Kornimate/medical-research-clean huggingface dataset:
a post approval multicenter 10 year follow-up observational trial of marketed product - mp01 vs. surgical standard of care (ssoc) used for the treatment of joint surface lesions of the knee

Conditions: Knee Injuries; Joint Surface Knee Lesions

Summary: the purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. the primary hypothesis is that marketed product (mp01) retains its superiority over surgical standard of care (ssoc) at 7 years in term of mean improvement in the overall knee injury and osteoarthritis outcome score (koos).

this is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of marketed product - mp01 vs ssoc used for the treatment of joint surface lesions of the knee. up to 12 sites in the united states (us) and outside of the us (ous) that participated in the pivotal study "a prospective multicenter open-label randomized controlled trial of marketed product - mp01 vs. surgical standard of care (ssoc) for the treatment of joint surface lesions of the knee" (marketed product - mp01 vs. ssoc) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty. enrolled subjects will be followed up to an additional 5 years post pivotal study procedure. as randomization was 2:1 in the pivotal study, the expected number of marketed product - mp01 and ssoc subjects enrolled into this study are approximately 114 and 56, respectively.

Eligibility criteria:
inclusion criteria: 1. participated in the pivotal study. 2. must be physically and mentally willing and able to comply with the follow-up schedule. 3. signed and dated the iec/irb approved informed consent form and hippa (if applicable). exclusion criteria: 1. withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty. 2. chemotherapy in the past 12 months. 3. participation in other clinical trials involving knee procedures. 4. vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).

Keywords: knee cartilage lesions joint surface lesions of the knee
high resistant starch (rs) cookies and appetite control

Conditions: Metabolic Syndrome

Summary: evaluation of the effect of ingestion of high rs-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. cookies were prepared with increasing rs content and were fed to 18 healthy students in a blind trial versus a placebo. parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).


Eligibility criteria:
inclusion criteria: * self-reported healthy * not suffering disorders of lipid metabolism and eating disorders exclusion criteria: * pregnant or breast-feeding * consuming an energy-restricted diet * vegan or vegetarians
pk study of sildenafil in neonate

Conditions: Neonates and Preterm Infants

Summary: the purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.


Eligibility criteria:
inclusion criteria: * admitted at nicu in seoul national university hospital or bundang seoul national university hospital * infants who were diagnosed with pah exclusion criteria: * severe allergic reaction to sildenafil * inotropics for hypotension within 3 days prior to enrollment * ast or alt \> 3x uln * any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud
animal assisted therapy in dentistry

Conditions: Anxiety

Summary: a cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.

patients will be consented, enrolled, and assigned to a control group (no dog) or to an experimental group (dog). the patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. pre-dental procedure and post-dental procedure surveys will be given to all the subjects asking the same questions. biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a shimmer or polar device.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: * 7-17 years of age * patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s) * history of moderate dental anxiety with a frankl score of 2-3 based on epic chart review exclusion criteria subjects presenting with any of the following will not be included in the study: * patients with developmental delay/special needs, autism spectrum disorders (asds), craniofacial defects, chronic pain conditions, and/or dental syndromes * no history of dental anxiety * moderate to severe allergy to dogs * previous traumatic experience with a dog and/or self-reported fear of dogs * patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only) * patients with severe, documented xerostomia * patients receiving sedation (pharmacological and conscious sedation) or general anesthesia * patients who will have physical restraints placed during the dental procedure * patient scheduled to have sedation or general anesthesia * severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the investigator, would make the subject inappropriate for entry into the trial * patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment. * inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).
safety and tolerability study of suprachoroidal injection of cls-ax following anti-vegf therapy in neovascular amd

Conditions: Neovascular Age-related Macular Degeneration

Summary: to evaluate the safety and tolerability of suprachoroidally administered cls-ax following intravitreal anti-vegf therapy in subjects with neovascular age-related macular degeneration (amd)

multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered cls-ax following intravitreal anti-vegf therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration

Eligibility criteria:
inclusion criteria: * diagnosis of neovascular age-related macular degeneration in the study eye. * active subfoveal choroidal neovascularization (cnv) secondary to amd * two or more prior anti-vegf intravitreal injections * edtrs bcva score ≤ 75 and ≥ 20 letters exclusion criteria: * any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than namd * other than ivt anti-vegf treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for cnv * iop ≥ 25mmhg or cup-to-disc ratio \>0.8 * uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, cva or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of gi perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study * currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the screening visit

Keywords: amd wet-amd suprachoroidal tyrosine kinase inhibitor microinjector scs
an open-label trial of pregabalin in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia study a0081056 and who wish to receive open-label pregabalin therapy.


