Kornimate/medical-research-clean huggingface dataset:
performance assessment of the pmd-200 in subjects at neurointensive care unit

Conditions: Anesthesia, General

Summary: performance assessment of the pmd-200, a novel pain monitor, in subjects at neurointensive care unit.

the proposed study is design to further demonstrates the performance of the nociception level (nol) index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the nol response to the eeg derived pain score. validating the performance of the nol index may provide a tool to monitor the pain/nociception in this population. in this study, the pi plan to demonstrate that the nol index is a continuous index. it is anticipated that a higher level of nociception will correspond to a higher nol index. on the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower nol index. the participants will be monitored as in a typical icu and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, bispectral index (bis), electroencephalography (eeg) etc.

Eligibility criteria:
inclusion criteria: * age \> 18 years old. * the subject is under general anesthesia * the subject have a blood pressure measurement (either arterial or cuff) during the study * a signed informed consent form (icf) has been obtain exclusion criteria: - the subject is constantly agitate or moving a lot
a study of fruquintinib in combination with tislelizumab in advanced solid tumors

Conditions: Triple Negative Breast Cancer; Endometrial Cancer; Solid Tumor, Unspecified, Adult; Colorectal Cancer

Summary: this is an open-label, multi-center, non-randomized, phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. this study will be conducted in 2 parts; a safety lead-in phase (part 1) and a dose expansion phase (part 2). the safety lead-in phase, open to any-comer solid tumors, will determine the rp2d. the rp2d will be administered to 3 cohorts of patients in the dose expansion phase. * cohort a: advanced or metastatic triple negative breast cancer (tnbc) (io-treated) * cohort b: advanced or metastatic triple negative breast cancer (tnbc) (io-naïve) * cohort c: advanced or metastatic endometrial cancer (ec) (io-naïve) * cohort d: advanced or metastatic colorectal cancer (mcrc) (io-naïve)


Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines; 2. age ≥18 years; 3. histologically or cytologically documented, advanced or metastatic triple negative breast cancer, histologically or cytologically documented, advanced or metastatic endometrial carcinoma, histologically or cytologically confirmed advanced or metastatic, unresectable adenocarcinoma of the colon or rectum. 4. tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment. 5. eastern cooperative oncology group (ecog) performance status ≤1. 6. at least 1 measurable lesion as defined by recist v1.1. exclusion criteria: 1. has at screening any central nervous system metastasis and/or leptomeningeal disease. 2. except for cohort a, prior therapy targeting ctla-4, pd-1, pd-l1 or programmed cell death protein ligand-2 (pd-l2) or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways. 3. prior treatment with a vegfr-tki or anti-vegfr antibody (eg, ramucirumab). 4. except for cohort d, prior treatment with an anti-vegfr antibody (eg, bevacizumab). 5. tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment. 6. active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: breast cancer triple negative her2- hr- er- pr- her2 negative hr negative er negative pr negative tnbc vegf vegfr endometrial cancer colon rectal mcrc colorectal
the national program for the improvement of management of fetal congenital heart disease in china

Conditions: Congenital Heart Disease in Pregnancy; Prenatal Diagnosis; Fetal Echocardiography

Summary: to investigate and evaluate the capacity of prenatal screening, diagnosis and counseling of congenital heart disease in medical institutions in china, in order to understand the current status and existing problems of prenatal prevention and treatment capacity of congenital heart disease in china, and to obtain corresponding baseline data, so as to provide scientific basis for further improving prenatal screening and diagnosis policies in china.

with the rapid development of medical imaging technology, the role of ultrasound screening and diagnosis in the prevention and treatment of birth defects is increasingly prominent. early screening, classified diagnosis, and standardized consultation are the basis for effective prevention and treatment of congenital heart disease. due to the uneven development of medical resources and medical service levels in the eastern, central, and western regions of china, as well as between urban and rural areas, the ability of prenatal ultrasound screening, diagnosis, and clinical consultation varies greatly, and there is a lack of relevant clinical research data, which makes it difficult to adopt effective intervention measures. this study aims to investigate and analyze the prenatal screening, diagnosis, and consultation abilities of medical personnel in different regions, evaluate the current status and problems of congenital heart disease abilities in various regions, explore a multidisciplinary transfer consultation integrated service mechanism, strengthen comprehensive prevention and control abilities, ensure maternal and infant health.

