Kornimate/medical-research-clean huggingface dataset:
irrisept spinal fusion pilot study protocol

Conditions: Lumbar Spine Disease

Summary: study objectives include assessing the use of irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. this includes assessing postoperative ssi as well as fusion rates in addition to patient reported outcome measures.

this is a randomized controlled pilot study with a study size of 50 patients. results will be utilized to plan a larger scale study. background literature supports the use of chlorhexidine gluconate as an irrigation solution to decrease ssi although this has not been conducted in this population of patients (lumbar spine fusion) to date. a decrease in ssi with irrisept, could support the possible use of this as an irrigation solution to decrease infections postoperatively. it will be important to know the effect if any of irrisept on fusion rates. this study will provide valuable information that may assist in future treatment and prevention of ssi in lumbar spinal fusion patients.

Eligibility criteria:
inclusion criteria: * age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels) exclusion criteria: * prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm
18f-mfbg pet imaging in the evaluation of pheochromocytoma

Conditions: Pheochromocytoma

Summary: the aim of this study is to evaluate the diagnostic performance and tumor burden of 18f-metafluorobenzylguanidine (18f-mfbg) positron emission tomography (pet) in patients with pheochromocytoma.

pheochromocytoma highly expresses norepinephrine transporter (net) which is targeted by function alanalogue of norepinephrine, 123/131i-mlbg. however, low spatial resolution of 123/131i-mlbg and inaccurate attenuation correction of single photon emission tomography (spect/ct) will affect the image quality of mlbg spect and lead to poor diagnosis of small lesions. in addition, 123l-mlbg imaging is usually performed at 24h after injection, while 131i-mlbg is performed at 48h or even 72h after injection. the procedure is complicated and takes a long time, which limits clinical application. 18f-labeled mfbg is an ideal tracer to show the expression of net. preliminary data show that 18f-mfbg imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. patients can undergo pet 0.5 hours after injection without special preparation. our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18f-mfbg. patients with suspected or histologically confirmed pheochromocytoma will be enrolled in this study.

Eligibility criteria:
inclusion criteria: * 1) aged 30-80 years old, primary school or above, with a regular caregiver; 2) clinically diagnosed patients with pheochromocytoma; 3) can provide informed consent, can understand and comply with the study requirements. exclusion criteria: * 1) patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system; 2) uncontrolled hypertension or high-risk bp (i.e., systolic bp \> 180 mmhg or diastolic bp \> 110 mmhg); 3) patients with mental disorders or primary affective disorders; 4) unable to understand and adhere to the study protocol or provide informed consent; 5) contraindications to pet imaging (including pregnant women, lactating women, and women of childbearing age with recent childbearing plans, etc.); 6) allergy to imaging agents; 7) patients who were unable to cooperate with pet scanning, such as hypoglycemia, severe pain or tremor.
effect of vpro5 therapy on clear aligner therapy

Conditions: Malocclusion

Summary: the investigators hypothesize that brief, daily application of hfa will increase the efficiency of clear aligner treatment by altering pdl metabolism without increasing pain or discomfort. the investigators will divide subjects into 5 groups changing clear aligners at different time intervals with or without hfa application for 5 minutes/day to assess the effect on: time intervals between aligners, cytokine activity, and pain perception.


Eligibility criteria:
inclusion criteria: 1. subject must be 18 - 45 years of age 2. subject is willing and able to comply with all study procedures and sign informed consent/hipaa forms 3. subject must have complete adult dentition (excluding third molars) 4. subjects must have class i malocclusion or mild class ii/iii malocclusions 5. subject is at least one month into aligner treatment. 6. subject has history of and current healthy oral hygiene (pd is\<4mm, gi\<1, and pi=1) exclusion criteria: 1. subjects who have received periodontal treatment in the previous 6 months 2. subjects who are taking medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporin, ant-inflammatory drugs, systemic corticosteroids, or calcium channel blockers. 3. subjects missing adult teeth (except the 3rd molars) or with severe class ii or class iii malocclusion. 4. subjects with skeletal class i but extreme dental malocclusion 5. severe crowding that require extraction 6. more than 4 mm positive overjet and more than 2 mm negative overjet 7. extreme deep bite (more than 90%); 8. severe openbite (more than 2 mm) 9. pregnant women 10. subjects do not have any systemic diseases effecting bone metabolism 11. smoking 12. vulnerable subjects per irb definitions 13. subjects with current caries 14. subjects that require interproximal reduction or attachments during the study period 15. subjects who are non-compliant regarding aligner wear or vpro5 recommended daily usage

