Kornimate/medical-research-clean huggingface dataset:
immunomodulation using vb-201 to reduce arterial inflammation in treated hiv - vital hiv trial

Conditions: Inflammation; HIV Infection; Cardiovascular Disease

Summary: this study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of vb-201 80mg taken orally once daily to placebo for anti-inflammation in hiv-infected subjects.


Eligibility criteria:
inclusion criteria: * documented hiv infection * on continuous antiretroviral therapy and virologically suppressed hiv infection for ≥12 weeks prior to study entry * cd4 t-cell count \> 350 cells/mm3 * male or female between the ages ≥ 40 years of age to \<≤75 * documented cardiovascular disease (1. prior myocardial infarction, 2. history of percutaneous coronary intervention, 3. history of coronary artery bypass graft or 4. angiographic evidence of \>50% stenosis in at least one coronary artery\] or 1 cvd risk factor (t2dm, current smoking, hypertension, dyslipidemia, hscrp≥2mg/l, family history) * tbr of \>1.6 of the mds of the carotid/aorta at baseline. this baseline arterial tbr cutoff excludes the rare individual that lacks appreciable arterial inflammation. it is notable that while 5-10% of uninfected individuals will have lower tbrs, it is rare that an hiv infected individual will fall below this range. * female subjects must either be of non-childbearing potential as defined by menopause with amenorrhea for \>2 years, bilateral oophorectomy, or agree to use adequate contraception throughout the study and for at least one month following termination and have a negative pregnancy test at screening prior to the first dose of drug. * males must use at least one method of contraception throughout the study. exclusion criteria: * pregnant/nursing women * uncontrolled hypertension or diabetes requiring insulin * ast/alt or alkaline phosphatase \>2x uln * cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma * nephrotic syndrome or egfr \<60 ml/min/1.73m2 * cytopenias which include 1) wbc \<3.5 x103/ul 2) platelet \<120 x103/ul 3) anc \<1.5 x103/ul, and absolute lymphocytes \<0.8 x 103/ul * anemia as fined by \<10 g/dl * evidence of tuberculosis infection at screening within 30 days prior to screening. * family history of long qt syndrome, using medication that prolongs qt internal, or evidence of prolonged qt of \>470 msec as evidenced by ecg * acute systemic infection within 30 days * on additional immunosuppressant or immunomodulatory therapies
effect of exogenous growth hormone on ocular findings

Conditions: Precocious Puberty; Early Puberty; Refraction Error

Summary: body size and eye function play an essential role in adapting to the environment and human survival. growth hormone is commonly recognized by its effect on the height of individuals; although from an evolutionary perspective, the effects of growth hormone on eye development are more important. although the effect of growth hormone on eye development has not been accurately determined, the results of a number of studies suggest the effect of growth hormone on eye development. despite the large number of studies that have investigated the effects of growth hormone on height growth, there are few studies that have investigated the effects of growth hormone on the eye. to the best of our knowledge, no study has been conducted to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty. therefore, we intend to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty.

investigators will achieve the following data from the participants: 1. demographics 2. past medical history 3. bone and calendar age 4- stage of puberty 5- ocular examination 6. ocular biometry

Eligibility criteria:
inclusion criteria: sample group (with early or precocious puberty): 1. children with precocious puberty based on tanner classification 2. girls 4 to 10 years old 3. boys aged 4 to 11 4. no known eye problems including: history of eye trauma, eye surgery 5- lack of family history of glaucoma or increased intraocular pressure 6. lack of previous history of receiving growth hormone 7. lack of systemic disease or known syndromes 8. consent to participate in the study exclusion criteria: 1. incidence of growth hormone adverse reactions leading to discontinuation of treatment 2. changing the patient's treatment plan during the study 3. ocular complications requiring treatment during the study 4. unwillingness of the patient to continue participating in the study

Keywords: precocious puberty early puberty human growth hormone refraction error axial length
radiographic comparison of obturation performed by conventional method and obtura ii.

