Kornimate/medical-research-clean huggingface dataset:
a study to assess frailty of subjects during zoster-006 and zoster-022

Conditions: Herpes Zoster

Summary: as part of the zoster-006 and zoster-022 pivotal trials of the hz/su vaccine, all study participants completed quality of life (qol) questionnaires. the only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. the purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in zoster-006 and zoster-022. the aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

as part of the study procedure, each subject enrolled in studies zoster-006 and zoster-022 was asked to complete two quality of life (qol) questionnaires named respectively sf-36 and eq-5d at predefined study time points. these questionnaires were to provide relevant information about the quality of life (functional status, ability to socialize, mental health, etc.) of subjects before they develop shingles extracting some elements of the quality of life questionnaires (qol), eq-5d and sf-36, completed by all study subjects at baseline, and combining them with other medical history data allows attributing of frailty scores. analyses pertaining to efficacy, safety and immunogenicity as per frailty score might be performed according to the methodology used in the zoster-006 and zoster-022 studies. additionally, the data collected can be used to assess if some physical, physiological and/or psychological characteristics reported by the subjects before the onset of hz would be predictive of hz.

Eligibility criteria:
inclusion criteria: * all subjects who participated in the zoster 006 and zoster 022 trials. * subjects who died or were lost to follow-up during zoster-006 and zoster-022 will be considered for enrolment in zoster-064 and their data/questionnaires up to that point will be used. exclusion criteria: * subjects who were excluded from all analyses from zoster-006 and zoster-022. this will include any subject eliminated following deviations from gcp compliance. * subjects who developed a suspected hz case during zoster-006 and zoster-022 (since their qol questionnaires were encoded in the ecrf for zoster-006 and zoster-022).

Keywords: immunogenicity herpes zoster efficacy safety frailty shingles vaccine
use of various laser systems in peri-implatit

Conditions: Peri-Implantitis

Summary: objectives: in recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. the aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis. materials and methods: according to the study protocol, patients, who were diagnosed with peri-implantitis based on the clinical and radiographic evaluations, were divided into six groups: group 1: smokers undergoing diode laser application; group 2: smokers undergoing erbium, chromium: yttrium, scandium, gallium, garnet (er, cr:ysgg) laser application; group 3: smokers undergoing erbium:yttrium-aluminum-garnet (er:yag) laser application; group 4: non-smokers undergoing diode laser application; group 5: non-smokers undergoing er, cr:ysgg laser application; and group 6: non-smokers undergoing er:yag laser application. peri-implant sulcus depth (sd), clinical attachment level (cal), suppuration, modified plaque index (mpi), gingival index (gi), and modified sulcus bleeding index (msbi) were recorded and peri-implant sulcus fluid (pisf) was collected to evaluate osteocalcin.


Eligibility criteria:
inclusion criteria: 1. presence of pocket in probing depth of ≥4 mm in at least one implant 2. no mobility in implant 3. implants with bridge foot and opposite occlusion 4. having no systemic disease that may affect the outcome of treatment 5. no systemic use of antibiotics for the last six months 6. not receiving peri-implantitis treatment for the last three months 7. individuals at the 30-60 years of age. exclusion criteria: 1. individuals who did not agree to participate in the study 2. individuals receiving radiation therapy 3. individuals using alcohol 4. presence of pregnancy and lactation period 5. individuals with parafunctional habits such as clenching or bruxism.
low back motor control in rhythmic gymnasts during hip extension

Conditions: Low Back Pain

Summary: context: low back pain (lbp) is a common complaint in gymnasts. a deficit in the control of lumbopelvic movement has been related to low back pain. objective: this study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement control of elite gymnasts. design: single-group, pretest-posttest clinical trial. participants: 70 elite rhythmic gymnasts intervention: one standardized theoretical practical session of 15 min that includes anatomical issues and one practical exercise in quadruped position for controlling the movement of lumbar spine during hip extension and flexion.