Keywords: hfv hfa high frequency vibration
stress toolbox for healthcare providers in mexico

Conditions: Distress, Emotional; Burnout, Professional; Inflammation; Emotion Regulation

Summary: the goal of this randomized wait-list clinical trial is to test in patient facing mexican healthcare providers the efficacy of the integrated toolbox for healthcare providers (isth) on psychological functioning, well-being, occupational performance, and peripheral inflammation. the main questions this study aims to answer are: * does assignment to the isth predict reduced psychological distress and increased well-being? * does assignment to the isth predict improved occupational outcomes and social-emotional competencies? participants will be randomly assigned to either the isth, a 12-week synchronous and app-based well-being training or to a wait-list control condition and complete assessments 8 times over the nine-month study period. researchers will compare the isth and the wait-list control group across time to evaluate isth impacts.

using the random permuted block method, healthcare providers from up to six mexican states in three tiers of healthcare facilities (low, middle, and high resource) will be randomly assigned to either the 12-week isth intervention or wait-list control. the isth consists of eight, two-hour synchronous sessions (via zoom) that are recorded and available to participants on a private youtube channel for one week. class learning is reinforced through content provided on a special version of the healthy mind program app designed for this study. weeks 8-12 of the intervention are app only, with a final two-hour synchronous session at week 12. all study content (i.e., intervention, assessments) are in spanish. all participants will be asked to complete a baseline assessment battery, shorter assessments after weeks 1, 3, 5, and 8, and a battery of assessments after week 12 (post-intervention), after week 24 (three-month follow-up), and after week 36 (six-month follow-up). researchers will randomly sample from participants opting into the dried blood spot substudy 510 participants (255 per condition) for dried blood spot collection at baseline, after week 12, and after week 24. researchers will randomly sample from participants opting into the patient satisfaction substudy patient satisfaction reports from 4-10 of their patients at baseline, after week 12 (post-intervention) and after week 24 (three-month follow-up). researchers will prioritize that selected participants who opted into both substudies are enrolled in the substudies. healthcare systems/clinics within: nuevo león, coahuila, oaxaca, querétaro, campeche, jalisco, and sonora may participate.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * employee in a participating healthcare system in a participating mexican state exclusion criteria: * \<18 years old * not in a participant healthcare system in a participating state * does not work in a qualifying healthcare provider role * does not have regular access to reliable internet and/or a smartphone capable of downloading the healthy minds program app

Keywords: well-being
surgery and art for endometrioma

Conditions: Ovarian Endometrioma; Infertility, Female

Summary: endometriosis is an estrogen-dependent chronic disease, characterized by the presence of endometrial-like tissue, glands and stroma outside the uterine cavity. although endometriosis is classified in four stage (minimal, mild, moderate, severe), from the clinical point of view it is possible to subdivide among peritoneal superficial lesions, ovarian endometriomas and deep infiltrating endometriosis (die). according to the european society for human reproduction and embryology (eshre) guideline on the management of women with endometriosis, it is recommended to clinicians that in infertile women with endometrioma larger than 3 cm, cystectomy should be considered prior to assisted reproduction technology (art) to improve endometriosis-associated pain or the accessibility of follicles. they further recommend that clinicians counsel women with endometrioma regarding the risks of reduced ovarian function after surgery, the possible loss of the ovary, and consider that the decision to proceed with surgery should be taken carefully if the woman has had previous ovarian surgery. in addition, this guideline suggests that clinicians can prescribe prolonged (3-6 months) pituitary downregulation with gonadotropin releasing hormone-agonists (gnrh-a) prior to art, in order to increase live birth rate by four-fold. despite these recommendations, to date there is not robust evidence to choose between the two strategies prior to art in order to improve reproductive outcomes. for this reason, the aim of the current study will be to compare reproductive outcomes in infertile women affected by ovarian endometrioma, undergoing laparoscopic enucleation or prolonged pituitary downregulation with gnrh-a, prior to art.


Eligibility criteria:
inclusion criteria: * indication for art: compromised tubal function, male factor infertility, other treatments have failed and/or prolonged infertility of more than 4 years. * age between 18 and 35 years. * ultrasound diagnosis of one ovarian endometriotic cyst with a diameter of 30 mm or more, according to the international ovarian tumor analysis (iota)-criteria for reliable diagnosis of endometriomas in premenopausal women. exclusion criteria: * any comorbidity other than ovarian endometrioma. * deep infiltrating endometriosis. * previous ovarian surgery. * bilateral endometriomas. * the use of donor oocytes/sperm. * art with preimplantation genetic testing, as the number of embryos suitable. for transfer or cryopreservation is significantly lower compared to normal art.

