Kornimate/medical-research-clean huggingface dataset:
the effect of oral use of lyophilised royal jelly on cognitive functions and immune system in elderly individuals

Conditions: Cognitive Change

Summary: dementia is a significant public health problem, affecting 47 million people worldwide in 2015, according to world health organization data. it is expected to increase to 75 million in 2030 and reach 132 million in 2050. royal jelly is used as a supplement in treating of cancer, hypertension, diabetes and neurodegenerative diseases due to its antioxidant, anti-inflammatory, neuroprotective, cardioprotective, anti-proliferative and anti-fatigue properties. there are preclinical studies on the curative and protective effects of royal jelly on cognitive functions. this randomized controlled, double-blind clinical trial is aimed to study the effect of oral use of lyophilized royal jelly for 4 weeks on immune system cytokine levels and cognitive functions in individuals aged 50-80 years without any neurological disease diagnosis. primary outcome measures are the mini-mental state examination, the alzheimer's disease assessment scale-cognitive subscale, and the geriatric depression scale. secondary outcome measures are serum interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α and transforming growth factor-β levels.

volunteers who apply to bağcılar medipol mega university hospital neurology polyclinic will be recruited, and their demographic information will be recorded. volunteers who meet eligibility criteria will be randomly divided into three groups considering age groups (50-64 years old and 65-80 years old). primary and secondary outcome measures will be evaluated in volunteers. the results obtained will be recorded. diet recommendations will be made to the volunteers for four weeks. the products detailed in the protocol will be used by the volunteers orally for four weeks on an empty stomach in the morning. primary and secondary outcome measures will be reassessed in volunteers on day 28. the results obtained will be recorded. obtained results will be evaluated statistically.

Eligibility criteria:
inclusion criteria: * between the ages of 55 and 70, * male or female, exclusion criteria: * history of allergy to bee products * known history of lactose allergy * diagnosed dementia, * mmse score below 21, * adas-cog score of 12 and above, * body mass index of 35 and above, * be taking any medical medication, herbal product or dietary supplement for dementia, except for those who stopped using it at least 1 month before inclusion in our study, * being or having been treated for acute acquired brain injuries such as acute traumatic brain injury, acute onset stroke, * being followed up due to inflammatory disease, * diagnosis of chronic or acute infection, * taking corticosteroids or non-steroidal anti-inflammatory drugs, * being or having been treated for a psychotic illness, * severe anaemia, vital organ dysfunction or critical illness.
pulsed electro magnetic fields (pemf) treatment in patients with treatment-resistant major depression in ongoing pharmacological treatment of depression

Conditions: Depression

Summary: about 30% of patients with major depression are treatment resistant to pharmacological treatment. in the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. this study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (pemf = pulsed electro magnetic fields) can alleviate the symptoms of depression.

in this study, a patient with treatment resistant depression, as defined by harold sackeim, is subjected to 5 weeks of treatment with active or sham pemf treatment for 30 minutes on every working day. the pharmacological treatment for depression is maintained unaltered throughout the study. depression severity is measured at the beginning of the study and at each weekly visit. side effects are closely observed. the ability to concentrate is measured by the aqt test (alzheimers quick test). personality is assessed by use of the scid-ii-instrument (dsm-iv axis ii).

Eligibility criteria:
inclusion criteria: * major depression * treatment resistance * age above 18 years * hamilton 17 item score above 13 * unaltered pharmacological treatment in last 4 weeks exclusion criteria: * psychotic disorder * mental retardation * suicidality * earlier treatment with pemf * abuse of alcohol or other substances * patient not able to come to appointed visits * antisocial, borderline or schizotypic personality disorder * women lactating or pregnant * unreliable contraception

Keywords: major depression treatment resistant pemf aqt hamilton
fycompa in catamenial epilepsy

Conditions: Catamenial Epilepsy

Summary: the purpose of the proposed investigation is to carry out a pilot study of add-on perampanel (fycompa) in women with perimenstural (c1) catamenial epilepsy. perampanel, a noncompetitive ampa receptor antagonist, is uniquely positioned to decrease progesterone receptor mediated excitotoxicity. this mechanism of action would allow a novel use of perampanel as an effective treatment of c1 catamenial epilepsy.


