Kornimate/medical-research-clean huggingface dataset:
early intervention and autism: transformation from research to practice through a competency based model

Conditions: Autism Spectrum Disorder

Summary: this study evaluates the effect of a competency based model on program quality in swedish preschools for children with autism spectrum disorder (asd). half of the participating preschools will receive "treatment as usual" (early intensive behavioral intervention (eibi) provided to a child with asd in the preschool, supervised by an external supervisor from a habilitation center), while the other half will receive the above as well as, in-service training and monthly on-site coaching sessions also involving preschool staff other than the paraprofessional (competency based model). it is hypothesized that the competency based model will improve program quality, child's engagement, preschool staff knowledge, allegiance and self-efficacy compared to the comparison group.

almost all children in sweden between two and five years attend preschool including children with autism spectrum disorder (asd). high quality and structured early intervention programs grounded in the principles and procedures of applied behavior analysis have been found in numerous research studies and reviews to significantly improve developmental outcomes, adaptive behaviors and learning outcomes of preschool children with asd. a prerequisite of which is a high quality learning environment that includes both the physical set-up, learning climate and competence of staff. the primary purpose of this project is to improve program quality for preschool children with asd through a competency based model grounded in ecological systems theory sustainable over time and applicable within the swedish service support system. in total approximately 16 preschools will participate, half of which will receive "treatment as usual" eibi to a child with asd in the preschool, supervised by an external supervisor from a habilitation center), while the other half will also receive obtain in-service training and monthly on-site coaching through habilitation. involved habilitation specialists will obtain in-service training prior to the onset of the study on how to use the autism program environment rating scale (apers), the basic tenets of coaching based on the concept of reflective and collaborative dialogues in which the preschool teachers knowledge of the child and context are taken into account. it is hypothesized that the competency based model will improve program quality, child's engagement, adaptive behavior, increase preschool staff knowledge, allegiance and self-efficacy compared to the comparison group only receiving supervision in implementing a comprehensive program.

Eligibility criteria:
inclusion criteria: * autism diagnosis * receiving comprehensive program/eibi implemented in preschool setting with supervision from habilitation center exclusion criteria: -

Keywords: program quality intervention setting autism
the efficacy of dexmedetomidine versus labetalol in providing controlled hypotension in dacryocystorhinostomy surgerya comparative randomized prospective study

Conditions: Nasolacrimal Duct Obstruction

Summary: the most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge. the proposed treatment in this regard is dacryocystorhinostomy (dcr) surgery. therefore, hemostasis is of great significance in performing dcr surgery. in this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery. hence, there is no enough studies about controlled hypotension in dcr we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during dcr surgery.


Eligibility criteria:
inclusion criteria: * physical status i or ii according to asa classification, age between ( 18 - 60 years ) exclusion criteria: * patients with physical status other than 1 and 2 according to asa classification as :hypertension, diabetes mellitus, ischemic heart diseases, severe anemia, copd, history of stroke, impaired liver or renal function, increase intercranial tension. * allergy to any of the drug included in this study.
a phase 2 multi-center study to evaluate the efficacy and safety of a chemokine ccr2/5 receptor antagonist in adults with type 2 diabetes and overt nephropathy

Conditions: Diabetic Nephropathy

Summary: the study hypothesis under test is that administration of a ccr2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 ckd, based on an egfr of 20-75 ml/min/1.73m2. * evidence of persistent, overt albuminuria; defined as a uacr \>=300 mg/g (\>=33.9 mg/mmol) or upcr \>=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer. * stable background therapy of raas inhibition (ie, an ace inhibitor and/or an arb, which may also include an aldosterone antagonist in double raas but not triple raas inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study. exclusion criteria: * subjects with ckd resulting from type 1 diabetes or non-diabetic ckd. * subjects who are diagnosed with autosomal dominant polycystic kidney disease (adpckd), severe peripheral vascular disease (pvd) or obstructive uropathy.