Keywords: endometrioma infertility laparoscopy gnrh-a assisted reproduction technology reproductive outcomes
clinical outcomes of two symmetrical kera-rings implantation in grade three keratoconus

Conditions: Cornea Ectasia

Summary: clinical outcomes of two symmetrical kera-rings implantation in grade three keratoconus

a retrospective non- randomized controlled clinical study. the study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on amsler-krumeich classification the icrs surgery was performed with the patient under topical anesthesia. a tunnel channel was created by femtosecond laser using a 60-khz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (abbott laboratories inc., abbott park, illinois, usa). two symmetrical kerarings (mediphacos inc., belo horizonte, brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. after surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. for a period of 1-year, corneal topography readings were taken quarterly.

Eligibility criteria:
inclusion criteria: * stable keratoconus. * corneal cross-linking performed at least 6 months. * contact lens intolerance * minimum corneal thickness of 350 μm at the thinnest point (tp) * mean keratometry (k mean) value less than 59 d exclusion criteria: * any other associated ocular or systemic pathology could affect the vision.
the family cares trial

Conditions: Family Engagement; Critical Care, Intensive Care; Patient and Family Engagement; Health Care Delivery; Family-centered Care; Pilot Study; Caregiver; Caregiver Burden; Family Caregivers

Summary: the goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of icu survivors providing ongoing support to icu survivors after hospital discharge. the main question it aims to answer is: - are virtual peer support groups and/or strengths-based skills support feasible and acceptable for family caregivers of icu survivors? researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability. participants will: * participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm). * provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm). * complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.


Eligibility criteria:
inclusion criteria: * (1) family member of a person admitted to an icu for \>48 hours and survived to hospital discharge. "family" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care * (2) planned or current part or full-time caregiver of the icu survivor * (3) age ≥ 18 years * (4) within 6 months of icu survivor's hospital discharge. exclusion criteria: * (1) another family member participating in the study * (2) inability to communicate in english or french.

Keywords: patient- and family-centered care family engagement critical care intensive care unit person-centered care delivery of health care post-icu caregivers family caregiver
reliability of the freestyle libre cgm in the inpatient setting during the covid-19 surge

Conditions: Diabetes Mellitus

Summary: the fda has provided an emergency waiver for the use of non-invasive continuous glucose monitors (cgm) in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to covid-19 and preserving critical personal protective equipment (ppe). the freestyle libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. in order to evaluate the reliability of the freestyle libre cgm for in-patient use, we propose a study which will examine the correlation between the libre cgm data and capillary blood glucose test - the current standard of care taken by the accuchek inform ii platform.

in hospitalized patients diagnosed with covid-19, diabetes mellitus is associated with a higher mortality. patients with controlled blood glucose have a lower mortality rate than those who are uncontrolled. however, a rigid blood glucose control - which may lead to hypoglycemia- is associated with higher mortality rates. thus, adequate glucose monitoring is important for hospitalized diabetic patients. previous studies have shown that cgms, in the outpatient setting, engender better glycemic control thereby reducing risk of hypoglycemia. cgms offer a replacement for finger stick blood glucose monitoring which may not identify an incidence of hypoglycemia until symptoms drive the patient to test. furthermore, finger stick blood glucose monitoring is painful and time consuming thus causing many patients to avoid this aspect of diabetes self-care management. freestyle libre cgms sample interstitial fluid glucose subcutaneously. measurement frequencies typically range from 1 to 15 minutes and most commonly are every 5 minutes. previous studies in hospitalized patients living with diabetes mellitus on basal bolus regimen have shown: • use of the cgm increased detection of both hypoglycemic and hyperglycemic events versus those sensed by poct. one investigation identified 88 postprandial hyperglycemic excursions in patients with cgm use as opposed to 61 in those with poct. another noted that when comparing the cgm use with that of poct, the former identified 55 hypoglycemic events whereas the latter only found 12. • no difference in mean daily glucose cgm and poct readings. in a study of 38 patients, the investigators noted no difference in mean daily glucose between the cgm and poct.

