Kornimate/medical-research-clean huggingface dataset:
heartlight x3 endoscopic ablation system with excalibur balloon for treatment of symptomatic persistent af

Conditions: Atrial Fibrillation

Summary: the objective of the study is to demonstrate the improved ablation and procedure times of the heartlight x3 compared to the original heartlight catheter in the treatment of persistent atrial fibrillation.


Eligibility criteria:
inclusion criteria: * early persistent af, failure of at least one aad, others exclusion criteria: * overall good health as established by multiple criteria
characterisation of the immune infiltrate and molecular features of thymic epithelial tumors tumors (tets)

Conditions: Cancer

Summary: the immuno-tet trial aims to assess the feasibility of characterising the immune environment of tets and the constitutional and somatic molecular profiles of patients with localised thymic epithelial tumour (tet).

in this prospective study, patients undergoing thymectomy and thymomectomy as part of routine care undergo the following care pathway: 1. during the pre-surgical visit (for n = 50 patients): as part of routine care, a blood sample is collected for analysis of cbc, leukocytes, lymphocytes, crp, ferritinemia, tsh, t3l, t4l, anti-acetycholine receptor antibodies, ...cmv, ebv, hsv, hiv serologies, ...and hla class i and class ii typing. 2. during thymectomy and thymomectomy surgery, the following samples are taken (for n = 50 patients): * 6 blood samples on edta tubes are collected at the time of surgery for analyses. * 3 fresh samples of the surgical specimen are taken by the pathologist: tumour t, juxta-tumour j and distant d locations for analyses by flow cytometry and rna sequencing. anatomopathology blocks/slides are also cut in the same way (tumour t, juxta-tumour j and distant d locations) for additional exploratory analyses. * the feasibility of developing patient-derived xenografts (pdx) from tets will be tested for n = 20 tumor samples. these models will allow to test potential therapeutic agents for this pathology. 3. during the 1st month (+/- 7 days) post-surgery check-up, a blood sample is taken again (for n = 50 patients) for routine care: cbc, leukocytes, lymphocytes, crp, ferritinemia, anti-acetycholine receptor antibodies and for peripheral immune system analysis at a distance from surgery and for constitutional molecular analysis. informed consent is given to participate in this prospective study.

Eligibility criteria:
inclusion criteria: 1. patient with suspicion of localised thymic epithelial tumour. 2. age ≥ 18 years. 3. treatment-naïve patient for this disease. 4. patient with an indication for thymectomy and thymomectomy in one of the partner centers. 5. signed informed consent form of the patient. exclusion criteria: 1. neoadjuvant chemotherapy. 2. no social security affiliation. 3. person under legal protection. 4. other neoplasia in progress or cured within the last 3 years (except for operated carcinoma in situ).

Keywords: thymic epithelial tumors
celebrex premedication in teeth with symptomatic irreversible pulpitis

Conditions: Pulpitis

Summary: assessing the efficacy of celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits

owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension. previous clinical trials have shown that the use of nsaids as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment. in this study, celebrex (celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo. celebrex being a selective cox-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than non-selective nsaids (nsnsaids).

Eligibility criteria:
inclusion criteria: * medically free patients * patients able to understand visual analogue scale and sign the informed conset mandibular molar teeth with: * preoperative sharp pain * vital pulp tissue * normal peripaical radiographic appearance or slight widening of the lamina dura exclusion criteria: * patients allergic to nsaids * pregnant females * patients having significant systemic disorder * patients with psychological disturbances * patients with bruxism or clenching teeth that have: * associated with swelling or fistulous tract * acute or chronic periapical abscess * greater than grade i mobility * periodontitis * no possible restorability * previous endodontic treatment
nad supplementation and vascular health in pad

Conditions: Peripheral Artery Disease

Summary: this pilot open-label clinical trial was designed to investigate whether 4-week supplementation with 1g daily nr impacts endothelial function in peripheral circulation, cerebrovascular hemodynamics, cognitive function in older adults with peripheral artery disease.

peripheral artery disease (pad) is a prevalent age-related vascular pathology and the third leading cause of cardiovascular morbidity and mortality among older adults. accumulating evidence indicates that pad is associated with generalized endothelial dysfunction that expands from the periphery to central circulation and from macro- to microcirculation. one of the mechanisms that contributes to vascular dysfunction in aging and age-related diseases is the decline in the nicotinamide adenine dinucleotide (nad) levels. importantly, recent reports indicate that age-associated decreases in nad are exacerbated in age-related diseases, including in patients with pad. clinical data demonstrate that nad levels can be increased via per os supplementation with the nad precursor nicotinamide riboside (nr). although few ongoing studies provide initial evidence that nad supplementation with nr may benefit vascular health in older adults, including potential improvements in blood pressure and aortic stiffness, the effects of nr supplementation on vascular health in pad is understudied. this pilot open-label clinical trial was designed to investigate whether 4-week supplementation with 1g daily nr impacts endothelial function in peripheral circulation, cerebrovascular hemodynamics, cognitive function in older adults with peripheral artery disease.

