Kornimate/medical-research-clean huggingface dataset:
evaluation of retinal changes in systemic darbepoetin alpha treatment in patients with diabetes mellitus

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.


Eligibility criteria:
inclusion criteria: group a: * males and females aged 18 to 80 yrs * diabetes mellitus type 1 or 2 * haemoglobin level above the treatment threshold level (as described in the drug description) * receiving no darbepoetin alfa treatment * best corrected visual acuity (bcva) better than 20/200 * no clinically significant macular edema (csme) or csme already treated with laser photocoagulation. group b: * males and females aged 18 to 80 yrs * diabetes mellitus type 1 or2 * anaemia (due to renal failure), haemoglobin level under the treatment threshold level before the initialisation of the therapy (as described in the drug label) * starting to receive darbepoetin alfa treatment (darbepoetin alfa, aranesp, amgen) * bcva better than 20/200 * no clinically significant macular edema (csme) or csme already treated with laser photocoagulation. exclusion criteria: * history of retinal disease other than dr * history of intraocular surgery, including laser treatment in the past 4 month * a major change in the insulin treatment of the patient in the past 4 month or during the follow up period. * inability to communicate in german or english * dementia; inability to follow commands * epilepsy
reconstruction of hand soft tissue defects

Conditions: Hand Injuries

Summary: evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities.


Eligibility criteria:
inclusion criteria: 1. patients with complex defects over the dorsal and palmar aspect of the wrist and the hand up to the proximal interphalangeal joint level, the whole thumb, and the first web space. 2. small to moderate hand defects resulting from post-traumatic raw areas, post-traumatic deformities, postburn deformities and scar, post tumor resection, and congenital hand deformity. 3. availability of a healthy donor site. exclusion criteria: 1. patients with a major uncontrollable medical illness. 2. chronic heavy smokers. 3. traumatic injury to the donor site. 4. complex defects of the hand beyond the pip joint level.

Keywords: posterior interosseous artery flap hand soft tissue defects
effect of h2 receptor antagonist and proton pump inhibitor on the positivity rates and clinical outcomes of covid-19

Conditions: COVID-19

Summary: this retrospective cohort study aims to evaluate the effect of proton pump inhibitor (ppi) or histamine-2 receptor antagonist (h2ra) on the clinical outcomes and positivity rates of coronavirus disease-19 (covid-19).

previous researches on the association between the use of ppi and h2ra and the treatment and prevention of covid-19 have reported inconsistent findings. this study aimed to evaluate the effect of h2 receptor antagonists and proton pump inhibitors on the clinical outcomes and positivity rates of covid-19 using the korean national health insurance (nhi) data. this is a retrospective cohort study using the nhi covid-19 dataset, which includes health insurance data of individuals who underwent covid-19 pcr test in south korea. this study aims to evaluate the effect of the use of ppi and h2ra on the positivity rates and clinical outcomes of covid-19.

Eligibility criteria:
inclusion criteria: * individuals who were tested for covid-19 using real-time reverse transcriptase pcr assay of nasal and pharyngeal swabs exclusion criteria: * record of a new prescription of non-steroidal anti-inflammatory drugs (nsaid) within 1 month of the test date * patients who died within 48 hours after test.

Keywords: covid-19 proton pump inhibitor h2 receptor antagonist
genital hygiene education and pregnancy

Conditions: Genital Hygiene Behaviors; Self-Care Ability

Summary: genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. the study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. the hypotheses of this study were determined as follows: h1a: genital hygiene education affects genital hygiene behavior in pregnant women. h1b: genital hygiene education affects self-care ability in pregnant women.

genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. the study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infection on genital hygiene behavior and self-care ability. the study was conducted in the gynecology and obstetrics clinics of a hospital in eastern turkey between september 2021 and february 2022. personal information form, genital hygiene behaviors scale and self-care ability scale were used to collect data. in the power analysis, the sample size was calculated as 80 pregnant women in each group (80 experimental, 80 control). pregnant women in the experimental group received genital hygiene education in 4 sessions, while no intervention was applied to the control group. descriptive statistical analyses and t-test in dependent-independent groups were used in the analysis of the data.

