Kornimate/medical-research-clean huggingface dataset:
physical activity with tailored e-health support for individuals with intellectual disability

Conditions: Intellectual Disability

Summary: the main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (ids) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

individuals with intellectual disability (id) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. as increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. e-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with id. the purpose of this study is to examine the effectiveness of an individually tailored pa programme with motivational mobile e-health support on everyday level of pa in youths and adults with id. the pa-ide trial uses a prospective randomized controlled design. in total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. the intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. the intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). all participants will be assessed at baseline, 3-, and 6 months. participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the goal attainment scaling (gas) will be used. primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a pa setting, behaviour problems, and goal attainment. the investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. technology offers new opportunities to influence healthy behaviours. the trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with id.

Eligibility criteria:
inclusion criteria: * intellectual disability * age 15-60 years * low physical activity * sedentary lifestyle exclusion criteria: * medical contradictions for participation * high levels of physical activity
procalcitonin to predict infection after gastrectomy for gastric cancer

Conditions: Gastric Cancer

Summary: to investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer.

from june 2018 to may 2019, consecutive eligible patients who underwent surgery for gastric cancer in the department of gastroduodenal and pancreatic surgery, hunan cancer hospital and the treatment group of professor kai-xiong tao in the union hospital of tongji medical college were invited to participate in the study. after surgery, routine blood test were measured morning on post-operative day (pod) 1, 3, 5, and 7, and serum level of procalcitonin was measured morning on pod 3 and 5. the primary outcome of the present study was the accuracy of white blood cell (wbc) and neutrophil count, the neutrophil to wbc ratio (n%) and procalcitonin to detect post-operative infection (including intra-abdominal infection (iai), surgical site infections (ssis), pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified) within 30 days after surgery. the main secondary outcome was their ability to detect any post-operative complications (such as intestinal obstruction, bleeding, ascites, cardiovascular and cerebrovascular events) within 30 days after surgery. other secondary outcomes were the choice of the best timing to measure each inflammatory marker, the choice of a clinically meaningful cut-off value for the most accurate marker.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years 2. pathologically diagnosed gastric adenocarcinoma 3. radical gastrectomy with lymphadenectomy. exclusion criteria: 1. ongoing infection at surgery 2. pregnancy status 3. underwent non-resection surgery 4. underwent palliative gastrectomy 5. emergency surgery 6. taking corticosteroid or other immunosuppressive drugs

Keywords: procalcitonin infection gastric cancer gastrectomy
hcv treatment in a low-threshold clinic

Conditions: Hepatitis C; Substance Use Disorders

Summary: this is a cohort of people who inject drugs with chronic hcv infection. patients are seen at a low-threshold clinic. all patients are offered treatment for hcv and subsequently followed for to years

this is a cohort of people who inject drugs with chronic hcv infection. patients are seen at a low-threshold clinic. all patients are offered treatment for hcv and subsequently followed for to years inclusion consenting patients older than 18 years attending the low threshold hcv clinic in oslo the primary aims are to assess the efficacy (svr rate) of daa treatment among pwid treated in a low-threshold primary care setting (work package 1) and to estimate the incidence hcv reinfection f the secondary aims are to: * evaluate adherence to daa treatment (work package 1) * identify factors associated with svr and adherence (work package 1) * characterize reinfection using next generation sequencing (work package 2) * identify factors associated with reinfection (work package 2) * evaluate changes in recent injecting risk behaviours longitudinally (work package 2) * identify factors associated with changes in risk behaviours (work package 2) the hypothesis is that high svr rates and good treatment adherence will be achieved in pwid treated for hcv infection in a low-threshold primary health care setting. further,it is anticipated that the incidence of reinfection will be 5-10/100 py and associated with younger age, low education level and ongoing injecting risk behaviours. the study will include 300 patients and are close to achieving that aim the summer of 2019

Eligibility criteria:
inclusion criteria: * hcv rna positive attending the low-threshold hcv clinic in oslo exclusion criteria: -
npdt evaluation in children with cftr and (psc)

