Kornimate/medical-research-clean huggingface dataset:
skeletal health in bariatric surgery patients

Conditions: Bariatric Surgery; Osteoporosis; Fractures, Bone; Roux En-Y Gastric Bypass; Sleeve Gastrectomy; Menopause; Premenopause

Summary: the investigators propose a prospective cohort trial that will help to understand the impact of roux-en-y gastric bypass (rygb) and sleeve gastrectomy (sg) in pre- and post-menopausal female bariatric patients.

while highly effective both rygb and sg may lead to increased bone resorption, decreased bone mass, and increased risk of some fractures. very few studies have compared the effects of the rygb and the sg on changes skeletal health and findings have been inconsistent. furthermore, few studies have investigated the short- or long-term consequences of bariatric surgery on bone mineral density in pre- and post-menopausal women. to what extent and how bariatric surgery impacts the skeleton largely remains undetermined. because estrogen is protective against osteoporosis and fractures, the majority of fractures occur in postmenopausal women. it is important that women have higher rates of obesity (38.3%) compared to men (34.3%) and that ≥67% of bariatric patients are women. therefore, women may be at a significantly increased risk of developing osteoporosis. these data may help establish clinical guidelines to assess, maintain, and promote skeletal health in the preoperative and postoperative care of bariatric patients; and it may help to determine the appropriate bariatric procedure for women at risk of osteoporosis and fractures.

Eligibility criteria:
inclusion criteria: * adult females ≥ 19 years scheduled to undergo bariatric surgery (roux en y gastric bypass or gastric sleeve surgery) * class ii (bmi 35-39.9 kg/m2). * class iii obesity (bmi ≥ 40 kg/m2). * scheduled to undergo bariatric surgery with the ability to provide informed consent. exclusion criteria: * patients with a history of thyroid disorders, thyroidectomy and levothyroxine use. * patients with a history of known osteoporosis, steroid-induced osteoporosis, current or previous use of medications for osteoporosis. * patients with a history of gastrointestinal malabsorption. * patients with a history of renal diseases. * patients with a history of current or previous use of corticosteroids. * patients who have used tobacco products within a year of study enrollment. * patients with surgically-induced menopause e.g. bilateral salpingo-oophorectomy. * patients with a history of breast cancer, who have had or are currently on hormonal therapy or anti-hormonal therapy.
norwegian adenomyosis study iii: peristalsis

Conditions: Adenomyosis; Infertility; Dysmenorrhea

Summary: spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. at the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain. in this study, the uterine peristalsis of women with adenomyosis will be investigated. this condition is associated to heavy menstrual bleeding, menstrual pain and infertility.

the peristalsis of the non-pregnant uterus is widely investigated and the role of correct peristalsis seems to be most important for correct sperm transport towards the fallopian tubes and implantation of the embryo. at the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and menorrhagia. the connection of impaired peristalsis and various clinical symptoms has been shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis, though the concept seems to be widely accepted. it has also been repeatedly postulated that impaired peristalsis interferes with implantation of the embryo, yet martinez-conejero published a trial that showed a higher incidence of miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. this might either indicate that the postulated effect of peristalsis is wrong or, more likely, since this is a study in an ivf setting, that hormonal treatment with gonadotropin-releasing hormone (gnrh)-agonist could improve implantation. it is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of uterine peristalsis are defined by jiland already in 1996. findings resulting from the investigations in this study may help to determine the role and extent of impaired peristalsis in women with adenomyosis and possibly give new clues on potential treatments, as well as fill a gap in today's knowledge.

Eligibility criteria:
inclusion criteria: * premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms. exclusion criteria: * postmenopausal women, * pregnant women, * gynaecological cancer, * gnrh analog therapy or systemic hormone therapy in the last three months prior to hysterectomy, * endometriosis, * uterine fibroids

Keywords: peristalsis ultrasound
bioflow-iii belgium satellite registry

Conditions: Coronary Artery Disease; Myocardial Ischemia

Summary: this registry is a clinical post-market evaluation of the orsiro less in subjects requiring coronary revascularization with drug eluting stents (des).

for the majority of coronary artery disease (cad), treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedural success. however, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30%-50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. this observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the orsiro drug eluting stent system in an all-comers patient population in daily clinical practice.

Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease * subject has signed informed consent for data release * subject is geographically stable and willing to participate at all follow-up assessments * subject is ≥ 18 years exclusion criteria: * subject did not sign informed consent for data release * pregnancy * known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for pci, stainless steel, sirolimus or contrast media * planned surgery within 6 months of pci unless dual antiplatelet therapy will be maintained * currently participating in another study and primary endpoint is not reached yet.

