Kornimate/medical-research-clean huggingface dataset:
early versus interval appendectomy for ruptured appendicitis in children

Conditions: Ruptured Appendicitis

Summary: the purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. the primary outcome measure is time away from normal activities.

there are two surgical treatment options for children with ruptured appendicitis. early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. the rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. both of these treatment options are currently used by many pediatric surgeons across the united states and both appear to work well. the two treatment have never been compared in any prospective study. the primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. secondary outcome measures include complication rates, quality of life measures (sf10), hospital cost analysis, and others.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ruptured appendicitis exclusion criteria: * inability to have usual follow up care (e.g. transient to area)

Keywords: ruptured appendicitis children surgery randomized trial
respiratory muscle strength and aerobic capacity in scleroderma

Conditions: Scleroderma

Summary: primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. the secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

scleroderma is a systemic connective tissue disease characterized by progressive thickening of the skin, the etiology of which has not been fully elucidated, in which microvascular damage, immune activation and fibrosis play a role. primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. the secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. the study will include 15 patients and 15 healthy individuals of the same age and gender. respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

Eligibility criteria:
inclusion criteria: * being diagnosed with ssk according to acr/eular criteria * stable medical treatment for 3 months exclusion criteria: * having a regular exercise habit (doing regular exercise at least once a week for the last 3 months) * comorbidity with another chronic disease that may affect aerobic capacity or respiratory muscle strength * having concomitant acute respiratory diseases * having a smoking habit * history of orthopedic or neurologic disease in the lower extremities that may prevent cycling

Keywords: scleroderma respiratory muscle strength aerobic capacity
effect of hcl insulin delivery system on glycemic control in patients with t1d

Conditions: Diabetes Mellitus, Type 1

Summary: the goal of this study is compare the effect of hybrid closed loop system (hcl) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (t1d) in patient with different initial glycated hemoglobin.

rationale for the study: according to our hypothesis, even t1d patients with an initially optimal glucose level should benefit from this treatment method in the form of a reduction in glycemic variability. there are very few clinical studies from real practice in a larger group of patients.

Eligibility criteria:
inclusion criteria: * patients with t1d * type 1 diabetes for \> 1 years * ≥ 18 years old * csii (without hcl) or mdi exclusion criteria: * severe noncompliance * known severe diabetic retinopathy and/or macular edema, * lactation, pregnancy, or intending to become pregnant during the study; * a condition likely to require mri. use of acetaminophen-containing medication; * unwillingness to use the study device for \>70% of time. * conditions that affect red blood cell turnover (hemolytic and other anemias, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoesis, end-stage kidney disease).

Keywords: type 1 diabetes mellitus hybrid closed loop system for automatic insulin dosing glycated hemoglobin
comparing qlb type i block to intraperitoneal instillation added to wound infiltration for postoperative cesarian pain

Conditions: Analgesia

Summary: this study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and qlb type i for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.

this study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at atatürk university medical faculty hospital and after obtaining written consent from the participating patients. the study will include pregnant women aged 18 to 50 with american society of anesthesiologists (asa) ii classification, full-term and singleton pregnancies planned to undergo cesarean section using pfannenstiel incision with spinal anaesthesia. using a randomisation procedure, the participants will be allocated into two equal groups: group ipla+ lwi and group qlb.

Eligibility criteria:
inclusion criteria: * aged between 18 to 50 * american society of anesthesiologists (asa) ii classification, * full-term and singleton pregnancies planned to undergo cesarean section * using pfannenstiel incision * spinal anaesthesia exclusion criteria: * whom neuraxial anaesthesia is contraindicated, * those who are allergic to drugs to be used in the study, * who refused to participate in the study, * those with bmi\>35 kg/m2, * asa score ≥3 or higher, * diabetes mellitus, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain, * individuals who have received opioids during the surgical procedure for intraoperative pain, * patients who have undergone abdominal surgery, * patients who have experienced a transition from spinal anaesthesia to general anaesthesia due to failure, * those with excessive bleeding during the operation, * who have uterine atony, * those who have a drain placed in the area to be infiltrated, * those who cannot understand the visual analog scale (vas), * who have a history of drug addiction and psychiatric disorder
chronic low back pain randomized controlled trial