Keywords: diabetic nephropathy type 2 diabetes albuminuria chemokine antagonist
personalized theratyping trial

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to explore the use of off-label cftr modulators that may affect cftr function in patients with cftr mutations that are not currently approved for these drugs.

the purpose of this study is to explore the use of off-label cftr modulators that may affect cftr function in patients with cftr mutations that are not currently approved for these drugs. symdeko (tezacaftor/ivacaftor), orkambi (ivacaftor and lumacaftor), correctors of cftr misfolding and kalydeco (ivacaftor), a potentiator of abnormal cftr gating, will be explored as a treatment for patients with other cf mutations than those currently approved. patients who have a mutation that responds to a cftr corrector from in vitro study will be given symdeko, or orkambi, depending on the in vitro response pattern. patients who have mutation response to a potentiator of cftr function will be given ivacaftor monotherapy. patients with a mutation equivalent to wild type will be given ivacaftor. if the patient is 6-12 years old, we will only study orkambi or ivacaftor as symdeko is not yet fda approved in this patient population.

Eligibility criteria:
inclusion criteria: * diagnosis of cf * age ≥6 y.o. * cftr mutation that may respond to approved correctors/potentiators in the opinion of the study investigators * informed consent/assent * stable cf pulmonary regimen exclusion criteria: * exacerbation requiring antibiotic or steroids for \>28 days before trial entry * ongoing participation in a cftr modulator study * active smoking in the past 6 months * history of solid organ transplant * any condition which precludes the use of cftr modulators: e.g. advanced cirrhosis, end-stage renal disease (esrd) * any condition that precludes the patient from participation in the opinion of the investigator * any meds that have significant drug-drug interactions or any other off label use of cftr modulators
heart failure and hemodynamic stability during anesthesia induction

Conditions: Hemodynamic Instability; Anesthesia; Adverse Effect; Heart Failure; Diastolic Dysfunction; Venous; Return (Anomaly)

Summary: the study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (tci) in non-cardiac, non-morbidly obese surgery.

40 individuals are enrolled to the study after signed informed consent at the day of surgery. the study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg lbw, gelofusine™, fresenius kabi ab, sweden) or control (no preoperative fluids) before standardized tci- induction of anesthesia. no other intravenous fluids before anesthesia induction. preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Eligibility criteria:
inclusion criteria: * age over 18 years * body mass index ≤ 35 kg/m2 * electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery exclusion criteria: * instable angina pectoris * severe bronchial asthma * severe copd * dementia * severe heart valve disease * severe renal failure * body mass index \> 35 kg/m2

Keywords: hemodynamics venous return heart failure anesthesia
comparative study between intra articular injection of hyaluronic acid (ha) with platelet rich plasma (prp) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: intraarticular injection (iai) of platelet rich plasma (prp) with hyaluronic acid (ha) versus radiofrequency (rf) of genicular nerve for pain reduction of of knee osteoarthritis , improving daily activity and reduction analgesia requirements

in this study the investigators to comparing between the effect of intra articular injection of hyaluronic acid (ha) with platelet rich plasma (prp) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis. knee assessment and pain score recorded according to visual analogue scale (vas) after one week, one month, three months, six months following intraarticular injection and radiation. all analgesics stopped and only (arcoxia "etoricoxib" 60 mg, 90 mg) was taken after the procedure, total day dose and frequency will be reported, other analgesics taken by the patient is reported also. improvement of daily activities and clinical examination for the studied knees is observed.

Eligibility criteria:
inclusion criteria: * mild to moderate knee osteoarthritis. * body mass index: 24 - 42 kg/m2 exclusion criteria: * coagulopathy. * acute local or systemic infections with knee effusion previous knee surgery (relative contraindication).
pylorus dysfunction after esophagectomy and gastric tube reconstruction. effect of pneumatic pylorus dilatation during hospital stay, surgical complications during in hospital stay

Conditions: Esophagectomy; No Signs of Cancer Recurrence; Delayed Gastric Emptying

Summary: delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. no treatment is currently available. it can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. pneumatic dilatation may therefore be a potentially effective treatment.

patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. the study design is sham controlled single blind with a follow up extending to twelve months post treatment.

