Kornimate/medical-research-clean huggingface dataset:
the safety and adverse reaction study of neonatal to inhaled carbon monoxide

Conditions: Miscellaneous Disorders in the Fetus or Newborn

Summary: based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .phase 1 study as a foundation for the further test is, the safety and adverse reaction study of newborn to inhaled co

previous studies have demonstrated that, carbon monoxide has showed the effectiveness such as in inflammation ,apoptosis as well as relaxation of smooth muscle of the body. now we have a hypothesis to use carbon monoxide in pulmonary hypertension of the newborns, to observe whether it will decrease pulmonary artery hypertension on newborns. phase 1 study is ,the safety and adverse reaction study of newborn to inhaled co , after this,we can master the application of carbon monoxide dose

Eligibility criteria:
inclusion criteria: * the newborn whose physiological function is healthy or close to healthy exclusion criteria: * clinical considerations cannot survive or no treatment value of newborn diagnosis of congenital or hereditary diseases, or children with heart diseasecentral pulmonary vascular malformations in children

Keywords: carbon monoxide safety adverse reaction newborn
effects of non-drug therapy on cognitive function in healthy individuals and patients with first episode depression

Conditions: Depressive Disorder

Summary: mindfulness training, relaxation training, and cerebellar electrical stimulation were used to intervene in the cognitive function of healthy individuals and individuals with first episode depression

in this proposed study,the investigators will evaluate the effects of different non-pharmacological interventions (physical/psychological) on emotion-related cognitive function.this project will use a variety of intervention methods to conduct research in healthy individuals and patients with mood disorders. the main intervention methods include: (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation. the study will recruit 80 healthy subjects and 40 first-episode depression patients. the study consisted of three steps: first, subjects filled in personal data and completed the first screening, randomly assigned groups, and filled in the pre-intervention questionnaire;second, give a one-time non-drug intervention (mindfulness training, relaxation training or cerebellar electrical stimulation);step 3: after the intervention, the subjects filled in the post-intervention questionnaire and completed the cognitive task test.clinical efficacy and safety assessment will be done at first time. the specific aims are to evaluate the effect of non-drug therapy on cognitive function in healthy individuals and patients with first episode depression. and the behavior was evaluated by cognitive function task.

Eligibility criteria:
inclusion criteria: - healthy individuals group: 1. aged between 16 and 34; 2. does not meet the criteria of the diagnostic and statistical manual of mental disorders, dsm-5,does not meet the diagnosis of depression, bipolar disorder and other mental disorders. first episode depression group: 1. aged between 16 and 34; 2. clinically diagnosed as having depression according to the diagnostic and statistical manual of mental disorders (dsm-5); 3. first attack, not taking medicine, no risk of serious suicide nssi. exclusion criteria: 1. there are serious physical diseases, such as epilepsy, brain trauma, intracranial space-occupying lesions, severe audiovisual disorders, congenital heart disease, etc.; 2. both hamilton depression scale and beck depression self-rating scale indicate severe depression or severe mental illness; 3. affected by mental illness, it is difficult to conduct smooth and effective verbal communication and psychological measurement operation.
study of imm0306 in patients with relapsed or refractory cd20-positive b-cell non-hodgkin's lymphoma

Conditions: CD20-positive B-cell Non-Hodgkin's Lymphoma

Summary: this is a phase i/ii, single-arm, open-label, multicentre study to evaluate the safety and efficacy of imm0306 in patients with relapsed or refractory b-cell non- hodgkin's lymphoma (r/r b-nhl).


