Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of bioblock® intranasally administered virus-neutralizing bovine colostrum nasal spray in preventing of covid-19 (coronavirus disease-19) infection in healthy volunteer individuals

Conditions: SARS CoV 2 Infection

Summary: this is a proof-of-concept double-blind cluster randomized (1:1) parallel study. the randomization unit is healthy volunteers who have no symptoms of covid-19 at the start of the study and have not been infected with the sars-cov-2 (severe acute respiratory syndrome coronavirus 2) virus in the past 90 days. the selected individuals are randomly grouped in either the experimental group (individuals using the bioblock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days) or the control group (placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days).


Eligibility criteria:
inclusion criteria: agree to participate in the study age: 18-60 years (based on the age group with the best digital competence). exclusion criteria: * pregnancy * age less than 18 years and over 60 years, * a person identified with sars-cov-2 infection at the beginning of the study, * a person with symptoms of sars-cov-2 infection, * a person who has recovered from covid-19 in the last 3 months, * a person who regularly takes medicinal products administered by inhalation by nasal and oropharyngeal means. * patients with known allergies to bioblock® components and milk proteins * bioblock ingredients are: purified water • bovine colostrum sars-cov-2 antibodies • phosphate buffer: dpbs (without ca and mg salts) • viscosity-enhancing agents: peg400, pvp k30 • preservative: sodium benzoate • acidity regulator: citric acid • mucous membrane moisturizing agent: glycerol • potassium chloride - buffer solution component • potassium dihydrogen phosphate - buffer solution component • sodium chloride - buffer solution component • disodium phosphate - buffer solution component * . * bioblock® use in the last 24 hours if the subject has taken bioblock® during the last day and there are no other criteria for exclusion from the study, then the subject is suitable for inclusion in the study from the next day

Keywords: sars-cov-2 covid-19 nasal spray antiviral agent
prenatal screening for smith-lemli-opitz syndrome

Conditions: Smith-Lemli-Opitz Syndrome; Pregnancy

Summary: smith-lemli-opitz syndrome (slos) is a genetic condition that causes mental retardation and other birth defects. this study will evaluate a new prenatal screening test for slos.

slos is an inherited metabolic disorder characterized by moderate to severe mental retardation and congenital anomalies. slos is caused by a deficiency of the enzyme 7-dehydrocholesterol reductase and the resulting defect in the conversion of 7-dehydrocholesterol to cholesterol. slos can now be reliably detected prenatally by analysis of amniotic fluid 7-8- dehydrocholesterol (7/8-dhc) levels. unconjugated estriol (ue3) is one of the maternal serum analytes currently measured routinely to screen for down syndrome. this analyte requires cholesterol as a precursor, and its concentration in maternal serum is lower when the fetus has slos. currently, there is no national standard for the approach taken in prenatal screening; existing programs vary both in availability and in the protocol and algorithms used. the major barrier to identifying slos prenatally is the absence of sound screening methodology that takes into account the detection rate, the false positive rate, and the prevalence. this study will evaluate the efficacy of routinely identifying smith-lemli-opitz syndrome (slos) prenatally. the screening model in this study is based on data from slos pregnancies and will be tested in 1,000,000 pregnancies in which maternal serum ue3, alpha-fetoprotein, and human chorionic gonadotrophin measurements are being done as part of routine screening for down syndrome. the screening false positive rate is projected to be 0.34%, the detection rate 62%, and the odds of being affected given a positive screening result 1:70. these rates all compare favorably with prenatal screening tests now in routine use. the study will also determine whether slos diagnostic studies can be carried out in maternal urine or serum, rather than amniotic fluid, thereby avoiding invasive procedures. participants in this study will be pregnant women undergoing amnioscentisis during the second trimester. women who have a positive test for slos will be asked to provide a urine and blood sample. the study will collect data on patient demographics and family history; data will also be obtained from the participant's ultrasound, karyotype, alpha-fetoprotein, maternal serum screening, and slos reports. three months after the pregnancy due date, a genetic counselor will contact the participant to obtain basic information about the baby's delivery and health.

