Kornimate/medical-research-clean huggingface dataset:
phase 3 study of anifrolumab in adult patients with active proliferative lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this study is to evaluate the efficacy and safety of iv antifrolumab in adult patients with active proliferative lupus nephritis

this is a phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to soc (consisting of mmf and glucocorticoids) in adults with active proliferative class iii or class iv ln (both with or without concomitant class v). the total study duration may be up to approximately 116 weeks, including the screening and follow-up. approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the treatment period.

Eligibility criteria:
inclusion criteria: 1. active proliferative ln class iii or iv either with or without the presence of class v according to the 2003 isn/rps classification 2. renal biopsy obtained within 6 months prior to signing the icf or during screening period. 3. urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol) 4. egfr ≥ 35 ml/min/1.73 m2 (as calculated by the chronic kidney disease epidemiology collaboration formula). 5. fulfills updated 2019 eular/acr sle classification criteria. 6. no signs of symptoms of active tb prior to or during screening or no treatment for latent tb exclusion criteria: 1. a diagnosis of pure class v ln based on the renal biopsy obtained within 6 months prior to signing the icf or during screening. 2. known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for hiv confirmed by the central lab at screening - an hiv test must be performed during screening, and the result should be available prior to week 0 (day 1). 3. evidence of hepatitis c or active hepatitis b. 4. any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ. 5. receipt of the following for the current ln flare (ie, since the qualifying renal biopsy): iv cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or average mmf \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or tacrolimus \> 4 mg/day for more than 8 weeks; cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the icf; voclosporin for more than 8 weeks or during last 8 weeks prior to signing the icf; belimumab for more than 12 weeks or during last 12 weeks prior the icf. 6. previous receipt of \>◦2 investigation treatments (other than anifrolumab) for ln or sle since time of diagnosis and through the icf. 7. known intolerance to ≤ 1.0 g/day of mmf. 8. any history of severe covid-19 infection.

Keywords: lupus nephritis, anifrolumab, systemic lupus erythematosus, intravenous
quadratus lumborum block versus transversus abdominis block

Conditions: Postoperative Pain

Summary: the advent of laparotomy replacement by minimally invasive techniques brought the obvious benefit of postoperative pain reduction. the application of transversus abdominis block has already demonstrated to reduce postoperative pain in laparoscopic hysterectomy. the comparison between it and quadratus lumborum block in cesarean sections showed that the latter was superior in relation to postoperative analgesia. the aim of this trial is to compare postoperative analgesia in patients receiving one or the other of these regional anesthesia techniques to prevent postoperative pain in gynecological laparoscopic surgeries. the recruited sample will be randomly distributed in three groups to receive placebo, transverse abdominal plan block or quadratus lumborum block, in a covert way for the patients and team. the primary outcome evaluated will be the postoperative consumption of opioid and the secondary outcome will be the evaluation of postoperative pain scores.

: the sample will be divided into three groups and all participants will receive general anesthesia. patients in the placebo group (pg) will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery. patients in the tap block group (tbg) will receive 0.2 ml of 0.25% ropivacaine between the transverse and oblique internal muscles guided by ultrasound (us), on one side and after the other (the same dose), after the end of surgery. patients in the quadratus lumborum group (lqg) will receive 0.2 ml/kg of 0.25% ropivacaine inside the middle layer of the thoracolumbar fascia guided by us, on one side and after the other (the same dose), after the end of the surgery. in all participants, the monitoring will include cardioscope, oximetry, non-invasive blood pressure and monitor of hypnoses level. after peripheral venous puncture, antibiotic prophylaxis with 2g cefazolin, and pre-anesthetic medication with midazolam 0.05 mg/kg. after 5 min pre-oxygenation, the patients will receive venous anesthetic induction with 2% lidocaine 1mg/kg without vasoconstrictor; fentanyl 4 µ/kg; propofol 2 mg/kg, or even adequate hypnosis guided by proper monitor; cisatracurium 0.15mg/kg, with tracheal intubation and mechanical ventilation after anesthetic plan confirmed with proper monitor and adequate muscle relaxation. anesthesia will be maintained with propofol in continuous infusion guided by hypnoses monitor and remifentanil in continuous infusion between 0.1 and 0.5 µg/kg/min, according to patient need. all study participants will receive ondansetron 8 mg, dipyrone 2 g, ketoprofen 100 mg, dexamethasone 10 mg and morphine 3 mg. at the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation.