Eligibility criteria:
inclusion criteria: * previous esophagectomy and gastric tube reconstruction. * symptoms suggestive of delayed gastric emptying. * signed informed consent exclusion criteria: * signs of recurrent cancer disease * no symptoms suggestive of delayed gastric emptying. * unwillingness to participate
effects of corporal visualisation program of the static and dynamic balance after an operation of the lca

Conditions: Anterior Cruciate Ligament Rupture

Summary: the aim of this pilot study is to assess the feasibility of a rct whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone acl plasty.

primary and secondary outcomes will be measured twice at the hospital, a first time six weeks after the beginning of the intervention and a second time eight weeks after the four weeks of the intervention. twelves home-based motor imagery sessions will occur in four weeks, three times a week, to activate. the training sessions will last between 15 and 20 minutes. during each training session, the participant will note on his/her own "tracking sheet" how long they listened to the audio and their comments. the "tracking sheet" will document whether or not the patient has participated in each of the twelve sessions. in parallel, a control group will follow a placebo programme according to the same formalities. twenty-three participants (min.) will take part in this study.

Eligibility criteria:
inclusion criteria: * men and women of legal age * to be capable of discernment * to have a telephone number or email address to communicate with the investigators, to have a device with internet access to access the mental imagery programs. * to have had an acl surgery performed by the doctor siegrist within the last three days using the hamstrings tendon graft or the kenneth jones method. exclusion criteria: * not having a good spoken knowledge of the french language * recurrence of acl injury in the same knee * meniscal sutures * associated fractures * pre-existing balance problems (tested at recruitment) * pre-existing neurological problems diagnosed by a doctor.

Keywords: acl plasty anterior cruciate ligament motor imagery postural control
low glycemic index diets (with pulses) in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods emphasizing dried legumes and their products. the treatments will last 3 months with bloods taken for hba1c, glucose and blood lipids. if the study shows a benefit for either or both diets, then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.


Eligibility criteria:
inclusion criteria: men and women with type 2 diabetes who * are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks * have a hba1c in the range of 6.5% to 8.5% at screening and at the visit prior to randomization * have diabetes diagnosed \>6 months * have maintained stable weight for 2 months (within 3%) * have a valid ohip card and a family physician * if prescribed lipid medication, have taken a stable dose for at least 2 weeks * if prescribed blood pressure medication, have taken a stable dose for at least 1 week * can keep written food records, with the use of a digital scale exclusion criteria: individuals who * take insulin * take steroids * have gi disease (gastroparesis, celiac disease, ulcerative colitis, crohn's disease, ibs) * have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months * take warfarin (coumadin) * have had major surgery in the past 6 months * have a major debilitating disorder * have clinically significant liver disease (ast or alt \> 130 u/l), excluding nafl or nash * have hepatitis b or c * have renal failure (high creatinine \> 150 mmol/l) * have serum triglycerides ≥ 6.0 mmol/l * have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell) * have food allergies to study food components * have elevated blood pressure (\> 145/90) unless approved by gp * have acute or chronic infections (bacterial or viral) * have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis) * have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
evaluation of effectivity of quadratus lumborum blocks with adjuvant

Conditions: Postoperative Pain Management; Postoperative Pain; Analgesia; Nerve Blocks; Nerve Block Duration; Cholecystectomy

Summary: i̇n recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.conventionally adjuvants used to improve and prolonged the effect of periferic nerve, spinal and abdominal blocks.i̇n this study investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at patient underwent laparoscopic cholecystectomy.

laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. pain is one of the important causes of late discharge after surgery. laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. quadratus lumborum iii block is a regional technique performed for multimodal analgesia.adjuvants are known to improve the analgesic efficacy and prolonge the effect of the periferic and central nerve blocks.the aim of this study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for patients who underwent laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists physical statusⅰ-ii exclusion criteria: * inclusion criteria: * 18-65 years of age * american society of anesthesiologists physical statusⅰ-ii exclusion criteria: * local anesthetic allergy * infection at the procedure site body mass index \>35 kg/m2 anticoagulant use with bleeding disorder chronic analgesia and opioid use with mental and psychiatric disorders contraindications to regional anesthesia several lung and heart disease

