Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and efficacy study of prophylactic s. pneumoniae vaccine following challenge with s. pneumoniae

Conditions: Pneumococcal Infections; Pneumonia, Pneumococcal

Summary: this is a randomized, double-blind, placebo-controlled study. eligible subjects will be randomized in a 1:1 ratio to receive gen-004 with adjuvant or placebo. each subject will receive up to 3 doses at 4 week intervals. following the third dose, subjects will be inoculated intranasally with s. pneumoniae serotype 6b. nasal washes to identify s. pneumoniae colonization will be obtained pre-inoculation, and then 2, 7 and 14 days after inoculation. subjects will also be monitored for safety and tolerability throughout the dosing period, and then for 12 months after their last dose. the purpose of this study is to evaluate the effectiveness of gen-004 in reducing colonization rates and magnitude of colonization following the s. pneumoniae challenge.


Eligibility criteria:
inclusion criteria: * males and non-pregnant females, ages 18 to 55 years inclusive. * willing and able to provide written informed consent. * fluent english speakers only (for safety reasons) * willing to perform and comply with all study procedures including attending clinic visits as scheduled. exclusion criteria: * prior vaccination with pneumococcal vaccine. * history of invasive pneumococcal disease (i.e., sepsis, meningitis or pneumonia with bacteremia). * close contact with at risk individuals (young children \[under 5years\], immunosuppressed adults, elderly, chronic ill health). * current smoker or significant smoking history (\>10 pack years). * pregnant or breast-feeding woman. * women of child-bearing potential (wocbp) who are deemed not to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination. * allergy to penicillin or amoxicillin. * any screening laboratory value \> grade 1 * positive serologic test for hiv-1 or hepatitis c infection; positive hepatitis b surface antigen (hbsag). * asthma (on regular medication) or other respiratory disease. * immunocompromised individuals, including those receiving corticosteroids or other immunosuppressive agents. * presence or history of auto-immune disease (refer to appendix 4) regardless of current treatment. * no antibiotic treatment within 1 week of inoculation * previous involvement in ehpc study inoculated with pneumococcal bacteria * in any other clinical trial unless in observational stage or follow-up * diabetes, type 1 or type 2. * other active, uncontrolled co-morbidities that, in the opinion of the investigator would make the subject unsuitable for the study or unable to comply with the study requirements. note: subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to first dose of study drug.

Keywords: gen-004 aluminum hydroxide vaccine streptococcus pneumoniae pneumococcal infections strep pneumoniae pneumonia
the risk stratification of papillary thyroid cancer with aus/flus by fna

Conditions: Thyroid Cancer; Atypia of Undetermined Significance; FLUS

Summary: purpose: to investigate the clinical characteristics of papillary thyroid cancer (ptc) with bethesda category iii (aus/flus) by fine needle aspiration (fna) and to assisted the precision treatment. methods:a total of 290 patients who underwent thyroidectomies or thyroid lobectomies from august 2015 to september 2020, following a diagnosis of bethesda category iii (aus/flus) from preoperative thyroid fna were investigated. groups: in order to investigate the clinopathologic characteristics, the patients, were grouped according to cytology,gender, tumor size.

purpose: to investigate the clinical characteristics of papillary thyroid cancer (ptc) with bethesda category iii (aus/flus) by fine needle aspiration (fna) and to assisted the precision treatment. methods:a total of 1739 cases diagnosed with bethesda category iii (aus/flus) by fna from august 2015 to september 2020 were reviewed, and 523 patients received thyroidectomy or lobectomy. 290 patients were diagnosed with ptc and investigated retrospectively. groups: in order to investigate the clinopathologic characteristics, the patients, were grouped according to cytology,gender, tumor size.as follows:aus and flus\&aus/flus;male and female; tumor size≤1cm and\>1cm.