Eligibility criteria:
inclusion criteria: * female * diagnosis of focal onset seizures (fos) i. established by clinical history and an eeg ii. patients with a normal eeg may be included if they met other diagnostic criteria based on clinical history * presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses * ≥18-50 years old * ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (aed) * seizures must show a c1 catamenial pattern in 2 of 3 documented cycles i. c1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. the menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (herzog et al, 1997). of note, in the nih progesterone trial, the level of catameniality was 1.69 based on herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation. * willingness and ability to comply with scheduled visits and study procedures exclusion criteria: * progressive neurologic or systemic disorder * use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing iud who still have monthly periods may be enrolled) a. women on system hormonal contraception will be excluded as these women are not ovulatory * subject is pregnant or breastfeeding * active suicidal or homicidal ideation * comatose individuals.
impact of an interventional program on self-management

Conditions: Diabetes Self Management

Summary: the goal of this randomized clinical trial study is to assess the effect of an interventional program on diabetes self-management and therefore on effective glycemic control among diabetic students in assuit university

1. to formulate a strategy aiming to reduce the burden of diabetes morbidity \& mortality; 2. to determine degree of self-management in diabetic participants 3. to identify the obstacles facing the diabetic students to achieve an accepted self-management; 4. to assess the impact of the interventional program on overcoming such obstacles; and 5. to assess the impact of diabetes self-management on glycemic control among diabetic students in assiut university all university students who suffer from diabetes and attend the study's clinic seeking medical treatment during a full academic year (2023/2024) with inclusion and exclusion criteria are recruited. the sample is divided into 150 cases for intervention group and 150 for control group (traditional care), by systemic random technique. all participants will be exposed to questionnaires for assessment of diabetes self-management, and measurements of glycated hemoglobin (hba1c), body weight, height, at base line, three months, and 6 months after the end of the program.

Eligibility criteria:
inclusion criteria: •confirmed cases of diabetes mellitus (idd" type i" \& nidd "type ii") among assiut university students exclusion criteria: * diabetic students with severe disability or handicapped * diabetic students known to have another health problem make him un tolerable to do exercise such as cardiovascular disease, bronchial asthma * diabetic students with speech and hearing difficulties.
a study to investigate the ileo neo rectal anastomosis compared to the ileo pouch anal anastomosis for patients with ulcerative colitis

Conditions: Colitis, Ulcerative; Surgery

Summary: for patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.

this research is designed to answer questions from the medical profession and patients´ community (crohn en colitis ulcerosa society, the netherlands) whether the new inra technique needs further development on a broader scale or not. the research project will be conducted in the two institutes where inra procedures have been carried out and in the umcn to recruit matched control ipaa patients. there is a large experience with the ipaa procedure in this latter institute. the university of tilburg will participate to work on health status and quality of life aspects. they have a large experience with quality of life research in general and have participated in qol research in this topic before. the aim of this historical cohort study is to establish the value of inra, compared to ipaa, for patients with ulcerative colitis.

Eligibility criteria:
inclusion criteria: * uc patients with inra procedure * age, sex and disease specific matched group of uc-ipaa patients with temporary diverting ileostomy from the same period * written informed consent exclusion criteria * pregnancy * malignancy (apart from basalioma or carcinoma-in-situ of cervix) * psychiatric disease or inability to assess follow up

Keywords: colitis, ulcerative ileo neo rectal anastomosis ileal pouch anal anastomosis quality of life functional results reconstructive surgery surgery
a study of extended total mesopancreas excision(etme) for pancreatic head adenocarcinoma.

Conditions: Pancreas Adenocarcinoma

Summary: the study of extended total mesopancreas excision(etme) for pancreatic head adenocarcinoma is a retrospective multicenter cohort, collecting medical records and follow-up data of patients who underwent radical resection with pancreatic head adenocarcinoma.

the objectives of the study are as follows: 1. to evaluate the perioperative safety of extended total mesopancreas excision(etme) for patients who diagnosed with resectable pancreatic head adenocarcinoma. 2. to demonstrate the prognosis of extended total mesopancreas excision(etme) for patients who diagnosed with resectable pancreatic head adenocarcinoma.

