Kornimate/medical-research-clean huggingface dataset:
a clinical study of the efficacy of idebenone in the treatment of irbd into synucleinopathies

Conditions: Rapid Eye Movement Sleep Behavior Disorder; Synucleinopathy

Summary: 142 cases of patients with irbd will be recruited from the neurology department of ruijin hospital, th second affiliated hospital of soochow university and wuhan union hospital. after the informed consent was signed, they were divided into a trial group and a control group randomly. each group contains 71 cases. the patients in the trial group will be treated with idebenone, while the patients in the control group was treated with placebo. both groups of subjects will be treated for 5 years, and patients will be followed-up and evaluated in the first year, 3 years and 5 years after treatment. the observations include the mds-updrs questionnaires evaluation, blood biomarker measurements and fmri or pet-mr examination to make sure whether the patients has converted to synucleinopathies. study hypothesis: idebenone therapy for patients with irbd is safe and effective in delaying disease progression into synucleinopathies.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosed of irbd. 2. age between 40 and 75. 3. be voluntarily to participate in the experiment by signing an informed consent form. exclusion criteria: 1. sleep apnea hypopnea syndrome 2. slow movement, muscle rigidity, tremor or postural instability. 3. neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection. 4. other sleep disorders or seizures. 5. alcoholism or drug addiction patients.
physical activity level in patients with chronic kidney disease during covid-19 pandemic

Conditions: Covid19; Chronic Kidney Diseases

Summary: in the literature, there are no studies evaluating fear of covid-19, anxiety, depression, physical activity, fear of movement and quality of life in patients with chronic kidney disease during covid-19 pandemic. the investigators will evaluate these parameters in patients with chronic kidney disease and compare the findings of healthy individuals during covid-19 pandemic


Eligibility criteria:
inclusion criteria: * having been diagnosed with chronic kidney disease * being clinically stable * volunteering to participate in the research exclusion criteria: * having a cognitive problem * not being literate

Keywords: fear quality of life anxiety depression
influence of iyengar yoga on the bio-functional age of postmenopausal women

Conditions: Postmenopausal; Postmenopausal Flushing

Summary: the purpose of this study is to find out if iyengar-yoga has a rejuvenating effect on women after menopause. the biofunctional status of the study participants will be assessed before and after a 12-week yoga program.

postmenopausal women qualifying as participants for the study are patients at the universitätsklinik für frauenheilkunde in bern or are recruited through public advertisement. after giving informed consent the patients will be screened for inclusion and exclusion criteria and their biofunctional status will be assessed. the participants of the study will then be randomly assigned to the intervention group (12 week yoga program) or to the control group. in addition to the 90 minutes yoga sessions instructed by a professional yoga teacher, the participants of the intervention group are asked to perform two yoga sessions lasting 45 minutes per week at home and document these in a diary. after the 12 weeks the biofunctional status of all participants of the study will be reassessed.

Eligibility criteria:
inclusion criteria: * informed consent * women after menopause (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \>40mlu/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy) * age over 18 years * at least 4 hot flushes per day (examined through the menopause rating scale mrs-ii) * no regular yoga practice for two years * german as native language * willing to participate in 12 yoga classes as well as two 45 self practice sessions per week * willing to assess biofunctional status and give blood samples exclusion criteria: * acute and/or serious disease in the past two years (e.g. cancer, major surgery) * autoimmune or chronic inflammatory disease (e.g. rheumatism, thyroid dysfunction) * mental illness (e.g. depression or anxiety disorder (hads \>8)) * acute or chronic back pain or herniated vertebral disc * compulsion to participate in the trial * attendance of less than 10 yoga lessons out of 12. * hormone replacement therapy (hrt) * smoking \> 20 cigarettes per day or over 20 packyears * consumption of \>30g alcohol per day (\>1 liter of beer or \>0.3 dl of wine) * previous periodic participation in yoga classes within the last two years * inability or contraindications to undergo the investigated intervention * participants incapable of judgement or participants under tutelage diabetes mellitus

Keywords: biofunctional age yoga
growth, safety and tolerance of a rice protein hydrolysate formula in infants with cow's milk protein allergy

Conditions: Cow's Milk Allergy

Summary: this is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of cow's milk protein allergy (cmpa).

the main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of cma (cow milk allergy) from cow's milk protein allergy.

