Kornimate/medical-research-clean huggingface dataset:
association of transversus abdominis plane block (tapb) with postoperative delirium (pod) in elderly patients undergoing major gastrointestinal surgery

Conditions: Regional Anaesthesia; Postoperative Delirium (POD); Transversus Abdominis Plane Block (TAP Block)

Summary: postoperative delirium can increase postoperative adverse reactions and prognosis in elderly patients undergoing gastrointestinal surgery. this study studied the effects of ultrasound-guided transversal plane block on postoperative delirium, opioid consumption and prognosis in elderly patients undergoing gastrointestinal surgery, comprehensively evaluated the effectiveness and safety of tapb, and evaluated its clinical value.

postoperative delirium (pod) is a common neurocognitive disorder in elderly patients after surgery, which is characterized by attention deficit, memory impairment and confusion, usually occurring within one week after surgery. it occurs in 11%-51% of elderly patients undergoing gastrointestinal surgery and is associated with long-term poor prognosis such as dementia and increased mortality. risk factors include advanced age, high asa grade, hypoalbuminemia, and prolonged anesthesia. regional nerve block (nbs), as the core means of multimodal analgesia, has been shown to reduce the incidence of pod in orthopedic and thoracic surgery by reducing opioid use and stress response, but its effect in elderly gastrointestinal surgery still needs to be further explored. transverse abdominal muscle plane block (tapb) is a commonly used technique in abdominal surgery. it can effectively control pain and reduce inflammation and stress response by blocking sensory nerves in the abdominal wall. this study focused on the effect of tapb on pod in elderly patients undergoing major gastrointestinal surgery, aiming to provide evidence-based evidence for optimizing perioperative anesthesia management.

Eligibility criteria:
inclusion criteria: 1. age ≥65 years; 2. major gastrointestinal surgery, defined as procedures lasting more than one hour and involving partial resection of the stomach or intestines; 3. general anesthesia with endotracheal intubation. exclusion criteria: 1. emergency surgeries; 2. transanal endoscopic microsurgery (tem); 3. patients with a history of preoperative delirium, altered consciousness, or psychiatric conditions, such as epilepsy, alzheimer's disease, parkinson's disease, schizophrenia, and anxiety or depressive disorders, as well as encephalopathies (hepatic, pulmonary, and renal) and hydrocephalus, along with those experiencing significant preoperative visual or auditory impairments; 4. patients who died within 24 h postoperatively or missing data of \>50% in their medical records.

Keywords: regional anaesthesia postoperative delirium (pod) transversus abdominis plane block (tap block)
depression treatment and economic empowerment

Conditions: Depressive Symptoms

Summary: this pilot study randomized 48 depressed rural bangladeshi housewives to either intervention or control groups. the intervention groups received depression treatment and a financial empowerment intervention.

this study was conducted in the rural sirajganj region of bangladesh. working with the international centre for diarrhoeal disease research, bangladesh and a local ngo, we recruited 48 depressed rural housewives for the study. participants were randomized into intervention in control groups. the intervention groups (n=24) received 12 sessions of evidence based depression treatment, financial literacy education, agricultural training and skill building. they opened bank accounts and saved for six months. at the end of the six month period, participants who had met savings and attendance requirements received a cash transfer of approximately $186, which was used to purchase a productive asset. 22 participants purchased an agricultural animal, usually a goat; 1 financed a small retail business, and 1 leased land to grow crops for sale. depression scores on the phd-9 were sharply reduced. the study had 100% retention.

Eligibility criteria:
inclusion criteria: * age 18-40 * phq greater than 10 * able to save * able to read and write exclusion criteria: * not in age range phq below 10 unable to contribute to savings account illiterate
repetitive bihemispheric transcranial direct current stimulation after stroke

Conditions: Stroke

Summary: non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tdcs) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. in this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tdcs to the primary motor cortex (m1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (tms) and magnetoencephalography (meg) measures.

investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. all subjects will be randomly allocated to receive daily bihemispheric tdcs (anodal tdcs to ipsilesional m1 and cathodal tdcs to contralesional m1 with 2 ma stimulation for 20 min) or daily sham tdcs (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. changes in upper extremity motor function score (fugl-meyer test and action research arm test), corticospinal excitability from the transcranial magnetic stimulation(tms), and sensorimotor oscillations from the magnetoencephalography (meg) will be assessed before and after intervention, as well as 3 months after stroke. all stroke patients will receive tdcs and standard medical, rehabilitation treatments in rehabilitation ward.

