Kornimate/medical-research-clean huggingface dataset:
effect of gum arabic on gastrointestinal transit and permeability

Conditions: Diverticulitis

Summary: the study aims to determine the effect of gum arabic on gut bacteria and gi function.

to compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut microbiota composition and function, gi transit and permeability, and assess development of symptoms or a change in pre-existing symptoms present, in patients with recent history of clinically diagnosed diverticulitis which has been successfully treated.

Eligibility criteria:
inclusion criteria: 1. recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use 2. age 18-80 exclusion criteria: 1. prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy) 2. known diagnosis of inflammatory bowel disease (crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis 3. use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability) 4. use of nsaids or aspirin within the week prior to visit 2 and visit 5 (permeability and transit testing visit since nsaids affect intestinal permeability) 5. use of osmotic laxatives one week prior to visit 2 and for the duration of the study 6. use of oral corticosteroids within the previous 6 weeks and for the duration of the study 7. ingestion of artificial sweeteners such as splenda™ (sucralose), nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages 8. antibiotic use within 4 weeks of completion of the initial stool kit and/or visit 2 testing appointment and for the remainder of the study (they can complete the stool kit and visit 2 after a 4-week washout period) 9. bowel preparation for colonoscopy less than one week prior to the completion of the first stool kit and visit 2 and during the remainder of the study 10. pregnancy or plan to become pregnant within the study timeframe 11. vulnerable adults 12. egg allergy or resistant to ingesting eggs 13. diagnosis of diabetes 14. any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
safety and performance study of the argos-io system in patients undergoing boston keratoprosthesis implantation

Conditions: Graft vs Host Disease; Congenital Aniridia; Chemical Burns; Stevens-Johnson Syndrome; Congenital Glaucoma

Summary: the argos-io pressure sensor is intended to be implanted in the human eye in combination with boston keratoprosthesis (bkpro) surgery and to remain in place indefinitely. it is intended to be used together with the hand-held mesograph reading device to telemetrically measure the intraocular pressure (iop) of patients with a bkpro. the purpose of this study is to evaluate the safety and performance of the argos-io system in patients undergoing concomitant implantation of a bkpro and an argos-io sensor over the 12 month period beginning at implantation.

(see above)

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥ 18 and ≤ 80 years on the day of screening 2. keratoprosthesis surgery indicated, defined as having a severely opaque and vascularized cornea and either a verifiable history of two or more prior failed corneal transplant procedures or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation. 3. axial length \> 21 mm 4. ability and willingness to attend all scheduled visits and comply with all study procedures exclusion criteria: 1. reasonable chance of success with traditional keratoplasty 2. current retinal detachment 3. connective tissue diseases 4. history or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to argos-io implantation 5. history of ocular or periocular malignancy 6. history of extensive keloid formation 7. any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device) 8. presence of another active medical eye implant and/or other active medical implants in the head/neck region 9. signs of current infection, including fever and current treatment with antibiotics 10. severe generalized disease that results in a life expectancy shorter than a year 11. any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device 12. currently pregnant or breastfeeding 13. participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device 14. intraoperative complication that would preclude implantation of the study device 15. subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization. previous or concurrent enrollment of the contralateral eye in this clinical study.

Keywords: boston keratoprosthesis
link between plasma citrulline and lipopolysaccharide concentrations in the critically ill

Conditions: Critically Ill

Summary: in critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome. plasma citrulline is a validated biomarker of functional enterocyte mass. lipopolysaccharide (lps) is a part of gram negative bacteria, and plasma lps concentration is a biomarker of bacterial translocation. the link between plasma citrulline and lps in the critically ill is unknown. investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma lps concentration. investigators aimed to evaluate the link between plasma citrulline and lps concentrations in critically ill patients at the time of icu admission.


Eligibility criteria:
inclusion criteria: * critically ill patients requiring icu admission for at least 48 hours * adults exclusion criteria: * chronic small bowel disease * chronic renal failure (clearance of creatinine \< 50 ml/min) * pregnancy

Keywords: plasma citrulline lipopolysaccharide critically ill hospitalization in an intensive care unit
virtual reality for post-operative pain management

Conditions: Spinal Fusion

Summary: use an rct study design to measure pain experience, medication use, medical side effects, and length of hospital stay with and without availability of vr following spine fusion surgery

the purpose of this study is to prospectively assess the utility of virtual reality (vr) for pain and anxiety management in the post-operative period following major orthopedic surgery. while there is substantial evidence supporting the use of vr during dressing changes for burn victims, there is little known about vr use in post-surgical settings. in the proposed study, patients will be randomized to either receive vr in addition to standard of care or to receive only standard of care during their post-operative care following spinal fusion surgery for idiopathic scoliosis or neuromuscular scoliosis.

