Kornimate/medical-research-clean huggingface dataset:
comparison of cardiac output with lidco rapid and tee against thermodilution technique in cardiac surgery

Conditions: Low Cardiac Output

Summary: measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. it helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output. investigators would like to compare the most popular minimally-invasive devices used to measure cardiac output using arterial waveform: lidco rapid and tee with the thermodilution method at various phases of the cardiac surgery.

measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. it helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output, however over the past 10 to 15 years it has been questioned about its safety and efficacy. there has been a surge in recent years of less invasive devices capable of measuring cardiac output by various means, including bioimpedance, transpulmonary thermodilution, transthoracic and transesophageal echocardiography, and arterial waveform analysis. there is a variety of devices currently available for cardiac output measurement by arterial-waveform analysis. these devices have been compared to each other, and to the pulmonary artery catheter as the gold standard. however, the companies manufacturing these devices have made software upgrades that they believe improves their performance. no studies have been performed comparing the uncalibrated arterial waveform based cardiac output measurement device,lidcorapid since the software upgrades. in addition to baseline cardiac output measurements, investigators intend to study the effect of volume loading (by trendelenburg position), sympathetic stimulus (incision), a vasodilated state (15 minutes after separation from cpb) and chest closure on cardiac output measured by the three different techniques. in addition to cardiac output the investigators would like to measure stroke volume ,systemic vascular resistance, stroke volume variation with lidco . the main purpose is to validate the accuracy of measurements by these two minimally-invasive methods in comparison with thermodilution method in various hemodynamic states.

Eligibility criteria:
inclusion criteria: * elective cardiac procedures other than those specified in the exclusion criteria exclusion criteria: * all emergency cardiac procedures, prisoners and pregnant women, patients who are scheduled for ventricular assist devices and those with severe aortic, mitral and tricuspid insufficiency will be excluded.
joint attention intervention and young children with autism

Conditions: Autism

Summary: the purpose of this study is to investigate the effectiveness of an intervention aimed to increase joint attention in 2-4 year old children with autism. the study will be conducted in mainstream preschools in norway. the intervention will be implemented by preschool teachers and paraprofessionals supervised by trained counselors.

young children with autism experience severe deficit in joint attention skills (e.g. pointing to objects, showing, following another person's gaze, responding to invitations to social interaction). ability to initiate and respond to joint attention is linked to children's later language abilities. as a mean to improve language outcome in children with autism, it is important to target joint attention in early intervention programs. this study investigates the effectiveness of a joint attention intervention. sixty 2-4 year old children with autism will be randomized to an intervention group or a control group. children in both groups will continue their ordinary preschool program. however, the children in the intervention group will also participate in 80 joint attention intervention sessions. the sessions (20 minutes each) will be conducted twice a day for 8 weeks by preschool teachers or paraprofessionals working in the preschools. before starting the intervention preschool teachers and paraprofessionals will be taught how to teach joint attention skills and how to initiate and maintain episodes of joint engagement. during the course of intervention they will be supervised by trained counselors. outcome measures will include joint attention skills, language skills and joint engagement. children will be assessed at baseline, after 10 weeks and at follow up 6 months and 1 year after the end of the intervention. the measures are based on direct testing of the children, video observations and questionnaires to parent and professionals.

Eligibility criteria:
inclusion criteria: * diagnosis of autism * age 2-4 year old exclusion criteria: * severe mental retardation * severe clinical cns disorders

Keywords: autism joint attention intervention joint engagement language
ace1702 in subjects with advanced or metastatic her2-expressing solid tumors

Conditions: Locally Advanced Solid Tumor; Metastatic Cancer; Solid Tumor; HER2-positive Gastric Cancer; HER2-positive Metastatic Breast Cancer

Summary: ace1702 (anti-her2 onk cells) is an off-the-shelf natural killer (nk) cell product that targets human her2-expressing solid tumors. the ace1702-001 phase i study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ace1702 in patients with advanced or metastatic her2-expressing tumors, and to determine the phase ib/ii starting dose for ace1702.


