Kornimate/medical-research-clean huggingface dataset:
pulse pvc registry: multicenter study on focal pulsed field ablation for premature ventricular contractions

Conditions: Premature Ventricular Contraction (PVC); Pulsed Field Ablation

Summary: the pulse pvc registry is a european multicenter observational study designed to assess the safety and efficacy of focal pulsed field ablation (pfa) using the centauri generator system in patients with symptomatic premature ventricular contractions (pvcs). the registry collects standardized procedural and follow-up data across diverse pvc origins, enabling comparisons with historical radiofrequency (rf) ablation outcomes. data will include baseline characteristics, procedural details, complications, and long-term pvc burden reduction. each center will obtain local ethics approval, and only anonymized data will be analyzed.

the pulse pvc registry is a european multicenter observational registry designed to evaluate the safety, feasibility, and midterm outcomes of focal pulsed field ablation (pfa) for the treatment of symptomatic premature ventricular contractions (pvcs). the study includes patients undergoing focal pfa using a monopolar biphasic energy system (centauri generator), across multiple high-volume electrophysiology centers in europe. the registry collects detailed baseline demographics, comorbidities (e.g., hypertension, diabetes, chronic kidney disease), structural heart disease status, antiarrhythmic drug use, prior ablation history, and baseline pvc burden. procedural characteristics include pvc mapping approach, pharmacologic testing (e.g., isoproterenol, nitroglycerin), number and type of ablation applications (pfa and/or rf), use of coronary angiography, venous system access (gcv/aiv), and fluoroscopy metrics. outcomes assessed include: primary outcome: midterm clinical success, defined as a reduction in pvc burden to \<5% on follow-up (via holter monitoring) secondary outcomes: acute procedural success, complication rates (e.g., coronary vasospasm, conduction disturbances, stroke, vascular complications), and recurrence patterns. patients are stratified based on the site of origin of pvcs (e.g., rvot subregions, lvot, aortic cusps, papillary muscles). follow-up includes symptom assessment, pvc burden, antiarrhythmic drug use, and mode of follow-up (telephone or in-person). the registry provides a comprehensive overview of clinical outcomes with focal pfa and enables comparison with historical radiofrequency ablation data. this registry aims to generate robust real-world evidence to inform procedural strategy, patient selection, and safety considerations in pvc ablation using pulsed field energy.

Eligibility criteria:
inclusion criteria: * patients with symptomatic pvcs who underwent focal monopolar biphasic pfa * use of centauri generator system * minimum 3-month clinical follow-up at time of data entry exclusion criteria: * incomplete procedural or follow-up data * patients receiving exclusively rf ablation
phase ii randomized placebo-controlled study with vitamin k2 in asymptomatic calcified carotid stenosis

Conditions: Carotid Disease; Atherosclerosis

Summary: randomized placebo-controlled study with vitamine k2 (menaquinone-4) in calcified carotid stenosis. we evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.


Eligibility criteria:
inclusion criteria: * carotid stenosis between 50 and 70% (nascet criteria) with calcified plaque exclusion criteria: * renal and/or hepatic failure * diseases with secondary calcifications * dementia * previous strokes * concomitant use of anticoagulants * concomitant infections * pregnancy or breastfeeding * reduced patient's compliance
effect of belimumab on antibody titers in primary aps patients

Conditions: Antiphospholipid Syndrome (APS)

Summary: the purpose of this study is to evaluate the regulatory effect of belimumab on the antiphospholipid antibody (apl) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients.