Eligibility criteria:
inclusion criteria * pregnant, second trimester * singleton pregnancy * positive second trimester maternal serum screen for smith-lemli-opitz syndrome (using the foundation for blood research screening algorithm ) exclusion criteria: * gestational age at time of serum collection outside the range accepted for down syndrome screening * not pregnant * twin/multiple pregnancy * sample/clerical/assay error * physician not participating in study

Keywords: screening prenatal amniocentesis
effect of whole body vibration on blood pressure in obese postmenopausal women.

Conditions: Hypertension

Summary: all post-menopausal women followed an energy-restricted diet for 8 weeks. meal plan that creates an energy deficit of 500 to 1000 kcal per day less than the individual's average daily intake was suitable for weight reduction.each post-menopausal woman followed dietary approaches to stop hypertension (dash) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in potassium(6900mg), calcium(1200-1500mg) and magnesium, as well as vitamins a, c and e.group b (wbv group): for 8 weeks, wbv participants completed 3 supervised training sessions a week.

i-group a (control group): all post-menopausal women followed an energy-restricted diet for 8 weeks. meal plan that creates an energy deficit of 500 to 1000 kcal per day less than the individual's average daily intake was suitable for weight reduction.each post-menopausal woman followed dietary approaches to stop hypertension (dash) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in potassium(6900mg), calcium(1200-1500mg) and magnesium, as well as vitamins a, c and e. ii-group b (wbv group): for 8 weeks, wbv participants completed 3 supervised training sessions a week. each participant received an explanation of the wbv device and the treatment protocol. women stood in upright position and hold on handle bar before switching the wbv device at "on" position. the exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee ﬂexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions. all dynamic exercises were performed with slow controlled movements and between each set, there was resting period during which women assumed upright standing position for 1 minute. total duration of the training session was 30 minutes.

Eligibility criteria:
inclusion criteria: * age 55 -65 years * bmi 30 to 34.99 kg / m2 * prehypertension and hypertension stage i exclusion criteria: * systolic blood pressure exceeding 159 mm hg and diastolic blood pressure exceeding 99 mm hg, * diabetic neuropathy disease, * patients with mental or psychological disorders, * skin disorders or bleeding disorders, and * musculoskeletal disorders that limited wbv.
micropulsed laser in association with anti-vegf for the treatment of macular edema in diabetic patients (lamed).

Conditions: Macular Edema; Mellitus Diabetes

Summary: diabetes is a major cause of blindness in adults in the developed countries. the retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. this results in macular edema. currently, intravitreal injections of anti-vegf have demonstrated their effectiveness and are the first line treatment of macular edema. subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. by delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. micropulsed photocoagulation combined to anti-vegf injections, could be the most effective treatment with a minimum injection number and without epithelial lesions. the main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-vegf, allows to reduce the number of anti-vegf injections during the first year of treatment. in this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.


Eligibility criteria:
inclusion criteria: * 18 years or more * macular edema associated with a 1 or type 2 diabetes with a hemoglobin a1c level over 5.5% and under \<13% * indication for a treatment with intra-vitreal injections of ranibizumab exclusion criteria: * treatment with anti-vegf during the previous 2 months * treatment by intra-vitreous implant of dexamethasone during the previous six months * previous history of vitrectomy or glaucoma * photocoagulation during the previous 3 months * patient's opposition to participate to the study
pilot study immunomonitoring natural killers cells in patients with myeloid malignancies treated with lenalidomide

Conditions: Acute Myeloid Leukemia or Myelodysplasic Syndrome

Summary: this project is a framework for developing new therapeutic strategies for acute myeloid leukemia(aml)based immunotherapy. the role of nk cells was demonstrated in aml and especially gvl effect (graft versus leukemia) during allogeneic transplantation in these patients. however, it has been shown that the phenotype of nk cells and their cytotoxic functions were altered during this malignancy. in addition, in these patients, impaired nk function is associated with relapse. lenalidomide it would have a beneficial effect on nk cells of aml patients? does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? in vitro data show an effect of lenalidomide on the phenotype of nk cells from healthy donors and patients with lam, and despite these phenotypic changes, the cytotoxic capacity of nk is not altered.lenalidomide also induces a significant increase in the production of tnf-alpha (tumor necrosis factor) by nk. it also seems to have an effect on leukemic blasts of aml. so, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.


