Kornimate/medical-research-clean huggingface dataset:
treatment of functional abdominal distension

Conditions: Irritable Bowel Syndrome; Dyspepsia

Summary: background. abdominal distention is produced by an abnormal somatic postural tone. we developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. in a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. however, the technique is technically complex and unpractical. aim. to prove the efficacy of a simplified biofeedback technique for the treatment of abdominal distension. selection criteria. visible abdominal distension after meal ingestion; patients are able to identify the offending meal. intervention. patients will be randomized into biofeedback in placebo groups.three sessions of either biofeedback or placebo intervention will be performed 30 min after ingestion of the offending meal during the first 3 weeks of the intervention period. biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth); patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. primary outcome measure: effect of the probe meal on the activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) measured by electromyography before and after the probe meal. the response to the probe meal will be measured before and after treatment. secondary outcome measures: * effect of the probe meal on sensation of abdominal distension measured by 0-6 scales after the probe meal. * changes in girth produced by the probe meal measured using a non-stretch belt placed over the umbilicus before and after the probe meal. * sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.


Eligibility criteria:
inclusion criteria: * episodes of visible abdominal distension triggered by meal ingestion * patients are able to identify the offending foodstuff exclusion criteria: * organic cause detected by clinical work-up * constipation * abdominal distension not confirmed by the 7-day clinical questionnaires of after the probe meal in the pre-intervention evaluation
cyclosporin a eye drop treatment in vernal keratoconjunctivitis

Conditions: Vernal Keratoconjunctivitis

Summary: this interventional study aims to evaluate the efficacy of cyclosporine eye drop treatment in preventing relapses of vernal keratoconjunctivitis (vkc) and in treating the acute phases of the disease.

vernal keratoconjunctivitis (vkc) is a severe allergic disease, characterised by chronic ocular surface inflammation with seasonal relapses. active phases of vkc require treatment with topical steroids to control inflammation and corneal damage that may lead to impairment of visual function and severe ocular discomfort. to date, safe and effective therapies in preventing relapses and controlling active phases of vkc are not available. few controlled trials have used topical cyclosporine a (csa) for the treatment of vkc. the present multicenter, double-masked, randomised, controlled clinical trial will allow to obtain further data on the safety and efficacy of topical treatment with cyclosporine in patients affected by vkc. moreover, this study will evaluate the efficacy of topical csa in both preventing the relapses of vkc and controlling the active phases of the disease. it is important to highlight that cyclosporine eye drops are not currently commercially available in italy and must be custom-made by specialized pharmacies. as vkc mostly affects young patients, it influences their daily life and their social interactions. moreover, the severe signs and symptoms of the disease result in frequent ophthalmologic controls, influencing school activities of children and working days for their parents with a relevant economic cost for the national health system. comparisons: efficacy of cyclosporine a 0.05% eye-drops in preventing vkc relapses compared to standard antiallergic (ketotifen fumarate 0.025% eye-drops) treatment, and efficacy of cyclosporine a 0.1% eye-drops in controlling acute phases compared to antiinflammatory (desametasone 0.15% eye drops) treatments.

Eligibility criteria:
inclusion criteria: * patients affected by vkc will be enrolled by the three centres involved in the project * diagnosis of vkc will be performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping exclusion criteria: * contact lens wearers * patients affected by other ocular diseases * patients subjected to ocular surgery in the preceding 6 months * patients under eye drop or systemic treatments for other diseases, or * patients enrolled in experimental trials in the preceding 6 months

Keywords: vernal keratoconjunctivitis cyclosporine children clinical trial
treatment of tracheostomy granulomas

Conditions: Granuloma; Tracheostomy

Summary: this study plans to learn more about the different ways used to treat tracheostomy granulomas. investigators want to see which standard of care method (steroid application, silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.

upon joining the study patients will be assigned to one of the three treatment groups (steroid application, silver nitrate, and betadine). these three treatments are standard of care and patients would have been treated with one of them anyway. patients will be followed for an observation period of six weeks with follow-up appointments, per standard of care, every two weeks (+/- 3 days) in order for a physician to evaluate if the treatment method is working. if during a follow-up visit, the physician determines the treatment method is not working, the follow-up period will end and participation in the study will be complete. in addition, if a patient is given a different form of treatment during the observation period, such as in the emergency department or through their primary care physician, the follow-up period will end and participation in the study will be complete.