Conditions: Tooth Disease

Summary: root canal therapy plays an importanmt role in dental health care.an importanat parameter necessary to achieve a proper endodontic treatment is quality of root canal filling.this study compare the radiographic quality of obturation with cold lateral condensation and thermoplasticiszed gutta percha technique and obtura ii system.

the aim of this study is to assess and compare the radiogrphic quality of obturation with thermoplasticized injectable gutta percha technique obtura ii system and cold lateral compaction technique in permanent teeth.for this study selected patients will be divided into two groups in a manner that the odd numbers will be alotted to group a and group b .local anesthesia at 2% lidocainehcl with 1:100000 epinephrine as buccal infiltration in upper teeth and inferior alveolar nerve block in the lower teeth. access cavity preparation will be done. canals will be located and negotiated with a dg-16 endodontic explorer . initial filing will be done from number 8 to 10 k- files (iso standardized 0.02 taper) under 5.25% sodium hypochlorite) irrigation and ethylenediamine tetra-acetic acid as chelating agents.. working length will be confirmed with electronic apex locator , and then with working length radiograph will be taken. rotary preparation will be done with protaper using s1, s2, f1, f2, f3 files. master gutta-percha radiograph will be taken at the commencement of the first visit with protaper f3 gutta-percha point placed in the canals. intervention will be provided to both groups by the principal investigator. on the second visit, both the canals will be dried with f-3 paper points.root canal fillings will be then performed using cold lateral condensation in group a, and thermoplasticized injected gutta-percha in group b. postoperative periapical radiographs will be obtained immediately after the obturation. these radiographs will be examined under illumination in a darkened room at ×2 magnification to assess for voids and termination of obturation. our study will be based on the radiographic assessment of the buccolingual view of the canals, as it will be the only possible view to visualize on the radiograph in a clinical setting for assessing the quality of endodontic treatment. root canal fillings will be assessed * presence or absence of voids. * acceptable/flush: root canal filling is within the root canal system and within 2 mm of radiographic apex. * under-filled: root canal filling is \>2 mm short of radiographic apex. * over-filled: root canal filling is extruded beyond the radiographic apex

Eligibility criteria:
inclusion criteria: * single rooted teeth in which endodontic treatment was clinically indicated. * single rooted teeeth in which root canal treatment was recommended for elective reasons. exclusion criteria: * • teeth with severely curved roots. * sclerosed canals on periapical radiographs. * periodontally compromised teeth. * endodontic retreatment cases. * teeth with apical resorption. * teeth not salvageable by conventional root canal treatment.
evaluation of the vaginal renewal™ program in gynecologic cancer patients experiencing sexual dysfunction

Conditions: Sexual Dysfunction, Physiological

Summary: this is a randomized controlled trial designed to evaluate the effect of the vaginal renewal™ program (vrp), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers. in the university of wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. those women who report sexual dysfunction will be given the option to enroll in the study. after enrollment, the female sexual function index (fsfi) and other quality of life surveys will be administered at baseline. the participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (vrp). throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. they will also be evaluated with the fsfi, marinoff scale for dyspareunia, and functional assessment of cancer therapy-general (fact-g) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.


Eligibility criteria:
inclusion criteria: * age ≥18 * history of a gynecologic cancer * no evidence of disease at time of inclusion in the study * postmenopausal (either surgical or natural menopause) * self report of sexual dysfunction that did not predate cancer diagnosis * suspected physical component to sexual dysfunction with the participant, not sexual partner * desire to improve sexual function * ecog performance status score of 2 or better * six months or greater from last surgical and/or radiation treatment exclusion criteria: * history of sexual reassignment * presence of vaginal fistula * does not desire to improve sexual function * already using the vaginal renewal program * not fluent in english * incarceration

Keywords: sexual dysfunction gynecologic cancer cancer survivor vaginal dilator
palonosetron and blood coagulation

Conditions: Blood Coagulation Disorder

Summary: palonosetron may alter whole blood coagulation. however, little is known about the dose-response relationships according to the blood concentration of palonosetron. the investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.


Eligibility criteria:
inclusion criteria: * healthy volunteers * age: 20 to 65 years * body weight \> 50 kg * volunteers who provided informed consent exclusion criteria: * hematologic disease * anticoagulant medication
post-operative epidural analgesia after minimally invasive lumbar decompression and fusion