Conditions: Chronic Low Back Pain

Summary: chronic low back pain is a common condition that can negatively impact quality of life and that lacks highly effective treatment options. the ymca developed different iterations of a stretching exercise program as a community based treatment for low back pain from 1974-2004. though anecdotally successful, the ymca stretching exercise program(s) was not scientifically evaluated for efficacy and became obsolete. the purpose of the study is to test the efficacy of a previously popular ymca stretching exercise program(s) for back pain. the stretching exercise program that will be studied is a collection of all the resources available for the ymca stretching exercise program(s). the most recent criteria from a national institutes of health sponsored task force to study chronic low back pain were applied to this study.

the study will employ a two arm parallel group stratified controlled trial. statistics were prospectively formulated to compare outcomes of 60 people who completed the study, 30 participants in each intervention group. subjects from 18 through 64 years old with low back pain on at least half the days over the previous 6 months will be recruited by the wilton family ymca and new canaan community ymca to participate in the study. the participants within each recruitment cohort will be randomized by a sub-investigator who is a statistician to the two treatment arms in a ratio of 1:1 (stretching exercise experimental arm: self-care book active comparator arm). seven cohorts will receive the intervention stretching exercise program at the wilton family ymca and new canaan community ymca from january 2015 to december 2017. the stretching exercise program consists of 12 standardized weekly stretching exercise sessions that incrementally increase in duration from 15-30 minutes. participants who receive the stretching exercise intervention will be asked to practice the identical stretches that they did in class on non-class days and will be given handouts and a companion cd to assist in this. thirty control subjects will receive a self-care book. all analyses will be conducted assuming intent-to-treat principles using sas statistical software. all p values and 95% cis will be 2-sided with statistical significance at the p = 0.05 value.

Eligibility criteria:
inclusion criteria: * adults from 18 through 64 years old who have had low back pain on at least half the days over the previous 6 months exclusion criteria: * we will exclude persons whose back pain is attributed to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis. * patients with complex conditions will not participate in the study (eg, sciatica, medicolegal issues, or a previous back surgery). * we will also exclude persons who do not speak english. * finally, persons who are unable to attend classes or unwilling to do home practice will be excluded.

Keywords: chronic low back pain stretching exercises
mechanisms of disease r/r in car-t for hematologic malignancies

Conditions: Hematologic Malignancy

Summary: the primary purpose of this irb protocol is to perform immune profiling focusing on the measurement of myeloid derived suppressor cells (mdscs) over time in patients receiving chimeric antigen receptor (car) t therapy and determine the correlation between immune profile and disease relapse/resistance in car t therapy.

the primary purpose of this irb protocol is to perform immune profiling focusing on the measurement of mdscs over time in patients receiving car t therapy and determine the correlation between immune profile and disease relapse/resistance in car t therapy. blood samples and accompanying health information (including phi) may be collected from standard of care, non-significant risk, research-only procedures or obtained from our division research repository and database (duke irb pro00006268) or duhs biospecimen research and biobanking protocol (duke irb pro00035974). all hematologic malignancy patients treated with commercial car t products will be screened and enrolled for the study. the investigators will perform multivariable regression to see if the number and function of mdscs can be used as independent factors to predict disease relapse at 1 year after car t treatment, overall survival or progression-free survival. the studies will not require additional invasive procedure solely for the study. the investigators will use blood samples that are performed as part of standard care. therefore, no additional procedure is needed. the major potential risk associated with the study is the breach of confidentiality.

