Kornimate/medical-research-clean huggingface dataset:
oral health and its relation to development and well-being of schoolchildren before and after restorative treatments

Conditions: Dental Caries; Dental Atraumatic Restorative Treatment; Oral Health

Summary: the present study aims evaluate the oral health conditions of schoolchildren and its relation to growth, development and well-being. also, it seeks to evaluate different restorative interventions performed at school premises in primary teeth and its impact on the quality of life.

schoolchildren, aged 6-8 years old, from the six public schools of a deprived suburban area of brasília, brazil will be recruited. in the stage 1 of the study, an epidemiological survey of the oral health status and an anthropometric evaluation of the children will be performed. potential patient for study's stage 2 will be recruited. quality of life surveys, patterns of oral hygiene and socio-demographic data will be collected. children with restorative treatment needs will be included in the study's stage 2. in this second stage, primary molars with deep dentin lesions will be treated according to two techniques for selective excavation of carious dentin: subjective criteria or using an objective criteria (polymer burs). for both groups restorations will be performed using a high-viscosity glass-ionomer. in shallow and medium depth dentin lesions, carious dentin will be excavated using hand instruments only (art approach) and restored using two materials: a high-viscosity glass-ionomer or a combination of a self-etch adhesive and a bulk fill composite. all children will be followed up (study's stage 3) to assess efficacy of the restorative interventions and impact of the restorative treatment on children's quality of life and development.

Eligibility criteria:
inclusion criteria: * children 6-8 years old; * good general health; * minimum one cavitated dentin carious lesion in a primary molar with sensible asymptomatic pulp. exclusion criteria: * participating in other study; * plan to move or not residents; * systemic disease or general disability; * expected limited compliance; known allergy to study material; expected exfoliation of primary molars within 18 months.
targeting gut microbiota and metabolites for very preterm infants through oropharyngeal administration of colostrum

Conditions: Gut Microbiota; Metabolites

Summary: background: oropharyngeal administration of colostrum (oac) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. however, how oac promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. we aim to assess the changes of gut microbiota and metabolites after oac in very preterm infants. methods: a multicenter, double-blind, randomized controlled trial will be conducted in 3 large nicus in shenzhen, china, for preterm infants with gestational age less than 32 weeks and birth weight less than 1500g. the intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days; the control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. stool samples will be collected at the first defecation and the 7th day after birth. it is estimated that 320 preterm infants will participate in the study within 1 year. 16srna gene sequencing and liquid chromatography-mass spectrometry will be used to analyze the effect of oac on gut microbiota and metabolites. discussion: the proposal advocates for the promotion of oac as a safe and relatively beneficial initiative among neonatal intensive care units, and this initiative may contribute to the establishment of a dominant intestinal flora. findings of this study may help to improve the health outcomes of preterm infants by constructing targeted gut microbiota in future studies.

preterm infants with gestational age \< 32 weeks and weight \< 1500g will be evaluated. infants who met the inclusion criteria will be randomly divided into two groups according to the ratio of 1:1. the intervention group will be given oropharyngeal colostrum every 3 hours for 5 days; the control group will be given sterile water with the same dosage and administration scheme. stool samples will be collected at the first defecation and the 7th day to detect the gut microbiota and metabolites.

Eligibility criteria:
inclusion criteria: * gestational age less than 32 weeks and birth weight less than 1500g; * admission to nicu ≤ 24 hours; * be able to start the agreement within 72 hours of birth. exclusion criteria: * birth asphyxia (defined as umbilical artery / first hour arterial ph \< 7.0 or cardiopulmonary resuscitation in the delivery room); * birth complicated with severe gastrointestinal malformations (such as intestinal atresia, esophago-tracheal fistula, intestinal rotation abnormalities, congenital megacolon); * prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases; * maternal drug abuse or contraindications to breastfeeding (hiv and cytomegalovirus infection).
effects of isometric muscle fatigue on trunk muscle stiffness

Conditions: Muscle Tightness

Summary: interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.

single visit interventional study of the effects of a trunk extensor muscles fatigue protocol on multifidus and erector spinae muscle stiffness measured by ultrasound based shearwave elastography.