Eligibility criteria:
inclusion criteria: * children's hospital colorado inpatient or outpatient * 31 days to 17 years (inclusive) * needs treatment for a tracheostomy granuloma exclusion criteria: * tracheostomy granuloma has been treated in the last two weeks
gender identity and own body perception

Conditions: Gender Dysphoria

Summary: this study will provide valuable information on the neurobiological underpinning of gender dysphoria (gd) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment.

the purpose of this study is to understand the neurobiology of gender dysphoria (gd) and the interactions between cross hormone treatment, the brain, and the body phenotype. the investigators also aim to identify pre-treatment neurobiological and other factors to help predict body congruence and quality of life outcomes from hormone treatment. there is mounting interest in gender identity issues worldwide, as requests for gender-confirming treatments have increased in the past 3 decades, and alarmingly high suicide rates have recently been reported in those with gd. despite this, little is known about neurobiological or other etiological factors contributing to gd or gender incongruence. this study will address a core feature of gd that has been little studied in terms of the neurobiology: the incongruence between perception of self and one's own body.

Eligibility criteria:
participants with gender dysphoria (gd) inclusion criteria: * females and males from any racial or ethnic background, between the ages of 18 years and 40 years. * participants must meet diagnostic and statistical manual-5 criteria for gd (302.85) * intelligence quotient (iq) \> 80 participants with gd exclusion criteria: * previous or on-going sex hormone medication * previous sex reassignment surgery * oral contraceptives * participants with gd are not be taking any other psychotropic medication. (no participant will be recommended to discontinue or taper medications for the purpose of participating in the study.) * irregular menstrual cycles control participants inclusion criteria: * females and males from any racial or ethnic background, between the ages of 18 and 40. * iq \> 80 control participants exclusion criteria: * psychiatric medications * a score of ≥ 1 standard deviation higher than population norms on the madrs depression or the hamilton anxiety scale (hama) * sex hormone treatment * irregular menstrual cycles exclusion criteria for all participants: * any known chromosomal or hormonal disorder * current substance abuse or dependence * current neurological disorder or psychiatric disorder * pregnancy * current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders * head trauma associated with loss of consciousness * hiv positive individuals * individuals with ferromagnetic metal implantations or devices. this includes any electronic implants or devices, braces, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates * visual acuity worse than 20/35 for each eye as determined by snellen close vision acuity chart. acuity may be met with corrective lenses
study of tideglusib in adolescent and adult patients with myotonic dystrophy

Conditions: Myotonic Dystrophy 1

Summary: the purpose of this study is to determine whether tideglusib is safe and efficacious in the treatment of adolescents and adults with congenital and juvenile-onset myotonic dystrophy. the pharmacokinetics of tideglusib and its primary metabolite will also be investigated.


