Kornimate/medical-research-clean huggingface dataset:
melanoma molecular profiling analysis

Conditions: Melanoma

Summary: there is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. this protocol intends to collect and process a portion (\< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical sln resection: the sln(s) and 1 adjacent non-sln(s) are planned for study. in addition, blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected. material only from already-indicated and planned procedures as part of standard medical care will be used. the main goal of this study will be to properly collect and process material to be analyzed and explore the molecular features melanoma biological samples.


Eligibility criteria:
inclusion criteria: * primary melanoma with the following breslow thickness and stage * ≥ 2 mm with ulceration, t3b * ≥ 4 mm without (t4a) or with (t4b) ulceration * patients with a biopsied tumor that has not been widely resected will also be eligible for study according to the above-specified criteria for tumor thickness and stage. * age 12 years or older. * patients must have documented hemoglobin level of 10g/dl or higher. this can be drawn on the day of consent, or be documented from a previous visit within the past 30 days * subjects must have provided written, informed consent prior to any study procedures: collection of blood and ln tissue specimens for this protocol. exclusion criteria: * serious illnesses that may be considered a contraindication to surgery as determined by the physician investigator. if a subject is cleared for surgery as clinically indicated (wide excision of the primary melanoma and sentinel lymph node biopsy), subject would be eligible. * any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator or co-investigators, could prevent adequate informed consent or compromise participation in the clinical trial. * active infection or antibiotics within one-week prior to study * systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
an evaluation of weekly tafenoquine

Conditions: Falciparum Parasitaemia

Summary: this was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of p. falciparum in nyanza province, western kenya.

subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. at the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. after the treatment period subjects attended weekly follow-up safety visits until week 28.

Eligibility criteria:
inclusion criteria: * healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences). * subjects aged 18-55 years. * subjects planning to reside in the study area for the entire study duration of approximately 70 weeks exclusion criteria: * subjects with positive parasitaemia following halofantrine treatment for radical cure. * subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study. * subjects with personal or family history of seizures. * female subjects with a positive serum beta-hcg5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter). * women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant. * subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines. * subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study. * subjects with g6pd deficiency. * subjects with laboratory guideline values for exclusion: haemoglobin \<10 gm/dl, platelets \<80,000/mm3, wbc \<3000ul3, creatinine or alt more than twice the upper limit of normal for age. * subjects with an abnormal ecg, particularly an extended qtc interval \> 0.42 seconds. * subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks. * subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer. * subjects with a history of psychiatric disorder.

Keywords: falciparum parasitaemia, malaria
nexium® in the treatment of moderate and severe erosive esophagitis

Conditions: Erosive Esophagitis; Reflux Esophagitis; Gastroesophageal Reflux Disease

Summary: the purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (nexium®) 10 mg and 40 mg once daily.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years * patients must have moderate to severe erosive esophagitis exclusion criteria: * significant gastrointestinal bleeding * severe heart, lung, liver or kidney disease * esophagitis not related to acid reflux
acute kidney injury genomics and biomarkers in tavr study

Conditions: Acute Kidney Injury; Renal Insufficiency, Chronic; Heart Failure; Myocardial Infarction; Arrhythmias, Cardiac; Stroke

Summary: in the last decade, transcatheter aortic valve replacement (tavr) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. this study collects clinical information, dna, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (aki) in patients undergoing tavr and to identify key clinical and procedural predictors of aki. this study seeks to identify blood and urine biomarkers that can be used for early detection of aki around the time of the procedure. the study seeks to assess for novel genetic variants associated with development of aki after tavr. finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after tavr and to further explore how these events may inter-relate with acute kidney injury.

this study enrolls patients who have aortic stenosis who undergo tavr at the university of texas southwestern medical center university hospital. development of post-tavr aki defined according to the kidney disease: improving global outcomes (kdigo) scr based criteria will be ascertained. patients will be followed during primary hospitalization and during the 5 years following tavr for adverse kidney outcomes as well as potentially related adverse cardiovascular outcomes. clinical and procedural data is collected for each study patient. all subjects will have paired blood and urine collection done pre-tavr, 6 hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. subjects who develop aki will also have paired blood and urine samples collected on days 3, 4 and 5. patients receive follow-up questionnaires by mail or email asking about hospitalizations as well as visits to cardiology, nephrology and primary care physicians. questionnaires will also ask about health-related quality of life using validated study questionnaires. patient follow-up will occur at regular intervals until 5 years after tavr procedure.

