Kornimate/medical-research-clean huggingface dataset:
biofeedback vs electrical stimulation in treatment of fecal incontinence

Conditions: Fecal Incontinence; Encopresis; Fecal Soiling

Summary: fecal incontinence is one of the most psychological frustrating problems. it occurs in children due to many causes. there is a wide range of non-invasive therapeutic approaches like kegel exercise, biofeedback, and posterior tibial nerve stimulation. however, up till now, there are no established guidelines for treatment. the objective of this study is to evaluate and compare the early effect of biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (tpns) as non-invasive methods in the treatment of functional non-retentive fecal incontinence (fnrfi) in children.

functional non-retentive fecal incontinence (fnrfi) requires prolonged treatment with a wide range of non-invasive therapeutic approaches like kegel exercise, biofeedback, and posterior tibial nerve stimulation (ptns). however, up till now, there are no established guidelines for treatment.1 the aim of this study is to evaluate and compare the early effect of biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (tptns) as non-invasive methods in the treatment of (fnrfi) in children. methodology: the current prospective randomized controlled study included 93 children with fnrfi who were randomly divided and allocated into three groups. group a treated by conventional methods through dietetic regulation and kegal exercises. group b treated by biofeedback therapy while group c received bilateral (tptns). initial manometric findings including resting pressure, squeeze pressure, 1st sensation, 1st urge, and intense urge were recorded and repeated after 3 and 6 months together with incontinence score recorded in using st' mark's (varizey) with the primary endpoint of improvement of the incontinence score more than 50%.

Eligibility criteria:
inclusion criteria: * fecai incontinence * normal defecation frequency, * normal bowel habits and * normal stool consistency exclusion criteria: * children who are not cooperative, * children with traumatic sphincter injury, * children with fecal impaction, * children with spinal diseases causing incontinence, * children with anorectal malformation,

Keywords: fecal incontinence biofeedback transcutaneous posterior tibial nerve stimulation childern
prospective trial of the trifit™ web knee brace

Conditions: Satisfaction

Summary: this is a prospective trial comparing improvements in pain, function, and quality of life in patients with early-stage knee osteoarthritis conservatively managed with the trifit™ web knee brace. the study design will represent a consecutive series of conservatively managed patients with knee-pain not yet candidates for surgical intervention and is non-comparative in nature.

this clinical study will be conducted at the florida orthopaedic institute (foi) beginning in 2017. the trial will be a prospective trial of a convenience sample of skeletally mature patients with knee pain treated by the principal investigator (jeff sellman, md) at florida orthopaedic institute with clinically and radiographically confirmed early stage knee osteoarthritis that can be managed without surgical intervention. the study population will be defined as all adult patients (\>21 years) seen by the principal investigator and diagnosed with knee osteoarthritis. all patients will be independent in activities of daily living. all patients will be seen in the prinicpal investigator outpatient clinic at florida orthopaedic institute. patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study principal investigator will explain all essential elements of the clinical trial. if the patient agrees to participate, the study coordinator or principal investigator will obtain informed consent. the patient will still be followed clinically for 12 months after initial brace application.

Eligibility criteria:
inclusion criteria: 1. age \> 21 years; 2. bmi \< 40; 3. medial or lateral knee osteoarthritis as clinical diagnosis \[kellgren-lawrence grades 1-3 osteoarthritis\]; 4. persistent knee pain beyond current treatment; 5. no history of corticosteroid injection or viscosupplementation injections in the last 3 months; 6. able to comply with study requirements; 7. capable and willing of signing informed consent. exclusion criteria: 1. age \< 21 years; 2. history of diabetic neuropathy; 3. history of traumatic onset of knee pain; 4. undergone surgery on either lower limb within 6 months; 5. unable to comply with study requirements; 6. had previously received corticosteroid injections or viscosupplementation injections in the affected knee within 3 months of study; 7. kl grade \>3
efficacy and safety of vildagliptin compared to placebo on the incretin effect in patients with type 2 diabetes treated with metformin

Conditions: Diabetes Mellitus, Type 2

Summary: this mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks * agreement to maintain the same dose of metformin throughout the study * body mass index (bmi) in the range of 22-35 kg/m2 * hba1c in the range of 7.0 to 9.0% * fpg \<200 mg/dl (11.1 mmol/l) * agreement to maintain prior diet and exercise habits during the full course of the study * ability to comply with all study requirements and signed informed consent to participate in the study exclusion criteria: * a history of type 1 diabetes * a history of acute metabolic diabetic complications * evidence of significant diabetic complications * insulin treatment for longer than 10 days within the past 6 months * treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1 other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin incretin effect metformin
effect of pupilometer guided analgesia on postoperative pain