Eligibility criteria:
inclusion criteria: clinical cytology diagnosis of bethesda category iii (aus/flus) pathological confirmation of thyroid malignancy after surgery. exclusion criteria: 1. pathological confirmation of other thyroid carcinomas, including follicular carcinoma ,medullary carcinoma ,undifferentiated spindle cell carcinoma and lymphoma were excluded 2. female who were pregnant were excluded 3. patients with mental disorders were excluded 4. patients without the complete clinical data were excluded
norwegian capture the fracture initiative

Conditions: Hip Fracture; Vertebral Fracture; Other Low-trauma Fracture

Summary: the main aim is to assess the effectiveness of introducing a standardized intervention program for treatment of patients with a fragility fracture as measured by changes in the fracture rates and the mortality.

a fracture liaison service model of care is widely recommended but data on its effectiveness regarding reduced risk of recurrent fracture and fracture related mortality are scarce. the investigators therefore aim to assess the risk of subsequent fractures and mortality after a clinical fracture in patients who present to hospitals with a standardized intervention program. seven norwegian hospitals will be stepped wedge cluster randomized to a standardized intervention program with startup date between may 2015 and jan 2016. the intervention will last throughout 2018 with follow-up throughout 2019. outcomes before and after the intervention will be compared and each hospital will act as its own control. the effect of the intervention will be measured by using national patient registries on fractures and mortality.

Eligibility criteria:
inclusion criteria: * low-energy fracture exclusion criteria: * finger fracture, toe fracture, face fracture, skull fracture
safety and the efficacy of mesencure for the treatment of pulmonary manifestations of covid-19

Conditions: Covid19

Summary: an open label clinical study to evaluate the safety and the efficacy of mesencure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in covid19 patients

primary endpoint: the iv administration of mesencure is safe under the following conditions: in subjects hospitalized with covid19 moderate to severe disease, defined upon clinical situation and radiologic findings. secondary endpoint: the iv administration of mesencure is efficacious under the following conditions: clinical parameters: health questionnaire, respiratory rate, heart rate, blood pressure, ra o2 saturation, hospitalization duration. ______________________________________________________ laboratory findings: leukocyte and lymphocyte count, crp, d-dimer, renal and liver function, optional: cytokine levels. ______________________________________________________ radiologic findings: pulmonary infiltrates, pleural effusion.

Eligibility criteria:
inclusion criteria: 1. patients are able and agree to sign informed consent form before any study-specific procedure. 2. males or females, age range 18-80. 3. female subjects are eligible only if of non-child bearing potential. 4. documented covid19 5. o2 saturation of ≤93% 6. stable hemodynamic condition (blood pressure of systolic \<180mm hg and diastolic \<110mm hg) 7. evidence of covid19-related pulmonary infiltrates on chest x-ray/thoracic tomography. exclusion criteria: general: 1. pregnant or breast-feeding females. 2. history of drug abuse. 3. heavy smokers (above 2 packages a day). 4. subjects incapable of giving consent. background medical conditions: 1. known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation. 2. history of significant heart diseases, renal failure (estimated gfr of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as child-pugh b or c). 3. known autoimmune diseases. 4. received any investigational drug within 30 days prior to screening day (visit 1) (remdesivir is not considered investigational, and is not an exclusion criteria). 5. immunocompromised condition from any reason, at screening. 6. abnormal clinically significant laboratory test findings, as per the investigator's judgment. 7. poorly controlled diabetic subjects (hba1c \> 9%). 8. known active lung malignancy. concomitant treatment: 1. currently treated with immunosuppressive agents other than corticosteroids used for treating covid19. 2. treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months. hypersensitivity: 1. known history of hypersensitivity to dextran-40 (hypothermosol®). 2. known history of hypersensitivity to human serum albumin.
promotion of nurses' lower extremity health by foot(at)work intervention

Conditions: Lower Extremity Problem; Foot Deformities

Summary: the quasiexperimental study aims to analyse the effecs of foot(at)work intervention on nurses' lower extremity health. the foot(at)work intervention is in electronic format consisting of 5 themes. the idea is that the participants familiarizes with the foot health -related content. the primary outcome is knowledge about lower extremity self-care. secondary outcomes are work well-being, lower extremity health and musculoskeletal health. the outcomes are measured before the intervention (m0), after the intervention (m1), one month after the intervention (m2), six months after the intervention (m3) and 12 months after the intervention (m4). the purpose of the foot(at)work intervention is to support nurses ability to self-care their lower extremities. the intervention consists of text, videos, and pictures that educate nurses to self-care their lower extremities and to select proper footwear.