Eligibility criteria:
inclusion criteria: * adolescents or adults with diagnosis of congenital or juvenile-onset type 1 myotonic dystrophy (dm-1) * diagnosis must be genetically confirmed * subjects must be male or female aged 12 years to 45 years * subjects must have a clinical global impression - severity (cgi-s) score of 4 or greater at screening and run-in (v2) * subjects must be ambulatory and able to complete the 10 metre walk/run test (splints allowed) * subject's legally authorized representative (lar) must provide written informed consent and there must be written consent or assent (as age applicable and developmentally appropriate) by the subject before any study-related procedures are conducted exclusion criteria: * non-ambulatory (full time) wheel chair user * receiving stimulant medication * receiving other medications/therapies not stable (changed) within 4 weeks prior to run-in (v2) * medical illness or other concern which would cause investigator to conclude subjects will not be able to perform the study procedures or assessments or would confound interpretation of data obtained during assessment. * current enrolment in a clinical trial of an investigational drug or enrolment in a clinical trial of an investigational drug in the last 6 months * women of child bearing potential who are pregnant, lactating or not willing to use a protocol defined acceptable contraception method if sexually active and not surgically sterile. * gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication and impact the interpretability of the study results * current clinically significant (as determined by the investigator) cardiovascular, renal, hepatic, endocrine or respiratory disease * clinically significant heart disease (in the opinion of the investigator) or second or third degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia * a history of chronic liver disease with current out of range values for alanine transaminase (alt), clinically relevant hepatic steatosis or other clinical manifestations of ongoing liver disease * a history of significant drug allergy (such as steven-johnson syndrome, anaphylaxis) * a history of alcohol or substance use disorders
effects of lifestyle education programs on diabetes control in rwanda

Conditions: Diabetes Mellitus

Summary: strategies to reduce the burden of diabetes in rwanda, like in other resource poor settings, include involving diabetic patients in their own care and targeting modifiable risk factors through adopting appropriate dietary and lifestyle habits. according to previous research carried out in developed countries, lifestyle modifications may have effect on the development of diabetes and prevention of its complications. however, direct evidence to show whether lifestyle intervention is beneficial for diabetic patients in resources limited countries like rwanda is an open question. though in these countries, access to healthy diet is claimed to be the barrier of implementation of therapeutic lifestyle based initiatives, we hypothesize that knowledge gaps are more important barriers than access to healthier diets and other lifestyle habits. we therefore would like to carry out this intervention to assess the effects of lifestyle education programs on glycemic control among people with diabetes followed up at chuk.

the study is a randomized controlled trial with two groups (one interventional and one control) to be followed up for 12 months. it will be carried out in kigali university teaching hospital, the main referral hospital in rwanda. lifestyle intervention will consist in group counselling on dietary habits (meals composition, importance and ways to reduce unhealthy foods: salty (especially because hypertension is of concern among diabetic people and blood pressure will be one of the secondary outcome measures), sugar, unsaturated fats, smoking, alcohol abuse and adapt healthier regimens including fruits \& vegetables), effects of regular physical activity, importance of adherence to medications (including taking medications as directed, regular medical follow up,etc...), diabetes complications, actions to control blood sugar and ways of coping with stress. education \& counselling sessions will be provided by a team of registered dietitians, nurses and counselors who will have been trained for this purpose prior to the intervention and will be taking between 45 to 60 min. after baseline data collection, subjects in the control group will continue to receive usual care delivered by attending physicians and nutritionists at chuk. this includes usual monthly medical follow up and individual conselling on dietary habits and lifestyle change delivered by attending physicians and/or dietitians

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes known since three months at least, * being currently on treatment (insulin or oral hypoglycemiants), * able to follow up at chuk exclusion criteria: * patients with advanced diabetic complications (advanced nephropathy \& ckd, proliferative retinopathy, recent history of myocardial infarction \& severe heart failure (lvef\<35%), peripheral artery disease, stroke, severe diabetic foot disease, * any other severe illness that may impede the patient's functional capacity, * severe psychiatric disorders * pregnancy

Keywords: diabetes lifestyle intervention rwanda
assessing the effects of a neurobehavioral intervention on symptoms of obsessive compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: this experiment will examine if the use of computerized tasks that train individuals to control their attention more effectively will predict individual differences in obsessive-compulsive symptoms, rumination and bdnf change. after giving consent, filling out self-report forms, and giving blood for the bdnf test, 80 participants will be randomized to cognitive control training (cct) or peripheral vision task (pvt) (described below) which will be administered three times over a two week period. at the third visit, participants will also complete an anagram task and repeat the blood draw for bdnf testing. the investigators hypothesize that computerized tasks that train individuals to control their attention more effectively will reduce obsessive compulsive (oc) symptoms. additionally, individuals training in cct will show increased ability to disengage from unattainable goals as assessed by responses to an unsolvable anagram task. finally, individuals training in cct will show a greater increase in bdnf levels as compared to individuals training in pvt.


