Kornimate/medical-research-clean huggingface dataset:
haemolytic uraemic syndrome in childhood: clinical, cognitive and psychological aspects

Conditions: Hemolytic-Uremic Syndrome; Children; Parents; Psychological Adjustment

Summary: the purpose of this study is to investigate the clinical, cognitive outcome and psychosocial outcome of haemolytic uraemic syndrome in childhood. the haemolytic uraemic syndrome (hus) is the leading cause of acute renal failure in childhood. the more common typical hus is mostly caused by shigatoxin-producing enterohaemorrhagic escherichia coli (ehec). the rarer atypical hus is mainly caused by different genetic abnormalities in complement regulatory proteins. about 50 till 60 percent of all patients with hus develop a severe acute renal failure and require dialysis. resulting from new diagnostic and therapeutic approaches the survival rate increased during the last years. despite this, there are only few data concerning long-term prognosis, cognitive and motoric development, as well as psychological coping and health-related quality of life of affected children and their parents.

the main purposes of this study are: the evaluation of the long-term renal function of pediatric hus-patients; the evaluation of the dialysis method in the acute phase of the disease and its impact on the duration of the renal-placement-therapy, as well as the long-term renal function; the evaluation of the intellectual and motoric performance of affected children and the evaluation of the health-related quality of life and psychological processing of the patients themselves and their parents. all cases of hus treated at the university children's hospital zurich between 1995 and 2012 will be analyzed retrospectively. in the course of a routine-follow-up-examination the clinical data of patients up to the age of 17 years will be actualized and completed. the results of clinical and paraclinical investigations related to renal function will be evaluated to describe the clinical features of haemolytic uraemic syndrome in childhood. intellectual performance will be analyzed with the wechsler-intelligence scale for children-iv (wisc-iv) and motoric performance with the zurich neuromotor assessment in children at the age from 6 to 16 years. the health-related quality-of-life of all parents and affected children from the age of 7 years will be assessed by different generic quality-of-life-instruments.

Eligibility criteria:
inclusion criteria: * children and youth from 2 months to 17 years who had suffered from haemolytic uraemic syndrome * willingness and ability to participate in the study * freely signed informed consent exclusion criteria: * missing written informed consent * children who do not fulfil the age criterion

Keywords: haemolytic uraemic syndrome complications of hus renal replacement treatment renal function outcome neuropsychological sequelae psychological adjustment quality of life
the effect of interactive robot on children's after the surgery

Conditions: Pediatric Surgery

Summary: this project will be conducted with 5-10-year-old children who will undergo an outpatient surgery in trakya university health research and application center at pediatric surgery clinic and their parents. it is reported in the literature that technology-based applications and robot use are promising innovations in reducing pain, anxiety, and fear in children. this was the main starting point in the planning of the study. in this study, by using interactive robot, it was aimed to reduce postoperative mobilization anxiety, to increase frequency / duration of the mobilization and to increase parental satisfaction of the children undergoing outpatient surgery.

the use of interactive robots is expected to reduce the child's anxiety by ensuring that the child is physically, psychologically, and socially optimal. it is foreseen that the child with reduced anxiety will be willing to mobilize with the interactive robot and it will increase the mobilization time and the frequency of the mobilization during the day. decreasing the anxiety of children and increasing the desire for mobilization will increase the satisfaction of the families. the study will be conducted with 84 children (42 experiment + 42 control) aged 5-10 years. the study was planned as a randomized controlled study. data will be collected by "questionnaire form" and "child anxiety scale-state anxiety" and parental satisfaction scoring-visual analog scale" and "mobilization chart". families will be informed about the research and before the surgery, families, and children in both groups will be informed about the benefits of mobilization. two hours after the operation, just before the mobilization, the children in the experimental group will be introduced to the robot, and the children in the control group will be asked to mobilize with their parents. when the child is first mobilized at the time recommended by the physician for all groups after the surgery, the child's anxiety for mobilization will be assessed using the child anxiety scale (state anxiety). the mobilization time of the children will be measured by stopwatch and recorded in the mobilization schedule together with the frequency of mobilization. parental satisfaction scale- visual analogue scale will be applied to evaluate the satisfaction of the parents towards the application.