Eligibility criteria:
inclusion criteria: * pre-established level of practice: minimum 13 hours * taking part in the italian federal championship * sign an informed consent form exclusion criteria: * not fulfill inclusion criteria * had surgery in the low back pain or the hip joint

Keywords: gymnastics low back pain physical therapy specialty
stromal vascular fraction from lipoaspirate to treatment of chronic non-healing wound

Conditions: Chronic Wounds

Summary: this is a phase i, open-label, single arm study to demonstrate the safety of antria cell preparation process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of svf enriched fat grafting in chronic wounds

this is a phase i, open-label, single arm study to demonstrate the safety of antria cell preparation process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of svf enriched fat grafting in chronic wounds.

Eligibility criteria:
inclusion criteria: 1. female or male, age 18 years or older 2. subjects that are diagnosed with one or more chronic wounds. 3. able to understand and provide written and verbal informed consent exclusion criteria: 1. currently taking or have taken nsaids within last two weeks or corticosteroids within the last six weeks prior to screening. 2. diagnosis of any of the following medical conditions: * active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer) * active infection (other than their wound) 3. subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the investigator to be unlikely to complete the study) 4. subjects with a known drug or alcohol dependence within the past 12 months as judged by the investigator 5. any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase the risk for subjects. 6. subjects with life-expectancies less than 12 months 7. subjects with known collagenase allergies 8. pregnant females on radiotherapy or chemotherapy agents

Keywords: autologous adult stem cell lipoaspirate non-healing wounds stomal vasular fraction
video, telephone or face-to-face surgical consultations: a survey of patients' and surgeons' views

Conditions: Surgery

Summary: this study will send out questionnaires to surgical outpatients and surgeons to gather their views on the appropriate type of surgical outpatient consultation in different clinical scenarios, in order to establish a guideline for surgical outpatient planning.

as above - this study will send out questionnaires to surgical outpatients and surgeons to gather their views on the appropriate type of surgical outpatient consultation in different clinical scenarios, in order to establish a guideline for surgical outpatient planning.

Eligibility criteria:
inclusion criteria: patients adults attending general surgical outpatients in aberdeen royal infirmary during the study period presenting with: * lumps and bumps * hernias * biliary problems * jaundice * abdominal pain/mass/weight loss * gastro-oesophageal reflux * dysphagia * change in bowel habit * anorectal problems * thyroid nodules * parathyroid disease * adrenal masses surgeons consultant general surgeons in nhs grampian / tayside and highlands exclusion criteria: patients * lacking capacity * without language skills to answer questionnaires or ability to understand questionnaires * children \< 16yrs (no upper age limit) * patients presenting as emergencies * patients unwilling to complete questionnaires. surgeons - trainee surgeons.

Keywords: outpatient consultation
controlled pilot study to assess soft tissue reaction at the crestal part of a dental implant with esta surface

Conditions: Teeth Loss

Summary: this study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).

this is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject. the design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.

Eligibility criteria:
inclusion criteria: * subjects must have voluntarily signed the informed consent form before any study related action * males and females must be at least 18 years of age and not more than 80 years old. * partially edentulous in posterior (position 3-7) maxilla or mandible with implants planned for single crowns in an area with a healed extraction socket. * adequate bone quality and quantity at the implant site to permit the insertion of a straumann soft tissue level implant of 4.1mm diameter without augmentation (at least 1mm bone buccally and lingually/palatal) exclusion criteria: * oral surgery contraindicated according to the judgement of the investigator (should be explained in the crf) * local inflammation, including untreated periodontitis * patients with inadequate oral hygiene or unmotivated for adequate home care. full mouth plaque index \> 25% at time of surgery * presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) * major systemic diseases * medical conditions requiring prolonged use of steroids * current pregnancy or breastfeeding women * physical handicaps that would interfere with the ability to perform adequate oral hygiene * use of any investigational drug or device within the 90 day period immediately prior to implant surgery on study day 0 * alcoholism or chronically drug abuse * smokers; more than 10 cigarettes per day * immuno-compromised patients * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability. secondary exclusion criteria: * gbr procedures at or adjacent to the planned study site * lack of primary stability of the dental implant at site of interest (e.g., rotational movement of the implant at a minimum of 15 ncm torque at connection of the healing abutment, or tactile mobility)
intensive versus standard treatment for spinal anesthesia-induced hypotension

Conditions: Outcome

Summary: the objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. the 2016 asa guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. the 2018 international consensus in the united kingdom and northern ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. the objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.

