Kornimate/medical-research-clean huggingface dataset:
detection of phrenic nerve stimulation using sensors' signals

Conditions: Heart Failure

Summary: the purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.


Eligibility criteria:
inclusion criteria: * willing and capable of providing informed consent and of participating in all testing * age 18 or above or of legal age to give informed consent specific to national law * implanted with a boston scientific cognis™ family device * geographically stable and is available for follow-up procedures at a study centre exclusion criteria: * patients that are pacemaker-dependent * women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion) * patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry * patients who are not expected to support approximately 30 minutes of study testing procedures * patients who are not mentally competent enough to provide feedback on ps during study procedures

Keywords: phrenic nerve stimulation cardiac resynchronization therapy heart failure heart diseases
point-of-care testing in coagulopathic patients undergoing cardiac surgery - a multicenter study

Conditions: Coagulopathy During Cardiac Surgery

Summary: recently, the investigators study group showed in a mono center study that point of care (poc) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. the investigators aim to verify the obtained results by conducting this multicenter study.


Eligibility criteria:
inclusion criteria: step 1: * patients scheduled for elective, complex cardiothoracic surgery (combined coronary artery bypass graft and valve surgery, double or triple valve procedures, aortic surgery or redo surgery) with cardiopulmonary bypass (cpb) step 2: * diffuse bleeding after heparin reversal following extracorporeal circulation or * intra- or postoperative blood loss exceeding 250 ml/h or 50 ml/10 min exclusion criteria: * pregnancy

Keywords: coagulopathy hemorrhage cardiac surgery point-of-care testing poc rotem multiplate multiple electrode aggregometry (mea)
the outcomes of laparoscopic cholecystectomy for acute cholecystitis within and beyond the first 72 hours, does it differ?!

Conditions: Acute Cholecystitis

Summary: compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.

laparoscopic cholecystectomy (lc) is the mainstay treatment of acute cholecystitis. however, it remains a challenging procedure with low but significant risks of major complications such as bile duct injury increasing as the severity of ac progresses. new guidelines suggest that laparoscopic cholecystectomy should preferably be performed within 72 hrs of symptom onset but has acknowledged that this may not be always possible in practice. hence, it recommends that patients presenting after 72 h of symptom onset may still benefit from laparoscopic cholecystectomy in selected patients studies found that it is imperative to convert to open cholecystectomy when it is deemed unsafe to dissect the calot's triangle may occur even within or beyond first 72 hrs of attck symptoms. studies found a statistically longer mean total length of hospitalization, operation time and intraoperative blood loss for lc performed beyond 72 h, this did not translate into clinically significant adverse outcomes such as an increase in perioperative morbidity or the need for blood transfusion. after 72 h, chronic inflammation and fibrosis set in resulting in more technically demanding and longer surgeries.studies show differing results reporting longer operation times for laparoscopic cholecystectomy beyond 72 h, due to stiffer tissues that cannot be bluntly dissected during the subacute phase of tissue inflammation. however, other studies did not report any difference in operation times between both groups.

Eligibility criteria:
inclusion criteria: 1. patients with acute cholecystitis within and after 72 hours. 2. patients over 18 years. 3. patients with no common bile duct stones based on imaging and biochemical criteria 4. fit for surgery. exclusion criteria: 1. patients not fit for surgery 2. patients with pancreatitis. 3. significant medical disease rendering patient unfit for laparoscopic surgery (e.g. uncontrolled diabetes mellitus, chronic pulmonary disease, significant cardiac disease)
therapeutic effect of dapagliflozin combined with csii on newly diagnosed type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: to compare the effect of dapagliflozin combined with csii and csii alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

to compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (csii) and csii alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

Eligibility criteria:
inclusion criteria: * volunteer to participate and be able to sign informed consent prior to the trial. * patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old. * no acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. * subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise. exclusion criteria: * patients with insulin allergy. * impaired liver and kidney function with alt 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal. * drug abuse and alcohol dependence in the past 5 years. * systemic hormone therapy was used in the last three months. * patients with poor compliance and irregular diet and exercise. * patients with pregnancy, lactation or pregnancy intention. * any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Keywords: continuous glucose monitoring system (cgms) dapagliflozin continuous subcutaneous insulin infusion ( csii)
the effect of motivational messages by "whatsapp" on adherence to home exercise program