Eligibility criteria:
inclusion criteria: * registered nurse * working in the specialized health care in surgical or internal medicine wards of one certain hospital exclusion criteria: * nursing students
regional anesthesia in pediatric orthopaedic patients

Conditions: Anesthesia, Local; Anesthesia; Orthopedic Disorder

Summary: to identify the benefits from regional anesthesia use as pain management in the pediatric population by delineating the differences in efficacy of continuous nerve blockade versus single-shot techniques after pediatric orthopaedic limb procedures. by doing this, the investigators can determine if specific anesthetic techniques should become a standard of care in pain management for the pediatric population and supersede the need for opioid medication.


Eligibility criteria:
inclusion criteria: * patients undergoing primary orthopaedic limb surgery * outpatient orthopaedic surgeries * patients undergoing orthopaedic surgery who would normally receive regional anesthesia exclusion criteria: * patients younger than 5 years of ago or older than 18 years of age * revision orthopaedic surgeries * spinal orthopaedic surgeries * orthopaedic surgeries where the standard of care for type of regional anesthesia has been established (continuous regional for acl reconstruction) * patients with the inability to articulate pain scores * inpatient orthopaedic surgeries * patients undergoing orthopaedic limb surgery with risk of compartment syndrome (i.e. acute supracondylar humerus fractures)
prediction of copd severity using electrical impedance tomography

Conditions: Electric Impedance; Respiratory Function Tests; Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to predict the ct visual score of emphysema with eit-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of copd.

methods: by collecting pulmonary function data, ct visual scores, and eit data, and employing deep machine learning algorithms to compare the predictive capabilities of eit and pft for ct visual scores of pulmonary emphysema, this study aims to validate the ability of eit to assess the progression of copd.

Eligibility criteria:
inclusion criteria: * clinical physicians suspect a patient may have copd based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through pfts. * age \> 20 years, and be able to communicate with doctors. * willing to sign informed consent for the course of the study. exclusion criteria: * patient refusal of eit examination. * the ct scan information is incomplete, and the interval between the pulmonary function test and the ct scan is more than 180 days.
the effectiveness of lng iud for treatment of the patient undergone conservative surgery for pelvic endometriosis

Conditions: Endometriosis; Pelvic Pain; Dysmenorrhea

Summary: this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea are reduced in women with symptomatic endometriosis in whom a lng iud is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only

endometriosis is a common cause of chronic pelvic pain.laparoscopic surgery is often the treatment of choice for symptomatic disease and results are usually satisfactory but symptoms recur in 10-20% of treated women per year. postoperative medical therapy has been controversial. whereas some studies have observed a long pain free interval or higher pregnancy rates when surgical treatment is followed by an interval of medical suppressive treatment, numerous others have found no differences between the prevalence of recurrent pain or pregnancy rates 1-3 years after surgery treatment in women who did and did not receive postoperative medical treatment.endometriosis is generally a localized disease but is currently managed with systemic medical therapies. the use of drugs administered locally and specifically aimed at pelvic organs could limit the metabolic impact without reducing antalgic efficacy.an intrauterine device releasing levonorgestrel, a potent 19-nortestosterone derivative progestin, can induce amenorrhea with a different modality with respect to standard regimens. the levonorgestrel intrauterine device (lng-iud) provides an alternative means of administering progestins.some researchers reported the effectiveness of the lng iud in the patients with endometriosis.the primary objective of this study is to determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a lng iud is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only. the secondary objective is to compare about pain, bleeding, satisfaction and quality of life score between both groups

Eligibility criteria:
inclusion criteria: * women diagnosed endometriosis stage i-iv according to the revised american society of reproductive medicine classification * moderate or severe pelvic pain or dysmenorrhea * undergoing conservative laparoscopic surgery exclusion criteria: * patients who have uterine or adnexal anomalies other than endometriosis (chronic pelvic inflammatory disease, leiomyomas, endometrial polyps, genital malformations, pelvic varices) * using treatments for endometriosis other than paracetamol,nonsteroid anti-inflammatory drugs or narcotic derivative in the 3 months before study entry * unable to perform conservative surgery * patients who have contraindications to lng iud as defined by the world health organization (2004). * patients who are unwilling to tolerate menstrual changes. * plan to have children within 1 year * unable to evaluate pain with visual analogue scale * unwilling to participate this project

Keywords: endometriosis lng iud
resilient together for dementia

Conditions: Alzheimer's Disease and Related Dementias

Summary: the proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, resilient together for dementia (rt-d), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of alzheimer's disease or a related dementia (adrd).

both persons living with dementia (pwds) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. a tailored dyadic intervention, such as the proposed resilient together for dementia, delivered over live video to this at risk population during the window of opportunity when pwds can participate has the potential to prevent chronic emotional distress and preserve quality of life for pwds and their loved ones.

