Kornimate/medical-research-clean huggingface dataset:
informing the population of their level of protection against covid-19 in monaco: a prospective study (monavacc)

Conditions: SARS-CoV-2; COVID-19; Vaccines; Antibody

Summary: vaccines against the coronavirus type 2 causing severe acute respiratory syndrome severe acute respiratory syndrome coronavirus 2 (sars-cov-2) have been created in a short period of time due to the rapid spread of the virus. these vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (rna), or a non-replicating viral vector. efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.

severe acute respiratory syndrome coronavirus 2 (sars-cov-2)

Eligibility criteria:
inclusion criteria: * participant must live in the principality of monaco * deliver a written consent to participate to the study * and/or have been infected with sars-cov-2 * and/or have been, or are about to be, vaccinated against sars-cov-2 exclusion criteria: - none of the above
comparison of insulin aspart produced by current process and the nn2000 process in healthy japanese

Conditions: Diabetes; Healthy

Summary: this trial is conducted in japan. the aim of this trial is to compare insulin aspart produced by current process and the nn2000 process in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: * japanese * considered generally healthy based on medical history and physical examination * body mass index (bmi) between 18 and 27 kg/m\^2 (both inclusive) * fasting plasma glucose between 3.8 mmol/l (68.4 mg/dl) and 6.0 mmol/l (108.0 mg/dl) exclusion criteria: * clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis * any serious systemic infectious disease that occurred during the last 4 weeks before trial * any inter-current illness that may affect blood glucose * subject with a first degree relative with diabetes mellitus * blood donation of more than 400 ml (inclusive) in total within the last 12 weeks or more than 200 ml (inclusive) in total within the last 4 weeks
towards a high-fat feeding intervention study: identification of markers for inflammation and organ damage

Conditions: Systemic Inflammatory Response Syndrome; Sepsis

Summary: patients undergoing major surgery, trauma or burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. recently, the researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding administered before shock attenuates inflammation and reduces intestinal and hepatic damage. in the mechanism that underlies this protective effect, the release of cholecystokinin in gut wall and activation of efferent vagus bundles are crucial events. before investigating the effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ damage need to be selected. in this study, blood will be collected in patients undergoing different types of operations. consequently several markers for inflammation and organ damage will be determined. hence, suitable parameters for a future high-fat intervention study will be selected.


Eligibility criteria:
inclusion criteria: * \> 18 years * elective liver / colon / femur surgery exclusion criteria: * acute inflammation * chronic obstructive respiratory disease * recent history of abdominal pain or diarrhea * bmi \< 18.5 * alcohol or drugs abuses * recent intake of antibiotics

Keywords: sirs, sepsis and related syndromes
bli1100-202: bli1100 for the treatment of moderate to severe acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to compare the safety and efficacy of bli1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.


Eligibility criteria:
inclusion criteria: * males or females 12 to 45 years of age with facial acne vulgaris * qualifying investigator's global assessment severity score * qualifying number of non-inflammatory lesions * qualifying number of inflammatory lesions exclusion criteria: * facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade * using medications that are reported to exacerbate acne * any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin * have a known hypersensitivity or previous allergic reaction to any of the components * patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days * patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
full mouth ultrasonic debridement carried out either by piezoelectric or magnetostrictive device

Conditions: Periodontitis, Adult

Summary: treatment of periodontitis requires removal of dental biofilm both through professional mechanical plaque removal and domiciliar oral hygiene procedures. this study aims to compare biometric and psychological results after professional treatment of periodontitis carried out by piezoelectric or magnetostrictive ultrasonic devices.

patients diagnosed with periodontitis will be assessed for eligibility criteria. full-mouth periodontal assessment will be performed by an examiner to detect severity and extension of the disease. thereafter, patient will receive oral hygiene instruction and a closed envelope with patient allocation will be opened. after the allocation to the intervention group, full-mouth ultrasonic debridement will be delivered to the patient by an operator and information about patient perception will be collected. three months later, patients will be recalled for a new periodontal assessment.