Keywords: international multicenter observational registry orsiro drug eluting stent (des) stenting treatment of coronary artery disease coronary revascularization percutaneous coronary intervention stemi nstemi ischemia angina subgroups acute myocardial infarction diabetes small vessels chronic total occlusion (cto)
circadian rhythm status and cs (cesarean section) postoperative pain

Conditions: Circadian Rhythm

Summary: use huawei wristwatch to record maternal rhythm status and record the vas score after cesarean section under combined spinal-epidural anesthesia. based on this study the investigators intend to explore the correlation between maternal circadian rhythm status and postoperative pain after cesarean section.


Eligibility criteria:
inclusion criteria: * age 20 to 45 * asa(american society of anesthesiologists) status ii-iii * 37-42 weeks gestation * undergo elective cesarean section with subarachnoid anesthesia * participate in this study and sign informed consent exclusion criteria: * patients with contraindications of combined spinal and epidural anesthesia * patients with severe systemic disease * alcoholism and long-term use of anti-inflammatory and analgesic drugs * patients who were unable to cooperate or refused to participate in the trial * with psychiatric disorder * researchers considered unsuitable to participate in or unable to cooperate with the study

Keywords: circadian rhythm cesarean section pain
phase iia trial of oral sss17 for post-arthroplasty anemia

Conditions: Postoperative Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Summary: to assess the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (pk/pd) characteristics of orally administered sss17 capsules in patients with postoperative anemia following elective total hip or knee arthroplasty.


Eligibility criteria:
inclusion criteria: 1. signed informed consent obtained - 2. age 18-70 years (inclusive) - 3. candidates for hip/knee arthroplasty - 4. no dvt on pre-op venous ultrasound - 5. screening hb 80-110 g/l (no transfusion indication) - 6. commitment to effective contraception exclusion criteria: 1. hypersensitivity to the investigational product or any of its components 2. any other condition causing chronic anemia 3. coagulopathy or unstable anticoagulant dosing during screening 4. any of the following laboratory abnormalities at screening: 1. serum albumin \<35 g/l 2. alt or ast \>3×uln 5. active infections or carrier status including: * known hiv infection * active syphilis * active hbv infection (hbsag-positive with hbv dna \>10³ copies/ml) * active hcv infection (anti-hcv positive with detectable hcv rna) 6. acute joint injury with active trauma or infection at screening 7. cognitive impairment or psychiatric disorders,current or history of epilepsy 8. treatment with esas (erythropoiesis-stimulating agents) or hif inhibitors within 30 days prior to dosing 9. history of severe thromboembolic events or hematopoietic disorders 10. malignancy history 11. severe cardiovascular diseases including: * unstable coronary artery disease * heart failure (nyha class iii/iv) * myocardial infarction/stroke 12 .poorly controlled hypertension 13. alcohol abuse 14.pregnancy or lactation 15.participation in other drug trials within 3 months prior to enrollment 16.any other condition deemed by the investigator to compromise subject safety or trial validity
a study to evaluate the efficacy and safety of cnto328 plus best supportive care in multicentric castleman's disease

Conditions: Multicentric Castleman's Disease

Summary: the purpose of this study is to demonstrate that cnto 328 when administered in combination with best supportive care (bsc) is superior to bsc in terms of durable tumor and symptomatic response (complete response or partial response) among patients with multicentric castleman's disease.

this is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double blind (neither investigator nor the participant knows the treatment that the participant receives), placebo controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), study to assess the efficacy and safety of cnto 328 plus bsc compared with bsc in patients with symptomatic multicentric castleman's disease. the study mainly consists of 3 phases, including: the screening phase (majority of assessments performed within 28 days of first dose), the treatment phase (blinded and unblinded), and the follow up phase. in the blinded treatment phase, approximately 78 patients will be randomly assigned in 1:2 ratios to either of 2 treatment groups, ie, placebo + bsc, or cnto 328 + bsc. participants receiving placebo + bsc during blinded treatment period who do not respond and have treatment failure will have the option to crossover and receive siltuximab + bsc during unbllinded treatent period. the follow up phase will be 3 months after last dose of study medication and the survival will be followed up until the study ends. safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, patient-recorded temperature, and physical examination will be monitored throughout the study. the total study duration will be 5 years after the last patient starts study medication.

Eligibility criteria:
inclusion criteria: * measurable and symptomatic multicentric castleman's disease * adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment * eastern cooperative oncology group performance status of 0, 1, or 2 * corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment exclusion criteria: * human immunodeficiency virus or human herpes virus-8 positive * skin lesions as sole measurable manifestation of multicentric castleman's disease * previous history of lymphoma * malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years * concurrent medical condition or disease that may interfere with study participation * prior exposure to interleukin-6 or interleukin-6 receptor targeted therapies

Keywords: multicentric castleman's disease mcd cnto 328 best supportive care tumor symptomatic response pharmacokinetics interleukin-6 il6
spontaneous void requirements for patients undergoing ambulatory anorectal surgery

Conditions: Complications, Postoperative

Summary: the objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (pacu) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.

this study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). the spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. the no void group will be 50 patients who will be discharged home from the pacu once they meet ambulatory surgery center discharge criteria per hospital guidelines. patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. a post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.

