Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the efficacy of food supplement manremyc® against sars- cov-2 infection (covid-19) in healthcare workers

Conditions: COVID19

Summary: the purpose of this study is to assess the efficacy of manremyc® food supplement for reduce the incidence of sars-cov-2 infection in a high risk population, as healthcare workers.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent before initiating the selection procedures. 2. health system workers working in contact with subjects potentially infected with sars-cov-2. 3. people ≥ 18 years. 4. availability to meet the requirements of the protocol. 5. negative rapid serological test of sars-cov-2 exclusion criteria: 1. previous sars-cov-2 infection 2. pregnancy or breastfeeding. 3. suspected of active viral or bacterial infection. 4. symptoms compatible with covid-19, despite a negative pcr test. 5. vaccination in the last 4 weeks or planned vaccination during the study period, regardless of the type of vaccine. 6. participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the consent or during the study. 7. severely immunocompromised people. this exclusion category includes: 1. subjects with human immunodeficiency virus (hiv-1). 2. neutropenic subjects with less than 500 neutrophils / mm3. 3. subjects with solid organ transplantation. 4. subjects with bone marrow transplantation. 5. subjects undergoing chemotherapy. 6. subjects with primary immunodeficiency. 7. severe lymphopenia with less than 400 lymphocytes / mm3. 8. treatment with any anti-cytokine therapy. 9. oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months. 8. malignancy, or active solid or non-solid lymphoma from the previous two years. 9. bcg vaccination in the last 10 years. 10. treatment with manremyc® for the last 6 months. 11. chloroquine or hydroxychloroquine administration in the last two weeks. 12. direct involvement in the design or execution of the manrecovid19 clinical trial. 13. retirement, transfer, long-term leave (\> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study. 14. employee at the health center \<22 hours per week. 15. do not have a smartphone. 16. detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol. 17. any other findings that, at the discretion of the investigator, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of probiotic.
safety, tolerability, efficacy and pharmacodynamics of cal02 in severe pneumonia caused by streptococcus pneumoniae

Conditions: Pneumonia; Pneumococcal Infections

Summary: the objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by streptococcus pneumoniae after the intravenous administration of cal02 in addition of standard of care antibiotic treatment.

streptococcus pneumoniae is the most frequently identified pathogen of community-acquired bacterial pneumonia and its severe forms are associated with high morbidity and mortality, despite pneumococcal vaccines and medical treatment (antibiotic therapy, alone or in combination). bacterial toxins, such as the pore-forming toxin (pft) pneumolysin (from streptococcus pneumoniae), are involved in the development of invasive disease and play a key role in severe and fatal complications. cal02 offers a novel therapeutic approach by neutralising bacterial toxins, such as pneumolysin, which recognise specific microdomains on host cell membranes, called lipid rafts.

Eligibility criteria:
inclusion criteria: * adult male or female patients ≥ 18 years and ≤ 80 years of age * body weight 40-140 kg * severe pneumonia caused by streptococcus pneumoniae managed in an icu * curb-65 score ≥ 3 in patients aged \> 65 and curb-65 ≥ 2 in patients aged \< 65 * streptococcus pneumoniae identification with the urine antigen test or any other proven documented identification method * written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines exclusion criteria: * patients with hospital-acquired-, health care-acquired- or ventilator- associated-pneumonia * more than (i) 12 hours since diagnosis of severe capp and (ii) 24 hours or 60 hours since antibiotic treatment iv or per os, respectively, unless documented not to be active against s. pneumoniae, will have elapsed at the time of imp administration * apache ii score \> 30 points * sofa score \> 12 points * inability to maintain a mean arterial pressure ≥ 50 mm hg * known hypersensitivity to liposomal formulations * patients with severe neutropenia or lymphoma or current or anticipated chemotherapy * end-stage neuromuscular disorders * patients who have long-term tracheostomy * current or recent participation in an investigational study * presence of other pneumococcal site infection * patients with known acquired immune deficiency syndrome (aids) with cd4 count \< 200 cells/ml * patients with known post-obstructive pneumonia (active primary lung cancer or another malignancy metastatic to the lungs) * patients with cystic fibrosis, pneumocystis jiroveci pneumonia, or active tuberculosis * patients receiving immunosuppressant therapy * patients with a known liver function deficiency * splenectomised patients * patients who have experienced an allergic reaction to eggs * moribund clinical condition * nursing and pregnant women * women of child bearing potential not using an effective contraception.

