Kornimate/medical-research-clean huggingface dataset:
natural killer (nk) cell therapy for b-cell malignancies

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

Summary: this is an open-label, phase i study of qn-019a (allogeneic car-nk cells targeting cd19) as monotherapy in relapsed/refractory b-cell acute lymphoblastic leukemia (b-all) and in combination with rituximab in relapsed/refractory b-cell lymphoma. this clinical study is to evaluate the safety, tolerability and preliminary efficacy of qn-019a in patients with relapsed/refractory b-cell lymphoma or b-all. up to 22-36 patients will be enrolled.

this is an open-label, phase i study of qn-019a (allogeneic car-nk cells targeting cd19) as monotherapy in relapsed/refractory b-cell acute lymphoblastic leukemia (b-all) and in combination with rituximab in relapsed/refractory b-cell lymphoma. this clinical study is to evaluate the safety, tolerability and preliminary efficacy of qn-019a in patients with relapsed/refractory b-cell lymphoma or b-all, where a "3+3" enrollment schema will be utilized at dose escalation stage. up to 24-36 patients will be enrolled.

Eligibility criteria:
key inclusion criteria: * diagnosis of b-cell lymphoma or b-all as described below: b-cell lymphoma: * histologically documented lymphomas expected to express cd19 and cd20 * relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (hsct) b-all: * diagnosis of b-all that expected to express cd19 * relapsed/refractory disease following prior systemic treatment regimens all subjects: * provision of signed and dated informed consent form (icf) * age ≥ 18 years old * stated willingness to comply with study procedures and duration * eastern cooperative oncology group (ecog) performance status ≤1 * adequate organ function as defined in the protocol * donor specific antibody (dsa) to qn-019a: mfi \<= 2000 * at least 3 weeks after the last systemic immunochemotherapy treatment * the estimated survival days are expected to be over 3 months key exclusion criteria: all subjects: * females who are pregnant or lactating * evidence of insufficient organ function as defined in the protocol * ecog performance status ≥2 * prior allogeneic hematopoietic stem cell transplant (hsct) or allogeneic car-t/car-nk within 6 months of day 1, or ongoing requirement for systemic gvhd therapy * currently receiving or likely to require systemic immunosuppressive therapy * known active central nervous system (cns) involvement by malignancy. non-malignant cns disease such as stroke, epilepsy, or neurodegenerative disease * clinically significant cardiovascular disease as defined in the protocol * known hiv infection, active hepatitis b (hbv) or hepatitis c (hcv) infection * donor specific antibody (dsa) to qn-019a: mfi \> 2000 * other comorbid conditions and concomitant medications prohibited as per study protocol * investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
primary care clinicians' responses to a hypoglycemia risk calculator for diabetes mellitus in ambulatory care

Conditions: Hypoglycemia; Diabetes Mellitus

Summary: hypoglycemia (hg) is common and can be dangerous in diabetes mellitus, so identifying patients at risk may lead to useful preventive strategies and improved quality of care and health outcomes. this study will test the implementation of a computerized alert tool for clinicians.

diabetes mellitus is one of the most common non-communicable diseases worldwide and is a major cause of morbidity and mortality. an estimated 346 million people had diabetes in 2011, and diabetes is predicted to become the seventh leading cause of death in the world by the year 2030. in the united states, the incidence of diabetes nearly tripled between 1990 and 2010, with 1.9 million new cases diagnosed in 2010. hypoglycemia (hg) is recognized as a limiting factor in optimal glycemic management of patients with diabetes. this potentially costly condition, occurring in approximately 20% to 60% of patients who receive oral medications for diabetes, threatens patient safety, quality of life, and potentially, cardiovascular health. investigators have identified risk factors for hg, built a risk calculator for use by clinicians, integrated the calculator into the g3 electronic medical record system, and demonstrated our ability to collect data about outcomes. in this project, investigators studied the outcomes of implementing the risk calculator tool into clinical practice in ambulatory primary care. the findings and tools developed from this project will promote improved patient safety and medical care for diabetes.

