Kornimate/medical-research-clean huggingface dataset:
a study to evaluate efficacy and safety of casirivimab+imdevimab (monoclonal antibodies) for prevention of covid-19 in immunocompromised adolescents and adults

Conditions: Immunocompromised

Summary: the primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic sars-cov-2 infection in immunocompromised participants. the secondary objectives of the study are: * to evaluate the safety and tolerability of repeated sc injections of casirivimab+imdevimab in the study population * to characterize concentrations of casirivimab and imdevimab in serum over time * to assess the immunogenicity of casirivimab and imdevimab


Eligibility criteria:
key inclusion criteria: 1. meets ≥1 of the following criteria: * is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, hiv, rheumatological disease, autoimmune disease, multiple sclerosis or * currently taking immunosuppressant drugs 2. have been fully vaccinated against covid-19 or deemed medically ineligible to receive full course of vaccine 3. has documented negative serology/antibody response in an anti-sars-cov-2 spike protein igg clinical test or ≤50 u/ml on the elecsys® sars-cov-2 s total ig test 4. tested negative for the covid-19 virus within 72 hours prior to randomization key exclusion criteria: 1. weighs \<40 kg (only applies to participants ≥12 to \<18 years of age) 2. has any signs or symptoms consistent with covid-19 3. past covid-19 infection within 90 days prior to randomization 4. planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug 5. prior, current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment 6. is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening 7. has any known active acute respiratory infection 8. has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection 9. has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

Keywords: non-response to covid-19 vaccination covid-19 immunocompromised, weakened immune system
analysis of complementary exams prescriptions from an emergency unit of a university hospital

Conditions: Complementary Investigations

Summary: the objective of this study is to evaluate the appropriateness of prescribing additional tests in the emergency unit of the university hospital of monastir.

the objective of this study is to evaluate the appropriateness of prescribing additional tests in the emergency unit of the university hospital of monastir.

Eligibility criteria:
inclusion criteria: * all patients consulting emergency department of monastir aged more than 1 year exclusion criteria: * age \< 1 year

Keywords: complementary exam
cardiovascular effects of oligomeric procyanidins (opcs) in smokers

Conditions: Smoking

Summary: smoking has been identified as a key risk factor for the development of cardiovascular diseases (cvd). it was found that a persistent increase in levels of oxidative stress and prolonged inflammation play a pivotal role in the pathogenesis of smoking associated cvd. oligomeric proanthocyanidins (opcs) are widely known for their anti-oxidant and anti-inflammatory effects, in vitro and in vivo. however, there are hardly any studies available that systematically investigated their acute and long-term effects on vascular function as well as on established biomarkers of oxidative stress and inflammation in an "at risk" population such as smokers. therefore, the aim of the present study is to investigate the effects of an eight-week supplementation with opcs on vascular function as well as biomarkers of oxidative stress and inflammation in blood of smokers.


Eligibility criteria:
inclusion criteria: * healthy male subjects smoking ≥ 10 cigarettes per day with a regular smoking history of ≥ 5 years * bmi ≥ 20 and ≤ 27 kg/m2 exclusion criteria: * occurence of any adverse event, in particular those which require the use of medication that might interfere with the effects and/or the uptake of the investigational products * intolerance of study products * occurence of a serious adverse event * use of supplements, functional foods and/or other products containing vitamins, antioxidants and polyphenolic compounds or other ingredients with potential influence on vessel function for at least one month before the beginning of the study and during the entire study * use of a medically prescribed diet or slimming diet * vegetarian or vegan lifestyle * excessive alcohol consumption (\< 28 consumptions (approximately 250 g alcohol) per week) * participation in a clinical trial within 4 weeks before the study * non-compliance with the demands of the study

Keywords: smoking oligomeric proanthocyanidins polyphenols supplementation vascular function oxidative stress inflammation
ali in cancer patients

Conditions: Acute Limb Ischemia

Summary: the aim of the study is to describe and evaluate the outcomes of cancer patients presenting with and treated for ali at our center .

acute limb ischemia (ali) is a vascular emergency and is associated with significant morbidity and mortality. peripheral arterial embolism or thrombosis from malignant disease is uncommon and a rare cause of acute limb ischemia. limb ischemia can be caused by emboli from the tumor itself, from metastatic deposits within large vessels, as well as the tumors of adjacent organs such as the lung, which invade the left or right atrium of the heart and then disseminate to the main arteries of the body. this acute event may be the first indication of malignant disease in the patient.