Keywords: pneumonia streptococcus pneumoniae pneumolysin
the train study: a concussion prevention strategy in middle schools

Conditions: Concussion, Brain

Summary: purpose: the purpose of this study is to evaluate the effectiveness of a theory-driven intervention (train concussion education) to improve parental concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. participants: 180 parents of united states middle school aged children whose children have been engaged in organized sports within the past 2 years. procedures: the study is a single-blind (participants) randomized control trial. the investigators will randomize eligible parents into two groups: (1) control (standard concussion education); and treatment (standard concussion education and train concussion education) to evaluate the effectiveness of the train concussion education intervention.

a convenience sample of participants will be recruited from parents of united states middle school aged children whose children have been engaged in organized sports within the past 2 years. interested parents will contact study stuff, who will ensure eligibility criteria are met. upon this, and completing the written informed consent process, participants will be assigned a unique identifier and randomized (simple) without replacement to one of the two study arms (control vs. treatment), using a predetermined random number generator in excel. participants in the control group will receive standard concussion education materials focused on concussion prevention in youth sport. participants in the treatment group will receive the same standard concussion education materials and the train concussion education module. the train education module is grounded in a theoretical structure inclusive of the original intervention tenants of the popular opinion leader (pol) and diffusion of innovations frameworks, and within the context of the socioecological model. participants will complete a self-administered online pre-test survey, which includes assessments of concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. after completion of the pre-test survey, participants will complete their assigned intervention (train concussion education module + standard concussion education materials versus standard concussion education materials only). upon completion of their assigned intervention, participants will complete the online survey again to obtain post-test measures (post-test survey). participants will also be scheduled to complete individual semi-structured interviews.

Eligibility criteria:
inclusion criteria: * adult with a child/children enrolled in a united states middle school * adult whose child has participated in organized sports in the past 2 years exclusion criteria: • adult without a child/children enrolled in a united states middle school

Keywords: concussion prevention management
study of cosibelimab in subjects with relapsed or refractory lymphoma

Conditions: B-cell Non Hodgkin Lymphoma; Richter's Transformation

Summary: phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory b-cell non hodgkin's lymphoma.

this study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of cosibelimab + ublituximab + bendamustin.

Eligibility criteria:
key inclusion criteria: * histologically confirmed relapsed or refractory b-cell non-hodgkin lymphoma (nhl). * measurable disease and adequate organ function as specified in the protocol key exclusion criteria: * prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, or prior therapy with bendamustine. * subjects receiving cancer therapy or investigational drug within 21 days of cycle 1 day 1. * prior autologous stem cell transplant within 3 months * active hepatitis b or hepatitis c

Keywords: relapsed or refractory
evaluation of integra® artificial dermis for the treatment of leg ulcers

Conditions: Lower Limb Ulcer

Summary: the aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound. this is a multi-centre study on 60 patients who have a lower limb ulcer.


Eligibility criteria:
inclusion criteria: * patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (\> 10 cm²) * patients in whom the surgeon has recommended that an integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis. * not eligible for skin flap surgery, * the patient or patient's representative has agreed to sign the information letter before any investigation required by the research. exclusion criteria: * circumferential wound, * wound infection * immunosuppressed patient, * known allergy to bovine collagen, bovine glycosaminoglycans or silicone, * patients under legal guardianship, * pregnant women * patients whose health would compromise follow-up for at least 18 months, * patients whose mental health would compromise completion of the self-evaluation questionnaires. * wound located in an area not visible by the patient (as no self-assessment would be possible).
the role of emotional stress in patients with stress-induced cardiomyopathy

Conditions: Takotsubo Cardiomyopathy

Summary: the event-related potentials may be different in patients with takotsubo cardiomyopathy than in patients without takotsubo.

in patients with takotsubo diagnosed by coronary angiography, the event-related potentials are investigated and compared with a control group, which consists of subjects without takotsubo.

