Kornimate/medical-research-clean huggingface dataset:
the effect of calcifediol (hy.d 25 sd/s) and vitamin d3 on muscle strength in a frail elderly population

Conditions: Deficiency, Vitamin D; Elderly, Frail

Summary: in an ageing population, the need for interventions to help older people remain healthy, active and independent for as long as possible, increases. although several studies suggest a beneficial effect of vitamin d3 on maintaining or improving muscle strength and physical functioning, particularly in vulnerable populations, results are contradicting. randomized, placebo-controlled trials are needed to further establish the effect of vitamin d on muscle strength in the frail elderly population.the primary aim of this study is to determine the effect of daily supplementation with two different forms of vitamin d on muscle strength in frail elderly people over a period of 24 weeks.


Eligibility criteria:
inclusion criteria: * 25(oh)d levels 20-50 nmol/l. * age 65 or older. * physically frail (pre-frail or frail, based on the criteria designed by fried et al.) (30). frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), self-reported exhaustion (ces-d questionnaire), weakness (grip strength), slow walking speed and low physical activity (minnesota questionnaire). more details on these criteria are described in chapter 6.3.2. * body mass index between 18.5 and 35 kg/m2. * willingness and ability to comply with the protocol, including performance of the knee extension strength test. exclusion criteria: * medical illness: * malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease; * diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism; * abnormal indices of calcium metabolism, uncontrolled hypocalcaemia; * diagnosed renal insufficiency; * diagnosed cancer; currently diagnosed or undergoing treatment. * hypercalcemia: serum calcium adjusted for albumin of \> 2.6 nmol/l. * medication: interfering with vitamin d metabolism and vitamin d supplementation (bisphosphonate, pth treatment, tuberculostatica, anti-epileptica). * subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin d containing supplements during the study. * (expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period. * patient heavily consumes alcohol containing products defined as greater than \> 21 drinks of alcoholic beverages per week. * planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery). * participation in another clinical trial.

Keywords: muscle strength physical performance vitamin d3 cholecalciferol calcifediol
study sbx-01-101: a stool collection study in colorectal cancer (crc) patients treated with irinotecan-based regimens

Conditions: Colorectal Cancer

Summary: the primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.

study design: * this protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. the cohort is as follows: * cohort 1: colorectal cancer: (n=8) * the study will enroll participants per the eligibility criteria. * participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). the biospecimens collected from participants on this study are stool samples. * confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.

Eligibility criteria:
cohort 1: colorectal cancer inclusion: 1. the participant is willing and able to provide written informed consent 2. the participant is willing and able to provide appropriate photo identification 3. participants aged 18 to 85, inclusive 4. participants have been diagnosed with active colorectal cancer (crc) 5. subjects currently taking irinotecan exclusion: 1. participants who are pregnant or are nursing 2. participants with a known history of hiv, hepatitis, or other infectious diseases 3. participants who have taken an investigational product in the last 30 days 4. participants who have experienced excess blood loss, including blood donation, defined as 250 ml in the last month or 500 ml in the previous two months 5. subjects who are currently in remission for crc. * preference (not required for enrollment into study): exclude subjects currently taking antibiotics\*
whole food plant-based diet for hiv-associated reduction in cardiovascular risk (plant-hart)

Conditions: Heart Diseases; Hiv

Summary: the goal of this clinical trial is to evaluate the impact of using a whole food plant-based diet in the reduction of cardiovascular risk related to hiv in people who live with hiv infection. the main questions it aims to answer are: * does a whole food plant-based diet, nonrestrictive in calories and low in fat, reduce the cardiovascular risk associated with hiv infection in people with hiv infection? * does the whole food plant-based diet permit achievement goals in specific metabolic markers of cardiovascular risk (such as cholesterol, c reactive protein)? participants will follow a non-calorie restricted, low fat, whole food plant-based diet for 8 weeks researchers will compare standard nutritional care to see if there is a difference in the main outcomes

