Kornimate/medical-research-clean huggingface dataset:
a study of tildrakizumab in pediatric subjects with chronic plaque psoriasis

Conditions: Moderate-to-severe Chronic Plaque Psoriasis

Summary: the study has been designed with three components. part a is an open label pk study followed by a randomized trial component (part b) followed by open label long term extension (lte). the initial pk analysis is first done in adolescent subjects (12 to \<18 years) before initiating the pk study in younger cohort (6 to \<12 years)


Eligibility criteria:
inclusion criteria: * subject must be 6 to \< 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15kg. * diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator). * moderate to severe psoriasis at baseline defined as: at least 10% body surface area (bsa) involvement, pga score ≥ 3, and pasi score ≥ 12 * subject must be considered a candidate for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy * subject is considered to be eligible according to tuberculosis (tb) screening criteria * a maximum of 2 quantiferon tests will be allowed. a re-test is only permitted if the first is indeterminate; the result of the second test will then be used. exclusion criteria: * subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis * subject has laboratory abnormalities at screening including any of the following: alanine transaminase (alt) or aspartate transaminase, (ast) ≥2x the upper limit of normal, creatinine ≥1.5x the upper limit of normal serum direct bilirubin ≥ 1.5 mg/dl, white blood cell count \< 3.0 x 103/μl, and any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results * subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial * female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (sexually active adolescent girls will be required to use contraception) * subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with iv antibiotics within 8 weeks prior to screening * positive human immunodeficiency virus (hiv) test result, hepatitis b surface (hbs) antigen, or hepatitis c virus (hcv) test result
mouth handicap in systemic sclerosis

Conditions: Scleroderma; Systemic Sclerosis; Mouth Diseases

Summary: in this study, it is aimed to investigate the mouth handicap in systemic sclerosis.

systemic sclerosis is an autoimmune connective tissue disease with fibrosis. although its etiology and pathogenesis have not been clearly defined, it has a chronic course. systemic sclerosis is estimated to affect approximately 300,000 people in the united states. most commonly, it affects adults and women. narrowing of the mouth opening and mouth pain are the two most important causes reported by adults with systemic sclerosis. in patients with systemic sclerosis, orofacial findings such as microstomy or reduced mouth opening are frequently seen. microstomy is defined as the distance between the incisors is less than 40 millimeters. in severe microstomy, this distance is less than 30 millimeters. it is approximately 33 millimeters in adults with systemic sclerosis. microstomy in systemic sclerosis mainly results from submucosal collagen deposits that contribute to fibrosis in the perioral tissue. microstomy is seen in 43% to 80% of adults with systemic sclerosis. when the current literature is examined, bongi et al. evaluated the effectiveness of face-specific programs, which are applied together with general rehabilitation programs in patients with systemic sclerosis; they demonstrated that these techniques improve disability, health-related quality of life (hrqol), and facial functionality. in this study, it is aimed to investigate the mouth handicap in systemic sclerosis.

Eligibility criteria:
inclusion criteria: * to be diagnosed with systemic sclerosis * stability of medical treatments * turkish literacy exclusion criteria: * the patient has a history of neurological disease or trauma that may affect his symptoms * oral treatment for the last 6 months * being in active phase of the disease * skin infection and presence of open wound * having used dental orthosis in the last month * disorder of cognition or cooperation

Keywords: scleroderma systemic sclerosis mouth
italian validation of a tool for assessing sexual function after breast cancer, fsfi-bc

Conditions: Breast Cancer

Summary: this is a validation study of the italian language for the female sexual function index-breast cancer questionnaire. the validation of the instrument in italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.

the original version of the questionnaire will be validated in two phases: a) translation, b) reliability. 1. translation of the items and administration to a small sample of volunteers to assess usability. in the first phase, the questionnaire will be translated following the 5 steps: 1. forward translation by two independent translators (from english to italian); 2. synthesis (discussion between translators to resolve any discrepancies); 3. backward translation (from italian to english) by two additional independent translators; 4. expert committee (translators, psychologists, sexology consultants) comparing the two versions of the questionnaire; 5) testing the first version of the questionnaire with a sample (n=20) of native italian speakers to evaluate the adequacy of content and clarity of terms used and proceeding to the final version. 2. reliability of the questionnaire. to assess the reliability of the questionnaire, it will be administered again after a 2-week interval to a smaller sample compared to the recruited patient sample.