Conditions: Cholecystectomy, Laparoscopic; Anesthesia, General; Reflex, Pupillary

Summary: in this study, the investigators measure a pupil size every 5 minutes during the operation in patients undergoing laparoscopic cholecystectomy under general anesthesia. the investigators would compare the postoperative pain intensity between the group adjusted the anesthetic drug concentration based on the changes of the pupil (pupil group) and the group based on the changes of a surgical pleth index (spi group).


Eligibility criteria:
inclusion criteria: * patients aged 20 to 65 yr, american society of anesthesiologist physical status(asa ps) i to ii, scheduled for a laparoscopic cholecystectomy under general anesthesia exclusion criteria: * presence of ophthalmologic diseases such as horner's syndrome or sjogren's disease. * presence of neurologic or metabolic diseases * medicated that could interfere with the autonomous nervous system (e.g., b- blockers, anticholinergics) * history of substance abuse or psychiatric disease with chronic pain or preoperative analgesics with pacemaker or arrhythmia
evaluation of the archimedes™ system for transparenchymal nodule access 2

Conditions: Lung Cancer

Summary: the archimedes system is an image-guided navigation system used to access tissue samples in the lungs. this study is being conducted to confirm the performance of the archimedes system in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. navigation to and sampling of the patient's lung cancer tumor is conducted.


Eligibility criteria:
inclusion criteria: 1. age 21-75 years at screening 2. highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension 3. no known endobronchial tumor 4. tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a poe. 5. willing to participate in all aspects of study protocol for duration of study 6. able to understand study requirements 7. subject or legally authorized representative signs study-related informed consent document exclusion criteria: 1. any contraindication to bronchoscopy, for example: 1. untreatable life-threatening arrhythmias 2. inability to adequately oxygenate the patient during the procedure 3. acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated) 4. recent myocardial infarction 5. previously diagnosed high-grade tracheal obstruction 6. uncorrectable coagulopathy 2. known coagulopathy 3. platelet dysfunction or platelet count \< 100 x 103 cells/mm3 4. history of major bleeding with bronchoscopy 5. suspected pulmonary hypertension: additional testing required, such as echocardiogram 6. moderate-to-severe pulmonary fibrosis 7. severe emphysema or copd: additional testing and pi consent is required 8. bullae \>5 cm located in vicinity of target nodule or tunnel 9. any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or atv tunneling, for example: 1. asa class \> 3 2. \> stage 3 heart failure 3. severe cachexia 4. severe respiratory insufficiency or hypoxia 10. ongoing systemic infection 11. contraindication to general anesthesia 12. inability to stop anticoagulants (e.g., heparin, warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure 13. participation in any other study in last 30 days 14. prior thoracic surgery on the same side of the lung as the spn. 15. breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study. 16. life expectancy of less than one year. 17. scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy 18. prior radiation therapy treatment in the target lobe
pms to evaluate the safety and efficacy of picato® gel

Conditions: Actinic Keratosis

Summary: this study is a mandatory post launch observational study in south korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (picato®), approved for topical treatment of actinic keratosis. each patient is observed for 8 weeks after treatment completion.

picato® (ingenol mebutate) gel is a new topical therapy for actinic keratosis (ak) in adults which was approved by the korean ministry of food and drug safety (mfds) in december 2013. for ak in face or scalp the 0.015 percent gel is approved to be applied once a day for 3 consecutive days, and for ak in trunk or extremities the 0.05 percent gel is approved to be applied once a day for 2 consecutive days. the re-examination period for picato® runs from december 2013 to december 2019, during which at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment must be documented in a standard post marketing surveillance (pms) study. each patient is to be observed for 8 weeks following application of ingenol mebutate gel. if a patient is unable to visit the pms site, the investigator may contact the patient by phone to assess the safety.

