopathy

Summary: * haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients * trauma induced coagulopathy (tic) is a complex coagulopathy associated with severe trauma * hypo/dysfibrinogenaemia plays an important role in tic * early replacement of fibrinogen may improve outcomes * fibrinogen replacement is potentially inadequate in standard fixed ratio major haemorrhage protocols (mhp) utilising plasma and/or cryoprecipitate * the majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a mhp * cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio mhp * it is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - crash 2 and proppr studies * increasing interest in the use of fibrinogen concentrate (fc) in severe bleeding but not supported by high level evidence * benefits of fc - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay * no previous studies comparing fc and cryoprecipitate in bleeding trauma patients * fibrinogen supplementation will be guided by an accepted rotem targeted treatment algorithm * it will be a pilot, multi-centre randomised controlled trial comparing fc to cryoprecipitate (current standard practise in fibrinogen supplementation) * hypothesis: fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using fibrinogen concentrate compared to cryoprecipitate * it is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible


Eligibility criteria:
inclusion criteria: 1. adult affected by trauma (\>18yrs) and 2. judged to have significant haemorrhage or 3. predicted to require significant transfusion with abc score ≥ 2 or by treating clinician judgement exclusion criteria: 1. injury judged incompatible with survival 2. pregnancy 3. known objection to blood products 4. previous fibrinogen replacement this admission 5. pre-trauma centre fibrinogen replacement 6. participation in competing study

Keywords: fibrinogen cryoprecipitate
efficacy of ultrasound-guided multifidus cervicis plan block vs greater occipital nerve block for cervicogenic headache

Conditions: Cervicogenic Headache

Summary: background: cervicogenic headache (ch) described as a chronic hemi-cranial pain resulted from a disorder of the cervical spine and its anatomic structures innervated by the c1, c2, and c3 cervical spinal nerves. traditionally noninvasive and invasive techniques were used for treatment. greater occipital nerve block is the most frequent peripheral nerve block invasive technique used for the management of cervicogenic headache objectives: the study was done to compare the efficacy of two different techniques: multifidus cervicus plan block and greater occipital nerve block in treatment of refractory cervicogenic headache using ultrasound guided. patients and methods: sixty patients with cervicogenic headache were recruited and diagnosed according to ichd-ш beta version. divided into two group, one for greater occipital nerve block and the other for multifidus cervicis plane block with ultrasound guided.

this study was done to compare the efficacy of two different techniques: multifidus cervicus plane block and greater occipital nerve block in treatment of cervicogenic headache using ultrasound guided. this prospective study that was approved by institutional review board (irb), mansoura faculty of medicine, mansoura university, cairo egypt (code number: r/19.04.483) and all participants gave written informed consent. the procedures followed were in accordance with our protocol. this study included patients with cervicogenic headache disorders that diagnosed according to international classification of headache disorder version iii (ichd-iii beta version) criteria (18) full clinical neurological examination was done for all patients. blood samples for routine laboratory investigations (complete blood count, creatinine, liver function tests, pt, aptt) were taken from all patients, electrocardiography (ecg) were done for all patients. pain intensity was evaluated via visual analog scale (vas) scores (0 -10). pain intensity evaluation will be done at initial presentation then after 2 and 4 weeks, using the vas scale for affected side of cervicogenic headache. saturation of pulse oxygen (spo2), all procedures performed using ultrasound system with a 7 - 13 mhz multi-frequency transducer (logiq p5; ge healthcare).

Eligibility criteria:
inclusion criteria: history of occipital nerve injection, occipital nerve stimulation or history of surgical procedures in the occipital region, exclusion criteria: * history of allergic reaction to the substance to be applied as local anesthetic., * pregnancy or lactation, * uncontrolled hypertension, * uncontrolled diabetes mellitus, * uncompensated congestive heart failure, * chronic renal failure, * chronic liver disease, * tumor and/or vascular disease, * inflammatory and/or infectious diseases, * anticoagulant or antiplatelet medication use that may interfere with the injection process were also excluded.

