Kornimate/medical-research-clean huggingface dataset:
conversion to sirolimus: effects in cytomegalovirus infection recurrence

Conditions: Cytomegalovirus Infections

Summary: cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence. namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence. given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.

this protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.

Eligibility criteria:
inclusion criteria: * adult kidney transplant recipients \> 18 y.o. * kidney transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone. exclusion criteria: * re-transplant; * patients with any panel reactive antibody (pra) equal to or above 50%, class i or class ii; * acute rejection episode in the last 30 days, or episode \> 2a in the banff criteria; * gfr (mdrd) \< 40 ml/min; * proteinuria \> 0,5 g/l; * hemoglobin \< 10 g/l and/or leucocytes \< 4000 cels/mm3 and/or platelets \< 150.000 cels/mm3; * triglycerides \> 500 mg/dl with or without use of fibrate; * cholesterol total \> 300 mg/dl with or without use of statin; * hepatic abnormalities; * significant periphery edema; * pulmonary abnormalities or breast x-ray abnormalities; * hyper sensibility to sirolimus formula;

Keywords: cytomegalovirus sirolimus cytomegalovirus recurrence kidney transplant conversion
comprehensive care program for their return to normal life among lung cancer survivors

Conditions: Lung Cancer; Lung Neoplasm

Summary: the purpose of this study is to develop a comprehensive care program for their return to normal life and community among lung cancer survivors and evaluate the effectiveness of the program.

lung cancer patients scheduled for curative surgery will be enrolled in this study. the comprehensive care program will be developed, and provided to the intervention group before and after surgery. outcomes will be assessed 6 months and 1 year after surgery. to evaluate the effectiveness of the program, a control group will be enrolled first and used as a comparator.

Eligibility criteria:
inclusion criteria: * patients diagnosed with non-small cell lung cancer(nsclc) and scheduled for curative resection. * nsclc with clinical stage ⅰ-ⅲ * patients who understood the study and gave written informed consent. exclusion criteria: * recurred lung cancer * patients with extra-pulmonary synchronous double primary cancer. * patients with history of other cancer diagnosis or treatment in the last 3 years. drop criteria: * when surgery was canceled or pathologic stage iv was confirmed after surgery. * when the tumor was not found to be non-small cell lung cancer, including benign tumor, after surgery * withdrawal informed consent.

Keywords: lung cancer survivorship quality of life
optimal dosing of preoperative gabapentin for prevention of postoperative nausea and vomiting

Conditions: Nausea, Postoperative; Vomiting, Postoperative; Pain, Postoperative

Summary: overall incidence of postoperative nausea and vomiting (ponv) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. interestingly, gabapentin has also been noted to reduce the effects of chemotherapy-induced nausea, effective in treatment of gravidarum hyperemesis, and postdural puncture emesis. different dosing regimens were tested.the goal of the study is to determine the most effective dose of oral gabapentin given 1 hour prior to surgery on the occurrence and severity of ponv and drug side effects in the first 24 hours postoperatively to find the most effective dose of gabapentin with the least side effects.

a total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. written informed consent will be obtained from all patients before randomization. randomization will be done with the help of a computer generated list of numbers. patients will be divided randomly and equally into three groups (50 patients each(. the first group of patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group g1), the second group of patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group g2), the third group of patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group g3). drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed

Eligibility criteria:
inclusion criteria: * age between (18- 65) years * asa i-ii * scheduled for elective laparoscopic abdominal surgery. exclusion criteria: * age below 18 and above 60 years * asa iii- iv * pregnancy or breastfeeding * psychiatric illness * administration of antiemetic or systemic corticosteroids within 24 hours prior to surgery * vomiting within 24 hours prior to surgery * alcohol or drug abuse; * known hypersensitivity or contraindications to gabapentin * impaired liver or kidney function * history of motion sickness * patients on anti-depressants * patients on whom laparoscopic procedure converted into open technique.

Keywords: gabapentin postoperative nausea and vomiting laparoscopic surgeries visual analogue scale
study for the clinical roadmap and prognosis of pulmonary artery sarcoma.

Conditions: Pulmonary Artery Sarcoma

Summary: this is an observational study in which patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

this is an observational study covering mainland china, and patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

Eligibility criteria:
inclusion criteria: * computed tomography pulmonary angiography indicated that there were intraluminal defects * malignant histopathology was sarcoma * informed consent form was signed exclusion criteria: * life expectancy was less than 3 months due to diseases other than pulmonary artery sarcoma * expected inability to complete follow-up
a study of an investigational medication for severe primary hyperparathyroidism or parathyroid cancer

Conditions: Hyperparathyroidism; Parathyroid Neoplasms

Summary: this study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.


Eligibility criteria:
* patients must have parathyroid carcinoma or severe primary hyperparathyroidism; \* abnormally elevated calcium levels above 12.5 mg/dl; \* not be pregnant or nursing; \* not have had any type of cancer other than parathyroid carcinoma within the last 5 years.

