Kornimate/medical-research-clean huggingface dataset:
rat-hemato : return to work after malignant hemopathy

Conditions: Leukemia; Lymphoma; Multiple Myeloma

Summary: return to work (rtw) of patients after cancer treatment has been a topic of growing interest for the past two decades. advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. the return of patients to their "pre-cancer life" can thus become an objective. indeed, rtw after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). however, many difficulties can interfere with rtw. many factors have been identified: disease, treatment, patient and occupational factors. the feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. it corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case rtw. the majority of studies on rtw concerns solid cancer and are retrospective. very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. moreover, very few interventional studies exist. there is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on rtw. the investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early rtw-consultation in patients who have been treated for a hematological malignancy. the investigators hypothesize that this consultation will improve patients' rtw rates and rtw quality.


Eligibility criteria:
inclusion criteria : * patient with hematological malignancy controlled after treatment * induction/consolidation chemotherapy completed (excluding maintenance therapy) * patient aged 18 to 55 * patient having worked at least 6 months in the 2 years before diagnosis of hematological malignancy * patient who has not yet returned to work since diagnosis of hematological malignancy * signed informed consent form exclusion criteria: * patient choosing not to return to work * patient not affiliated to a social security system * patient with legal guardian or legal trustee * patient not understanding french * patient with severe cognitive impairment at diagnosis, incompatible with the study
a study of h3b-6545 in combination with palbociclib in women with advanced or metastatic estrogen receptor-positive human epidermal growth factor receptor-2 (her2)-negative breast cancer

Conditions: Receptors, Estrogen; Genes, Erbb-2; Breast Neoplasms

Summary: the primary objective of this study is to evaluate the safety and tolerability of h3b-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (mtd) and/or the recommended phase 2 dose (rp2d) of this combination in women with advanced or metastatic estrogen receptor-positive (er+) her2- breast cancer.


Eligibility criteria:
inclusion criteria: 1. er+ her2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory 2. prior therapy in the advanced/metastatic setting 3. has an eastern cooperative oncology group (ecog) performance status of 0 or 1 4. has adequate bone marrow and organ function exclusion criteria: 1. uncontrolled significant active infections 2. major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug 3. inability to take oral medication or presence of malabsorption 4. active cardiac disease or a history of cardiac dysfunction 5. evidence of ongoing alcohol or drug abuse

Keywords: h3b-6545 palbociclib metastatic estrogen receptor-positive her2-negative breast cancer
sepsis in geriatric patients with suspected infection.

Conditions: Sepsis

Summary: sepsis is a complex clinical syndrome that has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. it is more frequent and severe in older subjects, at least in part because of delayed diagnosis and treatment due to low clinical suspicion and atypical manifestation. the sepsis-iii consensus proposed the easy to use bedside clinical score quick sequential organ failure assessment (qsofa) to identify patients at risk for sepsis and death outside intensive care units. however, some authors have disputed this recommendation, proposting the use of other more complex bedside tools such as the national and modified early warning scores (news and mews, respectively) for the same purpose. published studies on these scores included generally younger, selected subjects, not fully representative of the population at risk for sepsis. in the present study we aimed to evaluate the incidence of sepsis in older subjects with suspected infection in a geriatric acute ward setting, to determine and compare the accuracies of qsofa, news and mews to identify sepsis and to investigate factors associated with in-hospital mortality.


Eligibility criteria:
inclusion criteria: * hospitalization in the acute geriatric unit * presence of at least one national institute for health and care excellence (nice) guidance risk factor for sepsis (i.e. age ≥75 years, impaired immune function - diabetes mellitus, previous splenectomy, hematologic diseases - long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures in the previous 6 weeks, any breach of skin integrity - e.g. pressure ulcers - intravenous drug misuse, indwelling lines or catheters) exclusion criteria: * refusal to give written informed consent

Keywords: sepsis diagnostic accuracy geriatric patients older adults early warning score qsofa
effect of blue light on vagus nerve stimulation in patients with refractory epilepsy

Conditions: Refractory Epilepsy

Summary: vagus nerve stimulation (vns) is an adjunctive treatment for refractory epilepsy. although widely used, there is still a substantial number of patients with insufficient response. light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. this project aims at understanding how exposure to blue enriched light may influence vns effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of vns action. this could possibly lead to new therapeutic strategies to increase efficacy of vns.


