Kornimate/medical-research-clean huggingface dataset:
mirtazapine plus gemcitabine versus gemcitabine in metastasis pancreatic cancer

Conditions: Pancreatic Cancer

Summary: depression and anxiety accompany with advanced cancer. the effect of anti-anxiety depression has not evaluated in special cancers. mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. so the investigators assume mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. the drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

the investigators design a phase ii/iii trial to compared mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. the investigators planed to enroll 33 patients for each arm after randomization. the inclusion criteria included: 1. patients shall have normal organic function such as liver function, cardiac function and renal function. 2. before enrolled, anxious and depression states will be evaluated by the hamilton degree of depression and anxiety scale. only patients with definite depression and/or anxiety will be considering participating this trial. 3. pancreatic cancer patients with ecog 1～2 scores will be enrolled. 4. patients should be expected to live no shorter than 1.5 months the investigators will evaluated the quality of life by sf-36 scale as primary outcome. the second outcomes include anxious and depression scores, objective response rate, progress free survival, overall survival and chemotherapy induced nausea and vomiting.

Eligibility criteria:
inclusion criteria: 1. patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function. 2. before enrolled, anxious and depression states will be evaluated by the hamilton degree of depression and anxiety scale. only patients with definite depression and/or anxiety will be considering participating this trial. 3. pancreatic cancer patients with ecog 1～2 scores will be enrolled. 4. patients should be expected to live no shorter than 1.5 months exclusion criteria: 1. patients receiving other anti-cancer drugs; 2. patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received postoperative adjuvant chemotherapy less than 6 weeks. shorter than 4 weeks after operation; 3. patient with inadequate blood system,liver function and renal function. 4. brain metastasis is of symptoms 5. patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease; 6. chronic enteritis or intestinal obstruction 7. bone marrow failure 8. mental disease difficult to control 9. participated other clinic trial within 3 months 10. pregnant or lactation patients 11. the researcher evaluate the patient is not suitable for this trial.

Keywords: mirtazapine gemcitabine placebo rct pancreatic cancer
a study of the safety and efficacy of fabrazyme (agalsidase beta) as compared to placebo in patients with advanced fabry disease

Conditions: Fabry Disease

Summary: people with fabry disease have an alteration in their genetic material (dna) which causes a deficiency of the a-galactosidase a enzyme. fabrazyme (agalsidase beta) is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." these glycolipids are normally present within the body in most cells. in fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase a is not present, or is present in small quantities. the build up of glycolipid ("globotriaosylceramide" or "gl-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to fabry disease. this study will test the safety and efficacy of fabrazyme in the treatment of patients with fabry disease.


Eligibility criteria:
inclusion criteria: * patients must provide written informed consent * patients must be at least 16 years old * patients must have a current diagnosis of fabry disease and have a clinical presentation consistent of fabry disease (decreased sweating, fabry pain, angiokeratoma, etc.) * patients may not have received enzyme replacement therapy as a treatment for fabry disease * patients must have a documented plasma a-galactosidase a (agal) activity of \< 1.5 nmol/hr/ml or a documented leukocyte agal activity of \< 4 nmol/hr/mg * patients must have one or more of the following: a serum creatinine measurement of 1.2 to 3 mg/dl (106.1 to 265 umol/l) or estimated creatinine clearance \< 80 ml/min only if the patient's serum creatinine measurement is \< 1.2 mg/dl * female patients of childbearing potential must have a negative pregnancy test prior to each dosing and all female patients must use a medically accepted form of contraception exclusion criteria: * patient has undergone or is currently scheduled for kidney transplantation or is currently on dialysis * patient has acute renal failure * patient has participated in a study employing an investigational drug within 30 days of study entry * patient has diabetes mellitus or presence of confounding renal disease * patient has a history of transient ischemic attack (tia) or ischemic stroke within 3 months of study entry documented by mild-to-moderate neurological deficit * patient has critical coronary disease * patient has congestive heart failure * patient has severe residual neurological deficit that will confound the detection of new events as determined by an attending neurologist and/or principal investigator * patient is unwilling to comply with the requirements of the protocol or the patient has a medical condition, serious intercurrent illness, or extenuating circumstances that would significantly decrease study compliance, including prescribed follow-up