Eligibility criteria:
the study included clinicians who were scheduled to provide primary care during the four-month intervention period. inclusion criteria for patients: * being at least 21 years of age * have been prescribed or dispensed a drug for diabetes mellitus exclusion criteria for patients: n/a

Keywords: hypoglycemia diabetes mellitus clinical decision support electronic health records
study to assess adverse events (aes) when oral atogepant tablet is given to adult chinese participants who completed study 3101-303-002 to prevent chronic migraine

Conditions: Chronic Migraine

Summary: migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. the main objective of the study is to evaluate how safe and effective the atogepant is in preventing chronic migraine in adult chinese participants who completed study 3101-303-002. adverse events will be monitored. atogepant is an investigational drug being developed to prevent chronic migraine. all participants will receive the same treatment. approximately 120 adult participants who completed study 3101-303-002 will be enrolled at approximately 25 centers in china. all participants will receive atogepant oral tablet once daily for 12 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * eligible participants completed the double-blind treatment period, and the safety follow-up period, if applicable, depending on the timing of study initiation, of study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (ae) that, in the investigator's opinion, may indicate an unacceptable safety risk. exclusion criteria: * participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments, that cannot be discontinued or switched to an allowable alternative. concomitant medications with demonstrated efficacy for the prevention of migraine is exclusionary, except that participants from lead-in study 3101-303-002 taking 1 medication with demonstrated efficacy for the prevention of migraine may participate in the current study provided that the dose was stable prior to the lead-in study and the participant is willing to continue taking that medication. * participants with an electrocardiogram (ecg) indicating clinically significant abnormalities at visit 1. * participants with hypertension (sitting systolic blood pressure (bp) \> 160 mm hg or sitting diastolic bp \> 100 mm hg) at visit 1. * participants with a significant risk of self-harm columbia-suicide severity rating scale (c-ssrs), or of harm to others (investigator opinion); participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded. * participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Keywords: chronic migraine migraine atogepant agn-241689
evaluation of the possible vertical transmission of sars-cov-2 through study of amniotic fluid and chorionic villi of affected pregnant women for the covid-19

Conditions: Covid19; Pregnancy Related

Summary: longitudinal prospective study in pregnant women withpositive serology or pcr for sars-cov-2 and indicationinvasive technique (amniocentesis or chorionic biopsy) that has the objective to evaluate the possible vertical transmission of sars-cov-2in the amniotic fluid or chorionic villi of pregnant women affected by coronavirus in the different periods of gestation.

patients will be recruited at the time theypresent an indication to perform a techniqueinvasive (amniocentesis or chorion biopsy). eitherscreening for first or second trimester aneuploidies ofhigh risk, due to the presence of fetal malformation, due toearly intrauterine growth retardation (icr) or due tosuspected chorioamnionitis. the study population will be pregnant women diagnosed with sars-cov-2 infection(by pcr on nasopharyngeal aspirate or serology)that have an indication to perform an invasive technique(chorionic biopsy or amniocentesis) along thegestation.the sample size will depend on the duration of thesars-cov-2 pandemic.initially we propose a study period of 18 months in which we would have an approximate total of 225 pregnant women with indication of invasive technique.it is planned to conduct a pcr study for sars-cov-2 in amniotic fluid or chorionic villi to those pregnant women diagnosed with sars-cov-2 infection(approximately 5% of the total pregnant womenwith indication of invasive technique (11-12 pregnant women)).this determination is made as part of theroutine clinical practice in the context of the study ofscreening for perinatal infections.

Eligibility criteria:
inclusion criteria: * pregnant women diagnosed with sars-cov-2 (by pcr in aspiratenasopharyngeal or serologies) * patients indicated for an invasive technique(chorionic biopsy or amniocentesis exclusion criteria: * patients who do not meet the inclusion criteria
effect of yoga on psychological aspect and quality of life in premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: this study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome.

premenstrual syndrome (pms) is characterized by a collection of physical, emotional, psychological, and behavioral symptoms that appear in a cyclic and recurring pattern during the late luteal phase of the menstrual cycle and alleviate within two to four days of menstruation. premenstrual syndrome has a negative impact on young girls' lives, which can lead to reduced work efficiency and quality of work, increased accidents and lack of school attendance. therefore, there is a need to develop treatment protocols for coping with premenstrual symptoms. yoga denotes union and integration and improves biopsychosocial and spiritual wellness. in other words, yoga is a form of mind-body health that combines physical activity with inner-directed mindfulness to achieve self-consciousness through breathing and meditation. so, this study will be conducted to contribute and add new information that may help the field of physical therapy. it will provide an evidence base for the efficacy of yoga on management of psychological aspect and quality of life in premenstrual syndrome, owing to its low cost, and ease use that may lead to improvement of symptoms.