Eligibility criteria:
inclusion criteria: patients: vns implanted since at least 3 months age \>18-60 years; iq \>55 on wechsler scale (normal status or mild cognitive impairment) healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease) exclusion criteria: patients: other medical implanted devices than vns, ocular diseases helthy participants: medical implanted devices, cerebral trauma, ocular disease
nrti-sparing pilot study

Conditions: HIV; Mitochondrial Toxicity

Summary: this study will compare a nucleoside reverse transcriptase inhibitor-sparing (nrti-sparing) regimen (kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (combivir + nevirapine and combivir + kaletra). participants will be randomly assigned to receive one of the following drug combinations: * lopinavir/ritonavir (kaletra) and nevirapine (viramune) twice a day; * combivir (zidovudine (azt) plus lamivudine (3tc)) and nevirapine twice a day; * combivir and lopinavir/ritonavir twice a day.


Eligibility criteria:
inclusion criteria: * be hiv-positive * be at least18 years of age * have viral load above 5 000 copies/ml * be likely to comply with the study protocol * agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs * agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator exclusion criteria: * have ever received antiretroviral therapy * pregnancy or breastfeeding * have abnormal laboratory tests (see investigator) * have received an investigational drug within 30 days of study drugs administration * be receiving systemic chemotherapy * have an acute illness
long-term surgical treatment outcome of peri-implantitis lesions

Conditions: Peri-Implantitis

Summary: the surgical treatment outcome of patients that have been or are consecutively treated at the university of malmö, at blekinge hospital, and at the dental clinic of the sigmund freud university vienna will be evaluated on an a regular base; specifically all patients treated since 2014 and those receiving treatment in the future, will be regularly assessed, max. once per year after the 1-year control from the surgical intervention for clinical and radiographic assessment of healing. clinical peri-implant parameters (e.g., probing pocket depth) and peri-implant sulcus fluid (pisf) are collected, and a peri-apical radiographic examination is made. further, from 200 patients treated in the future, the inflammatory peri-implant lesion will be collected and subjected to histological, microbiological, and molecular analysis. the removal of these lesions is a standard procedure and performed in all patients independent of study participation; i.e., the lesion has anyway to be removed during surgery and if the lesions are not stored, they would be thrown.


Eligibility criteria:
inclusion criteria: * all patients being treated since 2014 and continuously being treated will be called in for regular check-ups after the surgical intervention and an examination for study purpose will be performed annually. exclusion criteria: - implant loss
impact of defecation posture on ease of first bowel movement following posterior repair

Conditions: Postoperative Constipation; Pelvic Organ Prolapse Vaginal Surgery; Defecation Function

Summary: this study will determine if defecation posture, when using a defecation posture modification device (dpmd), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery by one of the sub investigators including a posterior compartment repair exclusion criteria: * anyone currently using a defecation posture modification device * unwillingness or unable to participate in the study * presence of ileostomy/colostomy * wheelchair bound * device may pose fall or safety hazard risk to patient * patients weighing over 250 lbs, as per device manufacturer guidelines * inability to understand english * pregnant women
association between triglycerides glucose ratio with homa -ir as indicators of insulin resistance in obese adults

Conditions: Insulin Resistance

Summary: the aim of the present study was to investigate the correlation between the triglyceride/glucose index (tyg index) and homeostasic model assessment of insulin resistance (homa-ir) to predict insulin resistance (ir) in obese adults

obesity is a chronic disease that has an increasing prevalence in both developed and developing countries and affects adults and children\[1\] obesity is an important risk factor for the development of some chronic diseases such as insulin resistance, hypertension, and type 2 diabetes \[2\] . insulin sensitivity is inversely related to body mass index and body fat. insulin resistance can be defined as impairment of the normal biological response to both endogenous and exogenous insulin. one of the primary defects underlying the development of type 2 diabetes is thought to be insulin resistance. so, it is present in 85% of these patients with type 2 dm. it is also related to the pathogenesis of many illnesses which includes coronary heart disease, and hypertension\[3\] early detection of insulin resistance (ir) is important to prevent the development of cardiometabolic diseases such as type 2 diabetes mellitus, metabolic syndrome, and coronary heart disease. the homeostatic model assessment for insulin resistance (homa-ir) index, which has high sensitivity and specificity, has been shown to be more useful in estimating the risk of insulin resistance, instead of more invasive, complex, and expensive direct tests such as pancreatic suppression test and hyperinsulinemic-euglycemic glucose clamp technique \[4\] homa-ir is an approved method for evaluating insulin resistance using fasting glucose and insulin levels and is widely used in clinical practice \[5\]. triglyceride glucose (tyg) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying insulin resistance \[6\]. recently, the use of the triglyceride glucose (tyg) index, a product of fasting glucose and triglyceride are more easily accessible assessment tools both at the outpatient clinics and at the community level, and are low cost \[7\].

