Kornimate/medical-research-clean huggingface dataset:
short effects of simt and em in prolonged mechanically ventilated patients

Conditions: Ventilator Dependent

Summary: using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. the aim of this study is to: 1. compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period. 2. compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program.

the prolonged mechanical ventilation results in difficulty weaning off the ventilator. inspiratory muscle strength and early mobilization can contribute to the expansion of lung parenchyma and facilitate success in weaning off respiratory support. thus, this study aimed to explain the impact of inspiratory muscle training and early mobilization on dynamic lung compliance, spontaneous breathing time, and success rate in patients who have undergone mechanical ventilation for more than 48 hours.

Eligibility criteria:
inclusion criteria: * patients with respiratory diseases who have been on mechanical ventilation for more than 48 hours and are ready to be weaned off or undergoing weaning trials with continuous positive airway pressure (cpap) or synchronized intermittent mandatory ventilation (simv). * the pao2/fio2 ratio is ≥ 150-200, with fio2 ≤ 0.4-0.5 and peep ≤ 5-8 cmh2o, and a ph \&gt; 7.3 in blood plasma. * the age range is between 40 and 80 years old. * patients exhibit good self-awareness and cooperation in training (riker score of 4). * they can understand and communicate in thai exclusion criteria: * clinical instability (hr \&gt; 120 beats/minute, rr \&gt; 30 breaths/minute, sato2 \&lt; 90%, sbp \&gt; 140 mmhg or \&lt; 90 mmhg) * patients who can be extubated and use non-invasive ventilation only or successfully extubated within the first 24 hours. * patients with altered mental status (glasgow coma score \&lt; 10) and inability to cooperate with training (riker score \&lt; 4 or \&gt; 4) * patients with limitations or contraindications such as inability to adjust the bed to a 45-degree angle or sit on the side of the bed, such as those with spinal cord injuries or recent head surgeries. * history of hemoptysis, pneumothorax * history of neuromuscular diseases causing muscle weakness and decreased sensation. * patients with excessive cardiac stimulation (\&gt; 5 micrograms per kilogram per minute) * heart rate \&gt; 140 beats per minute * hemoglobin levels \&lt; 8-10 grams per deciliter * patients with difficult airway issues.

Keywords: specific inspiratory muscle training early mobilization lung compliance prolong mechanical ventilation weaning outcome
exploring the potential of finger prick blood for assessment of biomarkers for low grade inflammation and cvd risk

Conditions: Biomarker

Summary: there are currently no minimally invasive techniques for the measurement of lipopolysaccharide (lps) and apo-b48 that can be used in samples collected in field settings. in this project we want to explore whether postprandial assessment of biomarkers lps and apob48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for cvd. the primary objectives of this pilot study are to a) determine whether postprandial lps and apob48 levels can be assessed in finger prick blood of both lean subjects and obese subjects; and b) compare postprandial lps and apob48 levels assessed in venous blood and blood collected through a finger prick test. this study is an observational pilot study in which postprandial lps and apob48 will be assessed before and after ingestion of a high fat load in 5 lean and 5 obese subjects in the age range 18-70 years. samples will be collected under fasting conditions and in response to a high fat challenge test (1, 2, 4 and 6 hours post ingestion). the risks for participation are very small if not negligible. no adverse effects of the high fat challenge were reported previously. consumption of high amounts of saturated fat may cause some gi discomfort. blood sampling will be performed via a cannula and the insertion can be a painful and may cause a bruise. finger prick might also give a short pain sensation and small bruises. the amount of blood that is drawn from participants is relatively small (total 37.5 ml) and is therefore within acceptable limits. there are no direct benefits for the participants. in the biologic study we include both lean subjects and obese subjects as we expect differences in postprandial responses related to differences in chylomicron production and lps levels. therefore it is important to explore these biomarkers in both target groups. this study can therefore be regarded as group-related, non-therapeutic research.


Eligibility criteria:
inclusion criteria: * age 18-70 years * living in the surroundings of wageningen (max. 25 km) * stable body weight for past 6 months * suitable veins for insertion of cannula * bmi 18.5-22 kg/m2 (lean subjects) * bmi ≥ 30 kg/m2 (obese subjects) exclusion criteria: * use of cholesterol-lowering medication (e.g. statins) * use of diabetes medication (e.g. insulin, metformin) * use of antibiotics or anti-inflammatory medication (e.g. nsaids such as ibuprofen) * known allergy for any of the food components used in the study (milk, cream, sugars) * blood clotting disorders * current smokers * alcohol consumption of \> 21 units per week * participation in another clinical trial at the same time * being an employee of wageningen food \& biobased research