Eligibility criteria:
inclusion criteria: * their ages will be ranged from 18 to 25 years old. * their body mass index (bmi) will be less than 30 kg/m². * they will be virgin. * they will have regular menstrual cycles. * they will suffer from premenstrual syndrome based on daily record of severity of problems. * all women will be conscious and free from any medical disease. exclusion criteria: * women with the following criteria should be excluded from this study: * women with endocrine disturbance. * endometriosis. * pelvic inflammatory disease. * any pelvic pathology conditions. * women had hysterectomy or ovariectomy. * women use medications as contraceptive pills, pain relief drugs and antidepressant drugs.
impact of mulligan squeeze technique on meniscal derangement in knee osteoarthritis patients

Conditions: Osteoarthritis, Knee; Knee Injuries; Meniscus; Derangement; Meniscus Tear; Meniscus Lesion

Summary: the objective of this study is to find out the effects of mulligan's squeeze technique added as a complementary treatment to the conventional physiotherapy for the management of meniscal derangement in knee osteoarthritis patients.

this study was performed to determine the consequences of conventional physical therapy with and without mulligan's squeeze technique for meniscal derangement treatment in patients with knee osteoarthritis. this research study was a randomized controlled trial. the sample size was of 26 subjects. the subjects were nominated in accordance to the inclusion and exclusion criteria. they were equally and randomly divided into two groups. one group received mulligan's squeeze technique along with conventional physiotherapy exercises, with hot pack prior to the exercise session. the control group was only given conventional therapy exercises with hot pack application prior to any exercise. the treatment was given for two weeks and a total of six sessions, three sessions each week. the primary outcome measures were numerical pain rating scale (nprs) for pain rating and goniometer to record range of knee flexion. the secondary outcome measures were patient-specific functional scale (psfs) and knee-injury osteoarthritis outcome score (koos). the measurements were taken at baseline, at end of first week and after the second week. the data was analyzed by using ibm spss software version 27.

Eligibility criteria:
inclusion criteria: * • pain during maximal knee flexion, pain when maximal extension of knee occurs * both genders were taken; male and female * age between 30 to 55 years * tenderness along the line of joint * complain or history of abnormal clicking sounds and/or popping of knee * if any of the mentioned special tests are positive: "apley's compression and distraction test", the "disco test or thessaly's test" with almost 20° flexed position of knee, and "mcmurray's test" * participants who were willing to take part in the study exclusion criteria: * • presence of any knee co-morbidities * knee oa of grade 4 * acl or some other knee ligament injury/tears * contusion present on knee, fracture of knee * knee dislocation * knee instability due to any ligamentous injury * constant pain or discomfort due to underlying reasons (e.g. hyper-algesia), and any other wound or ailment * participant not willing to be a part of the study

Keywords: knee osteoarthritis manual therapy intervention; rehabilitation menisci;
treatment of cerebral radiation necrosis (crn) with nerve growth factor (ngf)

Conditions: Cerebral Necrosis; Nashopharyngeal Cancer; Nerve Growth Factor

Summary: cerebral radiation necrosis (crn) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (qol). however,crn was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for crn. in our clinical practice, we have used nerve growth factor(ngf) to treat crn, and found that gm1 can successfully reverse crn. a case report has been published in journal of clinical oncology (jco) in 2011. so we carried out this prospective study to test the efficacy of ngf for crn.


Eligibility criteria:
inclusion criteria: * the necrotic mass shown on mri must be measured in two dimensions. no local or regional recurrence, no distant metastasis. karnofsky performance status of at least 70 and were supposed to live more than 6 months. exclusion criteria: * crn combined with local or regional relapse, or with distant metastasis. * crn combined with other cerebrovascular disease. * crn combined with the second primary malignancy. * crn without neurologic symptoms or signs. * crn combined with diabetes. * crn patients that were supposed to live less than 6 months.
hearing changes after surgery

Conditions: Hearing Loss

Summary: the purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surgeries

high-speed drills that are capable of producing elevated levels are used during skull based surgeries (hilmi et al., 2011; yu et al., 2014). recently, it has been shown that surgical drilling may have a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (baradaranfar et al., 2015; shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. this study aims to to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the non operative ear, during surgical site during skull-based or mastoid surgeries. as part of the study patient will receive audiometry for extended high frequencies, dpoae, ecochg before and after the procedure.

