Kornimate/medical-research-clean huggingface dataset:
database concerning patients consulting the obesity clinic

Conditions: Overweight and Obesity; Bariatric Surgery

Summary: a registry of individuals that visit the obesity clinic of the university hospitals of leuven will be established. the objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.

a registry/database is constructed with data of the individuals that visit the obesity clinic of the university hospitals of leuven. data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, qol, ...

Eligibility criteria:
inclusion criteria: * signed informed consent * age 18 years or older * subjects with overweight, obesity or after bariatric surgery
hepatitis b vaccination in hiv-infected persons

Conditions: HIV Infections; Hepatitis B

Summary: in this study we compare the efficacy of two different hbv-vaccination schedules in hiv-infected persons concerning immune response and compliance. short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.

it is known that hiv-infected persons are more prone to develop chronic hepatitis b infection when they get infected with this virus. after developing chronic hepatitis b these patients are more likely to get livercirrosis and hepatocellular carcinoma (bodsworth et al.). hepatitis b vaccination is available and the vaccine is about 95% protective in preventing immunocompetent persons from developing chronic hepatitis b infection (lemon). the response on this vaccin is less effective in hiv-infected persons (carne et al.). furthermore there is a compliance problem in the standard scheme. in this study we compare the efficacy of two different hbv vaccination schedules in hiv-infected persons concerning immune response and compliance. a short schedule: t=0,1,3 weeks, in which there are good results concerning immune response and compliance in immunocompetent persons (saltog et al.) and the standard schedule: t=0,1,6 months. patients not immune at week 28 will be offered boostervaccination. this consists of double doses at t=0,1,2 months. 800 persons are needed to show non-inferiority with lower margin of 10% of the short schedule in comparison with the control group. powercalculation is 80%. randomization is stratified according to cd4 count(cd4 \ 500). the hypothesis of the study is a better compliance and a comparable immune response in the short schedule, through which persons will be protected against hepatitis b in an early stage.

Eligibility criteria:
inclusion criteria: * hiv positive * negative for hbsag and anti-hbc * 18 years or older exclusion criteria: * previous hepatitis b vaccination * current opportunistic infection

Keywords: hiv
facbc pet and pem as a staging tool and indicator of therapeutic response in breast cancer patients

Conditions: Breast Cancer

Summary: this study has been designed to help us determine if facbc pet or pem can accurately evaluate how far the breast cancer has spread in the breast. also, to help determine if facbc pet or pem can accurately measure your response to chemotherapy.


Eligibility criteria:
inclusion criteria: * women presenting for evaluation at mskcc with biopsy proven primary idc or ilc * no prior therapy for idc or ilc * clinical need for local disease staging with breast mr (group a only) * clinical need for neoadjuvant chemotherapy (group b only) * patients must provide written informed consent exclusion criteria: * age \<21 years * men * pregnancy or lactation * patients who have already started treatment for the current malignancy * patients who cannot undergo pet scanning (i.e. because of weight limits) * patients who are known to have contraindication for mri (e.g. metal implants) * patients may only participate in group #1 or group #2, but not both

Keywords: facbc pet/pem mr 11-177
surgical outcomes database for faculty of hepatopancreatic biliary surgery

Conditions: Cancer of Liver; Pancreatic Cancer; Biliary Tract Cancer

Summary: the collection of data regarding patient outcomes after surgical intervention creates imperative knowledge to include surgeon performance, cost analysis, base for surgical research and publication, which in turn assist surgeons to improve the standard of care utilizing evidence-based practice.

the concept of disease management stems from a logical evolution in the field of outcomes applications by healthcare provides is the concept of disease management. the basic premise of disease management is that there is a more optimal way to manage patients in order to reduce costs and improve health outcomes. the data collected from patient-reported outcomes allows the physician and staff to screen for specific health conditions, monitor patients individually, evaluate outcomes for specific groups, assess quality of care, determine impact of intervention and predict outcomes. most of the follow-up results from this study will be obtained directly from the patient during follow-up visits, but other information may be obtained from medical records. evaluation of the surgical database application will identify both patient and procedural variables that can predict adverse outcomes.