Eligibility criteria:
inclusion criteria: * all pregnant women who were literate, - who had completed their pharmacological treatment (antibiotic treatment) for uti according to medical records were included in the sample exclusion criteria: * - those who had previously received training to increase genital hygiene behavior, * those who had a risky pregnancy, * those who were diagnosed with any health problems related to the pregnant woman and the fetus were not included in the study

Keywords: midwife pregnant hygiene self-care urinary tract infections
study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of sam-315

Conditions: Alzheimer Disease

Summary: primary: to assess the safety and tolerability of ascending multiple oral doses of sam-315, an investigational drug, in healthy young adult and elderly subjects. secondary: to assess the pharmacokinetic and pharmacodynamic profiles of multiple oral doses of sam-315 in healthy young adult and elderly subjects.


Eligibility criteria:
inclusion criteria: young healthy subjects: * men and women of nonchildbearing potential (woncbp) aged 18 to 45 years inclusive on study day 1. * body mass index (bmi) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg. elderly healthy subjects: * men or women aged 65 years and above as of study day 1. * bmi in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * history of any clinically important drug allergy.
efficacy and safety of csa+ava in the treatment of nsaa in the elderly

Conditions: Aplastic Anemia

Summary: for elderly patients who cannot tolerate anti-thymocyte globulin (atg) treatment, the addition of avatrombopag (ava), which has a slight adverse reaction, can theoretically improve the hematological response rate in elderly patients with non-severe aplastic anemia (nsaa) without significantly increasing adverse reactions. based on this, this study treated nsaa patients older than 60 with ava combined with csa to evaluate the hematological response rate and safety of ava in the elderly who could not tolerate atg therapy.

aplastic anemia (aa) can be divided into severe aa (saa) and non-severe aa (nsaa), according to the severity of the disease. anti-thymocyte globulin (atg) in combination with csa is the most typical combined immunosuppressive therapy regimen. for elderly patients who cannot tolerate anti-thymocyte globulin (atg) treatment, the addition of avatrombopag, which has a slight adverse reaction, can theoretically improve the hematological response rate in elderly patients with nsaa without significantly increasing adverse reactions. based on this, this study treated nsaa patients older than 60 with ava combined with csa to evaluate the hematological response rate and safety of ava in the elderly who could not tolerate atg therapy.

Eligibility criteria:
inclusion criteria: 1. elderly patients with well-defined nsaa anemia who meet the diagnostic criteria for aplastic anemia (aa) but do not meet the diagnostic criteria for severe aplastic anemia (saa). 2. age 60 years or older, male or female. 3. able to swallow or administer orally. 4. intolerant or refused anti-thymocyte globulin treatment 6. no previous treatment with cyclosporine, tacrolimus or hormones or treatment for less than 1 month. 7. no prior treatment with thrombopoietin (tpo) receptor agonists (including eltrombopag, herombopag, romiplostim, etc.) 8. informed consent must be signed before the start of all specific research procedures. considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent shall be signed by the patient's immediate family. exclusion criteria: 1. known congenital aa (such as fanconi anemia) and other causes of pancytopenia and hematological bone marrow disorders; 2. with paroxysmal nocturnal hemoglobinuria (pnh) clone ≥ 50% 3. with a history of hematopoietic stem cell transplantation. 4. history of thrombosis 5. patients with underlying cancer who also have malignant tumors or are receiving immunosuppressive therapy. 6. baseline creatine levels greater than twice of the upper limit of normal (uln) and/or alanine aminotransferase (alt) greater than 2.5 times of the uln; 7. serious heart, liver and kidney disease. 8. with uncontrolled bleeding and/or infection after standard treatment. 9. participants considered unsuitable for inclusion by the researchers.
continuous video- eeg monitoring in the acute phase in patients with a cerebrovascular attack- randomisation of a subpopulation regarding treatment strategy