Eligibility criteria:
inclusion criteria: * age \>18 years * written informed consent * takotsubo cardiomyopathy for group 1. acs for group 3. exclusion criteria: * psychiatric diseases * impaired versus, non compliant patients, heart disease for group 2. * takotsubo-like syndrome.

Keywords: stress-induced cardiomyopathy erp
the effect of parental presence on pain and anxiety levels during peripheral intravenous catheterization in infants

Conditions: Family Centered Care

Summary: children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.parental presence during invasive procedures is important in family-centered-care. family-centered-care is a basic principle of pediatric nursing. it is extremely important that parents are with their children during painful procedures. research; parents during peripheral intravenous catheterization in infancy it was planned to determine the effect of inclusion on pain and anxiety.

this randomized controlled trial included data from 120 cases in the pediatric health and diseases department of istanbul, during march 2020-august 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). information form, state-trait anxiety inventory and flacc scale were used to collect data.

Eligibility criteria:
inclusion criteria: * children within the age group of 1-24 months parents know turkish language exclusion criteria: -

Keywords: family centered care
the effectiveness of eating disorder treatment

Conditions: Eating Disorders

Summary: family-based treatment (fbt), a form of family therapy for eating disorders (ed) in young patients, has proven to be effective in numerous large-scale studies. this study aims to evaluate outcomes of the treatment for anorexia nervosa (an) in a 'real-world' setting in a specialized outpatient clinic in helsinki, finland. fifty-two young female patients seen for treatment between june 2013 and december 2017 were included in the study. demographic and treatment characteristics, weight, and ed symptoms before and after treatment are reported

aim: the naturalistic outcome of outpatient fbt for adolescent an was investigated. methods: fifty-two female patients and their families who received fbt at a tertiary eating disorders unit participated in the study. data on their pre-treatment parameters, treatment details, and condition at the end of treatment (eot) was collected from their medical records

Eligibility criteria:
inclusion criteria: * clinical diagnosis of anorexia nervosa * admitted to fbt at the eating disorder unit from june 1, 2013, through december 31, 2017 exclusion criteria: * no exclusions
efficacy and safety of grass-spire registration study

Conditions: Rhinitis; Conjunctivitis

Summary: the purpose of this study is to evaluate the safety of grass-spire compared with placebo and to evaluate the treatment effect of grass-spire on symptoms and use of rescue medication during the grass pollen season


Eligibility criteria:
inclusion criteria: * clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years * score of ≤ 21 on rcat questionnaire * rye grass specific ige of ≥ 0.7 ku/l * positive skin prick test to rye grass whole allergen extract exclusion criteria: * history or findings of significant disease * asthma requiring gina step 3 or higher treatment * history of severe drug allergy, severe angioedema or systemic allergic reaction * course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years * contraindications for administration of epinephrine

Keywords: rhinitis conjunctivitis grass allergy
brain-based biomarkers in response to tms in mdd

Conditions: Major Depressive Disorder; Depression

Summary: the overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. by using concurrent tms and eeg, the investigators can overcome a major limitation of eeg - the inability to demonstrate causality. here, we plan to recruit patients with medication-resistant depression undergoing rtms treatment. at multiple time points, we will perform tms-eeg to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. this study aims to provide objective brain network measures that can predict and track clinical response to tms treatment. findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.

goals of the study are as follows: * to evaluate the ability to predict and track brain network changes during tms treatment for medication-resistant depression. * to develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse tms-eeg. * to determine the feasibility of recording eeg biomarkers in the clinic without disrupting clinical care.

Eligibility criteria:
inclusion criteria: * men and women, ages 18 to 60 * medication-resistant depression as assessed by psychiatrist * must comprehend english well to ensure adequate comprehension of the eeg and tms instructions, and of clinical scales * has failed \>1 previous adequate antidepressant medication trials * right-handed * no current or history of neurological disorders * no seizure disorder or risk of seizures * no use of prn medication within 48 hours of the scheduled study appointment exclusion criteria: * any unstable medical condition, any significant cns neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc * current electroconvulsive therapy (ect) or prior treatment failure with ect * currently pregnant or breastfeeding
choosing ovarian preservation or removal before surgery for endometrial cancer

Conditions: Endometrial Cancer

Summary: the purpose of this study is to learn more about the factors that influence decision-making before surgery (distress about cancer and/or reproductive concerns) and the possibility of regret after surgery.