Eligibility criteria:
inclusion criteria: * age 18-80 years old * patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision exclusion criteria: * age \ 80 yo * prisoners * pregnant women * unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study
prognosis in subacute ischemic stroke using multimodal imaging

Conditions: The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke

Summary: we enrolled patients with subacute is, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4d asl. perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified rankin scale \[mrs\] ≤ 2) and poor prognosis (mrs \> 2).


Eligibility criteria:
inclusion criteria: 1. confirmed unilateral internal carotid artery/mca atherosclerotic stenosis/occlusion with a stenosis degree \> 50% verified through computed tomography angiography (cta), magnetic resonance angiography (mra), or digital subtraction angiography (dsa). 2. presence of is or transient ischemic attack (tia) symptoms in the circulating blood supply area within the preceding 48 h. 3. asymptomatic patients with no history of is or tia in the past 6 months. 4. performance of 4d asl tests during hospitalization. exclusion criteria: 1. moderate-to-severe stenosis/occlusion of the contralateral internal carotid artery/middle cerebral arteries. 2. age ≤ 18 years old. 3. cardioembolic cerebral infarction. 4. moyamoya disease. 5. combined or previous cerebral hemorrhage or subarachnoid hemorrhage 6. history of previous cerebral infarction. 7. claustrophobia or the presence of intracranial metal implants, cochlear implants, or pacemakers.
influence of sodium intake on left ventricular-arterial coupling

Conditions: Hypertension

Summary: the objective of the present study is to asses the effectiveness of the aorta-ventricular coupling according to low and high sodium intake in 28 controled hypertensive patients.

comparison of left ventricular function in two groups of 13 patients according to their different salt's consumption in double blind and crossover study. performance estimation of the left ventricle by echocardiographic and central arterial pressure by tonometry.

Eligibility criteria:
inclusion criteria: * hypertension stage 1, with medium or high risk, when the treatment (mono or therapy without diuretics) is efficient, when the great pressure is reached (\<140/90 mmhg) * high sodium intake (sodium urinary excretion for 24h (unav) \> or = 170 mmol/24h before visit 0 * limited sodium intake objective (unav\<85 mmol/24h)attempted at the end of the limited sodium intake period of 2 weeks * patients aged between 18 and 80 years * subject has given written informed consent * subject has subscribed a health care insurance exclusion criteria: * secondary hypertension * complications associated with the arterial hypertension : history of cardiovascular diseases or myocardial infarction, cerebrovascular accident, coronary disease, ... * arterial hypertension associated with cardiopathy * arterial hypertension associated with nephropathy * arterial hypertension associated with diabetes * measure of central arterial pressure by tonometry is impossible * cardiac echogenicity is not satisfactory for the analysis of left ventricular loop analysis * patient refuses informed consent * follow-up impossible for 15 weeks * pregnant or women without efficacy contraception * patient without freedom by administration decision * patient in exclusion period * patient without french insurance * adult protected by the law

Keywords: hypertension, sodium intake, left ventricular function
rsa vs. nonop for 3 & 4-part proximal humerus fractures

Conditions: Humerus Fracture; Humerus; Shoulder Fractures; Shoulder Arthropathy Associated With Other Conditions; Arthropathy Shoulder; Shoulder Injury; Arthropathy

Summary: there is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. no surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. this study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.


Eligibility criteria:
inclusion criteria * displaced 3- and 4-part proximal humerus fractures. * age greater than or equal to 65 years old. exclusion criteria * less than 65 years old. * medical comorbidities precluding surgical treatment or anesthesia * dementia or inability to provide adequate follow up. * pathologic fractures * open fractures * associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
phase 2a study of safety and tolerability of spn-810 in children with adhd and persistent serious conduct problems

Conditions: Attention Deficit Disorder With Hyperactivity; Conduct Disorder

Summary: it is hypothesized that, when given at the lowest effective dose, the favorable side effect profile combined with it's lower propensity for weight gain would make spn-810 a candidate for treatment of persistent serious conduct problems in pediatric subjects with adhd.


Eligibility criteria:
inclusion criteria: 1. healthy pediatric male or female subjects, age 6 to 12 years. 2. diagnostic and statistical manual of mental disorders - iv -text revision (dsm-iv-tr) diagnosis of adhd. 3. ncbrf-tiq disruptive behavior disorder subscale 27 or greater at baseline; and a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people. 4. iq greater than 71. exclusion criteria: 1. current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified. 2. currently meeting dsm-iv-tr criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder. 3. any other anxiety disorder as primary diagnosis. 4. use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline. 5. unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.

Keywords: adhd and conduct problems