Eligibility criteria:
inclusion criteria: * patients that are hepatopancreatico biliary surgical patients. exclusion criteria: * patients that are not hepatopancreatico biliary surgical patients.
immune modulation from trichuris trichiura

Conditions: Crohn Disease; Colitis, Ulcerative; Intestinal Helminthiasis

Summary: mucosal immunology during helminth infection

the present study investigates the effects of trichuris trichiura on human mucosal and systemic immunity in a single self-infected individual.

Eligibility criteria:
inclusion criteria: * the included volunteer is a researcher within parasitology with main focus on trichuris trichiura and trichiura suis. he planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. the only clinical criterion for his inclusion in the study was that he was healthy. exclusion criteria: * n/a
point-of care ultrasound for patients with hiv

Conditions: HIV/AIDS; Opportunistic Infections, HIV Related

Summary: rationale: point-of-care ultrasound (pocus) is increasingly used by various specialists in the netherlands, but its role in managing patients with hiv is unclear. in settings endemic for tuberculosis, fast assessment with sonography for hiv/tuberculosis (fash) has proven its value to detect extrapulmonary tuberculosis in patients with hiv. however, there is no data to support pocus for patients with hiv in resource affluent settings. objective: the investigators aim to determine the feasibility and diagnostic value of pocus in detecting opportunistic disease in hiv patients with advanced disease stages in the netherlands. study design: the investigators will perform a prospective observational pilot study. study population: the investigators will include new adult patients with hiv presenting with a cluster of differentiation 4 (cd4) t-cell count below 350 cells/mm3, and all adult hiv patients requiring admission to hospital. intervention (if applicable): the investigators will perform a focused ultrasound examination including fash, and ultrasound of the lung, liver and kidneys. in case of positive findings additional examinations will be undertaken to determine the underlying pathology and/or treatment started as indicated. in case of negative findings, patients will be followed for 12 months to observe for (possibly missed) opportunistic infections. main study parameters/endpoints: our primary outcomes include acceptability of pocus by patients, interobserver variation in interpretation of pocus images, and number of diagnosed aids and non-aids related problems. secondary outcomes include sensitivity and specificity, negative predictive value and positive predictive value of our pocus protocol. in addition, incidence rates of opportunistic infections will be compared to a historical matched control group. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the ultrasound examination is painless and without risk to the participants. it will take approximately 30 minutes and will be combined with routine visits to the hospital. benefits include potential earlier detection of opportunistic disease, while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety. the rate of false positive findings in pocus has not been formally investigated, but appears low. the effect of pocus in advanced hiv/aids can only be studied in hiv patients.


Eligibility criteria:
inclusion criteria: * new patients with hiv presenting with a cd4 t-cell count below 350 cells/mm3 * patients with hiv who are admitted to hospital exclusion criteria: - absence of informed consent

Keywords: hiv opportunistic disease ultrasound
effects of metformin on airway ion channel dysfunction in cystic fibrosis-related diabetes

Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis

Summary: the purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with cf-related diabetes (cfrd)

up to 30 patients with cfrd on highly effective cftr modulator therapy who meet criteria and agree to participation in the study will be placed on metformin 500mg twice daily (low) and 1000mg twice daily (normal) in a randomized order (simple randomization). there will be a dose-escalation with each dosing regimen starting with 500mg twice daily for a week, followed by 500mg in the am and 1000mg in the pm for another week and finally followed by 1000mg twice daily until the end of normal dose cycle (in those in the normal dose portion of the crossover trial). a matching placebo pill will be utilized so participants do not know which dosing regimen, low or normal, they are on during each 14-week period. participants will continue each dosing regimen of metformin for 14 weeks with a washout period of 2 weeks between dose changes. to minimize risk of b12 deficiency, a known side effect of long-term metformin use, we will also provide a supplement of 1000 µg oral cyanocobalamin daily for the duration of the trial.