Conditions: Primary Sclerosing Cholangitis; Inflammatory Bowel Disease

Summary: the investigators hypothesize that psc in children is associated with mutations and functional changes of the cystic fibrosis (cf) gene.

the purpose of this protocol is to perform nasal transepithelial potential difference (ntpd) testing to assess the function of the cystic fibrosis gene product, a chloride channel referred to as cftr, in patients diagnosed with psc and/or inflammatory bowel disease in childhood and currently 12 years of age and greater. dr. freedman's laboratory has shown that there is an increased prevalence of cftr abnormalities in adults with psc as demonstrated by genotype and phenotype analysis. we hypothesize that abnormalities in cftr based on exhaustive genotype and phenotype assessments are associated with the presence of psc in children. we would like to enroll patients with inflammatory bowel disease and no psc to use as a "control group". subjects with psc and/or inflammatory bowel disease diagnosed in childhood, currently aged 12 years and above, will be enrolled in study protocols at children's hospital in boston, which will have received their local irb approval. the only role for bidmc will be to perform ntpd testing on these subjects. no other assessment or testing will be performed at our site. we will not be involved in any other aspect of care for these subjects.

Eligibility criteria:
inclusion criteria: * 12 years of age and older * must have diagnosis of primary sclerosing cholangitis and/or inflammatory bowel disease * absence of other liver disease, such as viral hepatitis, drug-induced liver disease, and metabolic/hereditary liver disease * no exclusion based on sex, race, and ethnic background

Keywords: psc ibd cftr
safety and efficacy study of pf-06473871 to reduce hypertrophic scars from recurring post-revision surgery

Conditions: Reduction of Hypertrophic Skin Scarring

Summary: the study will compare how well pf-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. the study will also evaluate the safety of pf-06473871 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * subjects must have hypertrophic (raised) breast scars from previous surgery * subjects must be healthy exclusion criteria: * currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding. * presence of history of breast cancer

Keywords: skin scarring cicatrix breast scar hypertrophic scar
tamsulosin vs placebo to prevent postoperative urinary retention in female pelvic reconstructive surgery

Conditions: Urinary Retention; Lower Urinary Tract Symptoms; Stress Urinary Incontinence; Pelvic Organ Prolapse

Summary: this is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.


Eligibility criteria:
inclusion criteria: * patients must be 18 years or older as well as willing and able to provide informed consent * patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence * standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1. exclusion criteria: * patient unable or unwilling to provide informed consent * severe allergy to sulfa drugs * known allergy to tamsulosin or another alpha antagonist medication * history of urinary retention * planned bladder catheterization greater than 24 hours after surgery * current use of alpha antagonist medication for hypertension * end stage renal or liver disease
the role of a mycobacterium growth inhibition assay to quantify host immune control of m. tuberculosis

Conditions: Tuberculosis; Immunologic Activity Alteration

Summary: the goal of this observational study is to learn about how the blood leucocytes from patients with and without exposure or disease from tuberculosis (tb) are able to kill live mycobacteria (m. tuberculosis). the main question it aims to answer is: is intracellular growth suppression of m. tuberculosis in peripheral blood mononuclear cells variable among healthy blood donors and higher than in patients with latent tb compared to active tb?