Eligibility criteria:
inclusion criteria: * scheduled to gynecological video laparoscopy. exclusion criteria: * allergy to any component of the study protocol, coagulopathies.
study of the safety of substituting exenatide for insulin in patients using insulin and oral antidiabetic agents

Conditions: Type 2 Diabetes Mellitus

Summary: this study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

this is an exploratory, multicenter, open-label, 2-arm, parallel trial. approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. all patients will continue their current diet and exercise regimen during the study.

Eligibility criteria:
inclusion criteria: * patients have been treated with insulin for \>=3 months up to 12 years. * hba1c \<=10.5%. * body mass index (bmi) between 27 kg/m2 and 40 kg/m2. exclusion criteria: * patients previously received exenatide or glp-1 analogs. * patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

Keywords: exenatide exendin-4 amylin eli lilly diabetes
a study of sss17 in healthy subjects

Conditions: Anemia in Chronic Kidney Diseases

Summary: this is a first-in-human, phase 1, single-center, randomized, single-blind, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, pk, pd of sss17 following oral administration in healthy subjects. approximately 65 subjects (53 receiving active drug and 12 receiving placebo) will participate in this study.

the study will enroll healthy volunteers from a single academic medical center in china. all participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures. the improved fibonacci dose escalation design will be implemented. the protocol specifies 10 mg, oral, one time for the first cohort without placebo control. successive cohorts will be given doses up to 540 mg with placebo parallel control. only no observation meets the criteria under stop rules, dose will escalate to the next higher level. the study will be divided into 2 stages: 1st period (fast) and 2nd period(fed). first period (fast): subjects will be allocated 1:4 to receive placebo or sss17, which will be administered by oral route. at each dose, tolerability, safety, pk and pd characteristics will be investigated. second period (fed): in order to investigate the effects of food on pk and pd of sss17. subjects in one cohort will be administered again after meal on day15. the accurate dose will be adjusted according to the findings in 1st period (fast)

Eligibility criteria:
inclusion criteria: * body weight≥50 for male or ≥45 for female, and bmi between 19.0-26.0 kg/m2 * good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ecg, clinical laboratory tests and b-type ultrasound test. * participants of reproductive potential must agree to utilize reliable methods of contraception from screening to 6 months after the last administration of the study intervention. no plan for sperm (or egg) donation or pregnancy. * understand and sign the informed consent. * ability to understand and follow study-related instruction exclusion criteria: * a known allergy to any component of the sss17 formulation, or allergy history of two kinds of drugs or food * medical history or conditions of digestive system. * female volunteers who are pregnant, menstrual, lactating or menopause with hormone therapy. * eyes diseases, including diabetic retinopathy, age-related macular degeneration. * vascular anomalies. * drug, alcohol or nicotine addiction. * blood donation or bleeding (more than 200 ml). experience of treatment with epo or blood transfusion. * any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ecg) deviating from normal and deemed by the investigator to be of clinical relevance * abnormal results in test of tibc, serum iron or ferritin * acute diseases before administration. * other situations that the researcher believes may affect validity judgment or are not suitable for participation
the impact of surgical treatment of endometriomas on ovarian reserve

Conditions: Endometriosis

Summary: the aim of this study is to assess which of two commonly used surgical procedures in the treatment of ovarian cysts called endometriomas (cutting out of the cyst - "cystectomy", or draining it and cauterising it's inner lining - "ablation") causes the least damage to the ovary and is therefore best at maintaining the future fertility potential of a patient.


