Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of guselkumab in the treatment of participants with moderate to severe plaque-type psoriasis

Conditions: Psoriasis

Summary: the purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using selfdose device in participants with moderate to severe plaque-type psoriasis.


Eligibility criteria:
inclusion criteria: * a woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at week 0 * before randomization, a woman must be either: a) not of childbearing potential: premenarchal; postmenopausal (greater than \[\>\] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (fsh) \>40 international units per liter \[iu/l\]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (iud) or intrauterine system (ius); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant) * agree not to receive a bacillus calmette guerin (bcg) vaccination during the study, or within 12 months after the last administration of study drug * have a psoriasis area and severity index (pasi) greater than or equal to \[\>=\] 12 at screening and at baseline * have an involved body surface area (bsa) \>= 10 percent (%) at screening and at baseline exclusion criteria: * has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months * has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (mgus); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly * has a transplanted organ (with exception of a corneal transplant \>3 months before the first administration of study drug) * has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) * has received any anti-tumor necrosis factor alpha (tnf-alpha) biologic therapy within 3 months before the first administration of study drug
titanium mesh coated with natural hydroxyapatite nanocrystals in orbital reconstruction

Conditions: Orbital Deformity

Summary: reconstruction of maxillofacial continuity defects has always been a challenging task for scientists and surgeons over the years. the main goal of the reconstruction of the maxillofacial region is to restore facial form, function, and full rehabilitation of occlusion and articulation. a refinement in surgical technique and methods of reconstruction has improved patients' quality of life. aim of this study: evaluation of titanium mesh coated with natural hydroxyapatite in orbital reconstruction.

twelve patients having orbital defects will be selected. six defects will be reconstructed using titanium mesh coated with natural hydroxyapatite nanocrystals (study group) and the other six will be treated with uncoated titanium mesh (control group). patients will be evaluated clinically, then a radiographic follow-up will be performed immediately postoperatively and after three months to evaluate the bone density at the defect. also, the coated and uncoated titanium mesh will be mechanically evaluated to compare the tensile strength of the two groups.

Eligibility criteria:
inclusion criteria: * all patients requiring reconstruction of acquired orbital defects using titanium mesh. * both genders with age group ranging from 18-60 years old. * limited size defects according to cordeiro and santamaria. * isolated unilateral or bilateral orbital fractures or combined with other facial fractures. * orbital reconstruction after removal of benign pathological lesions. exclusion criteria: * infected fracture sites. * chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, metabolic bone disease, immunocompromised status etc. * defects requiring soft tissue reconstruction. * patients suffering from burns. * patients suffering from carcinomas and sarcomas in the oral cavity.
effectiveness of internet-based depression treatment (evident) in severe depression

Conditions: Severe Depressive Symptoms

Summary: online self-help is an innovative way of providing self-help. the investigators want to study the effect of an interactive online self-help-program (deprexis) in the treatment of severe depressive symptoms. participants will be randomised to either twelve weeks of online-self help or a waiting-list control. symptoms of depression and other aspects will be assessed over a six months period. the investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.


Eligibility criteria:
inclusion criteria: * age between 18 and 65, ability to read german, willingness to participate in a telephone diagnostic interview, achieving a score of at least 15 on the phq-9 in an initial screening, and providing written informed consent exclusion criteria: * lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)
effect of superficial keratotomy on reducing postoperative pain fallowing conjuctival flap

Conditions: Reduced Corneal Sensation

Summary: during conjunctival flap surgery the corneal epithelium is removed and a conjunctival flap is placed on the cornea and after a few weeks the conjunctiva covers the surface of the eye. complications of this operation are flap retraction, conjunctival inclusion cysts, bleeding, infection and pain. pain is one of the main complications of conjunctival flap surgery. two sources are conceivable for pain: 1) conjunctival pain 2) corneal pain, the second of which is the main part of the pain. numerous methods for controlling corneal pain have been reported in various articles. eye patches are often recommended for the treatment of corneal abrasions despite the lack of evidence. recommended analgesics to control corneal scratch pain include nonsteroidal anti-inflammatory drugs (nsaids), local anesthetics, and topical cycloplegias. in this article, we are going to review and evaluate a new method called corneal neuorotomy, i.e., corneal nerve endings that inserted radially can be cut to reduce postoperative pain.