Eligibility criteria:
inclusion criteria: * all cancer patient presented to vascular and endovascular surgery departement with ali. exclusion criteria: * patients with benign tumors or without active malignancy. * patients with iatrogenic limb ischemia related to a tumor chemoembolization procedure.
quality control: a prospective analysis of evd effectiveness

Conditions: Catheter Related Infections

Summary: the purpose and/or hypothesis: to decrease the amount of external ventricular drain (evd) related catheter infections by comparing the efficacy of oklahoma university medicine standard evd catheters, both impregnated and non-impregnated, in three principle areas: incidence of infection, cost analysis, and average durations of placement, all while maintaining the standards of technique.

experimental design: track external ventricular drain (evd) associated infections and through quality prospective analysis and compare the usage of standard catheters used by the department here at oklahoma university, 1) the 35cm codman bactiseal rifampin and clindamycin impregnated catheter, 2) the ventriclear evd antibiotic catheter, and 3) the 36 cm integra hermatic large style ventricular catheter, in terms of incidence of infections, cost, duration of placement, and differences in placement technique. proposed procedure: monitor for infections associated with and related to evd placement in patients and assess if infections rates are affected by usage of antibiotic impregnated evd catheters. importance of knowledge reasonably expected to result from the research: while use of sterile techniques and periprocedural antibiotics have traditionally been used to combat infection, infection rates remain above goal leading to the question of whether the antibiotic impregnated catheter should be added to the standard of care. with the knowledge gained, the investigators hope to decrease the amount of external ventricular drain related catheter infections and reduce use of prolonged antibiotics.

Eligibility criteria:
inclusion criteria: * patients who require placement of external ventricular drain. exclusion criteria: * prisoners and/or those who may be pregnant.
long term effects of an early response to certolizumab pegol (czp, cimzia®) in rheumatoid arthritis (ra) patients

Conditions: Arthritis,Rheumatoid

Summary: to determine if early clinical response at 12 weeks to certolizumab pegol (czp, cimzia ®) therapy in adult rheumatoid arthritis (ra) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.

clinical response will be assessed by the percentage of patients achieving a reduction from baseline in disease activity score 28-joint count (erythrocyte sedimentation rate) \[das28(esr)\] score of greater than 1.2 points, which is considered the minimum clinically important difference.

Eligibility criteria:
inclusion criteria: * informed consent is signed and dated * the patient is considered capable of and prepared to adhere to the study protocol procedures * the patient is prescribed czp according to the summary of product characteristics (smpc) (uk and eire) and national institute of clinical excellence (nice) (uk only) guidelines for anti tumor necrosis factor (tnf) α therapy for rheumatoid arthritis (ra). * the patient is screen-negative for tuberculosis * the patient is 18 years of age or above exclusion criteria: * the patient has been exposed previously to biological disease modifying anti rheumatic drugs (dmard) agents. * patient has previously participated in this study or the patient has previously been assigned to treatment in a study of czp or another biological agent used to treat ra. * patient has participated in another study within the last 30 days * patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study * patient has inadequate literacy to understand and complete the questionnaires. * contraindications stated in the smpc * patient is pregnant or breast feeding

Keywords: certolizumab pegol cimzia®
shotblocker and breastfeeding on pain/comfort during heel lance

Conditions: Pain, Acute; Comfort

Summary: shotblocker and breastfeeding are an attempt to reduce pain during invasive procedures in newborns. this study was planned to evaluate the effect of non-pharmacological interventions on the pain and comfort level of newborns, whose heel blood will be taken in the 1st level neonatal intensive care unit.