background: the host immune response is crucial in determining the outcome after exposure to mtb. a substantial proportion of exposed individuals (40-70%) never develop infection indicating an efficient cell mediated immune response against mtb and early clearance by the host immune defense (verall et al, immunology 2014). thus, the outcome of exposure is highly dependent on host immunity. in this study, our aim was to investigate whether the previously developed mycobacterium groth inhibition assay (mgia) method (andersson et al, tuberculosis 2020) could be used to quantify the host immune response to mtb. study design: in this study we will include healthy donors (n=80), patient with active tb (n=40), subjects recently exposed to active tb (n=80) and patients with latent tb (ltbi) (n=80). exclusion criteria for all groups are known hiv infection or other immunosuppression from treatment or disease. patients and healthy blood donors will be recruited at the departments of infectious diseases in region kalmar and region östergötland. from patients giving oral and written consent, 40 ml of blood will be collected for mgia analysis. primary aim: to determine the difference in mgia between healthy blood donors and patients with latent and active tb as well as the variation in host control of mtb within each group. method: the mycobacterial growth inhibition assay (mgia) using human pbmcs isolated by density gradient by lymhoprep (axis-shield) and sepmate tubes (stemcell technologies) will be performed as described in study i with minor modifications. the pbmcs are infected with gfp expressing m. tuberculosis h37rv and intracellular growth of mtb and viability of pbmcs are assessed by live-cell imaging (incucyte©) and measured as relative fluorescence units (rfu) during 5 days with and without stimulation with the purified protein derivate (ppd) is included. the cytokine response following exposure to gamma-irradiated h37rv will be quantified by olink proteomics.

Eligibility criteria:
inclusion criteria: healthy blood donors or subjects who will get vaccinated. exclusion criteria:known hiv infection, not swedish citizen, chronic liver och kidney disease,immunosuppression from treatment or disease.
acute effect of osteopathic visceral mobilization techniques

Conditions: Multiple Sclerosis; Pelvic Floor Disorders; Urinary Incontinence; Visceral Mobilization; Osteopathic Manipulative Treatment

Summary: multiple sclerosis (ms), caused by lesions in the white matter of the central nervous system, is an autoimmune inflammatory demyelinating chronic disease. the disease may present with many findings from fatigue, spasticity, balance and gait disturbances to bladder-bowel dysfunction (ferreira, a.p.s., et al., 2019). when the rehabilitation methods for incontinence were examined, pelvic floor muscle training, tibial nerve stimulation and sacral neuromodulation were frequently encountered (rahnama'i, ms., 2020). pelvic floor muscle training should create an effective result in ms patients, and the training should be done for a long time, such as 8-12 weeks. no study has been found examining the effects of manual therapy techniques and diaphragmatic breathing exercise in the acute phase in functional or neurogenic bladder-intestinal dysfunctions.

the study was planned as a randomized controlled trial. ms patients included in the study will be divided into two groups according to inclusion and exclusion criteria. diaphragmatic breathing exercises and sacral relaxation, bladder mobilization, which are osteopathic manual therapy techniques, will be applied to the study group. on the other hand, only diaphragmatic breathing exercises will be applied to the control group. individuals will be treated in a single session. the acute effect of intervention will be examined by making a total of 3 evaluations, pre-intervention, post-intervention, and 1 week after the intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * the age of 18 years and the older * individuals with stable medical condition * having complaints of urinary dysfunction for at least 6 months, * mini mental test score \> 24 points * edds less than 6.5 (0-6.5 points will be) * volunteering to participate in the study exclusion criteria: * having cognitive problems * presence of pelvic organ prolapse or prostate * pregnancy * abdominal surgery history * presence of urinary system infection * continuing drug use for overactive bladder * having received pelvic floor muscle training * concomitant other neurological or kidney disease
a safety and pharmacokinetics study of idp-118 lotion in pediatric participants with plaque psoriasis

Conditions: Psoriasis

Summary: this study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (hpa) axis suppression potential for topically applied idp-118 lotion in pediatric participants with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * is 4 to 16 years 11 months of age at time of informed consent/assent obtained. * verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian. * has a clinical diagnosis of psoriasis at screening and baseline with an investigator's global assessment (iga) score of 3 or 4. the face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present. * has an area of plaque psoriasis appropriate for topical treatment that involves a bsa of at least 10% at screening and baseline. the face, scalp, axillae, and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is \>18 μg/dl at the screening visit. * females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study. exclusion criteria: * has a history of adrenal disease. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device. * received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening hpa axis stimulation test. * has a history of hypersensitivity or allergic reaction to any of the study drug constituents. * is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Keywords: plaque psoriasis
the umbilical access in laparoscopic surgery

Conditions: Scars; Patient Satisfaction; Cosmesis

Summary: the aim of this study is to access to the abdominal cavity using different incision-types within the umbilical area. effects of different incisions on scarring and on the umbilical form will be investigated.


