Kornimate/medical-research-clean huggingface dataset:
endoscopy and radiology-guided ablation for inoperable cholangiocarcinoma

Conditions: Perihilar Cholangiocarcinoma

Summary: this prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.

this clinical trial proposes a personalized treatment approach to inoperable perihilar cholangiocarcinoma consisting of endoluminal ablative therapy via radiofrequency ablation followed by endoscopic biliary drainage. patients presenting with jaundice / biliary obstruction caused by inoperable perihilar cholangiocarcinoma as assessed during multidisciplinary case discussion will be invited to enroll in this trial. patients will be randomized in a 1:1 fashion to receive biliary plastic stenting (control arm) or biliary plastic stenting + radiofrequency ablation via endoscopic approach. in cases where ercp fails to achieve adequate biliary drainage, stenting and/or drainage will be attempted via percutaneous approach. additional systemic chemotherapy will be offered to all eligible patients according to the local standard of care. patients will be followed up with a clinical visit at 2 weeks and stent exchange (+ additional rfa treatment in the control arm) will be offered at 8-12 weeks interval until disease progression, clinical deterioration precluding ercp or death. the main study objectives are: * to assess the technical feasibility of implementing the proposed therapeutic protocol involving a combined endoscopic-radiologic approach to drainage and ablation * to evaluate the efficacy of radiofrequency ablation in local disease control * to evaluate whether complete drainage and radiofrequency ablation have a cumulative benefit in patients with inoperable perihilar cholangiocarcinoma * to evaluate the safety of our proposed therapeutic protocol combining interventional endoscopy with radiology

Eligibility criteria:
inclusion criteria: * perihilar cholangiocarcinoma * locally advanced disease (unresectable) * m1 (limted to 1 site) exclusion criteria: * refusal to sogn the icf * poor performance status (ecog \>2) * surgically altered anatomy (i.e bilroth ii or roux-en-y interventions) * significant comorbidities * asa score \>3 * life expectancy \<3 months

Keywords: perihilar cholangiocarcinoma ercp radiofrequency ablation
improved erectile function after bariatric surgery: role of testosterone and other factors

Conditions: Bariatric Surgery; Erectile Dysfunction

Summary: the prevalence of obesity has risen dramatically worldwide. beyond its metabolic implications, obesity profoundly impacts sexual health, particularly in males, with erectile dysfunction emerging as a prevalent and distressing comorbidity. studies show that bariatric surgery alleviates erectile dysfunction. patients suffering from obesity have lower testosterone levels, which increase after weight-loss surgery. this study aims to investigate the relationship between erectile dysfunction improvement, weight loss and hormonal changes after surgery.

in recent decades, the prevalence of obesity has risen dramatically worldwide, presenting significant public health concerns. beyond its metabolic implications, obesity profoundly impacts sexual health, particularly in males, with erectile dysfunction (ed) emerging as a prevalent and distressing comorbidity. obesity exacerbates the risk of ed through complex interplays of physiological and psychological mechanisms. physiologically, excess adiposity leads to chronic inflammation, endothelial dysfunction, and hormonal imbalances, all of which contribute to impaired vascular health and reduced testosterone levels, key factors in erectile function. psychologically, body image dissatisfaction and decreased self-esteem associated with obesity can exacerbate sexual performance anxiety and further contribute to ed. bariatric surgery is an established treatment method for long-term weight loss which also alleviates symptoms of diabetes, hypertension, and other weight-related comorbidities.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic sleeve gastrectomy who were qualified according to guidelines of the international federation for the surgery of obesity and metabolic disorders exclusion criteria: * lack of data during follow-up visit (at 1-year).

Keywords: bariatric surgery erectile dysfunction obesity
mature dendritic cell vaccination against unique immunogenic peptides in patients with non small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell-Lung; Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer

Summary: the purpose of this research study is to study the safety and immune response of people who receive a personalized dendritic cell vaccine with the intention of stimulating the immune system to react to lung cancer cells.

tumor vaccines represent a promising area of clinical investigation in solid tumors based on evidence of clinical activity and minimal toxicity. the underlying hypothesis of this research is that immunization against tumor neoantigens is effectively required to elicit antigen-reactive t cells capable of recognizing and eliminating cancer. moreover, both quantitative and qualitative improvements in cd8 immunity are necessary (but not sufficient) for clinical response and improved survival. the goal of this study is to build on our prior clinical trial results in melanoma by studying the immune response to tumor neoantigens in patients with stage 1 nsclc.

