Kornimate/medical-research-clean huggingface dataset:
prospective huntington at risk observational study

Conditions: Huntington Disease

Summary: the purpose of this study is to define the natural history and experiences of people who are at risk for developing huntington's disease but who do not know their genetic status.

huntington's disease (hd) is a genetic disease characterized by changes in movement and behavior. to date, little research has been done on individuals who are at risk for developing the disease. pharos is an observational study designed to monitor people who are at risk for developing hd, and to survey their attitudes and beliefs about their "at-risk" status. investigators hope this study will help answer some important questions about hd, such as: 1.) what are the earliest signs of hd and when do they start? 2.) how accurate are the measures that physicians use in detecting the onset of hd? 3.) what factors influence the age at which a person carrying the hd gene develops the illness? and 4.) in a group of people at risk for hd, how many will develop signs of the illness over a minimum three-year period of observation? participants in the study will be evaluated every 9 months (for 5 years) using the unified huntington's disease rating scale (uhdrs)--a clinical tool which looks at movement, psychological and behavioral function. the participants will also be asked to complete surveys about their mood, life events, and attitudes or beliefs about being at risk for hd. a blood sample, taken at the beginning of the study, will be confidentially tested to determine if the participant has the abnormal gene for hd. neither the participant nor any of the pharos physicians or coordinators will learn the results of individual gene tests. the scientists hope that this study will provide essential information for future trials of experimental drugs for hd.

Eligibility criteria:
inclusion: * men and women between 26-55 years of age; * who are at risk for hd by virtue of having (or had) a parent or sibling with the illness; * who have never been tested for the hd gene, and who do not desire to be tested for the hd gene during the duration of the study; * agree to blinded (sample will be coded) genetic testing of the hd gene; and * who have never been diagnosed with hd. exclusion: individuals who: * have been diagnosed with hd; * are taking antipsychotic medications; * use antiemetic (anti-nausea) medications with on a regular basis (greater than 3 times per month); or * exhibit clinical signs/symptoms of psychosis at the screening visit

Keywords: huntington's disease hd huntington disease
point-of-care ultrasonography for intussusception

Conditions: Intussusception; Emergencies

Summary: pediatric emergency medicine (pem) physicians are increasingly utilizing point-of-care ultrasound (pocus). there is currently limited data regarding pocus evaluation for intussusception in pediatric patients. to better understand the role of pocus for identification of intussusception, the investigators plan to conduct a randomized, noninferiority study comparing pocus and radiology-performed ultrasound (radus), utilizing experienced sonographers across multiple institutions.

intussusception is the most common causes of bowel obstruction among children less than 6 years of age. limited abdominal ultrasonography is recommended as the initial screening study, prior to enema or surgical reduction for definitive treatment. although ultrasonography is typically performed by ultrasound technicians and interpreted by radiologists, recently published guidelines include identification of intussusception as an adjunct pocus application for emergency physicians to use at the bedside. two previous studies have investigated pocus use by pem physicians for the diagnosis of intussusception, both of which largely incorporated novice sonographers with limited training in bowel ultrasonography. only one previous prospective investigation has investigated pocus for the identification of intussusception, with a reported pocus sensitivity of 85% (95% confidence interval 54-97%) and specificity of 97% (95% confidence interval 89-99%) when compared to radus. in contrast, the sensitivity and specificity of radus have been reported to range from 98-100% and 88-98%, respectively, when compared to enema or surgical reduction. given the limited evidence available, it remains unclear whether pocus performs similar to radus in terms of diagnostic accuracy. the primary aim of this study is to determine whether pocus is noninferior to radus for the detection of intussusception. the secondary aims are to determine whether rates of serious complications or resource utilization measures differ among patients randomly assigned to receive pocus prior to radus or radus alone. the investigators hypothesize that diagnostic accuracy, expressed as sensitivity and specificity, is similar for pocus and radus, and that rates of serious complications and resource utilization measures do not differ across groups.