Keywords: lps biomarker finger prick test postprandial
stem cell educator therapy in alopecia areata

Conditions: Alopecia Areata

Summary: alopecia areata (aa) is one of the most common t cell-mediated autoimmune diseases, leading to the chronic and relapsing hair loss. the prevalence of aa worldwide is 0.1 to 0.2%, affecting an estimated 5.3 million people in the united states. to date, the clinical therapies are limited and disappointed for the treatment of aa. alternative approaches are needed. increasing evidence demonstrates that stem cells possess the function of immune modulation. we established the stem cell educator therapy by using cord blood-derived multipotent stem cells (cb-scs)(zhao y, et al. bmc medicine 2012). a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent cb-scs in vitro, and returns the educated lymphocytes (but not the cb-scs) to the patient's circulation. our clinical trial reveals that a single treatment with the stem cell educator provides lasting reversal of autoimmunity that allows regeneration of islet beta cells and improvement of metabolic control in subjects with long-standing type 1 diabetes (t1d), which is another most common t cell-mediated autoimmune disorder in the united states. here, we develop and explore the therapeutic effectiveness of stem cell educator therapy in aa patients.

a 16-gauge iv needle is placed in the left (or right) median cubital vein, and the patient's blood is passed through a blood cell separator mcs+ (haemonetics®, braintree, ma) at 35 ml/min for 6 to 7 hours to isolate lymphocytes in accordance with the manufacturer's recommended protocol. the collected lymphocytes are transferred into the device for exposure to allogeneic cb-scs (or process control without cb-scs), and other blood components are returned to the patient. after 2 to 3 hours in the device, lymphocytes are returned to the patient's circulation via a dorsal vein in the hand under gravity flow control (2 to 3 ml/min) with physiological saline. approximately 10,000 ml of blood is processed during the procedure resulting in approximately two repeated educations for the lymphocyte fraction. patients are hospitalized for two days to monitor temperature and conduct routine laboratory blood tests for adverse reactions following treatment. follow-up visits are scheduled 4, 12, 24, 40, and 54 weeks after treatment for clinical assessments and laboratory tests

Eligibility criteria:
inclusion criteria: * patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards recommended by the national alopecia areata foundation (www.naaf.org). exclusion criteria: * exclusion criteria are any clinically significant diseases in liver, kidney, and heart. additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Keywords: stem cell educator cord blood stem cells immune modulation alopecia areata
associations between the oral and intestinal microbiome and neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: a pilot study for associations between the oral and intestinal microbiome and neovascular age-related macular degeneration and the investigation on the effect of oral probiotics as a treatment the investigators recruit the neovascular amd patients and control patients. 1. 15 neovascular amd patients with anti-vegf treatment and oral probiotics supplement 2. 15 neovascular amd patients with anti-vegf treatment and no oral probiotics supplement 3. 15 control patients and no oral probiotics supplement the investigators will collect stool, blood, and saliva sample at the baseline and 6 months, and analyze the oral and intestinal microbiome changes.


Eligibility criteria:
inclusion criteria: * normal bmi patients * diagnosed as neovascular amd (experimental \& sham group) * normal patients (control group) exclusion criteria: * obese (bmi \> 30) * past surgical history involving intestinal diseases * previous oral antibiotic treatment before 1 week at the baseline enroll * previous oral probiotics supplement * previous ophthalmic retinal diseases except neovascular amd

Keywords: neovascular amd microbiome
high-dose chemotherapy with rituximab for adults with aggressive large b-cell lymphoma

Conditions: B-Cell Lymphoma

Summary: a prospective pilot trial was proposed to patients with dlbcl, with ih or high adjusted ipi, up to the age of 60 y.o. this program consisted of 2 courses of high-dose r-chop-like regimen, followed by a course of high-dose methotrexate with cytarabin. for patients who achieved at least a pr, asct started with a beam regimen.

superiority of hdt with autologous stem cell transplantation (asct) in the upfront treatment of poor-risk dlbcl remains an option for intermediate-high (ih) or high ipi young adults. we updated results of the prospective trial goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent hdt with asct.

