Kornimate/medical-research-clean huggingface dataset:
intra-abdominal instillation of fresh frozen plasma versus corticosteroids in prevention of recurrent attacks of adhesive intestinal obstruction: a 2 years' experience clinical study

Conditions: Adhesive Peritoneal Band

Summary: adhesive intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. most of them (73% - 90%) can be managed conservatively.despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. because of the nature of the disease recurrence has been estimated to be 30%.many attempts to prevent formation of postoperative adhesions have been tried. in this trial, we will study the effect of corticosteroids and ffp in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.


Eligibility criteria:
inclusion criteria: * patients with attacks of adhesive intestinal obstruction exclusion criteria: * associated abdominal malignancy, patients with adhesive io who respond to conservative treatment.

Keywords: adhesions corticosteroids fresh frozen plasma
a study in healthy men to test how different doses of bi 3000202 are tolerated and how food influences the amount of bi 3000202 in the blood

Conditions: Healthy

Summary: the single rising dose (srd) part of the trial investigates safety, tolerability, and pharmacokinetics of bi 3000202. the food effect (fe) part is conducted to assess the effect of food on the relative bioavailability of the bi 3000202 formulation.


Eligibility criteria:
inclusion criteria 1. healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests without any clinically significant abnormalities 2. age of 18 to 45 years (inclusive) 3. body mass index (bmi) of 18.5 to 29.9 kg/m\^2 (inclusive) 4. signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial exclusion criteria 1. any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator 2. repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmhg), diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.
clinical outcome of posterior cruciate ligament (pcl) posterolateral reconstruction

Conditions: Knee Injuries

Summary: the purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (pcl) and posterolateral structures of the knee joint. the outcome will be determined with validated and rigorous knee rating systems between 2 and 10 years postoperatively. the results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation. we hypothesize that the appropriately indicated procedures will effectively restore normal knee stability and function in patients with isolated or combined injuries to these structures.

because injuries to the pcl and posterolateral structures occur with less frequency than other structures in the knee joint (such as the anterior cruciate ligament and menisci), fewer studies are available to assist the surgeon and patient with appropriate decision-making regarding conservative versus surgical treatment. the majority of patients who sustain injury to these structures are treated conservatively. unfortunately, several investigations describe noteworthy symptoms and functional limitations following conservative management, and a high percentage of patients develop knee osteoarthritis that can be disabling for both recreational and daily activities. the investigators of this study have nearly three decades of experience and have extensively studied the effects of this injury in both the laboratory and clinic settings. it is our opinion that surgical reconstruction provides significant benefit when appropriately indicated, as has been demonstrated in our previous studies. especially in athletic individuals, pcl and posterolateral reconstructive procedures have advanced to the point where more predictable results can be expected to restore sufficient knee function. studies have demonstrated, at least in the short-term, that the majority of patients with acute ligament ruptures treated with reconstruction are able to return to various levels of sports activities.12 whether these procedures will decrease the risk of the patient developing future osteoarthritis is unknown and requires further study.

Eligibility criteria:
inclusion criteria: * complete rupture to the posterior cruciate ligament, greater than 10 mm of increased posterior tibial translation * rupture to the posterolateral knee structures, greater than 5 mm of increased lateral tibiofemoral joint opening, greater than 10 degrees of increased external tibial rotation * patient willing to comply with postoperative rehabilitation program exclusion criteria: * patient unwilling to participate

Keywords: pcl posterolateral
dexmedetomidine versus magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia after elective laparoscopic cholecystectomy

Conditions: Dexmedetomidine; Magnesium Sulfate; Adjuvants; Intraperitoneal Bupivacaine; Postoperative Analgesia; Elective Laparoscopic Cholecystectomy

Summary: this study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.

pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. intraperitoneal (ip) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum. bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. it is available mixed with a small amount of epinephrine to increase the duration of its action. it typically begins working within 15 minutes and lasts for 2 to 8 hours. dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics. magnesium is an n-methyl-d-aspartate receptor antagonist in addition to its effects on calcium influx. the anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. it is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.

