Kornimate/medical-research-clean huggingface dataset:
genomics of chronic renal allograft rejection (the gocar study)

Conditions: Kidney Transplantation

Summary: doctors have had success preventing certain types of kidney transplant rejection by suppressing the immune system. however, an individual's genetic make-up and the strength of an immune response to a transplant may also determine whether a transplanted organ is rejected. the purpose of this study is to look at the genetic profile and immune response of people who have had kidney transplants and to correlate the findings with kidney transplant rejection episodes. donor genetic profiles will also be studied and correlated with the recipient's information.

new immunosuppressive drugs have improved short-term transplant survival but have not affected long-term transplant survival. rejection is caused by both immunological and non-immunological factors from both the donor and the recipient. although the exact cause of chronic rejection is not known, it is associated with the presence of c4d, a degradation product of the antibody response cascade, and the presence of circulating donor-specific antibodies (dsas). the purpose of this study is to determine the role of cell- and antibody-mediated responses in chronic rejection of transplants, to determine the gene expression profile associated with the development of chronic rejection, and to determine whether variants of specific genes cause susceptibility to rejection. this is an observational study of people who will be receiving kidney transplants and participants will be followed for 2 years. study visits for kidney transplant recipients will occur at study entry and at months 3, 6, 12, 18, and 24 after transplant. at these visits, adverse event assessment, rejection assessment, medication history questionnaire, and blood collection will occur. at some visits, a physical exam and a kidney biopsy will occur. blood will also be collected from living kidney donors at the time of donation if both donor and recipient agree to be in the study. this study will be take place at 4 clinical sites: mount sinai school of medicine, university of wisconsin-madison, westmead hospital, and northwestern memorial hospital. brigham and women's hospital and massachusetts general hospital will also participate in the study as central laboratories.

Eligibility criteria:
inclusion criteria: * kidney transplant candidates from living or deceased donors * male or female, ages 18-75 years * subject must be able to understand and provide written informed consent * living donors - recipient also consents to participate in the study exclusion criteria: * presence of donor specific antibodies in living donor recipients prior to transplantation or positive cross match according to site-specific technique in cadaveric donor recipients * recipients of multiple organ transplants, with the exception of kidney/pancreas transplants. * inability or unwillingness to comply with the study protocol.

Keywords: elispot rt-pcr luminex genomics
combination therapy with fluoroquinolone in staphylococcus aureus bacteremia

Conditions: Staphylococcus Aureus; Bacteremia; Endocarditis; Sepsis

Summary: to study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in staphylococcus aureus bacteremia.


Eligibility criteria:
inclusion criteria: adult patients with at least 1 blood culture positive for staphylococcus aureus were included within 1 to 7 days of blood culture sampling. exclusion criteria: * age younger than 18 years * imprisonment * proven or suspected pregnancy * breastfeeding, epilepsy * another bacteremia during the previous 28 days * polymicrobial bacteremia (_\>3 microbes) * history of allergy to any quinolone antibiotic * previous tendinitis during fluoroquinolone therapy * prior fluoroquinolone use for more than 5 days before randomization * positive culture for staphylococcus aureus only from a central intravenous catheter * neutropenia (\<0.5 x 109/l) or failure to supply an informed consent * patients with bacteremia due to methicillin-resistant s. aureus and a s. aureus strain resistant to any fluoroquinolone * patients with meningitis at the time of randomization

Keywords: staphylococcus aureus bacteremia endocarditis sepsis fluoroquinolone rifampin levofloxacin trovafloxacin
eswt vs cryo-us therapy in the treatment of chronic lateral epicondylitis: one year follow up study

Conditions: Tendinopathy

Summary: chronic lateral epicondylitis is usually managed conservatively. the purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (eswt) in comparison with cryoultrasound (cryo-us) therapy in chronic lateral epicondylitis (le) during a period of 12 months.

eighty participants with chronic le were randomly assigned to receive 3 eswt sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mj/mm2 at each session- (eswt group, n=40) or 12 cryo-us therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 watt/cm2 and -2˚c at each session- (cryo-us group, n=40). visual analogue scale (vas) and satisfactory results, considered as the sum of the excellent and good scores in the roles and maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.