Eligibility criteria:
inclusion criteria: * physically active at least 3 hours a week exclusion criteria: * low back pain in the past 6 months * history of chronic low back pain * history of spinal or pelvic operation * hypermobility, more than 4 points on beighton scale * cardiovascular or systemic diseases * pregnancy

Keywords: multifidus erector spinae muscle stiffness
cocoa flavanol and coronary vasomotion vascular function in patients with coronary artery disease

Conditions: Stable Coronary Heart Disease

Summary: the aim of the present study is to investigate whether the ingestion of a cocoa flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and platelet function in patients with overt coronary artery disease acutely (after 2 hours)


Eligibility criteria:
inclusion criteria: patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention * age 20 - 80 * written obtained informed consent exclusion criteria: * acute st-elevation myocardial infarction * acute non-st-elevation myocardial infarction (enzyme positive) * ventricular tachy-arrythmias or av-block \>i° * renal insufficiency (gfr mdrd \ 150 iu) * pregnancy * known allergy to compounds of cocoa product * known allergy to contrast media * known allergy to nuts * intolerance to coffein and theobromin * acute infectious disease * disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) * participation in another study within the last month * concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts * no study visits ± 1 week before eastern, christmas and new year holyday (altered eating habits) * extreme eating habits (as assessed by a questionnaire) * alcohol or drug abuse * lactose intolerance
prospective follow-up of patients with chronic inflammatory rheumatism

Conditions: Inflammatory Disease; Rheumatoid Arthritis; Spondyloarthritis

Summary: it is a prospective follow-up. the aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)

all subjects were followed up on a yearly basis collection with clinical data (weight, sex, age, comorbidities, treatment), biological (vs, crp, acpa, lipid balance, cross laps), radiology (hand and foot radiographs and ultrasonography ), bmo measure

Eligibility criteria:
inclusion criteria: * more than 18 years * rheumatoid arthritis meeting acr criteria spondyloarthritis meeting asas criteria exclusion criteria: * patient under guardianship
cook micronized small intestinal submucosa (sis) for critical limb ischemia

Conditions: Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases

Summary: this study is intended to collect safety and effectiveness data on the cook micronized small intestinal submucosa (sis)


Eligibility criteria:
inclusion criteria: * rutherford stage 4 or 5 or leriche-fontaine classification iiib * patient is unable to be treated by endovascular or surgical means exclusion criteria: * patient is pregnant or breastfeeding * patient has had a previous surgery within 30 days of the study procedure * patient has a planned surgical or interventional procedure within 30 days after the study procedure * patient has a life expectancy of less than 1 year * patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue. * additional restrictions as specified in the protocol

Keywords: critical limb ischemia amputation
verification of prediction algorithm

Conditions: Shortness of Breath Episode; Tachycardia; Bradycardia; Difficulty Breathing

Summary: prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

a novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ed has recently been reported. unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ecg data to solve the risk classification problem. data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician. verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. as such, the proposed study will investigate the accuracy of the algorithm.

Eligibility criteria:
inclusion criteria: 18 years of age or older admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system. exclusion criteria: pregnant or suspected pregnancy significant trauma do not resuscitate order known as ward of the state

Keywords: cariopulmonary, cardiac arrest
patient registry to study the tined lead used with the interstim system for urinary control