Eligibility criteria:
inclusion criteria: * women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter exclusion criteria: * patients who have received oestrogen suppressing drugs (e.g. oral contraceptive pills, gnrha) during the previous six months * patients who have previously undergone surgical treatment of endometriomas * patients with bilateral endometriomas * patients with endometriomas of less than 3cm in size or more than 8cm in size * pre-surgical evidence of reduced ovarian reserve * pregnant patients * patients unable to give informed consent e.g. patients with mental incapacity

Keywords: ovarian endometriomas laparoscopy cystectomy ablation
adjunctive use of a novel hyaluronic acid/chlorhexidine gel in the non surgical treatment of periodontitis

Conditions: Periodontitis; Hyaluronic Acid; Chlorhexidine

Summary: general objective : to evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning specific objective : to determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .


Eligibility criteria:
inclusion criteria: * age : 20-60 years old * at least 20 remaining teeth * periodontitis stage iii and iv ,grade a, b and c exclusion criteria: * patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory * previous periodontal therapy in the past 3-6 months. * immunocompromised patients * systemically diseased patients: diabetes ,osteoporosis etc * history of allergies or hypersensitivity reactions to chlorohexidine or hyaluronic acid * pregnant or lactating women. * heavy smokers (more than 20/day)
the effects of acupuncture for major trauma

Conditions: Major Trauma

Summary: major trauma is a significant cause for morbidity and mortality in the world. after traumatic injury, the damage tissue could induce systemic inflammatory response (sirs) and activate autonomic nervous system in response to stress, followed by compensatory anti-inflammatory response (cars). imbalance of sirs and cars may lead to organ failures, sepsis and death.

the investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.

Eligibility criteria:
inclusion criteria: * male or female aged 20 years or older * confirmed diagnosis of major trauma with iss ≥ 16 exclusion criteria: * pregnancy * malignancy * pacemaker * status epilepticus * severe medical disease * life threatening * prior history of drug or alcohol dependence * immunodeficiency * vagotomy

Keywords: major trauma acupuncture laser acupuncture
evaluating "health at every size"(haes) as an alternative obesity treatment model

Conditions: Hypercholesterolemia; Hypertension; Depression; Diabetes Mellitus, Type 2

Summary: increasingly more individuals are trying to lose weight. indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. there is little data to show improved long term success for the majority of participants who engage in weight loss behaviors. the specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging "health at every size" (haes). this treatment model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). the haes model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.


Eligibility criteria:
* caucasian; * female; * age 30-45 years; * body mass index (bmi)\>30 m/kg2; * non-smoker; * not pregnant or lactating; * restraint scale (herman and polivy, 1988) score \>15, indicating a history of chronic dieting; * no recent myocardial infarction; * no active neoplasms, type 1 diabetes or insulin-dependent type 2 diabetes, nor history of cerebrovascular or renal disease.

Keywords: type 2 diabetes self-esteem
inter-day reliability of the oral glucose tolerance test using indirect calorimetry

Conditions: Glucose Intolerance

Summary: the main aim of this study is to determine the inter-day reliability, by using indirect calorimetry, of the post-prandial macronutrient oxidation and energy expenditure after consuming oral glucose load solution.

the maintenance of blood glucose concentrations and the oxidation of carbohydrate after consuming carbohydrate is related with a low risk of mortality and morbidity from cardiometabolic diseases. the oral glucose tolerance test is a diagnostic test widely used in the clinical field. however, its inter-day reliability has not been deeply studied. therefore, it is of clinical interest to study the inter-day reliability of the diagnostic test oral glucose tolerance test using indirect calorimetry and monitoring the response of the glucose levels. 20 young adults will undergo two trials visit with 7 days of separation between conditions. each evaluation day will conform to the following tests: 1. basal metabolic rate assessment through indirect calorimetry. 2. basal heart rate variability through heart rate monitor. 3. intake of the corresponding glucose load solution. 4. postprandial nutrient oxidation and energy expenditure assessment through indirect calorimetry 5. glucose monitoring through glucose meter.