hypotheses h1: newborns who undergo breastfeeding attempt during heel lance procedure feel less pain and have a higher comfort level. h2: newborns who undergo breastfeeding attempt and are applied shotblocker during heel lance procedure feel less pain and have a higher comfort level. h3: newborns who undergo shotblocker intervention during heel lance procedure feel less pain and have a higher comfort level. h4: there are a difference between the comfort levels, hr and po2 of newborns in terms of group, group-time and time according to the intervention applied. data collection process mothers of newborns whose heel blood will be taken will be informed about the research. consent will be obtained from the mother regarding the video recording during the heel lance precedure. after informed consent is obtained, it will be determined which group the newborn belongs to by stratified randomization. a standard approach will be applied to all newborns. standard approach involves performing the heel lance procedure on the caregiver's lap. heel lance procedure will be scheduled between 09:00 and 10:00 in the morning, one hour after babies are breastfed. babies to be included in the study in each group; they will be in their beds, in the undisturbed rest period, until 30 minutes before the start of the test. all babies; 2 minutes before, during and up to 2 minutes after blood collection; they will be video-recorded including their heart rate, faces, and upper and lower extremities (especially the heel to be operated). no additional care will be given to ensure physiological stability during each intervention (breastfeeding, shotblocker, etc.)

Eligibility criteria:
inclusion criteria: * birth week is between 34-42 weeks, * postnatal in the first 10 days * birth weight is between 2500-4000 grams, * stable general condition, * being with her mother and literate, * breastfeeding, * newborns of mothers who agreed to participate in the study exclusion criteria: * in need of oxygen support, * unsuccessful heel lance attempt, patients whose heel lance cannot be taken in 30 sec.(in groups with shotblocker) * needing parenteral nutrition, * receiving analgesic treatment, * having physical, metabolic and genetic diseases, * having a mental or mental health problem in the mother * non-breastfed newborns * newborns hospitalized in the 3rd and 4th level neonatal intensive care unit

Keywords: breastfeeding shotblocker
percutaneous immunostimulating interstitial laser thermotherapy in pancreatic cancer

Conditions: Neoplasms Pancreatic

Summary: thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. immunostimulating interstitial laser thermotherapy (imilt) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. in laboratory animals the imilt method has also been shown to induce a so called abscopal effect. this means that when one tumor is treated with imilt other, untreated, tumors also decrease in size. the purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imilt treatment method performed pecutaneously in patients diagnosed with pancreatic cancer. the purpose is also to investigate the functionality and safety of the method. this trial is an open-label, double-arm study. twenty patients diagnosed with pancreatic cancer will be treated in this trial, ten recieving imilt treatment and ten recieving standard chemotherapy. the study is estimated to be carried out during a time period of 21 months.


Eligibility criteria:
inclusion criteria: * a diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage ii-iii) or of stage iv disease with hepatic metastasis (staging according to uicc 2009) * locally advanced disease shall have a lesion diameter less than 4cm * if stage iv disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter * the patient is a candidate for standard chemotherapy (as described at point 5.1) * age between 18 and 80 years, males and females * anticipated compliance with treatment and follow-up * have given informed verbal and written consent to participation in the trial * have stable and adequate haematologic, renal and hepatic functions: 1. hemoglobin ≥9 g/dl 2. platelet count ≥75 x 109/l 3. international normalized ratio (inr) ≤1.7 4. wbc count ≥2 x 109/l 5. absolute neutrophil count (anc) ≥1 x 109/l 6. albumin ≥2.8 g/dl, total bilirubin ≤3.0 mg/dl (51.3 μmol/l); alt, ast ≤5 times upper limit of normal (uln) 7. serum chemistries sodium, potassium, and calcium within normal limits (wnl) 8. serum creatinine \ 60 ml/min according to cockroft-gault formula * at least a part of the tumour can be treated with imilt without damage to adjacentvital structures * have an ecog performance status \ 60%) exclusion criteria: * hiv 1 or 2 positive * active autoimmune disease which is judged to reduce an anti-tumour immune response * pregnancy or breast feeding * have known bleeding disorder that cannot be managed accordingly with the protocol rules, such severe acute or chronic liver failure, other genetic blood diseases not properly managed prior to treatment or other any disease treated with anticoagulant or anti-platelet medication that cannot be interrupted prior to treatment

Keywords: hyperthermia, induced laser coagulation laser therapy
ipsilateral and contralateral index for the interpretation of adrenal vein sampling (avs) in primary aldosteronism

Conditions: Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Summary: adrenal vein sampling (avs) is currently considered the gold standard for subtype diagnosis of primary aldosteronism (pa). however, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, and there is no general consensus on the criteria that should be used for the interpretation of the results of an avs study in these specific cases.

