Kornimate/medical-research-clean huggingface dataset:
safety of lactobacillus reuteri (l. reuteri) in healthy adults

Conditions: Colic; Gastrointestinal Tract Infections

Summary: this study will evaluate the safety and tolerability of the probiotic lactobacillus reuteri (lr) in healthy adult patients. patients will be randomized to receive either lr or placebo orally each day for a total of 60 doses. the effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.

lactobacillus reuteri oil drops are a natural product containing lactobacillus reuteri (lr), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (gi) tract micro flora and prevention and treatment of mild diarrhea associated with gi-tract infections. the oil drops contain a dietary supplement of lactobacillus reuteri dsm 17938. the patients will receive 5 drops (10\^8 live organisms) by mouth daily for 60 days. daily administration will include 5 drops (5x10\^8) of l. reuteri or placebo daily for two months. during this time,circulating peripheral blood mononuclear cell (pbmc) toll-like receptor-2 and -4 levels will be measured, along with pbmc cytokine production levels in vitro. fecal dgge analysis(with sequencing of bacterial rdna) will be completed identifying changes in fecal microbiota. inflammation in the gut will also be assessed by fecal calprotectin assay (elisa). the time on study treatment is 2 months, with 4 months observation, for a total of 6 months. there will be 7 required visits, during which, we will assess safety and immune system effects.

Eligibility criteria:
inclusion criteria: * healthy adults (18 - 60 years old) * no other recognized illness exclusion criteria: * pregnancy or breastfeeding * patient taking immunosuppressive medications, including oral corticosteroids * positive result of hiv, hepatitis b, and/or hepatitis c test * abnormal lab test results * gastrointestinal related diseases and surgeries * patients with an allergy to antibiotics * presence of fever or a pre-existing adverse event monitored in the study * no more than two study participants in one household * use of probiotics in the last 90 days * diarrheal illness within the past 30 days * recent or current use of oral antibiotics /anti-fungals(in the past 2 weeks) * current use of oral laxatives * chronic alcohol use or more than 1 drink per day * subjects with implanted prosthetic devices including prosthetic heart valves * known sensitivity to sunflower oil or products containing linolenic/oleic acids * will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the 6-month period

Keywords: l. reuteri cytokines toll like receptors healthy adults probiotics
perioperative reduction of inapparent myocardial injury

Conditions: Perioperative Myocardial Injury

Summary: recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. therefore, new methods of limiting myocardial damage are urgently needed. ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. in remote ischemic preconditioning (ripc), this initial stimulus is carried out away from the region of interest, normally a limb. in meta-analysed syntheses the effect size of ripc in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%. the prime study will assess the value of ripc in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. post-operative troponin release will be used as a surrogate marker of myocardial damage. there is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent vision study. the investigators intend to build a clinically powered study from the results of this study. study design will be by single-centre single-blind randomised control trial. allocation will be 1:1. all treatments will be carried after induction of anaesthesia, prior to surgery. in the ripc-treatment group, a blood pressure cuff inflated on an upper limb to 200mmhg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. in the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time. primary endpoint will be peak post-operative 5th generation hs-tnt (highly sensitive troponin-t, ng/ml). secondary endpoint will be hs-tnt area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.


Eligibility criteria:
inclusion criteria: * is ≥ 45 years old; * is undergoing elective major colorectal or upper gi surgery. exclusion criteria * diabetic patients that are taking glibenclamide medication * patients with upper limb peripheral vascular disease, including those with arteriovenous fistula for dialysis * untreated hypertension (defined as two or more readings \>180mmhg systolic on admission for surgery) * current participation in any study investigating troponin levels or ischaemic preconditioning * unable or lacks capacity to give informed consent to participation
myeloid derived suppressor cells in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. among regulatory cells, myeloid derived suppressor cells (mdscs) have been described as being increased during sle, furthermore during flares. mdscs are defined phenotypically as being hla-dr-cd3-cd19-cd33+cd11b+, and either cd14+ (monocytic mdscs), cd15+ (granulocytic mdscs), or cd14-cd15- (early-stage mdscs). however, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of th17 lymphocytes. the objectives of this study is to assess the involvement of mdsc in sle through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.

systemic lupus erythematosus (sle) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. among regulatory cells, myeloid derived suppressor cells (mdscs) have been described as being increased during sle, furthermore during flares. mdscs are defined phenotypically as being hla-dr-cd3-cd19-cd33+cd11b+, and either cd14+ (monocytic mdscs), cd15+ (granulocytic mdscs), or cd14-cd15- (early-stage mdscs). however, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of th17 lymphocytes. to gain insight into the involvement of mdsc in sle, both deep phenotypical characterization of mdsc and functional assessment will be performed, as well as immunometabolic characterization. this data will be correlated to the clinical presentation and activity of sle.