Keywords: a-galactosidase a agal r-hagal fabry gl-3 fabrazyme
preventing burnout among caregivers through physical activity

Conditions: Burn Out

Summary: the purpose of this study is to evaluate the impact of an adaptive physical activity programme to prevent the risk of burnout at the end of the programme (10 weeks after the start of the intervention).

the paca trial is a pilot, prospective, comparative, randomised (2 arms), controlled, single-centre study. the study population consisted of adult healthcare professionals at the clinique de la sauvegarde with a low to moderate level of physical activity and no contraindications to physical activity. participants will be randomised into two arms (ratio 1:1): * arm a (intervention): participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period. * arm b (control): participants will receive the recommendations of the world health organisation for physical activity.

Eligibility criteria:
inclusion criteria: * age \> 18 years ; * non-physician health professionals at the clinique de la sauvegarde ; * low or moderate level of physical activity, as assessed by the questionnaire international physical activity questionnaire. in fact, work-related physical activity is not associated with a reduction in burnout ; * absence of serious chronic pathology incompatible with the physical activity of the protocol ; * willing and available to commit to the project for the duration of the study ; * using a personal smartphone or tablet and with an internet connection ; * able to read, write and understand french ; * membership of a social security scheme. exclusion criteria: * high level of physical activity (not including work-related physical activity) ; * contraindication to physical activity (uncontrolled hypertension, uncontrolled heart disease...) ; * concurrent participation in another physical activity study ; * pregnant or likely to be pregnant ; * unable to be monitored for medical, social, family, geographical or psychological reasons for the duration of the study ; * persons deprived of their liberty by judicial or adm inistrative decision, or adults protected by law.
a study of omega-3 as an augmentor of antidepressant treatment for major depression

Conditions: Major Depression

Summary: the purpose of this study is to determine whether augmentation of antidepressant medication with omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for patients with major depression

the study will be a 4 week, parallel-group double blind randomised control trial of the efficacy pf omega-3 as an augmentor of antidepressant treatment for depression. people aged between 18 and 65 with a first or new episode of depression warranting treatment with antidepressant medication will be recruited. in addition to their antidepressant medication, participants will be randomly allocated to receive either omega-3 (fish oil) or placebo (paraffin oil)for 4 weeks. participants will commence treatment with the antidepressant and omega-3/placebo simultaneously. participants will be followed up at 1,3 and 4 weeks and will be asked to rate their mood daily for the 4 week study period. blood samples will be taken pre and post treatment to measure change in omega-3 levels.

Eligibility criteria:
inclusion criteria: * participants must present with a first or new episode of dsm iv non-psychotic major depression warranting treatment with antidepressant mediation. * must be able to give informed consent. exclusion criteria: * history of psychosis or mania/hypomania or personality disorder. * non-english speaking or otherwise unable to provide historical information. * having taken omega-3 dietary supplements in the last 3 months. * history of allergy to omega-3 supplements, finfish or shellfish. * pregnancy, breast feeding or plans to become pregnant during course of study. * post-natal depression * current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months. * unstable thyroid function * hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of omega-3 polyunsaturated fatty acids * coagulopathy or anticoagulant treatment due to theoretical bleeding risk. * patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who will not likely be able to comply with the study protocol.

Keywords: mood disorder
analysis of chronic non-infectious diseases dynamics after covid-19 infection in adult patients

Conditions: Covid19; SARS-CoV-2 Infection; Pneumonia; Copd; CKD; Cardiac Event; Overweight and Obesity; Cardiovascular Diseases; Diabetes; Hypertension; Coronary Heart Disease

Summary: non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after sars-cov-2 infection in adults.

non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after sars-cov-2 infection in cohort of russian adult patients. retrospective analysis of medical histories and outcomes in adults with pre-existing conditions after sars-cov-2 infection and prospective monitoring of health status during 3, 6 and 12 months after discharge. comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, ckd, copd, bronchial astma, incidence of hypertonic crises, vascular events and others.