Eligibility criteria:
inclusion criteria: 1. ability to understand and provide signed informed consent that fulfills institutional review board guidelines. 2. has a confirmed diagnosis of hematologic malignancy and will be undergoing car t therapy with commercial car t product. 3. patient who has a confirmed diagnosis of hematologic malignancy and will be receiving car t therapy under clinical trial protocol will also be eligible if the clinical trial sponsor and the investigator approve patient participation in the study. exclusion criteria: * na

Keywords: car-t
a study to determine effective and tolerable titration scheme for oros-methylphenidate in children with attention-deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of the study is to investigate the clinical benefit of switching children with adhd from immediate-release methylphenidate (ir-mph) to oros-methylphenidate under the correct dosage conversion scheme.

this is a prospective, non-comparative study. each patient will be treated for 10 weeks including 6-week titration phase and 4-week maintenance phase. after an initial baseline evaluation, patients currently receiving ir-methylphenidate (ir-mph) therapy will switch to receiving oros-methylphenidate once daily. patients receiving ir-mph =15 mg per day will switch to receive 18 mg once daily oros-methylphenidate. for patients on ir-mph daily dosage \>15 mg and =30 mg, the initial dose of oros-methylphenidate will be 36 mg once daily. other patients receiving ir-mph higher than 30 mg per day, will switch to receive 54 mg once daily oros-methylphenidate. during the 6-week titration phase, those patients who do not achieve the criteria of "optimal response" will be titrated by biweekly increase to next dose level (36 mg per day, and then 54 mg per day). the maximum dose of oros-methylphenidate per day is 54 mg as package insert indicates. however, dose decreases are allowed if clinically intolerable adverse events emerge. at the end of 6-week titration phase, the final titration dose should be maintained for the last 4 weeks of the trial regardless of the optimal response. in summary, all patients will attend bi-weekly clinic visits for the first 6 weeks (visit 2 to 4) and monthly clinic visits for the subsequent 4 weeks (visit 5). patients will receive 18 mg or 36mg or 54 mg once daily oros-methylphenidate for 10 weeks.

Eligibility criteria:
inclusion criteria: * patients who used to be treated their attention-deficit hyperactivity disorder with ir-mph less than 70 mg/day (inclusive) for at least one month without severe adverse events or possible contraindications with mph * patients must be living with the parent/caregiver who can complete the questionnaires during the study * patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires exclusion criteria: * known to be non-responders to methylphenidate * marked anxiety, tension, aggression/agitation * known or suspected mental retardation or significant learning disorder * glaucoma, ongoing seizure disorder, psychotic disorder, diagnosis or family history of tourette's disorder, bipolar disorder, eating disorder * subject who require drug therapy or hospitalization for treatment of a mood or anxiety disorder * other psychotropic medication subject is taking at study entry could be continued during study period they were maintained at a stable dose for a minimum of 4 weeks pre-study entry

Keywords: methylphenidate attention deficit hyperactivity disorder
effect of a 4-week fun fast interval training (ffit) activity programme on physical fitness and quality of life in adolescent school pupils

Conditions: High-intensity Interval Training

Summary: low-volume high-intensity interval exercise training may improve aspects of health and fitness in young people, but the effect of this type of exercise on quality of life has yet to be assessed. the investigators aim to examine the effect of a 4-week school-based low-volume high-intensity interval training programme (called the fun fast interval training \[ffit\] activity project) on physical fitness and quality of life in adolescent school pupils. approximately 145 english adolescents aged 11-12 years will be approached and invited to take part in the study. participants will be healthy female volunteers, recruited from one school in northeast england. using a non-randomised design, one school year group will be assigned to take part in the intervention, and a second year group assigned to the control condition.those in the intervention group will complete a 4-week school-based high-intensity interval exercise training programme. the intervention will take place twice per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and basketball drills), each interspersed with 90-s rest. participants will be encouraged to work maximally during the 45-s repetitions. control participants will be instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine. study outcomes will be 20 m shuttle run test performance, health-related quality of life, standing broad jump performance, hand dynamometer performance, waist circumference and 10 m and 20 m sprint performance.