the participants in the group within the intervention will follow a whole food plant-based diet for 8 weeks, which consists of increasing the daily consumption of fruits and vegetables, including sources of vegetable protein such as legumes (beans, lentils, chickpeas, peas, etc. ), soybeans and their derivatives (tofu, textured soybeans, soymilk), and whole grains (oats, wheat, rice, quinoa, corn), nuts and seeds high in omega-3 fatty acids (chia, flaxseed, hemp ), minimize processed foods and foods high in saturated fat. there will be no caloric restriction, however, visual support will be provided, in the form of a traffic light, to distinguish the frequency with which each type of food can be consumed. a small recipe book will be provided with suggestions for breakfast, lunch, and dinner dishes. patients will receive vitamin b12 supplements of 1000 micrograms twice a week. there will be no caloric restriction, however, visual support will be provided, in the form of a traffic light, to distinguish the frequency with which each type of food can be consumed. a small recipe book will be provided with suggestions for breakfast, lunch, and dinner dishes. patients will receive vitamin b12 supplements of 1000 micrograms twice a week. the participants in the other group will attend a consultation with a nutritionist every month in which will receive recommendations about nutrition and lifestyle in order to reduce cardiovascular risk.

Eligibility criteria:
inclusion criteria: * over 20 years but under 60 years * individuals with a bmi \>25 * individuals with some classic cardiovascular risk factor (dyslipidemia, smoking, type 2 diabetes mellitus, systemic arterial hypertension, obesity) * individuals under art with adequate cd4+ cell count and viral load undetectable exclusion criteria: * patients currently diagnosed with aids * patients who have suffered an ami and/or stroke * patients who use drugs * patients who have had poor adherence to art

Keywords: hiv heart disease risk factors plant-based cardiovascular
the effect of micellized food supplements on health-related quality of life in patients with post-acute covid-19 syndrome.

Conditions: Post-acute COVID-19 Syndrome

Summary: food supplements like curcumin and boswellia serrata have been used traditionally for anti-inflammatory purposes. a well-known problem of these substances in their natural form is the low bioavailability. micellization of these substances has been shown to increase the bioavailability significantly and thereby the clinical efficacy. the clinical value of these micellized substances has been presented in numerous clinical studies and in particular in patients with acute covid-19. this study aims to examine the effect of a mixture of micellized curcumin, boswellia serrata and ascorbic acid on patients with long covid.

the participants will be asked to take the micellized supplements daily, at home for 6 weeks. during this 6 weeks several questionnaires will be taken to asses general health-related quality of life. follow-up measurements will be done at 14 weeks.

Eligibility criteria:
inclusion criteria: * patients with confirmed sars-cov-2 infection at least 28 days prior to study participation * patients who are experiencing symptoms of pacs (with a pcfs of 1 or higher) * 18 years or older and younger than 85 * good understanding of written german exclusion criteria: * currently under pharmacological treatment for pacs * any planned medical surgery or intervention where medication intake is necessary in the coming 14 weeks * allergy to curcumin or boswellia * active malignancy * medical history of human immunodeficiency virus (hiv) infection, or any serious immunocompromised state. * pregnancy (or planned pregnancy in the coming 14 weeks) ( - patients who are taking anticoagulants or have diabetes type i or ii are only allowed to participate if their general practitioner is informed)

Keywords: micelles dietary supplements
ultrasound in acute dyspnea in the field

Conditions: Heart Failure; COPD; Asthma

Summary: acute heart failure is one of the main causes of acute respiratory distres in prehospital emergency setting. the early and correct diagnosis is important because the misdiagnosis can result in deleterious consequeance to patients. rapid bedside tests (like nt-probnp) and point-of-care lung ultrasound could be useful methods in field. this study confirmed that the combination of ultrasound sign in combination with rapid nt-probnp test has a hibh diagnostic accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea in the field and the tretament possibilities in clinical obscure cases are mainly improved.


