Kornimate/medical-research-clean huggingface dataset:
analysis of plasma for diagnosis and follow-up of neurofibromatosis type 1

Conditions: Neurofibromatosis 1

Summary: the purpose of this study is to find blood plasma based biomarkers of disease progression in neurofibromatosis type 1 (nf1). nf1 is associated with the development of benign cutaneous tumors as well as a variety of malignancies. analysis of plasma dna and chemical composition may provide tools for diagnosis and follow-up of nf1. the hypothesis of the study is that nf1-associated tumor burden and malignant transformation of tumors can be detected in plasma. to test this hypothesis, finnish patients with nf1 are recruited and blood sample is taken. blood plasma is separated and analyzed chemically. dna is then also extracted and quantified.

neurofibromatosis type 1 (nf1) is a dominant hereditary multiorgan disease that causes both benign cutaneous neurofibromas and malignant tumors. timely detection of malignant transformation in nf1 tumors is of great clinical importance. also methods to easily monitor individual's overall tumor burden would be useful. blood plasma is collected from nf1 patients and age- and gender-matched controls. the samples are stored at -80 c until analysis. free circulating plasma dna is extracted and quantified using commercial reagents. also a previously described chemical detection method to observe overall changes in plasma composition is utilized. the analysis results are compared between nf1 patients and healthy controls, and also correlated with nf1 tumor burden and diagnosis of malignancy during five-year follow-up.

Eligibility criteria:
inclusion criteria: * finnish-speaking * 18-85 years old * for nf1 group: diagnosis of type 1 neurofibromatosis and visit to turku neurofibromatosis centre * for control group: suitable as an age- and gender-matched control for some of the nf1 patients exclusion criteria: * non-finnish-speaking * for control group: diagnosis of neurofibromatosis type 1 or cancer
smart technology facilitated patient-centered venous thromboembolism management

Conditions: Venous Thromboembolism; Digital Health; Health Education

Summary: smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. these technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. they are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention. the objective of this study is to evaluate the impact of mobile venous thromboembolism application (mvtea) based patient-centered management of venous thromboembolism (vte) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with vte.


Eligibility criteria:
inclusion criteria: * inpatients ≥18 years of age at admission; * previous or current definitive diagnosis of dvt and/or pe by imaging, or at high risk of vte at discharge: padua score ≥4 for medical patients and caprini score ≥5 for surgical patients. * signed informed consent exclusion criteria: * mental disorder or combination of other serious diseases leading to incapacity for independent living; * inability to use smartphones, computer tablets and other smart devices; * being pregnant or breastfeeding; * have participated in similar trials or are undergoing other clinical trials.

Keywords: venous thromboembolism mobile health prophylaxis health education
effect of intense sport practice in athletes with non-ischemic scar

Conditions: Athletes With Isolated Non-ischemic LGE With no Underlying "Labelled" Cardiomyopathy

Summary: the prognostic relevance of isolated non-ischemic lge (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice. the principal objective of the study is to evaluate during a five-years follow up, the clinical outcome of athletes with this kind of findings. the secondary objective is the determination of prognostic factors. the management and follow-up of the athletes will be let at the appraisal of each center.

the presence of a scar, assessed by late gadolinium enhancement (lge) on cardiac resonance imaging (cmr), is associated with a poor prognosis in patients with ischemic heart disease or cardiomyopathy. but the prognostic relevance of isolated non-ischemic lge (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines do not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice. the objective of the study is to evaluate the clinical outcome of athletes with isolated non-ischemic lge with no underlying "labelled" cardiomyopathy during a five-years follow-up. the secondary objective is the determination of prognostic factors based on the baseline inclusion data: indication of cmr (i.e. symptoms, abnormal ecg, presence and morphology of arrhythmias, abnormal echocardiography); localization and amount of lge, left and right ventricular geometry and function, characteristics of sport practice (amount, type, competition). the management of the athletes will be let at the appraisal of each centre, as regards to the initial assessment, the follow-up and the medical clearance for competitive sports participation. nevertheless, due to the absence of consensus, we propose that the patient should at least undergo clinical examination, ecg, echocardiography, cardiopulmonary exercise test (cpet) and holter ecg each year. a cmr should be performed at one and five years.