Eligibility criteria:
inclusion criteria: subjects are eligible to participate if they are undergoing tavr for aortic stenosis at the university of texas southwestern medical center. exclusion criteria: 1. the patient cannot or will not provide informed consent. 2. the patient is aged less than 18 years. 3. the patient's pre-procedural hematocrit is less than 25%. 4. the patient has known human immunodeficiency virus infection 5. the patient has known hepatitis c that has not been treated with antiviral medications 6. in the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons (this includes transient patients and patients who have no fixed address).

Keywords: acute kidney injury transcatheter aortic valve replacement genomics biomarker
prediction of cytomegalovirus (cmv) reactivation in intensive care unit (icu) by immunological study

Conditions: CMV Infection

Summary: cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. in immunocompetent individuals, cmv remains latent in a number of cells, without any pathological consequence. immunosuppression may reactivate the virus causing either a cmv-active infection or a cmv disease with attributable symptoms. in intensive care unit (icu), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present cmv reactivation. our aim is to study the risk factors for developing viremia or cmv disease in icu patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.

immunosuppression statuses causing both cmv active infection or disease are mainly consecutive to hiv infection, bone marrow or solid organ transplantation. however, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. the length and extent of this immunodeficiency is correlated with the duration of icu stay, the occurrence of nosocomial infection and mortality. a better understanding of cmv's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.

Eligibility criteria:
inclusion criteria: * 18 years or older * icu admission for more than 3 days * admission for septic shock * patient with mechanical invasive ventilation exclusion criteria: * immunodepression status before icu admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, hiv infection) * seronegative patient for cmv * patient under anti-virus treatment * patient under guardianship

Keywords: cmv reactivation cmv disease predictive factors critically ill patients septic shock
evaluation of colonic perfusion by indocyanine green angiography during colorectal surgery

Conditions: Anastomotic Leak

Summary: despite advancements in technology and improved surgical techniques, the occurrence of anastomotic leakage (al) after colorectal surgery remains between 4% and 30%. al is a feared complication associated with significant morbidity and mortality in colorectal surgery, with its causes being multifaceted. inadequate blood supply to the intestines is believed to be a major contributor to its development. various methods have been proposed to objectively assess intestinal perfusion beyond the subjective evaluation done by surgeons during surgery. however, these methods face challenges such as poor reproducibility and high costs, limiting their routine use. in recent years, indocyanine green (icg) angiography has emerged as a tool for assessing organ perfusion in various medical scenarios. however, only one randomized clinical trial has been conducted regarding its use in evaluating colorectal surgery outcomes, which found that while icg angiography sometimes led to additional bowel resection, it didn't significantly reduce the rate of anastomotic leaks compared to conventional methods. this could be due to the trial's small sample size, potentially reducing its statistical power. this study aims to investigate whether icg angiography can lower the rate of anastomotic leaks during laparoscopic colorectal cancer surgery, while also examining its impact on resection margins, perioperative morbidity, and mortality rates. a total of 561 subjects undergoing laparoscopic colorectal surgery for malignancy, will be randomized in 2 arms: a study group undergoing icg angiography (i.e. colonic perfusion is intraoperatively assessed by icg angiography and level of resection is selected based on the fluorescence) and a control group (i.e. resection is performed based on subjective judgment).