Eligibility criteria:
inclusion criteria: 1. women with operable breast cancer; 2. operated on between 2012 and 2020; 3. randomly selected from the institutional database; 18 years of age (age stratification: equally represented women aged \<50 years and women aged ≥50 years); 4. signing of the informed consent. exclusion criteria: 1. severe psychiatric or cognitive illness; 2. ongoing psychological treatment.
aesthetic reconstruction of onco-surgical maxillary defects using fsf with and without cad/cam customized cutting guide

Conditions: Maxillary Tumors

Summary: the aim of the study is to compare aesthetic results and operation time of free scapular flap with and without cad/cam customized osteotomy guide for reconstruction of maxillary defects.

maxillofacial defects create unique challenges for the reconstructive surgeon, often involving bony and soft tissue components of the midface. surgical reconstruction following maxillectomy is currently a topic of interest for reconstructive head and neck surgeons. maxillary defects were reconstructed with maxillofacial prosthetics including obturation. while the latter is an effective reconstruction. over the past two decades, there has been increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla. scapular flap it is an excellent candidate for maxillectomy defects because of its unique feature, which is characterized by additional skin paddles or muscles. and can be harvested along with a part of the scapular bone for bony reconstruction traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact planning, poor communication between the resective and reconstructive teams or surgical difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3d) defect without the help of any templates or surgical guides the advent of 3d modeling in head and neck reconstruction has allowed surgeons to improve upon functional and aesthetic outcomes, which are crucial to patient satisfaction and can be difficult to achieve in maxillectomy defects the cutting guides used or not used, however debate still present for its benefits and worth for patient and surgeon. current study to evaluate how such virtual planning with using of customized cutting guide is effective and worth for patient aesthetic and operation time. our priori-hypothesis is that utilization cad/cam assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing maxillary reconstruction using free scapular flap. in order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive fsf by cad/cam-assisted with customized osteotomy guide to results of another group of patients receive fsf but without customized osteotomy guide. only model will be performed as conventional method aiding in reshaping of reconstruction plate which is another well-established concept of management of maxillary defect.

Eligibility criteria:
inclusion criteria: * patients affected by tumor involving maxillary bone. exclusion criteria: * patients having poor oncological prognosis * patients with poor performance status together with other relative or absolute vascular contraindication.

Keywords: maxillary tumors resection\ reconstruction cad\cam osteotomy, cutting guide aesthetic operation time free scapular flap
clinical outcomes and costs analyses in use of goal directed therapy

Conditions: Postoperative Complications

Summary: the aim of the study is to evaluate clinical and economic impact of goal directed fluid therapy according to nice haemodynamic protocol. haemodynamic parameters were assessed using automated pulse contour analysis (flotrac/vigileo®). a specific dedicated software has been developed to perform clinical and expenditures data collection, both retrospective and prospective data are archived.


Eligibility criteria:
inclusion criteria: * patients selected for major abdominal surgery exclusion criteria: •patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Keywords: fluid therapy cost-benefit analysis hemodynamics cost control
a study to assess the anamnestic immune response in healthy 4 to 7 year-old children after a primary vaccination series with either hexavac® or infanrix®-hexa

Conditions: Hepatitis B

Summary: primary objective: * to describe in subjects vaccinated with 3 doses of hexavac® or 3 doses of infanrix®-hexa during the first two years of life the percentage of subjects with an anti-hbs antibody titre ≥10 miu/ml 1 month after a booster dose of either hbvaxpro® 5 µg or engerix b® 10 µg . secondary objectives: * additional immunogenicity assessments * standard safety assessment.