Eligibility criteria:
inclusion criteria: * relapsed or refractory cd20-positive b-cell non-hodgkin's lymphoma (b-nhl) that has been diagnosed, including but not limited to diffuse large b-cell lymphoma (dlbcl) follicular lymphoma (fl), mucosal lymphoma (malt-l), small lymphocytic lymphoma (sll) / chronic lymphocytic leukemia (cll). * at least one measurable or assessable tumor lesion. * adequate organ and hematologic function. * eastern co-operative oncology group (ecog) score 0 to 2. * all adverse events from prior treatment must be ctcae v5.0 grade \<= 1 exclusion criteria: * active central nervous system (cns) lymphoma. * systemic steroid therapy (dose equivalent to \> 10 mg prednisone / day). * history of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (ctcae v5.0 grade \>=3). * have evidence of severe uncontrollable active infection. * subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
fertility after prostate brachytherapy

Conditions: Prostate Cancer

Summary: although brachytherapy toxicity data on erectile dysfunction, urethral dysfunction and bladder and bowel impact has been collected for a number of years, there is limited information on its effect on male fertility. this study aims to investigate the effect of brachytherapy on fertility

brachytherapy is a commonly employed technique in the treatment of all prostate cancer risk groups. it delivers a high radiation localised to the prostate gland. the effects of this on fertility have not been systematically studied. an increasing number of younger men for whom fertility is an issue are being diagnosed with prostate cancer and may be offered brachytherapy amongst their treatment choices. this study therefore addresses this issue with a systematic evaluation of sperm count and quality before and after both high dose rate and low dose rate brachytherapy.

Eligibility criteria:
inclusion criteria: * male * 18 years or older * receiving brachytherapy monotherapy; high or low dose rate * ability to ejaculate * able to provide written informed consent exclusion criteria: * history of infertility or vasectomy * previous chemotherapy or pelvic radiotherapy * prior use of androgen deprivation therapy * 5 alpha-reductase inhibitors within the last 4 months * alpha blockers within 7 days of semen collection
sildenafil citrate and intrapartum fetal distress

Conditions: Fetal Distress

Summary: induction of labour (iol) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. the most common causes are failed induction and intrapartum fetal distress. in spite of significant advances in methods of iol and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress


Eligibility criteria:
inclusion criteria: 1. singleton pregnancy. 2. pregnant ≥ 37 weeks gestation. 3. fetus with longitudinal lie and vertex presentation. 4. healthy fetus with efw\>2500 gm exclusion criteria: 1. patients with previous cesarean delivery or uterine surgery. 2. antepartum hemorrhage. 3. cephalopelvic disproportion. 4. category ii or iii non-stress test. 5. medical disease as hypertension, cardiac, renal and hepatic disorders 6. intrauterine fetal death. 7. fetal growth restriction. 8. fetuses with major congenital malformations. 9. women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors. 10. women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
interest of occlusion of permeable foramen ovale after a cryptogenic cerebrovascular accident (cva)

Conditions: Permeable Foramen Ovale; Cerebrovascular Accident

Summary: facing the lack of recommandations of neurology and cardiology societies, the investigators decided in 2002 some good medical practices to define a specific and precise population for whom the closure of permeable oval formaen after a first cva seem to be necessary. current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. one year after implantation, the investigators systematically realized a control by mri associated to a contrast echography. in the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "good medical practice" before the publication of prospective and randomised clinical studies.


Eligibility criteria:
inclusion criteria: * less than 55 years old * occlusion of fop after cryptogenic cva exclusion criteria: * characterized thromboembolic event * patients who have a surgery after transitory ischemic accident
aspirin in reducing events in dialysis ( aspired )

Conditions: CKD (Chronic Kidney Disease) Stage 5D

Summary: people with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (cv) disease compared with the general population. a cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (eskd). at the same time, this population has increased risks of clotting as well as bleeding episodes. while aspirin is known to reduce cardiovascular complications in the general population, evidence to support the use of aspirin in people with eskd receiving dialysis therapy is currently lacking. the aspirin to reduce event in dialysis (aspired) trial will test whether aspirin use in dialysis patients safely improves outcomes compared with no aspirin use.

aspired is an investigator-initiated, multi-center, double-blind, parallel group, event-driven, pragmatic, registry-based randomized controlled trial that will define the value of low dose aspirin (100 mg daily) on cardiovascular events in people with eskd receiving dialysis. the study will be conducted using the existing platform of the chinese peritoneal dialysis (pd) and hemodialysis (hd) dialysis registry to screen, recruit and to collect study data as part of patient's routine clinical care during dialysis to improve efficiency and to minimize cost of a clinical trial. aspired is an event driven trial with an anticipated duration of approximately 5 years. randomization will be performed using a web-based system via a pass word protected encrypted website interface. the study procedure utilizes routine six-monthly clinic visits for study follow-up to increase efficiency and minimize the burden on participants. the analysis will be based on intention-to-treat principles. an independent data safety and monitoring board (dsmb) will established to monitor the study for safety and efficacy.