Keywords: severe primary hyperparathyroidism parathyroid carcinoma
lung and breast cancer prevention by an integrated intervention of maternal smoking cessation and breastfeeding

Conditions: Smoking, Cigarette; Breastfeeding

Summary: this pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. the investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

the investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. the investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. they will be randomized into either the intervention (n=20) or control group (n=20). the two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. specifically, the control group will receive instructions on general pregnancy and infant care. the intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). two female certified lactation counselors (interventionists) will be trained to run study sessions during home visits. interventionists will provide additional support via phone and text messaging until 6 months postpartum. main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.

Eligibility criteria:
inclusion criteria: * be 18 years or older * at ≤28 weeks of pregnancy * daily smoking cigarettes and/or cigars in the past 7 days * be able to read, listen, and talk in english exclusion criteria: * being diagnosed with cancer * current heavy drinking (more than 2 drinks a day) * current use of illicit substances * medical conditions contraindicating breastfeeding such as hiv infection, active tuberculosis, and breast removal

Keywords: pregnancy postpartum smoking abstinence breastfeeding intention breastfeeding duration
does non-steroidal anti-inflammatory drugs decrease the quality of pleurodesis after mechanical pleural abrasion/pleurectomy for treatment of pneumothorax?

Conditions: Primary and Secondary Spontaneous Pneumothorax

Summary: investigators aim to assess if nsaids affect the quality of pleurodesis resulting from mechanical pleurodesis (open surgery or vats) regarding : primary outcome: recurrence of pneumothorax in 6 monthes. (assessed by x ray after 2 weeks and 6 months or symptoms requiring x ray at any timing) secondary outcome: ▪ adjusted length of stay ( from day zero surgery day to discharge ). ▪ time of removal of the chest tube .(relatively longer with air leak presence). ▪ need of opioids (n-said may decrease the need of opioids) .

pneumothorax is a relatively common clinical problem which can occur in individuals of any age. irrespective of aetiology (primary, or secondary to lung disorders or injury), immediate management depends on the extent of cardiorespiratory impairment, degree of symptoms and size of pneumothorax.non-steroidal anti-inflammatory drugs (nsaids) are being used with increasing frequency, due to their potent analgesic effects without having side-effects on the central neural system and additionally due to the large number and varieties of these agents. the analgesic, antiinflammatory properties, and efficacy of nsaids in a wide variety of diseases have been already established . wound healing and formation of adhesions involve inflammation, cell proliferation, matrix deposition, and neovascularization. the exact mechanism by which nsaids affect collagen deposition and the time course of the events leading to the formation of fibrin and of adhesions after pleurodesis have not been completely elucidated until now. nsaids can inhibit the inflammatory process and the formation of fibrosis, due to their ability to suppress prostaglandin synthesis .

Eligibility criteria:
inclusion criteria: * patients presented with primary or secondary spontaneous pneumothorax * age: all age groups are included * approach: open and video assisted thoracoscopic surgery ( open and vats pleurodesis). exclusion criteria: * refusal of procedure or participation in the study. * patient with any contra indication for nsaid (bleeding tendency , ckd , gastritis , allergy to nsaid ,.....)
rivaroxaban with diosmin in long-term treatment of deep vein thrombosis

Conditions: Deep Vein Thrombosis; Postthrombotic Syndrome

Summary: the randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.

deep vein thrombosis is an acute inflammatory disease that affects vein wall and leads to the structural changes in the wall and valves reflected with chronic venous insufficiency that called postthrombotic syndrome (pts). diosmin as a flavonoid agent has properties to reduce leukocyte-endothelial interaction and inflammatory response, that could reduce the damage to venous wall and valves. the hypothesis of the study is based on assumption that diosmin combined with standard anticoagulation can improve outcomes of femoro-popliteal dvt due to increase speed of veins recanalization, decrease of vein wall inflammation and finally decrease the incidence of pts at 6 month and 1 year after index dvt.

Eligibility criteria:
inclusion criteria: * age over 18 years * the first episode of femoro-popliteal deep vein thrombosis (dvt) * verification of dvt by duplex ultrasound * informed consent signed exclusion criteria: * suspicion of pulmonary embolism (pe) * verified pe * bilateral dvt * contraindications for rivaroxaban (in accordance with the official instructions) * contraindications for diosmin (in accordance with the official instructions) * active cancer * verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins c, s, antithrombin 3) * use of other anticoagulants for more than 7 days from the dvt verification * impossibility of using compression stocking after 3 days from dvt verification * performed surgical intervention on the superficial or deep veins of the lower extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior cava filter) * continuous use of other drugs that affect the hemostasis system (except for acetylsalicylic acid in a dose of not more than 100 mg). * low compliance

Keywords: deep vein thrombosis postthrombotic syndrome anticoagulation treatment prevention
pneumococcal vaccine in untreated cll patients

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (cll) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.