Eligibility criteria:
inclusion criteria: * an age range from 18 to 75 years * clinical or instrumental diagnosis of chronic lateral epicondylitis, present for at least three months * intensity of pain of more than 5 on the visual analogue scale (vas) performing a maximum voluntary resisted isometric wrist extension with the elbow in extension (cozen test) * the failure of conservative treatments previously made * a wash-out period of at least 12 weeks since the last conservative therapy carried out before inclusion in the study * capability of filling in the questionnaires and signing the consent form exclusion criteria: * previous treatment with cryo-us, ultrasound therapy, eswt * the conjoint presence of bilateral or lateral and medial epicondylitis * acute infection of the soft tissues or the bones adjacent to the area of treatment * local bleedings or skin lesions, pathologies of the blood coagulation, or use of anticoagulant drugs * pacemaker, pregnancy * neoplastic disease * raynaud's disease, altered thermal and pain sensitivity, or cold intolerance * evidence of elbow bursitis, or articular or synovial pathologies; signs of elbow laxity or instability * cervicobrachialgia; syndrome of ulnar, radial, or posterior interosseous nerve entrapment

Keywords: elbow pain lateral epicondylitis conservative treatment shock wave treatment therapeutic ultrasound
in vivo kinematics for subjects having a microport medial pivot or depuy attune pcr tka

Conditions: Total Knee Arthroplasty; Osteo Arthritis Knee; Knee Injuries; Knee Imlant

Summary: in vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a microport medial pivot or depuy attune posterior cruciate retaining (pcr) total knee arthroplasty (tka) by dr. russell nevins of nevada orthopedic \& spine center \[this is the location from which participants will be recruited\].

there will be ten subjects with the microport implant and ten with the depuy attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. all tkas should be judged clinically successful based on the surgeon's evaluation and each patient's forgotten knee score. each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.

Eligibility criteria:
inclusion criteria: * subjects will have either a microport medial pivot or depuy attune pcr tka. * subjects must be at least six months post-operative. * participants must be judged clinically successful based on the surgeon's evaluation and their forgotten knee score. * participants must be able to perform the required activities - stepping up and a deep knee bend. * subjects must be willing to sign the informed consent (ic) / hipaa form to participate in the study exclusion criteria: * pregnant, potentially pregnant or lactating females. to satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. a pregnant person will not be allowed to participate in the study. * subjects without one of the two types of knee implants under investigation. * subjects who are unable to perform stepping up and deep knee bend. * subjects who are unwilling to sign informed consent/ hipaa documents. * does not speak english.
role of preoperative counselling with nsqip surgical risk calculator

Conditions: Satisfaction, Patient

Summary: surgical patients undergo preoperative counseling which varies in quality and duration. proper communication during the preoperative consultation can deliver relevant health information and guide improvement of perioperative health status. the methods, however, are non-standardized and the explanation of the postoperative course is generally vague or varies from person to person. we hypothesize that high-risk patients who receive pre-operative counseling with the help of the nsqip surgical risk calculator compared to the current standard of care will have higher satisfaction concerning information on the perioperative journey.

the control arm will receive standard preoperative counselling and written consent will be taken. the nsqip arm will receive standard preoperative counselling along with the details provided by nsqip surgical risk calculator and written consent will be taken. anxiety among the patients will be accessed with the use of preoperative anxiety measured by amsterdam preoperative anxiety and information scale (apais) questionnaire written in nepali. duration of counselling period will be noted from the start of counselling session till the consent is signed.

Eligibility criteria:
inclusion criteria: * asa iii or above and/or age above 65 high-risk surgical patients undergoing surgery at nepal mediciti hospital exclusion criteria: * adults who cannot consent pregnant women non-nepali speakers consent by surrogate

Keywords: nsqip surgical risk calculator preoperative counselling anxiety
effects oxygen supplementation determined better exercise capacity in eisenmenger syndrome

Conditions: Eisenmenger Complex; Hypertension, Pulmonary

Summary: the purpose of this study was to evaluate the acute effects of oxygen supplementation during a submaximal exercise test in patients with eisenmenger's syndrome.

patients with eisenmenger's syndrome were submitted to a submaximal exercise test (six-minute walking test) with and without supplemental oxygen. the distance walked during the two tests were compared to assess the impact of oxygen supplementation on the walking distance.