Eligibility criteria:
inclusion criteria: * incident or prevalent adults (≥18 years old) dialysis patients are included in the dialysis registry. * commenced on dialysis with the expectation of ongoing maintenance dialysis requirement. * willing and able to provide informed consent for this study. exclusion criteria: * requirement for any form of antiplatelet agent (aspirin, glycoprotein iib/iiia inhibitors etc), or oral anticoagulation (warfarin, noacs), in the view of the treating physician. * contraindication to aspirin, in the view of the treating physician. * dialysis requirement due to acute kidney injure with expectation of kidney function recovery. * history of haemorrhagic stroke or intracranial bleed within 12 months of screening. * coagulopathy from any cause. * unable to provide informed consent.

Keywords: aspirin dialysis end stage kidney disease
the study to treat superficial femoral artery occlusions.

Conditions: Arterial Occlusive Diseases

Summary: the main objective of this study is to assess the performance of the cordis smart™ nitinol self-expandable stent for the treatment of superficial femoral artery (sfa) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

this is a multi-center, prospective, randomized, two-arm study evaluating the performance of the cordis smart™ nitinol self-expanding stent as compared to angioplasty only. it is anticipated that a total of 150 patients will be entered into the study. patients will be randomized on a 1:1 basis of stent versus angioplasty only. 150 patients with de novo or restenotic native sfa occlusions (5-22 cm) with reference vessel of \>= 4.0 to \<= 6.0 mm in diameter will be randomized to the smart™ nitinol self-expanding stent or to angioplasty only. all patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. this study will be conducted at up to 12 investigational sites.

Eligibility criteria:
inclusion criteria: * one superficial femoral artery de novo or restenotic lesion (\> 70% stenosis or occlusions), with a lesion length \> 5 to \< 22 cm. * patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions exclusion criteria: * revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure patient having total occlusions of the iliac artery on the same side must be excluded. however, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion. * patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the cordis medical monitor and the principal investigator of this study.

Keywords: peripheral artery occlusive disease
neoadjuvant chemotherapy or chemoradiotherapy in resectable oesophageal carcinoma（newec study）

Conditions: Radiotherapy Side Effect; Chemotherapy Effect; Oesophageal Carcinoma; Effect of Drugs; Safety Issues

Summary: to provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (ncrt) versus neoadjuvant chemotherapy (nct) versus surgery alone in resectable oesophageal carcinoma.

neoadjuvant chemotherapy (nct) or neoadjuvant chemoradiotherapy (ncrt) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.previous evidence-based findings and the current guidelines have not established a survival advantage of ncrt over nct or an acceptable safety profile of the addition of radiotherapy to nct; whether ncrt or nct is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.this study aims to provide comprehensive efficacy and safety profiles of ncrt versus nct versus surgery alone in resectable oesophageal carcinoma.

Eligibility criteria:
inclusion criteria: * patients with histologically documented untreated scc or adenocarcinoma of the oesophagus or gastro-oesophageal junction. * patients clinically staged as stage i-iii (t1-3, n0-1 and m0) as assessed by a contrast-enhanced multislice computed tomography (ct) scan, positron emission tomography, or endoscopic ultrasonography. * patients had an eastern cooperative oncology group (ecog) performance status of 0 to 2. exclusion criteria: * patients had received any previous treatment for oesophageal cancer. * patients who were unsuitable for surgery because of comorbidities. * patients had evidence of distant metastatic disease by history and physical examination.