Eligibility criteria:
inclusion criteria: * diagnosis of pad * intermittent claudication * limited walking capacity exclusion criteria: * macologically uncontrolled type 2 diabetes, hypercholesterolemia, hypertension * major depressive disorder * current or prior cerebrovascular complications (including large vessel ischemic stroke with chronic functional impairment) * neurodegenerative diseases

Keywords: peripheral artery disease endothelial function cognition
beijing children and adolescents metabolic syndrome study (bcams study)

Conditions: Obesity; Metabolic Disease

Summary: base on enriched resources from the metabolic syndrome cohort in children, a long-term prospective cohort study will be carried out. this cohort is a unique biochemical and genetic database of chinese population with large number of subjects in the world. by collecting information of disease history and lifestyle, measuring clinical and metabolic parameters, especially biomarkers which can reflect the underlying mechanism of insulin resistance and metabolic syndrome, we intend to sort out some unique biochemical and genetic markers for chinese population.

a representative sample of 19,593 school children, aged 6-18 years, were chosen from four of the eight urban districts and three of seven rural districts in the beijing area between april and october, 2004. among these children and adolescents, 4,500 were recognized as having risk factors defined by the presence of any one of the following: overweight, total cholesterol (tc) ≥ 5.2 mmol/l, triglyceride (tg) ≥ 1.7 mmol/l or fasting glucose (fg) ≥ 5.6 mmol/l based on initial finger capillary blood tests. moreover, all subjects at increased risk for metabolic syndrome, together with a parallel reference population of 1,095 children, were invited to undergo medical examinations for verification based on venipuncture blood samples. clinical data, biomarkers including adipokines, and lifestyle factors such as physical activity and diet were measured and documented. genetic variants previously reported from genome-wide association study (gwas) of obesity and diabetes and dna-methylation were also assessed. further, high-throughput analysis of proteomics and metabolomics of the blood samples were conducted. cross-sectional and follow-up evaluations will be undertaken. the unique biochemical and genetic markers for chinese population will be identified in the bcams study. the biomarkers will build a solid foundation for progressive study on mechanism of metabolic diseases and lead to early prediction of these diseases.

Eligibility criteria:
inclusion criteria: * children aged 6 to 18 years old from beijing area in china exclusion criteria: * children or their parents refused to participate in the study

Keywords: children obesity metabolic disease
sirolimus-eluting bx velocitytm balloon-expandable stent in a compassionate use registry (secure)

Conditions: Coronary Artery Disease

Summary: the objective of this study is to allow treatment with the sirolimus-eluting bx velocitytm stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female patient minimum 18 years of age 2. there is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon; 3. target lesion is 2.50mm and 3.50mm in diameter (visual estimate); 4. target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents; exclusion criteria: 1. there is currently another method of treatment for the patient, including coronary artery bypass surgery (cabg) or brachytherapy; 2. the study target lesion has definite or possible thrombus present by angiographic criteria.
continuous vs intermittent monitoring of respiratory and heart rate in relation to length of stay

Conditions: Perioperative Complication; Perioperative/Postoperative Complications; Surgery-Complications

Summary: is heart rate and respiratory rate measured continuously with a new wireless sensor better as compared to standard care, with manually measured spot checks by nurses on general wards? does continuous monitoring detect more abnormal respiratory- and heart rate? are abnormal values associated with increased lenght of stay?