this is a single center, randomized controlled trial in ruijin hospital. the enrolled patients will be randomized in a 1: 1 ratio to receive either soc+belimumab or soc treatment. belimumab is administered intravenously at a dose of 10mg/kg once a month for 18 months.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * positive for high-titer antiphospholipid antibodies according to the criteria of the "eular guidelines for the treatment of antiphospholipid syndrome in adults" published in 2019. * stable aps regimen according to eular recommendations for antiphospholipid syndrome. * female patients who are not pregnant, breastfeeding, of childbearing potential, or not using contraception. exclusion criteria: * patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years; * patients with a history of primary immunodeficiency; * serious lack of igg (igg level \&lt; 400 mg/dl); * iga deficiency (iga level \&lt; 10 mg/dl); * patients with a current history of infection; * patients with a current history of drug or alcohol abuse or dependence, or have a history of drug or alcohol abuse or dependence within 365 days before day 0; * hiv test is historically positive or hiv screening is positive; * hepatitis status; * patients with a history of allergic reaction caused by injection of contrast agent, human or mouse protein or monoclonal antibody; * patients with other abnormal laboratory values with clinical significance; * if women with reproductive potential (wcbp) are included, please refer to the following special instructions; * patients with concurrent major medical or mental illnesss; * patients with diseases of liver, kidney, heart and other important organs,blood and endocrine system; * patients who have been vaccinated with live vaccine in the last month; * patients who have participated in any clinical trial within 28 days before the initial screening and/or within 5 times of the half-life of the study compound (whichever is longer); * patients who use b-cell targeted therapy drugs within one year, such as rituximab or epratuzumab; * patients who use tumor necrosis factor inhibitor and interleukin receptor blocker within one year; * patients who use intravenous gamma globulin (ivig) and prednisone ≥100mg/d for more than 14 days within one year or plasma exchange; * patients with active infection (such as herpes zoster, hiv infection, active tuberculosis, etc.) during the screening period; * patients with depression or suicidal thoughts; * other conditions that the investigator considers would make the candidate unsuitable for the study.

Keywords: belimumab antiphospholipid syndrome (aps) antiphospholipid antibodies
mri guided sbrt for localized prostate cancer

Conditions: Prostate Cancer

Summary: this study utilizes advanced imaging techniques (mpmri prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. in patients without identifiable prostate cancer lesions, sbrt to the prostate in 5 sessions (fractions) will be administered. in patients with mri-identified lesion(s), pelvic imrt in 25 fractions will be administered followed by an sbrt prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.

radiotherapy (rt) is considered standard of care treatment for prostate cancer. conventional rt regimens consist of 8-9 weeks of daily rt. recent data support the use of hypofractionated rt (5-6 weeks) due to similar disease control in a contracted treatment time. this study combines the benefits of rt dose escalation while shortening the overall rt treatment course. in this protocol, patients will undergo a pretreatment mpmri prostate scan and be stratified to two separate sbrt regimens depending on whether prostate lesions are present. for patients without any positive mpmri lesions, an sbrt monotherapy (36.25 gy in 5 fractions) approach will be utilized. patients with an equivocal or positive mpmri lesion(s), will receive ig-imrt (45 gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a sbrt whole prostate boost (18 gy in 3 fractions) with a simultaneously integrated boost (sib) (21 gy in 3 fractions) to intraprostatic lesion(s) only. patients will be regularly assessed every 3 months for the first 2 years and then every 6 months, indefinitely. side effects will be monitored using the standardized international prostate symptom score (i-pss) and sexual health inventory of men (shim) questionnaires at baseline and subsequent follow-up appointments. hypothesis: mri-guided treatment planning and delivery can selectively target high-risk prostate cancer nodules and deliver a higher effective rt dose, to achieve maximal tumor control without increasing toxicity, all in a shortened treatment duration.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma within 1 year of randomization * nccn low to high risk localized prostate cancer * zubrod performance status 0-1 within 60 days prior to registration exclusion criteria: * prior or concurrent invasive malignancy (except non-melanoma skin cancer) * regional lymph node (n1) involvement * distant metastases (m1) involvement * history of prior pelvic irradiation (external beam radiotherapy or brachytherapy) * prior chemotherapy * severe, active co-morbidities (unstable angina and/or chf; mi; copd; liver disease; aids) * acute bacterial or fungal infection requiring iv antibiotics * inability to undergo mri * inability to receive fiducial markers

Keywords: prostate cancer radiotherapy sbrt stereotactic body radiotherapy mri
preoperative gonadotropine-releasing hormone agonist therapy before surgery for uteri̇n fibroids

Conditions: Uterine Fibroid; Gonadotropin-Releasing Hormone-Dependent Precocious Puberty

Summary: uterin fibroids are the most common operation indication for hysterectomy. dyring laparoscopic hysterectomy the amount of bleeding is a great difficulty.there are a lot of clinical researchs to reduce the haemorrhage during open hysterectomy but not laparoscopic procedure. in alku erh clinic, researchers decided to smaller the size of fibroid by using gnrh analogues before total laparoscopic hysterectomy to reduce the haemorrhage amount.

after randomising patients to two groups, one of the group will be controle group and the other group will be working group and researchers decided to use 3,75 mg leuprolide acetate as gnrha subcutanously in every four week, throughout 3 months before surgery to the working group, researchers will record intraoperative amount of bleeding by measuring the blood in suction scale, the duration of surgery, difference between preoperative haemoglobin levels and uterin weight. researchers will comparise all theese parameters ibn to two groups.

