Kornimate/medical-research-clean huggingface dataset:
tranexamic acid and spontaneous chronic urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: spontaneous chronic urticaria (ucs) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, berlin consensus 2016). these high doses are often accompanied by side effects requiring cessation of treatment. the therapeutic alternative is then omalizumab, an expensive biotherapy. ucs is secondary to non-specific mast cell activation. it has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. patients with ucs resistant to levocetirizine were shown to have higher d-dimer levels than patients who responded to antihistamines. tranexamic acid is a molecule with antifibrinolytic propertiesseveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. in our department, investigators also noticed the improvement of some of their patients on tranexamic acid. the combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis. the investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.

multicentric controlled randomized crossover study, double-blind to evaluate the efficacy and safety of levocetirizine 10mg / day + tranexamic acid (at) 2g / day versus levocetirizine 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks. a hierarchical analysis will be implemented in the following order: 1. non-inferiority of the combination levocetirizine 10 mg / day + tranexamic acid (ta) 2 g / day versus levocetirizine alone 20 mg / day in terms of effectiveness 2. superiority of the combination levocetirizine 10 mg / day + tranexamic acid (at) 2 g / day versus levocetirizine alone 20 mg / day in terms of tolerance 3. superiority of levocetirizine 10mg / day + tranexamic acid (at) 2g / day versus levocetirizine alone 20mg / day in terms of effectiveness each objective will be tested sequentially if and only if the previous objective is validated.

Eligibility criteria:
inclusion criteria: * patients with spontaneous chronic urticaria, according to the criteria of the european academy of allergology and clinical immunology (eaaci) in agreement with the european dermatology forum (edf), and the world allergy organization (wao), corresponding to an association of the following symptoms : urticarial eruptions and / or recurrent angioedema for at least 6 weeks exclusion criteria: * urticaria associated with a specific systemic disease including cutaneous and systemic mastocytosis, urticarial vasculitis, autoinflammatory diseases associated with cryopyrin * bradykinin angioedema and isolated angioedema whose origin is not clearly attributable to spontaneous chronic urticaria. * presence of a contraindication to tranexamic acid and to levocetirizine
transition of inflammatory bowel disease (ibd) patients from pediatric to adult gastroenterologist (gi)

Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis

Summary: the purpose of this study is to determine if the program that has been made to ease the transition of care for adolescent patients with ibd from pediatric gastroenterology to adult gastroenterology is effective to reduce the risk of disease flare during this period. patient satisfaction with this program will also be assessed.

approximately 15 to 25% of patients with inflammatory bowel disease are diagnosed prior to the age of 18. the chronic course of this disease means that approximately one quarter of all ibd patients will need to transition from being cared for by a pediatric gastroenterologist to an adult gastroenterologist. studies in other chronic disease states have identified several problems with the current means of transitioning care from a pediatrician to the adult caregiver including lack of adherence with the proposed treatment, lack of knowledge about the disease, and limited self-care skills. even without ibd, this can be a time of tremendous turmoil for the adolescent patient. for the chronically ill ibd patient, this stress is further intensified by the underlying illness. several studies have shown that the risk of flare is increased by non-adherence with medical treatment. the main factors associated with poor adherence include young age and either being under the doctor's care for less than one year or being a new patient for that doctor. therefore, young adults transferring care from a pediatric gastroenterologist to an adult gastroenterologist are at the highest risk for a bad outcome. several recommendations have been published on how to best transition the adolescent ibd patient from pediatric to adult care. the general consensus is that there should be a gradual age specific increase in patient autonomy and involvement in their care prior to being transitioned to an adult gastroenterologist. no study however has incorporated combined clinic visits for the patient with both the pediatric and adult ibd specialist. furthermore, although these recommendations make logical sense, they have not been assessed objectively.