Eligibility criteria:
inclusion criteria: * undergo day surgery, * speaking turkish, * being a volunteer to participate in the study, * being 5-10 aged, * do not have a visual, auditory, or mental problem and their parents will be included in the research. exclusion criteria: * no undergo day surgery, * no speaking turkish, * not being a volunteer to participate in the study, * not being 5-10 aged, * have a visual, auditory, or mental problem and their parents will be included in the research.

Keywords: interactive robot child surgery mobilization anxiety parental satisfaction
periconception prep for hiv-exposed ugandan women

Conditions: HIV Prevention

Summary: in this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 hiv-uninfected women reporting an hiv-infected or high-risk partner and personal or partner plans for pregnancy in rural uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration \>40ng/ml, opening pill device to take \>80% of dispensed pills) to prep and other safer conceptions strategies among ugandan women exposed to hiv.

the study plans to enroll 150 hiv-uninfected women with an hiv-positive or hiv-serostatus unknown partner and personal or partner pregnancy plans. eligible women will participate in comprehensive safer conception counseling including offering daily, oral tdf/ftc as prep. the primary outcomes are to evaluate uptake of and adherence to periconception prep among hiv-exposed women in rural uganda. to accomplish this, women will participate in quarterly study visits, hiv and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. participants will be eligible to initiate prep at any time during the first 6 months of the 9-month study follow-up period. participants who initiate prep will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma tfv at quarterly study visits. for women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate prep use, pregnancy and infant outcomes. study duration will be a maximum 19 month follow-up period (through pregnancy outcome) . investigators will offer objective sexually transmitted infection (sti) testing to all participants in order to measure the prevalence, incidence, and factors associated with stis. investigators will compare incidence among women who choose and who do not choose prep. investigators will also measure the number of episodes of condomless sex each month as a mediator variable for sti development.

Eligibility criteria:
self report inclusion criteria: 1. female 2. aged 18-35 3. likely to be fertile based on reproductive health history \[55\] 4. reported personal or partner desire to have a child in the next year \[56-59\] 5. with a partner she reports as hiv-infected or likely to be hiv-infected (e.g. taking medicine daily, goes to clinic routinely, has hiv-infected partners, he has implied that he is "sick" but has not disclosed). 6. live within 60km of clinic. not planning on relocating to an area incompatible with ability to attend quarterly clinic over a 9-month follow-up period objective inclusion criteria: 1. hiv-negative (onsite rapid testing) 2. not currently pregnant (onsite urine b-hcg testing) 3. fluent in english or local language 4. otherwise able to participate in the informed consent process exclusion criteria 1. currently pregnant 2. hiv-positive

Keywords: prep conception prevention
assessment of uterine access, uterine patency and intrauterine adhesions following endometrial ablation

Conditions: Intrauterine Adhesion

Summary: the objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. the presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.

prospective single center observational study. up to 30 subjects will be enrolled (up to 10 subjects per time point). patients who sign the institutional review board (irb) approved consent form who have undergone endometrial ablation within the prior 14 months from time of consent will be asked to participate in this study. patients meeting all eligibility criteria will undergo either a 3, 6 or 12 month diagnostic second look hysteroscopy (slh) as assigned by the investigator depending on the duration of time between the ablation and the signature date of the informed consent (up to 10 subjects for each time point). a diagnostic slh will be performed for scoring of intrauterine adhesions by the investigator and an independent reviewer. the ability to access the uterine cavity (or not) will be documented.

Eligibility criteria:
inclusion criteria: * premenopausal female patients ≥ 18 years of age * patient has undergone endometrial ablation within the prior 14 months. * there were no contraindications for endometrial ablation as specified in ablation system labeling * patient agrees to undergo an slh either at 3, 6 or 12 months post-ablation * patient abstained from any form of hormonal contraception including an iud after the ablation and through the period that the slh is performed. * patient has signed the irb approved informed consent. exclusion criteria: * additional intrauterine procedures performed between time of endometrial ablation and the slh; e.g., endometrial and/or myometrial resection. * iud in situ * pregnant (positive urine pregnancy test) or lactating * active sexually transmitted infection or genital infection, or other clinically significant active and/or systemic infection per clinical or laboratory examinations at the time of endometrial ablation procedure or second look hysteroscopy (e.g., cervicitis, vaginitis, endometritis, or salpingitis). * systemic steroid within 1 week of endometrial ablation * previous adhesiolysis procedure or diagnosis of asherman's disease. * no noted clinically significant uterine anomalies at the time of the ablation (e.g., septate uterus or other anomalies that distorts the uterine cavity) * any other condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements. * participating or considering participation in a clinical trial of another investigational drug or device during this study
effect of 2-year administration of cp-945,598 on weight loss efficacy and safety.