Eligibility criteria:
inclusion criteria: * children 3 months through 6 years of age; * clinical suspicion for intussusception per treating emergency physician. exclusion criteria: * need for critical care resuscitation (intubation or vasopressors); * emergent situation where the treating provider determines that pocus prior to radus may interfere with clinical care.

Keywords: point-of-care ultrasound intussusception pediatric emergency medicine ultrasound
effect of rehabilitation programs based on eccentric exercise of knee extensor muscles in isotonic and isokinetic conditions after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: a randomized clinical trial involving 30 individuals submitted to acl reconstruction will be conducted. participants will be randomized into: group i, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and group ii, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 45 days after acl reconstruction. the programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.


Eligibility criteria:
inclusion criteria: * young adults aged between 18 and 40 years; * recreational athletes; * unilateral acl injury; * presence of total or partial rupture of unilateral acl within 90 days after injury; * male subjects; * classification of body mass index up to pre-obese (25.0 - 29.9 kg / m2); * not undergoing any strength training program for the lower limbs in the six months prior to the study. * acceptance of individuals in participating in the procedures proposed by the research. exclusion criteria: * recidivism in ligament injuries; * associated ligament and / or meniscal lesions; * previous history (\<6 months) of musculoskeletal lesions in the thigh; * patellar tendinopathy; * patellofemoral pain syndrome; * respiratory or cardiovascular conditions that limit the performance of exercises; * users of dietary supplements or anabolic steroids
the disease progression of chinese axial spondyloarthritis in a real-word cohort study

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis (AS)

Summary: an observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axspa) according to the changes from baseline in measures of disease activity, function, and imaging.

this is an observational cohort study of chinese patients (≥18 years of age) diagnosed with axspa. patients are followed at 4-6 month intervals. data will be collected at baseline and at every follow-up time points. primary outcomes are the structural damage measured with imaging(conventional radiography, low-dose ct and mri) and the disease activity measured with the ankylosing spondylitis disease activity scale (asdas) and the bath ankylosing spondylitis disease activity index (basdai). secondary outcomes are inflammatory markers, bath ankylosing spondylitis functional index (basfi) and bath ankylosing spondylitis metrology index (basmi).

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older and diagnosed with the assessment of spondyloarthritis international society axial spondyloarthritis criteria. exclusion criteria: * patients with serious disease in cardiovascular, kidney and blood and endocrine system; history of schizophrenia or epilepsy; pregnant or in lactation period.
study evaluating the bioavailability of naproxen 500 mg in three formulations

Conditions: Arthritis

Summary: we will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.


Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature exclusion criteria: * standard exclusion criteria for a study of this nature
optimization of cyclosporin in atopic dermatitis through multiomic predictive models of treatment response

Conditions: Atopic Dermatitis

Summary: this is a low-intervention phase iv trial. the main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis who require systemic treatment.

primary outcome is the percentage of patients with primary non- response to treatment with cyclosporin. defined as fail to achieve easi-75 (a 75% improvement in easi score) at week 16 of follow-up. a 12-month recruitment period is planned and about of 100 patients with moderate-severe atopic dermatitis will be recruited. the study is divided into two cohorts. all patients diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporin in the dermatology service of la paz university hospital and associated specialty centers are selected in cohort 1. patients will receive the starting dose used in routine clinical practice. all patients diagnosed with moderate-severe atopic dermatitis who are receiving or have received cyclosporin therapy in the dermatology service of la paz university hospital and associated specialty centers are selected in cohort 2.