the main idea of this randomized clinical trial is to test the extent of pain relief after incision of radial corneal nerve endings. patients are divided into two groups. in the first group, the same classic method of conjunctival flap surgery was used and in the second group, conjunctival flap surgery was performed adjuncted by cutting the radial superficial nerves of the cornea. the postoperative pain scores of these two groups will be measured using visual analogue scale, after 6 hours, 24 hours and 48 hours, and finally the average pain of the two groups will be compared.

Eligibility criteria:
inclusion criteria: * vle (vision loss eye)patients who are candidates for prosthesis implantation exclusion criteria: * 1 painful vision loss eye * 2 patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.)

Keywords: keratotomy.conjuctival flap.radial corneal nerve
chemical peels and fractional laser on igf-1 levels in skin

Conditions: Skin Cancer

Summary: the purpose of this study is to evaluate the impact of fractional laser versus chemical peels on igf-1 levels in skin.

this study is designed to assess the feasibility of using a fractional non ablative laser and chemical peels to wound skin, and thereby elicit a change in igf-1. our hypothesis is that fractional non ablative laser and a tca chemical peel can induce similar effects as the fractional ablative laser at three months. in other words, our theory is that these approaches can stimulate the production of igf-1 in older skin and restore uv damage repair and response mechanisms.

Eligibility criteria:
inclusion criteria: * male and female subjects \>55 years old * fitzpatrick type i-ii * able to provide informed consent. * cutaneous photodamage of 3 or above on the larnier photodamage scale (see appendix). exclusion criteria: * prior laser or peel treatment in the area evaluated in the current study in the past year. * currently taking immunosuppressant medications known to interfere wound healing or anti-inflammatory medications (such as nsaids, or steroids). * subjects who have underlying diseases that could alter wound healing response (such as diabetes). * currently taking insulin. * history of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study. * history of abnormal scarring such as keloids. * history of vitiligo. * allergy or sensitivity or allergy to topical anesthesia * inability to use sunscreen. * history of smoking in the last 10 years * scar or prior surgery in the area of treatment. * use of isotretinoin in the prior 6 months * subjects who have bleeding disorders or who are taking anticoagulants
burden of influenza at emergency department level : bied

Conditions: Emergencies; Flu

Summary: seasonal influenza surveillance in france relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. however, the data collected do not fully measure the impact of epidemics on the hospital system. increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients. the study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the emergency rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.


Eligibility criteria:
inclusion criteria: * age \> 18 years * consultation for a medical cause exclusion criteria: * consultation for a non-medical cause (trauma...) * pregnant, parturient and lactating women * persons deprived of their liberty * persons of full age who are subject to a legal protection measure * persons not affiliated to a social security system
a comparative study evaluating the vein of marshall ethanol infusion ablation using an over-the-wire (otw) balloon versus a microcatheter in patients with atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: the goal of this study is to compare otw balloon with microcatheter in the marshall vein alcohol ablation study. the main questions it aims to answer are: • is there a difference in the effectiveness and safety of otw balloon and microcatheter in marshall vein alcohol ablation? participants will be asked to: undergo treatment with otw balloon undergo treatment with microcatheter if there is a comparison group: researchers will compare the otw balloon group and the microcatheter group to see different effects.


Eligibility criteria:
inclusion criteria: 1. age range: 18-80 years. 2. persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus. 3. inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs. 4. new york heart association functional class ≤ iv,with left ventricular ejection fraction (lvef) ≥ 35% exclusion criteria: 1. patients with known allergies to alcohol. 2. participants with a history of serious cardiovascular events such as myocardial infarction or stroke within the past three months will be excluded from the study

Keywords: marshall vein mitral valve isthmus line
prospective longitudinal cohort study of vasculitis patients

Conditions: Vasculitis

Summary: vasco is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.