Eligibility criteria:
inclusion criteria: * patient aged 18 years and above, * patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with revlimid, * signed consent to participate, * patient affiliated to a social security system or benefiting from such as a system. exclusion criteria: * allogeneic patients beyond, * patient deprived of liberty or under supervision of a guardian, * impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.

Keywords: acute myeloid leukemia or myelodysplasic syndrome
probiotic in treatment of adult patients with drug-resistant epilepsy

Conditions: Epilepsy; Treatment

Summary: this study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.


Eligibility criteria:
inclusion criteria: drug resistant epilepsy exclusion criteria: * hypersensitivity to probiotic * acute pancreatitis * pregnancy * breastfeeding * being under treatment with corticosteroids * being under treatment with antibiotics during 2 months before enrollment * need for antibiotic therapy during the study * change in anti-seizure medication within the month before enrollment
a study to compare a new eye drop formulation with systane® gel drops and genteal® lubricant gel drops for moderate to severe dry eye relief

Conditions: Dry Eye Syndromes

Summary: a study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: * current use of an artificial tear product * visual acuity of at least 20/40 (while wearing glasses, if necessary). exclusion criteria: * use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * cataract surgery, laser-assisted in situ keratomileusis (lasik), photorefractive keratectomy within 6 months * use of restasis® cyclosporine ophthalmic emulsion or any topical cyclosporine within 3 months * diagnosis of glaucoma.
efficacy and tolerability of an intra-nasal testosterone product

Conditions: Hypogonadism

Summary: this clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

primary objective: the primary objective of this study was to determine the efficacy of nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following nasobol treatment, and comparing it to that of the active control, androderm®. secondary objective: to establish a safety profile for nasobol.

Eligibility criteria:
inclusion criteria: * men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels \>100 ng/dl and ≤ 300 ng/dl. * normal otolaryngological nasal endoscopy examination. * normal prostate examination (no palpable prostatic mass), and serum psa ≤ 4.0 ng/ml. exclusion criteria: * current treatment with other androgens (i.e. dhea), anabolic steroids or other sex hormones * treatment with estrogens, gnrh antagonists, or growth hormone within previous 12 months * history of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery. * history of nasal disorders (e.g. polyposis, recurrent epistaxis ( \> 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.

Keywords: primary hypogonadism secondary hypogonadism
effectiveness of cricoid and paratracheal pressures for occluding esophagus

Conditions: Intubation Complication

Summary: comparing the effects of 'cricoid pressure' or 'paratracheal pressure' during direct laryngoscopy

the effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.

Eligibility criteria:
inclusion criteria: * who would be scheduled any surgery under general anesthesia and agree with the purpose of the study exclusion criteria: * risk of aspiration * history of esophageal surgery * diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus * known or predicted difficult airway.
evaluation of two varnishes on the improvement of white spot lesions in children

Conditions: White Spot Lesion

Summary: a randomized control trial evaluating the effect of the giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months


Eligibility criteria:
inclusion criteria: * • patients with good general health. * adequate oral hygiene, * patients who didn't receive remineralizing agents during the last 3 months other than regular toothpaste. exclusion criteria: * uncooperative child. * active carious lesion. * labial surface restoration.

Keywords: white spot lesion fluoride varnish giomer varnish
the value of visual field examination in driving licence.