Eligibility criteria:
inclusion criteria: * \>18 years * periodontitis of stage 1 and 2 * absence of systemic chronic disease exclusion criteria: * anticoagulants treatment * antibiotic treatment 3 months before the screening visit

Keywords: periodontitis patient centred outcomes magnetostrictive
amino acids in ileal pouch-anal anastomosis for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the detrimental effects of catabolism, insuline resistance and muscle wasting on surgical outcome is wellknown. this catabolism is especially pronounced in patients with acute or chronic inflammation (ibd, cancer) and for those undergoing major surgery. patients with ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into both these categories. to prevent this undesirable catabolism, we will investigate the effects of intravenous administration of predominantly anabolic amino acids (with an amino acid content equal to breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and intracellular signalling pathways. twenty-four patients will be block-randomized by gender in this parallel-group, randomized, assessor-blinded, placebo-controlled trial to receive either vaminolac® (fresenius kabi) or saline. metabolism before and after the intervention will be assessed by palmitate- and amino acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be analyzed for differences in intracellular signaling pathways (pi3 kinase, akt, etc.) as a measure of cellular activity. with this study we hope to find evidence for anabolic effects of intravenous amino acids in j-pouch surgery for ulcerative colitis. the perspective is a potential for primary prophylaxis of surgical complications, reduction in the length of hospitalization, and subsequently optimized long-term functional outcome of the pouch.


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis who are having an ileal pouch-anal anastomosis performed, 18 \< age \< 50, written informed consent. exclusion criteria: * inability to understand written danish, postmenopause, severe asthma, diabetes mellitus, severe rheumatologic disease, severe comorbidity (asa group iii-iv) in general. acute or progressing liver failure, uremia without possibility for dialysis, phenylketonuria, defects in amino acid metabolism. participation in scientific studies in the preceding year, where ionizing radiation has been used, including significant x-ray investigations.
effectiveness of a physical activity and diet program in patients with psychotic disorder (capicor)

Conditions: Schizophrenic Disorders; Schizoaffective Disorders; Bipolar Disorders

Summary: the aim is to evaluate the effectiveness of an intervention based on a program of physical activity and diet coordinated between primary care teams (pct) and mental health centres (mhc) to modify the weekly physical activity (pa) amount, body mass index (bmi) and waist circumference in patients with severe mental disorder diagnoses. to assess changes in cardiovascular risk, quality of life and lifestyles, secondarily. methods: a randomized clinical trial with a control group, of one year of follow-up, carried out in four mhc barcelona and santa coloma, and pct of reference. the investigators studied patients aged 18 - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with antipsychotic medication and a low level of pa. 240 patients will be selected in each group (difference to be detected in the bmi:\> 1.89 kg/m2; common sd: 6.2, 30% loss). intervention: group educational pa program (basically walking) of 24 sessions over 12 weeks, and diet (8 sessions in the first 8 weeks) by nurses and specialists in pa. key measurements: level of pa (ipaq questionnaire), physical examinations: bmi, waist circumference, blood pressure, cardiovascular risk, quality of life (sf-36), smoking habits, dietary habits (predimed questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose. evaluations will be masked and conducted at 0, 3, 6 and 12 months. analysis of variance for repeated measures to adjust for differences attributable to the effect of the intervention for potential confounders: pharmacological treatment, care level of intervention and mental state.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old, * understand catalan or spanish * will be located for at least twelve months. * psychiatric disorders with icd-10 diagnosis codes: f20\*, f31\* and f25\*. * taking an antipsychotic drug at, a least, three months * low physical activity level exclusion criteria: * active addiction to psychoactive drugs, except tobacco. * pregnancy * diseases that doesn't allow physical activity * psychotic acute exacerbation in the last month

Keywords: psychotic disorders, heart diseases
estrogen and perimenopausal depression

Conditions: Depressive Disorder, Major; Menopause

Summary: during perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. in particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. this study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of unipolar major depression, currently taking antidepressants * ham-d between 10 and 17 exclusion criteria: * history of psychosis, breast cancer, smoking, dementia, clotting disorders * current substance abuse