Eligibility criteria:
inclusion criteria: * active systemic lupus erythematosus (sledai \> or = 1) * written informed consent exclusion criteria: * chronic or acute infection * other active auto-immune condition * active cancer * age below 18

Keywords: myeloid derived suppressor cells
feasibility and preliminary efficacy of a group-based telerehabilitation program in people with post-covid-19 sequelae (tepco).

Conditions: Long COVID-19 Syndrome; Long COVID; Long COVID Syndrome

Summary: the goal of this study pilot randomized controlled study is to evaluate the feasibility of the study procedures and to compare the preliminary efficacy of a rehabilitation program given in a "remote" (telerehabilitation) or "face-to-face" model for adult patients who had confirmed sars-cov-2 infection and still have symptoms after eight weeks of infection. the main question it aims to answer is: * are the study procedures feasible? * will the two groups have similar results for the preliminary efficacy outcomes? researchers will compare group telerehabilitation to a face-to-face group to see if it's comparable. participants will: * take part in a 60-minute training session, 3 times a week in person or remotely * visit the clinic before starting the training program and after 8 weeks of training * keep a diary of their symptoms, if any


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * confirmed sars-cov-2 infection defined by positive polymerase chain reaction (pcr) testing and/or antigen test results * referred to the pneumology clinic for a modified british medical research council (mmrc) dyspnea score of 2-3 after a minimum of eight weeks of infection * vo₂max of less than 80% of the predicted value * receiving a medical prescription for rehabilitation following initial assessment by a pulmonologist * being able to walk independently * providing informed consent * having a good internet connection (i.e., a minimum download speed of 4 mbps and an upload speed of 4 mbps) * being in possession of a computer or tablet equipped with a camera enabling videoconferencing. exclusion criteria: * requiring in-hospital rehabilitation at discharge * evidence of medical instability (i.e., moderate or severe cardiac disease, ischemic or severe hemorrhagic stroke, or neurodegenerative disease, unstable fracture) * history of severe cognitive or mental impairment * already enrolled in another rehabilitation program

Keywords: telerehabilitation
pilot study for a prospective surveillance program for rehabilitation following surgery for breast cancer

Conditions: Breast Cancer

Summary: breast cancer treatment often results in long-term arm morbidity. a prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. this study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.


Eligibility criteria:
inclusion criteria: * age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction. exclusion criteria: * prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion \<75% of non-affected side; or a diagnosis of primary lymphedema

Keywords: surveillance physiotherapy arm morbidity
molecular imaging of prostate-specific membrane antigen using labeled technetium-99m bq0413

Conditions: Prostate Cancer

Summary: the study should evaluate the biological distribution of \[99mtc\]tc-bq0413 in patients with prostate cancer. the primary objective are: 1. to assess the distribution of \[99mtc\]tc- bq0413 in normal tissues and tumors at different time intervals. 2. to evaluate dosimetry of \[99mtc\]tc- bq0413. 3. to study the safety and tolerability of the drug \[99mtc\]tc- bq0413 after a single injection in a diagnostic dosage. the secondary objective are: 1. to compare the obtained \[99mtc\]tc- bq0413 spect imaging results with the data of ct and/or mri and/or ultrasound examination and immunohistochemical (ihc) studies in prostate cancer patients.

the overall goal is to study the effectiveness of spect imaging prostate cancer patients using technetium-99m labeled bq0413. phase i of the study: biodistribution of \[99mtc\]tc-bq0413 in patients with prostate cancer. the main objectives of the study: 1. to evaluate the distribution of \[99mtc\]tc-bq0413 in normal tissues and tumors in patients with prostate cancer at different time intervals. 2. to evaluate dosimetry of \[99mtc\]tc-bq0413 based on the pharmacokinetic parameters of the drug after a single intravenous administration. 3. to study the safety of use and tolerability of the drug \[99mtc\]tc-bq0413 after a single intravenous administration in a diagnostic dosage. additional research tasks: 1. to conduct a comparative analysis of the diagnostic information obtained in the visualization of prostate cancer by spect using \[99mtc\]tc-bq0413 with data obtained by ct and/or mri and/or ultrasound examination and immunohistochemical (ihc) research of postoperative material. methodology: open-label, exploratory, single centre study. the subjects will receive a single injection of the labeled tracer.