Conditions: Obesity

Summary: the purpose of this study is to examine the long-term weight loss and safety of cp-945,598 in obese adults

the cp-945,598 program was terminated on november 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the cb1 class and likely new regulatory requirements for approval. no safety issues were involved in the termination decision.

Eligibility criteria:
inclusion criteria: * obese adults with a body mass index \> or = 30 kg/m ; \> or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia exclusion criteria: * pregnancy * diabetes * adults with serious or unstable current or past medical conditions
stratagraft® skin tissue expanded access at specific study sites ( stratacat )

Conditions: Deep Partial-thickness Burn

Summary: an autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. stratagraft skin tissue was an investigational tissue that could be used as an alternative to an autograft. * stratagraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (dpt) burns. * there were no safety concerns reported to date. the sponsor submitted a treatment protocol to food and drug administration (fda) for doctors who participated in the phase 3 strata 2016 study (nct 03005106) to allow for expanded access to stratagraft before it was commercially available. the main purpose of the study was to allow patients to receive stratagraft during biologics license application review and prior to approval by the fda for the treatment of dpt burns. the primary outcome measure was the number of participants with adverse events and safety concerns.

the primary purpose of this trial was to provide expanded access to stratagraft for thermally induced dpt burns that contained intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.

Eligibility criteria:
inclusion criteria: to be considered for inclusion, a participant must: * provide written informed consent * have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary * have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities: 1. that are the right size for treatment areas, 2. with intact dermal elements for which excision and autografting are clinically indicated, and 3. have not been previously excised and grafted. exclusion criteria: a participant must be excluded from participation if he/she: * is pregnant, a prisoner, or expected to live less than 3 months * has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives * has participated in an investigational study within 90 days before enrollment

Keywords: alternative to autograft
endotoxinemia and vasoplegia following cardiothoracic surgery with cardiopulmonary bypass (cpb)

Conditions: Vasoplegia; Vasoplegic Shock

Summary: this observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

through previous research, it has been well established that cardiothoracic surgery using cardiopulmonary bypass (cpb) causes a systemic inflammatory response. this is in part due to the surgical trauma, the extracorporeal circulation and factors that come with it (e.g. blood contact with foreign surfaces, mechanical stress etc.), and ischemia. this inflammatory response is a key contributor to the incidence of vasoplegia and vasoplegic shock following these types of surgery - a common complication that in turn causes significant morbidity and mortality. over the years, many factors that contribute to this reaction have been discussed. one potential explanation is the release of endotoxin into the bloodstream during cpb. endotoxin is a molecule that is a part of bacteria which are native to the human gut. in healthy subjects, cell-barriers prevent release of relevant amounts of endotoxin into the blood stream. during major interventions, and especially during cardiac surgery with cpb, this barrier function is impeded, allowing endotoxin levels to rise and potentially exert detrimental effects. while previous studies have indicated that endotoxin may in fact be released into the bloodstream in significant concentrations, and there are some mechanistic explanations to how endotoxin may contribute to the resulting inflammation and vasoplegia, available studies have been small and the evidence is inconclusive. this study aims to show whether different blood-levels of endotoxin are associated with vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with cpb.