Eligibility criteria:
inclusion criteria: 1. age \>18 years with a prior diagnosis of cf. 2. use of ivacaftor or elexacaftor/tezacaftor/ivacaftor for 30 days prior to day 0 3. 3. diagnosis of cfrd with evidence of continued glucose intolerance at least 6 months after starting elexacaftor/tezacaftor/ivacaftor will be based upon one of the following: 1. insulin use 2. hemoglobin a1c \>6.5% 3. fasting glucose \>126 mg/dl 4. non-fasting glucose \>200 mg/dl (random or as part of a 2-hr ogtt) exclusion criteria: 1. prior lung or liver transplant 2. use of supplemental oxygen 3. bmi \<18 4. cf pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days 5. systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days 6. cardiac, renal (creatinine clearance \<45 ml/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study 7. alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase \>1.5x the upper limit of normal; bilirubin \>3 mg/dl 8. taking medications that interact with metformin. 9. vitamin b12 deficiency 10. pregnancy or lactation 11. inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age) 12. use of medications known to be strong cyp inducers or moderate to strong cyp inhibitors 13. in the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the subject inappropriate for enrollment 14. participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

Keywords: metformin
evaluation of renal perfusion with nirs in laparoscopic surgery

Conditions: Pneumoperitoneum; Renal Injury

Summary: the investigators aimed to show the renal damage caused by increased intra-abdominal pressure in laparoscopic surgeries and to investigate whether its reflection on nirs would be clinically effective.the main question it aims to answer are: does pneumoperitoneum cause renal damage? nrs monitoring will be performed in patients undergoing laparoscopic surgery. preoperative and postoperative blood tests will be performed at certain hours. n-gal, urea and creatinine values will be recorded.

renal nirs monitoring will be performed in patients undergoing laparoscopic cholecystectomy surgery. age, gender, bmi, asa scores, hemogblin/hematocrit values, intraoperative hemodynamic parameters, nirs values, n-gal (preoperative, 2nd hour and 24th hour), urea/creatinine (preoperative, postoperative 24th hour) values of the patients will be recorded. . before the general anesthesia is performed, the renal tissues of the patients will be visualized by ultrasound, the skin-renal cortex distances will be measured, and suitable patients will be included in the study. basal rso2 values will be recorded by placing nirs probes under the 10-11. intercostal space in the bilateral posterior lateral flank region.

Eligibility criteria:
inclusion criteria: * patients who undergoing elective laparoscopic cholecystectomi surgery lasting longer than 60 minutes * bmi:18-25 * skin-renal cortex distance measured less than 4 cm on ultrasound * asa i-iii exclusion criteria: * patient who did not give consent * patient who had renal operation before, * infection, abscess, catheter in the perirenal region * hemodynamically unstable patients, * patients with renal pathology and abnormal kidney function tests, * emergency cases

Keywords: laparoscopy nirs n-gal
evaluation of a new coating in cement less femoral stems

Conditions: Hip Osteoarthritis

Summary: the purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.

60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. this patients will be followed for at least 5 years. the outcome is evaluated by comparing stability measured by rsa and periprosthetic bone remodeling measured by bone densitometry.

Eligibility criteria:
inclusion criteria: * non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants exclusion criteria: * infection, revision surgery, severe morbidity and obvious bone loss
telemonitoraggio domiciliare della saturazione arteriosa di ossigeno in pazienti covid-19

Conditions: COVID-19

Summary: the covid-19 pandemic created an urgent need to implement digital health solutions for remote clinical management of infected patients who could be monitored at home. the gemelli polyclinic in rome provided a digital health program (satcov) to monitor at home newly diagnosed covid-19 patient, or after an early discharge from the covid units. a digital application and a wireless oximeter were provided to patients. oxygen saturation, heart rate and body temperature were monitored. the aim is to evaluate the feasibility and safety of the oxygen saturation telemonitoring in covid-19 patients. clinicians personalized their remote assistance defining specific alerts for each patient and/or required a timely hospitalization in a dedicated covid unit if necessary.


Eligibility criteria:
inclusion criteria: * adult patients (age\>18) * confirmed diagnosis of sars-cov-2 infection by a positive nasopharyngeal and oropharyngeal swab (pcr or rapid test) * clinical condition compatible with hospital discharge (for recoving covid group) or home management (for ongoing covid group) exclusion criteria: * non-autonomous patients * patients without a smartphone and home internet connection * patients unable to refer to emergency room in less than 2 hours or unable to observe home isolation * the presence of severe comorbidities that could compromise the safety of telemonitoring
endoscopic submucosal dissection in upper gastrointestinal canal with hybridknife

Conditions: Endoscopy, Digestive System; Esophageal Neoplasms; Stomach Neoplasms

Summary: endoscopic submucosal dissection (esd) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. esd has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection. new endoscopic instruments have been developed to increase the efficacy and safety of esd, and a combined endoscopic instrument (hybridknife) has been developed and evaluated with promising results in animal studies. this hybridknife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes esd possible without changing instrument. the purpose of this study is to evaluate the feasibility and safety of using hybridknife for esd in humans.