Conditions: Urge Incontinence; Urinary Retention

Summary: the purpose of this study is assess the long-term safety and effectiveness of the interstim tined lead using a minimally invasive approach.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * 16 years of age or greater * willing and able to complete voiding diaries and questionnaires at various time points during the study * located geographically near the physician, or willing and able to travel to the physician's site as necessary for all required visits * failed or is not a candidate for more conservative treatment exclusion criteria: * severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement * pregnancy or planned pregnancy * concomitant medical conditions which would limit the success of the procedure such as: pelvic pain with uncertain etiology, active degenerative disc disease, spinal cord injury less than six months old, bleeding complications, or a cerebrovascular accident (cva) less than six months old. * anatomical limitations that would prevent successful placement of an electrode * neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia) * subject characteristics indicating a poor understanding of the study or poor compliance with the study protocol (e.g. subjects with psychological and/or emotional problems, subjects unable to adequately operate equipment) * subjects with knowledge of planned magnetic resonance imaging (mri), diathermy, microwave, high output ultrasonics, ultrasound scanning, or radiofrequency (rf) energy * mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture * symptomatic urinary tract infection (uti). upon completion of therapy for uti, or if the subject is receiving prophylaxis for uti, subjects can be considered for test stimulation or the full system implant (whichever is applicable) if symptom free for one month prior to the procedure. * subjects with other implantable neurostimulators, pacemakers, or defibrillators * primary stress incontinence or mixed incontinence where the stress component overrides the urge component * active participation in another clinical study

Keywords: urinary urgency-frequency
blood pressure lowering of aliskiren hctz compared to hctz in stage 2 systolic hypertension in older population

Conditions: Hypertension

Summary: the purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren hydrochlorothiazide (hctz) compared to hydrochlorothiazide in older population with stage 2 systolic hypertension.


Eligibility criteria:
inclusion criteria: 1. male or female outpatients, ≥ 55 years old 2. patients with essential hypertension 3. prior to randomization: patients must have an office cuff mean sitting systolic blood pressure ≥ 160 mm hg and \< 200 mm hg 4. patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed exclusion criteria: 1. office blood pressure measured by cuff (mssbp ≥ 200 mm hg and/or msdbp ≥ 110 mm hg) at visits 1-5 2. history or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma). 3. history of hypertensive encephalopathy or heart failure (new york heart association \[nyha\] class ii-iv) 4. cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) within 1 year prior to visit 1 5. serum sodium less than the lower limit of normal, serum potassium \< 3.5 meq/l (corresponding to 3.5 mmol/l) or ≥ 5.3 meq/l (corresponding to 5.3 mmol/l), or dehydration at visit 1. 6. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\> 5 miu/ml) 7. use of other investigational drugs within 30 days of enrollment. other exclusions may apply.

Keywords: hypertension older population aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure amlodipine, stage 2
angioplasty and heart stents to treat individuals with an occluded artery following a heart attack

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction

Summary: the purpose of this study is to evaluate arterial patency and left ventricular ejection fraction by examining angiographic data one year following a heart attack and treatment with late revascularization.

background: the occluded artery trial (oat) is an international study with 3200 participants. its goal is to determine if delayed mechanical reperfusion by means of percutaneous transluminal coronary angioplasty (ptca) and stenting reduces death, heart attacks, and hospitalization in individuals with new york heart association (nyha) class iv heart failure and a persistently occluded infarct-related artery (ira) 3 to 28 days following a heart attack. while left ventricular (lv) function improvement has been suggested as a benefit of late reperfusion, solid evidence to support this claim is lacking. furthermore, while stenting has reduced reocclusion rates after total occlusion ptca, the reocclusion rate after a recent heart attack is unknown. design narrative: this study is a substudy of oat and will enroll 380 participants. the primary aims of the study include the following: 1) to compare long-term patency rates between the two treatment groups (conventional medical therapy or ptca and stenting) by means of follow-up coronary angiography one year after enrollment; and 2) to compare the change in global lv ejection fraction between the two treatment groups utilizing baseline and follow-up contrast lv angiograms. secondary aims include the following: 1) comparison of regional wall motion and lv volumes; 2) study of the effect of reocclusion and spontaneous recanalization on lv function; and 3) study of the effect of duration of occlusion on changes in lv function after percutaneous coronary intervention (pci). the substudy will be conducted at 21 oat study sites. the substudy coordinating center (scc) is at the university of alberta in edmonton, canada. the data coordinating center (dcc) is at the maryland medical research institute, which is the dcc for the oat study. the angiographic core laboratory is at the university of british columbia.