Keywords: depression menopause perimenopause mood memory perimenopausal antidepressant estrogen
digital variance angiography for contrast media dose reduction in carotid artery stenting

Conditions: Carotid Artery Diseases

Summary: digital variance angiography (dva) is a new tool in medical imaging with a proven image quality reserve (1, 2). previous studies have demonstrated the quality reserve of dva in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the image quality (3). cas is an alternative treatment option for carotid artery revascularization in selected patient groups. similar to most of the minimally invasive endovascular interventions, cas also carries the risk of contrast-induced acute kidney injury, which is considered to be an independent predictor of 30-day major adverse events (4). the aim of this study is to apply dva in patients undergoing carotid artery stenting (cas) and utilize this technique to reduce contrast dose during the interventions, without affecting the intraprocedural radiation dose and the clinical outcome of the procedures. investigators believe that the reduction in contrast media use and the associated image quality with the technique of dva imaging can be incorporated into the everyday clinical practice, and will play an important role in improving the rate of contrast-induced acute kidney injury.


Eligibility criteria:
inclusion criteria: * age \> 18 y * carotid stenosis defined as: stenosis ≥70% by computer tomography angiography (nascet criteria); or by duplex-ultrasound with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s * carotid stenosis is treatable with cas exclusion criteria: * history of stroke or tia ipsilateral to the stenosis within 30 days of randomization * acute myocardial infarction * severe chronic kidney disease: gfr\>30ml/min/m2 * severe heart failure: nyha iv * severe liver failure: child-pugh 3 * iodine contrast allergy * coagulopathy * hematological bleeding disorders

Keywords: radiocontrast media reduction x-ray angiography digital variance angiography digital subtraction angiography carotid artery stenting kinepict
the effects of chicken extract and a peptide supplement for the prevention of cognitive decline in non-demented elderly adults

Conditions: Cognitive Decline; Mild Cognitive Impairment; Aging

Summary: this trial investigates the effect of a chicken extract supplement and a peptide supplement on cognitive function and potential mechanisms of action of cognitive decline during ageing, among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical trial design.


Eligibility criteria:
inclusion criteria: * male or female at 55 - 75 years of age * baseline cognition: * normal cognition with feelings of cognitive decline (subjective cognitive decline) or * mild cognitive impairment (mci+) with memory impairment * agree to participate in the study and provide written informed consent exclusion criteria: * inadequate visual and auditory acuity to allow neuropsychological testing * significant cerebrovascular disease * history of allergy to chicken meat * diagnosis of alzheimer's disease (ad) with dementia or any other dementia * clinical dementia rating (cdr) score of \> 0.5 at screening * evidence of other neurological, psychiatric or physical illness that can produce cognitive deterioration per investigator's judgment * inability or unwillingness to undergo pet scan * current diagnosis or history of alcoholism or substance addiction * regular use of any medication in the past 6 months that may affect cognitive functioning * regular use of cognitive enhancing supplements in the past 6 months * subjects with excessive blood donation or blood drawn prior to baseline * persons with a history of cardiovascular disease or any other cardiovascular or cerebrovascular diseases which investigators deem unsuitable to participate in the clinical study.
overcoming barriers and obstacles to adopting diabetes devices (onboard) trial

Conditions: Type 1 Diabetes

Summary: this study is a comprehensive, multicomponent behavioral intervention package (onboard; overcoming barriers \& obstacles to adopting diabetes devices). onboard will provide adults with t1d the skills to maximize benefit and minimize daily interference from barriers associated with continuous glucose monitoring (cgm) and increase readiness for closed loop.

the investigators will enroll 178 adults with t1d between 18-50 years of age. participants must not have been using cgm regularly for past 6 months. once consented and enrolled, baseline demographic and psychosocial data will be obtained. participants will receive 12 weeks of cgm supplies at no cost to them and provided with initial standard cgm introduction and education. participants will then be randomized to receive onboard or cgm-only. those randomized to the onboard condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). hemoglobin a1c values, cgm usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.

