Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and pharmacokinetics of second generation vir-7831 material in non-hospitalized participants with mild to moderate covid-19

Conditions: Covid19

Summary: this is a phase 2 study in which subjects with coronavirus disease 2019 (covid-19) will receive vir-7831 (sotrovimab) generation 1 (gen1) or vir-7831 (sotrovimab) generation 2 (gen2) and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * for part a, participants must be aged 18 years or older at the time of obtaining informed consent * for parts b and c, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent * participants who have a positive sars-cov-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have covid-19 symptoms and ≤7 days from onset of symptoms exclusion criteria: * currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours * symptoms consistent with severe covid-19 * participants who, in the judgement of the investigator are likely to die in the next 7 days. * severely immunocompromised participants * for parts a and b, prior receipt of a sars-cov-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved sars-cov-2 vaccine will not be allowed for 90 days after dosing) * for parts b and c, conditions that would prohibit receipt of im injections in the investigator's opinion * for parts a, b and c, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved sars-cov-2 vaccine will not be allowed for 90 days after dosing)

Keywords: sars-cov-2 coronavirus coronavirus disease 2019 covid-19
diet and whole-body vibration training on cardiovascular and autonomic function

Conditions: Obesity; Pre-hypertension; Hypertension

Summary: obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. however, along with decreases in fat mass, hypocaloric diet reduces muscle mass. whole body vibration results in similar increases in muscle mass and strength than those observed after resistance exercise and is feasible for special populations such as the obese and the elderly. the investigators hypothesis is that weight loss via diet combined with whole body vibration training would additively reduce arterial stiffness and blood pressure in obese women. the investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in bp regulation.

the purpose of the study is to examine the effects of 12 weeks of whole body vibration training (wbvt) and diet on arterial function, autonomic function, and body composition in obese women. specific aims of the study are to: to evaluate the extent to which diet and (wbvt) will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference. to investigate that combined diet and (wbvt) are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic bp and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity \[low-frequency power of systolic bp variability\], and baroreflex sensitivity). flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (no metabolites \[nox\], 6-keto pgfia, insulin, and ghrelin) and vasoconstrictors (endothelin-1 \[et-1\],8-iso pgf2a,vascular endothelium growth factor \[vgef\]) will be assessed as secondary outcome variables.

Eligibility criteria:
inclusion criteria: * female * 45 to 65 years of age * at least 1 year after menopause * body mass index of 27-39.9 * sedentary or low active (less than 2 hr per wk) exclusion criteria: * younger than 45 or older than 65 years of age * body mass index lower than 27, or 40 or higher * physically active or competitively active * smoker * use of hormone replacement therapy of less than 1 yr * use of calcium channel blocker or beta blockers * use dietary supplementations (e.g.,l-arginine,l-citrulline,antioxidants) * uncontrolled diabetes * any restriction that would significantly interfere with compliance with the diet (e.g., allergy to nuts or dairy, or need to avoid soy)

Keywords: whole body vibration training hypocaloric diet prehypertension hypertension obesity arterial function arterial stiffness pulse wave velocity autonomic function endothelial function adipocytokines
psychiatric comorbidities in type 1 diabetes mellitus.

Conditions: Type 1 Diabetes Mellitus

Summary: this study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1. assessing the impact of diabetes mellitus type 1 on quality of life. and determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.

type 1 diabetes mellitus (tdm) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. it's one of the most common endocrine and metabolic conditions in childhood. there's 9 million people live with t1dm worldwide according to international diabetes federation. in egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. living with t1dm has been associated with a significant impact on a person's social, mental, and psychological quality of life (qol). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in long-term uncontrolled dm. therefore, these children and adolescents with t1dm have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. they appear to have a greater incidence of depression, anxiety and poor health-related quality of life (hrqol) compared to their healthy peers. this is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. this occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. there are no available studies that assess the presence of psychiatric comorbidities in t1dm in our locality.