Conditions: Low Back Pain

Summary: minimally invasive (mis) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. current research demonstrates a modest improvement in these areas beginning on the third post-operative day. mis fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. in order to fully maximize the benefits of an mis technique, early post-operative analgesia/pain must be improved. the aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. this will be a randomized trial involving 32 patients undergoing mis decompression and fusion with half the study group receiving active epidural and iv-pca and the other half receiving epidural placebo and iv-pca. the hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after mis decompression and fusion.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo minimally invasive lumbar decompression and fusion at the toronto western hospital * both genders * asa i to iii * bmi less than 35 exclusion criteria: * refuses treatment randomization * inability to give informed consent * language barrier * local anesthetic allergy * allergy to shellfish or eggs * bleeding diathesis * sickle cell disease or trait * pregnancy * drug addiction * psychiatric history * severe intercurrent illness (asa iv or v) * patients requiring anesthesia of other surgical sites

Keywords: minimally invasive decompression and fusion postoperative analgesia epidural lumbar
rehabilitation in severely ill inpatients with covid-19

Conditions: COVID-19

Summary: inpatient rehabilitation of severe-to-critical covid-19 patients(a longitudinal, single-center retrospective cohort)

patients who underwent intensive care at least two days and classified as severe-to-critical covid-19 (who ordinal scale 5-7) were enrolled. patients received comprehensive rehabilitation including active exercise program, nutritional support, and psychological support.

Eligibility criteria:
inclusion criteria: covid-19 patients who 1. underwent intensive care at least two days, 2. eventually got negative conversion with two consecutive tests, 3. were classified as severe covid-19 (who ordinal scale 5-7) and 4. participated in the inpatient rehabilitation program were included. exclusion criteria: covid-19 patients who died (who ordinal scale 8) before discharge were excluded

Keywords: rehabilitation critical illness coronavirus disease 2019 (covid-19_ severe acute respiratory syndrome coronavirus 2 (sars-cov-2) recovery of function
probiotic-muscle study

Conditions: Old Age; Debility; Muscle Weakness; Protein Deregulation; Protein Deposition

Summary: this study will examine the effect of probiotic supplementation (bacillus coagulans) on muscle protein synthesis in older adults in response to a plant-based diet. the investigators hypothesize that probiotic supplementation will enhance the digestibility of plant protein, therefore increasing the proportion of ingested amino acids that appear in systemic circulation and enhancing rates of muscle protein synthesis.

there is increasing interest in the use of plant-based proteins, both from the perspectives of global sustainability and growing consumer markets; however, plant-based proteins are known to have lower digestibility and lower ability to stimulate muscle protein synthesis (an important determinant of muscle mass) compared with animal-based proteins. emerging evidence indicates that the probiotic bacillus coagulans gbi-30, 6086 (ganedenbc30) can enhance plant protein digestibility. as such, bacillus coagulans treatment may augment rates of muscle protein synthesis in response to plant-based protein intake in humans, by increasing the proportion of ingested amino acids that appear in systemic circulation after a plant meal, as circulating amino acids act as both a trigger to stimulate muscle protein synthesis in humans as well as providing the building block for new muscle tissue. an increase in muscle protein synthesis rates would be particularly critical in older adults as it is well established that one of the key mechanisms driving the loss of muscle mass with age is a reduction in muscle protein synthesis rates in response to dietary protein intake. therefore, if probiotic supplementation can improve muscle protein synthesis rates following plant protein consumption, this indicates it may represent an effective and environmentally sensitive strategy to attenuate adverse age-related loss of muscle mass and muscle function. this is critical as the maintenance of skeletal muscle health is an important factor in the preservation of independence and quality of life as we age.

Eligibility criteria:
inclusion criteria: * age: ≥65 y * sex: males and female * body mass index (bmi) between 20-35 kg/m2 * non-smokers * generally healthy according to responses to a standard health screening questionnaire exclusion criteria: * cancer (malignancy in the past 5 years) * cvd * chronic kidney disease * liver failure * diabetes or pre-diabetes * conditions that will affect the ability to consume, digest and/or absorb the study supplement (i.e. gastrointestinal disease) * smokers * excess alcohol intake * regular resistance training * total walking incapacity * musculoskeletal or neuromuscular impairments * medications interfering with muscle metabolism * ongoing probiotic supplementation * antibiotic use in the previous 6 weeks * significant body mass loss in the 1 month period prior to the study
surgical outcome studies in thoracic wall reconstruction with codubix® ribs

Conditions: Thoracic

Summary: the aim of this observational study is to analyze the short- and long-term outcome after surgical implantation of the codubix® ribs prosthesis in a descriptive and non-statistical way.