Eligibility criteria:
inclusion criteria: a patient may be considered for study participation if all of the following apply: 1. outpatient of either sex aged ≥ 16 years or older. 2. the patient has a confirmed diagnosis of ibd. 3. no plans to move \> 200 miles from nashville in the subsequent 12 months. 4. the patient has read, understood and signed a written informed consent form. permission of a minor participant will be obtained via a parent consent form. exclusion criteria: the patients will be excluded from the study if one or more of the following apply: 1. unable to give consent. 2. does not meet inclusion criteria above.
behaviour of tricuspid valve regurgitation in volume and/or pressure loaded right heart

Conditions: Tricuspid Valve Insufficiency

Summary: right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. up to now, tricuspid valve regurgitation (tr) and right heart hemodynamics have not been extensively investigated. however, it is plausible that a significant degree of tr and the associated volume-overload of the right ventricle cause significant right ventricular wall stress. although minor tr generally is well tolerated, major tr can lead to clinical symptoms, right ventricular dilatation and ultimately right ventricular heart failure. up to now, the investigators do not dispose of any tools to diagnose and anticipate this unfavourable evolution. nevertheless it is likely that right ventricular failure is preceded with a subclinical dysfunction of the right ventricle and a possibly reversible change in contractility of the myocardium. recently, new techniques to evaluate the systolic function, the contractility and the hemodynamics of the heart have become available. first, this study will help us assessing the feasibility and accuracy of several imaging modalities in right-sided heart pathology with focus on tr and right heart myocardial performance. second, this study will contribute to a better understanding of the hemodynamic effect of volume-overload and/or pressure-overload of the right ventricle. it will clarify the behaviour of tr, the evolution of right ventricular myocardial contractility and dysfunction during exercise and its impact on exercise capacity. by doing this, discrimination between well tolerated and ill-tolerated tr will be possible, thus identifying patients who might be eligible for treatment (medical, corrective, ...).


Eligibility criteria:
inclusion criteria: * pulmonary arterial hypertension * pulmonic valve stenosis * pulmonic valve homograft * pulmonic valve insufficiency * atrium septum defect * ebstein's anomaly * transvalvular rv pacemaker/ shock lead * control exclusion criteria: * age \< 16 years * not fit for bicycle testing

Keywords: myocardial contractility quantification of regurgitant flow exercise capacity
effects of thoracic mobility exercises in geriatric individuals

Conditions: Geriatric

Summary: aging leads to a gradual decline in muscle function and structural changes in the musculoskeletal system, which can affect balance and increase the risk of falls. this study aimed to assess the effects of thoracic mobility exercises on balance, exercise capacity, sleep quality, pain, and daily activities in 28 geriatric individuals (65+ years). participants were divided into two groups: the thoracic mobility exercises group performed conventional exercises with additional thoracic mobility exercises, while the conventional physiotherapy exercises group did not.

aging is a natural and irreversible process of the human body that involves a gradual decline in physiological, structural and functional activities. the general muscle function in the body decreases, and in this respect, in addition to structural changes in the musculoskeletal system, there are also changes in the internal function of the muscles. this change may cause an increase in the thoracic curvature in the sagittal plane and postural changes, a shift in the center of gravity forward, disrupting balance and increasing the risk of falling. the intervertebral disc spaces narrow, which causes an increase in the kyphosis angle of the spine. although studies in the literature use thoracic mobility exercises, the investigators found that these studies specifically evaluate effects on respiratory functions. the aim of this study is to examine the effects of thoracic mobility exercises on balance, exercise capacity, sleep quality, pain and daily living activities in geriatric individuals. 28 geriatric individuals aged 65 and over who do not need care were included in this study and were divided into 2 groups as experimental and control by randomization. the conventional physiotherapy exercises group; while the thoracic mobility exercises group was made to do conventional exercises including warm-up, stretching, strengthening, posture and breathing exercises, in addition to these exercises, thoracic mobility exercises were done. the individuals included in the study were studied for a total of 8 weeks, 1 week for pre-assessment, 1 week for post-assessment and 6 weeks for exercise training.

Eligibility criteria:
inclusion criteria: * elderly individuals over the age of 65 * those who scored at least 24 points on the mini mental test * those who did not need care in their daily living activities exclusion criteria: * those with uncontrolled diabetes mellitus and hypertension * those with severe obesity * those who use medications that may increase the risk of falling * those with serious auditory and visual problems * those with physical and psychological problems affecting physical mobility * those who have undergone surgery in the last 6 months

Keywords: balance exercise capacity geriatrics thoracic mobility sleep quality
protection against pneumococcal infection in children with t1dm