Eligibility criteria:
inclusion criteria: 1. adult patients undergoing cardiac surgery requiring cpb 2. written informed consent exclusion criteria: 1. emergency surgery in the context of acute coronary syndrome 2. patients with chronic inflammatory diseases of the gut 3. patients receiving immunosuppressive drugs 4. patients with infectious endocarditis 5. patients with sepsis 6. patients with chronic kidney disease with estimated glomerular filtration rate (egfr) \<20 ml/min/1,73m² 7. persons with any kind of dependency on the investigator or employed by the institution responsible or investigator 8. persons held in an institution by legal of official order -

Keywords: endotoxin cardiopulmonary bypass (cbp) vasoplegia vasoplegic shock
an efficacy and safety study of rimonabant for treatment of nonalcoholic steatohepatitis (nash) in patients with type 2 diabetes

Conditions: Fatty Liver

Summary: the purpose of this study is to assess the effect of rimonabant treatment on the histological features of nonalcoholic steatohepatitis (nash) in patients with type 2 diabetes.

the total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus and a diagnosis of nash exclusion criteria: * excessive alcohol use * presence of type 1 diabetes mellitus * other chronic liver disease * previous or current hepatocellular carcinoma * use of medication known to cause steatosis * previous bariatric surgery * pregnancy or breastfeeding * presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: nash chronic liver disease
studies of hereditary hemorrhagic telangiectasia

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: objectives: i. examine screening modalities for pulmonary vascular arteriovenous malformation (pavm) in individuals with endoglin mutations. ii. examine the prevalence of cerebral arteriovenous malformations (cavm) in individuals with hereditary hemorrhagic telangiectasia (hht). iii. investigate whether modifier genes exist that determine which individuals with hht due to an endoglin mutation develop pavms and which develop cavms. iv. investigate the frequency of cardiac valve abnormalities in individuals affected with hht due to an endoglin mutations.

protocol outline: patients with hereditary hemorrhagic telangiectasia (hht) undergo 5 different screening methods to determine which method is most effective in detecting arteriovenous malformations (avm). patients may participate in more than one screening method. in part 1, patients undergo 3 different screening techniques (e.g., pulse oximetry, spiral computed tomography (ct), and contrast echocardiography) to detect pulmonary arteriovenous malformations (pavm). patients in part 2 undergo magnetic resonance imaging (mri) using gadolinium as the contrasting agent for avm in the brain, known as cerebral arteriovenous malformations (cavm). for pregnant women, this procedure may only take place if there is clinical evidence that suggests cavm. in part 3, doppler ultrasound is used to screen for hepatic arteriovenous malformations (havm). the abdomen of each patient is viewed to detect avm in the liver. patients in part 4 undergo echocardiograms as the screening method used to determine common heart valve abnormalities. in part 5, blood samples are drawn from patients and analyzed to locate modifier genes as a possibility in determining severity of hht.

Eligibility criteria:
* osler-rendu-weber disease (or hereditary hemorrhagic telangiectasia)

Keywords: genetic diseases and dysmorphic syndromes hematologic disorders hereditary hemorrhagic telangiectasia rare disease osler-rendu-weber disease
effects of iastm in the treatment of adhesive capsulitis

Conditions: Pain, Shoulder; Adhesion; Shoulder; Myofacial Pain

Summary: this study aimed to determine the effects of iastm in combination with exercise in frozen shoulder. thirty-five patients with phase ii frozen shoulder included in this single-blind, randomized study. patients were divided into two groups. in the first group exercise programme (group 1) and in the second group iastm in combination with exercise programme (group 2) were applied for twelve sessions (two days per week for six week). the primary outcome was the disabilities of the arm, shoulder and hand (dash) score and secondary outcomes were the visual analogue scale (vas), the range of motion (rom), the constant score and short- form-36 (sf-36). outcome measures were performed at baseline, after the 6th session and the 12th session.

instrument assisted soft tissue mobilization (iastm) is a popular treatment for myofascial restriction based on the logic developed by james cyriax. iastm is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. iastm can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of iastm use in patients with frozen shoulders in the literature. this study aimed to determine the effects of iastm in combination with exercise in the treatment of frozen shoulder. therefore, it was hypothesized that exercise programme combined with iastm are more effective in improving pain, range of motion (rom), and functionality than are the exercise programme alone.

Eligibility criteria:
inclusion criteria: * aged between 30 and 65 years; * duration of complaint of more than three months * rom in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions exclusion criteria: * having cervical radiculopathy * thoracic outlet syndrome * rheumatological disorders * fractures or tumors of either upper extremity * corticosteroid injections in the affected shoulder within the previous 4 weeks

Keywords: adhesive capsulitis function pain exercise