Eligibility criteria:
inclusion criteria: * participants acquired from among all non-critical care in patients who are living with diabetes mellitus. because the patients will have to be instructed on the use of the cgm, this study will be limited to english speaking/reading adults (18 years of age or older), who possess the cognitive and physical ability to participate. exclusion criteria: * minors, pregnant women, and critically ill.
microbiome and genetic analysis of familial ibd

Conditions: Inflammatory Bowel Diseases

Summary: inflammatory bowel disease(ibd) is a chronic inflammatory condition for gastrointestinal tract. regarding its pathogenesis, there has been numerous studies to reveal the complex association between genetic and environmental factors. in korea, the incidence of ibd is growing rapidly but genetic studies solely including patients with korean descent were not sufficient enough. therefore, the investigators planned to conduct genetic and fecal microbial analysis for the 60 individuals from 30 korean ibd families to find out the pathogenesis of ibd.

under the hypothesis that more risk variants will be observed among the familial ibd patient than in ibd patients without any other affected family members, the investigators designed genetic and fecal microbiome analysis for 60 patients form 30 families. after extracting the dna from blood samples, whole genome sequencing will be performed and data will be comprared with the previously reported variances. novel variances or incidence of specific variances will be measured. genome-wide single nucleotide polymorphism array using immunochip will be performed to search common genetic variants and to calculate genetic risk score of ibd. in this study, fecal microbiome is a surrogate marker for the enviromental aspect of pathogenesis of ibd. the investigators assumed that family members are sharing similar mode of lifestyle therefore we're presumed that their fecal microbial composition is alike. comparing genetic and microbial datas altogether with the data from unaffected family member(healthy internal control), investigators expecting to explain the genetic and enviromental aspect of ibd pathogenesis.

Eligibility criteria:
inclusion criteria: * 60 individuals from 30 families of crohn's disease or ulcerative colitis. * unaffected 30 individuals from each family as healthy internal control. exclusion criteria: * person with history of using antibiotics or probiotics within previous 4 weeks.

Keywords: gastrointestinal microbiome genetics
a clinical trial to study the effect of the addition of vitamin d to conventional treatment in new pulmonary tuberculosis patients

Conditions: Pulmonary Tuberculosis

Summary: there is some evidence that supplemental vitamin d may contribute to quicker recovery from tb when given in addition to normal tb therapy. this needs to be proven with a controlled clinical trial. people receiving vitamin d with anti tb therapy will be compared against people receiving anti tb therapy alone to see if vitamin d contributes to a quicker recovery (as shown by a quicker sputum culture conversion).

the proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in tb patients treated with vitamin d in combination with standard dots therapy. it will take place in four south indian dots centres. the required sample size is 250 patients receiving att, to be randomised in a 1:1 fashion (125 patients to receive vitamin d and 125 patients to receive placebo).

Eligibility criteria:
inclusion criteria: 1. newly diagnosed smear positive pulmonary tuberculosis. 2. age between 18 to 75 years 3. no pre-existing liver or renal disease 4. available for return visits as outlined in the trial protocol 5. a firm home address exclusion criteria: 1. extra-pulmonary or smear negative tuberculosis 2. patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of att 3. pregnant or lactating women 4. active diarrhoea, indicating possible fat-soluble vitamin malabsorption. 5. baseline hypercalcemia \>10.5 mg/dl
does caffeine reduce dipyridamole-induced protection against ischemia-reperfusion injury?

Conditions: Cardiovascular Disease; Ischemia-Reperfusion Injury

Summary: the purpose of this project is to explore the interaction between caffeine and dipyridamole on ischemia-reperfusion injury in the forearm.

dipyridamole has been proven to reduce targeting of annexin a5 in responses to ischemic exercise, indicating protection against ischemia-reperfusion injury in humans (pharmacological preconditioning). dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ent-1). activation of the adenosine receptor protects against ischemia-reperfusion injury. we hypothesize that endogenous adenosine mediates the protective effect of dipyridamole against ischemia-reperfusion injury. therefore the adenosine receptor antagonist caffeine will reduce the benefit of dipyridamole on forearm ischemia-reperfusion injury.

Eligibility criteria:
inclusion criteria: * male * age between 18-50yr. exclusion criteria: * cardiovascular disease * hypertension (systole \> 140 mmhg, diastole \> 90 mmhg) * hypercholesterolemia (random total cholesterol \> 6.5 mmol/l) * diabetes mellitus (fasting glucose \> 7.0 mmol/l or random glucose \> 11.0 mmol/l) * asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or b2-agonists) * participation in any clinical trial during the last 60 days prior to this study. * administration of two doses of annexin a5 (0,1mg; 450mbq) during the last 5 years prior to this study.

Keywords: ischemia-reperfusion injury adenosine dipyridamole caffeine