Eligibility criteria:
criteria: inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥37 weeks * american society of anesthesiologists physical status classification i to ii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥180 mmhg * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly
a study to detect advanced liver disease via ai-enabled electrocardiogram

Conditions: Cirrhosis

Summary: the overall objectives of this study are to determine the effectiveness of ace 2.0 model in early detection of advanced liver fibrosis, and to determine the acceptance and barriers for use of an ai-enabled algorithm for prediction of liver disease in primary care.

a pragmatic, cluster randomized trial in 45 mayo clinic primary care practices will be conducted over a period of 6 months with 6 months of follow up. care teams will be randomized 1:1 to intervention or usual care, stratified by region and patient volume. in the intervention arm, the dulce score will be used to alert consenting providers to the likelihood of advanced liver disease with a recommendation for a fibrotest-actitest. the primary endpoint will be detection of advanced liver disease. secondary outcomes will include completion of noninvasive fibrosis assessment tests and hepatology referral within 180 days of ecg, new diagnosis of liver disease stratified by etiology (nonalcoholic fatty liver disease, alcohol-associated liver disease, hepatitis c, and others) and severity (compensated with and without clinically-significant portal hypertension, and decompensated disease), initiation of prophylactic nonselective beta-blockers and imaging for hepatocellular carcinoma surveillance, according to published society guidelines. post-study surveys to participating clinicians will be applied.

Eligibility criteria:
criteria: inclusion criteria: * primary care clinicians (physicians, nurse practitioners, and physician assistants). * part of a team that cares for adult patients (≥18 years). * have the ability to order ecg. * consent will be obtained from primary care clinicians. * patients' data will be collected from electronic medical records (emr). * adult patients (≥ 18 years) undergoing an ecg for any indication over a period of 6 months will be included. exclusion criteria: * patients with known cirrhosis based on noninvasive fibrosis assessment tests, liver biopsy or complications of decompensated disease, or with a documented history of cirrhosis identified by clinical notes.
short active lives survey in chronic lung conditions

Conditions: Lung Diseases

Summary: short actives lives survey is a common tool used to measure physical activity in the uk population. self-reported measures such as the short active lives survey can be prone to bias. as such, during project evaluations, benefits may be exaggerated due to over-reporting of physical activity or downplayed due to underreporting of physical activity. there is also a lack of research reporting the typical short-term and long-term changes in physical activity (measured by the short active lives survey) in people with chronic lung conditions who are not receiving support to become active (i.e. usual care, control groups). accelerometers are small lightweight activity monitors that can be worn on the waist. these monitors are known to provide accurate and reliable objective assessment of physical activity in people with lung conditions. this research study will recruit a cohort of inactive people with lung conditions and determine changes in physical activity measured by both the short active lives survey and one of the most valid accelerometers used in people with lung conditions (actigraph gt3x). the study will also evaluate how these physical activity measures relate to general health (health status and health care use) of people with lung conditions over 12 months. this study will provide information on the usefulness of using the short active lives survey in the future for measuring physical activity in people with lung conditions.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, lung cancer, mesothelioma or asthma * physically inactive defined as completing less than 30 minutes ore more of moderate intensity equivalent physical activity per week (measured by the short active lives survey) exclusion criteria: * adults without a diagnosis of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, lung cancer, mesothelioma or asthma * age \< 18 years * completing 30 minutes or more of moderate intensity equivalent (mie) physical activity per week * inability or unwillingness to sign informed consent

Keywords: physical activity health status
single versus double hamstring harvest for anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: the aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.

the aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction. the study will recruit 60 patients per each of two arms.