Eligibility criteria:
inclusion criteria: * inclusion criterion for the study was shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea). exclusion criteria: * exclusion criteria were age \<18 years, history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: pneumonia, pulmonary embolism, carcinoma, pneumothorax, pleural effusion, intoxications (drugs), anaphylactic reactions, upper airway obstruction, bronchial stenosis, and gastroesophageal reflux disorder

Keywords: acute dyspnea prehospital emergency setting differential diagnosis ultrasound nt-probnp
retrospective observational study on the risk in developing long-covid syndrome and in contracting sars-cov-2 infection after covid-19 vaccination in relation to vitamin d3 supplementation

Conditions: Vitamin d Deficiency; COVID-19; Long COVID

Summary: the aim of this observational retrospective study is to evaluate the effect of supplementation with cholecalciferol d3 in reducing the risk of: * occurence of long covid syndrome after acute covid-19 illness * occurence of sars-cov-2 infection after anti-covid-19 vaccination

anamnestic, laboratory and therapeutic data will be collected during outpatient visits.

Eligibility criteria:
inclusion criteria (for aim i): * age ≥18 * outpatient with first visit on endocrinology department performed from 01/01/2020 to 31/12/2022 * previous sars cov-2 infection * clinical,anamnestic and therapeutic data 6 months post sars cov-2 infection * data on cholecalciferol supplementation * signature of informed consent exclusion criteria (for aim i): * age ≤ 18 * pregnant or breastfeeding women * patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions * patients treated with drugs that interfere with vitamin d metabolism * first vaccination anti sars covid performed before the acute infection * first vaccination performed within 6 months of the acute infection * patients unable to sign the informed consent inclusion criteria (for aim 2) -- age ≥18 * outpatient with first visit on endocrinology department performed from 01/01/2020 to 31/12/2022 * vaccination with bnt162b2 biontec mrna pfizer/biontech * clinical, anamnestic and therapeutic data 6 months post sars cov-2 infection * data on cholecalciferol supplementation * signature of informed consent exclusion criteria (for aim 2): * age ≤ 18 * pregnant or breastfeeding women * patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions * patients treated with drugs that interfere with vitamin d metabolism * additional vaccination performed before 6-12 months * acute infection before the vaccination * patients unable to sign the informed consent
electro-acupuncture for the prevention of taxane induced myalgias and neuropathy

Conditions: Breast Cancer; Neuropathy

Summary: this study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.

chemotherapy induced neuropathy (cin) is a common and disabling toxicity of cytotoxic chemotherapy. depending on the drug, it is often irreversible even after the offending agent is removed. the consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with stage i-iii breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.

Eligibility criteria:
inclusion criteria: * age\>21 years * history of stage i-iii breast cancer * patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks * signed informed consent exclusion criteria: * previous treatment with acupuncture in the last 12 months * diabetic neuropathy or other neurological conditions * inflammatory, metabolic or neuropathic arthropathies * current narcotic use * severe concomitant illnesses * severe coagulopathy or bleeding disorder * dermatological disease within the acupuncture area * have a pacemaker

Keywords: taxane induced neuropathy taxane induced myalgias electro-acupuncture
feasibility study on the use of mindfulness-based intervention for family carers of people with dementia

Conditions: Anxiety; Depression; Dependency Burden; Stress, Psychological

Summary: the aim of this study is to examine which mindfulness-based intervention protocol, mbct or mbsr, is more suited for use among local carers of people with dementia (pwd), as measured by better mental health outcomes in pwd such as reductions in stress and improvements in mental well-being.

60 subjects will be recruited in the community and randomized into either the mbct or mbsr group. both mbsr and mbct will be delivered through a face-to-face teaching session followed by regular telephone follow-ups. the primary outcome measures of the dementia caregivers will be stress with perceived stress scale (pss; cohen \& williamson, 1988). the secondary outcome measures of the dementia caregiver will be 1) anxiety with hospital anxiety and depression scale (hads; zigmon \& snaith, 1983), 2) depression with center for epidemiologic studies depression scale (cesd; radloff, 1977), and 3) burden with zarit burden inventory (zbi; zarit, reever, \& bach-peterson, 1980). the control measure will be their level of mastery of the five facets mindfulness with five facets mindfulness questionnaire (ffmq; baer, smith, hopkins, krietemeyer, \& toney, 2006). focus group interviews with each group of participants will be conducted post-intervention to explore their experiences and perceptions. data will be collected at baseline (t0), at 2 months (the mid-point of the intervention; t1), 4 months (immediately after the intervention; t2), and 7 months (the follow-up assessment; t3). adherence rates, response rates, and drop-out rates will be collected and analyzed. the triangulation of both qualitative and quantitative data will be performed to determine the suitability and benefits of mbsr and mbct for carers of pwd in the local setting.