Eligibility criteria:
inclusion criteria: * myoma uteri * appropi̇ate for laparoscopy exclusion criteria: * mali̇gnancy
waiting time to operation for hip-fracture patients

Conditions: Hip-fracture

Summary: this study investigates the relationship between waiting time to surgery and the risk for medical complications and 1-year mortality in hip-fracture patients.


Eligibility criteria:
inclusion criteria: * hip-fracture patient exclusion criteria: * periprosthetic fracture * pathological fracture

Keywords: hip-fracture
study of the effect of water soluble oral contrast (gastrografin) on postoperative ileus after colorectal surgery

Conditions: Postoperative Ileus

Summary: the purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.


Eligibility criteria:
inclusion criteria: * all patients with postoperative ileus after colorectal surgery, defined as the presence from the third postoperative day, abdominal distension, nausea, vomiting with or without abdominal pain or discomfort by dilation of bowel loops, confirmed radiology of the abdomen, and which are: age \> 18 years patients undergoing laparotomy or laparoscopy for the following variants of colorectal disease with or without stoma: 1. neoplasia. 2. inflammatory disease. 3. diverticular disease. patients who have been treated with standard pca as postoperative analgesia. signed informed consent. undergoing elective or scheduled exclusion criteria: * patient's refusal to sign informed consent * pregnancy or lactation * hypersensitivity to iodinated contrast agents (it´s the only contraindication to oral gastrografin) presence of other problems that justify the etiology of postoperative ileus: 1. anastomotic leakages. 2. mesenteric vascular disease. 3. incarcerated hernias. 4. intra-abdominal abscesses or collections. 5. metabolic or electrolyte disturbances. if during the course of the study one of the reasons previously cited as the etiology of postoperative ileus is present, the patient shall also be excluded. also excluded patients undergoing emergency surgery.

Keywords: gastrografin postoperative ileus colo-rectal surgery effects on morbidity and mortality of postoperative ileus
interest of lc-oct for diagnosing inflammatory dermatoses: odin (oct dermotoses inflammatoires)

Conditions: Inflammatory Skin Disease, Psoriasiform Dermatoses, Eczematiform Dermatoses, Lichenoid Dermatoses, Psoriasis, Eczema, Lichen, Lupus, Dermatomyositis

Summary: inflammatory dermatoses (eczematiform dermatoses, psoriasiform dermatoses, lichenoid dermatoses, toxic dermatoses, auto-immune and auto-inflammatory dermatoses, etc.) and their differential diagnoses (infectious or para-infectious dermatoses, deficiency dermatoses, etc.) are frequent reasons for dermatology consultations. these dermatoses are clinically heterogeneous eruptions for which a skin biopsy for histological examination may be routinely required to confirm the diagnosis. lc-oct (deeplive damae medical machine) is a new non-invasive skin imaging technique (using non-ionizing infrared light), enabling observation of skin tissue to a depth of 500 µm with a resolution of 1 µm (= "cellular" resolution, the keratinocyte, the main skin cell, measuring between 5 and 10 µm). this technique has already proved its worth in the diagnosis of skin cancers, and has the advantage of being non-invasive, painless and quicker than a biopsy. the investigators of the study want to study its value in the diagnosis of inflammatory dermatoses. during the consultation dedicated to skin biopsy, a cutaneous lc-oct examination is routinely performed, but only for exploratory purposes, allowing better targeting of the most modified area. the aim of the study is to describe and analyze the characteristics of cutaneous imaging (lc-oct) in inflammatory dermatoses, comparing them with the histological appearance of biopsy specimens. this is a preliminary study aimed at defining the value of lc-oct in the diagnosis of inflammatory dermatoses, in the hope of replacing skin biopsy in the future.