Eligibility criteria:
inclusion criteria: * women aged ≥ 18 and ≤ 50 years * premenopausal * endometrioid histological diagnosis * scheduled for surgical intervention at mskcc * figo grade 1-2, clinical stage i * disease confined to uterus, no clear evidence of deep (≥50%) myoinvasion on imaging (mri preferred, ultrasound optional) * normal ovaries on preoperative imaging * able to provide informed consent * english-speaking exclusion criteria: * known lynch syndrome * prior bilateral oophorectomy * personal history of hormone receptor-positive breast carcinoma * increased risk of ovarian cancer identified on the basis of family or personal history * women currently on hormonal contraception, letrozole, or tamoxifen may not opt-in to amh * women who recently underwent ovarian stimulation within the past 3 months may not opt-in to amh * women who have pituitary dysfunction (or any pituitary disorders) may not opt-in to amh * women who completed chemotherapy within \<12 months may not opt-in to amh

Keywords: endometrial cancer ovarian preservation ovarian removal endometrial malignancies gyn poem trial 20-429 memorial sloan kettering cancer center
compare the effect of pendulum exercises with the kaltenborn mobilization among the patients of adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: to determine the effect of pendulum exercises with the kaltenborn mobilization among the patients of adhesive capsulitis


Eligibility criteria:
inclusion criteria: * subjects will be of the age group of 40-60 years. * can be male or female * diagnosed with adhesive capsulitis by orthopedic or physical therapist. * pain, stiffness, and limitation of passive shoulder lateral rotation, abduction, and internal rotation of more than 50% compared with the opposite side for at least 3 months exclusion criteria: * presence of neurological disorders (e.g., stroke, parkinson's disease) leading to deficiency of shoulder muscles activity, severe trauma related to painful stiff shoulder which leads to bony changes of the affected shoulder on radiographs, previous surgeries and manipulation under anesthesia of the affected shoulder
prospective clinical and biological follow-up of acquired haemophilia : sacha study

Conditions: Acquired Haemophilia; Register

Summary: the aims of sacha study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. inclusion criteria were factor viiic below 30% associated with presence of facgteur viii inhibitor (titer \> 1 u bethesda. clinical and biologival data were obtained at day 0 (as soon as possible and at 1, 3, 6 and 12 months.informations were notified to co-investigators with the help of two french medical society (internal medicine, french haemostasis and thrombosis society.


Eligibility criteria:
inclusion criteria: * factor viiic \ 1 u bethesda exclusion criteria: * absence and signed consent, haemophilia a

Keywords: acquired haemophilia
bruni® training in ophl patients

Conditions: Substitution Voice

Summary: surgically treated patients with type ii ophl being treated at the phoniatrics unit of the fondazione policlinico universitario a. gemelli-irccs, but not satisfied with their voice after the first cycle of therapy with a standard rehabilitation approach, will be recruited. to interested patients, a specific vocal rehabilitation program based on bruni training will be proposed in order to compare the results obtained using this method with those following the previous treatment.


Eligibility criteria:
inclusion criteria: * age over 18; * italian mother tongue; * ability to produce the replacement voice; * ability to provide written informed consent exclusion criteria: * \< 1 year from the end of both surgical and radiotherapy treatment; * presence of disease recurrence; * sensory, neurological deficits * learning disabilities
efficacy study of oral seliciclib to treat non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: a phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (nsclc).

a randomized phase ii study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens * must have measurable disease according to recist * eastern cooperative oncology group performance status 0-1 * adequate bone marrow, hepatic and renal function * ability to swallow capsules * at least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities * at least 3 weeks from major surgery exclusion criteria: * non-small cell cancer histology contains a component of small cell lung cancer * previously untreated cns metastasis or progressive cns metastasis * prior treatment with a cdk inhibitor * currently receiving radiotherapy, biological therapy, or any other investigational therapy * uncontrolled intercurrent illness * having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer * pregnant or lactating women * known to be hiv-positive * active hepatitis b and/or hepatitis c infection