Kornimate/medical-research-clean huggingface dataset:
preemptive treatment with grazoprevir and elbasvir for donor hcv positive to recipient hcv negative kidney transplant

Conditions: Renal Failure

Summary: proof of concept, open-label single center study for the donation of hcv positive kidneys to hcv negative patients, with preemptive, interventional treatment to prevent hcv transmission upon transplantation.

the study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of hcv infection from a donor kidney with known hcv genotype 1 or 4 infection to a hcv negative recipient as evidenced by a negative hcv viral rna at 12 weeks post treatment

Eligibility criteria:
inclusion criteria: 1. must meet massachusetts general hospital (mgh) transplant center criteria and already be listed for isolated kidney transplant 2. no available living kidney donor 3. has ≤ 730 days (two years) of accrued transplant waiting time if blood type a and ≤ 1095 days of accrued transplant waiting time if blood type b or o. 4. on chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \<15ml/min/1.73m2 at the time of screening 5. weight ≥ 50kg 6. serum alanine transaminase (alt) within normal limits exclusion criteria: 1. ab blood type 2. body mass index (bmi \> 35 3. history of liver disease 4. pregnant or nursing (lactating) women 5. cardiomyopathy (lv ejection fraction \< 50%) 6. positive crossmatch or positive donor specific antibodies 7. human immunodeficiency virus (hiv) positive 8. hepatitis c virus (hcv) rna positive 9. hepatitis b virus (hbv) surface antigen positive 10. any contraindication to kidney transplant per mgh center protocol

Keywords: hemodialysis peritoneal dialysis renal failure kidney transplant
safety and efficacy in long term use of lyrica (regulatory post marketing commitment plan)

Conditions: Neuropathic Pain

Summary: the objective of this investigation is to evaluate the safety and efficacy of long term use with lyrica in medical practice. also, occurrence of unknown and known adverse drug reactions (adrs) in subjects treated with lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

patients who fulfill criteria below: 1. patients who have previously enrolled in a0081261. 2. patients who have been administered lyrica for more than 52 weeks.

Eligibility criteria:
inclusion criteria: * patients need to be administered by lyrica for over 52 weeks in order to be enrolled in the surveillance. exclusion criteria: * patients not administered lyrica.

Keywords: lyrica regulatory post marketing commitment plan safety neuropathic pain post marketing surveillance
diabetes medication choice

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Eligibility criteria:
* have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required * use 1 or 2 oral hypoglycemic agents; not using insulin therapy * are not pregnant * have stable but inadequate glycemic control: both a1c at the time of eligibility and previous a1c within 6 months between 7-9.5% * recognize their primary care provider as their main diabetes care provider * do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in english) to participate in shared decision-making (per provider?s assessment) * have no plans to relocate out of town in the next 6 months * enrolment is open to males and females of diverse racial backgrounds

Keywords: decision aid, diabetes, primary care
vibroacoustic study of lung development in newborn infants

Conditions: Prematurity; Premature Birth; Premature Lungs; Prematurity; Extreme

Summary: investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes. investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable ai algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination.

worldwide preterm birth (\<37 weeks of gestation) affects approximately 10% of live births and is the leading cause of death in children less than 5 years of age. preterm birth disrupts normal lung development leading to several respiratory complications in the neonatal period and later in life. consequently, factors that negatively affect prenatal and early life respiratory growth can compromise the achievement of "personal-best lung function". this novel study will generate normative, audible/inaudible frequencies, visible/invisible frequencies, and perceptible/imperceptible energies, termed vibrome biosignatures, of cardiopulmonary development and function during early postnatal development. once baseline patterns are established, future studies will be designed to characterize vibrome biosignature differences across acute neonatal respiratory problems, such as respiratory distress syndrome, meconium aspiration, sepsis, persistent pulmonary hypertension, and congenital heart disease.

Eligibility criteria:
inclusion criteria: * eligible participants include all infants admitted to the nicu. exclusion criteria: * there are no exclusions to enrollment in this study.

