Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of max-40279-01 in combination with azacitidine (aza) in patients with myelodysplastic syndrome (mds) or relapsed/refractory acute myeloid leukemia (r/r aml)

Conditions: Leukemia; Acute Myeloid Leukemia; Relapsed/Refractory Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: this study is a phase ib/ii study of max-40279-01 in combination with azacitidine (aza) in patients with myelodysplastic syndrome (mds) or relapsed/refractory acute myeloid leukemia (r/r aml). this study include phase ib and phase ii study. the phase ib study is designed to evaluate the safety and tolerability of max-40279-01 in combination with azacitidine (aza) in patients with relapsed or refractory aml. the phase ii study is designed to preliminarily assess the efficacy and safety of max-40279-01 in combination with azacitidine (aza) in patients with myelodysplastic syndrome (mds) or relapsed/refractory acute myeloid leukemia (r/r aml).

this is a two-part study comprised of a dose escalation part and a dose expansion part.

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. a diagnosis of aml according to the world health organization (who) 2016 criteria with relapsed or refractory disease and have exhausted, or are ineligible for therapeutic options, or int-risk or high-risk or very high-risk mds according to revised international prognostic scoring system (ipss-r); 3. eastern cooperative oncology group (ecog) performance status of 0-2. 4. expected survival \>3 months. 5. no radiotherapy, surgery or hormonal therapy for any kind of within 2 weeks prior to participating in this study. patients must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer drugs (including hypomethylating agents in mds patients), radiotherapy or other anti-cancer modalities (i.e., returned to baseline status as noted before most recent treatment) for any tumors. patients with persisting, stable chronic toxicities from such prior treatment ≤grade 1 are eligible, but must be documented as such. 6. signed informed consent form. exclusion criteria: 1. acute promyelocytic leukemia according to world health organization 2016 criteria 2. known central nervous system involvement 3. medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product 4. known allergies, hypersensitivity, or intolerance to max-40279-01 or aza or the excipients of these treatments 5. previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry

Keywords: relapsed/refractory acute myeloid leukemia myelodysplastic syndrome
the effect of intravenous lidocaine on post-extubation laryngospasm

Conditions: Laryngospasm

Summary: in the literature, we found no randomized clinical trials addressing the using of iv lidocaine as prophylaxis for postoperative laryngospasm among adults. the aim of this study was to assess the effects of iv lidocaine on the incidence of postoperative laryngospasm of adults patients.

during anesthesia practice, one of the common complications of airway management is laryngospasm. the etiology of laryngospasm is unknown but may be due to insufficient depth of anesthesia during tracheal intubation, light plane of anesthesia during tracheal extubation, pain, or presence of airway irritant like laryngoscope blade, irritated volatile agent, suction catheter, surgical debris, mucus, blood, or other foreign body. laryngospasm occurs in both genders and all ages. incidence of laryngospasm was reported to the australian incident monitoring study (aims) was 5% with of 22% of them without an attributable cause. currently, there is no proven prophylaxis for laryngospasm and the known treatments of laryngospasm are used post-occurrence. however, elimination of factors that lead to laryngospasm is the most indispensable item for reduction of its incidence. intravenous (iv) lidocaine interrupts nerve conduction by blocking sodium channels. recent meta-analysis study showed that iv lidocaine was able to prevent laryngospasm in children. however, in the literature, we found no randomized clinical trials addressing the using of iv lidocaine as prophylaxis for postoperative laryngospasm among adults. the aim of this study was to assess the effects of iv lidocaine on the incidence of postoperative laryngospasm of adults patients.

Eligibility criteria:
inclusion criteria: * american society of anesthesia score are i or ii * undergo for laparoscopic cholecystectomy exclusion criteria: * patient's refusal * history of upper respiratory tract infection (urti) within 2 weeks * persistent type of hyper-reactive airway or asthma * history of airway surgery * history of gastro-esophageal reflex disease (gerd) * currently receiving sedating or analgesic medication * currently receiving the following medications: * fluvoxamine * erythromycin and itraconazole * β -blocker or cimetidine * history of lidocaine allergy * history of epilepsy disorder * pregnant or breastfeeding women * history of heavy smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces * history of increased salivation by a disease or medication * history of difficult intubation * two or more attempts of intubation