Eligibility criteria:
inclusion criteria: * subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade ii anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study: * negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates) * negative or positive specific ige for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk) * negative or positive milk atopy patch test * positive double blind placebo control food challenge (dbpcfc) with cow milk * gestational age 37-42 weeks inclusive * apgar score \>7 at 5 minutes * singleton birth * birth weight ≥2.500 g * written informed consent exclusion criteria: * previous signs of allergy to any extensively hydrolysed formula * confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade iii, as this could not be compatible with an allocation to the ehf group * daily formula intake \< 100 ml * major congenital malformations or neonatal diseases * severe concurrent or chronic diseases * intrauterine growth retardation * neonatal infections ( e.g. cmv, hiv) * simultaneous participation in other clinical trials * parents not signing written informed consent * unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers. * liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.
internet-based interventions for bipolar disorder (moodswings 2)

Conditions: Bipolar Disorder

Summary: this study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be most useful.

this study will examine whether exposure to the three different components of the moodswings 2.0 intervention results in decreased depressive symptoms as measured by the montgomery asberg depression rating scale (madrs), and decreased manic symptoms as measured by the young mania rating scale (ymrs). the three components of the moodswings 2.0 intervention are: * moderated peer discussion board * psychoeducation learning modules * interactive psychosocial tools this study will also examine whether there is an association between graduated levels of involvement and resulting improvement. these graduated levels are: * moderated peer discussion board only (level 1) * moderated peer discussion board and psychoeducation learning modules (level 2) * moderated peer discussion board, psychoeducation learning modules and interactive psychosocial tools (level 3). we expect that those participants assigned to the control condition (level 1), will have fewer positive outcomes than those in level 2 or level 3 conditions.

Eligibility criteria:
inclusion criteria: * current diagnosis of bipolar i disorder, bipolar ii disorder, or bipolar disorder not otherwise specified (nos) verified with the structured clinical interview for the diagnostic manual for mental disorders (scid) mood disorders module. * age 21 to 65 * access to a computer with internet access. access to a printer is preferable, but not required. * able to speak and read english proficiently. * some degree of medical supervision of bipolar disorder (sees a health professional at least twice a year to discuss symptoms and treatment needs). * local access to emergency care. exclusion criteria: * current psychosis, as assessed in screening phone interview with the scid psychotic screening module. * acutely suicidal (defined as having a hamilton rating scale for depression \[ham-d\] item 3 scores of ≥ 3) * current mania, assessed using the scid mood disorder module.

Keywords: bipolar disorder bipolar online intervention internet intervention self help
betafit study: beta cell imaging after faecal microbiota transplantation

Conditions: Type 1 Diabetes

Summary: the main goal is to investigate whether beta cell mass is correlated to beta cell function after autologous faecal microbial transplantation (fmt) in patients with newly diagnosed type 1 diabetes

the incidence of type 1 diabetes mellitus (t1d) has tripled in the last thirty years, and t1d is associated with a lifelong increase of considerable morbidity and mortality compared to healthy subjects. as the increased t1d incidence is primarily observed in subjects who are not genetically predisposed, environmental factors including altered diet, antibiotic use as well as mode of birth have been suggested to play a role, and these factors have invariably been linked to changes in the gut microbiome. indeed, an altered composition of the faecal microbiota composition was observed in adolescent t1d patients. a previous study by de groot et al. (2021) showed that faecal microbiota transplantation stops the decline in endogenous insulin production in newly diagnosed type 1 diabetes patients. however, it is unknown whether this is due to an increase in beta cell mass, or increased function of the remaining beta cells. in this study, the investigators aim to investigate whether beta cell mass (quantified by 68ga-nodaga-exendin-4 pet/ct imaging) is correlated to beta cell function after autologous faecal microbial transplantation in patients with newly diagnosed type 1 diabetes.