tachypnea is not just a sign of ventilatory problems with hypoxia, but also a precursor of sepsis, metabolic acidosis and severe pain reflecting its role as an indicator of severe derangement in many body systems. a high respiratory rate has been shown to be the most reliable vital sign to predict clinical deterioration, cardiac arrest and is even associated with higher mortality rates. despite this, it is the vital parameter most neglected; poorly documented or not recorded at all. studies have shown that respiratory rate is measured in less than half of cases consequently jeopardizing patient safety. the lack of understanding why respiratory rate is important and its superiority to pulse oximetry in predicting clinical deterioration may be one of the reasons why it is not measured accurately. badawy and colleagues stated in their study "is everyone really breathing 20 times a minute?" that respiratory rate was inaccurately recorded and had little variation in the recordings, even in patients with cardiopulmonary compromise, findings that's been supported with later studies. respiratory rate has traditionally not been objectively measured in general wards, but instead calculated manually over 30 seconds or a minute. this could be changed by new wireless monitoring technology. a recent large study showed that continuous measured respiratory rate together with heart rate and age in a clinical deterioration model outperformed traditional early warning scores in predicting icu admission. the present study evaluates heart rate and respiratory rate measured continuously with a new wireless sensor as compared to standard care, with manually measured spot checks by nurses on general wards.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. planned to go through a major high-risk surgery 3. american society of anesthesiologists (asa) class 2-4 due to present comorbidities 4. planned to stay in the postoperative high dependency unit for \>12hours where they also would have wired continuous monitoring. exclusion criteria: 1. pregnancy 2. presence of implantable defibrillator or pacemaker 3. allergy to skin adhesives
study of as1411 in advanced solid tumours

Conditions: Advanced Solid Tumors

Summary: a phase i open label study of as1411 in advanced solid tumours. objectives include determining the mtd and dlt of as1411, to determine the pk profile of as1411 and to obtain preliminary evidence of clinical and biological responses to as1411 therapy.


Eligibility criteria:
inclusion criteria: * patients with advanced solid tumours that were refractory to conventional/standard treatment * age \>/ 18 years * ecog performance status \ /60% * life expectancy \>/ 8 weeks * adequate organ and marrow function exclusion criteria: * radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for nitrosourea or mitomycin c * lack of recovery from adverse events (aes) caused by agents administered before study entry; current use of other investigational agent(s) * uncontrolled brain metastases including a need for corticosteroid therapy * pregnancy * uncontrolled intercurrent illness * psychiatric illness/social situations that could limit compliance
comparing photodisinfection of chitosan np enriched icg over icg as adjunct to ofd: rct

Conditions: Periodontal Pocket

Summary: the current study is a prospective randomised study-comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage ii/iii grade b/c periodontitis.

a total of 24 patients fulfilling inclusion criteria will be randomly assigned into two treatment groups (test and control). open flap debridement followed by photodynamic therapy using dyes is carried out. test group (n=12) - pdt with chitosan nanoparticles enriched icg control group(n=12) - pdt with icg microbial levels of p.gingivalis is analysed with pcr analysis on baseline and 3 months after intervention.

Eligibility criteria:
inclusion criteria: * systemically healthy subjects * age group 30-55yrs. * diagnosed with stages ii/iii grade b/c periodontitis. * presenting with persistent pocket depth ≥5mm after initial non-surgical therapy. * optimal plaque control * good compliance exclusion criteria: * subjects on antibiotic therapy within last six months of enrollment * previous history of periodontal surgery * allergy to drugs and materials used in this study * pregnant woman * subjects with deleterious habits like smoking, tobacco chewing.
integrative approaches for cancer survivorship 2: project 2

Conditions: Breast Cancer

Summary: the purpose of this study is to develop and test a 6 month manualized health education intervention in recent breast cancer survivors.

post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. the investigators aim to develop and test a health education intervention in breast cancer survivors. specifically, the investigators aim to develop the manualized health education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. the data from this pilot study will be used to inform future study.

Eligibility criteria:
inclusion criteria: * female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * having received chemotherapy as part of their primary therapy for breast cancer * be in complete remission * aged 18 years or older * able to read, write, and understand english * karnofsky performance status (kps) greater than or equal to 60 * have impaired quality of life * ability to give informed consent exclusion criteria: * receiving chemotherapy or radiotherapy at the time of study enrollment. anti-her2 directed therapy is not exclusionary. * being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). smaller surgical procedures such as implant exchange are not exclusionary. * patients on adjuvant hormone therapy for less than 2 months * have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. smaller surgical procedures such as implant exchange are not exclusionary.
masitinib for the treatment of severe mast cell activation syndrome

Conditions: Mast Cell Activation Syndrome

Summary: to evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe mcas with handicap unresponsive to optimal symptomatic treatment.