Keywords: laryngospasm lidocaine
direct aortic vs subclavian access for tavi: a review of the outcomes in the uk

Conditions: Aortic Stenosis

Summary: a retrospective analysis of outcomes of all patients who received tavi via the subclavian or direct aortic approach between january 2011 and january 2016


Eligibility criteria:
inclusion criteria: * recieve tavi via subclavian or direct aortic apporach in the uk exclusion criteria: * nil
adjuvant chemoradiotherapy versus chemotherapy for pancreatic cancer (adjupanc)

Conditions: Pancreatic Cancer

Summary: in this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.

pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. in china, the mortality of pancreatic cancer ranked the sixth among all cancers. although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. in nccn guidelines and chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. however, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. in meta-analyses, it was demonstrated that patients with lymph nodes metastases, r1 or r2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, r1 or r2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.

Eligibility criteria:
inclusion criteria: * aged 18-75 years * pathologically confirmed pancreatic ductal adenocarcinoma * pathologically confirmed lymph node metastasis, r1 or r2 resection or lymphovascular invasion (one of the risk factors) * no history of cancer treatment after surgical resection * no disease progression confirmed by imaging examinations * ecog 0 to1 point * no abnormality in blood routine test, liver and kidney function test and coagulation test (white blood cell count ≥4.0×10\^9/l, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/l, platelet count ≥100×10\^9/l, alt and ast level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2) exclusion criteria: * history of cancer treatment after surgical resection * history of other cancers within 5 years * disease progression, including local pprogression or metastasis, confirmed by imaging examinations * ecog ≥2 points * significant abnormality in blood routine test, liver and kidney function test and coagulation test * active inflammatory bowel disease * gastrointestinal bleeding or perforation within 6 months * infections requiring antibiotics * heart or respirotory insufficiency * pregnant women or breastfeeding women

Keywords: pancreatic cancer adjuvant chemoradiotherapy adjuvant chemotherapy
rutgers pilot for dental health care worker sars-cov-2 testing

Conditions: SARS-CoV2 Infection

Summary: 10 asymptomatic dhcws in the oral medicine clinic, rutgers school of dental medicine, with no history of documented covid-19 infection or viral exposure, were enrolled in a study that interrogated dhcws' perceptions of safety and adoption of risk mitigation behavior. following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. samples were processed using an in-house elisa assay to detect igm and igg directed against the receptor binding domain (rbd) of the spike protein. weekly rapid antigen testing of nasal swab specimens was used to document antigen negativity during the study.

10 asymptomatic dhcws in the oral medicine clinic, rutgers school of dental medicine, with no history of documented covid-19 infection or viral exposure, were enrolled in the dhcw arm of the study. the dchws underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (see dhcw arm in results section). weekly rapid antigen testing of nasal swab specimens was used to document antigen negativity during the study (bd veritor plus analyzer, bd sciences). the dhcws' perceptions of safety and adoption of risk mitigation behavior were interrogated. following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a neoteryx mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. each microsampler tip (20µl in the present study) was added to 200 μl vams extraction buffer (1x pbs (corning) supplemented with 1% bovine serum albumin (roche diagnostics, mannheim, germany) and 0.5% tween20 (sigma, mo, usa) in a 1 ml deep-well 96 well plate (greiner bio-one-780261). the plate was then covered with an adhesive seal and incubated 16 hours at 40c on a shaker at 250 rpm. the resulting eluates were heat inactivated at 560c for 60 minutes and centrifugation to collect the supernatant (eluate). eluates were further processed for an in-house elisa assay to detect igm and igg directed against the receptor binding domain (rbd) of the sars-cov-2 spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..