Eligibility criteria:
inclusion criteria: * any athlete, aged of more than 15 years, symptomatic or not, * in whom non-ischemic lge with no underlying "labelled" cardiomyopathy is detected on cmr. scare of an acute myocarditis will also be included. athletes will be defined by a practice of ≥4 hours/week of sport activity and/or competitive sport activity at the time of the assessment which triggered the realization of the 1st cmr. exclusion criteria: * athletes with any unequivocal cardiac disease that might explain the lge (i.e. hypertrophic cardiomyopathy, ischemic cardiac disease). in case of borderline or doubtful diagnosis the athlete can still be included (for example an athlete with a dilated lv and borderline function, or with borderline wall thickness). * patients who refuse their participation in the study. * patients under legal protection or deprived of their liberty.

Keywords: athletes late gadolinium enhancement fibrosis
bms-936558 (mdx-1106) in subjects with advanced/metastatic clear-cell renal cell carcinoma (rcc)

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to measure how active bms-936558 (nivolumab) is against renal cell carcinoma (rcc) as measured by the disease not progressing and whether a dose response relationship exists.


Eligibility criteria:
inclusion criteria: * histologic confirmation of renal cell carcinoma (rcc) with a clear cell component * previous treatment with at least one anti-angiogenic agent * progressed within 6 months of study enrollment * subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease * must have available tumor tissue for submission * subjects must also meet various laboratory parameters for inclusion exclusion criteria: * subjects with any active autoimmune disease or a history of known autoimmune disease other protocol-defined inclusion/exclusion criteria apply

Keywords: advanced/metastatic clear cell component
cervical cancer brachytherapy with interstitial needles in 3 fractions

Conditions: Cervical Cancer

Summary: aim to determine the feasibility and safety of 3 fractions of high dose rate (hdr) brachytherapy with interstitial needles for cervical cancer in the outpatient setting primary objective to determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival) secondary objective to determine the long-term toxicities of this regimen based on ctcae v5

this study is designed as a single arm phase ii prospective study that will be open for recruitment for approximately 3 years. an estimated 56 cervical cancer patients treated in nuh will be recruited. pre-treatment assessment 1. case reviewed in gynae multidisciplinary meeting 2. detailed gynaecologic assessment on diagnosis 3. staging scan - mri pelvis, ct tap or pet ct 4. baseline blood result - full blood count, renal panel, liver panel, coagulation profile and group screen and match treatment all patients will be registered and reviewed in nuh radiotherapy centre. written consent will be obtained if patient is agreeable to be recruited. brachytherapy a pre-brachytherapy planning magnetic resonance imaging (mri) scan is performed to evaluate the response and extent of the parametrial involvement if any, as well as to determine the ideal placement of interstitial needles to achieve optimal coverage. the applicator to be used should be chosen prior to bt if possible. twenty-four hours prior to the procedure, oral fleet is given to the patient to ensure adequate bowel preparation. the 3 fractions of hdr brachytherapy may be delivered in the following ways: option 1: 3 insertions over 2 non-consecutive days: 9 gy to the hrctv in the first fraction on day 1 of the brachytherapy procedure and 7 gy x 2 fractions at least 6 hours apart on day 2, retaining the same brachytherapy applicators of the second insertion for the final fraction. option 2: 3 insertions over 3 non-consecutive days 8gy to the hrctv per fraction per day for 3 non-consecutive days. acute and late radiation toxicities will be scored according to common terminology criteria for adverse events (ctcae), version 5 patients will be followed up at 1 month with a physical examination and with an mri of the cervix within 3 months post procedure. patients will subsequently be followed up every 3 monthly with vaginal examination for the next 2 years. at each follow-up, toxicity will be recorded as per the ctcae.

