Kornimate/medical-research-clean huggingface dataset:
probiokid as prevention among kids with frequent urti

Conditions: Respiratory Tract Infections

Summary: this study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of probiokid® on the incidence of respiratory infections and related complications in frequently sick children.

the microbiota is very important for the development of the immune system in children. lactic acid bacteria, such as lactobacillus and bifidobacterium, are usually administered as probiotics (defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host). some probiotics were shown to sustain the development of immune competency in newborns, as well as to modulate the adaptive immune response and response to infections. for example, previous research suggests that probiotics decrease the incidence of upper respiratory tract infection (urti). probiokid® is a commercially-available formulation that consist of probiotics (lactobacillus helveticus, bifidobacterium infantis, bifidobacterium bifidum) and fructooligosaccharides. this formulation has been shown to decrease the rate of respiratory infection in children supplemented for 3 to 9 months. therefore the aim of this clinical trial is to assess the efficacy of probiokid® supplemented for 6 weeks on the prevention of urti and related complications among children (aged 3 to 10 years-old) that frequently suffer of acute respiratory infections. in addition, the impact of a prophylactic intervention with probiokid® on the number of physician visits and antibiotic courses prescribed is assessed.

Eligibility criteria:
inclusion criteria: * age of children from 3 to 10 years, * high frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. aris more often than once every 3 months). * absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment). exclusion criteria: • chronic pathological conditions.

Keywords: frequent respiratory infection pediatrics probiotics
a trial to assess the pharmacokinetics, safety and tolerability of semaglutide in healthy chinese subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: the main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy chinese subjects. different dose levels (0.5 and 1.0 mg) will be investigated in this trial. participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. the trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. the total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.


Eligibility criteria:
inclusion criteria: * healthy male and female chinese subjects * age between 18 to 55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 20 and 24.9 kg/sqm (both inclusive) * body weight greater than or equal to 54.0 kg exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including follow-up period. adequate contraceptive measures are sterilisation, intrauterine device (iud), oral contraceptives or barrier methods * any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases * use of prescription or non-prescription systemic products (including routine or non-routine vitamins or herbal products) or topical medicinal products (except paracetamol and oral contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2 (randomisation) * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * history of pancreatitis (acute or chronic) * calcitonin greater than or equal to 50 ng/l * blood donation, surgery or trauma with significant blood loss (400 ml) within the last 12 weeks prior to screening
evaluation of the bioweld1 system as a method for surgical incision closure

Conditions: Child Delivery Using an Elective C- Section

Summary: the purpose of this study is to assess the safety and performance of the bioweld1 system procedure for surgical incision closure of the skin in women scheduled for elective c-section procedure.

in every surgical procedure, there is a need to close the incision that was made. current methods for incision closure include stitching, gluing and stapling. some of these methods are time consuming, have potential for infection and may leave a significant scar. the bioweld1 technology suggests a new approach for incision closure. it is a novel medical device that consists of a chitosan film and the bioweld1 plasma ejecting device. the chitosan film is intended to be applied to the skin incision, while the bioweld1device is used for welding the chitosan to the skin by means of cold plasma technology.

Eligibility criteria:
inclusion criteria: 1. age between 20 to 40 years old. 2. women scheduled for child delivery using an elective c- section. 3. women in their first or second pregnancy having a c-section for the first time 4. healthy women with no systemic diseases such as diabetes, heart disease etc. 5. women with average weight, bmi prior pregnancy of 18.5-25. 6. women with no skin diseases 7. subject understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. 8. the subject commits to return for the scheduled post-operative follow-up visits at the clinic general exclusion criteria: 1. women intended for any abdominal surgery other than c-section procedure 2. women intended for c-section procedure for other purpose than child delivery 3. any prior c-section procedure for any purpose 4. women received/receiving radiotherapy or chemotherapy of any kind. 5. women receiving steroids or any other medication that interferes with wound healing. 6. women receiving acutan in the last half year. 7. women with bleeding diathesis or hypercoagulable state. 8. women with prior cosmetic or medical treatment in the target area (e.g. phosphatydilcholine injections). 9. women suffering from thrombocytopenia (platelets count\<100,000/mm3) pre-procedure. 10. women who is currently participating or have participated in an investigational study, other than this study, within the past 60 days. 11. psychiatric background. intra operative exclusion criteria: 1. severe excessive bleeding from the wound 2. patient is not eligible for an experimental closure according to the physician discretion.