Eligibility criteria:
pwd inclusion criteria are: * recent (\~1 month) chart documented adrd diagnosis, * adrd symptom onset after age 65 , * cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the clinical dementia rating scale scores of .5 or 1.0 * cognitive awareness of his/her problems (as determined by the treating neurologist), and * ability to understand study and research protocol, as determined by a standardized teach-back method assessment84. additional inclusion criteria for dyads are: * english speaking adults (18 years or older), * dyad lives together, * at least one partner endorses clinically significant emotional distress during screening (\>7 on hospital anxiety and depression scale subscales) exclusion criteria: * patient is deemed inappropriate by the neurology team, * either partner has a co-occurring terminal illness, * patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., frontotemporal dementia- behavioral variant), as determined by treatment team.
performance of different resin infiltration materials on white spot lesions: clinical and laboratory assessments

Conditions: White Spot Lesion

Summary: the study is a clinical controlled trial. ethical approval will be obtained from imam abdulrahman bin faisal university, dammam. the study participants will be recruited from the dental hospital and conducted between november 2020 to november 2020. this will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of icon® resin infiltration, mi paste plus and both treatments


Eligibility criteria:
inclusion criteria: * patients who are willing and able to observe good oral hygiene and attend for the study visits. * subjects with ≥1 visible and accessible early caries lesion present. * no prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste. exclusion criteria: * active carious lesions * facial surface restorations * deciduous teeth * enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia) * intrinsic and extrinsic strains * physically and mentally challenged volunteers * patients with systemic diseases under medication * smokers
hand functions of children with a specific learning disorder

Conditions: Specific Learning Disability; Specific Learning Disorder; Fine Motor Skills; Hand Functions

Summary: children with specific learning difficulties (sld) may have problems with fine and gross motor skills compared to their healthy peers. these children may have poor manual dexterity. taken together, it is not clear how motor and sensory competence of the hand are affected together. in this study, it was aimed to evaluate the sensory and motor ability of the hand and to compare the examined parameters between the sld group and the healthy control group.

specific learning disability (sld) is a common neurodevelopmental disorder that begins at school age and sometimes goes undetected until adulthood. its incidence in school-aged children is about 5-15%. children with sld have difficulty in fulfilling academic qualifications. in addition, there are various problems with fine motor skills, motor-coordination, balance and gross motor skills. upper extremity speed and dexterity affect fine motor performance (as they involve manipulative tasks that require a certain amount of time and higher motor skills). in the literature, it is reported that manual dexterity is a stronger predictor than balance on the functional mobility of children with sld, and it is emphasized that strategies to improve dexterity performance should be focused in interventions for fine motor skills for these children. in addition, it is demonstrated that taking the necessary precautions and planning by evaluating the gross and fine motor skills in detail in sld is important for the independence and achievements of children in their daily living activities. weak hand skills are expected in children with sld. problems based on hand performance can be addressed in a more comprehensive way by comparing these children with children with typical development in terms of motor performance and functional mobility. similarly, although it is recommended to evaluate senses such as touch and stereognosia when evaluating fine motor performance in these children, no comprehensive study including sensory and motor evaluations has been found in the literature. in this study, in children with sld; it is aimed to examine the limitations of hand motor and sensory functions in daily activities in terms of general motor competencies and hand skills of the child and to compare them with the healthy control group.

Eligibility criteria:
inclusion criteria: * to have a diagnosis of special learning disability (regarding dsm-v criteria) * to be in the age range of 8-14 exclusion criteria: * any acute or chronic orthopedic or neurological disease that may affect walking performance, * any surgery within the last 6 months, * severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking commands * cognitive and mental severe impairment