Keywords: postoperative pain laparoscopic cholecystectomy quadratus lumborum block abdominal wall blocks adjuvant dexamethasone postoperative analgesia
a 6-week open label cross-over study with 2 different daily doses of minirin® oral lyophilisate in children and adolescents with primary nocturnal enuresis (pne)

Conditions: Primary Nocturnal Enuresis

Summary: to evaluate the preference of subjects for minirin® oral lyophilisate treatment compared with minirin® tablet treatment after 6 weeks. to compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. to compare ease of use of both formulations at 3 and 6 weeks using a vas-scale. to validate a pne quality of life (qol) questionnaire. to evaluate safety. to compare compliance with the 2 formulations

to evaluate the preference of subjects for minirin® oral lyophilisate treatment compared with minirin® tablet treatment after 6 weeks. to compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. to compare ease of use of both formulations at 3 and 6 weeks using a vas-scale. to validate a pne quality of life (qol) questionnaire. to evaluate safety. to compare compliance with the 2 formulations

Eligibility criteria:
inclusion criteria: * children suffering from primary nocturnal enuresis with no organic pathology. * children of either sex, not below 5 and not above 15 years of age (not below 6 years in the netherlands and france). * children with a minimum of 6 wet nights in 2 weeks. exclusion criteria: * children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms. * children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. ssri, tricyclic antidepressant drugs, chlorpromazine and carbamazepine. * diagnosed renal diabetes insipidus or central diabetes insipidus with an avp (arginine vasopressin) deficiency. * proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
high-intensity vs. low-intensity inspiratory muscle training in patients with heart failure

Conditions: Heart Failure

Summary: it is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with hf. interestingly, not only peripheral muscles are impaired, but also respiratory muscles. studies have shown that patients with hf may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (imt) reasonable in cardiovascular rehabilitation.the specifications of the loads to be imposed during imt is the main factor determining the outcome. studies of imt have highlighted the need for a fixed inspiratory workload during exercise. thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity imt to combined aerobic and resistance exercise in patients with heart failure.


Eligibility criteria:
inclusion criteria: * the target population consists of adults patients aged ≥ 18 years with heart failure and new york heart association (nyha) class i-iii. exclusion criteria: * unstable angina; * coronary revascularization; * decompensated heart failure functional class iv (nyha); * recent transplant or hospitalization (6 months \<); * chronic obstructive pulmonary disease; * neuromuscular, orthopedic, neurologic and neoplastic diseases; * recent myocardial infarction or cardiac surgery (less than 6 months); * atrial fibrillation.

Keywords: heart failure; rehabilitation
anastomotic leakage in right colectomy

Conditions: Anastomotic Leak

Summary: data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among austria for the period between january 2010 and december 2019. demographic, peri- and postoperative data of patients were analyzed retrospectively.


Eligibility criteria:
inclusion criteria: * patients with benign or malignant diseases in the right portion of the colon. * elective surgery exclusion criteria: * emergent surgery
prophylactic ivermectin in covid-19 contacts

Conditions: COVID

Summary: asymptomatic family close contact of confirmed covid -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of covid -19


Eligibility criteria:
inclusion criteria: family contact of confirmed covid-19 case exclusion criteria: * refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin
cgh-array in prenatal diagnosis of isolated severe and early intra-uterine growth restriction

Conditions: IUGR; Prenatal Disorder; Genetic Disease

Summary: according to french recommandations for iugr management we have to propose a cgh-array analysis if the iugr is severe (bellow the 3rd percentile) and early (in the second trimester). however there is no data to support this point of view.


Eligibility criteria:
inclusion criteria: * pregnant women * fetus with an isolated intra-uterine growth restriction (iugr) severe (bellow the third percentile on cfef curves) and early (between 21 and 24 gestational weeks). exclusion criteria: * associated iugr (with other abnormalities during prenatal screening)