Eligibility criteria:
inclusion criteria: 1. subject is age 18-50 years at time of enrollment 2. subject must not have been using cgm regularly for past 6 months 3. subject has a clinical diagnosis of type 1 diabetes 4. subject comprehends spoken and written english exclusion criteria: 1. subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol. 2. subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
repetitive transcranial magnetic stimulation for freezing of gait

Conditions: Parkinsonian Disorders

Summary: freezing of gait (fog) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. patients descirbe their feeling of the feet suddenly being glued to the floor. transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. transcranial magnetic stiumation (rtms) can selectively change brain activity to enhance desired effects. the aim of this study is to the therapeutic effect of rtms for the fog.


Eligibility criteria:
inclusion criteria: * parkinson's disease or primary progressive freezing of gait * age 18 and older * freezing of gait exclusion criteria: * pregnant or any, other medical, surgical, neurological or psychiatric conditions * other restrictions which prevent you from undergoing tms recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines * any past or current history of seizure disorder or epilepsy * unable to give informed consent
group psychotherapy for people with hiv

Conditions: HIV; Depression; Risk-taking; Pain

Summary: this study will examine the effectiveness of supportive-expressive group therapy plus education compared with an educational intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with hiv or aids.

the major goal of this project is to examine the effectiveness of supportive-expressive group therapy plus education in comparison to an educationally intervention in improving the quality of life and promoting health-enhancing behavior of men and women living with hiv/aids.

Eligibility criteria:
inclusion criteria: * 1) a positive hiv diagnosis (either symptomatic or asymptomatic), 2) at least eighteen years of age, 3) english language skill (to complete questionnaires and participate, if assigned, to the group psychotherapy condition) and, 4) geographical proximity to groups in order to attend if assigned. exclusion criteria: * 1) severe psychiatric disorders (i.e. schizophrenia or other psychotic disorders)who would not be appropriate for participating in the group intervention, 2) active tuberculosis, 3) acute intoxication, 4) participation in an ongoing hiv/aids support group or 5) suicidal/homicidal ideation.
the correlation between prelabor analgesic plan and actual labor analgesia with satisfaction, postpartum depression, and breast feeding success

Conditions: Depression, Postpartum

Summary: in this study the investigators would like to evaluate how prelabor analgesic plan and actual labor analgesia effects the labor satisfaction, breastfeeding success, and whether or not it reduces postpartum depression. although postpartum depression has been researched and reviewed, there is little information on how satisfaction during labor affects postpartum outcomes. the relationship between epidural analgesia is also complex, and there has yet to be found a valid correlation between the two parameters. in addition although an attempt has been made to evaluate relationship between breastfeeding and epidural analgesia, results are unclear and further research is needed.

this is a prospective, single center study, which will be conducted at the rabin medical center (beilinson campus), petach tikva, israel, a tertiary university hospital. all women undergoing vaginal delivery on the first day postpartum will be enrolled after filling out an informed consent. they will be given out a labor satisfaction questionnaire detailing initial desire for epidural analgesia, final desire for epidural analgesia, adequacy of pain relief during labor and satisfaction with labor. (see appendix 1). the investigators will evaluate breastfeeding success according to the latch scoring system in the first day postpartum which is routinely administered by nurses/ lactation consultants in the maternity ward. according to their initial desire verses final analgesic choice they will be divided into four groups: 1. women who initially didn't want and didn't receive one. 2. initially didn't want and did receive one. 3. initially wanted an epidural and didn't received one 4. initially wanted an epidural and did receive one. on the third day postoperatively the parturients will be called and assessed for mood and signs of postpartum depression using edinborough postnatal depression scale validated into hebrew (10) , and the investigators will assess whether or not they are breastfeeding. at 6 weeks the investigators will follow-up to assess breastfeeding duration ,and postpartum depression using the edinborough postnatal depression scale. the investigators' comparison will include average pain scores, breast feeding success, and postpartum depression assessment.

Eligibility criteria:
inclusion criteria: * women above 18 undergoing vaginal delivery in beilinson hospital * following obtaining written informed consents * ability to comply with the study requirements will be included in the investigators' study exclusion criteria: * women undergoing cesareans sections.