Eligibility criteria:
inclusion criteria: * patient is having a spinal fusion at gillette children's specialty healthcare * patient with a diagnosis of adolescent idiopathic scoliosis (ais) or a diagnosis of neuromuscular scoliosis exclusion criteria: * non-english speaking parents/patients * patients with history of motion sickness * patients with epilepsy * patients with a ventricular shunt * patients with severe/profound cognitive impairments

Keywords: virtual reality
mindfulness based stress reduction app for african american caregivers (mbsr)

Conditions: Stress

Summary: the study investigators are developing and testing a mobile-friendly web-based app that contains features related to mindfulness and reducing stress for african american informal caregivers of people with chronic conditions. the purpose of the app is to help a vulnerable population reduce stress by learning and practicing mindfulness activities.

for aim 1, the study investigators conducted 10 formative interviews with african american caregivers and key informants to elicit recommendations for features to be included in the app as well as feedback on preliminary ideas for features. for aim 2, the study investigators developed the programming for the app with the desired features, which included modules for journaling, tracking stress ratings, practicing mindfulness exercises by using two videos and two audio tracks developed for the app, and viewing weekly suggestions for caregiver/care recipient bonding activities, inspirational quotes and positive affirmations. for aim 3, the study investigators are testing the app using a feasibility trial with 30 caregiver participants. the study participants answer questions on depression, anxiety, perceived stress, overload and self-compassion at baseline and follow-up. participants are instructed to use the app for four weeks and to return for their follow-up visit to fill out the same surveys assessed at baseline plus a satisfaction questionnaire to assess their evaluation of the app. these data will inform future enhancements, which will be proposed in a phase ii sbir/sttr application.

Eligibility criteria:
inclusion criteria: * informal caregiver participants will be screened for the ability to speak english. in addition, the caregivers must currently be providing support for a person living with hiv. support can include: 1) emotional support, 2) physical support, 3) financial support, 4) opportunities for social participation, and/or 5) health advice. exclusion criteria: * psychiatric problems such as untreated psychosis, which could preclude their ability to successfully adhere to the intervention
s-1 plus oxaliplatin compared with fluorouracil, leucovorin calcium plus oxaliplatin as perioperative chemotherapy for advanced gastric carcinoma

Conditions: Stomach Neoplasms

Summary: this is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (folfox) compared with s-1 plus oxaliplatin (sox) as perioperative chemotherapy for advanced gastric cancer. hypothesis: sox is not inferior to folfox as perioperative chemotherapy for advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa * ambulatory males or females, aged 18-80 years old * ecog score 0-2 * given informed consent * life expectancy more than 3 months * measurable lesion * normal cardiac, hepatic, renal, and bone marrow function(wbc:3.5×10\^9/l\~12×10\^9/l;plt:\>100×109/l;bil:\ 80ml/min;cr:1.5mg/dl) exclusion criteria: * prior stomach surgery * previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor * history of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * distant metastasis(such as no.16 and no.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis) * severe bleeding * bowel obstruction, ileus or complete pyloric obstruction * serious uncontrolled concomitant disease * history of myocardial infarction in 6 months * woman with on-going pregnancy or breast-feeding, or contemplating pregnancy * systemic treatment with corticosteroid * patients judged inappropriate for the trial by the physicians

Keywords: gastric cancer
inter- and multidisciplinary, cross-sectoral feto-neonatal pathway

Conditions: Pre-Eclampsia; Intrauterine Growth Restriction; Maternal Care for Known or Suspected Poor Fetal Growth