Eligibility criteria:
inclusion criteria: * has experienced a heart attack 3 to 28 days prior to study entry * has a persistently occluded ira
a study to evaluate the safety and efficacy of vsj-110 compared to placebo in the treatment of dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to determine the safety and efficacy of vsj-110 compared to placebo in the treatment of dry eye.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race. * provide written informed consent and sign the hipaa form. * be willing and able to follow all instructions and attend all study visits. exclusion criteria: * use of any of the disallowed medications during the washout and study period.
anti-angiogenesis combined with pd-1/pd-l1 therapy in patients with advanced liver cancer

Conditions: Carcinoma, Hepatocellular

Summary: to observe and explore the effect of anti-angiogenesis combined with pd-1/pd-l1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people.

this project is a non-interventional, prospective, multicenter, case follow-up registry management, aiming to observe and explore the effect of anti-angiogenesis combined with pd-1/pd-l1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people. therefore, the data collected and reported in this project will reflect the actual efficacy and safety of anti-angiogenesis combined with pd-1/pd-l1 therapy in patients with advanced liver cancer. 490 patients are planned for follow-up, and enrollment is expected for this program to last for 2 years, starting in december 2021 and ending with the last patient enrollment in december 2023. the treatment period was 24 months, and the patient follow-up was 24 months after the last patient was enrolled.

Eligibility criteria:
inclusion criteria: 1. age: ≥ 18 years old, male or female; 2. patients diagnosed with advanced liver cancer, including barcelona stage b, c or chinese liver cancer guidelines stage iia, iib, iiia, iiib liver cancer patients; 3. doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy; 4. patients voluntarily join the program and sign informed consent. exclusion criteria: the above selection criteria are not met
tumor molecular profiling in early phase clinical trials

Conditions: Advanced Solid Tumor; Lymphoma

Summary: prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.

single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials. part a: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer ngs ion torrenttm oncominetm comprehensive assay v3 platform. part b: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with htg edgeseq oncology biomarker panel assay for rna-seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctdna at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.

Eligibility criteria:
inclusion criteria: 1. male or female patients age at least 18 years. 2. patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials. 3. eastern cooperative oncology group (ecog) performance status 0 or 1 4. live expectancy of at least 6 months. 5. availability of ffpe archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis. 6. ability to understand the patient information and study consent. signed and dated written informed consent must be available before performing any study-related procedure. 7. willing and able to comply with study procedures exclusion criteria: 1. presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial. 2. any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.
targeting weight and shape concern among women with high body weight

Conditions: Body Image Disturbance; Overweight and Obesity; Weight Loss

Summary: this study is a randomized controlled trial to evaluate the effect of an adapted version of the body project program among adult women of higher body weight who want to lose weight. the study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.

the objective of this study is to conduct a randomized controlled pilot trial to test the effects of a 28-week treatment protocol that combines a modified body image intervention (the body project: weeks 1-4) with a 6-month standard behavioral weight management treatment (weeks 5-28). the combined protocol will be evaluated in comparison to a control group that receives an education only program during weeks 1-4 followed by the same 6-month weight management treatment. it will be tested among women with high body weight who report high weight and shape concern and would like to lose weight. the goals of the study are: 1. to evaluate effects of a manualized intervention on weight and shape concern prior to starting weight management. 2. to evaluate the effects of the modified body project intervention on momentary weight/shape-related thoughts and overeating episodes during behavioral weight management. 3. to conduct exploratory analyses comparing effects of the two treatment conditions on weight loss and other weight-related behaviors (e.g., exercise, adherence to self-monitoring).

Eligibility criteria:
inclusion criteria: * female * body mass index between 25-40 * eating disorder examination-questionnaire weight concern subscale greater than or equal to 4 * eating disorder examination-questionnaire shape concern subscale greater than or equal to 4.25 * personal use of cell phone * able to engage in moderate intensity activity * desire for weight loss exclusion criteria: * no eating disorder history * not pregnant * not breastfeeding * no childbirth/delivery within 9 months * no substance use disorder * no weight loss medication or history of bariatric surgery * no other weight loss program participation