Eligibility criteria:
inclusion criteria: * all pregnant women and fetuses who underwent prenatal ultrasound examination in the above hospitals were enrolled exclusion criteria: * pregnant women not willing to cooperate

Keywords: congenital heart disease prenatal diagnosis fetal echocardiography maternal-fetal medicine digital health technologies
pancreatic enzyme replacement and glucose regulation in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: recent studies have demonstrated reduced pancreatic volume is present within months of t1d diagnosis in children, adolescents, and adults. as the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of t1d being solely a disease of the endocrine pancreas. to date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of t1d. in individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved glp-1 responses to mixed meal tolerance testing. as post-prandial excursions and glucose variability are a significant challenge in t1d, how enzyme replacement may impact these parameters is an important question. the investigators hypothesize that patients with t1dm who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (creon).


Eligibility criteria:
inclusion criteria: * currently receive care at the eskind diabetes clinic at vanderbilt university medical center * diagnosed with t1dm for at least 12 months * age over 18 * total daily dose of insulin greater than 0.7u/kg/day * current use of a continuous glucose monitor * current use of smart phone * able to read and speak english * willingness and ability to download and provide cgm and pump (if applicable) data * reduction of pancreas volume (\<0.6ml/kg body weight) exclusion criteria: * history of celiac disease or inflammatory bowel disease * use of medication or supplements other than insulin to control blood glucose * pregnancy or breast feeding * following a restrictive diet (such as very low carb diet)
semi-recumbent vibration therapy in older adults

Conditions: Sarcopenia; Aging

Summary: this proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and muscle mass.

there are four study visits; screening/baseline followed by eight weeks of training three times a week, visit 1 at eight weeks followed by 4 weeks of washout, visit 2 at 12 weeks followed by eight weeks of training three times a week, and a final visit 3 at 20 weeks. at the screening visit, volunteers will be asked to perform tests included in the short physical performance battery (sppb) (gait speed, chair rise, balance). if the participants score is ≤ 9 or ≤ 2 in any of the three tests included in the sppb they will be eligible for the intervention phase. at the baseline visit several questionnaires will be obtained and participants then will proceed with muscle function tests (sppb, jumping mechanography, grip strength, timed-up-and-go test). participants will then be randomized into one of two groups. the first group will receive vibration + loading treatment for the first 8 weeks, the second group will receive sham treatment (loading only). after 8 weeks both groups will go through a 4 week wash-out period and then crossover will occur. the first group will now receive sham treatment (loading only) while the second group will receive vibration + loading treatment. the participants will train for 10 minutes, 3 times a week, during the active 16 total weeks.

Eligibility criteria:
inclusion criteria: 1. men and women age ≥ 70 years 2. able and willing to sign informed consent 3. able to stand without assistance 4. able and willing to train for 10 minutes, 3 times per week 5. total sppb score of ≤ 9 or ≤ 2 in any of the three tests included in the sppb exclusion criteria: 1. cognitive impairment to the degree that it limits the ability of signing informed consent 2. unable to sit upright for 10 minutes 3. history of injury or surgery within the prior six months which limits the ability to ambulate 4. major illness that might cause missed training sessions or visits.
peripheral nerve block techniques during cleft palate

Conditions: Postoperative Pain

Summary: regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. suprazygomatic maxillary nerve block (smn) and greater palatine nerve block (gpn) are regional blocks described for use during cleft palate (cp) repair surgery.the aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral gpn and bilateral smn blocks in children undergoing palatoplasty surgery.


Eligibility criteria:
inclusion criteria: * asa i-iii scheduled to undergo palatoplasty exclusion criteria: * bleeding disorders, * skin lesions or wounds at site of proposed needle insertion, * congenital heart disease, * respiratory or * cardiovascular disorders, * children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting, * known hypersensitivity to local anesthetics or opioids and * lack of parental consent.