Eligibility criteria:
inclusion criteria: * subject is \> 18 years of age * clinical and radiological diagnosis of prostate cancer with histological verification. * white blood cell count: \> 2.0 x 10\^9/l * haemoglobin: \> 80 g/l * platelets: \> 50.0 x 10\^9/l * bilirubin =\< 2.0 times upper limit of normal * serum creatinine: within normal limits * blood glucose level not more than 5.9 mmol/l * subject is capable to undergo the diagnostic investigations to be performed in the study * informed consent exclusion criteria: * active current autoimmune disease or history of autoimmune disease * active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) * known hiv positive or chronically active hepatitis b or c * administration of other investigational medicinal product within 30 days of screening * ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's

Keywords: prostate-specific membrane antigen prostate cancer [99mtc]tc-bq0413 spect
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for skin ulcer

Conditions: Skin Ulcer

Summary: this trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of skin ulcer

this patient funded trial aims to study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of skin ulcer. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of skin ulcer * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: skin ulcer stem cell treatment
effectiveness of a community intervention in the chronic use of benzodiazepines: (benzostopjuntos)

Conditions: Inappropriate Prescribing

Summary: this study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for benzodiazepines withdrawal compared to standard care.

the excessive use of benzodiazepines (bzds) presents significant health concerns and high healthcare costs, particularly in spain, where usage rates are among the highest globally. in andalusian, over a 10% of the population use bzds long-term, prompting the need for safe and effective reduction strategies. this study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for bzd withdrawal compared to standard care. the intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Eligibility criteria:
inclusion criteria: * users of health centre's with more than 4 weeks of benzodiazepines use. * users of health centre's over 18 years of age. exclusion criteria: * users of health centre's with mental disorder. * users of health centre's terminal. * users of health centre's with alcohol dependence. * users of health centre's with dementia. * users of health centre's who had intellectual disabilities. * users of health centre's unable to cooperate with the questionnaires.

Keywords: benzodiazepine medication overuse. inappropriate prescribing
using optical coherence tomography (oct) to evaluate the efficacy and safety of pegylated interferon beta-1a (biib017) in patients with relapsing multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this research sub-study is being completed as a part of the multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of pegylated interferon beta-1a (biib017) in subjects with relapsing multiple sclerosis (protocol #: na_00028117). this substudy is being done to understand the efficacy of biib017 by measuring the nerve fiber thickness in the eye.


Eligibility criteria:
inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. * a participant in the advance study aged 18 to 55 years old, inclusive, at the time of informed consent exclusion criteria: * as per the advance main study * history of intraocular surgery, retinal disease, glaucoma, or diabetes * refractive errors of more than ±6.0 diopters * inability to tolerate oct procedure

Keywords: multiple sclerosis relapsing ms injectable subcutaneous sc pegylated interferon peg oct optical coherence tomography
study of methodologies to measure blood flow and oxygenation in adults with sickle cell disease

Conditions: Healthy; Sickle Cell Disease

Summary: the purpose of the study is to determine whether imaging techniques, such as magnetic resonance imaging (mri), near infrared spectroscopy (nirs), laser speckle contrast imaging (lsci), and optical imaging (oi), can detect differences in blood flow and oxygen levels in different organ systems of participants with sickle cell disease (scd). differences in blood flow and oxygen levels detected by these techniques will be evaluated to determine their utility as biomarkers of clinical disease pathophysiology.


Eligibility criteria:
key inclusion criteria: 1. have a diagnosis of scd confirmed by hemoglobin analysis. 2. be in stable clinical condition, as determined by the investigator. subjects enrolled in part b must also meet the following eligibility criterion at screening: 3. receiving scheduled standard of care rbc exchange transfusion therapy, with ≥3 transfusions already received. 4. be deemed healthy, as determined by the investigator, based on the physical examination, medical history, vital signs, 12-lead electrocardiogram (ecg), and clinical laboratory measurements. key exclusion criteria: 1. inability to lie still for ≥5 minutes, claustrophobia sufficient to interfere with generating reliable mri scans, body weight exceeding 320.0 lbs., or girth exceeding the magnet bore. 2. presence of a metal device affected by mri (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) which would be a contraindication for mri. 3. acute pain crisis requiring hospitalization, with a discharge ≤4 weeks prior to the first imaging visit, or when determined by the investigator to not be at steady state. 4. recent (≤3 months) treatment with hydroxyurea therapy. note: other protocol defined inclusion/exclusion criteria may apply.
topical lidocaine after arthroscopy on knee

Conditions: Postoperative Pain; Topical Anaesthesia

Summary: more than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue. the patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology. it is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. the aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee. the researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically. this study is planned to be a pilot study in order to complete a future large medical science study.


Eligibility criteria:
inclusion criteria: * planned resection of meniscus (ds832, dm232) * planned meniscus suture (ds832) * planned plica resection (dm659) * patients \>=18 years and \<50 years * statement of consent * tolerance to lidocaine (analgesics) exclusion criteria: * type 1 diabetes or type 2 diabetes * allergic to lidocaine (analgesics) * heart disease, liver disease, kidney disease * bmi \>=35 * unability to read or speak danish * rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage * insufficient coagulation * medication of morphine pre-operatively * pregnant and nursing women

Keywords: arthroscopy meniscus lidocaine