Eligibility criteria:
inclusion criteria: 1. 21 years old and above 2. histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or poorly differentiated cervical cancer 3. clinically or radiologically stage ib - iva cervical cancer based on tnm 8th edition 4. ecog performance status 0, 1, or 2 5. to complete external beam radiotherapy and brachytherapy in nuh 6. written, voluntary informed consent 7. patients must be accessible for follow up and management in nuh exclusion criteria: 1. post operative cervical cancer cases 2. pregnant or breastfeeding women
study to compare the bioavailability, safety and tolerability of xm17 in healthy, down regulated young women

Conditions: Bioequivalence

Summary: aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of xm17 and gonal-f® in a confirmatory design. furthermore, safety and tolerability will be assessed in human healthy female subjects. only female subjects will be included in the study to reach the objectives of the study.


Eligibility criteria:
inclusion criteria: * having signed written informed consent * healthy female subjects of any racial origin * 18-39 years at the time of screening * body mass index (bmi) between 18-29 kg/m2 and a body weight of ≥ 50 kg * use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months * normal uterus and two functioning ovaries * agrees to use an adequate method of contraception during the study * non-smoking or moderate smokers of \< 10 cigarettes a day exclusion criteria: * pregnancy * polycystic ovary syndrome, impaired ovarian function, severe endometriosis class iii or iv, submucosal myoma uteri * history of endocrine abnormalities with treatment within the last six months. * contraindications for the use of gonadotropins and goserelin * breast-feeding or being within a period of 2 months after delivery or abortion. * use of an injectable hormonal contraceptive within a period of 6 months prior to screening * treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ
prevalence of cognitive disorders in newly diagnosed epilepsy

Conditions: Epilepsy; Cognition

Summary: a prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (aed). multiple factors exist and interact in the same patient. cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). these factors in turn influence cognitive abilities in a triangular and bidirectional relationship. in addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (aed, surgery) and etiology also have an impact on cognitive performances. the burden of these factors differs from patient to another and must be determined individually. longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time. the main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of aed with healthy subjects matched on age, sex, manual laterality and socio-educational level. but also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.


Eligibility criteria:
inclusion criteria (patients): * individuals who have received full information about the organization of the research and have not refused to participate and to use their data. * person aged 16 and over * for minor patients: the non-opposition of the parental authority holders * newly diagnosed epileptic patient who had never taken antiepileptic drugs. inclusion criteria (normal controls): * individuals who have received full information about the organization of the research and have not refused to participate and to use their data. * for minor participants: the non-opposition of the parental authority holders * person aged 16 and over. exclusion criteria (patients): * person of full age who are subject to a legal protection measure or who are unable to express their consent * person with a progressive brain injury * person who regularly use psychoactive substances (cannabis, alcohol, etc.) * patients who started an antiepileptic treatment before the neuropsychological assessment. exclusion criteria (normal controls): * persons of full age who are subject to a legal protection measure or who are unable to express their consent * person with a neurological (traumatic brain injury, stroke, etc.) and/or psychiatric (mental illness, depression, etc.) history. * people who regularly use psychoactive substances (cannabis, alcohol, etc.).

Keywords: newly diagnosed epilepsy cognition epilepsy
changes in function of the upper limb with physiotherapy

Conditions: Burn of Upper Limb, Except Wrist and Hand

Summary: this paper describes a pilot clinical study designed to compare changes in rom, muscle strength and functional recovery of the upper limb during the inpatient treatment period of burn injury.

patients with burns can face challenges throughout their recovery, including contractures and a reduced range of motion (rom) in the upper limb (ul), upper and lower limb impairment. restoring range of motion, muscle strength, and mobility is essential to reduce scarring formation and contractures. the study included 17 patients with unilateral or bilateral superficial, deep partial and full thickness burns to the upper limbs, with or without burns to the upper body, covering 10% or more of the total body surface area

Eligibility criteria:
inclusion criteria: * patients aged 18-69 years * had burns on the upper limb(s) with or without burns on the upper body * burns involving ≥ 10% total body surface area (tbsa) with the presence of deep partial thickness or full thickness burns * who agreed to take part in the study exclusion criteria: * inability to perform or understand tests * other injuries (fractures, brain injury) * central and peripheral nervous system disorders * amputation * with burns on the head, hands, feet, and genital area
xy-zone program evaluation: a school-based dropout prevention program for at-risk youth

Conditions: Adolescent Problem Behavior at School; Risk Behavior; Truancy; Socialized