Conditions: Stroke

Summary: stroke is a major cause of epilepsy. the pathophysiological mechanisms of poststroke epilepsy are not known. subclinical epileptiform discharges could contribute to the neuronal damage and influence functional outcome. electro-encefalography (eeg) is the golden standard to detect interictal, ictal and subclinical epileptic brain activity. patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack will undergo a 24 hours video-eeg monitoring to detect epileptiform discharges. clinical and paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together with the eeg results. the eeg results will be correlated with the occurence of epileptic seizures and functional outcome and mortality in the acute phase and in the long-term. when subclinical epileptic discharges are found on the eeg, patients will be asked to participate in a second part of the study where they will be randomised into a treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months. outcome parameters will be the occurrence of epileptic seizures, mortality and functional outcome. our main hypothesis is that the occurrence of subclinical epileptiform discharges during the acute phase following stroke influences functional outcome.


Eligibility criteria:
inclusion criteria: * patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding exclusion criteria: * patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention
lace (lactobacillus paracasei lpb27 on early childhood eczema)

Conditions: Eczema; Allergy

Summary: the lace study is a double-blind, randomised, placebo-controlled trial examining the effectiveness of the probiotic lactobacillus paracasei lpb27 in treating eczema in young children.

childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. eczema has significant impact on the quality of life of those affected. its main symptoms are dry skin and intense itching. there is currently no cure for eczema but there are treatments that try to relieve symptoms. these commonly include topical moisturisers and topical corticosteroids. although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance. there have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. the gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. it was shown that people with eczema have different bacteria in their gut compared to people without eczema. therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.

Eligibility criteria:
inclusion criteria: * age: 3 months to 3 years old * diagnosis: eczema (atopic dermatitis) diagnosed clinically by a paediatric dermatologist or immunologist. * severity: investigator global assessment for atopic dermatitis (iga) severity of 1-3 (almost clear, mild, moderate) and a scorad score greater than 8.7. * willingness and ability of the subject to comply with the protocol requirements. exclusion criteria: * patients on systemic immunosuppression and/or biologic agents (participants who start systemic immunosuppression and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their scorad index scores). * mothers who are breastfeeding and on probiotics but not willing to stop probiotics. * child already on probiotics and parents not willing to stop during the entire study period (washout period of 4 weeks; including formulas that contains probiotics). * eczema complicated by active skin infection e.g. impetigo/cellulitis/ eczema herpeticum (can be considered once active infection resolved). * child currently on oral or iv antibiotics (washout period of 4 weeks allowable once antibiotics completed). participants who require antibiotics after being enrolled in the study may continue on the study as usual. * immunodeficient disorders. * chronic disorder involving the gastrointestinal tract (e.g., inflammatory bowel disease, short gut syndrome, cystic fibrosis). * known hypersensitivity to components contained in study product.

Keywords: immunology microbiome paediatrics
migraine stimulation crisis of migraine

Conditions: Migraine Without Aura

Summary: migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. currently, there is no treatment for migraine. millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain. mistic is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.

mistic is a multicenter, controlled, randomized, double-blind study. eligible patients will have to report their migraine crisis in a diary during a one month pre-selection phase. then, patients will be randomized into one of two treatment groups : * active millimeter wave emission bracelet * or placebo bracelet patients will have to use the medical device twice a day for 3 months. the investigators will follow them for an additional 3 months to assess the persistence of the effect. throughout the follow-up, patients will report their migraines crisis in a journal. the primary outcome will be the impact of wearing a millimeter wave bracelet for 3 months, on the number of days with migraine headaches.