Keywords: infrasound vibrome vibroacoustics
surgical complications related to primary or interval debulking in ovarian neoplasm

Conditions: Stage IIIC Ovarian Cancer

Summary: patients with advanced ovarian cancer (figo stage iii c) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (ids). the primary end point is the evaluation and comparison of the surgical complications of primary surgery and ids and the evaluation of the progression free survival (pfs)


Eligibility criteria:
inclusion criteria: * patients with suspected advanced ovarian cancer (figo stage iiic) * piv ≥ 8, piv ≤ 12 * estimated life expectancy of at least 4 weeks. * ps ≤ 2 * appropriate respiratory, hepatic, cardiological, bone marrow and renal functions (creatinine clearance \> 60 ml/min according to cockcroft formula) * patient capable of consent. exclusion criteria: * pregnancy or breastfeeding. * non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions * large size mass reaching the xiphoid, occupying all the abdominal cavity and/or infiltrating the abdominal wall. * mesenteric retraction
individualized nutritional risk and oriented nutritional support

Conditions: Malnutrition

Summary: the objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.

patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the departmental simple operating unit admission room of the policlinico universitario a. gemelli and who have undergone nrs-2002 screening. data only of patients with nrs-2002 \> 3 admitted will be considered and extracted via the foundation's computer system (trackcare). patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. therefore, the study will not change current clinical practice. two cohorts will be formed and compared: cohort 1: patients at risk of malnutrition (nrs-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission. cohort 2: patients at risk of malnutrition (nrs-2002 ≥ 3) who did not receive clinical nutrition counseling beyond 72 hours after ward admission. currently, at fondazione policlinico universitario a. gemelli, the clinical nutrition unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in clinical nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. the formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. in a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (nrs-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. the enrollment department is the same for all patients.

Eligibility criteria:
inclusion criteria: * age \>18 years * nrs-2002 ≥3 * length of stay \> 4 days * informed consent to participate in the study exclusion criteria: * nrs-2002 \<3 * length of stay \< or = 4 days * absence of informed consent
effects of anesthesia on immunity in cancer

Conditions: Surgery; Renal Cancer

Summary: the aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.

the severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. a series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. it is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. the aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.

Eligibility criteria:
inclusion criteria: * surgery for renal cancer * signed informed concent exclusion criteria: * propofol or sevoflurane intolerance * contraindications for epidural anesthesia * renal failure * hepatic failure * congestive heart failure * previous hemotherapy * hematological diseases
effect of myofascial release technique with ultrasound therapy in adults with nonspecific low back pain.

Conditions: Low Back Pain

Summary: low back pain is common problem the purpose of this research will be to determine the comparison of ultrasound therapy and myofascial release technique for treatment of low back pain in adults.

low back pain is common problem the purpose of this research will be to determine the comparison of ultrasound therapy and myofascial release technique for treatment of low back pain in adults. to increase lumbar spine range of motion chest wall mobility and flexibility, reduction in level of lumbar disability

Eligibility criteria:
inclusion criteria: * both male and female * between age of 18 and 60 reported with chronic low back pain (lasting more than 3 months) exclusion criteria: * unresponsive psychologically disturbed patient * people under 18 * following coexisting conditions cancer, diabetes, pregnancy, cardiovascular system, gynecological disease. * neurological conditions, spine injury contraindicated to mfr treatment (infectious disease, viral and bacterial infections, active malignant disease, aneurysm * arthrodesis
analgesic effect of intra-articular dexamethasone and dexamethasone added to bupivacaine in interscalene brachial plexus

Conditions: Postoperative Pain

Summary: the aim of this study was to investigate the analgesic efficacy of intra articular dexamethasone administration for arthroscopic shoulder surgery.

shoulder surgery can be very painful and interscalene brachial plexus block is the gold standard in the management of acute pain after shoulder surgery. various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexamethasone are frequently used for this purpose. dexamethasone has also been found the prolong the duration of lidocaine axillary blocks and intravenous regional anaesthesia. intraarticular administration of medicines can be used for management of joint pain and opioids , local anaesthetics and dexamethasone are used for this purpose.in addition, there are no studies available to compare the different treatment methods used in clinical practice directly.