Eligibility criteria:
inclusion criteria: * participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear * participants have normal or near-normal hearing thresholds in the un-operated ear exclusion criteria: * participants have hearing loss (pta \> 40 db hl) in pure tone audiometry testing before surgery in the un-operated ear * participants have medical conditions after the surgery which prevents having hearing tests * participants have abnormal tympanometric results

Keywords: hearing changes non-surgical ear hearing loss vibration exposure skull-based surgery un-operated ear
regional lung opening and closing pressures in patients with acute lung injury

Conditions: Acute Lung Injury

Summary: the purpose of this study is the measurement of regional opening and closing pressures of lung tissue by electrical impedance tomography in lung healthy and patients with acute lung injury. these values might help the setting of positive endexpiratory pressure during artificial ventilation to avoid the cyclic opening and closing of alveoli.

during artificial ventilation the cyclic opening and closing of alveoli during artificial ventilation results in patients with acute lung injury (ali) in a higher mortality. a positive endexpiratory pressure (peep) is applied with the intention to avoid these cyclic opening and closing of alveoli. the distribution of ventilation in patients with ali is extremely inhomogeneous, consequently there are different regional opening pressures needed to open up the alveoli and avoid closing. finding the best level of peep in patients with injured lungs to avoid atelectasis and alveolar strain induced by inadequately high or low peep levels is a challenge. the purpose of this study is to develop a protocol for measuring regional opening and closing pressures using the method of electrical impedance tomography in lung healthy and ali patients. a ventilator setting guided by regional opening and closing pressures might help reducing the impairment of the lung by artificial ventilation.

Eligibility criteria:
inclusion criteria: * artificial ventilation * acute lung injury / healthy lung (control group) exclusion criteria: * pregnancy * cerebral trauma / surgery * age \< 18 years * instable cardiovascular disease * instable chest wall

Keywords: electrical impedance tomography eit acute lung injury regional lung opening pressure regional lung closing pressure
impact of the use of new complete denture on the oral health related to quality of life (ohrqol)

Conditions: Edentulous Jaw; Quality of Life

Summary: the aim of this project was to evaluate the impact before and after (3, 6, 9, and 12 months) of oral rehabilitation with conventionalof the insertion of new complete dentures (cd) in the oral health-related quality of life (ohrqol) in total edentulous patients compared to dentate individuals. this is a clinical trial study approved by the research ethics committee (nº 31105714.7.0000.5626 ) which was conducted on 122 patients who attended the clinics of federal fluminense university, with the necessity of cd. the eligibility criteria were: healthy patients without disabilities; aged up to 50 years; complete upper and or lower jaw edentulism for a minimum 5 years; the presence of adequate healthy tissue to support the prosthesis; adequate cognitive ability and understanding to respond to the questions posed. it will be excluded patient with motor disabilities, cognitive impairment and people with special needs. after the installation of the cd a follow-up of one week, three, six, nine, twelve and eighteen months will be performed. the oral health impact profile (ohip-edent) instrument will be applied (in form of an interview) to evaluate the impact of cd on ohrqol. the scores of the ohip-edent index will be calculated using the additive method, summing the numeric response codes for each item. shapiro-wilk test revealed nonparametric distribution of data. chi-square, mann-whitney u, and kruskal-wallis tests were performed for comparing groups according to sociodemographic data. kruskal-wallis test was per- formed for comparing groups and treatments throughout time. a significance level of 5% was adopted, and all analyses were performed on statistical analysis system (sas) version 9.3 software. the responsiveness was assessed by analyzing the change of the scores on the scales and subscales. the changes was calculated by subtracting the post-treatment scores from the before-treatment scores. positive change scores will indicate an improvement in ohrqol, while negative scores will indicate deterioration.


Eligibility criteria:
inclusion criteria: * healthy patients without disabilities; * aged up to 50 years; * patient with complete upper and or lower jaw edentulism for a minimum 5 years; * patient with presence of adequate healthy tissue to support the prosthesis; * patient with adequate cognitive ability and understanding to respond to the questions posed exclusion criteria: * patient with motor disabilities; * patient with cognitive impairment * people with special needs.

Keywords: dentadures edentulous mastigatory performance
evaluation of diagnostic accuracy of artificial intelligence in treatment planning for non-growing class ii cases

Conditions: Class II Malocclusion

Summary: the goal of this observational study is to evaluate the diagnostic accuracy of artificial intelligence in non-growing class ii cases. the main question it aims to answer is: is artificial intelligence (ai) accurate in choosing a treatment modality for non-growing class ii cases -whether to camouflage or surgical treatment? participants already undergone orthodontic treatment, their pre-treatment and post-treatment records will be collected from the archive of orthodontic department at cairo university


Eligibility criteria:
inclusion criteria: cases of non-growing patients with class ii malocclusion exclusion criteria: growing patient with class ii malocclusion