Eligibility criteria:
inclusion criteria: * any obese adult (18 years or older) with bmi greater than or equal 30 of both sexes admitted to assiut unversity hospitals and clinics exclusion criteria: * cases \<18 years old * cases with bmi \< 30 * adult with endocrine abnormatilies under treatment for dm ,hypertension , dyslipidemia
the effectiveness of epidermal growth factor serum in improve facial skin hydration, elasticity, pigmentation, and wrinkles.

Conditions: Aging

Summary: egf is a polypeptide that promotes cell differentiation and collagen production while decreasing melanin production. this study is designed to study its effectiveness in improving the texture and appearance of facial skin after daily topical application. we hypothesized that egf would improve facial skin hydration, elasticity, pigmentation, and wrinkles.

all patients gave written informed consent for epidermal growth factor serum application on the face. the pilot study enrolls thirty patients compared to pre and post-serum used to evaluate facial skin hydration, transepidermal water loss, elasticity, pigmentation, and wrinkles measured by corneometer, tewameter, cutometer, visioscan, and mexameter respectively on day 0, then 8, 12, and 16 weeks. the study evaluates subject satisfaction and side effects after serum application as secondary outcomes.

Eligibility criteria:
inclusion criteria: * thai * mild to moderate facial skin condition, as measured by 1-2 points on the hyperpigmentation status scale or 2-3 points on the wrinkle severity grading scale. exclusion criteria: * use of lotions or skin care products containing ingredients such as vitamin a/c, hydroquinone, or anti-aging agents. * sunbathing * hypersensitivity to serum components * pregnancy and breast-feeding * active skin diseases such as eczema or atopic dermatitis at the application site
first-in-human study of s-588210 (s-488210+s-488211)

Conditions: Lung Cancer; Head and Neck Cancer; Bladder Cancer; Esophageal Cancer; Mesothelioma

Summary: the primary objective is to evaluate the safety and tolerability of s-588210 (s-488210+s-488211) in patients with unresectable recurrent and/or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. patients with unresectable recurrent and/or metastatic solid tumor of lung, esophageal, head and neck, mesothelioma, or bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra), who have progressed after conventional systemic therapies or have exhausted or are intolerant to existing treatment options. 2. human leukocyte antigen (hla)-a\*02:01-positive patients. 3. patients who are male or female aged ≥18 years at the time of informed consent. 4. patients with the eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 at enrollment. 5. patients who have a lymphocyte count accounting for 15% or higher of the total white blood cell count within 28 days before enrollment. 6. patients who provide a personally signed and dated informed consent document for participation in the study. 7. patients with expected life-span of at least 3 months from the time of enrollment. exclusion criteria: 1. patients who are expected to require any of the following therapies between enrollment and completion of the observation period. * anti-malignant tumor drug * systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone ≤ 10 mg/day orally) * systemic immunosuppressant drug * radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the cancer(s) * surgical therapy for the cancer(s) * hyperthermia for the cancer(s) * traditional chinese herbal medicine with anti-tumor or immunosuppressant effect * other investigational products 2. patients who have severe concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with cancer(s). 3. patients who have known human immunodeficiency virus infection. 4. patients with uncontrolled systemic or active infection. 5. patients who had any diseases with the risk of sudden death within 12 months before enrollment. 6. patients with a history or evidence of autoimmune diseases and/or immunodeficiencies. 7. female patients who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations. 8. patients who are considered ineligible for this study by the investigator or subinvestigator due to any reasons, including inability to understand and follow the requirements of the study.