Eligibility criteria:
inclusion criteria: * suspected or confirmed covid-19. exclusion criteria: * refuse to be involved in study; * age under 18 years.
the effect of methotrexate on sperm quality in men with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease (IBD)

Summary: inflammatory bowel disease (ibd) is a chronic inflammatory disorder of the gastrointestinal tract which includes crohn's disease (cd) and ulcerative colitis (uc) which peak in incidence (rate or frequency) during the reproductive years. an increasing number of young people will face challenging decisions regarding medical management of this chronic disease during a period of time when they are still completing schooling, establishing their career, and/or are building a family. treatment options for ibd consist of immunosuppressive therapy, such as immunomodulators (azathioprine and methotrexate). methotrexate (mtx) is a folic acid antagonist (a substance that interferes with or inhibits the action of another). it is thought that mtx works by decreasing the inflammation in the gastrointestinal tract. mtx has been studied for many years and in used as treatment in not only ibd, but also in conditions such as rheumatoid arthritis and lupus. however, due to concerns about the safety of mtx, particularly in regards to fertility and pregnancy has limited its current use. participants are invited to take part in this research project to determine whether the treatment of ibd patients with mtx is associated with an increased risk for infertility. investigators will recruit 75 male ibd patients under mtx treatment for their ibd as well as 75 healthy male controls for a total of 150 patients at the university of wisconsin hospital \& clinics.


Eligibility criteria:
inclusion criteria: 1. cases: men aged 18 to 40 years with a confirmed diagnosis of uc or cd based on endoscopy, pathology, and/or radiology and who regularly take mtx (per oral, subcutaneous, or intramuscular) either as monotherapy or in combination with mesalamine (any except sulfasalazine), corticosteroids, anti-tnf agents, or anti-adhesion molecules for at least one month specifically for the treatment of ibd. controls: men aged 18 to 40 years with a confirmed diagnosis of uc or cd based on endoscopy, pathology, and/or radiology and who do not take mtx (per oral, subcutaneous, or intramuscular) either as monotherapy or in combination with other ibd-specific drugs. 2. individual able and willing to consent to donate their sperm to research. exclusion criteria: 1. men with previously documented problems with male reproductive health such as known hypothalamic-pituitary disorders (e.g. pituitary macroadenomas, pituitary infarction), primary hypogonadism (e.g. cryptorchidism, klinefelter's syndrome), or disorders of sperm transport (e.g. erectile dysfunction, history of vasectomy) 2. current use of alkylating agents, ketoconazole, sulfalsalazine, h2-receptor antagonists or spironolactone 3. men who have undergone ileal pouch anal anastomosis within 3 months of study entry
blood biomarkers for screening of alzheimer's disease

Conditions: Alzheimer's Disease; Blood Biomarkers

Summary: the goal of this observational study is to estimate the screen performance of blood biomarkers of interest (aβ40 and aβ42, p-tau181, p-tau217, gfap and nfl) in patients with alzheimer's disease (ad), mild cognitive impairment due to ad, and cognitively normal individuals. the main questions it aims to answer are: * to identify core blood biomarker suitable for early screening of ad. * to establish a comprehensive model for the early identification of ad.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years; * ad (meets the 2011 nia-aa ad diagnostic criteria), or mci (meets the 2004 peterson mci diagnostic criteria), or cognitively normal subjects; * signed informed consent form. exclusion criteria: * the presence of other disorders that can cause cognitive impairment; * unable to cooperate with the completion of cognitive assessment; * refusal to draw blood.
high-resolution ultrasound imaging of the retina and choroid for detection on age related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: the macula is the site of central vision within the retina. the retina is oxygenated by the underlying choroid. these tissues are less than 1 mm thick in total. while optical techniques can reveal much about the structure of the retina, ultrasound allows imaging of the choroid and deeper tissues. this study will investigate use of high frequency (20 mhz) ultrasound for imaging of the retina and choroid in patients with age-related macular degeneration, a prime cause of blindness. the investigation will involve use of novel post-processing methodologies to achieve maximum resolution of the fine tissue structures involved in this disease.