Eligibility criteria:
inclusion criteria: * age: 18-85 years * malignant colorectal tumors * elective surgery exclusion criteria: * abdomino-perineal resection * emergency procedures * conversion to open surgery * no anastomosis * multifocal tumors * locally advanced cancer (t4) * distant metastases (m+) * major vasculopathies (previous pe, dvt, abdominal aorta surgery) * icg allergy

Keywords: anastomotic leak colorectal surgery colorectal cancer
factors predicting urethral stricture recurrence after dorsal onlay augmented, buccal mucosal graft urethroplasty

Conditions: Urethral Stricture

Summary: in this observational study, the investigators will evaluate potential risk factors associated with urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal graft during the past 10 years. patients' medical files will be reviewed for data relevant to demographics, clinical and operative characteristics. data will be analyzed using the appropriate statistical tests and the independent predictors of urethroplasty outcome will be identified.

in this series, the investigators will study different factors related to the stricture and to the patients to identify the independent predictors of urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal graft. a retrospective review of medical records will be performed to identify patients who underwent augmented anastomotic anterior urethroplasty with dorsal onlay graft at al-azhar university hospitals in egypt since 2010. patients will be included only if they were two or more years out of surgery. the data will be recorded without patients' identification. data to be collected are patient age, body mass index (bmi), smoking status, diabetes status, overall comorbidity, stricture etiology, prior endoscopic treatment and open urethroplasty, urethral stricture length and location, degree of urethral obliteration, urethral plate width, presence and degree of spongiofibrosis. estimated intraoperative blood loss, catheter size, overall operative time, hospital stay and early postoperative complications. the diagnosis of urethral stricture recurrence is based on the radiological and endoscopic features of stricture recurrence. time to recurrence will be calculated from the date of surgery till the date restricture diagnosis. univariate and multivariate regression analysis will be performed and factors predicting urethral stricture recurrence will be identified.

Eligibility criteria:
inclusion criteria: * patients who will be 2 years or more out of surgery exclusion criteria: * patients with incomplete medical records or follow-up informations
multicenter study of impulse oscillometry in chinese

Conditions: Healthy Subjects; Chronic Obstructive Pulmonary Disease; Asthma; Interstitial Lung Disease; Upper Airway Obstruction

Summary: the purpose of this study is to establish the reference values of impulse oscillometry (ios) in healthy chinese, and compare the indices of ios in patients with lung disease, such as chronic obstructive pulmonary disease (copd), asthma, interstitial lung disease (ild), and upper airway obstruction (uao).


Eligibility criteria:
inclusion criteria for healthy subjects: * life-long non-smokers * no symptoms and history of chronic cardiopulmonary diseases (chronic bronchitis, asthma, lung cancer, pulmonary fibrosis, pulmonary tuberculosis, chronic heart diseases, etc.) * no abnormal findings on physical examination * written informed consent was obtained inclusion criteria for copd: * diagnosis of chronic obstructive pulmonary disease (copd), as classified by the global initiative for chronic obstructive lung disease (gold) guidelines and post-bronchodilator fev1/fvc (forced vital capacity) \< 70%. inclusion criteria for asthma: * diagnosis of asthma, as classified by national and international asthma guidelines. inclusion criteria for ild: * ild diagnosis confirmed by lung biopsy, x ray or balf analysis. inclusion criteria for uao: * diagnosis of uao. exclusion criteria for healthy subjects: * upper or lower respiratory infection within 4 weeks * long-term exposure to harmful gas or particles * using β-blocker for treatment * pregnant women, epileptic * other diseases or surgeries potentially affecting lung function

Keywords: impulse oscillometry chinese healthy subjects chronic obstructive pulmonary disease asthma interstitial lung disease upper airway obstruction reference values
study of peri-articular anaesthetic for replacement of the knee

Conditions: Knee Osteoarthritis

Summary: the clinical and cost effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: a multi-centre, patient-blinded, randomised controlled trial.

the trial design is a patient-blinded multi-centre, active comparator, randomised controlled two-arm parallel group superiority trial of liposomal bupivacaine plus bupivacaine hydrochloride versus bupivacaine alone for post-operative pain in patients undergoing knee replacement surgery. patients will be randomised in a 1:1 ratio. the randomised controlled trial (rct) design is robust and reduces any potential bias. patients will be blinded as to which treatment they receive. blinding of patients is possible as they will be under general anaesthetic for their knee replacement surgery at the time of the drug administration. blinding of surgeons, who administer the medication and outcome assessors was not necessary as the primary outcome is a patient reported outcome measure.