Eligibility criteria:
inclusion criteria: * patient with episodic migraine without aura (according to icdh3 classification criteria) * patient with at leat 4 migraine days per month and no more than 8 migraine days per months * background treatment (or not) stable for at least 1 month * drug management of migraine stable for at least one month * non-drug management of stable migraine at least 1 month prior to the study * patient affiliated to social security or beneficiary of such a scheme exclusion criteria: * patients with chronic migraine (defined according to ihs criteria) * patients already included in an interventional clinical research protocol * patients with chronic headache due to drug abuse (according to ihs criteria) * patients with only migraine crisis with aura * wrist size \ 21 cm * situations of dermatological pathologies on pre-existing wrists (oozing dermatosis, hyper sweating, eg.) or unhealed lesions on both wrists. * presence of metallic object (bracelet, watch, piercing...) on both wrists. * presence of a tattoo on both wrists * allergic reactions on contact with silicone or metal * persons referred to in articles l 1121-5 to l 1121-8 of the csp (corresponds to all protected persons) pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure * women of childbearing age with a short-term pregnancy project

Keywords: migraine prophylaxis millimeter waves pain neuromodulation
propolis in reducing dentin hypersensitivity

Conditions: Dentin Sensitivity

Summary: objective: this randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life. materials and methods: volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: group 1- placebo - toothpaste without active ingredient, group 2- toothpaste with 10% propolis and group 3. - toothpaste with 15% propolis. number of teeth will be used as sample unit, totaling 22 teeth per group. volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. the evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (vas). the self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. the data regarding hd in vas, if present normal distribution, will be used two-way analysis of variance (anova) with tukey's post hoc for comparison between treatments. however, if the data show anormal distribution, friedman to compare the different times in the same group (intra group), and kruskal wallis to make the comparison between groups (inter group). to evaluate the qehd ordinal data, wilcoxon and mann-whitney tests will be used. bioestat 5.3 (belém, pará, brazil) will be used, considering an alpha level of 5%.


Eligibility criteria:
inclusion criteria: * two to four hypersensitive teeth with a response ≥ 04 on the visual analogue scale (vas) from 0 to 10, where 0 represents no pain and 10 extreme pain, during the application of tactile (explorer probe) and evaporative (jet air); * dentinal exposure on the posterior teeth, due to the presence of a shallow non-carious lesion up to 02 mm in depth, according to the smith \& knight index (measured with a millimeter probe), and / or class i gingival recession according to miller classification. exclusion criteria: * restorations; tooth decay and/or periodontal pockets; dental pulpitis; enamel cracks or fractures on sensitive teeth; * continuous treatment with anti-inflammatory drugs and/or analgesics or desensitizing treatment induced three months prior to research recruitment data; * pregnancy or lactation; * systemic diseases; * fixed orthodontic appliances; * occlusal instability.

Keywords: dentin desensitizing agents; propolis.
a study to evaluate the safety and efficacy of obinutuzumab compared with placebo in participants with lupus nephritis (ln)

Conditions: Lupus Nephritis

Summary: this phase ii study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (mmf)/mycophenolic acid (mpa) with placebo plus mmf/mpa in participants with proliferative ln.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle), according to current american college of rheumatology (acr) criteria * diagnosis of international society of nephrology/renal pathology society (isn/rps) 2003 class iii or iv ln as evidenced by renal biopsy performed within 6 months prior to or during screening. participants may co-exhibit class v disease in addition to either class iii or class iv disease * proteinuria (urine protein to creatinine ratio) greater than (\>) 1.0 * for women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug * for men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period exclusion criteria: * retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from sle * presence of rapidly progressive glomerulonephritis * severe renal impairment as defined by estimated glomerular filtration rate (gfr) \<30 milliliters per minute (ml/min) or the need for dialysis or renal transplant * greater than 50% of glomeruli with sclerosis on renal biopsy * treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization * unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions * history of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion * significant or uncontrolled medical disease in any organ system not related to sle or ln, which, in the investigator's opinion, would preclude participant participation * concomitant chronic conditions, excluding sle, (e.g., asthma, crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening * previous treatment with an anti-cluster of differentiation (cd20)-targeted therapy within 12 months * previous treatment with a biologic b-cell-targeted therapy (other than anti-cd20) within 6 months of randomization * known intolerance to mmf or mpa