Eligibility criteria:
inclusion criteria: * previously participated in encapsulate-dm1 or fmt preserve-dm1 trial * type 1 diabetes with the diagnosis being made in the last 4.5 years * presence of at least one autoantibody associated with type 1 diabetes (anti-gad-65, anti-ia2, islet cell antibodies, insulin autoantibodies) * age ≥ 18 years * bmi 18-30 kg/m2 * insulin use exclusion criteria: * inability to provide written informed consent * other medication use than insulin * smoking * evidence of compromised immunity * presence of a second autoimmune disease (other than type 1 diabetes); e.g. celiac disease, hyper- or hypothyroidism, inflammatory bowel disease. vitiligo is allowed. * pregnancy or the wish to become pregnant within 1 month after the study * breastfeeding * liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range * renal disease defined as mdrd \< 40 ml/min/1.73 m²

Keywords: faecal microbiota transplantation glp-1 receptor exendin beta cell mass beta cell function imaging microbiome
diagnosis of gabhs tonsillitis - comparison between culture from tonsills and culture from the bucal surface

Conditions: Tonsillitis; Tonsillitis Streptococcal

Summary: diagnosis of group a beta hemolytic strep tonsillitis - * cultre of tonsills (gold standard) * culture from bucal surface (test)

this study will examine 2 groups. first group of 50 children aged 3-18 years and the second group of adults aged 18-65 with a clinical diagnosis of tonsillitis and centor criteria of 2 or more (fever, exudates on tonsills, no cough, enlarged lymph nodes). in each patient we'll take 2 cultures - the first from the tonsills and the second from the bucal surface. both of them will be sent to mega-lab . the treatment will be based only on the gold standrad culture from the tonsills.

Eligibility criteria:
inclusion criteria: * tonsills exudates * centor criteria - 2 or more exclusion criteria: * tonsillectomy

Keywords: diagnosis, tonsillitis, streptococcus, gabhs
study to evaluate the safety for the treatment of inflammation associated with cataract surgery

Conditions: Cataract

Summary: the study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * a single 5 mcl anterior chamber injection of ibi 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (qid) for 3 weeks safety will be assessed by adverse events (aes), slit lamp biomicroscopy, fundus examination, intraocular pressure (iop), visual acuity, and specular microscopy endothelial cell count.

the study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * a single 5 mcl anterior chamber injection of ibi 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (qid) for 3 weeks

Eligibility criteria:
inclusion criteria: * undergoing cataract surgery exclusion criteria: * glaucoma patient, pregnancy, allergy to dexamethasone
finding and treating unsuspected and resistant tb to reduce hospital transmission

Conditions: Tuberculosis

Summary: the study is designed to evaluate the clinical impact of a novel strategy for tuberculosis (tb) infection control known as fast (find cases actively based on cough surveillance, separate temporarily, and treat effectively). it is anticipated that this will decrease time to effective treatment initiation and also decrease transmission of tb to health care workers.

there is longstanding evidence that tuberculosis (tb) transmission is not from tb patients on effective treatment, but from unsuspected cases, and cases with unsuspected drug resistance. this study seeks to investigate the implementation of a refocused tb transmission control approach that we call fast (find cases actively based on cough surveillance, separate temporarily, and treat effectively based on molecular drug-susceptibility testing \[dst\]). we will conduct this study at hospital nacional hipólito unanue in lima, peru. our hypothesis is that fast will reduce delays in identifying infectious tb patients (and unsuspected drug resistance) entering the hospital, facilitate timely effective therapy, and thereby reduce the risk of tb transmission in a cost-effective manner. we will assess the impact of fast on tb transmission by evaluating igra conversions among health care workers at the intervention site, hospital nacional hipolito unanue (hnhu), and two control sites, hosptial nacional arzobispo loayza (hnal) and hospital nacional sergio bernales (hnsb). we will also evaluate acceptability and barriers to/facilitators of fast, novel screening strategies, and health care worker igra testing using a mixed methods approach.