Eligibility criteria:
inclusion criteria: * age 18 to 60 y.o * aggressive large b-cell lymphoma (cd20+) * ann arbor stage iii, iv * ih or high adjusted ipi * signed inform consent exclusion criteria: * age \ 60 y.o * other type of lymphoma * serology vih + * other neoplasms apart from basal cell carcinoma or situ carcinoma

Keywords: aggressive large b-cell lymphoma (dlbcl) intensive chemotherapy rituximab asct
a dose response effect of atomoxetine to the acute effects of alcohol

Conditions: Alcohol Craving; Mood Changes

Summary: this two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; strattera) (a selective ne transporter (net) inhibitor) on alcohol-elicited craving and sensitivity to alcohol. the novelty of this study is that of atomoxetine and the fact that it targets net, neither of which has heretofore been examined in the context of alcohol dependence. it is hopeful that this pilot study, of 86 total individuals, will provide the pi with sufficient preliminary data to submit a subsequent r01 application to study atomoxetine and the involvement of specific single nucleotide polymorphisms within the net gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations. the long-term objective of this research is to develop more efficacious treatment interventions for alcohol abuse and dependence. hypothesis 1: it is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who receive a placebo. hypothesis 2: it is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication) than subjects who receive a placebo.


Eligibility criteria:
inclusion criterion: 1. males and females age 21 to 35, as verified upon the presentation of a valid driver's license; 2. must drink alcohol at least twice a week and have a minimum of 3 drinks per occasion (2 for women); 3. must score 8 or higher on the alcohol use disorders identification test (audit; babor et al., 1992). the audit is a screening instrument used to identify persons whose alcohol consumption is characterized by moderate to heavy drinking; 4. no history of alcohol treatment or desire for treatment; 5. not currently take medications that are contraindicated for concurrent use with alcohol; 6. female subjects must not be pregnant, as indicated by a pregnancy test that will be conducted immediately prior dispensing of medication. exclusion criterion: subjects who have hypertension, tachycardia, cardiovascular disease, hepatic or renal impairment, pregnant or who are currently using mao inhibitors, albuterol or other pressor agents will be excluded from this study.

Keywords: alcohol craving mood optimum dose of atomoxetine
stun (stop unhealthy) alcohol use now! implementing evidence-based services for unhealthy alcohol use in primary care

Conditions: Risky Health Behavior; Drinking, Alcohol; Alcohol Use Disorder; Drinking, Binge; Drinking Excessive

Summary: stun alcohol use now is an intervention designed to use primary care practice support services (practice facilitation) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. the original recruitment goal was 135 primary care practices in north carolina, which we were unable to meet due to pandemic-related barriers.

stun alcohol use now is an intervention designed to use primary care practice support services (practice facilitation or pf) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. 135 primary care practices in north carolina will be recruited. specific aim 1 will evaluate the effect of pf on uptake of evidence-based screening and brief intervention (sbi) for unhealthy alcohol use. the investigators hypothesize that pf will increase screening for unhealthy alcohol use and provision of brief counseling. the secondary hypothesis is that practice-level and contextual factors (capacity for quality improvement, organizational readiness to implement change, and implementation climate) will moderate the effect of pf on use of evidence-based screening and brief intervention (sbi) for unhealthy alcohol use. specific aim 2 will evaluate whether pf increases provision, among those identified as having an alcohol use disorder (aud), provision of medication assisted treatment (mat) or referral to specialty care. aim 3 (effect of providing embedded telehealth services) will not be evaluated due to lower enrollment than anticipated and delayed data collection (both related to the covid-19 pandemic) which have prevented randomization among practices with slower uptake of sbi after 6 months of pf. in aim 4 the investigators will evaluate the effect of pf on the implementation of clinical practice and office systems changes to improve evidence-based sbi and mat. the primary hypothesis is that pf will increase implementation of clinical practice and office systems changes to improve evidence-based sbi and mat. the secondary hypotheses are that (a) practice capacity for quality improvement (qi), organizational readiness to implement change, and contextual factors will moderate the effect of pf on the implementation of clinical practice and office systems changes and (b) embedded telehealth services will increase implementation of clinical practice and office systems changes among practices with slower uptake.

Eligibility criteria:
inclusion criteria: * small-to-medium sized primary care practices (10 or fewer providers) in north carolina exclusion criteria: * practices with fewer than 100 adult patients (18+ years) or more than 10 providers; * practices unwilling to implement evidence-based screening and management of patients with unhealthy alcohol use.

Keywords: alcohol, screening, counseling, primary care
to compare the efficacy of carbepenem versus carbepenem plus gm-csf in difficult to treat spontaneous bacterial peritonitis

Conditions: Spontaneous Bacterial Peritonitis

Summary: a minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the institute of liver and biliary sciences hospital with a diagnosis of difficult to treat sbp will be included and randomized into two treatment groups. group a - carbepenem+albumin group b - carbepenem+albumin+gmcsf.