Eligibility criteria:
inclusion criteria: adult patient with ak first time treatment with ingenol mebutate 0.015 or 0.05 percent gel exclusion criteria: * children and adolescents

Keywords: actinic keratosis topical treatment ingenol mebutate
effect of fpca on incidence of emergency delirium in children after surgery

Conditions: Postoperative Complications; Child; Family; Emergence Delirium; General Anaesthesia; Perioperative Care

Summary: emergence delirium (ed) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (pombs). there is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ed. therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (fpca) in mitigating the incidence of ed in children, compared with routine anaesthesia.


Eligibility criteria:
inclusion criteria: 1. children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours; 2. receiving first general anaesthesia by inhalation, and american society of anaesthesiology (asa) physical status i to ii; 3. a parent signed the informed consent form. exclusion criteria: 1. suffering important organ diseases; 2. history of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment; 3. history of severe hearing or visual impairment; 4. children are not suitable for inhalation anaesthesia considered by the researchers; 5. the parent involving in this trial spends less than three months a year with the child; 6. the parent is not competent for companionship considered by the researchers; 7. neither father nor mother is able to participate in the screening interview and the trial.

Keywords: perioperative care emergency delirium paediatric general anaesthesia postoperative maladaptive behaviours
prognosis factors of cardiac complications after liver transplantation

Conditions: Hepatopathy

Summary: this is a prospective, multicenter, non-interventional, observational study of a cohort with a biological plasma and urine samples collection for the study of prognosis factors of cardiac complications after liver transplantation

liver transplantation (lt) is the standard treatment for chronic or acute hepatic insufficiency with 87% of one-year survival. cardiovascular complications are common after lt with an incidence at 6 months ranging between 25 and 50 %. these complications are associated with significant morbidity and represents the third cause of post lt mortality. myocardial perfusion imaging or stress echocardiography, used for preoperative cardiovascular evaluation, are not enough efficient to predict the risk of post lt cardiovascular complications. however, to improve the prediction capacity of cardiovascular disease is fundamental in order to better select the candidates for lt or to develop preventive strategies. such a strategy could reduce the morbidity and mortality from cardiovascular diseases after lt and improve the results of lt. cardiovascular biomarkers such as troponin or natriuretic peptide are known to be predictive factors of postoperative cardiovascular complications in non cardiac surgery. the use of biomarkers in combination with conventional tests could improve the preoperative prediction of post lt cardiovascular complications. hypothesis: the preoperative biomarkers dosage could improve the prediction of cardiovascular complications occurring in the year after lt.

Eligibility criteria:
inclusion criteria: - patients older than 18 years, on list for lt because of chronic hepatic disease. non-inclusion criteria: - emergency lt, patient under guardianship or trusteeship. secondary exclusion criteria: * patient out of list before liver transplant because of his death, his improvement, the existence of a contraindication * patient not presenting laboratory tests older than 1 year at the liver transplantaion. * patient included for over 2 years at the time of liver transplantation.
effects of spironolactone on collagen metabolism in patients with pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to determine the effects of spironolactone on collagen markers in a large number of patients with pulmonary hypertension. in addition, safety and tolerability of spironolactone, an aldosterone receptor antagonist, in patients with pulmonary arterial hypertension, will be determined.

pulmonary arterial hypertension (pah) is an orphan disease characterized by pulmonary artery hypertrophy, and resulting vascular remodeling of involved vessels, often leading to right heart failure. accumulating evidence from vascular biology, animal models, and therapeutic drug trials suggests significant contributions of the neurohormonal milieu to the disease process, morbidity, and mortality. the renin-angiotensin-aldosterone system (raas) is an important neurohormonal pathway that induces collagen synthesis in the myocardium and systemic vasculature. there is paucity of data regarding the contribution of raas in the pathogenesis of pah and the effects of aldosterone blockade in the amelioration of pah. thus, the overall goal of this proposal is to investigate the contribution of raas to the pathogenesis of pah, and to explore the effects of an aldosterone blocker, spironolactone, in pah.