Eligibility criteria:
inclusion criteria: * healthy male or female * ages 18-30 years * bmi: 18-27.5 kg/m2 * stable weight over the last 3 months (body weight changes\<35kg) * participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols. exclusion criteria: * history of cardiovascular disease * diabetes or hypertension * pregnant, planning to become pregnant, or breastfeeding * have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results. * any non-controlled medical condition which could influence results or could be worsened by the participation in the study. * claustrophobia * needle phobia * are deemed unsuitable by the investigator for any other reason, that prevent data collection.
counterfactual thinking and decision-making in osa syndrome

Conditions: Obstructive Sleep Apnea

Summary: the aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals with obstructive sleep apnea syndrome when compared with healthy individuals


Eligibility criteria:
inclusion criteria: - diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment. exclusion criteria: - concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders

Keywords: counterfactual thinking decision-making neuropsychological assessment clinical setting
arthritis foundation exercise program & "10 keys" to healthy aging--prevention research center

Conditions: Arthritis; Diabetes; Hypertension; Preventive Behaviors

Summary: older adults are at high risk for loss of independence because of age-related chronic health conditions. of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community. the investigators propose to target older adults who have self-reported arthritis or joint pain for dissemination of a disability prevention program. the program will be a collaborative effort of the arthritis foundation, the investigators prevention research center staff and other key partners in the community. the project will develop information needed to provide guidance for implementation of the investigators intervention by other agencies and organizations. as a major thrust of the investigators cdc prevention research center, the investigators have developed a comprehensive program focused on preventing disease and disability in older adults: the "10 keys to healthy aging". each of the 10 keys disseminates proven approaches and current recommendations for prevention in older adults, focusing on age 65+ but also addressing age 50-65 years. the overall objective is to determine if an integrated evidence based exercise intervention (afep) combined with health education on preventive practices for older adults ("10 keys") is more effective for improving mobility and risk factors for mobility disability and use of preventive services compared to exercise alone (afep). the investigators will also propose to evaluate the impact of geographic location on outcomes and overall sustainability of the program.


Eligibility criteria:
inclusion criteria: * 50+ years old * attends at last one exercise class in a 10 week program exclusion criteria: * on oxygen * hospitalized for cardiac event in past 6 months (at least 1 overnight) * had major surgery in past 6 months

Keywords: arthritis preventive behaviors
analgesia for positioning hip fracture patients for spinal anesthesia

Conditions: Hip Fracture

Summary: the purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.


Eligibility criteria:
inclusion criteria: * hip fracture exclusion criteria: * contraindications for central nervous blockade * impaired cognition or dementia * multiple fractures * any previous analgesic administration during the last 12 hours
a study of alks 5461 for the treatment of major depressive disorder (mdd) - the forward-4 study

Conditions: Major Depressive Disorder

Summary: this study will evaluate the efficacy and safety of alks 5461.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of 18.0 to 40.0 kg/m2, inclusive * agree to use an acceptable method of contraception for the duration of the study * have a major depressive disorder (mdd) primary diagnosis * have no more than 2 inadequate responses to antidepressant therapy (adt) in the current major depressive episode (mde) * additional criteria may apply exclusion criteria: * have a current primary axis-i disorder other than mdd * have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime * have attempted suicide within the past 2 years * have a positive test for drugs of abuse * are pregnant, planning to become pregnant, or breastfeeding * have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * have had a significant blood loss or blood donation within 60 days * additional criteria may apply

Keywords: major depressive disorder depression alkermes alks 5461 samidorphan
magnetic resonance fingerprinting for preoperative evaluation of lymphovascular space invasion in early stage cervical cancer

Conditions: Cervical Cancer

Summary: the aim of this observational prospective study is to investigate the role of magnetic resonance fingerprinting in preoperative assessment of early cervical cancer


Eligibility criteria:
inclusion criteria: * patients with biopsy-proven cervical cancer figo stage ia-iia undergoing surgery; * women aged \>18 years old; * signed informed consent. exclusion criteria: * concurrent malignancies at other sites; * previous history of neoplasm; * refusal to sign written informed consent