Eligibility criteria:
inclusion criteria: * submucosal tumor (\< 4 cm) * mucosal tumor (t1) in patients unsuitable for surgery exclusion criteria: * endoscopic ultrasound (eus) or ct signs of metastasis * insufficient access to tumor

Keywords: endoscopic submucosal dissection submucosal tumor minimal invasive gastroscopy
a study of the ability of functional magnetic resonance imaging (fmri) to detect and characterize the effects of two marketed centrally active drugs, placebo, and ro4917523 in healthy volunteers

Conditions: Healthy Volunteer

Summary: this is an exploratory study to evaluate the usefulness of fmri as a biomarker to characterize the response to three centrally active drugs and placebo.


Eligibility criteria:
inclusion criteria: * adult patients, 18 to 45 years of age * in good general health * weight of \&#x2265;120 lbs (55 kg) and a body mass index (bmi) between 18 to 30kg/m² * males and females with reproductive potential: willing to use a reliable method of contraception exclusion criteria: * evidence of clinically significant disease * medical or surgical condition that could alter the absorption, metabolism, or elimination of drugs * family history of sudden death or ventricular arrhythmia * history of any psychiatric disorder and/or marked anxiety * history of glaucoma * history (including family) of motor tic or diagnosis of tourette's syndrome * active suicide ideation * contraindication to mri
itraconazole for fungal sensitive chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis

Summary: the purpose of this randomized controlled double-blinded trial is to determine if the addition of an oral antifungal to typical post-operative medical therapy can prevent or reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic rhinosinusitis with nasal polyps (crswnp).

crswnp patients scheduled for medically-indicated sinus surgery will undergo screening elispot assay to identify patients with fungal sensitivity based on positive fungal induced interleukin 4 (il-4) elispot. enrolled fungal sensitive crswnp patients will undergo their sinus surgery and randomized into either placebo or itraconazole 200 mg taken by mouth twice a day (po bid) for 24 weeks in addition to standardized post-surgical regimen (9 days of perioperative prednisone, saline irrigations and pain medication as needed). patients will be followed as outpatient in rhinology clinic for 48 weeks total. during these post-op visits, compliance with medications will be determined. patients will be questioned about any possible side effects or adverse events to post-operative medications. then, the patients will be evaluated by 2 nasal specific quality of life questionnaires and nasal endoscopy. the goals of the nasal endoscopy are to evaluate the state of the sinus mucosa and to determine recurrence of nasal polyps.

Eligibility criteria:
inclusion criteria: * meet criteria for diagnosis of crs with nasal polyps undergoing medically indicated sinus surgery exclusion criteria: * cystic fibrosis * aspirin exacerbated respiratory disease * uncontrolled or unstable chronic diseases such as uncontrolled diabetes * active or history of cancer * hiv positive * history of liver or kidney disease * history of disease with effects on immune system * pregnant * allergy to triazole antifungals
sintilimab with p-gemox versus the p-gemox in the teatment of advanced-stage extranodal natural killer/t cell lymphoma

Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Summary: extranodal nk/t-cell lymphoma is a rare and highly aggressive subtype of non-hodgkin lymphoma. while the overall survival rates have improved for early-stage enktl patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. pd-1/pd-l1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal nk/t-cell lymphoma as well. although pd-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. this study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal nk/t-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal nk/t-cell lymphoma patients.


Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed with enktl. 2. advanced stage. 3. has at least one measurable or assessable lesion. 4. age \> 18 years, no gender restrictions, with an expected survival of more than 3 months. 5. willing to participate in the clinical study; fully informed and has signed a written informed consent form. 6. adequate organ and bone marrow function. exclusion criteria: 1. aggressive nk-cell leukemia. 2. central nervous system involvement. 3. patients with significant dysfunction of vital organs. 4. history of allergy to the investigational drug, similar drugs, or excipients. 5. less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes). 6. pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception. 7. active infection, excluding fever related to tumor-associated b symptoms. 8. known history of human immunodeficiency virus (hiv) infection and/or acquired immunodeficiency syndrome (aids).