Eligibility criteria:
inclusion criteria: * abscence of heart failure and/or respiratory infection * advanced therapy for pulmonary hypertension exclusion criteria: * lung, liver or connective tissue diseases * neuromuscular diseases * inability to perform a pulmonary function test and/or chronic lung disease * inability to walk
efficacy, safety and tolerability of agomelatine in the prevention of relapse of major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will demonstrate the efficacy of agomelatine (ago178) 25 mg and 50 mg in the prevention of relapse in patients with major depressive disorder (mdd). eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.


Eligibility criteria:
inclusion criteria: * male and female adults, 18 through 70 years of age, inclusive * diagnosis of major depressive disorder, recurrent episode, according to diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) criteria * a history of at least two previous episodes of major depression plus the current episode * hamilton depression rating scale (ham-d17) total score ≥ 22 at screening and baseline exclusion criteria: * history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder * any current axis i disorder other than major depressive disorder which is the focus of treatment * substance or alcohol abuse in the last 30 days, dependence in the last 6 months * use of any psychoactive medication after the screening visit * patients who have been previously treated with agomelatine * female patients of childbearing potential who are not using effective contraception other protocol-defined inclusion/exclusion criteria may apply

Keywords: agomelatine, major depressive disorder, mdd, depression
timing of influenza vaccination in patients with heart failure

Conditions: Heart Failure

Summary: heart failure (hf) is one of the most common causes of hospital admission in canada and costs the canadian healthcare system over $1 billion annually. influenza vaccination is an inexpensive strategy to prevent influenza infections and reduce an important trigger for hf decompensation and hospital readmission. yet, the optimal timing of vaccine administration remains unclear. when patients with hf are admitted to the hospital with an acute decompensation in advance of, or during, the 'flu season', this can be an ideal time to administer the vaccine. however, patients with acute hf decompensation have significant inflammatory injury, and may have substantially impaired immune responses; thus vaccine administration while admitted during an acute decompensated hf episode may not lead to high anti-influenza antibody titres. a more effective strategy can be to vaccinate after the decompensation has resolved, when patients are more stable. the flu-hf randomized trial will determine whether administering the influenza vaccine to patients admitted in-hospital with an acute hf decompensation or waiting until they have stabilized as an out-patient leads to an improved anti-influenza response.


Eligibility criteria:
inclusion criteria: * age \> 18 years * admitted in hospital with primary diagnosis of acute hf * prior diagnosis of chronic hf \> 3 months prior to admission * not on inotropes, mechanical support, or iv diuretics for 24 hours * able to follow-up within the muhc hf clinic as per schedule * agree to receive influenza vaccination exclusion criteria: * any person who does not meet the above criteria and/or who refuses to participate * already received this seasons influenza vaccination * known allergy to influenza vaccination or components of the influenza vaccination * unlikely to survive to discharge as per admitting physician * prior organ transplant * undergoing chemotherapy for active malignancy * currently randomized in another clinical study
using tdcs in speech-based stroke rehabilitation

Conditions: Apraxia of Speech

Summary: the purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. transcranial direct current stimulation (tdcs), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tdcs provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. this will be examined with a series of single-case experimental designs.


Eligibility criteria:
inclusion criteria: * right-handed * monolingual (english) * single left-hemisphere cva * a minimum of six months post-stroke * clinical diagnosis of apraxia of speech * normal speech perception * passing score on the hearing screening. exclusion criteria: * diagnosis of laryngeal voice disorder * dysarthria * history of speech impairment prior to cva * presence of potential tdcs risk factors: damaged skin at site of stimulation; * presence of electrically or magnetically activated implant (including pacemaker); * metal in any part of their body; * history of medication-resistant epilepsy in the family; * past history of seizures or unexplained spells of loss of consciousness.

Keywords: stroke
efficacy and safety of da-3002 in children with idiopathic short stature

Conditions: Idiopathic Short Stature

Summary: growth hormone therapy will improve the height of idiopathic short statured children. da-3002(recombinant human growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.