Conditions: Knee Osteoarthritis

Summary: this study aims to examine the effect of the text message platform (whatsapp) on the adherence to home exercise programs, pain and physical function among middle age and older adults with knee oa in two public hospitals in riyadh city, saudi arabia


Eligibility criteria:
inclusion criteria: saudi adults aged 45 to 65. diagnosis of unilateral or bilateral, mild to moderate knee oa exclusion criteria: diagnosis of severe knee oa diagnosis of neurological conditions diagnosis of cardiopulmonary conditions diagnosis of mental disorders on wait for surgical intervention.
world health organization disability assessment schedule (whodas-ii) for patients with symptomatic lumbar disc herniation

Conditions: Lumbar Disc Herniation

Summary: the main purpose of this study is to determine the measurement characteristics of whodas ii (world health organization disability assessment schedule), as well as to analyze its correlation with symptomatic lumbar disc herniation (visual analog scale, vas), disability (spanish version of the roland morris questionnaire, rmq), fear avoidance beliefs and attitudes (spanish version of the fab questionnaire, fabq) and quality of life (sf-12). measurements will be taken at baseline and 6 days later (day 7).


Eligibility criteria:
inclusion criteria: * patients seen for symptomatic lumbar disc herniation * radiated pain concordant with nerve root * with or without motor restriction * able to read and write * signed the informed consent form exclusion criteria: * central nervous system pathology (with or without treatment) * diagnosis of rheumatic inflammatory disease or fibromyalgia * red flags for underlying systemic disease * criteria for diagnosis of symptomatic spinal stenosis * symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis * motor deficit that progresses or does not improve in 6 weeks

Keywords: symptomatic lumbar disc herniation disability fear avoidance beliefs quality of life
transperineal ultrasound to assess the progress of labour

Conditions: Placenta Praevia; Vaginismus

Summary: this is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.

this is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women. aims: this study aims to firstly assess the effectiveness and acceptability of transperineal ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital vaginal examination (ve). secondly, in all term (37-42 weeks) labouring women, investigators aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.

Eligibility criteria:
inclusion criteria: * gestation 24-42 completed weeks at study entry * aged 18-44 * cephalic * singleton pregnancies * nulliparous * multiparous (excluded for the term predictive model group) * multiple pregnancies (excluded for the term predictive model group) * established (active) phase of labour (included for the term predictive model group) o clinician opinion that patient is in the established phase of labour according to the current nice guidelines exclusion criteria: * younger than 18 years. * imminent iatrogenic intention to deliver * life threatening maternal or fetal compromise needing immediate medical attention and/or delivery * women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study. * miscarriage * intra-uterine death * previous cervical surgery eg. cone biopsy, cervical cerclage. note- single lletz is not excluded. * non-cephalic presentations * multiple pregnancies (for the term predictive model group) * multiparous patients (for the term predictive model group) * not in established labour (for the term predictive model group)

Keywords: transperineal ultrasound labour sonopartogram prediction model
training with elastic tubing in cardiopaths: clinical trial

Conditions: Resistance Training; Muscular Strength; Cardiovascular Diseases

Summary: background: resistance training is effective in cardiac rehabilitation; however, other types of training, such as elastic tubing, are rarely used and may present good therapeutic alternatives. due to its practicality and cost effectiveness, training using elastic tubing may become an important tool in cardiovascular rehabilitation. objective: to evaluate muscular strength, functional capacity, aerobic capacity and quality of life in patients with cardiovascular diseases in phase ii of rehabilitation, after resistance training with elastic tubing. methods: patients with cardiovascular diseases performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days. the following muscle groups were evaluated and trained: shoulder abductors and flexors, elbow flexors, and knee flexors and extensors. muscular strength was evaluated using a dynamometer; functional capacity with a 6-minute walk test and ergospirometric test; and quality of life using the sf-36 questionnaire. data normality was assessed using the shapiro wilk test. comparisons before and after training were performed using the paired student's t test or the wilcoxon test (p \<5%).