Keywords: suprazygomatic maxillary palatine cleft palate
fluoxetine on motor rehabilitation after ischemic stroke

Conditions: Ischemic Stroke; Motor Impairment

Summary: recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. some drugs may have a positive effect when combined with physical rehabilitation. previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. in 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (selective serotonin reuptake inhibitor - ssri) improved motor performance and modulated cerebral plasticity. we conducted a phase iib prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

we project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. nine stroke centers in france are involved. each patient will receive daily, during three months, 20 mg of fluoxetin or placebo. patients will be evaluated at inclusion, day 30, m3 (3 months), m12.

Eligibility criteria:
inclusion criteria: * men and women aged from 18 to 85 * no motor relapse from a previous stroke * inclusion from day 5 to day 10 after stroke * ischemic stroke with unilateral motor deficit * motor nihss ≥ 5 on the affected side of the body * nihss \< 20 * fugl meyer motor scale \<55 * modified rankin scale between 1 and 5 * informed consent obtained from the subject or a member of his family exclusion criteria: * pregnant or breast-feeding woman * woman able to procreate without valid contraception * subject protected by law * concomitant disease with unfavourable prognosis within 1 year * drug addiction * allergy to fluoxetine * hepatic failure (tgo and tgp \>2n) * permanent renal failure (creatinin \>180micromol/l) * patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (imao), and neuroleptics in the past month * depression requiring pharmacological treatment * previous stroke with motor relapse * fugl meyer motor scale \> 55 * modified rankin scale = 0 or 6 * patients needing carotid surgery within 3 months * aphasia preventing correct evaluation of motor and depression scales.

Keywords: stroke recovery pharmacological modulation selective serotonin reuptake inhibitor (ssri) fluoxetine brain plasticity ischemic stroke and motor impairment modulation of recovery and cerebral plasticity by fluoxetine
isolation procedure vs. conventional procedure during distal pancreatectosplenectomy for pancreatic cancer

Conditions: Resectable Pancreatic Body/Tail Carcinoma

Summary: in the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the end.


Eligibility criteria:
inclusion criteria: * resectable pancreatic cancer (adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer) * asa-ps (american society of anesthesiology, general condition classification) is class 1-3. * age are over 20 years old. * able to understand the content of the research and has obtained written consent from the person himself/herself. exclusion criteria: * non-resectable pancreatic cancer by image diagnosis at the initial diagnosis * cases suspected of portal vein (superior mesenteric vein) invasion * patients with severe ischemic heart disease * patients with cirrhosis or active hepatitis requiring treatment * patients with dyspnea requiring oxygen administration * patients undergoing dialysis due to chronic renal failure * cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary * patients with strong suspected paraaortic lymph node metastasis * active double cancer thought to affect adverse events and prognosis * long-term oral steroids that may affect adverse events * patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms. * cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. invasive intraductal papillary mucinous carcinoma (ipmc) is excluded. * patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy * cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis
improving neurodevelopment in adolescents with congenital heart disease

Conditions: Congenital Heart Disease; Neurodevelopment; Executive Function; Working Memory Training; Infant Open-heart Surgery

Summary: executive dysfunction can profoundly impact all dimensions of a child's development. impairments in executive function are a central component of the neurodevelopmental phenotype associated with chd, and manifest as behavioral dysregulation and problems with attention, working memory, and organization/planning abilities. identifying effective treatment strategies is vital for providing optimal care for these patients. the cogmed executive function intervention, an evidence-based computerized neurocognitive program, improves outcomes in several pediatric populations. the investigators propose to conduct a pilot study to evaluate its efficacy in reducing morbidities in patients with chd. this is a single center, single blinded 2-arm randomized controlled trial to test the immediate post-treatment and 3-month follow-up efficacy of cogmed intervention versus standard of care in adolescents with chd.