Eligibility criteria:
inclusion criteria: * untreated cll patients all rai stages (0 to iv), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and/or chemotherapy exclusion criteria: * immunosuppressive therapy planned to start within 1 month * other malignancies * corticosteroids or other immunosuppressive drugs * previous allergic reaction to any vaccination in the past * neutropenia (pmns \< 500 cells/mm3)
study evaluating the safety, pharmacokinetics, and pharmacodynamics of sam-531 in healthy young and elderly subjects

Conditions: Alzheimer Disease

Summary: to assess the safety and tolerability of ascending multiple oral doses of sam-531, an investigational drug, in healthy young adult and elderly subjects.to assess the pharmacokinetics (pk) and pharmacodynamics (pd) profiles of multiple oral doses of sam-531 in healthy young adult and elderly subjects.


Eligibility criteria:
inclusion criteria : * men or women of nonchildbearing potential aged 18 to 45 years * elderly men or women aged 65 years and above as of study day 1. * body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. body weight for elderly subjects must be ≥45 kg. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ecgs, or clinical laboratory test results. * tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period. * elderly men or women aged 65 years and above as of study day 1. * body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. body weight for elderly subjects must be ≥45 kg.
a retrospective analysis of the adherence to clinical practice guidelines using the "medicbk" digital platform in patients with hypertension and atrial fibrillation

Conditions: Atrial Fibrillation; Arterial Hypertension

Summary: the clinical decision support systems (cdss) based on real clinical data and its own algorithms can help to make the right choice. this trial is designed to assess the difference between retrospective electronic medical cards (emc) therapy prescriptions and medicbk prescriptions based on key patient characteristics.

there is a lot of data from registries about poor adherence to guidelines. it is connected with a problem that patients usually have a lot of comorbidities and physicians need to know сonsequently the huge number of medications and combinations. it is very difficult to decide quickly according to available data from libraries like pubmed. the clinical decision support systems (cdss) based on real clinical data and its own artificial intelligence algorithms can help to make the right choice. this trial is designed to assess the difference between retrospective electronic medical cards (emc) therapy prescriptions and medicbk prescriptions based on key patient characteristics. two groups of experts (cardiologists with clinical practice for more than 5 years) will be participating in the trial. using main characteristics from emc the first group of experts will put this data into medicbk platform and assess retrospective treatment. the next blinded group of experts will perform prescriptions using medicbk algorithms based on current guidelines and data from available clinical trials. the main hypothesis is the use clinical decision support systems (cdss) better than current clinical practice. this option can help to make the right choice of medical combination based on main patient's clinical characteristics

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to european guidelines. exclusion criteria: 1. valvular cause of atrial fibrillation 2. gfr less than 30 ml / min 3. active liver disease 4. acute coronary syndrome 5. the presence of thyroid diseases as a cause of atrial fibrillation 6. secondary arterial hypertension

Keywords: atrial fibrillation arterial hypertension digital medicine clinical decision support system
effect of daily glucomannan in overweight patients

Conditions: Overweight; Obesity

Summary: glucomannan is a dietary supplement that has been marketed for weight loss. there is some research that supports this claim but more research is necessary. this is research study is being conducted to determine if the dietary supplement glucomannan is effective for weight loss in adults greater than 18 years of age who are overweight. participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times daily. the study will last for 12 weeks. at the start of the study participants will be asked questions about current medications and diet/exercise regimen, a weight and height will be obtained, and they will be given a one-month's supply of study supplement. an investigator will call each participant after they have been taking the supplement for 2 weeks to ensure that the participant is tolerating the supplement and answer any questions. throughout the study, participants will be required to follow-up with investigators in the office every 4 weeks (a total of 3 follow-up appointments). every 4 weeks, the investigators will weigh participants, count the leftover capsules from the previous month, and ask about any adverse effects you may be experiencing. at the conclusion of the study, a final weight will be compared with the baseline weight to determine if the medication had an effect on weight loss.


Eligibility criteria:
inclusion criteria: * patients ≥18 years old * overweight (bmi ≥ 25 kg/m2) exclusion criteria: * pregnant or nursing women * women of childbearing age will be excluded unless they are on some form of contraception * participation in any other formal or informal weight reduction program 1. currently enrolled in another weight loss study 2. currently enrolled in a weight loss program 3. active attempt to lose weight with diet and/or exercise within the last month 4. currently on one of the following medications known to cause weight loss: * alli/xenical(orlistat) * adipex-p (phentermine) * bontril (phendimetrazine) * dexoxyn (methamphetamine) * didrex (benzphetamine) * tenuate (diethylpropion) * meridia (sibutramine) * byetta (exenatide) or victoza (liraglutide) * stimulants * recently (within the last three months) started on any medication that may cause weight gain * a diagnosis of heart failure * structural abnormalities of the esophagus or gut * previous gi surgery for weight reduction * inflammatory bowel or irritable bowel disease * a life expectancy of \<6 months * allergy to glucomannan or any component of the placebo

Keywords: obesity overweight weight loss