an intact thoracic wall is essential for maintaining organ and respiratory function and upper extremity mobility, and therefore may require surgical intervention if portions of the thoracic wall have been destroyed or removed. thoracic wall reconstruction is typically needed for cancers originating in or invading the chest wall or for large defects resulting from surgery that removes multiple ribs or the sternum. less commonly, it is required due to malformations, infections, radiation injuries, or trauma to maintain respiratory function, protect internal organs, and avoid cosmetic defects. there are several synthetic, metallic, and biologic materials on the market for thoracic wall reconstruction, each with its advantages and disadvantages, and none has proven superior to the others, often being chosen based on the surgeon's experience and preference. codubix® ribs, a knitted prosthesis made of polypropylene and polyester yarn, has been used since 2018 for thoracic wall reconstruction due to its high strength, low weight, and non-reactive properties. moreover, it is radiolucent, easily adjustable to the chest wall's curvature, and maintain enough stiffness to not require additional materials, even for large defects. although well-established in neurosurgery, its use in thoracic surgery is relatively new and not yet extensively reviewed in literature. the primary objective is to evaluate the postoperative outcomes after thoracic wall reconstruction with codubix® ribs examining mobility, stability, aesthetic outcome and pain. the secondary objectives are to evaluate specific indications for chest wall resection found in the participants and in-hospital complications during the hospital stay. the results of this study, summarizing our experiences with the relatively unknown prosthesis codubix ribs, aim to provide valuable insights and contribute to the broader knowledge base of the medical community regarding effective thoracic wall reconstruction materials.

Eligibility criteria:
inclusion criteria: * patients that received full thickness resection of the thoracic wall and reconstruction using codubix® ribs * patients of all co-morbidities and gender * patients that signed written informed consent according to ich-gcp regulations prior to initiation of any protocol-specific follow-up events * patients of age \>18 years at the time of informed consent exclusion criteria: * patients who have not signed hospital's general consent form for the use of their health-related data for scientific purposes will not be included into the project. * patients that received thoracic wall reconstruction with other materials than codubix® ribs * inability to follow procedures or insufficient knowledge of language * inability to give consent

Keywords: thoracic wall reconstruction surgical implantation reconstruction materials codubix® ribs prosthesis
diagnosis of renal osteodystrophy in patients with reduced renal function

Conditions: Renal Osteodystrophy

Summary: the aim of the study is to 1. to describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (pth) respectively. 2. to investigate if the non-invasive method 18-fluoride positron emission tomography (18f-pet) can describe the bone turnover and reflect the bone histomorphologic changes 3. to investigate if non-oxidized pth reflects bone turnover

patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited. a bone biopsy and a 18f-pet scan are performed and it is investigated if the 18f-pet can discriminate high turnover from low turnover bone disease

Eligibility criteria:
patients with reduced renal function: inclusion criteria: -≥ 18 years * estimated glomerular filtration rate (egfr) ≤ 20 ml/min/1,73m2 * pth \ 300 pg/ml exclusion criteria: * ongoing malignancy * allergy towards tetracyclin * pregnancy control group: inclusion criteria: -≥ 18 years * egfr \>= 60 ml/min * under examination for c prostata * prostatic specific antigen (psa) total \<40 µg/l exclusion: * former kidney disease * ionized calcium or pth outside normal range * known metabolic bone disease * treatment with anticoagulants * disturbed thrombosis and hemostasis
lips and tongue of mouth breathing children

Conditions: Mouth Breathing

Summary: purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children. methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in são paulo, sp, brazil . it was used the mbgr protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.


Eligibility criteria:
inclusion criteria: * mouth breathing children diagnosed by doctor. exclusion criteria: * children with mental, neurological or hearing diseases, or with cold or flu at the examination day.
efficacy safety study of arformoterol/tiotropium combination versus either therapy alone in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Bronchitis; Emphysema

Summary: the purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with chronic obstructive pulmonary disease (copd).

this study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with copd. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * male and female subjects must be at least 45 years old at the time of consent. * subjects must have a pre-established primary clinical diagnosis of copd. * subjects must have a baseline fev1 of ≤65% of predicted normal value at visit 1. * subjects must have a fev1 ≥ 0.70l at visit 1. exclusion criteria: * subjects who do not have a fev1/forced vital capacity (fvc) ratio of ≤70% at visit 1. * subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (modified medical research council \[mmrc\] dyspnea scale score) at visit 1.

Keywords: copd including chronic bronchitis and emphysema