Eligibility criteria:
inclusion criteria: * age from 21 to 65 years. * both sexes. * american society of anesthesiologists (asa) class i-iii. * scheduled to undergo elective laparoscopic cholecystectomy. exclusion criteria: * patient refusal. * body mass index ≥40. * allergy to the study drugs. * advanced cardiac, renal and hepatic diseases. * patients with peritoneal drain or peritoneal wash after surgery. * uncooperative patients. * chronic pain medications. * hypomagnesaemia or hypermagnesaemia.
the dexter-assisted non-emergent and acute cholecystectomy study (the nest study)

Conditions: Cholecystectomy

Summary: this study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the dexter robotic system, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * aged \> 18 years * patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed. exclusion criteria: * morbidly obese patients (bmi \> 40) * any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments * need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery * bleeding diathesis * pregnancy * patients with pacemakers or internal defibrillators * any planned concomitant procedures * patient deprived of liberty by administrative or judicial decision * participation in another interventional clinical trial
effects of black tea on cardiovascular disease in the mauritian population

Conditions: Cardiac Disease

Summary: it is proposed to investigate the association between consumption of black tea and various selective fasting blood serum and urine biomarkers in a mauritian population with ischaemic heart diseases. this study, the first of its kind, will provide clinical data on the potential prophylactic propensities of mauritian black tea against cardiovascular disease, which remains one of the major health threats to the mauritian population.

objectives our broad objectives will be to: * survey and recruit patients with ischaemic heart diseases in a randomized sample representative of the mauritian population (ethnicity, gender, age, social and economical status) and record their medical history, * collect fasting blood serum and urine at baseline and after supplement of control volume of tea infusion and water from study group and control group respectively, * optimize techniques to determine levels of specific biomarkers from above body fluid samples, * investigate existing correlation between tea consumption and risk of cardiovascular diseases in mauritian population our specific objectives will be to: * select a randomised group of the mauritian population, with ischaemic heart disease, who has been referred to the cardiac centre, pamplemousses for angiography and a group of people showing no risk of cardiovascular diseases * inform the people about the motives of the study and seek consent from those willing to participate in the study, * evaluate the levels of biomarkers of oxidative stress (total cholesterol, ldl, hdl, triglycerides, homocysteine, atrial natriuretic peptides, brain natriuretic peptides, 8-hydroxydeoxyguanosine, isoprostanes, hydroxyeicosatetraenoic acid, products of protein damage, uric acid and glycosylated haemoglobin) from 8-10 hr fasting blood serum and urine at baseline from all participants * supply the study group with a control volume of tea infusion and the control group with the same amount of water for a defined period of time followed by a two week wash out period with water. * study biomarkers as above from 8-10 hr fasting blood serum and urine in two week intervals during the supplement regime * investigate the existing correlation between tea consumption and levels of biomarkers of cardiovascular diseases in a mauritian sample population.

Eligibility criteria:
inclusion criteria: * 25-70 years * non smokers * left ventricular ejection fraction\>40% exclusion criteria: * alcohol consumption \> 4 standard drinks/day * postmenopausal women receiving hormone replacement therapy

Keywords: tea oxidative stress markers cardiovascular disease polyphenolics double blind ischaemic cardiac disease
eat, move, live intervention in reducing chronic disease risk in medically vulnerable communities

Conditions: Healthy Subject

Summary: this randomized pilot research trial studies how well eat, move, live (eml) works in reducing chronic disease risk in medically vulnerable communities. obesity, unhealthy diet, and physical inactivity are linked to increased cancer risk, especially hormone-related cancer (example, breast cancer). improving healthy lifestyle practices, namely increasing physical activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and chronic disease.

primary objectives: i. level of exercise. ii. reduction in barriers to exercise. iii. level of self-reported 5-9 servings of fruits and vegetables consumption. iv. reduction in barriers to fruit and vegetable consumption. v. improvement in biologic/metabolic markers such as hemoglobin a1c, fasting plasma glucose, and body weight. outline: participants are randomized to 1 of 2 groups. group i: participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community eml program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by certified health educator (che), a physical activity conducted by duarte fitness centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the che and local chef over 30 minutes over 12 weeks. participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for \> 30 minutes) including salsa, zumba and other aerobic exercises that are provided at duarte fitness center. group ii: participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12. after completion of study, participants are followed up immediately and at 3 months.

Eligibility criteria:
inclusion criteria: * mothers/female guardians of elementary aged students * self identify as latina * not adherent to the standard for \> five servings of fruits and vegetable and 150 minutes of physical activity exclusion criteria: * not a parent of elementary aged student in duarte unified school district (dusd) * does not self-identify as latina * does not speak/read/write/understand english/spanish - diagnosed with diabetes * consumes 5+ servings of fruits and vegetables and is active for at least 30 minutes 5+ days per week * has a condition or psychological difficulties that affects day-to-day activities * has physical limitations and cannot participate in physical activity
montelukast for treatment of uremic pruritus

Conditions: Renal Insufficiency, Chronic

Summary: in this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. these patients should have at least a course of therapy without proper response. after proper informing patients and taking testimonial patients enter to study. then patients randomized in case and control group. in case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. calcium, phosphorous, urea, creatinine, highly sensitive crp (hscrp), parathyroid hormone (pth), hemoglobin and kt/v were measured at beginning and at end of study. pruritus severity assessed by detailed pruritus score that introduced by duo and visual analogue score in beginning and at end of study in both group. sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.

montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.