Eligibility criteria:
inclusion criteria: * signed informed consent * subjects must be ≥ 18 years of age ( ≥ 20 years of age for taiwan site) * subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit. * histologically confirmed her2 expression. * eastern cooperative oncology group (ecog) performance status ≤ 1 * measurable or non-measurable evaluable disease according to recist 1.1 * adequate hematologic and end-organ function at baseline * oxygen saturation via pulse oxygenation ≥ 90% at rest on room air exclusion criteria: * untreated central nervous system (cns) metastases * multiple primary malignancies * clinically significant cardiovascular disease such as new york heart association (nyha) cardiac disease (class iii or greater) * pregnant or lactating female * serious, uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive study treatment * history of autoimmune or immune mediated symptomatic disease * any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study

Keywords: nk cell therapy cellular therapy breast cancer gastric cancer ovarian cancer endometrial cancer metastatic cancer colorectal cancer head and neck cancer pancreatic cancer bladder cancer non-small-cell lung carcinoma
forced fluid removal in high risk acute kidney injury

Conditions: Acute Kidney Injury; Fluid Overload; Critical Illness

Summary: the objective of this pilot trial is to assess the feasibility of forced fluid removal in patients admitted to the intensive care unit (icu) with high-risk aki and severe fluid overload. the intervention will use furosemide infusion and/or continuous renal replacement therapy (crrt) to achieve and maintain a neutral cumulative fluid balance. the intervention will be compared to standard of care as reflected in the kidney disease improving global outcome (kdigo) guidelines.

acute kidney injury (aki) is a common and serious complication in patients admitted to icu. a core element of critical care is resuscitation with crystalloid solutions. in many cases fluid accumulates and patients become fluid overloaded (positive fluid balance \> 10% of bodyweight). this is especially true in patients with aki, since they often have impaired ability to excrete salt and water. most observational suggests harm with increased positive fluid balance. objectives: to assess feasibility of forced fluid removal with diuretics and/or crrt in icu patients with aki and severe fluid overload, compared to current clinical practice. design: multicentre, parallel group, randomized, assessor blinded pilot-trial with adequate generation of allocation sequence, and allocation concealment. trial size: the pilot study is planned to include 50 patients. inclusion is expected to start in august 2015.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * acute kidney injury defined according to the kdigo criteria * renal recovery score ≤ 60%. (calculated using www.renal-recovery-score.com) * fluid overload defined as a positive fluid balance ≥ 10% of ideal body weight. * able to undergo randomization within 12 hours of fulfilling other inclusion criteria exclusion criteria: * known pre-hospitalization advanced chronic kidney disease. (egfr \< 30 ml/minute/1.73 m2 or chronic rrt.) * severe hypoxic respiratory failure (use of invasive ventilation and fio2 \> 80% and peep \> 10 cm h2o) * severe burn injury (≥ 10% tbsa) * severe hypo- or hyper- natremia (\ 155 mmol/l) * hepatic coma * mentally disabled undergoing forced treatment * pregnancy/breast feeding * lack of commitment for on-going life support including rrt * lack of informed consent

Keywords: icu intensive crrt fluid removal aki critical care
intervention for anxiety after falls

Conditions: Posttraumatic Stress Disorder (PTSD); Specific Phobia; Anxiety

Summary: the purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls.

falls are the most commonly occurring cause of traumatic injury among older adults. for many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. most interventions for falls do not address anxiety in the aftermath of falling. after an initial study assessment, participants will complete 8 home-based sessions of a cognitive-behavioral therapy (cbt). the sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people). participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.

Eligibility criteria:
inclusion criteria: * age \> or = 65 years * english-speaking * injured due to fall * hospitalized * returned home \< or = 3 months * ambulatory * full or subsyndromal ptsd or fear of falling * residing in one of the five boroughs of new york city exclusion criteria: * inability to understand assessment questions * marked cognitive impairment * dementia * schizophrenia * bipolar disorder * depression with psychotic features * delusional disorder * substance use disorder or dependence * active suicidal ideation, intent, or plan * active homicidal ideation, intent or plan * aphasia * acute or severe medical illness or life expectancy \< 6 months * initiated psychotropic medications \< 6 weeks prior * initiated mental health treatment \< 6 weeks prior * psychosocial factors that would compromise study participation (such as not having a telephone)

Keywords: ptsd fear of falling older adults injurious falls exposure therapy
proteomic analysis of crohn's disease macrophages in response or not to aiec