Eligibility criteria:
inclusion criteria: * patients with completely resected stage i non-small cell lung cancer who are not considered for adjuvant post operative therapy. * age ≥ 18 years. * ecog performance status 0-1. * hla-a2 positive. * required initial laboratory values (submitted within 14 days prior to registration): * wbc \> 3,000/mm3 * hg ≥ 9.0 gm/dl * platelets \>75,000/mm3 * serum bilirubin \< 2.0 mg/dl * serum creatinine \< 2.0 mg/dl * sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy. * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * prior treatment with cytotoxic chemotherapy * prior treatment with targeted therapy or immunotherapy. * active untreated cns metastasis. * active infection. * prior malignancy (except non-melanoma skin cancer) within 3 years. * pregnant or nursing. * concurrent treatment with systemic corticosteroids; local (inhaled or topical) steroids are permitted. * known allergy to eggs. * prior history or uveitis or autoimmune inflammatory eye disease. * known positivity for hepatitis b sag, hepatitis c antibody, or hiv antibody.
immunogenicity and safety study of 2 doses of live attenuated varicella vaccine

Conditions: Chickenpox

Summary: the purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(gmts) of 2 doses of live attenuated varicella vaccine.


Eligibility criteria:
inclusion criteria: * parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent * participant is aged ≥ 1 year to ≤ 3 years * participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster * subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures * body temperature ≤ 37.5℃ exclusion criteria: * known allergy to any constituent of the vaccine * known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction * failed to the expanded programme on immunization(epi) * receipt of any vaccine in the 4 weeks preceding the trial vaccination * plan to receive any vaccine in the 4 weeks following the trial vaccination * known bleeding disorder * receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination * reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination * an acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial * participation in any other interventional clinical trial * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
a study to evaluate treatment with nivolumab alone and nivolumab combined with ipilimumab in children with melanoma

Conditions: Melanoma

Summary: the purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage iib-iv melanoma. demographic and clinical characteristics, and treatment patterns, will also be described in this population.


Eligibility criteria:
inclusion criteria: * participants with confirmed diagnosis of unresectable or metastatic cutaneous melanoma, or stage iib-iv cutaneous melanoma who have undergone complete resection * initiated treatment with nivolumab monotherapy or in combination with ipilimumab for unresectable or metastatic melanoma, or as adjuvant therapy for resected stage iib-iv melanoma, between january 1, 2015 and 6 months prior to data collection * for the adjuvant nivolumab cohort, initiated treatment with nivolumab for stage iib-iv melanoma within 12 weeks following index resection * aged \<18 years at the time of nivolumab/ipilimumab treatment initiation * at least 6 months of follow-up from index treatment date (unless deceased prior to end of 6 months) exclusion criteria: * prior malignancy active within 3 years prior to nivolumab or ipilimumab treatment index date except for locally curable cancers that have been apparently cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast) * receiving nivolumab therapy (monotherapy, combination with ipilimumab, or adjuvant therapy) for melanoma as part of a clinical trial during the study period
the role of bariatric surgeries in management of nonalcoholic fatty liver disease

Conditions: NAFLD; Bariatric Surgery Candidate

Summary: the role of bariatric surgeries in management of nonalcoholic fatty liver disease