Eligibility criteria:
inclusion criteria: cohort 1: 1. subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine. 2. participants must be willing and able to provide written informed consent prior the initiation of any study procedures. 3. for children, parent/legal guardian must provide written informed consent. if age \>11 years old, the minor must give assent. 4. participant is willing and able to adhere to the procedures specified in this protocol. cohort 2: 1. subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine. 2. participants must be willing and able to provide written informed consent prior the initiation of any study procedures. 3. for children, parent/legal guardian must provide written informed consent. if age \>11 years old, the minor must give assent. 4. participant is willing and able to adhere to the procedures specified in this protocol. exclusion criteria: 1. subjects participating in a clinical trial in the last three months. 2. any condition or situation precluding or interfering the compliance with the protocol. 3. women of childbearing potential must have a negative urine pregnancy test at screening and day 0. 4. women of childbearing potential must commit not to become pregnant. they must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
dieta mediterranea e sindrome dell'intestino irritabile in pazienti pediatrici

Conditions: Irritable Bowel Syndrome

Summary: the goal of this observational study is to observe pediatric patients with ibs (irritable bowel syndrome). the main question it aims to answer are: * adherence to the mediterranean diet of children with ibs * in patients not adhering to the mediterranean diet, evaluate the efficacy of the nutritional intervention participants will be visited, blood samples will be taken, abdomen ultrasound and they will answer questionnaires.

the goal of this observational study is to observe pediatric patients with ibs (irritable bowel syndrome). the diagnosis of ibs will be placed in reference to the rome iv criteria. to make a diagnosis, at least 2 of: * abdominal pain for at least 4 days per month associated with one or more of: pain associated with bowel movements, change in bowel frequency, change in stool consistency must be present. * in children with constipation, pain persists as the constipation resolves. * the symptoms are not explained by another medical condition. participants will be visited, blood samples will be taken, abdomen ultrasound if necessary will be performed and they will answer questionnaires. the main question it aims to answer are: * adherence to the mediterranean diet of children with ibs * in patients not adhering to the mediterranean diet, evaluate the efficacy of the nutritional intervention. if bmi between 5 and 85, nutritional education will be carried out for a healthy and correct diet. if bmi between 85 and 95 or greater than 95, personalized mediterranean food scheme.

Eligibility criteria:
inclusion criteria: - diagnosis of ibs, based on rome iv criteria. exclusion criteria: * use of nsaids in the last 3 months; * allergies or intolerances; * recent diagnosis (last 3 months) of bacterial or parasitic infections of the gastrointestinal tract; * psychiatric diseases; * chronic inflammatory diseases of the gastrointestinal tract.

Keywords: irritable bowel syndrome pediatric mediterranean diet childhood ibs treatment
the influence of inspiratory muscular training (imt) on diaphragmatic mobility in morbidly obese

Conditions: Obesity

Summary: the purpose of this study is whether an inspiratory muscle training protocol would be associated with an improvement in of the diaphragm mobility, an increase in pulmonary function values , gain strength and endurance of respiratory muscles and improving quality of life.

few studies have investigated the effects of an inspiratory muscle training in obese patients on the diaphragmatic mobility and thickness. obesity, especially morbid, triggers changes in the respiratory system, which can affect the work activities and daily life of individuals with this multifactorial syndrome. these functional changes in mechanical ventilation may be linked to weakness and poor respiratory muscle strength, so by promoting rehabilitation of these muscles can minimize the losses that come with obesity

Eligibility criteria:
inclusion criteria: * bmi \> 40 kg/m² * absence of acute or chronic lung disease exclusion criteria: * acute or chronic inflammatory process * thyroid disorders

Keywords: obesity diaphragm inspiratory muscular training
a study to evaluate thb001 in adult patients with chronic cold urticaria

Conditions: Chronic Cold Urticaria

Summary: this is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.


Eligibility criteria:
key inclusion criteria: 1. women and men ages 18-75 2. diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment 3. positive cold stimulation test assessed by temptest® at the screening and baseline visits 4. considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ecg recording 5. willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions key exclusion criteria: 1. a diagnosis of acute urticaria or non-cold chronic inducible urticaria 2. ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others) 3. a positive test for pregnancy, hiv, hepatitis b or hepatitis c 4. clinical laboratory values outside of the normal ranges at the screening visit 5. history of any clinically significant abnormality that would contraindicate participation there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
impact of chyme reinfusion compared to parenteral nutrition on the incidence of complications in patients with a temporary high-output double enterostomy: a multicentre randomized controlled trial - fry: efficiency of reinfusion of chyme - (fry)

Conditions: Intestinal Failure With a Temporary High-output Double Enterostomy

Summary: in the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (pn) is the gold standard treatment until the surgical reestablishment of digestive continuity. pn has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. chyme reinfusion (cr) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. in patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that cr, compared to pn will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.