Eligibility criteria:
inclusion criteria: * age 18 years or older * body weight \> 40 kg * pah diagnostic group i * stable subjects with no change in pah specific therapy within the last 4 weeks * no change in dose of background therapy (digoxin, diuretic) within the last 2 weeks excluding anticoagulation exclusion criteria: * unable to give informed consent * hemodynamically unstable subjects * pregnant or breast feeding * have significant renal insufficiency (serum creatinine \>2.5 mg per deciliter or required hemodialysis) * have significant liver dysfunction (ast or alt more than three times upper limit of normal) * currently on aldosterone receptor blocker (spironolactone or eplerenone) or ace inhibitor * ph due to left heart disease * unable or unwilling to comply with study procedures

Keywords: potassium sparing diuretics right-sided heart failure edema
educational program on self-management for women with post-mastectomy lymphedema

Conditions: Post Mastectomy Lymphedema

Summary: post mastectomy lymphedema is a chronic disease that negatively affect physical, social, psychological and emotional well-being, so patient education regarding self-management is crucial to enhance women's self -care and quality of life.

improvement in screening and treatment modalities of breast cancer has translated into higher survival rates in these patients. unfortunately, this gain in survival leading to high prevalence of serious consequences of cancer treatments. among these, post mastectomy lymphedema. it was estimated that 10 million women had breast cancer- related lymphedema (bcrl) worldwide, with 3-5 million affected in the united states. approximately one in five women undergoing breast cancer surgery at risk for developing lymphedema . post-mastectomy lymphedema is a chronic and progressive tissue swelling caused by the abnormal buildup of protein-rich fluids in the interstitial space due to disrupted lymphatic drainage. this swelling results in physical symptoms such as heaviness, pain, decreased flexibility or tightness, stiffness, fatigue and numbness in the affected extremity. its long-term burden extends beyond these physical symptoms, to significantly impact social, psychological, emotional functioning .also pose financial burdens to patients, the healthcare system, and society which lead to poor quality of life . lymphedema self-management constitutes the standard lymphedema treatment that should be maintained throughout life. in this context, the nurse's role becomes magnified. self-management is the ability of individual to manage one's own chronic condition, encompassing the management of symptoms , physical and psychosocial impacts, treatment, and incorporating these management practices into daily activities to attain optimal quality of life. nurses contribute significantly in management of post mastectomy lymphedema through educating the patients about lymphedema self-care behaviors which are important to control lymphedema symptoms, decrease lymphedema stages and prevent further progression of the disease. lymphedema self-care involves maintaining risk-reduction behaviors, exercising, weight control, good nutrition, healthy lifestyle behaviors, caring and proper fit of compression garments, self-lymph drainage, skin care, signs and symptoms, preventing and managing infections.

Eligibility criteria:
inclusion criteria: * women diagnosed with post-mastectomy lymphedema,free from other disabling conditions impeding self-care practices, no prior participation in lymphedema-related educational programs, and provided an agreement for participation in the study exclusion criteria: * women with mental problems * unable to communicate with health team

Keywords: post mastectomy lymphedema quality of life self-care self-management educational program
efficacy and safety of telitacicept combined with tofacitinib for refractory rheumatoid arthritis

Conditions: Telitacicept; Treatment Compliance; Rheumatoid Arthritis

Summary: the aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of d2tra patients


Eligibility criteria:
inclusion criteria: 1. age 18-85 years 2. diagnosed with refractory rheumatoid arthritis according to the 2021 eular (european alliance of associations for rheumatology) diagnostic criteria 3. the traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients 4. voluntarily provided written informed consent - exclusion criteria: 1. exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs) 2. patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis) 3. history of allergy/hypersensitivity to the study medications (telitacicept or tofacitinib) 4. active tuberculosis or active infectious diseases requiring systemic treatment 5. pregnancy, lactation, or refusal to use contraception during the study 6. failure to complete the prescribed telitacicept + tofacitinib regimen due to: non-adherence or severe adverse reactions 7. other conditions contraindicating participation per investigator judgment -
a 2 week, crossover trial of dietary nitrate in obstructive sleep apnoea syndrome (osas).

Conditions: Obstructive Sleep Apnoea Syndrome

Summary: acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. obstructive sleep apnoea syndrome (osas) is associated with high blood pressure, dysglycaemia and impaired vigilance. the effect of dietary nitrate in osas has not been reported.

acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. obstructive sleep apnoea syndrome (osas) is associated with high blood pressure, dysglycaemia and impaired vigilance. the effect of dietary nitrate in osas has not been reported. the investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice. this study is a randomized, double-blind placebo-controlled, crossover trial. at baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance and blood draw. after baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.

Eligibility criteria:
inclusion criteria: * clinically stable, * untreated osas out-patients exclusion criteria: * using continuous positive airways pressure therapy * pulmonary hypertension * active cvd * active musculo-skeletal conditions * taking vasodilators * diabetes mellitus