the overall global prevalence of nonalcoholic fatty liver disease diagnosed by imaging is around 25.24%. the highest prevalence of nafld is reported from the middle east 31.79% and south america 30.45% whereas the lowest prevalence rate is reported from africa 13.48%. unlike nafld, nonalcoholic steatohepatitis is more aggressive and is associated with a risk of approximately 10 to 29% of progression to cirrhosis within10 years. therefore, early-stage nash represents a group of patients that is most likely to benefit from treatments in order to prevent progression to cirrhosis and its complications. obesity is the most common and well documented risk factor for nafld, the majority (\>95%) of patients with severe obesity undergoing bariatric surgery will have nafld. to date, weight loss achieved via lifestyle intervention remains the mainstay of treatment of nash. bariatric surgery contributes to weight loss in two main ways: restrictive procedures and malabsorptive procedures. in 2018, the aasld board stated that it is premature to consider foregut bariatric surgery as an established option to specifically treat nash. accordingly, the effects of bariatric surgery on hepatic fibrosis are still unclear. in egypt there is lack in such type of study thus this research will conducted to evaluate the prevalence of nafld and nash in obese patients undergoing bariatric surgery and to assess the role of bariatric surgery in management of nafld related hepatic morbidity in our locality.

Eligibility criteria:
inclusion criteria: 1. above 20 years of age 2. morbid obesity 3. severe obesity with as arterial hypertension or type 2 diabetes mellitus (t2dm), exclusion criteria: * 1- chronic liver diseases 2-long term consumption of hepatotoxic drugs. 3-active alcohol abuse 4-medical or psychological contraindications for bariatric surgery. 5-refusal of giving a consent
effect of compression dressing after upper eyelid blepharoplasty on edema, ecchymosis, pain and ocular surface irritation

Conditions: Dermatochalasis of Eyelid

Summary: study to analyze whether there is a difference in postoperative outcome regarding edema, ecchymosis, pain, osi and discomfort of the patients after blepharoplasty if a compression dressing is used or not.


Eligibility criteria:
inclusion criteria: * patients with upper eyelid dermatochalasis who were scheduled for upper eyelid blepharoplasty exclusion criteria: * previous surgery on the upper eyelid, previous eye lid trauma, congenital lid changes, blepharochalasis syndrome, coagulation disorders or indication for combined ptosis and blepharoplasty surgery
dental anxiety during restorative dental treatment

Conditions: Hypnotherapy; Virtual Reality; Mindfulness

Summary: anxiety refers to behavioural disorders associated with excessive fear and anxiety. dental anxiety refers to excessive fear and anxiety at the thought of going to the dentist. this may cause patients to avoid dental treatments and may adversely affect oral health. this study aims to evaluate the effects of hypnotherapy, virtual reality distraction and mindfulness-based meditation practices on dental anxiety during restorative dental treatment.


Eligibility criteria:
inclusion criteria: * a modified dental anxiety score of 20 and above * a dental fear scale score of 59 and above * d2 level caries according to radiographic caries classification system, * systemically healthy patients exclusion criteria: * balance disorders such as nystagmus and vertigo, * pregnant woman * claustrophobia * physical or mental disability * not knowing how to read and write * psychological disturbance * taking antidepressants or anxiolytics

Keywords: dental anxiety, hypnotherapy, virtual reality glasses application, mindfulness-based meditation practice
exploratory study in healthy elderly subjects to collect urine for development of assays to detect s. pneumoniae

Conditions: Infections, Streptococcal

Summary: gsk biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. for the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. some tests on urine are already on the market but need to be improved in the laboratory. for that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 65 and 85 years of age at the time of the study. * written informed consent obtained from the subject * healthy subjects as established by medical history and clinical examination before entering into the study exclusion criteria: * previous vaccination against streptococcus pneumoniae in the 3 months before study start, * history of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start

Keywords: invasive pneumococcal diseases pneumonia
evaluation of inflammatory markers and periodontal viruses on periodontitis patients with cad

Conditions: Periodontitis; Coronary Artery Disease

Summary: to assess and compare the demographic variables, periodontal parameters, cardiac parameters and the expression of periodontal viruses (cmv, hsv and ebv) and inflammatory biomarkers(ptx-3, tlr-2 \& tlr-4) in periodontally healthy and generalized periodontitis patients with and without coronary artery disease(cad).