Eligibility criteria:
inclusion criteria: * hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly * presence of uremic pruritus * patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities * patients should took a course of antipruritic treatment with no proper response exclusion criteria: * presence of pruritus less than three months * kt/v less than 1.2 * presence of pruritus due to other cause other than uremic state * presence of other pruritic diseases; malignancies; cholestasis; hepatitis b and c infection * treatment with corticosteroid * presence of anemia with hemoglobin less than 10
a phase 2 study of belzutifan (pt2977, mk-6482) for the treatment of von hippel lindau (vhl) disease-associated renal cell carcinoma (rcc) (mk-6482-004)

Conditions: VHL - Von Hippel-Lindau Syndrome; VHL Gene Mutation; VHL Syndrome; VHL Gene Inactivation; VHL-Associated Renal Cell Carcinoma; VHL-Associated Clear Cell Renal Cell Carcinoma

Summary: this study is designed to investigate belzutifan as a treatment for vhl disease associated rcc.

this open-label phase 2 study will evaluate the efficacy and safety of belzutifan in participants with vhl disease who have at least 1 measurable rcc tumor. belzutifan will be administered orally and treatment will be continuous. participants will be evaluated radiologically approximately 12 weeks after initiation of treatment and every 12 weeks thereafter while continuing in the study for a minimum of 3 years and then every 24 weeks or more frequently if clinically indicated. changes in vhl disease-associated non-rcc tumors will also be evaluated.

Eligibility criteria:
inclusion criteria: * has a diagnosis of von hippel lindau disease, based on a germline vhl alteration * has at least 1 measurable solid rcc tumor and no rcc tumor that requires immediate surgical intervention. the diagnosis of rcc can be radiologic (histologic diagnosis not required). participants may have vhl disease-associated tumors in other organ systems exclusion criteria: * has received prior treatment with belzutifan or another hif-2α inhibitor * has had any systemic anti-cancer therapy (includes anti-vascular endothelial growth factor \[vegf\] therapy or any systemic investigational anti-cancer agent) * has an immediate need for surgical intervention for tumor treatment * has evidence of metastatic disease on screening imaging

Keywords: vhl
neurophysiological rct of qigong in elderly with depression

Conditions: Depression

Summary: summary of project: elderly depression is a common mood disorder and the individuals will have persistent low mood and self-absorption that adversely affect their quality of life. cognitive deficits including attention and executive function are commonly seen in elderly with depression. qigong, a mind-body practice, is found to have an anti-depressive effect and improve cognitive functions. yet, the underlying mechanism is still elusive. hence, the present study aims to conduct a randomized controlled trial to investigate how the practice of eight-section brocades, a type of qigong, affects the function of the central nervous system in elderly with depression, as measured by fnirs. a total of 60 elderly (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 65 or above, with depressive mood as indicated by the geriatric depression scale (gds) will be recruited and randomly assigned to the treatment (eight-section brocades) and control (exercise) groups. we anticipate that this ancient chinese mind-body based practice will result in (1) decreased depressive moods and improved cognitive functions, and (2) acute changes in the functional brain activation patterns in the pfc in elderly with depression. the results of this study will shed light on the neurophysiological underpinnings of the therapeutic effects associated with qigong, which will be invaluable for designing intervention for elderly with depression.


Eligibility criteria:
inclusion criteria: * elderly aged 65 years or above with depressive symptoms as indicated by the geriatric depression scale (gds). exclusion criteria: * current positive history of head injury, seizure, stroke, other cns diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.

Keywords: depression qigong neurophysiology functional near infra-red spectroscopy fnirs executive function attention
parent telehealth intervention for children with autism

Conditions: Autism Spectrum Disorder; Autism

Summary: as a result of the covid-19 pandemic, telecoaching/telepractice models are of urgent importance. given this, parents in the study will receive parent coaching through weekly video calls. to help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. this information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.


Eligibility criteria:
inclusion criteria: child inclusion criteria include: * diagnosis of asd or showing signs of asd based on autism screening * chronological age of less than 48 months * a parent who is willing to learn intervention strategies * english as the primary language spoken in the home parent inclusion criteria include: - biological mother exclusion criteria: * children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study. * fathers or caregivers other than the child's mother will be excluded from the study.

Keywords: autism parent intervention parent coaching early intervention parent-mediated intervention