Eligibility criteria:
inclusion criteria: 1. diagnosis of chd requiring open-heart surgery before age 1 year. 2. ages 13-16 years old. 3. ≥ 6 months post-cardiac surgery. 4. followed-up at the cardiology clinic of boston children's hospital. 5. english and/or spanish speaking. 6. home internet access and a computer on which the cogmed program can be installed 7. informed consent of parent/guardian as well as assent of child. exclusion criteria: 1. chromosomal anomalies and/or genetic syndromes. 2. severe physical and/or sensory impairments (hearing, visual, or psychomotor). 3. iq scores \<85 at baseline 4. confirmed diagnosis of an autism spectrum disorder or a severe developmental disorder that would prevent successful completion of the planned study testing. 5. scheduled to undergo major cardiac interventions in the 6 months following enrollment. 6. received, receiving, or scheduled to receive cogmed or any other computerized behavioral training program targeting executive functions or adhd.
optimization strategy for oxygen delivery under cardiopulmonary bypass

Conditions: Cardiac Surgery

Summary: cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (aki) or postoperative delirium. during the intervention, a cardiopulmonary bypass (cpb) is used to ensure tissue perfusion and oxygen delivery (do2). the hypothesisis that an individualized strategy to optimize do2 during cpb could decrease complications rate after cardiac surgery. indeed, it is known that do2 depends on cpb output, hemoglobin level and o2 tension. to this day, a do2 threshold below 280 ml is known to be associated with postoperative aki. from these data, a "goal directed perfusion" strategy is widely used to maintain a do2 above this threshold during cpb. but do2 decrease in unpredictable, and the other factors influencing do2 interindividual variability are not known. moreover, the relation between do2 and tissue perfusion is not well established, as do2 requirement could differ between individuals or organs. population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. using this method, the aim of this study is to evaluate do2 variability during cpb and develop a model to optimize gdp strategy.


Eligibility criteria:
inclusion criteria: * patients aged over 18 * patients scheduled for elective cardiac surgery under cpb at the university hospital of lille, france * patients with given written consent * patient insured under the french social security system exclusion criteria: * pregnant or breastfeeding * off pump cardiac surgery * lack of do2 monitoring * emergency surgery (infectious endocarditis, aortic dissection, cardiac transplantation, lvad implantation) uncontrolled sepsis

Keywords: oxygen delivery cardiopulmonary bypass cardiac surgery goal-directed perfusion acute kidney injury
tuvusertib (m1774) human mass balance and absolute bioavailability study (ddriver solid tumors 303)

Conditions: Solid Tumor

Summary: this is a single sequence 2-period open label study in participants with advanced solid tumors. the purpose of period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. the purpose of period 1a is to assess the extent of aba of tuvusertib and the mass balance, pk, metabolism, and elimination of 14c-tuvusertib after iv dosing in participants with advanced solid tumors. after either period 1 or period 1a; participants may enter an optional extension phase (period 2) where participants will receive tuvusertib until disease progression or other criteria for study intervention discontinuation are met.


Eligibility criteria:
inclusion criteria: * are histologically proven advanced solid tumors that are considered appropriate for treatment in period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated * eastern cooperative oncology group performance status (ecog ps) less than or equal to 1 (\<=) 1 * have evaluable disease according to response evaluation criteria in solid tumors (recist) 1.1 at screening * are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and this protocol * other protocol defined inclusion criteria could apply exclusion criteria: * uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (new york heart association classification more than equal to (\>=) class iii), uncontrolled cardiac arrhythmia, calculated corrected qt interval (qtc) average using the qt interval corrected using fridericia's formula (qtcf) more than (\>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start * presence of toxicities due to prior anticancer therapies (e.g. radiotherapy, chemotherapy, immunotherapies, et cetera (etc.)) that do not recover to (\<=) grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the investigator (e.g. ongoing grade 2 alopecia) * treatment with live or live attenuated vaccine within 30 days of dosing (non-replicating vector vaccines are permitted) * participation in a study involving administration of 14c-labeled compound(s) within last 6 months prior to start of study intervention * other protocol defined exclusion criteria could apply

Keywords: ataxia telangiectasia mutated and rad3-related (atr) inhibitor adme tuvusertib (m1774)