Eligibility criteria:
inclusion criteria: * age 20-80 years old * patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness * brain mri confirmed subcortical stroke in the middle cerebral artery territory * post-stroke 2-6 weeks with stable clinical condition exclusion criteria: * stroke with cortical lesions * containing metal implants (such as implanted electrodes, pacemakers) * sensitive or fear of electromagnetic waves * pregnant women * history of alcohol or drug abuse * history of seizures or epilepsy * claustrophobia * other significant disease or neuropsychiatric disorders

Keywords: transcranial direct current stimulation neuroplasticity
validation of a sensor for non-invasive measurement of stroke volume and cardiac output

Conditions: Cardiac Failure

Summary: tosense, inc. has developed a novel, non-invasive, body-worn sensor -cova patch-that offers an alternative to invasive continuous cardiac output monitoring. to validate this new sensor's measurements of stroke volume and cardiac output, tosense, inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.

this in an introductory clinical study with cardiac icu patients featuring cova patch. this is a single site, non-blinded, non-randomized study. it will employ a retrospective analysis comparing the accuracy of sv and co. the 'test sensor', cova patch, which will measure sv and co quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. these measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. it uses an invasive technique called thermodilution that will be made approximately every 4 hours. measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age at visit x. * subject is a patient in the cardiac icu and meets the following criteria: pulmonary artery catheterization scheduled or completed. * written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. * subject is not pregnant at the time of consent exclusion criteria: * pregnant in the study. * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.
assessment of carotid flow during general anesthesia

Conditions: Anesthesia; Fluid Responsiveness

Summary: proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. reliability of several invasive measurements used for this purpose for many years have been questioned recently. the study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (lidco rapid) in navigation of intraoperative fluid therapy.


Eligibility criteria:
inclusion criteria: * major abdominal surgery * artery catheter required exclusion criteria: * laparoscopic surgery * known history of carotid endarterectomy * known history of carotid stenosis * non-sinus rhythm * systolic or diastolic heart failure * chronic kidney disease * pulmonary hypertension * carotid artery anomaly * unable to visualise carotid artery * angle of correction \> 60

Keywords: fluid responsiveness, anesthesia, surgery, stroke volume variation, fluid status,
a study to evaluate the drug-drug interaction of edp-323 with midazolam, caffeine, and rosuvastatin in healthy participants

Conditions: RSV Infection; Drug Drug Interaction

Summary: the primary aim of this study is to assess the effect of edp-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject * healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive * screening body weight \>50 kg and body mass index (bmi) of 18 to 32 kg/m2 * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 30 days after the last dose of edp-323. a male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of screening to 90 days after his last dose of study drug. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * positive for hiv or hepatitis * positive urine drug screen * current tobacco smokers or use of tobacco within 3 months prior to screening. * received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer. * drug sensitivity to midazolam, caffeine, rosuvastatin

Keywords: drug drug interaction
comparative effect of functional task training versus function therapy program

Conditions: Cerebral Palsy

Summary: cerebral palsy is the brain injury or brain malformation occur before, during and immediately after birth (while brain is still under development) and its effect muscle tone, reflexes, posture coordination gross and fine motor skill and oral motor functioning. the functional training is the physiotherapist and occupational therapy rehabilitation technique focus on strength and function of musculoskeletal system and its help the patients to making their daily life activity easier. the functional task training program consisted of non-walking (i-iii) and walking (iv-v) activities: (i) standing from a seated position; (ii) reaching for an object overhead, which required ankle plantar flexion from the standing position, and returning to the initial position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and down stairs; and (v) walking on flat surfaces and ramps. children with cerebral palsy frequently receive. functional therapy programs the children participated in activities pertaining to everyday skills such as eating, playing, communication, and mobility. to optimize the child's opportunities to practice towards the goals, parents and preschool staff were guided on efficiently encouraging the child. support and instructions from the professional to help them to develop better motor skills and increase independence in tasks like self-care, play, and recreational activities.so the study aimsto improve balance, gross motor function, and range of motion by using these functional training task and functional therapy program. in my study compare the compare task training versus functional therapy programsm on gross motor function, range of motion on, and balance in cerebral palsy children.