Keywords: chitosan plasma incision closure
cryo-touch ii for the treatment of wrinkles

Conditions: Facial Wrinkles

Summary: this is a prospective, non-randomized study to evaluate the performance of the myoscience cryo-touch ii device for the treatment of wrinkles.


Eligibility criteria:
inclusion criteria: * age 30-70 years * subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point wrinkle scale (5ws)\* * subject has signed irb-approved informed consent form exclusion criteria: * subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising * subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites * the investigator is unable to substantially lessen facial lines by physical separation * subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months * subject is participating in another facial cosmetic research study patient has any of following conditions: * history of facial nerve palsy * marked facial asymmetry * ptosis * excessive dermatochalasis * deep dermal scarring * thick sebaceous skin * history of neuromuscular disorder * chronic dry eye symptoms * allergy or intolerance to lidocaine
prospective, post-registration, interventional, randomized, in parallel groups, multicenter eurasian clinical study of derivo®/derivo® mini aneurysm embolization device, europe-asia

Conditions: Intracranial Aneurysm

Summary: prospective, post-registration, interventional, randomized, in parallel groups, multicenter eurasian clinical study of derivo®/derivo® mini aneurysm embolization device, europe-asia

prospective, post-registration, interventional, randomized, in parallel groups, multicenter eurasian clinical study of derivo®/derivo® mini aneurysm embolization device, europe-asia

Eligibility criteria:
inclusion criteria: * localization and structure of the aneurysm allows the use of a derivo®/derivo® mini flow-diverting stent for treatment; * the aneurysm cannot be cured by other methods of endovascular therapy, or there is a higher risk of complications when using other methods of endovascular therapy or microsurgery; * clipping or embolization with spirals (if performed earlier) led to a recurrence of the aneurysm. exclusion criteria: 1. age less than 18 years. 2. pregnancy. 3. the presence of a previously implanted stent in a cerebral artery. 4. dissection of cerebral or peripheral vessels. 5. the presence of contraindications to the use of the derivo®/derivo® mini medical device, specified in the instructions for use: * non-compliance of the aneurysm and/or the carrier vessel with the indications for the use of the device; * non-physiological structure of cerebral vessels; * vascular disorders that are a contraindication to endovascular interventions. 6. the presence of contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.
dose-escalation study to assess safety, tolerability and pharmacokinetics of medi-573 in japanese subjects

Conditions: Cancer; Advanced Solid Malignancies

Summary: the primary purpose of this study is to explore the safety and tolerability of medi-573 in japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.


Eligibility criteria:
inclusion criteria: * japanese men or women at least 20 years of age * histological or cytological confirmation of a solid, malignant tumour excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist * who performance status 0-2 with no deterioration over the previous 2 weeks exclusion criteria: * previous therapy with medication against igf (ie, monoclonal antibodies with igf-1r or igf-targeting tyrosine kinase inhibitors) * inadequate bone marrow reserve or organ function * poorly controlled diabetes mellitus as defined by the investigator's assessment and/or glycosylated hemoglobin (hba1c) reading \> 6.5% within 28 days prior to the first dose of medi-573 * history of allergy or reaction to any component of the medi-573 formulation or drugs with a similar chemical structure or class to medi-573

Keywords: phase i cancer solid tumours advanced solid malignancies dose escalation insulin like growth factor japanese
phase ib study of sc milatuzumab in sle

Conditions: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic; Lupus Vasculitis, Central Nervous System; Lupus Nephritis

Summary: milatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (sle).