Conditions: Type 1 Diabetes Mellitus

Summary: children/ young people with diabetes may be at a higher risk of acquiring certain infections. these infections include those caused by a bacterium called the pneumococcus which can cause pneumonia, meningitis and ear infections. in the uk older children with diabetes are given a vaccine against the pneumococcus bug called pneumovax (or pps23 for short). although pps23 causes a good immune response in children over 2 years of age it is not actually known how well pps23 protects against infection in children of any age. in addition there is some data in adults and children that pps23 may result in a reduced response to future doses of pneumococcal vaccines (hyporesponsiveness). because of the lack of information on how well pps23 protects and potential hyporesponsiveness the investigators would like to study the use of an alternative vaccine against pneumococcus called prevenar13 (or pcv13). this vaccine is known to be safe and to work well in babies and young children and there have been no concerns about hyporesponsiveness. it has been approved for use in children up to 17 years of age but there is little information on the size and duration of immune response to pcv13 in children aged 6 years and older.


Eligibility criteria:
inclusion criteria: * diagnosis of t1dm and being followed in the oxfordshire children's diabetes service. * aged between 6 years and 17 years. * parent/legal guardian willing and able to give informed consent. * no previous immunisation with a pneumococcal conjugate vaccine (pcv). * willing to allow the general practitioner to be notified of participation in the study. exclusion criteria: * known allergic reaction to the vaccine antigen or any of the excipients. * bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

Keywords: diabetes pneumococcal
electrical activity of the diaphragm during the weaning period

Conditions: Respiratory Insufficiency

Summary: the study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) whether the electrical activity of the diaphragm may predict the weaning outcome

optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. weaning failure is associated with major complications. even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an icu ventilator may help to predict in a more accurate way the weaning outcome. the patients will be ventilated in nava with the titration method (1). as soon as patients passed successfully a daily screening eadi will be measured during a spontaneous breathing trial.

Eligibility criteria:
inclusion criteria: * all patients older than 18 years and mechanically ventilated for \>= 48 h. * in the resolving stage of the disease which brought to mechanical ventilation. * pao2/fio2 ratio \>150 on positive end-expiratory pressure (peep) \<=8 cm h2o. * sedation discontinued for a minimum of 24 hrs * analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr. * patient fully alert and cooperative. * intact respiratory drive evaluated with glasgow coma scale \>=10. exclusion criteria: * the attending physician refuses to allow enrolment * the patient refuses informed consent * hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine \> 5 mcg/kg/min or norepinephrine \> 0.1 mcg/kg/min to maintain systolic arterial blood pressure \> 90 mmhg) * no collaborative patient * coagulation or platelets disorders * neuromuscular disease * phrenic nerve damage/diaphragm paralysis * contraindication to exchange naso-gastric tube * history of heart or lung transplantation * presence or suspicion of a central nervous system disorder

Keywords: electrical activity of diaphragm weaning outcome nava
adaptations of exercise energy metabolism in response to weight loss in healthy normal weight people

Conditions: Healthy; Weight Loss; Body Weight; Diet Habit; Healthy Nutrition

Summary: more and more normal weight people are dieting in the general population. the nutrilex study aims to better understand the physiological adaptations in response to weight loss in healthy normal weight individuals. after an inclusion visit to verify the eligibility criteria of the subjects, they will complete a "t0" control session. the subjects will then have to complete two phases. the first transversal phase consists of 4 randomized sessions with lunch ad libitum after a physical exercise: i) a control session (no exercise, con); ii) an exercise session at initial body weight (bwt0); iii) an exercise session with a simulated weight loss of 3% performed on an anti-gravity treadmill (bw-3%) and; iv) an exercise session with a simulated weight loss of 6% performed on an anti-gravity treadmill (bw-6%). during the second longitudinal phase, the participants will perform a dietary rebalancing and a slight caloric restriction (dietary intervention) in order to induce a weight loss of 6% of their initial body weight. subjects will then perform an exercise session after losing 3% (t1) and then 6% (t2) of their initial body weight.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 and 24.9 kg/m², * subjects abled to understand the information note and abled to sign the consent form, * subjects with stable body weight (variation \< 3% of body weight) until at least 6 months, * subjects subjected to a social security plan. non-criteria: * have achieved a minimal bmi \< 18.5 or maximal bmi ≥ 25 kg/m² in adult life, * subjects with high levels of physical activity (\> 5 h of exercise per week), * presence of comorbidities or medical conditions that may interfere with study data, * subjects undergoing energy restriction or physical activity weight loss program at the time of inclusion or within the past 6 months, * taking medication that may interfere with study results, * surgery within the last 3 months, * person under guardianship, curatorship, or safeguard of justice; or not subject to a social security plan, * pregnant or breastfeeding women, * refusal to sign the consent form, * person in a period of exclusion from another study, * regular consumption of tobacco or alcohol, * voluntary weight loss in the last 6 months, * present or past eating disorders.
focus-ci: a preventive intervention with children and families of the combat injured