Eligibility criteria:
inclusion criteria: * children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment. exclusion criteria: * patients with major psychiatric disorders or have cognitive difficulties. * patients unable or refuse to give consent.
evaluation of intravenous infusion of labetalol versus magnesium sulfate

Conditions: Magnesium Sulfate; Labetalol

Summary: the purpose of this study is to compare intravenous infusion of labetalol versus magnesium sulfate on cerebral hemodynamics of severe preeclampsia patients using transcranial doppler

after being informed about the study and potential risks. all patients giving written consent will be randomized by double blind manner into 2 groups each one containing 30 patients , (group m) : will be given intravenous infusion of magnesium sulfate at a dose of 4 gm intravenously over 20 min as a loading dose then mgso4 intravenous infusion is continued at a rate of 1 gm/h for 24 h or until obtain and stabilize the targeted blood pressure.. (group l) : the patients will be given intravenous infusion of labetalol (trandate™,) available in 20 ml ampoules containing 100mg labetalol (5mg/ml). starting the infusion with 20mg/h and then titrate to obtain and stabilize the targeted blood pressure by adjusting the infusion as required every 15 - 30min to a maximum dose of 160mg/hr.

Eligibility criteria:
inclusion criteria: * acceptance * 21 to 45 years old. * mass index ≤ 35 kg/m2. * singleton pregnant female complicated with severe preeclampsia * systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 110 mmhg on two occasions at least 4 hours apart * thrombocytopenia (platelet count less than 100,000 ) * impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis. * renal insufficiency (serum creatinine concentration more than 1.1 mg/dl or doubling of the serum creatinine concentration in the absence of other renal disease) * pulmonary edema * new-onset headache unresponsive to medications and not accounted for by alternative diagnoses * visual disturbances. exclusion criteria: * preexisting heart disease * known pulmonary disorders. * inadequate temporal window. * atrial fibrillation and any rhythm abnormality. * history of allergy or contraindications to either magnesium sulfate or labetolol. * exposure to any of the study medications within 24 hours of enrollment.

Keywords: magnesium sulfate, labetalol, severe preeclampsia
the effects of body scan on enteroception in patients with heart failure

Conditions: Heart Failure

Summary: the study aims to explore the effects of body scan on enteroception in people with heart failure


Eligibility criteria:
inclusion criteria: * diagnosed with heart failure * italian speaking * willing to sign the informed consent form exclusion criteria: * cognitive impairment documented in the medical records

Keywords: heart failure enteroception body scan mindfullness self-care monitoring
tracking renal tumors after cryoablation evaluation

Conditions: Kidney Neoplasms

Summary: trace is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. subjects will be observed for five years from the date of their cryoablation procedure.

the registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject. a subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care. physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of trace. subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician. the enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.

Eligibility criteria:
suggested inclusion criteria: * patient is at least 18 years of age. * patient has a renal lesion suspicious for malignancy. * patient is to undergo renal lesion cryoablation via a galil medical cryoablation system using galil medical needles for treatment of primary or recurrent disease. * patient is to be available for long-term follow-up per the enrolling physician's standard care practices. * patient has provided written informed consent. suggested exclusion criteria: * patient is either currently using or has used within the last 30 days an investigational product of any type. * patient has metastatic disease to or from the kidney. * patient has had previous therapy on the index lesion (e.g. radiofrequency, cryoablation, partial nephrectomy).

Keywords: kidney tumors renal tumors renal cell carcinoma kidney lesions renal lesions cryoablation cryotherapy cryosurgery
quantification of transition metals

Conditions: Neurodegenerative Diseases; Infections

Summary: in this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (csf) and blood serum samples. quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (icp-ms). the treating physicians as well as the patients will not be informed about the results of drug concentrations.

samples used include: remaining portions of samples collected for diagnostic or therapeutic reasons (paired csf and blood serum samples). no lumbar puncture will be done specifically for this protocol. the objective of this study is to gain an overview about transition metals concentrations in blood serum and csf in order to provide preliminary data on patients. the effect of neurodegenerative diseases on metals or the other way round will be assessed if possible.