Eligibility criteria:
inclusion criteria: * patients of both sexes * aged between 45-79 years * clinical diagnosis of heart disease (coronary artery disease, postoperative myocardial revascularization, acute myocardial infarction) * in phase ii of crp for at least three months exclusion criteria: * patients hemodynamically unstable * patients with changes in medication for a minimum of 30 days * patients who presented arteriopathies, neurological, muscular or orthopedic disorders, such as rheumatism and unstable heart disease that could be detected by electrocardiogram, and lung diseases.
national survey on gastroesophageal reflux disease (gerd) patients

Conditions: GERD

Summary: the purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of gerd symptoms .


Eligibility criteria:
inclusion criteria: * male or female \> or = 18 years old * patient with symptomatic gerd * without ppi or h2 antagonist treatment during the 3 previous months * agree to take part in this study exclusion criteria: * pregnant women

Keywords: gerd symptoms- waist circumference patients with symptomatic gerd
safety and efficacy of asfotase alfa in patients with hypophosphatasia (hpp)

Conditions: Hypophosphatasia

Summary: the aim of this study is to assess safety and efficacy of asfotase alfa (alxn1215) in patients with hypophosphatasia


Eligibility criteria:
inclusion criteria: patients must meet one selection criteria of following "1", "2", and "3", and must meet the selection criteria of "4." 1. patient who has been already treated with asfotae alfa (alxn1215) out of this clinical trial 2. patient who has been diagnosed as hpp 3. documented diagnosis of hpp as indicated by: 1. total serum alkaline phosphatase below the lower limit of normal for age 2. ultrasonographic features of prenatal, characterized by: 1) severe short extremities (femur length \ 0.33) 3) craniotabes 4) hypoplastic thorax (thoracic or abdominal circumference \<0.6) (3) computed tomographic findings of prenatal, characterized by: 1. generalized decreased ossification 2. extreme shortening of tubular bones 3. hypoplastic thorax (4) radiographic evidence of hpp, characterized by: 1) flared and frayed metaphyses 2) severe, generalized osteopenia 3) widened growth plates 4) areas of radiolucency or sclerosis (5) two or more of the following hpp-related findings: 1. history or presence of: - nontraumatic post-natal fracture - delayed fracture healing 2. nephrocalcinosis or history of elevated serum calcium 3. functional craniosynostosis 4. respiratory compromise or rachitic chest deformity 5. vitamin b6 dependent seizures 6. failure to thrive 7. premature tooth loss (6) patient who have the mutation of tissue non-specific alp gene 4. parent or legal guardian(s) must provide written informed consent prior to any study procedures being performed and must be willing to comply with all study-required procedures exclusion criteria: 1. current evidence of treatable form of rickets 2. serum calcium or phosphate levels below the normal range 3. pregnant women and nursing mothers 4. patient who cannot enforce suitable contraceptive measures during the clinical trial 5. prior treatment with bisphosphonates 6. treatment with an investigational drug within 1 month prior to the start of asfotase alfa treatment 7. current enrollment in any other study involving an investigational new drug, device or treatment for hpp (e.g., bone marrow transplantation) 8. clinically significant disease that precludes study participation, in the opinion of the investigator
impact of acetabular fractures on sports performance

Conditions: Acetabular Fracture

Summary: acetabular fractures are complex, relatively rare lesions that are difficult to manage. given the surgical challenge they represent, they are often managed by expert centers. the overall incidence of these fractures is around 3 fractures/100,000 persons/year. it is now well established that the quality of the reduction obtained is an important predictive factor of the postoperative outcome in patients with displaced acetabular fractures. obtaining an anatomical reduction, at least satisfactory, is not always easy, even in trained teams. indeed, it can be difficult because of the structural environment. this is due to the proximity of the acetabulum to the vasculo-nervous elements, but also to the complexity of the fracture itself. the contribution of new technologies appear to be important tools to achieve this objective. indeed, investigators have demonstrated that the use of the o-arm imaging system (medtronic®, sofamor, memphis, tn) allowed the improvement of their results. although they occur more frequently in the elderly population, the average incidence is maintained in the 20-59 age group. in these young populations, the fracture occurs most frequently as a result of a high-energy mechanism (road accident, more exceptionally, during a sporting activity). these patients, in the prime of their lives, are often athletic. the desire to resume sports after surgery is a powerful motivating factor for these patients. often, it is the primary measure of surgical success from the athlete's perspective. in a previous work, giannoudis et al. reported a 42% rate of return to activity at the previous level. the quality of the surgery is associated with the possibility of resuming sports activity after the procedure. thus, the objective of this work is to determine the results of acetabular surgery in a population of previously athletic patients, in particular the return to athletic performance.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 45 years at the time of surgery at saint joseph hospital * patients with an isolated acetabulum fracture * patients with intraoperative management with o-arm * patients with at least 2 years of follow-up * french-speaking patients exclusion criteria: * presence of pre- or post-operative neurological lesions * presence of associated fractures * asa (american society of anesthesiologists) score ≥ 3 * absence of pre- and postoperative ct scans available on pacs * patients under guardianship or curatorship * patients deprived of liberty * patients under court protection * patients objecting to participation in the study * low preoperative physical activity (= ucla activity score ≤ 5) * unsatisfactory criteria for surgical reduction on ct scan
non coeliac gluten sensitivity in children