Eligibility criteria:
inclusion criteria: * dental healthcare workers (dhcw)s employed at rutgers school of dental medicine exclusion criteria: * previous participation

Keywords: dental healthcare worker testing seroprevalence perception of safety adoption of risk mitigation practice
effect of vitamin b on plasma neurofilament light protein (nfl) in hiv-infected individuals with increased plasma homocysteine

Conditions: HIV

Summary: the purpose of this study is to investigate if b vitamin substitution have effect on nfl (neurofilament light protein) plasma levels and neurocognitive performance in hiv-infected individuals with increased plasma homocysteine


Eligibility criteria:
inclusion criteria: 1. the ability to understand and give informed consent to participate. 2. hiv-1 infected with stable art \> 12 months 3. plasma hiv-rna \< 50 copies/ml 4. plasma homocysteine ≥ 12 μmol/l (subjects with \< 12 μmol/l will be included in the analysis of secondary endpoint 3 (see 5.4). 5. male or female, age 18 or older. exclusion criteria: 1. treatment with trimethoprim-sulfamethoxazole or methotrexate 2. ongoing b6, b12 or folate substitution 3. antiepileptic treatment 4. small bowel or ventricular resection 5. disturbed absorption in small bowel (mb crohn, untreated coeliac disease) 6. ongoing neurological disease or severe psychiatric disease 7. any malignant tumor in the history. 8. severe ongoing infection or opportunistic infection 9. audit \> 7 for men and \> 5 for women 10. madrs \> 20 11. significant b12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)). 12. pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (not due to toxicity of triobe, but to elevated risk of being prescribed b-vitamins outside of trial. if study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other b-vitamin treatment than triobe.)
the cohort study for chronic obstructive pulmonary disease (copd) in china

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to establish the large copd cohort and biological database in china, aiming for precision medicine to optimize diagnosis and treatment choices and to monitor and improve clinical outcomes in this disease.

this is a 5-year multi-center observational prospective longitudinal cohort study to to establish the large copd cohort and biological database in china, including copd subjects( n= 3000) and gold 0 subjects (n= 800).sites investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in china, with the equipment and ability to conduct pulmonary function test, hrct.patients must meet all the inclusion criteria and none of the exclusion criteria.no additional investigational drugs will be applied to the patients. full analysis set will be used for all analyses. missing data will be analysed as it is. statistical analysis will be conducted by epidemiology \& statistics work group from chinese academy of sciences, using sas and sudaan software. an electronic data capture system will be used in this study. paper-based questionnaire administration will also be used.questionnaire variables will be checked before data entry.during the study, pi will be in charge of the monitoring of the whole procedure. two working group will do the data cleaning and data analysing.

Eligibility criteria:
inclusion criteria: * aged 40-75 years * copd group: baseline post-bronchodilator fev1/fvc \< 0.7 * gold 0 group: individuals with chronic respiratory symptoms and/or high risk factors * signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years exclusion criteria: * acute exacerbation in the past 3 months * having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc * the usual criteria of serious uncontrolled diseases * thoracic or abdominal surgery in the last 3 months * eye surgery in the last three months * retinal detachment * myocardial infarction in the last 3 months * admission to hospital for any cardiac condition in the last month * heart rate over 120 beats per minute * antibacterial chemotherapy for tuberculosis * pregnant or breast feeding
association between cancer and anti-synthetase syndrome

Conditions: Antisynthetase Syndrome

Summary: among idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. however, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. the aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in grand est and bourgogne franche-comté regions.

idiopathic inflammatory myopathies area heterogeneous group of disease involving mainly muscles, which paraneoplastic feature has been well characterized, specifically in some subgroups such as dermatomyositis. in contrast, antisynthetase syndrome is thought to be rarely associated with cancer. however, clinical observations of the association of those diseases led us to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. the aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in grand est and bourgogne franche-comté regions, describing the type of cancer observed as well as clinical features of patients and diagnostic work-up leading to the diagnosis of cancer.

Eligibility criteria:
inclusion criteria: * adult patients * positive antisynthetase antibodies (jo-1,pl12, pl17, ej, oj, ks, rs, yrs) exclusion criteria: * age under 18 * opposition to data collection * no positive antisynthetase antibodies * absence of clinical involvment

Keywords: cancer idiopathic inflammatory myopathies
evaluation of sarcopenia in patients with stroke