Eligibility criteria:
inclusion criteria: * patients must have met the inclusion criteria for the preceding fibromyalgia protocol a0081056 * must have received pregabalin/placebo under double-blind conditions. exclusion criteria: * patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study a0081056 which was determined to be related to the study medication by the investigator or the sponsor.
clinical application of cytokine adsorption technique in aids patients with severe pneumonia and/or septic shock

Conditions: AIDS Pneumonia; Septic Shock

Summary: observing the real-world application effectiveness of cytokine immune adsorption technology in aids patients with severe pneumonia or septic shock.

this is a prospective, single-center, non-randomized, clinical observational cohort study primarily focused on observing the clinical effects of cytokine adsorption technology in patients with aids complicated by severe pneumonia and/or septic shock. based on the real-world application of cytokine adsorption technology in aids patients with severe pneumonia or septic shock, the study divides patients into two groups: one receiving cytokine adsorption combined with standard treatment, and another receiving standard treatment only. the study aims to observe the impact of these two different treatment strategies on clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. confirmed hiv infection; 2. progression to aids stage: cd4+ count \<200 cells/ul and/or occurrence of aids opportunistic infections; 3. age between 18 and 65 years; 4. meeting the diagnosis of severe pneumonia or septic shock: 1. the criteria for severe pneumonia diagnosis refer to the 2021 ats (american thoracic society) and idsa (infectious diseases society of america) guidelines for the treatment of community-acquired pneumonia; 2. the criteria for septic shock refer to the chinese society of critical care medicine's "chinese guidelines for the emergency treatment of sepsis/septic shock (2018). exclusion criteria: 1. coexisting central nervous system lesions, severe liver disease, or cirrhosis; 2. concurrent aids-related or unrelated tumors; 3. women who are pregnant or breastfeeding; 4. severe underlying diseases of the heart, lungs, liver, kidneys, etc.; 5. alcohol abuse or drug use; 6. the researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.

Keywords: aids severe pneumonia septic shock cytokine adsorption technique
adenoid hypertrophy, respiratory complications and correlation with infant feeding position

Conditions: Adenoid Hypertrophy

Summary: 500 children aged 0-5 years followed since birth by principal investigator (pi)since january1, 2003 till december 31, 2018 and diagnosed with adenoid hypertrophy (ah) (study group) and 500 children aged 0-5 years followed by principal investigator during the same years and diagnosed as urinary tract infection (uti), gastroenteritis (ge), diarrhea, vomiting but without ah (control group) were compared. morbidity and treatment will be compared and correlated with gastro-esophageal reflux (ger), allergy and infant feeding position during the first few years of life in the two groups.

the 2 groups are children aged 0-5 years and treated by pi and followed since birth during years 2003-2018. study group consists of children diagnosed at least 2 times as ah and control group as similar children with uti, ge, vomiting or diarrhea. respiratory problems (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media om, serous om), antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ics), chest x-rays, anomalous laboratory results, emergency room visits and hospitalization rates will be compared in the two groups, together with details concerning feeding position during the first years of life. correlation between morbidity, degree of nasopharyngeal obstruction, allergy, ger and supine feeding position, will be evaluated.

Eligibility criteria:
inclusion criteria: study group: young children with diagnosis of adenoid hypertrophy followed by pi control group: young children with diagnosis of uti, ge, vomiting or diarrhea followed by pi exclusion criteria: children with cystic fibrosis, primary dyskinesia, immune deficiency, congenital anatomical malformations of nasal or airway passages. children older than 6 months of age when starting to be followed by pi.