Eligibility criteria:
inclusion criteria: 1. age more than 18 years 2. patients of decompensated liver cirrhosis who present with- spontaneous bacterial peritonitis (presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- dtt-sbp: * hospital acquired - new onset sbp (spontaneous bacterial peritonitis) after 48 h of hospitalization. * recurrent sbp - one or more prior episode(s) of sbp in year. * antibiotic resistant - resistance to 3rd gen cephalosporin in last 3 m. * antibiotic non-response -non-response to 3rd gen cephalosporin, sepsis on 3rd gen cephalosporin. exclusion criteria: 1. \< 18 years. 2. advanced hcc (hepatocellular carcinoma) 3. post liver transplant 4. hiv + ve, immunosuppressive therapy 5. pregnancy 6. domiciliary treatment 7. no consent
instrumental respiratory physiotherapy in difficult-to-wean icu patients

Conditions: Ventilator Weaning

Summary: difficult ventilatory weaning is associated with a 20% mortality rate. 40% of these patients will develop intensive care unit (icu)-acquired neuromyopathy, associated with reduced cough strength and a 4-fold increase in the risk of reintubation. the objective measure of cough strength is peak expiratory flow (pef). instrument-assisted coughing is a respiratory physiotherapy technique capable of significantly increasing pef in chronic neuromuscular patients and draining bronchial secretions. the objective of the study is to determine whether an early, systematic, instrumental, intensive respiratory physiotherapy strategy in patients with difficult ventilatory weaning and icu-acquired neuromyopathy significantly improves pef immediately prior to extubation, compared with a conventional, protocolized management strategy.


Eligibility criteria:
inclusion criteria: * patient 18 years or more, affiliated to a social security system * patients on invasive mechanical ventilation for 48 hours or more * failure of at least one mechanical ventilation weaning test (spontaneous breathing trial, sbt) * first successful sbt on the day of eligibility assessment * medical research council (mrc) score \< 48 and/or cough strength ≤ 2 on the 6-point likert scale exclusion criteria: * recent brain injury (\< 3 months, stroke, cardiopulmonary arrest) * delirium tremens (cushman score \> 7) * chronic neuromuscular pathology * patient under continuous intravenous sedation * patient unresponsive to simple commands and richmond agitation and sedation scale (rass) score \ +1 * fio2: inspired oxygen fraction\> 50%, percutaneous, o2: oxygen saturation \ 5 centimeter of water (cmh2o) or respiratory rate ≥ 35 min-1 * failure of 7 or more sbt at time of eligibility * vasopressor catecholamine at a dose \> 0.5 μg/kg/min * tracheostomized patient * undrained pneumothorax * pulmonary emphysema (identified as antecedent in medical record) * uncontrolled hemoptysis * surgery \< 3 months of esophagus and/or the ear, nose and throat (ent) sphere * pregnancy or lactating * patient deprived of liberty by judicial or administrative decision * patient under guardianship or curatorship * patient already included in the same study or in another study sharing the same primary endpoint

Keywords: critical care mechanical ventilation ventilatory weaning peak cough expiratory flow cough strength mechanical cough extubation reintubation chest physiotherapy
effect of dietary fat cooking blend on energy expenditure in children

Conditions: Childhood Obesity

Summary: the purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.


Eligibility criteria:
inclusion criteria: * age 15-18 * body mass index 85% percentile or higher for age/sex * weight stable exclusion criteria: * ±5 lbs weight change in the the 3 months prior * use of medications * dietary allergies * metabolic disorder * eating disorder * behavioral or psychological disorders

Keywords: obesity dietary fat energy expenditure food intake
surgical pain control with ropivacaine by atomized delivery

Conditions: Pain

Summary: the purpose of this trial is to determine the effect of spraying a local anesthetic called ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. ropivacaine is a local anesthetic used to block pain in the body. there are studies showing that ropivacaine decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder removal but has not been tried in robotic pelvic surgery.

practice guidelines from the american society of anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years (3). current acute pain-management strategies include 1.) epidural or intrathecal opioids 2.) patient-controlled devices delivering systemic opioids and 3.) regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics. the use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay. the literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal. a recently published study describes the use of intraperitoneal ropivacaine (2mh/kg) during laparoscopic appendectomy(4). the study was a randomized, double-blinded, placebo-controlled study using ropivacaine (vs placebo) injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients(4). patients treated with ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo. there were no side-effects found with the one-time use of the ropivacaine. the results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly. hence this study was undertaken to investigate the role of intraperitoneal ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery.

Eligibility criteria:
inclusion criteria: * consent to undergo robotic assisted gynecologic or urologic surgery * between the ages of 18 and 75 * able to consent, fill out study documents, and complete all study procedures and follow-up visits exclusion criteria: * patients with an allergy to local anesthetics * patients with severe underlying cardiovascular, renal or hepatic disease * pregnant patients

Keywords: surgical pain management robotic surgery ropivacaine