Eligibility criteria:
inclusion criteria: * between 18-65 years * arthroscopic shoulder surgery * no known allergies to drugs * asa 1-2 patients exclusion criteria: * history of diabetes * history of chronic pain treatment * pregnancy * severe bronchopulmonary disease * systemic glucocorticoid use

Keywords: dexamethasone intraarticular injection interscalene brachial plexus block
prediction of outcome of non invasive ventilation copd patients by assessment of diaphragmatic performance

Conditions: Acute Exacerbation COPD

Summary: transthoracic ultrasonographic assessment of the diaphragmatic performance as a predictor for the outcome of niv in critically ill copd patients with acute exacerbation.

chronic obstructive pulmonary disease (copd) is considered a common disease worldwide, and it poses a major health and economic problem. copd was the fifth leading cause for death in 2022 and will rank third by 2030. so, it's considered a devastating disease for patients and their loved ones . patients presented with acute exacerbations of copd may need respiratory intensive care unit (ricu) admission. non invasive ventilation (niv) is considered a cornerstone management option in patients with acute exacerbation of copd (aecopd). therefore, early prediction of niv failure may help in decision making regarding escalation to invasive mechanical ventilation to date, the diaphragm is the main respiratory muscle, and derangement of it's function is an important factor in the pathophysiology of copd copd patients have increased airway resistance and airflow limitation, which in turn increases the mechanical load of breathing exerted on the diaphragm diaphragmatic weakness in copd patients results from decreased muscle strength and mobility . although, diaphragmatic performance is a key determinant of dyspnea in copd patients, it is rarely assessed in clinical practice in practice, only vital sign such as respiratory rate and arterial blood gases parameters (abg) such as ph, pao2, paco2, spo2, and fio2/pao2 are considered predictors of niv outcome. assessment of diaphragmatic function transthoracic ultrasound (tus) is a reliable, safe and bed side method for prediction of niv outcome . several tools commonly applied to determine diaphragmatic function such as; fluoroscopy, computed tomography (ct), transdiaphragmatic pressure measurement, phrenic nerve stimulation, and electromyography can't be routinely used in intensive care units due to technical challenges and limitations

Eligibility criteria:
inclusion criteria: * one hundred fifty five critically ill copd patients admitted to respiratory intensive care unit * diagnosis of copd and copd exacerbation is fulfilled according to gold 2022 criteria * age\>40years exclusion criteria: * age ˂ 40 years. * refusal to participate in the study. * patients with morbid obesity (bmi\>40). * absolute indication for intubation like coma ,hemodynamic instability, or life threatening arrhythmia. * contraindication to niv like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy, or active upper gastrointestinal bleeding.
a cohort study of incretin-based therapy combined with insulin in type 2 diabetic patients for 5 years

Conditions: Type 2 Diabetes Mellitus

Summary: the use of dipeptidyl-peptidase 4 (dpp-4) inhibitors and glucagon like peptide 1 (glp1) analogues for the treatment of diabetic mellitus (dm) type 2 is growing (1,2). currently, some of these agents have been approved in combination with insulin. the potential for combined use with insulin has garnered increasing attention due to reduce side effects associated with insulin therapy and improve glycemic control. some investigators reported that glp-1 analogue combined with insulin reduces hba1c and weight with low risk of hypoglycemia and high treatment satisfaction (3). however, their duration of treatment was short time with less than a mean of 3.0 years and the alterations of chronic diabetic complications by combination with incretin-based and insulin therapies are not known. we evaluated the long effects of adding incretin-based therapy (dpp-4 inhibitors or glp-1 analogues) to insulin therapy on glycated hemoglobin (hba1c) as glycemic control, body mass index (bmi), blood pressure (bp), insulin dosage, frequency of hypoglycemia, and chronic diabetic complications for 5 years-treatments.

patients were treated with diet, exercise, and/or oral conventional pharmacotherapy combined with insulin. oral conventional pharmacotherapy consisted of α-glycosidase inhibitors (α-gi), sulfonylurea (su), biguanide (bg), thiazolidinedione (tzd), or combinations of these agents. insulin therapy consisted of subcutaneous injections of long-acting insulin analogues prior to sleep and bolus subcutaneous injections of rapid-acting insulin analogues in multiple daily injections, or subcutaneous injections of mixed insulin analogues twice a day. in spite of the treatments, when the physician in charge judged that their values of hba1c were inappropriate, the physician added the pharmacotherapy combined the insulin to incretin-based therapy. 2.3.2. for ethical reasons, patients were treated with various anti-hypertensive, anti-diabetic, anti-dyslipidemia and/or anti-hypercoagulation agents during the course of the study by the patients' own doctors as a part of continuing standard medical care. as to the drugs that have been used for the treatment of other disorders and its complication since the time before the study, the content should not be changed during the study in principle unless the complication is cured. if any new complication occurs during the study period, an appropriate treatment is given by the judgment of investigator.