the randomized control trial will be conducted through convenient sampling. there will be two group the experimental group will receive functional task training. according to gmfs, pediatric balance scale and goniometer to assess the gross motor function, rom and balance in cerebral palsy, while control group will receive functional therapy program (bobath technique) to improve gross motor function, rom and balance in cerebral palsy. the duration of the treatment will be 8 weeks. gross motor function, pediatric balance scale, and goniometer will be used as outcome measure. data will be analyzed on spss version 29, normality of the data will be checked and test will be applied according to the normality of the data either in will be parametric test or nonparametric based on the normality

Eligibility criteria:
inclusion criteria: * both gender * gmfcs (gross motor function classification system) score is in between 1-2, * ability to follow command * cerebral palsy diagnosed child ( * age 6-12yr exclusion criteria: * • deformity like scoliosis. pelvic, oblique, and hip deformity * age more than 16 * visual disorder * mental retardation

Keywords: gross motor function, cerebral palsy
lynparza breast cancer in the adjuvant setting japan post-marketing surveillance (pms)

Conditions: Breast Cancer

Summary: to evaluate the frequency of bone marrow suppression adverse drug reactions (adrs) in patients with brca mutated her2 negative high recurrent risk breast cancer treated with lynparza for adjuvant treatment in the actual post-marketing use.

to evaluate the frequency of bone marrow suppression adverse drug reactions (adrs) in patients with brca mutated her2 negative high recurrent risk breast cancer treated with lynparza for adjuvant treatment in the actual post-marketing use. this investigation will be conducted for application for re-examination specified in article 14-4 of the pharmaceutical affairs law.

Eligibility criteria:
inclusion criteria: * the patients who started treatment with lynparza for the first time for the approved indication "adjuvant treatment for patients with brca-mutated her2 negative high recurrent risk breast cancer" exclusion criteria: * patients who have no treatment history with lynparza
careconekta: a pilot study of a smartphone app in south africa

Conditions: HIV/AIDS

Summary: population mobility is frequent in south africa and disrupts the continuity of hiv care. postpartum, hiv-positive women are at elevated risk of dropping out of hiv care and are highly mobile. this pilot study aims to engage peripartum, hiv-positive women as potential users to evaluate a novel smartphone application to assist these women with linkage to new hiv facilities and prospectively describe the mobility of this population.

south africa is home to the world's largest antiretroviral therapy (art) program, but sustaining high retention along the hiv care continuum has proven challenging in the country and throughout the wider region. population mobility is frequent in south africa and mobility likely disrupts retention in hiv care. in the absence of a facility-linked national electronic health data system, clinic switching as unreported transfers also obscures the true magnitude of loss to follow-up, hindering national evaluation efforts. postpartum women in south africa are known to be at high risk of dropping out of hiv care after delivery and are frequently mobile, partly due to cultural traditions of returning to one's rural home after giving birth. to address these challenges to retention in care, the investigators will enroll 30 peripartum, hiv-positive women as potential users to assess the acceptability and feasibility of deploying in a real-world setting a novel mhealth application to improve retention in hiv care. the app will operate on users' own smartphones and will serve two primary functions: 1) as a service tool to inform postpartum, hiv-positive women of art services in their area so that they may access continued hiv care, even while traveling, and 2) as a research tool to prospectively characterize travel and mobility patterns of these women. during this pilot study, women will be passively followed for 90 days following app installation at enrollment. after 90 days, they will be interviewed to determine acceptability and feasibility, and electronic user data will be analyzed. this information will be used to develop an app poised for nationwide adoption. the research team comprises leaders in the study of hiv implementation science, maternal/child health and biomedical informatics, with experience designing effective mobile health (mhealth) interventions in low-resources settings. this pilot study aims to engage potential users to test a smartphone application that both improves linkage to hiv care and provides essential research data to inform future health system strengthening efforts.