milatuzumab or placebo will be given subcutaneously once weekly for 4 weeks to determine if milatuzumab helps to control lupus (sle). the treatment portion of the study lasts 4 weeks. then patients are followed for disease activity for at least 12 weeks. if patients respond to the study drug, they may be eligible for one course of retreatment, again followed by 12 weeks of follow-up. patients who showed a response will continue to be followed at timepoints up to one year after treatment to assess how long the response lasts.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years old * signed written informed consent before study entry * diagnosis of sle by american college of rheumatology revised criteria (meets ≥ 4 criteria) * positive ana (titer ≥ 1:80) at study entry * at least 1 bilag a or 2 bilag b scores in any organ/body system and ≥ 6 selena-sledai score * receiving at least 5.0 mg/day oral prednisone (or equivalent) at stable doses for at least 4 weeks prior to study entry * if receiving immunosuppressives or antimalarial agents, at stable doses for at least 4 weeks prior to study entry exclusion criteria: * pregnant or lactating women. women of childbearing potential must have a negative pregnancy test. * women of childbearing potential and fertile men not practicing or unwilling to practice birth control during the study * rituximab, belimumab, other prior antibody, investigational or experimental therapy within 6 months * allergic to murine, chimeric, humanized or human antibodies * hematologic abnormalities not attributed to lupus: hemoglobin \< 8.0 mg/dl, wbc \< 2000/l, anc \< 1500/l, platelets \< 50,000/l, * ast, alt or alkaline phosphatase \> 3 times upper limit of normal and not attributed to lupus * serum creatinine \> 2.5 mg/dl, proteinuria \> 3.5 g/day * received live vaccine within 4 weeks * thrombosis, spontaneous or induced abortion, stillbirth or live birth within 4 weeks * antiphospholipid antibodies and a history of thromboembolic events * on oral anticoagulants (not including nsaids) within 4 weeks * active infection with antibiotics within 7 days * infection requiring hospitalization or herpes zoster treatment within 4 weeks * long-term infectious diseases (tuberculosis, fungal infections) active within 2 years * malignancy (except squamous or basal cell carcinoma, cervical cis) within 3 years (unless approved by the medical monitor) * history of recurrent abortions (2 or more) * known hiv, hepatitis b or c, other immunosuppressive states * other concurrent medical conditions that, in the investigator's opinion, could affect the patient's ability to tolerate or complete the study will not be eligible for the study.

Keywords: systemic lupus erythematoses lupus sle
pilot study of high risk lung cancer screening

Conditions: Lung Cancer

Summary: this study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.

this study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. potential subject's 6 yr lung cancer risk must exceed 1.5% by the tammamagi plco2012m calculator. patients will undergo a non contrast ct chest for lung cancer screening. this cutoff should encompass in excess of 80% of all lung cancer cases (10). however, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.

Eligibility criteria:
inclusion criteria: 1. adult 40-82 yrs of age. 2. presenting for lung cancer screening evaluation. 3. calculated 6 yr lung cancer risk \>1.5% for patients 40-77 years of age or \>4% for patients 78-82 years of age. 4. able and willing to provide informed consent. exclusion criteria: 1. eligible for clinically indicated lung cancer screening (55-80 yr old, \>30 pky smoking history, still smoking or quit smoking within the last 15 yr). 2. chest ct performed within the last year. 3. life expectancy less than 6 months. 4. symptoms clinically consistent with lung cancer. 5. unable or unwilling to undergo treatment for lung cancer. 6. any individual who does not give oral and written consent for participation.

Keywords: pilot study high risk prospective screening
studying a potential protective effect of l-dopa on retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to evaluate the effect of l-dopa on the progression of retinitis pigmentosa.

retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. it may be speculated that a protective effect on the pigment epithelium, as it is supposed for l-dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. to evaluate the effect of l-dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.

Eligibility criteria:
inclusion criteria: * all confirmed cases of retinitis pigmentosa * va of 20/400 or better exclusion criteria: * advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400) * co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...) * flat electroretinogram * intolerance or counterindication to drug * unability for long-term follow-up

Keywords: retinitis pigmentosa levodopa
dynamic pet acquisition-a quantitative technique for grading of malignant tumors and prediction of response to treatment

Conditions: Pancreatic Cancer

Summary: to assess a quantitative kinetic model of fdg uptake measurement using pet in patients with aggressive non-hodgkin's lymphoma and cancer of the pancreas, malignancies with known variability in disease aggressiveness and prognosis, for optimized tailoring of the therapeutic strategy in the individual patient.