Keywords: adenoid hypertrophy allergy infant feeding position ger pneumonia bronchitis otitis
the pain perception threshold in attention deficit disorder with hyperactivity

Conditions: Pain Threshold; Attention Deficit Disorder With Hyperactivity (ADHD)

Summary: the aim of this study was to evaluate whether the disease subtype affects the presence of chronic pain and pain perception threshold in pediatric patients followed up with the diagnosis of attention deficit and hyperactivity disorder, and to evaluate the factors that may be related to pain perception threshold in disease subtypes.


Eligibility criteria:
inclusion criteria: * diagnosed with attention deficit and hyperactivity disorder according to dsm-5 diagnostic criteria * being between the ages of 6-17 * being at a clinically normal mental level exclusion criteria: * having verbal and visual communication problems * having a history of perinatal complications or physical head trauma * having comorbid psychiatric disorders other than oppositional defiant disorder and conduct disorder * known history of chronic physical and neurological disease (such as cerebral palsy, diabetes, epilepsy, autoimmune diseases, liver and kidney failure) * presence of substance or alcohol use disorder * having a genetic disorder diagnosis
general population level estimation for type 1 diabetes risk in children during routine care delivery

Conditions: Type 1 Diabetes; Celiac Disease

Summary: in partnership with helmsley charitable trust, the sanford pledge study is a large-scale, observational, feasibility study of general population screening for t1d and celiac autoantibodies. screening is incorporated into routine health care visits within an integrated health system.

most children with type 1 diabetes (t1d) do not have a family member with diabetes and often are not diagnosed until the child is very sick. research suggests that screening and identifying children at risk for t1d autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes. the investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to t1d and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (t1d), or referred to clinical care (celiac).

Eligibility criteria:
inclusion criteria: * newborn entry: viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (ic) prior to the onset of active labor. who are born at a sanford health hospital and plan to have routine well-child care at a sanford clinic * pediatric entry: children less than 6 years of age who receive their routine care at a sanford facility and whose parents are able to provide ic. * adolescent entry: children, ages 9-16 years old, who receive their routine care at a sanford facility and whose parents are able to provide ic. * siblings of children known to have t1d-relevant antibodies; ages 6 to 17 years old who receive care at a sanford clinic * have an active mychart account (with proxy access). exclusion criteria: * subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol. * children known to have t1d

Keywords: population screening type 1 diabetes celiac disease autoantibodies prevention diabetic ketoacidosis (dka) genetic risk score differential gene expression economic modeling quality of life feasibility pragmatic t1d
role of the type of carotid stent and cerebral protection on cerebral microembolization during carotid artery stenting. a randomized study comparing carotid wallstent vs roadsaver® stent and distal vs proximal protection.

Conditions: Carotid Stenosis

Summary: stenting is an alternative to traditional surgery in the treatment of carotid stenosis.the intra and/or postprocedural cerebral embolization remains the most frequent complication. the type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. so far there no consensus on the the best stent and cerebral protection.


Eligibility criteria:
inclusion criteria: significant, unilateral carotid artery stenosis with soft plaque defined as: * symptomatic patients: \> 1.3 m/sec peak systolic velocity and \> 50% diameter stenosis by doppler ultrasound and \< 60 hounsfield unit by ct angiography * asymptomatic patients \> 2.5 m/sec peak systolic velocity and \> 70% diameter stenosis by doppler ultrasound and \< 60 hounsfield unit by ct angiography exclusion criteria: * severe cerebral vasculopathy with cognitive impairment * contraindication to double antiplatelet treatment * controlateral carotid occlusion
pattern and outcomes of chest diseases

Conditions: Chest--Diseases

Summary: the objective of this study is to determine the pattern and outcome of respiratory diseases in adults patients admitted to the department of chest diseases at assiut university hospital.

respiratory diseases constitute an important global health burden. pneumonia, tuberculosis, obstructive and restrictive lung diseases, pleural diseases, and malignancies are common respiratory conditions for hospital admission.before the emergence of covid-19, pneumonia, including community-acquired pneumonia (cap) and hospital-acquired pneumonia (hap)/ventilation-associated pneumonia (vap), was one of the most common infectious diseases, and could cause major health problems, associated with high morbidity and mortality in all age groups worldwide . the outbreak of covid-19 has significantly changed the epidemiology of respiratory tract infection. more than 376 million people have been infected and 5 million have died in the whole world. this in addition to the long term post covid pulmonary sequelae. chronic obstructive pulmonary disease (copd), lower respiratory tract infections, lung cancer and tuberculosis have been identified as top four respiratory diseases among ten leading causes of death worldwide. the forum of international respiratory societies (firs) estimated that 65 million people have moderate to severe copd resulting in 3 million deaths per year, making it third leading cause of death worldwide .currently, asthma affects an estimated 334 million people worldwide and is projected to increase to 400 million by the year 2025 . in ;2015 10,4million people developed tb with 1.4 million global deaths were reported. neoplasms of the lungs are the leading cause of cancer incidence and mortality worldwide.