Conditions: Sarcopenia; Stroke

Summary: the aim of this study is to investigate the prevalence of sarcopenia in stroke patients; to determine the relationship between sarcopenia and duration of stroke, age, gender, etiology of stroke, ambulation status, spasticity, nutrition and malnutrition

sarcopenia was defined as a loss of skeletal muscle mass and decreased muscle strength. the purpose of this study was to investigate the prevalence of sarcopenia following stroke, to investigate the relationship between sarcopenia and duration of stroke, age, sex, etiology of stroke, ambulation status, spasticity, nutrition and malnutrition. demographic characteristics, duration of stroke, sarcopenia presence (walking speed ≥ 0.8 m / s, sarc-f score ≥4, short physical performance battery score ≤ 8, thigh circumference \<33cm (the data for turkey) \<31cm (european data)) were recorded. hand grip strength (jamar) measured from the intact hand and tanita bia analysis were planned for all patients. ambulation level with functional ambulation classification (fac), nutritional status with 24-hour dietary recall (24hr) method, diagnosis of malnutrition with glim criteria, spasticity with modified ashworth scale, motor development for stroke patient brunnstrom staging, screening for frailty with frail questionnaire activity of daily living were evaluated with barthel index.

Eligibility criteria:
inclusion criteria: * patients with chronic stroke (stroke duration \> 3 months) * patients with a fac score \> 3 exclusion criteria: * patients unable to cooperate * other diseases that cause gait disorders such as neuromuscular disease, cardiopulmonary problems.

Keywords: sarcopenia stroke
effect of spring gravity bar on gait pattern in children with spastic diplegia

Conditions: Spastic Diplegia Cerebral Palsy

Summary: the purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia

the purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .

Eligibility criteria:
inclusion criteria: 1. their age will be extended from 7 to 10 years. 2. they can walk with limitation or holding on according to gmfcs (level ii \& ii). 3. they can understand and follow instruction. exclusion criteria: - 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function. 3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.
treatment of sleep apnea to improve metabolic health

Conditions: Sleep Apnea, Obstructive; Metabolism; CPAP; Patients Above 18 Years

Summary: diabetes and prediabetes prevail among obstructive sleep apnea (osa) patients. osa and short sleep both detrimentally affect glycemic control regardless of obesity. with 1 in 10 adults having diabetes, 1 in 10 with prediabetes, and an estimated 600,000 affected by osa in sweden, attaining glycemic control is crucial. though continuous positive airway pressure (cpap) is the most effective treatment for osa, its application lacks personalization, ignoring factors like comorbidities and sleep duration. key unanswered questions regarding cpap's impact on glycemic control include: 1) does high cpap adherence optimize glycemic control? 2) should short sleep be addressed alongside osa treatment for glycemic control? 3) does long-term diabetes hinder cpap's glycemic control efficacy? the purpose of this project is to enable precision health in cpap treatment and producing a personalized treatment model for achieving glycemic control in patients with osa, treated with cpap. taking advantage of a large unique patient cohort (600 patients followed over 18 months) with extensive and objective measures on cpap adherence, osa reduction, sleep duration, as well as information on comorbidities, anthropometric, lifestyle data, and a wide range of biomarkers related to glycemic control. this comprehensive approach and in-depth analysis will address these questions and generate a personalized treatment strategy for glycemic control in cpap-treated osa patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with obstructive sleep apnea * planned for cpap treatment * 18 years and above exclusion criteria: * patient not wanting to participate in study * non-swedish speaking * judged by physician as non-fit for study participation
aerobic training on lung function in fibromyalgia

Conditions: Fibromyalgia (FM); Respiration Disorders

Summary: exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia.

eighty women with fibromyalgia will be equally randomly assigned to the experimental (ex) group and the control group (con). the participants' age will be between 30 and 40 years and they will have mild restrictive lung affection. the ex group will attend 3 sessions/week of aerobic training at moderate intensity combined with diaphragmatic breathing exercises for 12 weeks, the con will only attend 3 sessions/week of diaphragmatic breathing exercises for 12 weeks. the lung functions will be assessed by the spirometry testing. the chest expansion will be determined using a tape measurement. additionally, exercise capacity will be tested using cardiopulmonary exercise testing protocol. all the outcomes will be examined at baseline, and after 12 weeks of the intervention.

Eligibility criteria:
inclusion criteria: * well controlled fibromyalgia. * mild restrictive lung affection. * body mass index less than 30kg/m2. * moderate level of physical activity. exclusion criteria: * any chest diseases. * musculoskeletal/ neurological limitations to exercise. * smokers. * pregnant.