Keywords: cervicogenic headache headache cervicis plan block occipital nerve block
assess the immunogenicity of gsk biologicals' 10-valent pneumococcal conjugate vaccine

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Summary: evaluate the immune response of gsk biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

test groups: 2 groups (60 subjects/group). 10pn-pd-dit group receiving gsk biologicals' 10-valent pneumococcal conjugate vaccine + dtpa-hbv-ipv/hib; control group receiving prevenar + dtpa-hbv-ipv/hib

Eligibility criteria:
inclusion criteria: * male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
immune checkpoint inhibitors and radiotherapy in relapsed/refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma; Immune Checkpoint Inhibitor; Radiotherapy

Summary: this is an observational retrospective study to investigate the efficacy and safety of the treatment with an immune checkpoint inhibitor (nivolumab or pembrolizumab) in combination with radiotherapy in patients with relapsed/refractory classical hodgkin lymphoma.

in patients with relapsed/refractory hodgkin lymphoma, treatment with immune checkpoint inhibitors (icis), nivolumab and pembrolizumab, leads to 20-30% of complete remission (cr) rate. this means that for the majority of patients a consolidation strategy is usually offered, in order to reduce relapse rate. strategies to improve cr rates should therefore be implemented, including combination treatments. in solid tumors, the combination of icis and radiotherapy led to higher response rates without mjor toxicity concerns. radiotherapy is an effective therapeutic option already used in hodgkin lymphoma patients, also in the setting of relapsed/refractory disease. in his observational study we aim to evaluate the efficacy and safety of icis and radiotherapy administered in combination in patients with relapsed/refractory hodgkin lymphoma.

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of classical hodgkin lymphoma, treated with one immune checkpoint inhibitor (ici) (nivolumab or pembrolizumab), as per label indication * having received a concomitant radiotherapy, as per clinical need (persistence of localized disease, bulky disease, other reasons). "concomitant" radiotherapy means a treatment received during the administration of ici, or during the 8 weeks that precede or follow the start or the end of the treatment with ici exclusion criteria: * having received a treatment with an ici and radiotherapy not "concomitant", according to the abovementioned definition * having received any other anti-lymphoma treatments during the same period of time * patients who have not been evaluated by ct-pet or ct at the end of the combination therapy
assessing the efficacy of crews01 to decrease usage of rescue inhalers in moderate to severe asthmatic adults

Conditions: Asthma

Summary: this is a double-blind, randomized, placebo-controlled, proof of concept, study in adults with poorly controlled moderate to severe asthma. the researchers believe that by using a local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma, such as decreasing the numbers of times patients have to use a rescue inhaler, and improving asthma treatment assessment questionnaire scores, with no bad changes to lung function and inflammation.

the proposed four-week, double-blind, placebo controlled study is designed to test the hypothesis that topical auricular anesthesia of the vagus nerve decreases the need for the usage of rescue inhalers in moderate to severe asthma in adults. we anticipate that up to 50 patients will be enrolled in the trial. particularly severe risks are not anticipated based on the prior investigational experience with this drug. this trial will be used to generate experience and data to support the design of a larger, crossover, comparator trial investigating the efficacy of antipyrine-benzocaine in reducing the need for rescue inhalers and hospital admissions in moderate to severe asthmatic adults.

Eligibility criteria:
inclusion criteria: * moderate to severe asthma * rescue inhaler 3 times per week * be able to give informed consent * must be on inhaled corticosteroid and long-acting beta agonist (laba), (either individually or as a combination product) and report using a short-acting beta agonist (saba) three or more times a week in at least 2 or 3 weeks prior to stud enrollment * moderate or severe persistent asthma according to the national heart, lung, and blood institute (nhlbi) guidelines, (epr 2007) * at least one appointment scheduled with the asthma physician during the 4 weeks of participation. * must be able to complete questionnaires over the phone or in person * must be able to maintain a basic diary/log of inhaler use and any side effects for 30 days. exclusion criteria: * severe psychiatric or cognitive problems * known or suspected sensitivity to the investigational medication * have a stenotic ear canal * have a perforated ear drum * active otitis media, otitis externa, or mastoiditis * allergic to benzocaine * unable to communicate in english * any other significant cardiopulmonary disease * smokers * hospitalized in the last 6 months for pneumonia * long term or lingering side effects to covid19 * lack of telephone or mobile phone * subjects who have received any investigational drug for asthma in the past 60 days