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: the m2ish laboratory showed with two previous clinical trials that crohn's disease (cd) macrophages present i) a defect to control adherent-invasive escherichia coli (aiec) infection related to polymorphisms associated with cd; ii) a cd - specific cytokine secretion profile after an aiec infection and intestinal inflammation dependent; iii) a modification of the response of cd macrophages at a basal state and after the aiec infection. these results consolidate the hypothesis of a defect specific to cd macrophages. that's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of cd patients infected or not with aiec and to compare them to ulcerative colitis (uc) patients and healthy volunteers.

the macrophages characterization will be realized at a basal state and in response or not to aiec. investigator aimed to 1) better understand the differences between macrophages of cd patients, uc patients and healthy volunteers but also the impact of aiec infection on these macrophages to provide key informations to detect and characterize the defect of these macrophages; 2) highlight one or several protein in cd macrophages that could represent, in a long term, a potential therapeutic target of cd.

Eligibility criteria:
inclusion criteria: * - crohn's disease or ulcerative colitis or healthy volunteers * age \> 18 years * patients benefiting from the health insurance plan * patients who can read and attest to understanding the information note and informed consent exclusion criteria: * pregnant or breastfeeding woman * under guardianship or curatorship * refusing the genetic part of the study

Keywords: crohn's disease ulcerative colitis macrophages adherent-invasive escherichia coli proteomic analysis
chemo-free in older (≥65) node-positive er+/her2- breast cancer

Conditions: Breast Cancer; Adjuvant Therapy

Summary: this study is a prospective, open-label, multicenter, randomized controlled phase iii clinical trial. based on the use of cdk4/6 inhibitors in endocrine-sensitive luminal-type (er+/her2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, hr+/her2- breast cancer.


Eligibility criteria:
inclusion criteria: -1. age: female patients aged ≥65 years. 2. disease status: histologically confirmed early-stage breast cancer after surgery with er expression ≥50% and one of the following: 1. ≥4 positive lymph nodes 2. 1-3 positive lymph nodes plus at least one of the following high-risk features: i. high-risk multigene assay result ii. primary tumor size \>2 cm iii. histologic grade 3 iv. lymphovascular invasion (lvi) positive v. ki-67 \>20% 3. treatment acceptance: willing to receive adjuvant cdk4/6 inhibitor therapy. 4. performance status: ecog score 0-2. 5. adequate organ function: a) hematology (within 14 days, no transfusion): i. hemoglobin (hb) ≥90 g/l ii. absolute neutrophil count (anc) ≥1.5×10⁹/l iii. platelets (plt) ≥100×10⁹/l b) biochemistry: i. total bilirubin (tbil) ≤1.5×uln ii. alt/ast ≤3×uln iii. serum creatinine (cr) ≤1×uln iv. estimated creatinine clearance (crcl) \>50 ml/min (cockcroft-gault formula) 6. consent \& compliance: willing to participate, sign informed consent, and comply with follow-up. exclusion criteria: * 1. patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy). 2. bilateral breast cancer. 3. history of other malignancies, except: cured basal cell carcinoma of the skin； carcinoma in situ of the cervix 4. distant metastasis (any site). 5. any t4 lesion (uicc 1987 tnm staging), including: skin invasion; fixed mass adherence; inflammatory breast cancer 6. concurrent participation in other clinical trials. 7. severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including: a) lvef \ 150/90 mmhg) iv. myocardial infarction or stroke c) poorly controlled diabetes mellitus d) severe hypertension 8. known allergy to taxane-based drugs or their excipients. 9. severe or uncontrolled infections. 10. history of psychoactive drug abuse (unable to abstain) or psychiatric disorders. 11. patients deemed ineligible by investigator assessment. 12. refusal to receive adjuvant cdk4/6 inhibitor therapy.
us-guided ficb after hip fracture: the effect of the local anesthetic volume on the quality of preoperative analgesia

Conditions: Hip Fractures

Summary: participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed. for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected

participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed. a linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. after identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 . pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.