Summary: due to the fetoneonatal pathway it is possible to identify pregnant women with an increased risk of fetal growth restriction or pre-eclampsia in early stages (from 10th week of pregnancy). women whose pregnancy is considered high-risk receives risk-adapted prenatal treatment as well as certain treatments for their newborn and infant until 1 year of age. the tasks of all involved persons are defined by standard operating procedures (sop)

by implementing a preventive feto-neonatal pathway, healthcare for pregnant women with high risk of fetal growth restriction (fgr) or pre-eclampsia will be improved and, therefore the occurence of children's health problems may be prevented.the pathway allows healthcare to be structured, ross-sectoral, inter- and multidisciplinary in consideration of medical and psychosocial imensions. the feto-neonatal pathway transfers scientific findings, which already determine international routine care, in the project region into clinical routine care. the anamnestically increased risk for fgr or pre-eclampsia is validated by ultrasound and the identified high-risk pregnancy is attended risk-adapted from birth until the end of the first year of life of the child.as a result, the mothers' pregnancy-related risks (death, premature delivery, traumatic stress disorders) as well as risks for the child (prematurity and associated problems, childhood growth restriction with the risk of metabolic syndrome, developmental neurological problems) are reduced and the sustainability of the interventions is ensured in the long term through improved health competence of the families. the feto-neonatal pathway shows how highly specialised fetoneonatal care of high-risk pregnancies can be ensured while ensuring primary care in a health region, and offers the possibility of being extended to other indications.

Eligibility criteria:
inclusion criteria: * female, minim. 10 weeks of pregnancy, maximum 36 weeks of pregnancy * anamnestic risk of preeclempsia or fetal growth restriction * being part of the project region exclusion criteria: * none
screening for pregnancy related heart failure in nigeria

Conditions: Cardiomyopathy; Pregnancy Related

Summary: this study will evaluate the effectiveness of an artificial intelligence-enabled ecg (ai-ecg) for cardiomyopathy detection in an obstetric population in nigeria.


Eligibility criteria:
inclusion criteria: * currently pregnant or within 12 months postpartum * willing and able to provide informed consent exclusion criteria: * complex congenital heart disease (single ventricle physiology or significant shunts with cardiac structural changes) * significant conduction abnormalities (ventricular pacing on recorded ecg, pacemaker dependence, or severely abnormal/bizarre qrs morphology on ecg tracings) * unable or unwilling to provide consent

Keywords: cardiomyopathy artificial intelligence women's health digital health
sensitivity comparison of follow-up mri between acute cerebral and cerebellar cortical microinfarctions ( cmi )microinfarctions

Conditions: Acute Cerebral and Cerebellar Cortical Microinfarctions (CMI)

Summary: cerebral cortical microinfarctions (cmi) are frequently observed on mri and histology studies, especially in elderly patients and in patients with cognitive dysfunction. the majority of these studies analysed chronic cerebral cmi lesions. the few studies reporting on temporal dynamics of mri signal of acute cerebral cmi showed very low sensibility for persisting signal changes on follow-up mri on standard mri sequences. a retrospective study, analysing follow-up 3t mri in 25 patients with acute cerebral cmi (defined as ≤10 mm on dwi), showed a chronic cerebral cmi detection rate of only 16% on t2-weighted and 5% on flair imaging after a mean follow-up period of 33 months (with a very wide range of 0.5-142 months). another 3t mri study including seven patients showed disappearance of all acute cerebral very small-sized cmi (defined as \<5 mm size on initial dwi) on all follow-up mri sequences (t1- and t2-weighted and flair imaging, performed after one month). recently, it has been shown that chronic relatively small (\<20 mm) cerebellar cortical infarctions (based on diffusion-weighted imaging) were frequently observed in acute stroke patients, especially in case of cardioembolic stroke (with chronic small cerebellar cortical infarctions observed in 32% of cases). the high prevalence of these chronic small cerebellar cortical infarctions suggest a possible higher detection rate of chronic small-sized infarction in the cerebellum compared to the supratentorial brain.