Eligibility criteria:
inclusion criteria: * all adults patients admitted to the chest department during the study period will be included. exclusion criteria: * patients who will die, be discharged, or be transferred before completing data collection will be excluded from our study.
analysis of hemostatic agents compared to physiologic hemostasis

Conditions: Rhino Sinusitis

Summary: this study is a prospective comparison between absorbable hemostatic agents as a group and the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus surgery with or without septoplasty.

the purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in comparison with physiologic hemostasis after endoscopic sinus surgery. the investigators aim to determine the relative efficacy of hemostatic agents to halt epistaxis and compare this with the degree of epistaxis observed without therapy and evaluate objective healing parameters.

Eligibility criteria:
inclusion criteria: -≥18 to \<75 years of age with bilateral chronic or recurrent rhino sinusitis recalcitrant to medical therapy that requires endoscopic sinus surgery -sinuses should have a similar degree of disease involvement bilaterally. exclusion criteria: * massive sinonasal polyposis, * history of underlying immunologic diseases, aids, cystic fibrosis, immunoglobulin deficiency, immotile cilia syndrome, and neutropenia, * known hypersensitivity to the aforementioned agents, * women who are pregnant or breastfeeding, * anyone with a known allergy to any of the treatments (potato starch, iodine, shellfish) * anyone with a known coagulopathy

Keywords: bilateral chronic rhino sinusitis
frailty among elderly emergency department patients with outcome measures

Conditions: Geriatric, Frailty, Emergency Department

Summary: our study aims to compare 4 clinical frailty scores, namely clinical frailty scale (cfs), edmonton frail scale (efs), frail 5-item scale (frail) and sarc-f sarcopenia score (sarc-f), which can potentially be adopted for daily practice in the busy ed. it is timely as we projected that we will be seeing more elderly patients attending the ed for various medical and surgical conditions. their attendance at the ed would be a good opportunity to screen for frailty among them, and to intervene to prevent adverse outcomes such as ed re-attendance or subsequent hospitalisation that might lead to poor functional outcomes and higher dependence on step-down care facilities.


Eligibility criteria:
inclusion criteria: - elderly patients aged 65 years and above attending ed irrespective of reason for attendance. exclusion criteria: * haemodynamically unstable patients * inability to obtain informed consent * inability to obtain reliable information from patient or caregiver (e.g. deafness, blindness, language barriers) * vulnerable populations (e.g. prisoners) * patients who are planned for hospital admission from the ed
allogenic bone marrow transplantation (bmt) compare with cytoreduction and chemotherapy in acute lymphoblastic leukemia (all) patients

Conditions: Acute Lymphoblastic Leukemia

Summary: patients with newly diagnosed acute lymphoblastic leukemia after providing consent, will be screened for eligibility. eligible patients will be treated with vincristine (1 mg/m2 at day 1 and day 8), dexamethasone 24 mg/d day 1-15 and it at days 1, 4, 8 and 12. at day 14 patients will be randomized in two group. bmt group who have donor and chemotherapy group who don't have suitable donor. bmt group treated with allogenic bone marrow transplantation and chemotherapy treated with cyclophosphamide at day 15, daunorubicin at day 15-18, vincristine at day 15 and 22 and dexamethasone at day 12-28 followed by standard chemotherapy. in bmt group patients will be received cns radiotherapy at +100 day after transplantation.


Eligibility criteria:
inclusion criteria: * diagnose of acute lymphoblastic leukemia * age between 16 to 50 year * new case of all exclusion criteria: * primary cns involvement * primary testis involvement * previously treated

Keywords: all bmt chemotherapy allogenic