Eligibility criteria:
inclusion criteria: * healthy child of 4 to 7 years of age of either gender, * child vaccinated with 2 doses of hexavac® during the first 6 months of life and with a 3rd dose of hexavac® before the end of the second year of life or child vaccinated with 2 doses of infanrix®-hexa during the first 6 months of life and with a 3rd dose of infanrix®-hexa before the end of the second year of life, * informed consent form signed by the parent(s) or by the legal representative. * parent(s) or legal representative able to understand and comply with the study procedures. exclusion criteria: * any recent (\<=3 days) history of febrile illness prior to vaccination, * receipt of more than 3 doses of any hepatitis b containing vaccine, either alone or in any combination, * history of clinical or serological-confirmed diagnosis of infection due to hepatitis b, * history or current close contact with known carriers of hepatitis b virus, * prior known sensitivity/allergy to any component of the study vaccines, * any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems, * any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, * any immune impairment or humoral/cellular deficiency or depressed immunity, * any recent (\ =14 days) administration of systemic corticosteroids given daily or on alternate days at \>=20 mg/day prednisone equivalent or scheduled administration through visit 2, * any receipt (\<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through visit 2, * any recent (\<=14 days) receipt of an inactivated vaccine or scheduled administration through visit 2, * any recent (\<=28 days) receipt of a live vaccine or scheduled administration through visit 2
planning message recommending same time/location as last vaccine

Conditions: COVID-19

Summary: this experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. the focal comparison in this experiment is between a message suggesting the same day of the week, at the same time of day, and at the same pharmacy location as their last vaccination and a control message telling patients that an updated covid booster vaccine is waiting for them. the intervention testing if text messages encouraging vaccination by suggesting patients receive a shot on the same day of the week, at the same time of day, and at the same pharmacy location as their last vaccination will produce more vaccinations than otherwise identical messages.


Eligibility criteria:
exclusion criteria: 1. the patient unsubscribed from texts before the send date and time of the patient's sms/mms message 2. the patient received a bivalent covid booster before the send date and time of the patient's sms/mms message.

Keywords: covid-19 behavioral science interventions vaccination promotion
covid-19 convalescent plasma (ccp) transfusion

Conditions: COVID-19

Summary: this research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus sars-cov-2 infection (covid-19). donors who have recovered from covid-19 with high antibody levels to the cov-2 virus will donate plasma at a mississippi blood services facility. recipients with coivd-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from covid-19.

the research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus sars-c0v-2 infection with high titers of igg antibody to this virus transfused into patients with severe or at high risk of progressing to severe coronavirus-induced disease (covid-19). the research hypothesis is that covid-19 convalescent plasma (ccp) transfusion improves outcomes in patients with covid-19. the use of ccp to treat serious and life threatening covid-19 has a sound biological as well as clinical rationale to provide virus-specific immune protection in patients unable to produce and/or maintain antiviral antibodies. this treatment protocol is designed primarily to offer a rescue therapy in patients with severe and life threatening disease and explore use in patients for whom a progression to serious disease is likely. examining the specific antibody responses to the virus in transfused patients if/when they show signs of recovery and comparing these values with those obtained before the transfusion may provide information to design more extensive trials aimed at identifying the best patient population for future use of ccp.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. clinician judged serious or life threatening covid-19 (or at significant risk to develop serious covid) manifested by at least one of the following: 1. laboratory confirmed diagnosis of sars-cov-2 infection 2. hypoxia (pao2/fio2 \<300, pulse oximetry \<93% at rest 3. evidence of pulmonary infiltration 4. respiratory failure 5. sepsis 6. multiple organ dysfunction or failure (assessed by sofa score) 3. informed consent provided by the patient or legally authorized representative (lar) exclusion criteria: 1. greater than 21 days from confirmed covid-19 diagnosis 2. receipt of pooled immunoglobulin transfusion in previous 28 days 3. history of prior reaction to transfused blood products 4. currently enrolled in other drug trials that preclude investigational treatment with cov-2 convalescent plasma transfusion

Keywords: covid-19 convalescent plasma coronavirus sars-cov-2
evaluation of dynamic balance after recovery from covid 19 disease