Eligibility criteria:
inclusion criteria: 1. must be in school year 7 or 8 at the school where the study will take place 2. must provide parental consent and participant assent 3. must be free from exclusion criteria exclusion criteria: 1. symptoms of or known presence of heart disease or major atherosclerotic cardiovascular disease. 2. condition or injury or co-morbidity affecting the ability to undertake exercise. 3. diabetes mellitus 4. early family history of sudden death 5. pregnancy or likelihood of pregnancy

Keywords: high-intensity interval training adolescents physical fitness quality of life school-based intervention
vaginal dilator therapy among women with gynecologic and breast cancers experiencing dyspareunia

Conditions: Dyspareunia

Summary: in this randomized controlled trial, the investigators will assess the difference in mean patient-reported pain scores and sexual function between women with gynecologic or breast cancers experiencing dyspareunia (painful intercourse) who are assigned to vaginal dilator use with vaginal moisturizer (intervention group, n = 29) compared to vaginal moisturizer alone (control group, n = 29) over 16 weeks.

between 2012 and 2016, approximately 94,000 women were diagnosed with a gynecologic cancer annually and over 1.2 million women with breast cancer between 2013 and 2017. it is well known that gynecologic and breast cancers, and their treatments including surgery, adjuvant chemotherapy and endocrine therapy, and radiation, result in significant effects on the female reproductive system which can lead to sexual dysfunction. in the u.s., sexual dysfunction among gynecologic oncology patients has been reported to be as high as 90%, and over 70% among breast cancer patients. patients who receive chemotherapy and/or endocrine therapy commonly experience dyspareunia, vaginal dryness, and challenges with desire and orgasm due to a low estrogen state. in fact, among patients with breast cancer, unaddressed sexual side effects from adjuvant endocrine therapy are one reason for early discontinuation. hysterectomy and oophorectomy, including for ovarian cancer risk-reduction, can cause similar physical symptoms in addition to psychologic effects like anxiety related to sexual intercourse.

Eligibility criteria:
inclusion criteria: * patients 18 years or older * english or spanish speaking * patients currently or previously treated for: * gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy) * breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause) * current desire for penetrative sexual activity * endorsement of at least one of the following in the last 6 months: * dyspareunia during penetrative sexual activity * reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina * avoidance of penetrative sexual activity due to fear of pain * physically able to insert a vaginal dilator by themselves * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients with prior primary or upfront pelvic radiation * patients with whole pelvic radiation at any time * patients with a history of chronic pelvic pain * patients with vulvodynia as noted on baseline pelvic exam with \> 5/10 pain score during an external exam with a cotton swab * patients with prior vaginal dilator use for any indication

Keywords: painful intercourse sexual dysfunction vaginal dilator vaginal moisturizer
prevention of chronic lung disease (cld) in preterm infants

Conditions: Respiratory Distress Syndrome; Chronic Lung Disease of Prematurity

Summary: pulmonary inflammation plays an important role in the early development of cld. postnatal glucocorticoids have been shown effective in the prevention or treatment of cld with various success. however, systemic glucocorticoid therapy often associated with various short term and long term complications. therefore, modification of the therapeutic regimen is needed. inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs. the investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. the result of our pilot study (pediatrics, 2008) indicated this high possibility.

after informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. group i will receive surfactant and budesonide and gii will receive surfactant and air as control through endotracheal route. therapy will be given every 8 hours until the infant require fio2 \< 30% or is extubated. the end point of assessment is the combined incidence of cld and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years. the incidence of cld and death in the selective group of infant is about 60%. using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type i error and 10% chance of type ii error. the total safe target number will be 300; 150 in each group. a collaborative study is therefore proposed. the primary outcome to be assessed is the combined incidence of cld and death. the secondary outcome to be assessed is short term and long term side effects.

Eligibility criteria:
inclusion criteria: * infant with birth weight between 500-1500 gram * severe respiratory distress syndrome and requires mechanical ventilation with fio2 \> 60% shortly after birth exclusion criteria: * severe congenital anomalities * lethal cardiopulmonary status at birth

Keywords: preterm infant respiratory distress syndrome chronic lung disease budesonide surfactant
mirvaso® utilisation and patient satisfaction evaluation (muse)

Conditions: Rosacea

Summary: the aim of the study is to evaluate the level of satisfaction among patients to whom mirvaso® / onreltea tm (trade mark) is prescribed.


Eligibility criteria:
inclusion criteria: * patients to whom the physician has already decided to prescribe mirvaso® /onrelteatm according to package insert