Conditions: Glaucoma Eye

Summary: the aim of the study is to identify clinical criteria, easily achievable with patient's follow-up tests, which can identify individuals at increased risk of being unfit to drive. only they, then, will be directed to further investigations. these clinical standards should also be suitable for implementing or substituting the current law's criteria, after appropriate additional studies, so that the law can be based on the clinic.

in this observational study, the investigators recruite patients referred at the glaucoma service of the ophthalmologic clinic of the asst sette laghi university hospital in varese. all the patients enrolled in the study require a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (humphrey sita 24-2 or 30-2 sita standard) performed in the previous six months. all patients undergo a full ophthalmologic examination and verbally submitted a questionnaire designed by the authors of the paper (ll, sd, md). the examination included visual acuity, refraction, slit lamp bio-microscospy, goldmann's applanation tonometry, gonioscopy with four mirror lens, oct rnfl and gcl imaging if necessary and re-evaluation of target iop. the investigators use the two monocular visual fields to build an integrated visual field which, according to d.p. crabb papers, is an efficient surrogate to the binocular esterman visual field test (evft). in short, each point in each monocular field is compared to its equivalent in the other eye, and the data, from the eye with the best sensitivity, are used. locations are dichotomized into groups with sensitivity \> 10 db and \< 10 db, representing whether a patient would see or miss a point in the esterman test, respectively. to match even better the ivf with the evft, 8 points of the inner 20° of the ivf were excluded since they have no direct equivalent in the evft.

Eligibility criteria:
inclusion criteria: * subjects above 18 years of age * clear diagnosis of glaucoma (of any type) * to show a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (humphrey sita 24-2 or 30-2 sita standard) performed in the previous six months. exclusion criteria: * other ocular conditions that could affect the visual field (i.e. cataract or macular degeneration). * patients that underwent a 10-2 test since it does not allow the composition of the integrated visual field.

Keywords: visual field driving licence glaucoma
the platon network

Conditions: Hepatocellular Cancer; Cholangiocarcinoma; Gallbladder Cancer; Pancreatic Cancer; Oesophageal Cancer; Stomach Cancer

Summary: the platon network study is designed to elevate personalized therapy based on genomic tumor profiles in gastrointestinal cancer patients. hereby, platon's study-design focuses on the patient's tumor molecular profiling. within the network a web application will be developed to link clinical investigators and information on study sites, cancer patients and genetic alteration data, as well as available clinical trials at platon's study sites.

the platon network is established as permanent open, multicenter, prospective, cohort study of patients with gastrointestinal cancer. the study design includes a study-specific biobank and a shared platform infrastructure for associated sub-studies and analysis projects. within platon results of genetic tests of different research projects like the platon pilot-study (nct04484636) as well as next-generation deep sequencing (ngs) according to local protocols will be documented - compiling genomic tumor-profiles including tumor mutational burden (tmb) and microsatellite instability (msi). the platon network infrastructure is designed to increase the likelihood of treating the patients with an individualized therapy in available clinical studies. therefore, molecular profiling must go hand in hand with inter-linking physicians and increasing inter-centre transparency. the feasibility of this approach will be tested in the platon network, keeping in mind the vision of cancer patients receiving the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of hepatocellular carcinoma or intra- cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant therapy is allowed if completed 6 months prior to enrolment) and no local curative therapy available * standard first line therapy is planned, or patient is currently receiving first-line therapy * available tumor-genomic profile ( ≥50-gene panel assay; approved and assessed by central review), unless central tumor genomic profiling is done within a sub-study * ecog 0-2 * life expectancy ≥ 6 months exclusion criteria: * not able to understand all implications of study participation * no written informed consent * age \< 18 years

Keywords: gastric cancer individualized cancer therapy targetable mutations ngs hepatocellular cancer cholangiocarcinoma gallbladder cancer pancreatic cancer oesophageal cancer stomach cancer platform-design biobanking
immune responses to pneumococcal vaccination among hiv-infected subjects

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (pv) to hiv-infected adults that have cd4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (art). participants in this study will be assigned by chance to receive vaccination with pv prior to starting art or after at least 6 months of art. antibody levels to components of the pv will be measured at 6 months and 12 months after vaccination. the results will tell us if patients that receive pv after 6 months of art have better response to the vaccine than those that get vaccinated prior to treatment.


Eligibility criteria:
inclusion criteria: * hiv infected * cd4 count \>200 * no acute illness * no pneumococcal vaccination within 3 years * naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months * willingness to start antiretroviral treatment as recommended by current guidelines exclusion criteria: * prior pneumococcal vaccination within 3 years * prior aids diagnosis based on opportunistic disease * acute illness

Keywords: pneumococcal polysaccharide vaccine