Keywords: metastatic solid tumor unresectable recurrent solid tumor s-588210 peptide vaccine
the effectiveness of using a mobile application for type 2 diabetes self-care

Conditions: Type 2 Diabetes; Diabetes Mellitus, Type 2; Disease, Chronic; Self-Care; Health Behavior; Mobile Apps; Mobile Phone Use

Summary: the purpose of the research is to evaluate and test the usefulness of the mobile application fordiabetes to improve the self-care of individuals with diabetes type 1. the investigators want to obtain the missing evidence from the field of application operation and their impact on individuals' self-care and study the acceptance of applications among healthcare staff, which plays an essential role in patient education.

the investigators will conduct a randomized study in which individuals included in the intervention group will use the fordiabetes app to self-care for their type 2 diabetes throughout the study. a randomized controlled trial will be conducted in family medicine clinics throughout slovenia. at the start of the observation and the first control visit, the investigators will assess self-care and disease perception of individuals with the help of validated questionnaires. measurement of body weight, blood pressure, blood sugar monitoring, and glycated hemoglobin will also be performed at the observation and a first control visit. for individuals who will use the fordiabetes application during the research, the investigators will also assess the frequency of using the mobile application in the home environment at the first control visit.

Eligibility criteria:
inclusion criteria: * patients older than 18 years; * with regulated and diagnosed type 2 diabetes; * patients who are managed in a family medicine clinic; * patients who have the option of using a mobile phone and a blood sugar meter in the home environment. exclusion criteria: * patients diagnosed with type 1 diabetes; * patients who have chronic complications as a result of diabetes.
the influence of different mood states and emotions on the physiologic, metabolic, and perceptual responses to feeding before exercise

Conditions: Other Gastrointestinal Disorders; Cramp, Abdominal

Summary: many athletes anecdotally report modifying their nutritional intake before competition in order to avoid gut problems, but no studies have evaluated whether emotional state impacts tolerance to pre-exercise feeding. therefore, this study will use movie clips (stressful, horror, and funny/amusing) to induce different mood states and emotions, which will be followed by ingestion of food before endurance running on a treadmill. in addition, metabolic and physiologic responses to mood induction will be evaluated.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 55 years 2. able to run for 30 min at a moderate-to-vigorous intensity without stopping 3. no diagnosis or signs/symptoms of cardiovascular disease (cvd) or metabolic disorders 4. currently physically active (at least 3 days/week of exercise at a moderate or higher intensity) 5. no visual or hearing impairments interfering with ability to see and hear video clips 6. no allergies to ingredients in boost drink exclusion criteria: 1. aged \ 55 years 2. unable to run for 30 min at a moderate-to-vigorous intensity without stopping 3. a diagnosis or signs/symptoms of cvd or metabolic disorders 4. currently physically inactive (\< 3 days/week of exercise at a moderate or higher intensity) 5. visual or hearing impairments interfering with ability to see and hear video clips 6. allergies to ingredients in boost drink
safety and immunogenicity of three seasonal trivalent influenza vaccines in china military

Conditions: Influenza

Summary: the purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (tivs)manufactured by glaxosmith kline (gsk), beijing sinovac biotech (sinovac) and shenzhen sanofi pasteur (pasteur) in chinese healthy servicemen. using imported gsk's tiv as control, to compare it with other two domestic tivs in chinese healthy servicemen.

this study is a 1:1:1 randomized, double-blinded, controlled phase ⅳ clinical trial in a military command in beijing. healthy individuals aged between 18～34 years who had not received any influenza vaccine during recent three years will be enrolled and administrated one dose tiv. safety data will be collected for whole study (day 0 to day 30).blood samples will be collected for immunogenicity assessments before injection and 21 days after vaccination.

Eligibility criteria:
inclusion criteria: * healthy servicemen aged between 18-34 years ,who had not received any influenza vaccine during recent three years; * proven legal identity; * written informed consent; * complying with the requirement of the study protocol; exclusion criteria: * pregnant, breast feeding women; * history of allergy to any vaccine or vaccine ingredient; * receipt of any immunosuppressant within 6 month prior to study entry; * congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, guillain-barré syndrome, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor; * acute disease or acute stage of chronic disease within 7 days prior to study entry; * axillaty temperature \> 37.0 °c; * any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;

Keywords: influenza vaccine safety immunogenicity