Eligibility criteria:
inclusion criteria: • * the trial will include any patient (with various diseases, especially neurodegenerative diseases) who received a lumbar puncture. exclusion criteria: * • the lower age limit is 18 years. in concordance with the objective of the project there is no specific exclusion criteria.
gingival crevicular fluid levels of sclerostin, osteoprotegerin (opg) and rankl in health, disease and after treatment

Conditions: Periodontitis

Summary: the primary objective of this case-control intervention study to explore the effectiveness of non surgical periodontal therapy on the gingival crevicular fluid (gcf) levels of sclerostin in patients with chronic periodontitis (cp) so as to get a more detailed insight into its diagnostic and prognostic potential as a biomarker of periodontal disease.

all individuals underwent a full-mouth periodontal examination, which included probing pocket depth (ppd), clinical attachment level (cal), plaque index (pi), gingival index (gi), bleeding on probing (bop). individuals were categorized into three groups: individuals with clinically healthy periodontium (group 1), patients with chronic periodontitis (group 2), and group 3 consisted of the patients with chronic periodontitis (group 2), treated by scaling and root planning. gcf samples in grup 1 were taken at baseline. in group 2, gcf samples were taken before and after non- surgical periodontal treatment. sclerostin, opg and rankl levels were determined using the enzyme-linked immunosorbent assay.

Eligibility criteria:
inclusion criteria: * criteria for the healthy group were gi = 0, ppd and cal ≤ 3 mm, and no signs of attachment and bone loss * criteria for the chronic periodontitis group were clinical signs of inflammation, such as red color and swelling of the gingival margin, gi ≥ 2, ppd and cal ≥ 5 mm with bone loss (\>30% of the existing teeth) exclusion criteria: * aggressive periodontitis, systemic diseases (i.e., diabetes mellitus, cancer, human immunodeficiency virus, bone-related diseases that compromise sclerostin, opg or rankl levels and collagen-metabolic diseases, or disorders), chronic high-dose steroid therapy, radiation or immunosuppressive therapy, allergy or sensitivity to any drug, pregnancy, lactation, and current smoking, smoking within the past 5 years. the individuals had no history of periodontal therapy or drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) for at least six months.

Keywords: sclerostin opg rankl
treatment of actinic keratosis with 5% koh solution

Conditions: Actinic Keratoses

Summary: this is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution. in total, 68 patients with actinic keratosis grade i/ii, who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated twice daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days. the primary objective is treatment success at the individual end-of-treatment visit of all ak lesions present at baseline and treated with the investigational product. beside this, adverse events will be collected at each visit and evaluated in order to investigate clinical safety.


Eligibility criteria:
inclusion criteria: * written informed consent * age: 30 to 80 years * adults with ak grade i (mild) or ii (moderate) exclusion criteria: * number of lesions requiring treatment \> 10 * lesion to be treated \> 20 mm (maximum diameter) * lesions directly adjoining to the eyes, eyelids, nostrils, mouth or mucosal tissue, * need for topical treatment of a cancerous area * presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion * presence of a persistent or relapsing lesion despite appropriate treatment with akohderm or another appropriate treatment * high risk of progression of ak according as assessed by a medical doctor * pharmacological or physical local therapy of ak in the area foreseen for treatment dur-ing the last 12 weeks * treatment with systemic corticosteroids during the last 2 weeks * planned concomitant treatment of the same ak lesions during the study in addition to study treatment * other skin diseases in the area of application which might interfere with clinical signs * known predisposition for hypertrophic scarring / keloidosis * primary or secondary immunodeficiency * treatment with interferons, interferon inducers or immunomodulators during the last 4 weeks * pregnancy and lactation * no reliable contraception in women of child-bearing potential * other serious diseases which are according to the investigator in conflict with the par-ticipation * obvious unreliability or lack of cooperation - known addiction to alcohol, medicinal products or drugs * dependent relationship with sponsor or investigator * participation in a clinical trial within the last 30 days * previous participation in this study
effects of lanthanum carbonate on fgf-23 in subjects with stage 3 ckd

Conditions: Chronic Kidney Disease

Summary: to assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact fibroblast growth factor 23 (fgf23) levels.