Eligibility criteria:
inclusion criteria: * willing to enroll and provide written informed consent * ≥18 years old * hiv-positive * pregnant (\>36 weeks gestation) * able to read basic written english * currently own a smartphone that meets the technical requirements * willing to opt-in to installation of the app on her personal phone and to mobility tracking exclusion criteria: -

Keywords: south africa retention in care pregnancy mobile health
impact of polymorphisms of oct2 and octn1 on the kinetic disposition of gabapentin in patients undergoing chronic use

Conditions: Epilepsy; Chronic Pain

Summary: this study aims to evaluate the influence of genetic polymorphisms of octn1 and oct2 and other possible covariates on the kinetic disposition of gab in patients undergoing gab chronic treatment. thus, patients treated with gab, for at least one week, are being investigated.

gabapentin (gab), an anticonvulsant used for the treatment of epilepsy and chronic pain, has nonlinear kinetics, it is not metabolized and it is mainly eliminated by renal excretion. studies suggest that the renal excretion of gab is dependent on active secretion by organic cation transporter 2 (oct2) and organic cation/ergothioneine transporter 1 (octn1). these transporters are expressed at the membrane of the renal proximal tubules and they are involved in the elimination of endogenous compounds and many drugs. the genetic polymorphism of drug transporters has been studied to explain the kinetic disposition variability of their substrates. the objective of this study is to investigate the influence of genetic polymorphisms of octn1 and oct2 and other possible covariates (e.g., sex, age, creatinine clearance, body mass index) on the kinetic disposition of gab in patients undergoing gab chronic treatment. patients treated with gab, for at least one week, are being investigated. blood and urine samples are being collected to gab pharmacokinetic analysis, serum creatinine analysis and for genotyping. the plasma concentration of gab will be assessed using liquid chromatography with uv detection (lc-uv).

Eligibility criteria:
inclusion criteria: * patients with 18 years old or older, both gender. * patients undergoing chronic use of gabapentin (at least one week). exclusion criteria: * pregnant and lactating patients. * patients who were in use of oct2 and octn1 inhibitors. * patients who disagree to continue the study.

Keywords: gabapentin oct2 octn1 pharmacogenetics pharmacokinetics polymorphisms
energy expenditure of high intensity functional training

Conditions: Obesity

Summary: the purpose of this study is to assess the energy expenditure and intensity of a high intensity functional training (hift) session in overweight and obese adult men and women.

high intensity functional training (hift), which alternates short periods of intense exercise using varied, multiple-joint movements, with less-intense active recovery periods, may offer an attractive, time efficient alternative to traditional aerobic exercise. variations of hift such as cross fit, home workout videos (ie.p90x and insanity), and boot-camp style group exercise classes have become increasingly popular. the cardiovascular benefits of hift have been demonstrated; however, by doing this study researchers hope to get more information regarding the potential effectiveness of hift for weight management, such as the actual level of energy expenditure and exercise intensity elicited by a hift session.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 25.0 and 39.9 * currently participating in hift (boot-camp) classes at kirmayer fitness center
safety, skin and plasma concentration of azithromycin dermal formulation

Conditions: Lyme Disease

Summary: ixodes gmbh intends to develop shb001, an azithromycin dermal formulation in order to prevent lyme disease at early stages of infection after tick bite.

in this study two consecutive cohorts will be treated: * cohort 1: 8 volunteers * cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each the study will be conducted in the following three phases: 1. treatment of cohort 1: the aim is to establish the maximal tolerated dose (mtd) for a local treatment with azithromycin dermal formulation. 1. treatment of cohort 1 with azithromycin dermal formulation and follow up 2. assessment of local safety within the 7 days following the first treatment 3. the maximal tolerated dose (mtd) will be determined 2. treatment of cohort 2: the aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of shb001 dermal formulation. 1. treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated dose (mtd), with a dose one or more concentrations lower than maximal tolerated dose (mtd) and with placebo 2. skin biopsies of treated skin areas will be taken for the pk assessment 3. study completion examination

Eligibility criteria:
main inclusion criteria: * male or female healthy volunteers, age 18 - 70 years main exclusion criteria: * a known hypersensitivity against azithromycin, erythromycin or any of the macrolide antibiotics * a known hypersensitivity against lidocaine * treatment by any route with any macrolide antibiotic within the last 2 month

Keywords: lyme disease borreliosis azithromycin