Conditions: COVID-19 Respiratory Infection

Summary: effect of post covid-19 on dynamic balance in patients after recovery from covid-19 disease.

effect of post covid-19 on dynamic balance in patients after recovery from covid disease. patients will treated with medical protocol of covid 19 an out-patient clinic , and followed up by the chest specialist . the balance tests of the patients were performed 2 to 14 weeks after their recovery from the disease, which was confirmed by the evaluations of the covid staff and negative polymerase chain reaction test.the patients will evaluated using questionnaires. first, the question will whether feeling in balance in the daily life or not. the answer will classified as "yes"or "no". second, asked to fill "dizziness handicap inventory"(dhi), which is a multidimensional self- assessment scale created to evaluate the effects of dizziness and balance problems on the quality of life as well as the level of disability of the patients. assess balance , which consists of a movable balance platform that provides up to 20 of surface tilt in a 360 range of motion. the platform is interfaced with computer software that enables the device to serve as an objective assessment of balance . the measure of postural stability includes the overall (oa), the anteroposterior (ap) and the mediolateral (ml) stability scores. a high score in the oa index indicates poor balance. the oa stability score is believed to be the best indicator of the overall ability of the patient to balance the platform

Eligibility criteria:
inclusion criteria: * 25post covid-19 patients suffering from inbalance. * age will be ranged from 30 to 40 years old. * body mass index (bmi) will be ranged from 25 to 35 kg/m2. * diagnosed as covid-19 patients with a positive reverse transcription polymerase chain reaction (rt-pcr) result of sars-cov-2, or typical computerized tomography (ct) evidence of viral pneumonia. * all enrolled patients with moderate covid-19 infection. exclusion criteria: * severe disease or hospitalization at intensive care units will excluded from the study. * patients with previous hearing problems or balance disorders. * patients who had ear surgery, cardiovascular and circulatory problems,. * patients with orthopedic problems in the lower extremities due to other problems * patients with any history of neurological or psychiatric disease, severe visual or auditory impairments. * diabetic patients.
advanced breast cancer and lifestyle exercise study

Conditions: Metastatic Breastcancer

Summary: about 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. however, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. the physical, biological, psychological and clinical benefits of physical activity (pa) during treatment in patients with localized breast cancer have been widely demonstrated. numerous studies investigated the effect of pa in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of pa in patients with metastatic breast cancer.it seems appropriate to investigate the feasibility of pa intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. the able study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * aged 18 to 78 years old, * newly diagnosed with a metastatic breast cancer (i.e. within the last 3 months) * treated in the clb by chemotherapy, and/or radiotherapy and/or hormonotherapy and/or targeted therapy. * ecog performance status \<2, * being french-speaking * able to complete questionnaires and follow instructions in french * valid health insurance affiliation. * medical certificate of no contraindications to exercise physical activity exclusion criteria: * untreated brain metastases * uncontrolled cardiac disease, * contraindications to pa, * unable to be followed for medical, social, familial, geographical or psychological reasons over the study duration, * deprivation of liberty by court or administrative decision * pregnancy

Keywords: physical activity
delivery of nutritional services in nicaragua

Conditions: Nutrition in Cancer Survival and Treatment

Summary: this study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under asociación de hemato-oncología pediátrica de centro américa (ahopca) consortium in central america. the aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in central america.

in low and middle-income countries, children with cancer are simultaneously dealing with malnutrition in high proportions. without proper access to care and a minimal or basic level of care, these children are exposed to worse conditions. studies have shown that more than half of the children with cancer are also malnourished at diagnosis. this increases children's risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates. with an established nutritional education and clinical intervention program, the outcomes of these children can be improved, especially in central america where the cancer rates and malnutrition is high, as shown by several studies.

Eligibility criteria:
inclusion criteria: * recent diagnosis of childhood cancer (solid tumors) * recruited at diagnosis * under the age of 18 years exclusion criteria: * other cancer diagnosis * palliative care patients

Keywords: malnutrition childhood cancer central america nicaragua