multicenter, double-blind, placebo-controlled trial comparing two different dosing schemes over a 24-week treatment period. dosing scheme #1: oral masitinib treatment at 3 mg/kg/day for 4 weeks, then a switch to 4.5 mg/kg/day for the remainder of the treatment period, versus placebo with a matching titration scheme. randomization 2: 1 (masitinib mcas: placebo mcas). dosing scheme #2: oral masitinib treatment at 3 mg/kg/day for 4 weeks, then a switch to 4.5 mg/kg/day for 4 weeks, then a second switch to 6 mg/kg/day for the remainder of the treatment period versus placebo treatment with a matching titration scheme. randomization 2: 1 (masitinib mcas: placebo mcas)

Eligibility criteria:
inclusion criteria include: * patient with mast cell activation syndrome (mcas). * patient with severe symptoms over the 14-day run-in period defined as at least one of the following: pruritus score ≥ 9; number of flushes per week ≥ 8; hamilton rating scale for depression (hamd-17) score ≥ 19 * patient with documented treatment failures of his/her handicap(s) (within last two years) with at least two of the symptomatic treatments used at optimized dose. * patients must be on a stable dose of anti-h1 for a minimum of 4 weeks before screening and should remain at a stable dose throughout the study period. exclusion criteria include: * previous treatment with any tyrosine kinase inhibitor. * any change in the symptomatic treatment of mcas, including systemic corticosteroids, or administration of any new treatment for mcas within 4 weeks prior to screening. * patient with systemic indolent mastocytosis. * female patients who are pregnant or are breastfeeding.
effects of cladribine tablets on the pk of microgynon®

Conditions: Relapsing Multiple Sclerosis (RMS)

Summary: the purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (pk) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (ee) and levonorgestrel (lng).


Eligibility criteria:
inclusion criteria: * are pre-menopausal women with or without child-bearing potential with a negative serum pregnancy test, and women with child-bearing potential receiving adequate birth control * participants with diagnosis of clinically stable and definite relapsing multiple sclerosis (rms) * adequate hematological, hepatic and renal function as defined in the protocol * are able and willing to accept dietary restrictions and restrictions regarding the use of concomitant medications (including over-the-counter products, herbal medicines and dietary supplements) over the course of the study * had a body weight and body mass index (bmi) within the range at screening * other protocol defined inclusion criteria could apply exclusion criteria: * history of clinically relevant allergy or known hypersensitivity to the active substance or to any of the excipients of cladribine tablets or hypersensitivity to drugs with a similar chemical structure to cladribine - history of clinically relevant allergy or known hypersensitivity to 1 of the active substances levonorgestrel (lng) or ethinylestradiol (ee) or to any excipients of microgynon® tablets * positive results from serology examination for hepatitis b surface antigen (hbsag) not due to vaccination, hepatitis b core antibody (hbcab), hepatitis c virus antibody (anti- hcv) or human immunodeficiency antibody (anti-hiv) * presence or risk of venous thromboembolism (vte) arterial thromboembolism (ate) * diabetes mellitus (type 1 or type 2) with vascular manifestations * signs or symptoms of neurological disease other than multiple sclerosis (ms) that could explain the symptoms of the participant * presence of gastrointestinal (gi) disease or history of gastrointestinal -tract surgery * exposure to another investigational drug within the last 2 months or within last 6 month if agent is known to be immunosuppressive * other protocol defined exclusion criteria could apply

Keywords: multiple sclerosis cladribine microgynon®
subtotal cholecystectomy for difficult gall bladder due to chronic cholecystitis

Conditions: Gallstone

Summary: subtotal cholecystectomy (stc) is a valuable technique when severe inflammation, fibrosis, or anatomical variations obscure the critical view of safety essential for identifying the cystic duct and artery. it helps reduce the risk of bile duct injuries and other complications that arise during a total cholecystectomy (tc) when these structures are not visible. this study evaluates the safety and outcomes of subtotal cholecystectomy in chronic cholecystitis.

a retrospective analysis was conducted in all patients who underwent a cholecystectomy between may 2021 and november 2024. indications, complications, and perioperative outcomes of stc were compared with those of standard tc. the investigators concluded stc is an important bailout procedure in a difficult laparoscopic cholecystectomy associated with higher early postoperative complications but lower bile duct injury.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cholelithiasis planned for laparoscopic cholecystectomy * clinical diagnosis of gallbladder polyp planned for laparoscopic cholecystectomy exclusion criteria: * gall bladder malignancy * cholelithiasis and gallbladder polyp cases managed non-operatively * additional procedures along with cholecystectomy like bile duct exploration, bile duct excision for choledochal cyst.