Keywords: neoadjuvant chemoradiotherapy neoadjuvant chemotherapy resectable oesophageal carcinoma effective safety
piedmont aging, cognition & exercise study-2

Conditions: Mild Cognitive Impairment; Prediabetes

Summary: the purpose of this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. the investigators will also examine the effects of this exercise on certain proteins and hormones in body fluids, and on brain structure and function using magnetic resonance imaging (mri). recent studies indicate that exercise improves memory and thinking abilities for adults with mild memory loss or pre-diabetes. this study examines the effects of exercise on people with mild memory loss and pre-diabetes.


Eligibility criteria:
inclusion criteria: * 50 years or older * mild memory concerns * in good health * not taking diabetes medications * not currently exercising exclusion criteria: * significant neurologic disease that might affect cognition, such as ad, stroke, parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness \> 30 min or with permanent neurologic sequelae; * significant medical illness or organ failure, such as: * liver disease: history of hepatitis or hepatic failure * significant elevations in liver function tests: lab values more than 2.5 times the upper limit of normal * kidney disease known history of kidney failure. * uncontrolled hypertension * cardiovascular disease, defined as: any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional pvc's are ok) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema, is an exclusion. history in the last year of myocardial infarction, angina, coronary artery angioplasty, bypass grafting, pacemaker insertion, stent placement, postural hypotension, transient ischemic attack, or carotid artery surgery. * chronic lung disease, such as: copd/emphysema * hemoglobin a1c levels that fall outside the range of 5.7-6.4%; if 2-h ogtt glucose values 220 mg/dl and hemoglobin a1c levels meet inclusion criteria (5.7-6.4%), then pcp written indication that no pharmacologic intervention for type 2 diabetes is needed at present will be required for continued study participation. * current use of anti-psychotic, anti-convulsant, anxiolytic, or sedative medication; * current use of any cognition-enhancing medication, including experimental medications within the past 60 days; * current or previous use of hypoglycemic agents or insulin (except during pregnacy); diabetics previously on oral agents but have been off of them for \> 1 year are ok pending pi and study physician approval. * musculoskeletal impairment sufficient to interfere with study participation

Keywords: mild cognitive impairment cognitive disorders prediabetes exercise
mesentery guide identify microscopic clean resection and reduces crohn's endoscopic recurrence

Conditions: Crohn Disease; Recurrence

Summary: microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic crohn's disease (cd). we aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection.

despite proactive prophylactic treatment administered after surgery for crohn's disease (cd) patients, early postoperative endoscopic recurrence (eper) still occurs in 50-80% of patients within six months, increasing the risk of long-term clinical and surgical recurrence. risk factors for eper have already been identified, including active smoking, disease behavior, younger age, concomitant perianal disease, prior intestinal resections, and microscopic resection margin positivity. recently, the influence of microscopic inflammation at the resection margin on eper has been highlighted by various studies and meta-analysis. from a surgical perspective, it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks, while the optimal strategy to attain the microscopic clean margin and minimize eper remain unclear, considering the limited accuracy of frozen-section examinations. more importantly, the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization, potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery. therefore, identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division. as a hallmark of cd, the hyperplasia of mesenteric adipose tissue (mat) or "creeping fat," was found directly triggered by transmural inflammation and bacterial translocation from cd affected lumen11. correspondingly, creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12. however, its relationship with microscopic inflammation, as well as its potential role in determining the division position to achieve better eper outcomes, remains to be clarified.

Eligibility criteria:
inclusion criteria: * localized ileocolic cd exclusion criteria: * patients with a stoma,residuallesion ,history of bowel resection,or post-operative abdominalinfection were excluded

Keywords: mesentery guide microscopic clean resection endoscopic recurrence
counterfactual thinking and decision-making in parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by parkinson's disease when compared to healthy individuals.


Eligibility criteria:
inclusion criteria: • diagnosis of parkinson's disease, according to the medical assessment performed by trained neurologists. exclusion criteria: * diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment; * concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders; * dementia, according to the clinical/neuropsychological assessment.

Keywords: counterfactual thinking decision-making neuropsychological assessment clinical setting