Eligibility criteria:
inclusion criteria: 1. patients with pancreatic head adenocarcinoma who underwent curative-intent resection. 2. patients with accessible medical records exclusion criteria: 1. patients with unknown chemotherapy sequence or status 2. patients with history of previous malignant tumors 3. patients with distant metastases

Keywords: pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy
dendritic cell vaccine to prevent covid-19

Conditions: COVID-19

Summary: this is an adaptive phase i trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with sars-cov-2 spike protein, with or without gm-csf, to prevent covid-19 in adults.

subjects eligible for treatment will be those who at baseline, are not actively infected with sars-cov-2, have no evidence of prior infection with sarscov- 2 based on serologic testing, and give informed consent for a vaccination with av-covid-19. the patient population will include the elderly and others at higher risk for poor outcomes after covid-19 infection. for this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease. after enrolling for screening, subjects will undergo a nasal swab test to exclude active covid-19 infection and a rapid test for anti-coronavirus antibodies to exclude pre-existing anti-sars-cov-2 antibodies. 50 ml of blood will be collected, from which peripheral blood monocytes will be isolated and differentiated into dc before incubation with sars-cov-2 s-protein, during which time the protein is digested into 9 to 25 amino acid peptide sequences presented on the dendrites of dc in conjunction with histocompatibility class i and class ii molecules. safety and quality testing will be performed on a small quantity of the batch, and the remaining av-covid-19 will be cryopreserved for shipping to the treatment site. once the study drug is ready, if eligible, the subject will be seen at study week-0 for treatment. prior to injection of the study drug, a nasal swab test will be collected to confirm that they are still negative for covid-19, and blood will be drawn to determine baseline levels of anti-sars-cov-2 antibodies. at the treatment site, the product will be thawed and admixed with saline or (saline with gm-csf), and within 5 hours of thawing, will be injected sc via a 25- gauge needle

Eligibility criteria:
inclusion criteria: 1. 18 years or older, 2. in relatively good health with adequate physical and mental function 3. including factors associated with in increased risk for medical complications associated with covid-19 infection or increased risk for exposure to sars-cov-2 exclusion criteria: 1. active covid-19 infection by pcr testing 2. pre-existing igg or igm sars-cov-2 antibodies 3. pregnant, known hypersensitivity to gm-csf 4. known active immune deficiency disease or active hiv 5. hbv, hcv, on active treatment with corticosteroids or other immunosuppressive agent 6. participated in previous covid-19 vaccine study

Keywords: covid-19 vaccine dendritic cell
the dark-adapted retinal function response in choroideremia (darc) study

Conditions: Choroideremia

Summary: choroideremia (chm) is an inherited retinal disorder that causes progressive vision loss, ultimately leading to complete blindness. the first symptom is generally night blindness, although, to date, little is known about the extent, type, pattern, and progression of dark-adapted visual function measures in chm patients. we hypothesize that one of the key events causing night blindness in chm is deficiency in the chromophore of the rod visual pigment, rhodopsin. we propose that this deficiency is at least in part due to inadequate delivery of vitamin a (all-trans-retinol) to the photoreceptors (prs) from the ailing retinal pigment epithelium (rpe), characteristic of chm. we hypothesize that increased availability of vitamin a would potentiate its entry into the rpe-mediated visual cycle, ultimately enabling delivery to the prs. this would in turn allow rods to perform better by partially overcoming the rpe damage and the impaired chromophore recycling that we postulate exists in chm. the goals of this proposal are: (1) to test the hypothesis that oral vitamin a supplementation can improve night time and peripheral vision in chm patients, and (2) to provide detailed characterization of dark-adapted visual function outcome measures to guide interventional chm trials.


Eligibility criteria:
inclusion criteria: * males at least 15 years of age with molecularly-confirmed diagnosis of choroideremia exclusion criteria: * inability to participate in visual field testing reliably and reproducibly

Keywords: vitamin a night vision
prevention of falls and its consequences in elderly people

Conditions: Accidental Falls; Osteoporosis

Summary: falls are an important risk factor for fragility fractures. both are associated with the ageing process and as they rise also increase the risk of mortality, disability and dependency. interventions to prevent falls have been based on multifactorial approaches but the outcomes have shown little effectiveness. lately, it is being recommended interventions which foster physical exercise incorporating it to daily life activities. the otago exercise programme is based on easy physical exercises for older adults and has shown cost-effective outcomes for falls prevention and its consequences.

this is a randomized clinical trial carried out in primary care. the study's scope of activity will include ten urban primary care centers. all selected patients with inclusion criteria will receive a geriatric assessment and other required medical treatment. next, they will be allocated either to an intervention group or control group. the intervention group will be trained for three months according to the otago exercise program (training phase). followed by a loyalty phase during which they will be monitored quarterly for a year by their assessment team. the control group will be receive normal medical treatment. falls and fractures will be monitored quarterly in both groups during 15 months.