Conditions: Diet, Gluten-Free; Gluten-Sensitive Enteropathy

Summary: irritable bowel syndrome (ibs) is a very frequent condition in children. its management is difficult, often resulting in a persistence of chronical abdominal pain. in adults, many patients affected by ibs improve under a gluten-free diet, even in the absence of celiac disease (cd) or wheat allergy. this condition is called non coeliac gluten sensitivity (ncgs). however, it is still not clear how to diagnose and manage ncgs, and the pathophysiological mechanisms also remain elusive. the aim of this study is to determine if ncgs exists in children with ibs and to identify the clinical, serological, and histological characteristics, which could distinguish patients with ncgs from conventional ibs and cd patients. this is a prospective cohort study in a population of children affected by a moderate to severe ibs for more than 6 months. all children had a gluten free diet (gfd) for 6 weeks. then, children who improved under gfd were randomized in two groups for a double-blind placebo-controled trial. one group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.


Eligibility criteria:
inclusion criteria: * children with irritable bowel syndrome (ibs) exclusion criteria: * children with celiac disease (cd) * children with wheat allergy

Keywords: gluten-sensitive diet, gluten-free irritable bowel syndrome non coeliac gluten sensitivity children
exparel post-tonsillectomy clinical trial

Conditions: Tonsillectomy

Summary: tonsillectomy is one of the most commonly performed surgical procedures in the united states. the primary indications for tonsillectomy in the adult population include recurrent pharyngitis, chronic tonsillitis, and obstructive pathology. tonsillectomy is often associated with severe postoperative pain, which can result in prolonged poor oral intake, dehydration, and the need for high dose narcotics. in severely dehydrated patients, epithelial shedding and necrosis of soft tissues at the surgical site can lead to postoperative complications such as bleeding, delayed healing, and severe pain. the goal for this study is to explore the use of a long acting local anesthetic bupivacaine liposome injectable suspension (exparel) to manage pain experienced by adult patients after tonsillectomy

the proposed investigation will examine whether exparel (bupivacaine liposome injectable suspension 1.3%-13.3 mg/ml) when used as a post-excision adjunct to the standard of care bupivacaine hcl 0.25% (2.5 mg/ml) with epinephrine (5mcg/ml), will decrease the patient's post-tonsillectomy experience of pain intensity, especially for the first three days after surgery, and correspondingly reduce the requirement for pain medications and improve outcomes.

Eligibility criteria:
inclusion criteria: 1. scheduled to undergo bilateral palatine tonsillectomy as the only procedure 2. adults age 18 years and older. exclusion criteria: 1. severe systemic disease that is clinically significant in the judgement of the investigator. 2. coagulation disorder that is clinically significant in the judgement of the investigator. 3. current or previous history of analgesic dependence 4. allergy to any of the drugs used in the study (bupivacaine) 5. women known to be pregnant, planning to become pregnant, or lactating 6. hearing impairment that is clinically significant in the judgement of the investigator. 7. cardiovascular disease that is clinically significant in the judgement of the investigator. 8. impaired liver function that is clinically significant in the judgement of the investigator. 9. impaired renal function that is clinically significant in the judgement of the investigator. 10. unable to provide consent. 11. additional surgical procedures planned concurrently with palatine tonsillectomy. 12. planned use of topical or injected anesthetics other than those administered by the study within the two week follow up.

Keywords: adults pain