a total of 240 subjects will be recruited based on the power of the study. the selected subjects will be divided into four groups based on the inclusion and exclusion criteria. 1. group i: 60 healthy subjects ( no generalised periodontitis and no cad) 2. group ii: 60 generalised periodontitis subjects without cad 3. group iii: 60 cad subjects without generalised periodontitis 4. group iv: 60 subjects with generalised periodontitis and cad sub-gingival plaque samples will be collected from the subjects of all the four groups. coronary artery plaque samples will be collected from the patients who were indicated for coronary artery bypass graft surgery (cabg) among group iii and group iv. the demographic variables , periodontal parameters , cardiac parameters , expression of periodontal viruses and inflammatory biomarkers will be measured in all four groups ,

Eligibility criteria:
inclusion criteria: 1. patients willing to participate in the study. 2. patients with 30 to 65 years of age group 3. both genders 4. patients should have minimum of 10 natural teeth. 5. in case of group iii and iv patients with coronary heart disease to be included. exclusion criteria 1. patients who had undergone periodontal therapy within the previous 6 months. 2. type i and ii diabetes mellitus 3. sarcoidosis patients. 4. carcinoma patients. 5. rheumatic arthritis patients. 6. tuberculosis patients. 7. immunosuppressive conditions. 8. patients with other inflammatory diseases.

Keywords: ebstein barr virus cytomegalovirus herpes simplex virus pentraxins toll like receptors
weight loss plus omega-3 fatty acids or placebo in high risk women

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids epa and dha, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.

subjects will all participate in a 6-month weight loss intervention. subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.

Eligibility criteria:
inclusion criteria: * evidence of hyperplasia with masood score of 13 or higher and 500 or more epithelial cells on cytology slide of screening random periareolar fine needle aspiration (rpfna) * access to smart phone and or computer * willing to comply with diet, exercise and lifestyle modification during weight reduction and maintenance phase. * willing to start the dietary and exercise intervention within 9 months of rpfna * willing to complete quality of life questionnaires at multiple visits * willing to have a medical history and physical at multiple visits * willing to have an additional rpfna at two additional visits * be willing to have blood drawn at multiple visits * willing to sign and able to understand consent for the rpfna's and study participation * reasonable hematopoetic, kidney and liver function consistent with safe participation on this trial. exclusion criteria: * having taken medications that seriously affect metabolism such as steroids, dexatrim or other diet drugs within 3 weeks of study registration * have changed dose or type of hormone supplementation within 3 months * currently receiving other investigational agents * have been on a chemoprevention trial within 6 months or taken a selective estrogen receptor modulator or aromatase inhibitor within last 6 months. * need for chronic use of aspirin, nonsteroidal anti-inflamatory drug (nsaid) or other anti-inflammatory agents * taking metformin, or other diabetes medications * taking statins * unable to participate in moderate intensity exercise (walking, treadmill, elliptical, water aerobics) * would be unable to participate, by phone, in weekly phone call sessions * cells suspicious for malignancy as assessed by cytotechnologist or cytopathologist.

Keywords: breast cancer risk dha omega-3 fatty acids epa weight loss
id as a promoter of ih-induced cavd

Conditions: Iron Deficiencies; Calcified Aortic Valve

Summary: calcific aortic valve disease (cavd) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. elucidating viable therapeutic strategies for cavd is pressing. valvular interstitial cells (vics) control the structure and function of aortic valve. intra-leaflet haemorrhage (ih), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. in line with this, later exploration from vitro showed that iron stimulation alone could not promote vics calcification. iron deficiency (id) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as cavd; up to 50% of patients with severe aortic stenosis present id. data from a small clinical study in patients undergoing tavi showed those in id status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between id and aortic valve remodelling and dysfunction progress itself. here, the investigators aim to investigate for a tentative correlation between id and human aortic valve remodeling and dysfunction.


Eligibility criteria:
inclusion criteria: * if performed with both color doppler echocardiography and anemia profile on admission as part of routine checkup. exclusion criteria: * if younger than the age of 18; * if no anemia profile or doppler echocardiography was measured; * if anemia profile or doppler echocardiography was analyzed in external laboratories; * if had a history of rheumatic heart disease, infective endocarditis or any other congenital disorders that may implicate aortic valve structures, such as bicuspid aortic valve morphology, marfan syndrome, and so on.