Eligibility criteria:
inclusion criteria: * chronic anterior knee instability with mri-confirmed anterior cruciate ligament tear exclusion criteria: * revision anterior cruciate ligament surgery * other lower limb injuries

Keywords: arthroscopy
cognitively enriched walking program

Conditions: Healthy Aging; Cognitive Decline; Physical Inactivity

Summary: dementia currently affects more than 47 million people worldwide, its prevalence is forecasted to triple by 2050, and it has been reported to be one of the most costly disorders in belgium. there is good scientific evidence that the cognitive impairments associated with the development of dementia can be lessened or even reversed thanks to the plasticity of the brain (rewiring). recent research has shown that physical activity combined with performing cognitively challenging tasks is a very potent way to induce this rewiring of the brain, which can enable people to improve their cognitive functions. yet, so far, these studies are mainly limited to controlled laboratory conditions. the investigators developed a real-life cognitively enriched walking program, with input from experts and end-users. in this study, the investigators will examine the added value of enriching physical activity (walking) with cognitive exercises in improving cognition of older adults by conducting a six-month community-based randomized controlled trial. the investigators will also examine the longer term effectiveness in a follow-up measurement visit six months after the program. the investigators will focus on the following outcomes: cognitive functioning (i.e., objective, subjective and cognitive activity), psychosocial wellbeing (i.e., loneliness, social support, depressive symptomatology, positive wellbeing and expectations regarding aging), physical activity (i.e. both objective and subjective) and general health.


Eligibility criteria:
inclusion criteria: 1. male and female volunteers 2. aged 65 years and older 3. community-dwelling exclusion criteria: 1. have a neurodegenerative disorder (i.e. alzheimer's disease, parkinson's disease, multiple sclerosis,...); 2. are diagnosed with mild cognitive impairment (mci); 3. are diagnosed with a psychiatric disorder (e.g. schizophrenia, bipolar disorder, borderline personality disorder,...); 4. are currently having a depressive episode; 5. have had a serious brain injury in the past year, or before and still experience consequences (i.e. traumatic brain injury, stroke, brain haemorrhage); 6. have a history of, or current, addiction to drugs or excessive alcohol abuse; 7. are not able to walk approximately three kilometres in one hour (at an average walking pace); 8. make use of a walking aid (i.e. a cane, a (rollator) walker, or a wheelchair); 9. one or both of their parents were diagnosed with juvenile dementia; 10. know in advance that they will not be will not be present for one or more periods of longer than one month (e.g. because of a long holiday).
early use of norepinephrine in septic shock resuscitation

Conditions: Septic Shock; Severe Sepsis

Summary: current septic shock guideline recommends fluid resuscitation as the first treatment. vasopressors, including norepinephrine is recommended to start after achieve adequate fluid therapy. this can cause a certain duration of systemic hypotension before vasopressor is commenced. initiation of norepinephrine together with fluid therapy soon after diagnosis of septic shock may increase blood pressure quicker than start treatment with intravenous fluid alone. the rapid restoration of perfusion pressure may improve septic shock outcome.

we will include severe infection patient who had evidence of organ dysfunction and hypotension and randomize into 2 groups as following: 1. control group. the patient will receive treatment according to septic shock guideline 2013, which start with intravenous fluid replacement until achieve target central venous pressure (cvp) or pulmonary capillary wedge pressure (pcwp) or other fluid responsive test goal. if the patient's mean arterial blood pressure still lower than 65 mmhg, then norepinephrine or dopamine will initiate to rise blood pressure. the patient will receive 5% dextrose water as the placebo of norepinephrine. 2. early norepinephrine group. the patient will receive fluid therapy together with low dose of norepinephrine (0.05 mcg/kg/min). if after titrate intravenous fluid therapy until achieve goal cvp or pcwp or other fluid responsive test, but the mean blood pressure still lower than 65 mmhg, then additional titrate dose of norepinephrine will be given to the patient according to standard septic shock guideline.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years old * diagnosed severe sepsis or septic shock according to survival sepsis campaign 2013 * mean arterial pressure \< 65 mmhg exclusion criteria: * pregnancy * severe underlying condition that unexpected to survive more than 48 hours * severe peripheral vascular disease * patient who required major surgery within 24 hours

Keywords: septic shock severe sepsis norepinephrine