Conditions: Stress Disorders; Combat Disorders; Traumatic Stress Disorders

Summary: the purpose of this study is to implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. the study is a randomized study. the study will compare the effects of the newly designed focus-ci (families overcoming under stress - combat injury) with the existing standard of care (soc) at three military medical rehabilitation sites (walter reed amry medical center, brooke army medical center and madigan army medical center) on key aspects of family health and functioning.

injured service members who have at least one child between the ages of 5 and 18 years who have sustained a combat injury severe enough to require at least two weeks of inpatient hospitalization and who are within 6 months of discharge from inpatient hospitalization and currently receiving outpatient care will be recruited into this study.

Eligibility criteria:
inclusion criteria: for a family to be eligible for the study, the injured service member must: * have sustained a combat injury that was severe enough to require a minimum of two weeks inpatient hospitalization immediately after the injury; * currently be participating in outpatient rehabilitation for the same combat injury; * must be within 6 months of discharge from inpatient hospitalization at the start of the intervention; * families must have at least one child between the ages of 5 and 18 and be fluent in english. english fluency will be determined by asking, "is english spoken in your home?" * pregnant women are eligible to participate. exclusion criteria: * families in which the service member did not sustain a qualifying injury or has been discharged from inpatient care for more than six months will not be eligible to participate * families in which a member is actively psychotic * families in which a service member's primary relationship is with a "significant other" who is not eligible for military medical care * due to the limited ability of young children to comprehend the intervention activities, children under the age of 5 years will not be invited to participate in the intervention. * no one will be excluded based on race, ethnicity, gender, pregnancy, medical status, or cognitive functioning.

Keywords: intervention combat wounded family focus-ci
comparison of two drugs regimen in treatment of complicated typhoid fever in children

Conditions: Typhoid Fever

Summary: this study evaluates whether xdr typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).

complicated xdr enteric fever is a very serious systemic disease, caused by an extremely resistant mutant strain of salmonella typhi ( the h58 s. typhi superbug,) that as the name suggests is resistant to not only the first but also the second tier drugs conventionally used for treatment of the same. and as such, warrants immediate antibiotic therapy, but in view of the extended antimicrobial resistance the treatment options are limited to only two effective drugs viz carbepenem and azithromycin, as per culture sensitivity. so far, in the absence of universal standardized treatment protocols for xdr complicated typhoid fever in children, random use of either one or both in combination is the current practice. however, keeping antibiotic stewardship in mind, it is imperative to ascertain whether meropenum alone is effective or should be combined with azithromycin in the treatment of this serious disease. our study therefore compares the efficacy of monotherapy with meropenum or combination with azithromycin based on clinical and microbiologic remission, shortened hospital stay and less chances of relapse in order to then formulate a standardized protocol to treat complicated xdr typhoid in children thus preventing yet further antimicrobial resistance.

Eligibility criteria:
inclusion criteria: patients with extended drug resistant typhoid fever defined as culture proven typhoid fever caused by salmonella typhi or para typhi resistant to ampicillin, chloramphenicol,co trimoxazole,quinolones and ceftriaxone along with two or more of the following condition * high grade fever spikes for more than three days * refusal to eat or drink * drowsy or unconscious * convulsions * dehydration due to diarrhea or vomiting * abdominal distension with or without tenderness * bleeding diathesis like petechial rash, gum bleed, melena * jaundice or alanine transaminase more than twice of the normal range * thrombocytopenia less than fifty thousand * increase prothrombin time and activated partial thromboplastin time * electrolyte imbalance like hyponatremia, hypernatremia, hypokalemia, hyperkalemia, metabolic acidosis * hypoglycemia * signs of shock like cold and mottled skin, feeble pulses, tachycardia, decreased blood pressure exclusion criteria: * not given informed consent * children who need ventilator or two inotrope support * severe malnutrition/immunocompromised patient

Keywords: xdr typhoid fever