Eligibility criteria:
inclusion criteria: subjects meeting all of the criteria listed below may be included in the study: 1. ≥18 years old. 2. male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol. 3. been in the care of a physician for ckd for \>2 months, and are not expected to begin dialysis for at least 6 months. 4. screening serum c-terminal fgf23 \> 50.0ru/ml. 5. screening estimated glomerular filtration rate (egfr) of 30-59ml/min/1.73m2 using the mdrd formula. 6. normal serum phosphate (0.808-1.55mmol/l). 7. endogenous 25-hydroxy vitamin d levels \>20ng/ml. 8. adequate protein diet (includes 2-3 portions of protein-rich food per day). 9. an understanding, ability, and willingness to fully comply with study procedures and restrictions. 10. ability to provide written, signed, and dated (personally) informed consent to participate in the study. exclusion criteria 1. vitamin d supplementation required. 2. compounds containing calcium, phosphate, aluminium or magnesium required. 3. acute renal failure. 4. rapidly progressing glomerulonephritis. 5. vegetarian diet. 6. known allergy to iodine. 7. clinically significant uncontrolled concurrent illness, which, in the opinion of the investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study. 8. cirrhosis or other clinically significant liver disease (aspartate transaminase (ast) or alanine transaminase (alt) \>3 times the upper limit of normal or bilirubin \>2 times the upper limit of normal). 9. past (treated within the last 5 years) or present gi disorders including uncontrolled peptic ulcer, crohn's disease (or other conditions where the integrity of the gi tract may be compromised), malignancy, or gi bleed within the last 6 months. 10. life-threatening malignancy or current multiple myeloma. 11. known to be human immunodeficiency virus (hiv) positive. 12. history of poor compliance with diet or medication that in the investigator's opinion may interfere with adherence to the protocol. 13. history of alcohol or other substance abuse within 6 months prior to screening. 14. subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment. 15. subjects who have previously been enrolled into this study and subsequently withdrawn.
application of ihmt mri in multiple sclerosis

Conditions: Sclerosis, Multiple

Summary: the development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. the investigators recently proposed a technique, derived from the conventional magnetisation transfer (mt): inhomogeneous magnetisation transfer (ihmt). in preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. the goal of the project is to evaluate the ability of ihmt to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with ms at the the disease onset.

the development of in vivo biomarkers sensitive to myelin disruption (demyelination and remyelination) represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. the investigators recently proposed a technique, derived from the conventional magnetisation transfer (mt): inhomogeneous magnetisation transfer (ihmt). in preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. the goal of the project is to evaluate the ability of ihmt to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with ms at the the disease onset.

Eligibility criteria:
inclusion criteria: * for patients and controls : * adult patient, male and female, age 18 to 45 * patient affiliated with health insurance coverage, * patient who signed a free and informed consent after receiving detailed, understandable and honest information, * for patients only : * patient with relapsing-remitting multiple sclerosis according to the mcdonald 2010 criteria * disease duration of less than 5 years * patients treated or not treated with first-line disease modifying therapy * detection of at least one post-gadolinium injection active lesion identified on the initial brain mri (t0) exclusion criteria: * for patients only : • patients with a progressive form of ms other than the early relapsing-remitting form (primary progressive or secondary progressive) * for patients and controls : * patients with the usual contraindications for mri (pacemaker, agitation, metal shards, claustrophobia) * patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position * patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion * woman who is pregnant and breastfeeding * patients with a history of neurological or psychiatric condition * patients under guardianship or trusteeship