Eligibility criteria:
inclusion criteria: - patient undergoing laparoscopic surgery exclusion criteria: * pregnancy * patients following open abdominal surgery
risk factors for pyogenic liver abscess with carbapenem-resistant klebsiella pneumoniae: a matched case-control study

Conditions: Liver Abscess

Summary: pyogenic liver abscess (pla) is a complication of infectious disease, and the most common pathogen of pla is klebsiella pneumoniae, while pla caused by carbapenem-resistant klebsiella pneumoniae (crkp) has become a threat to public health. for achieving a better therapeutic outcome of crkp related pla, it is very important to figure out the basic characteristics and risk factors of crkp-pla. a retrospective cohort study was performed in which 15 pla patients carriage of k pneumoniae were screened at the xiangya hospital of central south university (changsha, china). the colonization and clinical infection isolates were analyzed by antimicrobial susceptibility testing to identify crkp. all admission patients diagnosed with pla who developed crkp were included, 5 adults pla patients with crkp infected and 10 adults pla patients with carbapenem sensitive klebsiella pneumoniae (cskp) infected were conducted. univariate and multivariate logistic regression was carried out using a stepwise selection method to compare prognostic factors between crkp and cskp groups.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. at least one positive culture reported by the clinical microbiology laboratory for crkp or cskp during the hospital length of stay. klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results. exclusion criteria: * less than 18 years old. patients with missing data without a drug sensitivity results.
cart-19 cells for r/r b-all

Conditions: Relapsed/Refractory B-cell ALL

Summary: there are limited treatment options for relapse/refractory b-cell acute lymphoblastic leukemia(all). however,cart-19 cells has emerged as a powerful targeted immunotherapy for highly refractory cd19+ acute lymphoblastic leukemia (all). this study aims to assess the safety and toxicity of cart-19 cells to patients with relapse/refractory b-cell all.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged between 1-60 years * patients with relapsed/refractory b-cell all * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females. * any co-morbidity precluding the administration of cart-19 cells.
impact of genotyping p450 2c19 on hospitalization period

Conditions: Infection

Summary: monocentric study with the objective to evaluate the impact of genotyping cyp2c19 on the hospitalization period. the genotyping will permit to adapt at best the voriconazole posology.

the main objective of this multi-center study is to evaluate the impact of dose adjustment of voriconazole after cyp2c19 genotyping at the start of treatment, on the length of hospital stay. thus, a new strategy will be proposed as part of this project and will be compared to the reference strategy: the new strategy: genotyping of cyp2c19 in any patient receiving treatment with voriconazole in order to better adapt the treatment regimen as quickly as possible (increase of the dosage of voriconazole in high-speed metabolisers or use of another antifungal, decreased dosage in poor metabolisers). the reference strategy: pharmacological therapeutic monitoring of voriconazole allowing an adaptation of the voriconazole dosage based on the residual concentration measured once steady state has been reached (5 elimination half-lives). multicenter, randomized study comparing two strategies of voriconazole adaptation according to whether or not genotyping of cyp2c19 is performed as soon as voriconazole is started. thus, the new strategy tested in this project and compared to the reference strategy (adaptation of voriconazole dosage depending on the residual concentration), will be a genotyping of cyp2c19 in any patient receiving a treatment based on voriconazole in order to better adapt the treatment regimen as quickly as possible (increase in the dosage of voriconazole or use of another antifungal agent in ultra-rapid metabolisers, decrease in dosage in poor metabolisers).

Eligibility criteria:
inclusion criteria: * patient with voriconazole treatment * man or woman * with social security number exclusion criteria: * patient or parent of patient who refuse to accept inform consent form * all patient under protection of adults

Keywords: genotyping techniques fungal infection