the differentiation between subtypes of primary aldosteronism (pa) is fundamental to refer each patient to the most appropriate therapeutic approach (surgical in case of unilateral disease and medical in case of bilateral disease). adrenal vein sampling (avs) is currently considered the gold standard for such differentiation between subtypes. however, despite significant progress in optimizing the avs procedure, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, especially in less experienced centers. it would therefore be important to identify criteria for the interpretation of the results of a suboptimal avs study (i.e. with sampling of only one of the two adrenal veins). this problem has recently been addressed by some groups; however, there is still no general consensus on these criteria and all existing studies must be considered exploratory in this field. in this study, therefore, all patients with pa followed by our center and who underwent a successful (i.e. with correct cannulation and sampling from both adrenal veins) unstimulated (i.e. without cosyntropin stimulation) avs procedure will be retrospectively evaluated. if a reliable unilateral index could be identified for subtype diagnosis, this tool could be used for the interpretation of suboptimal avs data, thus preventing a certain percentage of patients from the necessity to repeat the procedure and allowing to refer each one, also on the basis of an incomplete dataset, to the most appropriate therapeutic approach.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of primary aldosteronism * execution of adrenal vein sampling (avs) for subtype diagnosis exclusion criteria: * execution of avs in stimulated condition (i.e. with cosyntropin stimulation) * inability to achieve successful catheterization of one or both adrenal veins during avs (as established by adrenal/peripheral vein cortisol ratio)

Keywords: primary aldosteronism primary aldosteronism due to aldosterone producing adenoma primary aldosteronism due to adrenal hyperplasia (bilateral) adrenal vein sampling renin-angiotensin-aldosterone system blood pressure lateralization index ipsilateral index contralateral index
effect of photodynamic therapy on soft tissue healing after tooth extraction at sites of periodontal infection

Conditions: Periodontitis

Summary: main purpose: to evaluate the effect of photodynamic therapy on soft tissue healing after tooth extraction at periodontal infection site, and to compare the effect on pain degree and bone tissue remodeling after tooth extraction.

the aim of this study is to evaluate the effect of photodynamic therapy (pdt) on soft tissue healing and bone remodeling in tooth extraction sockets after tooth extraction. the enrolled patients will be randomized into two groups. the control group used conventional tooth extraction to clean the wound, and the experimental group used photodynamic therapy to help clean the wound. seven days and 14 days after extraction, the area of extraction socket was measured, the healing rate of extraction socket was calculated, and landry, turnbull and howley soft tissue healing index was measured. the degree of pain was recorded at 6h, 1 day, 2 days and 3 days after tooth extraction. bone remodeling indexes were measured at 1 month after tooth extraction.

Eligibility criteria:
inclusion criteria: * age range from 18 to 65 years old; * patients with extensive periodontitis of the whole mouth; * there was a deep periodontal pocket with pd≥5mm and at least one adjacent tooth at the extraction site; * periodontitis was controlled, and the extraction site and adjacent teeth were not in the acute inflammation or infection stage; * the extraction site has a hopeless prognosis or no preservation value, and it is the first and second molars or maxillary wisdom teeth that erupt in a positive position exclusion criteria: * pregnant and lactating women; * patients with systemic diseases that may affect the ability of postoperative healing (such as patients with radiotherapy and chemotherapy, history of hematological diseases, and uncontrolled disease) diabetes mellitus, etc.); * long-term use of drugs known to affect bone metabolism or mucosal healing such as bisphosphonates and non-steroidal anti-inflammatory drugs; * smoking \> 10 cigarettes per day; * root breakage or gingival tear occurred during tooth extraction.
improving activity engagement among persons with sci during covid-19

Conditions: Spinal Cord Injuries

Summary: during the current covid-19 pandemic many spinal cord injury (sci) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. physical activity has been demonstrate to have numerous benefits for individuals with sci ranging from enhanced health through prevention of secondary complications to improved subjective well-being. the current study proposes to provide an online physical activity program through web-based videoconferencing to person with sci to improve overall wellbeing and activity engagement. the program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a kinesiology graduate student will lead online sessions. the sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. in all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (sci ontario, national sci alliance, ontario neurotrauma foundation). ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with sci during the covid-19 quarantine.


Eligibility criteria:
inclusion criteria: * adult 18 years or older; living with a spinal cord injury; living in the community in ontario; access to a computer and internet exclusion criteria: * not cleared by a physician to participate

Keywords: spinal cord injury spinal cord injuries