Eligibility criteria:
inclusion criteria: * aged over 18 years * temporary high-output double enterostomy (≥1500ml/24 hours) * total small bowel length ≥ 120 cm * downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion * oral feeding resumed for at least 5 days * parenteral nutrition or hydration required until the surgical reestablishment of digestive continuity * affiliation to an health insurance (general social security scheme or an equivalent scheme) * no current or planned participation in another biomedical research * signature of an informed consent form exclusion criteria: * expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks * refusal by the patient to have a mixed texture diet, * chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity, * not drained intra-abdominal collection, * fever, uncontrolled infection, or infection treated for less than 72 hours, * shock of any cause, * creatinine clearance ≤ 60 ml/min * patients under guardianship.

Keywords: nutrition double enterostomy chyme reinfusion randomized controlled trial
parabiotics use with nutritional management in pediatric celiac patients

Conditions: Celiac Disease in Children

Summary: this is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with celiac disease.


Eligibility criteria:
inclusion criteria: • celiac cases diagnosed either by non-biopsy approach {serology based: high iga antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using march classification exclusion criteria: * immunocompromised patients * patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study
efficacy of diclofenac suppository for pain control in ultrasound guided biopsy of prostate

Conditions: Carcinoma Prostate

Summary: transrectal ultrasound guided biopsy of prostate (trus-bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. it is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.the purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.


Eligibility criteria:
inclusion criteria:all male patients undergoing ultrasound guided prostate biopsy due to any one of the following: * raised prostate-specific antigen level (\>4.0ng/ml) and palpable nodularity on digital rectal examination * palpable nodularity on digital rectal examination * hypo echoic lesion as compared to surrounding prostate on transrectal ultrasound exclusion criteria: * history of previous prostate biopsy * acute and/or chronic prostatitis or chronic pelvic pain syndrome * anal fissure, hemorrhoids, anal surgery * concomitant analgesic medication * chronic renal failure * allergy to diclofenac
letermovir prophylaxis for cytomegalovirus (cmv) in patients with graft-versus-host disease

Conditions: Graft-versus-host-disease; CMV

Summary: explore the tolerability and efficacy of letermovir in the prevention of cmv reactivation in patients with acute and chronic graft-versus-host disease (gvhd) beyond day 100.

42 patients meeting the inclusion criteria will receive letermovir 480 mg per day. patients receiving concomitant cyclosporine will receive 240 mg of letermovir. letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier. all the patients will continue herpesvirus prophylaxis with acyclovir or valacyclovir. patients will be evaluated biweekly until letermovir discontinuation. a pcr cmv test will be performed biweekly. patients in whom clinically significant cmv infection (defined as cmv disease or cmv viremia leading to preemptive treatment) develop, will discontinue the trial regimen and begin anti-cmv therapy according to local practice. the threshold for preemptive treatment for cmv viremia will be \>1000 copies/ ml.

Eligibility criteria:
inclusion criteria: * adult patients * after allogeneic transplantation * seropositive for cmv * who already received letermovir prophylaxis until day 100 without cmv reactivation * beyond day 100 after transplantation at enrollment * with acute or chronic gvhd * daily prednisone dose ≥ 0.5 mg/kg (or equivalent dose of another glucocorticoid) at enrollment. * negative polymerase chain reaction (pcr) for cmv at enrollment * provided informed consent exclusion criteria: * seronegative for cmv * positive pcr for cmv at enrollment * patient has previously had cmv reactivation under letermovir.