Kornimate/medical-research-clean huggingface dataset:
comparing use of a digital health system of pelvic floor exercise program to kegel exercises in stress urinary incontinence

Conditions: Stress Urinary Incontinence; Mixed Urinary Incontinence

Summary: a randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.

a randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. home kegel subjects will perform kegel exercises three times daily. following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.

Eligibility criteria:
inclusion criteria: * capable of giving informed consent. * self-reported stress-type ui symptoms of \>= three months duration * diagnosis of stress predominant urinary incontinence based on mesa stress symptom score greater than mesa urge symptom score (percent of total possible urge score). * udi-6 score \>/= 25 * willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for stress urinary incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor pt or surgery) during the first 8- weeks. exclusion criteria: * absence of a vagina. * age \<18 years. * stage 3-4 pelvic organ prolapse (as determined by pop-q). * diagnosis of any neuromuscular disease. * non-ambulatory. * currently pregnant or \<12 months post-partum. * \</= 3 months after failed surgery for stress urinary incontinence. * previous pelvic floor muscle training (pfmt) within the last 12 months under a supervised therapeutic plan of care. * currently taking, or has taken within the last 2 months, medication to treat urinary incontinence. * prior augmentation cystoplasty or artificial sphincter. * implanted nerve stimulator for urinary symptoms. * participation in another clinical study within 30 days of screening. * impaired cognitive function. * contraindication to the use of a vaginal probe. * unable to understand instructions on the use of the leva® plus pelvic digital health system. * unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction.

Keywords: digital health female
dgt versus tps in patients with initial pd cannulation by chance; prospective multi-center study

Conditions: Pancreatitis; Cholangitis; Cholecystitis

Summary: in patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. the incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the dgt group.

this was a prospective, randomized study conducted in three tertiary referral hospital in korea. three endoscopists performed the ercp who had ercp experience more than ten years from october 2010 to august 2012, ercps were performed on patients with pancreatobiliary diseases at soonchunhyang university seoul hospital, hanyang university guri hospital and kosin university gospel hospital. bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.). patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. exclusion criteria were: (1) refusal the ercp, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, billroth ii operation, whipples's operation etc. patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (dgt) group or the transpancreatic precut sphincterotomy (tps) group; a randomization list for group allocation was generated by using computer-based pseudo-random number generators. we compared both techniques , for a maximum of ten extra attempts which are cbd cannulation by each methods. we obtained the written informed consent from all enrolled patients.

Eligibility criteria:
inclusion criteria: * ercp patient, over 20 years old, pancreatic duct cannulation patients by chance exclusion criteria: * refuse the ercp, post procedure state(est, subtotal gastrectomy, whipples' op except gastroduodenostomy), use another method, under 20 years old.
g-wound (vz for wound treatment)

Conditions: Wounds; Wound Heal

Summary: this is a prospective, randomized, open-label, controlled, exploratory trial that aims to investigate the local skin tolerability of topically administered vz and to evaluate efficacy and safety parameters associated with improved wound condition and healing


Eligibility criteria:
inclusion criteria: 1. healthy male subjects 2. age 18-45 years at time of screening 3. subjects are in good clinical and mental health as established by medical history and physical examination 4. subject agrees to be compliant with study related visit and treatment schedule 5. written informed consent exclusion criteria: 1. regular use of medications affecting the blood clotting process (e.g. aspirin or any other over-the-counter medicine or complimentary health product affecting the blood clotting process) or immunosuppressive drugs. aspirin should not be taken in the 10 days prior to study participation or during the study 2. use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment 3. history of cancer (except for non-melanoma skin cancer) within the previous 12 months or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before the first administration of investigational product or at any time during the study 4. subjects with any known coagulation disorder 5. subjects who have pigmented skin (fitzpatrick classification level v - vi) due to an increased susceptibility to hypertrophic and keloid scarring 6. history of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing 7. chronic inflammatory dermatological disease 8. history of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes 9. subjects diagnosed with diabetes type i or ii 10. lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer 11. tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy 12. evidence of active infectious disease including hiv and hepatitis b or c 13. current smoker (or any kind of nicotine consumption) 14. known allergies to biopsy numbing medication, wound cleansing solution and wound dressing 15. known hypersensitivity to aluminium and/or silicon 16. allergy requiring medical treatment within the last 4 weeks prior to screening 17. active infection or fever \> 38°c within the last 7 days prior to randomization 18. clinically relevant abnormalities in the laboratory testing, vital signs, ecg or physical examination 19. alcohol abuse or a positive urine screen for drugs of abuse at screening 20. participation in another clinical trial with an investigational day within the last 4 weeks before study participation 21. employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor

Keywords: wound healing
incidental finding of gastrointestinal stromal tumors (gists) during laparoscopic sleeve gastrectomy, how to deal? how much safety margin