Eligibility criteria:
inclusion criteria: * chronological age ≥ 4 * bone age \<11 (for girls) and \<13 (for boys) * height \<3rd percentile for age * normal thyroid function exclusion criteria: * endocrine and/or metabolic disorders * growth failure caused by other disorders * previous use of drugs that could interfere with growth hormone treatment

Keywords: growth hormone
comparative atorvastatin pleiotropic effects

Conditions: Coronary Arteriosclerosis; Hypercholesterolemia

Summary: the primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing c-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.


Eligibility criteria:
inclusion criteria: * male or female subjects of age of majority to \< 80 years * subjects with ldl-c \> 0.5 g/l (1.29 mmol/l) and \ 1.5 mg/l and \< 15 mg/l * subjects with a documented coronary artery disease. exclusion criteria: * female subjects of childbearing potential without contraception * subjects with secondary hyperlipidemia * diabetic subjects receiving insulin * subjects with a contra-indication to statin therapy.
clinical feasibility of an advanced therapy medicinal product (atmp) preparation for autologous skin regeneration in case of chronic leg ulcers

Conditions: Leg Ulcer

Summary: this study deals with the feasibility of an atmp (advanced therapy medicinal product) production for the treatment of chronic wounds ulcer. recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. during surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).


Eligibility criteria:
inclusion criteria: * patient with chronic leg ulcers evolving for more than 6 months * patient to receive skin pellet transplant * chronic wound area between 10 and 30 cm² exclusion criteria: * patient without health insurance, * pregnant womens, * smoking patient, * chronic wound area \>30 cm²

Keywords: skin substitutes
entecavir plus adefovir combination therapy versus entecavir monotherapy vs therapy with adefovir plus lamivudine for chronic hepatitis b infected subjects with lamivudine-resistant virus

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine


Eligibility criteria:
inclusion criteria: * evidence of lamivudine (lvd) resistance * subjects must have a history of previous lvd treatment at screening, and must have evidence of at least 1 lvd resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (m204v/i/s) * nucleoside- and nucleotide-naive, except for lvd, and had chronic hepatitis b (hbv) infection * compensated liver function and must have met all of the following criteria:international normalization ratio (inr) ≤ 1.5; serum albumin ≥ 3 g/dl (≥ 30 g/l); serum total bilirubin ≤ 2.5 mg/dl (≤ 42.75 μmol/l) * hbv dna \> 1.72 x 10\*4\* iu/ml (approximately 10\*5\* copies/ml) * documentation of hepatitis b e antigen (hbeag) positive and hepatitis b e antibody (hbeab) negative status at screening * alanine aminotransferase (alt) ≤ 10 \* upper limit of normal (uln) at screening * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized * wocbp include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. post menopausal is defined as: * women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential * wocbp must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product exclusion criteria: * evidence of decompensated cirrhosis * coinfection with human immunodeficiency virus, hepatitis c virus , or hepatitis d virus * women who are pregnant or breastfeeding * sexually active fertile men not using effective birth control if their partners were wocbp * laboratory values out of protocol-specified range
real-world study on nano-crystalline megestrol acetate for cachexia in tki-treated advanced digestive tumors

Conditions: Cachexia; Digestive System Cancer; Gastric Cancer; Colorectal Cancer; Hepatocellular Carcinoma

Summary: this study is a prospective, observational clinical study aimed at evaluating the efficacy of megestrol acetate for cachexia in patients with advanced digestive system tumors receiving tki-based therapy.


Eligibility criteria:
inclusion criteria: * voluntarily sign a written informed consent (icf). * age ≥ 18 years at enrollment. * eastern cooperative oncology group (ecog) performance status of 0-2. * life expectancy ≥ 3 months. * histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition tnm staging classification. * not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive tki-based anticancer treatment, which may be combined with chemotherapy or immunotherapy). * meet the diagnostic criteria for pre-cachexia or cachexia (based on fearon diagnostic criteria). * good organ function determined exclusion criteria: * gastrointestinal obstruction. * anorexia due to difficulty in eating caused by neurosis, mental illness, or pain. * comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases. * major surgery or trauma within the last month. * allergy to any component of the investigational drug. * other conditions deemed unsuitable by the investigator.

Keywords: megestrol acetate nano-crystalline megestrol acetate targeted therapy tyrosine kinase inhibitors prospective studies observational studies antineoplastic agents digestive system cancer