Eligibility criteria:
inclusion criteria: * - age greater than or equal to 18 years. * definitive histopathological diagnosis of inflammatory dermatosis, including classification by type (eczematiform, psoriasiform or lichenoid) and subtype (e.g. atopic dermatitis for eczematiform dermatosis, lupus for lichenoid dermatosis, etc.). * availability of good-quality lc-oct images/videos, with at least one interpretable 3d block, a video scanning lesional and healthy skin in a manner deemed "sufficient", as judged collegially by the authors. exclusion criteria: * none
group metacognitive therapy for anxiety and depression in cancer survivors

Conditions: Cancer; Anxiety; Depression; Quality of Life

Summary: this study aims to test the potential of group metacognitive therapy in alleviating emotional distress in cancer survivors. the investigators aim to find out if a group based approach is acceptable to patients and feasible to deliver in a routine clinical health psychology service.

survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the united kingdom, projected to increase to 4 million by 2030. around 25% of these survivors require treatment for clinical levels of emotional distress. current pharmacological treatments are not very effective and are not well tolerated by patients, who prefer psychological treatments. however, meta-analyses of well-controlled studies of psychological treatments indicate that these achieve only small effect sizes. reflecting this limited efficacy in the face of the need for psychological treatment, the national cancer survivorship research initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. it is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. however modifications have been pragmatic rather than theory-driven and have not improved efficacy. the study addresses the stages of 'development' and 'piloting and feasibility' in medical research council guidance on intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of metacognitive therapy (mct) in other settings and promising preliminary evidence of applicability in cancer. the investigators will conduct a phase i open trial to test the potential efficacy of group mct in cancer survivors and the hypothesised causal metacognitive mechanisms underpinning treatment response.

Eligibility criteria:
inclusion criteria: * cancer diagnosis at least 6 months previously * a score of at least 15 on the total scale score of the hospital anxiety and depression scale (hads) * sufficient understanding of english to consent and engage in therapy * stable on, or free from, psychotropic medication * minimum of 18 years old exclusion criteria: * history of psychotic disorder, learning disability, or organic mental disorder * risk of self-harm or suicide warranting immediate intervention * in palliative phase of treatment * being considered for risk-reducing or reconstructive surgery within 1 year * concurrent psychological intervention for emotional distress * cognitive impairment precluding informed consent or participation * undergoing acute medical treatment (e.g. chemotherapy, radiotherapy) * current drug/alcohol abuse
a long-term assessment of physical activity, range of motion, and functional status following elective orthopedic surgery in hemophilia patients with inhibitors

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this study is conducted in the united states of america (usa). the aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (eos) patients from previously reported studies f7haem/usa/3/usa and f7haem/usa/4/usa (nct01561391) and furthermore to assess the impact of eos on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.


Eligibility criteria:
inclusion criteria: * haemophilia patients with inhibitors who have had eos during their participation in f7haem/usa/3/usa and f7haem/usa/4/usa (nct01561391)
longitudinal study of quality of life and activity in systemic lupus erythematosus

Conditions: Lupus Erythematosus

Summary: systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. to date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. among the specific questionnaires for systemic lupus, the lupusqol, which has been validated in french, shows interesting psychometric properties. the determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the french version of the lupusqol.


Eligibility criteria:
inclusion criteria: * - patients meeting acr 1997 classification criteria for systemic lupus erythematosus. * patients able to understand written and spoken french. * patients aged from 18 to 75 years * patients who have received written and oral information about the research. exclusion criteria: * - patients aged less than 18 years * patients aged more than 75 years * severe mental retardation any impairment of abilities to understand that make self-evaluation impossible
non-randomized prospective comparison between sasi bipartition and rygb

Conditions: Obesity, Morbid; Metabolic Syndrome; Bariatric Surgery Candidate; Postoperative Complications

Summary: the main aim of this project is to assess the safety and efficiency of the sasi bipartition.

the roux-en-y gastric bypass (rygb) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. recent data describes the sasi bipartition as being as efficient on weight loss and co-morbidities as the rygb, with the advantage of being less technically difficult and less morbidity. in order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary. patients with bmi over 40, or with bmi over 35 with comorbidities are offered sasi bipartition with 300 cm common limb or standard rygb. follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery. results on weight loss, comorbidities resolution, complications, and need of supplements are registered.

Eligibility criteria:
inclusion criteria: - morbid obesity with bmi ≥ 40 kg/m2 or bmi ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis) exclusion criteria: * mental diseases * drug addiction * alcoholic * malignancy * pregnancy

Keywords: gastric bypass, sasi bipartition weight loss gerd internal hernia