Eligibility criteria:
one participant (family carer) for each pwd (dementia of any type) living in the community inclusion criteria for the family carer: * is the primary carer * of an adult with a confirmed diagnosis of dementia. exclusion criteria: * has a major active psychiatric illness such as bipolar disorder or schizophrenia. * is currently undergoing cancer treatment. * has severe chronic pain (lasting more than six months).

Keywords: mindfulness-based interventions dementia caregiving burden stress anxiety depression community care
spiriva® in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: as part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of spiriva® 18 micrograms in patients with copd under conditions of daily practice


Eligibility criteria:
inclusion criteria: * men and women aged at least 40 years presenting with the symptoms of copd exclusion criteria: * patients presenting with the general and specific contraindications listed in the patient information leaflet and the basic product information
training about sudden infant death syndrome

Conditions: Sudden Infant Death

Summary: sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. the study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers.

sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. to examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers. pre-test post-test designed, randomized controlled, experimental study was conducted in turkey, 2024. sixty pregnant women were employed in intervention and control groups. face-to-face training on risk factors triggering sudden infant death syndrome was provided to pregnant women in intervention group. study data were collected using "personal information form, knowledge level on sudden infant death syndrome and risky behavior identification questionnaire". data were collected face to face before training and after training and via telephone 2 months after training.

Eligibility criteria:
inclusion criteria: * pregnant women who were in the 38th week of their pregnancy and older, * lived a healthy pregnancy, * had no communication problems, * can speak and understand turkish, * agreed to participate in the study were included. exclusion criteria: * pregnant women who were earlier than 38 weeks pregnant, * had difficulty in communicating, * were illiterate and unable to speak turkish, * who filled out the forms incompletely were not included.

Keywords: sudden infant death newborn mother risk factors
optimized anesthesia to reduce postoperative cognitive impairment in the elderly

Conditions: Elderly ; Moderate Risk Surgery

Summary: the aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (bp) by the use of a continuous and noninvasive bp monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.

postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . however, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated. the investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.

Eligibility criteria:
inclusion criteria: * elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia * patients who provide written informed consent * patient fluent in french exclusion criteria: * patients under 70 years of age * surgery under locoregional anesthesia or emergent surgery or minor risk surgery * patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery) * patients with arrhythmia and/or atrial fibrillation * patients with preoperative delirium or cognitive dysfunction (moca test \< 26) * patients not fluent in french * patients without the capacity to give written informed consent or refusal of consent * patients undergoing surgery or included in another protocol within 3 months

Keywords: elderly postoperative cognitive dysfunction postoperative delirium depth of anesthesia intraoperative blood pressure monitoring
the effect of liraglutide on endothelial function in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * diet and lifestyle changes or metformin monotherapy for at least three months * hba1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive) * body mass index (bmi) less than or equal to 40 kg/m\^2 exclusion criteria: * previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the investigator) * previous treatment with glucagon-like peptide-1 (glp-1) analogues/mimetics, including treatment in a clinical trial * treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening * current smoker or history of smoking within 6 months prior to screening * evidence of overt cardiovascular disease (documented coronary heart disease, class ii-iv congestive heart failure, cerebrovascular disease, or peripheral vascular disease) * abnormal, clinically significant exercise stress electrocardiogram (ecg) test, as judged by the investigator * known retinopathy or maculopathy requiring acute treatment, as judged by the investigator * known autonomic neuropathy, as judged by the investigator * initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening * systolic blood pressure more than or equal to 140 mmhg and/or diastolic blood pressure more than or equal to 90 mmhg