age-related macular degeneration (amd), a condition affecting over 40% of individuals 70 years or age or more, causes progressive loss of central vision. photocoagulation has long been used to slow the progress of amd, but new vision-preserving methods are currently under investigation. because destroyed photoreceptors are permanently lost, early management is essential for preservation of vision. the aim of this project will be to study amd using a suite of new high-resolution ultrasound imaging techniques that have been developed. specifically, high-resolution ultrasound will be used to generate images of the retina and choroid, including perfusion measurements using slow-flow methods developed by our research group. ultrasound studies will be performed in conjunction with optical coherence tomography (oct) imaging in a series of patients and age-matched control subjects with the aim of determining if choroidal thickness and/or perfusion might be used as an early indicator of amd and thus aid in patient management. we will study 20 subjects diagnosed with amd. we will attempt to have an approximately equal number of subjects with wet and dry forms of amd. a control group consisting of 20 non-amd age-matched subjects will also be recruited. ultrasound scan sequences will consist of b-mode images of the macula and surrounding tissues.

Eligibility criteria:
inclusion criteria: age related macular degeneration age matched control exclusion criteria: none

Keywords: age related macular degeneration ultrasound oct eye
observation of clinical routine care for patients with biotronik implantable cardiac monitors (icms)

Conditions: Tachycardia; Atrial Fibrillation; Syncope; Bradycardia; Cryptogenic Stroke

Summary: this registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the biomonitor iii and possible successors in a real-life clinical set-up. in addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.


Eligibility criteria:
inclusion criteria: * patient is intended to receive a biotronik implantable cardiac monitor (icm) * patient is able to understand the nature of the registry and to provide written informed consent. * patient is willing and able to use the cardiomessenger and accepts the biotronik home monitoring concept. exclusion criteria: * patient is pregnant or breast feeding. * patient is less than 18 years old. * patient is participating in another interventional clinical investigation other than the submodules of bio\|stream.icm

Keywords: implantable cardiac monitor biomonitor iii
midkine role with deregulated oxidative and immune milieu in induction of preeclampsia

Conditions: Pre-Eclampsia

Summary: preeclampsia (pe) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated. midkine (mdk) is a multifunctional protein that plays a unique role in the development of hypertension (htn), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. oxidative stress (os) upregulates the expression of mdk and mdk induces propagation of neoangiogenesis and acts as chemotactic for neutrophils.


Eligibility criteria:
inclusion criteria: * newly pregnant normotensive (nt) women with singleton fetus; * free of the exclusion criteria. exclusion criteria: * women with history of complicated pregnancy; * had manifest essential hypertension, diabetes mellitus or chronic kidney diseases; * had multiple gestational sacs, morbid obesity with body mass index at time of pregnancy diagnosis over 35 kg/m2; * had genetic disorders, coagulopathy, autoimmune diseases or maintained on immunosuppressive therapy.
redstroke - reducing europe's stroke incidence

Conditions: Atrial Fibrillation

Summary: in the redstroke study, the effect of a smartphone application in detecting atrial fibrillation (af) will be assessed in a double-blind randomised controlled multicenter trial. outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. all patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. this study will not cause any restrictions on the usual treatment of the study patients. the only difference between the two groups will be, that patients in the app group will be informed by their local pi, if the recordings of the app indicate af (and obtain a 14 day holter ecg for af verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.


Eligibility criteria:
inclusion criteria: * written informed consent * cha2ds2-vasc score of 3 and above, if patients are aged under 65 years * cha2ds2-vasc score of 2 and above, if patients are aged 65 years or older exclusion criteria: * history of atrial fibrillation * current anticoagulation treatment, * cardiac implanted electronic device (icd or/and pm) * app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other) * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * enrollment of the investigator, his/her family members, employees and other dependent persons

Keywords: atrial fibrillation smartphone app cha2ds2-vasc-score screening cardiovascular risk factors outpatient setting congestive heart failure stroke diabetes vascular disease