vasculitis is a group of disorders characterized by the inflammation of blood vessels, leading to an alteration of the vascular wall. the classification of vasculitides has evolved considerably over the last few decades. in 1990, the american college of rheumatology established a classification of the main systemic vasculitides based on clinical, biological and histological criteria. in 1994, the chapel hill nomenclature has been established as the reference classification system of vasculitides and vasculitides were classified according to the size of the affected vessels. the chapel hill nomenclature was revised in 2012, thus enabling to integrate new vasculitides and diagnostic tools. it is proposed here to conduct a non-interventional cohort study of the different forms of vasculitis, as defined in the chapel hill nomenclature. by collecting data from a large number of patients followed prospectively, our objective is to describe the clinical patterns of these diseases, the presentation, management, comorbidities and outcomes, and to evaluate their possible association with some immunological, genetic and molecular parameters.

Eligibility criteria:
inclusion criteria: * adult patients (age over 18 years), * patients with vasculitis, as defined in the chapel hill international nomenclature as revised in 2012, * patients included at an active phase of the disease, either the initial flare or a relapse, * patients who have been informed and have signed the consent * pregnant and breastfeeding women may be included in the study, * affiliated to a social security system (beneficiary or entitled person). exclusion criteria: * refusal of consent or inability to obtain consent, * a patient who is insane or not entitled, for psychiatric reasons or intellectual impairment, to receive information about the protocol and to give informed consent, * patient under guardianship / curators * patient on state medical assistance (ame) * hemoglobin less than 7 g/dl at the time of sampling, * hemoglobin level less than 9 g/dl at the time of sampling if the patient has respiratory or cardiovascular disease, * patient weighs less than 18 kg. * parallel participation in an interventional protocol is permitted.

Keywords: prospective vasculitis cohort
artificial intelligence use for the detection of atrial fibrillation drivers

Conditions: Fibrillation, Atrial; To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure

Summary: pilot clinical study, multicenter, prospective, open, nonrandomized

the hypothesis is that ablation targeting pvi alone for the treatment of persistent af is less efficient that ablation targeting electrophysiologic areas with spatio-temporal-dispersion with or without pvi

Eligibility criteria:
inclusion criteria: major patient with an indication of af or at ablation - exclusion criteria: -
multiparametric heart failure evaluation in internal cardioverter defibrillators (icd) patients

Conditions: Congestive Heart Failure

Summary: the boston scientific energen family is capable of measuring the respiratory rate trend (rrt) on a daily basis and transmission of data via the remote monitoring technology. this may result in early detection of imminent decompensation at a presymptomatic stage. the study will assess the respiratory trends correlation with clinically relevant heart failure events.


Eligibility criteria:
inclusion criteria: * patient eligible for 1-, 2- or 3-chamber icd implantation according to current guidelines or patient already implanted within the past 45 days with a energen device or successor * able to provide written informed consent exclusion criteria: * life expectancy \<12 months * anticipated non-compliance with the follow-up scheme * moderate to severe chronic obstructive pulmonary disease * primary pulmonary hypertension

Keywords: congestive heart failure cardiac resynchronization therapy internal cardioverter defibrillators
safety study of enterovirus 71 vaccine in children aged 6-35 months old

Conditions: Enterovirus 71 Vaccine

Summary: this phase iv clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.


Eligibility criteria:
inclusion criteria: * infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. and the legal guardian are willing to vaccination at his own expense. exclusion criteria: * history of allergy to any vaccine ingredient or gentamycin; * fever, or acute disease, or acute stage of chronic disease; * having serious chronic diseases, or allergic constitution; * refusal of follow-up for safety concern.

Keywords: vaccine safety
diagnostic performance of [18f]psma-1007 in the context of biochemical recurrence of prostate cancer

Conditions: Prostate Cancer After a Radical Treatment; Biochemical Recurrence of Malignant Neoplasm of Prostate; Biochemical Persistence of Prostate Cancer

Summary: following numerous retrospective studies and phase-3-studies with promising results, \[18f\]psma-1007 has been approved by european authorities. therefore, it is a growing deployment of this diagnostic method anticipated. this study aims to investigate the diagnostic performance and clinical impact in a real-world-evidence in the context of regular clinical care. the evidence generated by this approach is supposed to assist in optimizing the management of prostate cancer patients.