Summary: the objective of this study is to build upon preliminary research and conduct a pilot feasibility randomized controlled trial on a promising culturally-grounded and gender-specific treatment program, the xy-zone. the central hypothesis underlying this study purports that through receiving the xy-zone treatment, adolescents will decrease their risk for dropping out of school. this hypothesis is supported by two years of preliminary data investigating the effectiveness of the xy-zone. to test the central hypothesis, the following specific aims will be pursued: 1. identify school dropout risk and protective factors (protective factors defined as: adult support and peer support; risk factors defined as: low school attendance, inability to achieve grade promotion, substance use, delinquency, school disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a result of xy-zone intervention. 2. determine the extent to which moderating variables (affective strength, duration in the program, family functioning, interpersonal strength, intrapersonal strength, level achieved in the program, and resiliency) effect change in outcome variables (risk and protective factors). 3. identify participants' beliefs about the impact of the mechanisms of change (respect, responsibility, relationship, role modeling, and reaching out) on outcome variables (risk and protective factors ) to enrich understanding of quantitative data.


Eligibility criteria:
inclusion criteria: * students eligible to receive the xy-zone must display one of the following risk factors: * academic risks (failed classes, failed state examination text, lack of class participation, and homework incompletion) * attendance risks (absences and tardies) * behavioral risks (gang involvement, substance use, classroom conduct, social skills, self-esteem, violence, delinquent conduct, and family or emotional crisis)and * social service issues (difficulty with the following: college readiness, life skills, health, career/employment, housing, day care, and grief or loss). exclusion criteria: * youth who do not display any of the identified risk factors

Keywords: xy-zone school drop-out risk protective factors truancy
comparing efficacy and safety of 2 dose regimens of subcutaneous administration of tev-48125 versus placebo for the preventive treatment of chronic migraine

Conditions: Migraine

Summary: the study is being conducted to evaluate two doses of tev-48125 in adult patients with chronic migraine


Eligibility criteria:
inclusion criteria: * males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age * patient signs and dates the informed consent document * patient has history of migraine according to international classification of headache disorders, or clinical judgment suggests a migraine diagnosis * 85% e-diary compliance * total body weight between 99 and 250 lbs, inclusive * additional criteria apply, please contact the investigator for more information exclusion criteria: * clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator * evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years * history of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism * known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis b or c infection * past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma * pregnant or nursing females * history of hypersensitivity reactions to injected proteins, including monoclonal antibodies * participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer * additional criteria apply, please contact the investigator for more information
the relationship between sarcopenia and cardiovascular disease in chronic kidney disease and the risk involved.

Conditions: Sarcopenia; CKD; Cardiovascular Diseases

Summary: this study explores the risk factors for sarcopenia in patients with chronic kidney disease and the effects of sarcopenia on cardiovascular disease. treatment of sarcopenia and cardiovascular complications provides a basis for improving the quality of life and survival of patients with chronic kidney disease.

sarcopeniais a syndrome characterized by the loss of skeletal muscle mass, muscle strength, and muscle dysfunction. the high incidence of sarcopenia in patients with chronic kidney disease (ckd) is strongly associated with poor quality of life, cardiovascular events, and increased all-cause mortality. at present, the cause of sarcopenia in patients with ckd is still unclear, and factors such as inflammation, malnutrition, and hormone metabolism disorders may affect the occurrence and development of sarcopenia. this topic explores the risk factors of sarcopenia in patients with chronic kidney disease and the correlation between sarcopenia and the risk of cardiovascular disease, and provides a basis for the prevention and treatment of sarcopenia and cardiovascular complications, with a view to improving the prognosis of ckd patients.

Eligibility criteria:
inclusion criteria: * patients presented by the nephrology center during august 2019 and march 2021 * age 18-75 years; * patients with ckd2 or above (egfr≤60 ml/(min 1.73m2) exclusion criteria: * there are contraindications to bioelectrical impedance spectroscopy (bis) . examination, such as amputation, metal implants in the body, etc.; * complicated with other serious diseases, such as malignant tumors, cirrhosis, systemic infections, etc.