Conditions: Excision Margin

Summary: lsg is thought to be the best choice for obese patients with conincidental gists, as a tumour can be resected along with resecting the stomach within the same procedure. the primary endpoint is that, how much does gist suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

the incidence of unsuspected gist in lsg specimens in our series was high in comparison to cases reported in the literature. gists could be safely removed laparoscopically during lsg surgery with negative microscopic resection margins, with 1-2cm safety margin. margins less than 1cm, high mitotic rate are adverse prognostic factors. examining the whole stomach before resection is mandatory and can easily be done during lsg, gist can be removed safely with lsg

Eligibility criteria:
inclusion criteria: all morbid obese patients with bmi more than 35 exclusion criteria: * previous gastric surgery * patients with hiatus hernia * age under 21 years

Keywords: gastrointestinal stromal tumour coincidental gist with lsg gastric gist
high-flow nasal cannula flow rates, severe bronchiolitis

Conditions: Non-invasive Ventilation; Pediatric Pulmonary Disease

Summary: objective: the investigators aimed to compare the heated humidified high-ﬂow nasal cannula (hhhfnc) flow rate of 1-l/kg/min (1l) with 2-l/kg/min (2l) in patients with severe bronchiolitis presenting to the pediatric emergency department. study design: the investigators performed a study in which all patients were allocated to receive these two flow rates. the primary outcome was admitted as treatment failure, which was defined as a clinical escalation in respiratory status. secondary outcomes covered a decrease of respiratory rate (rr), heart rate (hr), the clinical respiratory score (crs), rise of peripheral capillary oxygen saturation (spo2) and rates of weaning, intubation and intensive care unit (icu) admission. keywords: bronchiolitis, emergency department, high-flow nasal cannula, flow rate


Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe bronchiolitis * must be less than 24 months * must have presented to the emergency department exclusion criteria: * immediate invasive ventilation and/or intensive care unit admission * congenital heart disease, * chronic lung disease * neuromuscular disease * netabolic disease * craniofacial anomalies * immunocompromised * bacterial pneumonia * pneumothorax * nasal trauma

Keywords: bronchiolitis emergency department high-flow nasal cannula flow rate
a clinical trial to evaluate the safety and effectiveness of resorbable collagen membrane - matrixflextm

Conditions: Periodontal Diseases; Intrabony Defects; Guided Tissue Regeneration

Summary: this is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by guided tissue regeneration (gtr). the patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 65 years, male or female; 2. patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999; 3. only solitary lesion site requires surgical treatment and must meet the following criteria: 1. the baseline pd≥7 mm ; 2. after debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected; 3. the wideness of the keratinized gingiva≥2 mm; 4. based on the x-ray image, the dental crowns at the bottom of the bone socket should be at least 3mm; exclusion criteria: 1. the test tooth has open surgical debridement history within the most recent one years; 2. known allergy to collagen of animal origin; 3. clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (cej) or on the root surface, subgingival restorations and/or restorations with open margins at or below the cej;

Keywords: resorbable collagen membrane
low vs. very low dose of prophylactic tranexamic acid for bleeding reduction during rhinoplasty

Conditions: Bleeding Reduction

Summary: the purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery.

background tranexamic acid is a drug registered for bleeding prevention and reduction. it is on the world health organisation (who) 'essential drugs list'. preoperative tranexamic acid efficacy is well proved for doses between 10 and 40 mg/kg and last years and decades publications showed that 'low dose' (10mg/kg) is as efficient as higher doses but connected with less adverse effects. objectives to determine whether 5 mg/kg dose is as effective as commonly used 10mg/kg dose in intraoperational bleeding reduction. methodology all patients would be randomised into one of two arms - low and very low dose. patients, investigators and caregivers would be blinded. patients would receive intravenous bolus of tranexamic acid at 15 minutes before admission to operation theatre in a dose dependent on the study arm. general, intravenous anesthesia (total intravenous anesthesia) would be performed due to hospital standards. at the end of the surgery total blood volume and adverse effects would be noted. surgeon would asses surgical field in the fromm scale. the survey is planned for a two years timespan or until 50 patients have enrolled (25 for each arm).

Eligibility criteria:
inclusion criteria: * age \> 18 y.o. * american society of anesthesiologists physical status classification (asa) 1-2 * signed informed consent form after reading the information about the study and talking with one of the investigators exclusion criteria: * pregnancy * known allergies for tranexamic acid or any other substance in exacyl * deep vein thrombosis * hormone replacement therapy or oral contraceptive usage * anticoagulants usage * obesity - bmi (body mass index) \>30 kg/m2 * renal disease, as glomerular filtration rate (gfr) \<60 ml/min/1,73 m\*m * seizures or epilepsy in the past

Keywords: tranexamic acid rhinoplasty bleeding reduction
study to evaluate the safety and efficacy of phenoptin™ in subjects with phenylketonuria who have elevated phenylalanine levels

Conditions: Phenylketonurias

Summary: the primary objective of this study is to evaluate the efficacy of phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (phe) levels in subjects with phenylketonuria.