Eligibility criteria:
inclusion criteria: after a detailed baseline examination, 500 japanese subjects with type 2 diabetes were followed up for all-cause mortality and morbidity. all participants visited our clinic regularly. all patients were fully informed about the purposes and procedures for the study and provided oral consent at enrolment. exclusion criteria: patients participating in other clinical study. other than the above, patients judged inappropriate as the subjects of this study by the investigator.
study of tenofovir alafenamide (taf) in children and teen participants with chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: the goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (taf), versus placebo in teens and children with chb and to learn more about the dosing levels in children.


Eligibility criteria:
key inclusion criteria: * males and non-pregnant, non-lactating females * weight at screening as follows: * cohort 1 = ≥ 35 kg (≥ 77 lbs) * cohort 2 group 1 = ≥ 25 kg (≥ 55 lbs) * cohort 2 group 2 = ≥ 14 kg to \< 25 kg (≥ 30 lbs to \<55 lbs) * cohort 2 group 3 = ≥ 10 kg to \< 14 kg (≥ 22 lbs to \< 30 lbs) or * 14 kg to \< 25 kg (≥ 30 lbs to \< 55 lbs) * willing and able to provide written informed consent/assent (child and parent/legal guardian) * documented evidence of chb (eg, hbsag-positive for ≥ 6 months) * hbeag-positive, or hbeag-negative, chronic hbv infection with all of the following: * screening hbv dna ≥ 2 × 10\^4 iu/ml * screening serum alt \> 45 u/l (\> 1.5 × uln: 30 u/l) and ≤ 10 × uln (by central laboratory range) * treatment-naive or treatment-experienced will be eligible for enrollment. * estimated creatinine clearance (clcr) ≥ 80 ml/min/1.73m\^2 (using the schwartz formula) * normal ecg key exclusion criteria: * females who are pregnant or breastfeeding * males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study. * coinfection with hepatitis c virus (hcv), hiv, or hepatitis d virus (hdv) * evidence of hepatocellular carcinoma (note: if screening alpha-fetoprotein (afp) is \ 50 ng/ml an imaging study is required) * any history of, or current evidence of, clinical hepatic decompensation * abnormal hematological and biochemical parameters * chronic liver disease of non-hbv etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis) * received solid organ or bone marrow transplant * currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants * significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator * malignancy within the 5 years prior to screening. individuals under evaluation for possible malignancy are not eligible. * current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: chb hbv
plant stanol esters and influenza vaccination

Conditions: Immune Response

Summary: plant stanols are known to lower low-density lipoprotein cholesterol (ldl-c). however, recent studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. bmi and age have previously been negatively associated to vaccination responses. if plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination.


Eligibility criteria:
inclusion criteria: * men and women * aged 60 years or older (or 59, but turning 60 years during influenza season 2022/2023 (in line with rivm guidelines)) * bmi between 20 and 35 kg/m2 * currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of becel proactiv, benecol, danacol, store brands) * willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of becel proactiv, benecol, danacol, store brands) * willing to keep the intake of fish oil and vitamin supplements constant exclusion criteria: * already received influenza vaccination in 2022 * already had influenza in 2022 * allergy to an ingredient of the chews * having donated blood within one month prior to the start of the study, or planning to donate blood during the study * excessive alcohol use (\>20 consumptions per week) * regular use of soft and/or hard drugs

Keywords: plant stanols immune system influenza vaccination
non-interventional study on compliance of inhaled treatment with ventavis in patient with pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: local, prospective, multicenter, non-comparative, non-interventional, observational study. it is planed to assess compliance of patients with ph (pulmonary hypertension) with the physician's recommendation in real practice.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years old * diagnosis of ph * planned or current treatment with ventavis (not more than 6 month) exclusion criteria: * contraindications for the use of ventavis in accordance with the local product information

Keywords: non-interventional ventavis iloprost pulmonary hypertension compliance russian federation