the advent of psma diagnostics and therapy has constituted a paradigm shift in the management of prostate cancer, supplanting other clinical and radiological diagnostic techniques. consequently, \[18f\]psma-1007 (radelumin®) has been approved in several eu countries, most recently in germany in 2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (bcr). this may be regarded as a landmark in the management of prostate cancer, with the potential to markedly enhance the uptake of psma-pet diagnostics in the coming years. the intention is to generate evidence-based data in everyday clinical practice with this so-called real-world-evidence (rwe) study. the planned study will facilitate a more detailed analysis of the diagnostic accuracy of radelumin® in everyday clinical practice. this will involve dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for future use of artificial intelligence (ai).

Eligibility criteria:
inclusion criteria: * informed consent * conduct of \[18f\]psma-1007 pet imaging in the context of regular clinical care exclusion criteria: * technical flaws in the acquisition protocol

Keywords: prostate cancer biochemical recurrence 18f-psma-1007 [18f]psma-1007 biochemical persistence
safety and efficacy study of il-10 (tenovil tm) in the prevention of post-ercp acute pancreatitis (study p02580)(terminated)

Conditions: Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases; Pancreatitis; Pancreatic Diseases

Summary: the purpose of this study is to determine if a single dose of il-10 compared to placebo is safe and effective in reducing the incidence of post-ercp acute pancreatitis for subjects with increased risk.


Eligibility criteria:
inclusion criteria: adults weighing up to 125 kg who are undergoing ercp for any of the following: * evaluate recurrent abdominal pain; * evaluate unexplained recurrent pancreatitis; * evaluate prior post-ercp pancreatitis; * treatment of pancreatic disorders; * treatment of common bile duct stones (without jaundice) exclusion criteria: * active (acute) pancreatitis; * chronic pancreatitis (moderate and severe cases); * ercp to perform a second procedure on biliary tract; * patients who previously had pancreatic sphincterotomy; * known or suspected pancreatic cancer or cancer of papilla of vater; * known or suspected other malignancy; * history of, or current clotting or bleeding problems; * moderate and severe anemia; * low platelet counts
pilates as an adjuvant therapy in parkinson disease.

Conditions: Parkinson Disease

Summary: although pilates has been proposed as a useful rehabilitation strategy in pd, research on its feasibility and potential effects on the motor symptoms and balance with this population is scarce. some works have included pilates as part of combined exercise session interventions, but information concerning their specific effects was not provided. under these circumstances, this study aims at identifying the effects of adding pilates as part of a conventional exercise rehabilitation program on the motor symptoms and static balance of pd persons. participants (n=15) were assigned to a pilates (pg) or to a conventional exercise group (cg) and performed one land-based and one water-based exercise session per week for 14 weeks. the mds-updrs and a stabilometer were used to assess the impact of the intervention on the participant´s motor symptoms and static balance.


Eligibility criteria:
inclusion criteria: * stages 1 through 3 on the hoehn and yahr staging scale; * stable reaction to anti-parkinson medication; * not having taken part in any physical exercise program during the month prior to the study. exclusion criteria: * people with pd who were not able to ambulate independently or presented any comorbidities other than pd or any acute illness that would make training inappropriate.

Keywords: parkinson disease neurodegenerative disorder physical activity pilates method stabilometer
patient and physician survey on satisfaction with somatostatin analogue (ssa) injections in acromegaly in china

Conditions: Acromegaly

Summary: the purpose of the protocol is to achieve an in-depth understanding of the current satisfaction status of somatostatin analogue (ssa) treatment for acromegaly through patient and physician surveys.


Eligibility criteria:
inclusion criteria: for patients: * age 18 years or older * diagnosed with acromegaly * receiving current ssa injections for acromegaly treatment for at least 3 months * signed electronic informed consent form (eicf) for physicians: * licensed endocrinologists or neurosurgeons * having prescribed ssas for at least five patients with acromegaly in the past 6 months * signed eicf exclusion criteria: * patients will not be included in the survey if they meet any of the following criteria: * patients who are not able to successfully complete the questionnaire independently * pregnant patients