Eligibility criteria:
inclusion criteria: * 8 years of age and older * received at least 7 out of 8 scheduled doses in study pku 001 * responsive to phenoptin™ in study pku-001, defined as a reduction in blood phenylalanine level of \>/=30% compared with baseline * blood phenylalanine level \>/=450 μmol/l at screening * willing and able to provide written informed consent or, in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained * negative urine pregnancy test at screening (females of child-bearing potential) * male and female subjects of childbearing potential (if sexually active) must be using acceptable birth control measures, as determined by the investigator, and willing to continue to use acceptable birth control measures while participating in the study * willing and able to comply with study procedures * willing to continue current diet unchanged while participating in the study exclusion criteria: * perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable * use of any investigational agent other than phenoptin™ within 30 days prior to screening, or requirement for any investigational agent or investigational vaccine prior to completion of all scheduled study assessments * pregnant or breastfeeding, or considering pregnancy * alt \>5 times the upper limit of normal (i.e., grade 3 or higher based on world health organization toxicity criteria) at screening * concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes, or organ transplantation recipient) * serious neuropsychiatric illness (e.g., major depression) not currently under medical management * requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate) * concurrent use of levodopa * clinical diagnosis of primary bh4 deficiency

Keywords: phenylalanine hydroxylase
chronotherapy for depressive episodes

Conditions: Depressive Episode

Summary: evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. there are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a secondary mental health care outpatient clinic. the investigators aim to test the effects and safety of chronotherapy in addition to tau compared to tau alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. the study is a randomized controlled trial with 76 patients with a depressive episode who initiate outpatient treatment at nidaros dps, st. olavs university hospital. participants will be allocated 1:1 to either chronotherapy + treatment as usual (tau) or to tau alone.


Eligibility criteria:
inclusion criteria. patients eligible for the trial must comply with all the following at randomization: * being 18 years or older * willing and able to provide a written informed consent * newly diagnosed with an ongoing moderate or severe depressive episode according to the international classification of disorders 10th edition (icd-10) and accepted for outpatient treatment for the depressive episode. the diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry/psychology. * the patient must score ≥ 9 on the hamilton depression rating scale-6. * must be able to communicate in a scandinavian language exclusion criteria. patients are considered ineligible for participation if any of the following are present: * illnesses where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression). * known pregnancy. * individuals with a known diagnosis of emotionally unstable personality disorder (f60.3). * individuals with a known psychotic disorder * shiftwork or other related social or work circumstances that inhibit participation * participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).
the mobile lifestyle intervention for food and exercise study

Conditions: Overweight and Obesity; Type2 Diabetes

Summary: the goal of the study is to examine long term sustained weight loss digital intervention in a diverse cohort of adults with overweight/obesity. the intervention includes social gaming (using game-like elements in nongame contexts to promote supportive social interactions and openness to positive behavioral influences) to reward behaviors, such as self-monitoring and social support. investigators will accomplish objectives and test hypotheses by following two specific primary aims: 1. determine if the intervention plus gaming produces significantly more weight loss at 12 months than the same intervention without gaming among 240 adults with overweight or obesity and ≥3 t2dm risk factors. 2. examine the differences in social support provision and receipt between groups at 12 months.

this is a 1-year behavioral intervention with standardized behavioral content that reinforces self-monitoring behavior delivered via twice-weekly podcasts, tips of the day, weight, physical activity and diet daily tracking. the mlife app will also encourage and facilitate social support among participants (to both groups). participants will be randomized to one of two groups: 1) a gamified mlife app (n=120) or 2) regular mlife app (n=120). participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. in addition, participants will complete assessment at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * must be between 18-65 years old * ≥3 t2dm risk factors (as defined by the american diabetes association) * own and use a smartphone with a data plan * bmi must be between 25-49.9 kg/m2 * must be willing to reduce caloric intake and increase physical activity * not currently participating in a weight loss study in a weight loss program * be free of major health or psychiatric diseases, drug or alcohol dependency. * no current use of medications that may impact blood glucose exclusion criteria: * over the age of 65 years old * currently participating in a weight loss program * has lost more than 10 pounds in the past 6 months * diagnosed with type 2 diabetes
reverse trendelenburg position versus semi-recumbent position in obese critically ill patients

Conditions: Ventilation and Oxygenation; Obese; Positioning; Critically Ill

Summary: the aim of this study is to assess the effect of reverse trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients

obese critically ill patients' position significantly impacts on their ventilation and oxygenation status. it is also associated with mechanical ventilation success or failure and may be a main determinant of the obese patients' outcome. reverse trendelenburg position is recommended for obese patients but in critical illness with mechanical ventilation little is known about its effect on respiratory therapeutic targets. this trial was conducted in four general intensive care unit of alexandria main university hospital in alexandria, egypt. one hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were randomly assigned by a computer program to either reverse trendelenburg position group (n=55) which is the intervention group or semi-recumbent position group (n=55) which is the routine unit position. patients were positioned in the study positions 4 times per day. patients were maintained in the study positions for 2 hours each time. baseline ventilation and oxygenation parameters were assessed immediately before positioning then it was reassessed every 10 minutes after positioning for 30 minutes.

Eligibility criteria:
inclusion criteria: * body mass index ≥ 30 * mechanically ventilated exclusion criteria: * trauma * shock * acute respiratory distress syndrome

Keywords: reverse trendelenburg position semi-recumbent position ventilation oxygenation obese patients