Eligibility criteria:
inclusion criteria: * age\>18 * newly diagnosed untreated aggressive nhl * newly diagnosed untreated cancer of pancreas exclusion criteria: * none
retrospective analysis of balloon expandable covered stenting in the common femoral artery

Conditions: Vascular Complications

Summary: the aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.

in the past decades, there has been a paradigm shift in the field of vascular surgery, with endovascular interventions replacing traditional open surgical procedures on an increasing scale. most of these interventions are performed via the femoral artery. even with modern percutaneous vascular closure devices, interventional laboratories report a high incidence of vascular complications, most commonly bleeding. interventional procedures are gaining ground as an alternative to surgery. having regard to the fact that femoral arteries are in constant motion due to their location and are subject to intense bending forces, the long-term durability of stents has been questioned in the absence of long-term follow-up data. there is currently no broad consensus on the strategy of care for vascular complications, and overall the decision is left to the discretion of the interventionalist, largely determined by the available local resources and infrastructure. the use of covered stents is an option for endovascular treatment of the complications: the self expanding nitinol framed stent graft with polytetrafluoroethylene (ptfe) coating and the cobalt-chrome framed, also ptfe coated balloon expandable stent. the main aim of this research is to analyse the short- and long-term outcome of these alternatives.

Eligibility criteria:
inclusion criteria: * over 18 years of age * intervention from the left or right common femoral artery * access complication treated by balloon expandable covered stent(s) or common femoral artery disease treated by balloon-expandable covered stent(s) exclusion criteria: * none

Keywords: covered stent bleeding closure device pseudoaneurysm stenosis stent fracture
multiple doses of ipti proposal: a lifesaving high yield intervention

Conditions: Malaria

Summary: as efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-saharan africa, with areas of moderate-to-high transmissions, to implement perennial malaria chemoprevention (pmc) delivered through the expanded program on immunization (epi), which is the only feasible, sustainable and cost-effective strategy to reach this high-risk group. pmc is a full therapeutic course of antimalarial medicine (with sulfadoxine-pyrimethamine, sp) delivered to infants in the context of routine immunisation services during the first two year of life. pmc has been shown to be safe, efficacious in reducing clinical malaria, anaemia and hospital admissions, and to be highly cost-effective; for all these reasons, the world health organization (who) recommended in 2010 intermittent preventive treatment for infants (ipti) for malaria prevention. only one african country - sierra leone -put ipti into policy and practice. concerned with this slow adoption, who in 2019 recommended adaptations be urgently tested through pilots assessing impact, operational feasibility and cost effectiveness. in 2022, who expanded that recommendation to cover children through the age of two because of studies documenting the value in children aged 12 to 24 months. the name for this preventive treatment has consequently changed to perennial malaria chemoprevention (pmc) as the updated recommendation is no longer just for infants. multiply is the pilot implementation of pmc in selected districts in mozambique, sierra leone and togo to maximise the delivery and uptake of pmc, to achieve the full potential of this intervention. working with the ministries of health in mozambique, sierra leone and togo, multiply will give up to 6 doses of pmc in the first two years of life. pmc will be given at health facilities and epi mobile outreach clinics using a paediatric dispersible formulation of sp, alongside routine vaccinations and vitamin a supplementation.

the study will be conducted in 3 sub-saharan african countries; sierra leone, mozambique and togo. sample size; assuming an average population of a district/project area of 150,000 inhabitants and a percentage of u2 children of 5%, the project intervention will target approximately 45,000 u2 children in total (i.e. 7,500 children per country and per year for 2 years). study population; children u2 who are eligible for ipti in the selected multiply district of each country.

Eligibility criteria:
inclusion criteria: all infants attending their 2nd epi contact who are eligible to receive the corresponding immunisations. exclusion criteria: infants/children; with acute malaria; known to have sulfa allergies; who have taken sp in the past 4 weeks; who are hiv-exposed or hiv-infected

Keywords: ipti sulfadoxine-pyrimethamine ipti-sp chemoprevention intermittent preventive treatment of malaria in infants children epi expanded programme of immunization ssa sub-saharan africa infants malaria