Eligibility criteria:
inclusion criteria: * patients ≥ 75 to 89 years at baseline assigned to primary care team and living in the community * ranking the folstein mini mental state examination test * expectation of permanence in the area at least 18 months. * agree to participate in the study by informed consent, after reading the patient information sheet. exclusion criteria: * current participation in another trial or institutional program of guided physical activity. * patients with who have had a hip and/or knee operation or major injury or any other intervention in the last 6 months. * patients with who are unable to follow an aerobic physical activity program. patients using assisted mobility devices are not excluded. * patients in home care programs or nursing homes at baseline or during the training phase. * terminal or severe cancer cases. * patients disabled prior to or during the study period. * have not been visited in reference's health center in the last two years (displacement / transfer * very advanced dementia that not allows to follow the instructions in the exercise program and nurse's instructions. in case of a caregiver who assume the realization of exercise program and the following of tips, it may be included. * displaced, will temporarily shifted (\>2months/year) o will definitively shifted patients of health center.

Keywords: elderly accidental falls osteoporosis fractures primary care randomized clinical trial otago exercise programme
indiana university dementia screening trial

Conditions: Dementia; Alzheimer's Disease; Mild Cognitive Impairment

Summary: the purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.

the objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive. the specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care. primary specific aim 1: test the impact of dementia screening on health-related quality of life of the patient at 12 months. primary specific aim 2: test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms). secondary aims: estimate the cost effectiveness of dementia screening.

Eligibility criteria:
inclusion criteria: * adults age 65 and older; * at least one office visit to their primary care physician within the previous year; * no previous diagnosis of dementia or memory problem as determined by icd-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine); * ability to consent to participate in the study; and * ability to communicate in english exclusion criteria: * adults who are a permanent resident of a nursing facility; * a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related icd-9 codes indicative of such an illness; or * a pre-existing diagnosis of dementia or cognitive impairment

Keywords: dementia alzheimer's disease mild cognitive impairment screening
efficacy and safety of rivipansel (gmi-1070) in the treatment of vaso-occlusive crisis in hospitalized subjects with sickle cell disease

Conditions: Anemia, Sickle Cell

Summary: this is a clinical study evaluating the efficacy and safety of rivipansel (gmi-1070) in treating subjects with sickle cell disease (scd) who are 6 years of age or older experiencing a pain crisis necessitating hospitalization.


Eligibility criteria:
inclusion criteria: * at least 6 years of age. * documented diagnosis of sickle cell disease. * diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including iv opioids. * able to receive the first dose of study drug within 24 hours from the administration of iv opioids. exclusion criteria: * serious systemic infection * acute chest syndrome * serious concomitant medical problems (for example, stroke) * scd pain atypical of voc * severe renal or hepatic impairment * chronic pain rather than a presentation of acute voc

Keywords: sickle cell anemia sickle cell disease sickle cell disorders pain crisis vaso-occlusive crisis rivipansel gmi-1070 selectin inhibitor scd voc
comparison between thrombolysis and primary percutaneous coronary intervention (pci) to treat st-segment elevation myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of st-segment elevation at 120 minutes after inclusion and thrombolysis in myocardial infarction (timi) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.

patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay. patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute). secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days. data on use of health care resources, loss of production and health-related quality of life were collected during one year. cost-effectiveness was determined by comparing costs and quality-adjusted survival.

Eligibility criteria:
inclusion criteria: * patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant st-segment elevation on ecg. exclusion criteria: * bp \>180/110 * known bleeding disorder * cardiogenic shock * cpr\>10 min * ongoing anticoagulant therapy * renal insufficiency * weight \>120 kg

Keywords: thrombolysis primary pci abciximab st-segment resolution timi flow