Eligibility criteria:
inclusion criteria: * adults ages 18-65 years * oci-r total score ≥ 16 * ability to read and provide informed consent. * familiarity with a computer keyboard and mouse. exclusion criteria: * bdi-ii suicidality score of \> 1

Keywords: high oci-r scores
observational study on inappropriate therapies

Conditions: Inappropriate Shocks From Implanted Defibrillator; ICD Replacement or Upgrade

Summary: the purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (vr/dr/crt) or upgrade from a previously implanted icd (vr/dr)

all subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. these follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring. additional follow-ups can be performed at physician's discretion. data on reportable adverse events will be collected throughout the study. all study data will be collected using an edc system. all delivered anti-tachycardia therapies (shock or atp) will be reviewed by an independent board of experts in order to evaluate appropriateness. the programming of the device parameters is at physician's discretion (suggested settings is slow vt monitoring zone 150 - 185 bpm with 30 cycles persistence, vt zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).

Eligibility criteria:
inclusion criteria: 1. any subject that had an icd/crt-d replacement/upgrade according to the latest relevant clinical guidelines with a microport crm icd / crt-d for less than 7 days 2. signed and dated the informed consent form exclusion criteria: 1. rv lead replacement 2. previous icd/crt-d inactivated or already explanted 3. active myocarditis 4. primary prevention for arrhythmogenic ventricular cardiomyopathy, ion channelopathies, hypertrophic cardiomyopathy and infiltrative or inherited cardiomyopathy. 5. heart transplant (done or on waiting list) or implanted with a ventricular assist device (vad) 6. already included in an interventional study that could confound the results of this study 7. inability to understand the purpose of the study or to meet follow-up visits as defined in the investigational plan 8. minor age (\<18 years) or under guardianship or kept in detention 9. ongoing drug or alcohol addiction or abuse which would interfere with the subject's ability to be compliant with the study. 10. life expectancy less than 1 year 11. pregnant or breast feeding
ibis megastudy- pilot

Conditions: HIV

Summary: in this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote hiv retesting among adults in rural kenya and uganda who have higher risk of hiv exposure.

hiv re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection by treating those identified to have disease promptly. the proposed study aims to identify approaches that would encourage individuals aged 15 years and above at high risk of hiv infection to retest. this ibis megastudy pilot trial will pilot 11 intervention prototypes for acceptability, feedback, and implementation outcomes prior to using the interventions in a larger-scale megastudy trial (main trial to be submitted as a separate ct.gov record).

Eligibility criteria:
inclusion criteria: * at least 15 years of age * at increased risk of hiv infection (defined by self-reported risk \[at least one of the following over the 3 months prior to enrollment: \>1 sexual partner, known hiv-positive sexual partner, diagnosed with a sexually transmitted infection, or paid or received gifts or money in exchange for sex\] or by kenya or uganda moh criteria for priority group) * documented negative hiv antibody test within 7 days of enrollment * no intent to migrate out of community in next 3 months * daily access to a mobile phone (required since some of the interventions will be delivered by phone) exclusion criteria: * hiv-positive

Keywords: behavioral economics &#34;nudge&#34; interventions uganda kenya hiv retesting
nalmefene in alcohol dependence and borderline personality disorder

Conditions: Alcohol Use Disorder; Borderline Personality Disorder

Summary: the objective is to study the effectiveness of nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid bpd.


Eligibility criteria:
inclusion criteria: * alcohol use disorder according to dsm 5 * borderline personality disorder according to dsm 5 * cgi-bpd \> 3 * female have to use contraception exclusion criteria: * other axis i disorders * severe organic disorder * pregnancy or breastfeeding * allergy to nalmefene * subjects with opioids use disorder or in treatment with opioid agonists