Eligibility criteria:
inclusion criteria: * patients aged above 65 years , american society of anesthesiologists physical status i to iii , and with body mass index (bmi) of 35 kg/m² or less , undergoing hip fracture surgical repair . exclusion criteria: * inability or refusal to sign informed consent * younger than 65 years * bmi greater than 35 kg/m² * presence of contraindications for regional nerve block or spinal anesthesia * impaired cognition or dementia * multiple fractures
pre-operative localization of ground glass solitary pulmonary nodules

Conditions: Lung Neoplasms

Summary: objectives: the main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (vats) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. in order to reduce the friction of the thread in the wall, the investigators modified the technique by first positioning a catheter in the chest wall and introducing the carrying needle through the catheter. the objective was to evaluate the success rate and complications of this technique. material and methods : the investigators retrospectively included all patients undergoing vats resection of solitary lung nodules after localization using the sliding wire technique.


Eligibility criteria:
inclusion criteria - all patients who underwent vats for pulmonary nodule resection in the thoracic surgery department of nice university hospital after pre-operative hook-wire insertion using the sliding-wire technique exclusion criteria: none
mechanism of growth hormone effects on adipose tissue

Conditions: Obesity

Summary: growth hormone treatment in humans has been shown to decrease body fat. this study aims to determine what adipose tissue depots are affected by gh and what is the mechanism.

growth hormone (gh) replacement in gh deficient adults results in an improvement in metabolic status, an increase in lean body mass and a reduction in visceral adiposity. gh might also decrease visceral adiposity in obese adults that are not gh deficient. the objective of the study is to determine the effects of gh on the metabolic syndrome and visceral adiposity in men with low blood levels of igf-1 and the durability of these effects after stopping gh therapy. we will use a double blind, placebo controlled 6 month intervention trial followed by a blinded follow-up period of 6 months. thirty non-diabetic middle aged men with central adiposity (bmi \> 27 kg/m2, waist circumference \> 102 cm) will participate.

Eligibility criteria:
inclusion criteria: * male, aged 40-70 * central obesity defined as waist circumference greater than 102 cm and bmi \> 27 and \< 35 kg/m2 * no weight loss in last 12 months * total igf-1 level \< 241 ng/ml (\~25th percentile for the assay) * body habitus which permitted accurate ct scan acquisition and analysis. exclusion criteria: * significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease * diabetes * known coronary heart disease * exercised more than 3 hours per week * unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work

Keywords: growth hormone, obesity, visceral adiposity
remote self-training program for patients with postural orthostatic tachycardia syndrome

Conditions: Postural Orthostatic Tachycardia Syndrome

Summary: the purpose of this research is to evaluate if a hybrid semi-supervised remote exercise training program can reduce symptoms and improve quality of life and physical fitness in individuals with postural orthostatic tachycardia syndrome (pots) and determine if this program is more effective than current standard of care.

to answer these questions, 60 individuals with pots will be recruited to complete a symptom-limited cardiopulmonary exercise test with measures of cardiac output, autonomic function testing, blood volume measurement, and qol questionnaires at baseline and following 3-months of treatment. thirty participants will be randomized to continue with the standard of care which can include lower body and core strengthening, fluids, salt, medications and sometimes exercise. the other thirty participants will be asked to complete at least three exercise training sessions a week (progressing to 3hrs/wk of aerobic and 1hr/wk of strength training) and receive eight supervised training sessions over the 3-month treatment period. all participants will be provided with a polar heart rate monitor which will be linked to a connected health application to allow patients to track any aerobic workout, ensure during a session they are in the correct training zone, and allow the study team to remotely monitor adherence.

Eligibility criteria:
inclusion criteria: * must be 18 years old or older * meet diagnosis criteria for pots = a heart rate increase of ≥ 30bpm with supine to 10 minutes of standing or head-up tilt or heart rate exceeding 120 ppm after 10 minutes of standing or tilt without evidence of orthostatic hypertension (a fall in bp of \> 20/10 mmhg) * been diagnosed with pots ≥6 months prior to participation in the study (chronic) * female subjects must not be pregnant or trying to become pregnant during duration of study participation * those in exercise training group must be on stable medications for at least 1 month and medication must remain consistent for duration of study participation. for those in the standard of care group, a change in medication will be allowed within the first month following baseline testing, but then must remain consistent until 3-month testing time point. * ehlers-danlos syndrome (eds) patients will be included, but will target equal randomization between treatment groups exclusion criteria: * individual is not eligible if they are currently exercising, cut off \>30 minutes of structured exercise/physical activity per week. (assessed by global physical activity questionnaire)