Eligibility criteria:
inclusion criteria: patients admitted to our stroke centre between february 2021 and june 2023 with the following inclusion criteria: * age \>18 years, * initial mri performed within one week after symptom onset, * symptomatic brain infarction confirmed by dwi, * presence of acute cerebral and/or cerebellar cmi exclusion criteria: * age \< 18 years
strength training in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study was set out to assess the effect of stretch-shortening (ssc) exercises on gait-symmetry and balance in children with unilateral cerebral palsy (ucp). forty-two children with ucp were randomly allocated to the control group (n = 21, received standard physical rehabilitation) or the ssc group (n =21, received standard rehabilitation plus ssc exercises). both groups were assessed for ait-symmetry and balance pre and post-treatment.

forty-two children with ucp were recruited from the physical therapy outpatient clinic of collee of applied medical sciences, prince sattam bin abdulaziz university, king khalid hospital, and a tertiary referral hospital, al-kharj, saudi arabia. their age ranged between 8 and 12 years, were functioning at levels i or ii according to the gross motor function classification system, and had spasticity level 1 or 1+ per the modified ashworth scale. children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to botox injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training. outcome measures 1. gait-symmetry indices: gait symmetry indices (spatial and temporal) were measured through a 3d motion analysis system. 2. balance capabilities: several aspects of balance including sensory organization, reactive balance, and rhythmic weight shift were tested through a pro balance master system. the control and ssc groups received a standard rehabilitation program for 45 minutes, twice a week for eight consecutive weeks. the program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. additionally, the ssc group received an ssc exercise program for 30 minutes, twice/week for eight weeks per the national strength and conditioning association guidelines and american academy of pediatrics safety standards. the ssc program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. the ssc training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown.

Eligibility criteria:
inclusion criteria: * unilateral cerebral palsy * age from 8 to 12 years * motor function level i or ii according to the gross motor function classification system * spasticity level 1 or 1+ according to the modified ashworth scale exclusion criteria: * structural deformities * musculoskeletal or neural surgery in the last year * botox injection in the last 6 months. * cardiopulmonary disorders interfering with the ability to engage in exercise training * hemispatial neglect
infusion of alloreactive nk cells for mrd-positive aml patients

Conditions: Acute Myeloid Leukemia; Minimal Residual Disease; Natural Killer Cell

Summary: this is a interventional, transplantation study. the procedure under study is the infusion of alloreactive nk cells in adult aml patients, eligible for asct, who achieved cr after conventional chemotherapy, but harbor mrd-positivity. haploidentical kir-l mismatched donors will be included if present at least one allele mismatch at a class i locus among the following ones: hla-c alleles with asn77-lys80, hla-c alleles with ser77-asn80, hla-bw4 alleles. kir-l mismatched donor alloreactive nk cell repertoire will be evaluated in order to determine the functional cell dose to be used for nk cell collection. phenotypical analysis of kirs will be correlated to functional tests. nk cells will be selected from a steady-state large volume leukapheresis product from a suitable haploidentical kir-ligand incompatible donor. nk cell purification will be performed if the donor leukapheresis product contains at least 10x106 nk cells/kg. immunomagnetic enrichment of nk cells will follow two subsequent steps: 1) depletion of cd3+ t cells followed by 2) positive selection of cd56+ nk cells. patients will receive immunosuppressive chemotherapy, fludarabine (flu) 25 mg/mq/ from day -5 to -3 and cyclophosphamide (cy) 2 g/mq on day -2 (flu/cy). two days after cy administration, patients will be infused intravenously with a single dose of cryopreserved nk cells (day 0), which will be followed by subcutaneous administration of il-2 (10 x 106 iu/day, 3 times weekly) for 2 weeks (6 doses total). pb samples will also be collected for biological studies. in particular, pb samples will be collected for molecular assessment of microchimerism and tracking of haploidentical nk cells for 30 days, immunophenotype studies, alloreactive nk cells cloning and functional assays (cytotoxicity). enrolled patients will be followed up for at least 12 months after nk cell infusion.


Eligibility criteria:
inclusion criteria: * diagnosis of de novo or secondary aml * age ≥ 18 years * morphologic cr * eligibility for asct * mrd-positivity after induction chemotherapy * availability of a kir-l incompatible haploidentical donor * performance status ≥ 70% (karnofsky score) or ≤ 2 (who). * adequate renal (serum creatinine \< 2 mg/dl), pulmonary (sat o2 ≥ 96%) and hepatic (alt/ast \< 2.5 x n) function. * left ventricular ejection fraction (lvef) of \>50% as determined by echocardiogram (echo). * signed informed consent. exclusion criteria: * diagnosis of aml fab m3 * hiv positivity. * hcv positivity with high viral load. * pregnant or nursing females. * current uncontrolled infection. * signs or symptoms of fluid retention (e.g. pleural effusion).