Eligibility criteria:
inclusion criteria (for patients): * adult (≥ 18 years) patients who are receiving care in the emergency department or being admitted for inpatient care from any other hospital area * patient presenting with cough or tb risk factors of prior or current tb diagnosis and/or contact of an individual with tb * able to participate by providing a sputum sample and/or exhaled breath test sample exclusion criteria (for patients): * no specific exclusion criteria at initial screening if the patient meets the above inclusion criteria. inclusion criteria (for health care workers): * being an employee or intern at hospital nacional hipolito unanue (hnhu), hospital nacional arzobispo loayza (hnal) or hospital nacional sergio bernales (hnsb) and deemed to be at risk of exposure to tuberculosis based on line of work * age ≥ 18 years * willing and able to provide informed consent for participation exclusion criteria (for health care workers): * no specific exclusion criteria

Keywords: tuberculosis infection control transmission
multiple sclerosis and respiratory and functional capacity

Conditions: Multiple Sclerosis

Summary: it is known that respiratory functions, physical activities and functional capacities of multiple sclerosis (ms) patients decrease with the progression of the disease. however, there is not enough information about the severity of the effects of these parameters in mild relapsing-remitting multiple sclerosis (rrms) patients. our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild rrms patients with healthy controls and to examine the relationship between them.

it is known that respiratory functions, physical activities and functional capacities of multiple sclerosis (ms) patients decrease with the progression of the disease. however, there is not enough information about the severity of the effects of these parameters in mild relapsing-remitting multiple sclerosis (rrms) patients. our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild rrms patients with healthy controls and to examine the relationship between them. forty individuals diagnosed with rrms between the ages of 18-60 and 40 healthy individuals with similar demographic characteristics were included in the study.

Eligibility criteria:
patient group - inclusion criteria: * having a definitive diagnosis of rrms according to the 2017 mcdonald criteria * being between the ages of 18-60. * to be willing to participate in the study. * edss score between 0-3. healthy group - inclusion criteria: * being between the ages of 18-60. * to be willing to participate in the study. patient group - exclusion criteria: * have other neurological, orthopedic and systemic problems * having a relapse 30 days before or during the study * changes in medication use in the past 30 days healthy group - exclusion criteria: * have neurological, orthopedic and systemic problems

Keywords: multiple sclerosis functional capacity physical activity respiratory system relapsing-remitting
evaluation of different prophylactic interventions toward covid-19 in solid organ transplant patients

Conditions: COVID-19 Pandemic; Transplant-Related Disorder

Summary: the goal of this observational study is to evaluate the immune response after covid-19 vaccination in liver(lt) and kidney(kt) transplant recipient. the main question it aims to answer are: * the evaluation of the antibody response after complete vaccination * the efficacy of prophylaxis with long-acting-antibody prophylaxis (laab) all lt and kt patients during follow-up have been enrolled. anti-covid-19 title was obtained by electrochemiluminescence immunoassay (eclia) test(elyx, roche). in the case of antibody level \<100 iu/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(azd7442, astrazeneca). at three months, a follow-up was performed to assess any covid-19 infection. at six months another anti-covid-19 title is obtained by eclia test(elyx, roche) in lt and kt who undergo to laab.

liver(lt) and kidney(kt) transplant patients are at high risk of mortality from covid-19(16-29%, 28%; respectively). although transplant patients undergo a full vaccination course(3 doses), they are frequently low-responders and long-acting-antibody prophylaxis (laab) has been proposed. however, the efficacy of these strategies has not yet been demonstrated in lt and kt. the goal of this observational study is to evaluate the immune response after covid-19 vaccination in liver(lt) and kidney(kt) transplant recipient. the main question it aims to answer are: * the evaluation of the antibody response after complete vaccination * the efficacy of prophylaxis with long-acting-antibody prophylaxis (laab) all lt and kt patients during follow-up have been enrolled. anti-covid-19 title was obtained by electrochemiluminescence immunoassay (eclia) test(elyx, roche). in the case of antibody level \<100 iu/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(azd7442, astrazeneca). at three months, a follow-up was performed to assess any covid-19 infection. at six months another anti-covid-19 title is obtained by eclia test(elyx, roche) in lt and kt who undergo to laab.

Eligibility criteria:
inclusion criteria: * kt and lt transplant patients in follow up in tor vergata university * age \>18 years * at least 3 month post transplantation exclusion criteria: * pediatric recipients * active covid infection at the time of the study * pregnancy * allergy to any ingredients included in the vaccine * acute liver or kidney acute rejection proven by biopsy * acute febrile state with either leucopenia or leucocytosis * high dose of corticosteroid at study timing (pulse methyl prednisolone)

Keywords: transplant vaccination covid-19 pandemic