Eligibility criteria:
inclusion criteria: * unilateral primary knee replacement, including both total knee replacement (tkr) or unicompartmental knee replacement (ukr), for end stage osteoarthritis * american society of anaesthesiologists (asa) grade i to iii * participant is willing and able consent for themselves * male or female, aged 18 years or above * in the investigator's opinion, is able and willing to comply with all trial requirements exclusion criteria: * allergy or intolerance to amide type local anaesthetics * objective evidence of nerve damage in the affected lower limb. * rheumatoid arthritis * any other significant disease, disorder or condition which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial, or the participant's ability to participate in the trial. * participants who have participated in another research trial involving an investigational product in the past 6 months. * participants who have significant cognitive impairment or language issues * contra-lateral knee replacement within the trial or within 12 months prior to randomisation
does active parent involvement in deliberation and choice improve medication persistence for their child with adhd

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: the purpose of the study is to determine whether active parent involvement in deliberation and choice improves subsequent medication persistence for their child with adhd.


Eligibility criteria:
inclusion criteria: * diagnosed with adhd based on dsm-iv criteria * enrolled in school-setting * no learning disability * no past use of psychoactive medication exclusion criteria: * do not meet dsm-iv criteria for adhd * not enrolled in school-setting * presence of learning disability * history of brain injury * past use of psychoactive medication

Keywords: decision aid informed choice adherence
micrornas as biomarkers in patients with chagas disease

Conditions: Chagas Disease

Summary: the purpose of this study is to analyze the efficacy of micrornas as biomarkers on the chagas disease prognosis. this analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

the patients included in the study must at first sign the written consent. they shall be accompanied in the specialized outpatient clinics for chagas disease - hospital são rafael - centro de biotecnologia e terapia celular. they will be submitted to several tests, including: * collection of blood samples for biochemical analysis; * electrocardiogram; * holter electrocardiogram; * echocardiogram; * treadmill test; * x-ray imaging; * magnetic resonance imaging; * evaluation of the quality of life through the application of questionnaires (sf 36 and the minnesota living with heart failure questionnaire).

Eligibility criteria:
inclusion criteria: * chagas disease diagnosis confirmed by 2 different serologies * diagnosis of chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction. exclusion criteria: * significant valve disease defined as aortic stenosis with a gradient of ve/ao \> 50 mmhg * mitral stenosis with a valve area inferior than 1,5 cm2 * severe or moderate aortic and/or mitral regurgitation * chronic use of immunosuppressive agents * dialysis treatment of terminal renal failure * fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the accp/sccm (american college os chest physicians/society of critical care medicine) * current abusive use of alcohol or illicit drugs (based on the dsm iv) * any other comorbidities that impact patient's survival within the next 2 years * liver disease in activity * continuous use of steroids as treatment for copd * hematologic, neoplastic or bone diseases * homeostasis disturbances * inflammatory diseases or chronic infectious diseases

Keywords: micrornas chagas disease biomarkers
dexamethasone and functional outcome after tka

Conditions: Chronic Knee Pain; Dexamethasone; Total Knee Arthroplasty

Summary: patients previously included in the dex-2-tka-trial (ethics committee id sj-695; clinicaltrials.gov: nct03506789) at næstved hospital will be invited for a follow up study consisting of questionnaires and a visit with a physical therapist. the study includes the following validated questionnaires: eq-5d-5l, oxford knee score and paindetect, and information on height, weight, daily pain-medication and co-morbidities. with the physical therapist, the patient will perform the following functional tests: knee range of motion, timed-up-to-go, 30 second chair stand test, 40m fast paced walk test, stair climb test and a measure of the thigh force.


Eligibility criteria:
inclusion criteria: * participation in the dex-2-tka-trial at næstved hospital in accordance with protocol * signed, informed consent for participation exclusion criteria: * lack of signed, informed consent
efficacy and safety assessment of t4032 versus lumigan® in ocular hypertensive or glaucomatous patients

Conditions: Ocular Hypertension; Glaucoma

Summary: the purpose of this study is to assess the efficacy and safety of t4032 versus lumigan.


Eligibility criteria:
inclusion criteria: * informed consent signed and dated. * both eyes with diagnosed open-angle glaucoma or ocular hypertension exclusion criteria: * history of trauma, infection, clinically significant inflammation within the 3 previous months. * uncontrolled diabetic patient. * pregnancy or breast feeding.