Kornimate/medical-research-clean huggingface dataset:
role of nitric oxide in the impact of aging on myocardial remodeling

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to determine, with positron emission tomography (pet), the role of nitric oxide in the age-associated effect on fatty acid and glucose delivery on myocardial substrate metabolism.

aging is associated with an increased incidence and severity of various cardiovascular disorders. previously, our laboratory has demonstrated an age-related shift in the substrates used by the heart for metabolism from primarily fatty acids to primarily glucose. furthermore, other institutions have demonstrated that a similar shift can be induced, in animal models, with specific nitric oxide synthase inhibitors, such as l-name (n-nitro-l-arginine methyl ester). our hypothesis is that a reduction in nitric oxide (no) synthesis is responsible for the age-related shift in heart function. accordingly, we aim to demonstrate, in young patients, an acute, transient shift in substrate use from fatty acids to glucose with l-nmma (citrate) in association with depressed heart function. also, we aim to demonstrate in the elderly an acute, transient shift in substrate use from glucose to fatty acids with l-arginine, in association with improved cardiac function. these results will demonstrate a portion of the mechanism for the age-related shift in substrate utilization. each participant will undergo a screening visit which will include a glucose tolerance test, an echocardiogram in conjunction with a treadmill stress test to exclude cardiac disease, and baseline blood work. then each patient will have 3 pet study days, each lasting about 5-6 hours. during this time, the patient will have two ivs (one in each arm). they will have 4 injections of different radioactive isotopes (015 water, c11 acetate, c11 glucose, and c11 palmitate). after each injection, about 8-10 blood samples will be drawn over the course of about ½ to 1 hour of time. in between each injection, there will be about an hour break for the patient to rest and move around. during one of the breaks, the patient will have another echocardiogram. on the day 2 and 3 pet, the patient will have a 30-60 minute infusion of l-name. then the pet study will commence. after the study is over the participant will have a 10-minute infusion of l-arginine to reverse the effects of l-name.

Eligibility criteria:
inclusion criteria: * between the ages of 18-35 or 60-75 * normal glucose tolerance test * normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dl) * normal rest/stress echocardiogram * bmi (body mass index) less than 30 kg/m2 exclusion criteria: * coronary artery disease * high blood pressure * current smoker * diabetes mellitus * cardiovascular disease (signs and symptoms of any kind) * history of stroke, peripheral vascular disease, or arrhythmia * pregnant or breastfeeding

Keywords: pet heart metabolism nitric oxide myocardial remodeling
effect of virtual reality-based visual training for myopia control in children

Conditions: Myopia; Myopia, Progressive

Summary: to assess the efficacy and safety of virtual reality-based visual training (vrvt) in myopia control among children.


Eligibility criteria:
inclusion criteria: 1. age 8-13 years old (inclusive), regardless of gender; 2. the spherical equivalent of both eyes after cycloplegia was -3.00d to -0.50d (including); 3. binocular astigmatism ≤3.00d during screening; 4. anisometropia (according to spherical equivalent) ≤1.50d during screening; 5. the intraocular pressure of any eye during screening was ≤21mmhg; 6. at the time of screening, the best corrected distance visual acuity of any eye was ≥1.0 or logmar≤0; 7. good binocular stereopsis and stereopsis acuity ≤60 "; 8. the subjects and their legal guardians were willing to participate in the study and signed written informed consent. exclusion criteria: 1. existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses; 2. using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months; 3. subjects with poor vestibular function such as motion sickness and seasickness; 4. any history of diseases or syndromes that may cause severe myopia (e.g., marfan syndrome, stickler syndrome, retinopathy of prematurity, etc.); 5, any eye refractive media abnormalities (such as cornea, lens abnormalities, etc.); 6. long-term use (i.e., more than 7 consecutive days in 1 month or more than 30 days in total in 1 year) of any local or systemic use of anticholinergic/anticholinergic drugs (e.g., atropine, scopolamine, tolacamide, etc.) within 21 days before screening and during the expected period of the study, allowing the use of cycloplegic drops for optometry and other examinations; 7. severe systemic disease considered by the investigator as not suitable for the study; 8. participation in other clinical trials within 30 days before screening; 9. only one eye met the inclusion criteria; 10. poor compliance, unable to go to medical institutions for treatment on a timely and regular basis as required; 11. any other circumstances deemed inappropriate by the investigator to participate in the study.
application of the best evidence of neonatal individualized developmental care assessment program (nidcap) in very low birth weight infant (vlbwi)

Conditions: NIDCAP

Summary: in order to help the growth and development of vlbwi in neonatal intensive care unit (nicu) and reduce the interference of external environment to them, we summarized the best evidence of nidcap care, and applied the evidence to the intervention group, and observed the compliance of nurses in the intervention group to the application of evidence, and the short-term outcomes of vlbwi.


Eligibility criteria:
inclusion criteria: * birth weight \<1500g; * admit within 24 hours of birth; * the guardian signs the informed consent; * oi (oxygenation index \>300) exclusion criteria: * newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases; * newborn who did not achieved discharge or death at the end of the study period
dilute povidone-iodine irrigation vs no irrigation for children with acute, perforated appendicitis

Conditions: Acute, Perforated Appendicitis

Summary: the goal of this study is to compare the efficacy of pvi irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. additionally, this study aims to verify the safety profile of dilute pvi for intra-abdominal irrigation.

postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis in pediatric patients despite utilization of evidence-based practices. povidone-iodine is a commonly used antiseptic in surgical procedures and has been shown to be effective in reducing postoperative abscesses in adults with perforated appendicitis. this trial will be the first to rigorously test the efficacy of povidone-iodine irrigation in children and to verify its safety profile in this patient population.

Eligibility criteria:
inclusion criteria: * children who undergo an appendectomy for perforated appendicitis. (appendicitis: diagnosis is made intraoperatively by the surgeon. diagnosis method: the visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.) exclusion criteria: * patients presenting with simple or gangrenous appendicitis * patients with a history of iodine sensitivity, thyroid disease or renal disease * patients undergoing interval or incidental appendectomy * patients/parents/legal guardians who are both non-english and non-spanish speaking

Keywords: povidone-iodine irrigation
safety and efficacy study for the field-directed treatment of actinic keratosis (ak) with photodynamic therapy (pdt)

Conditions: Actinic Keratosis

Summary: the purpose of this study is to evaluate the safety and efficacy of bf-200 ala (ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (pdt) when using the bf-rhodoled lamp.

the study was performed as a randomized, multicentre, double-blind, placebo- controlled, parallel-group, phase iii trial with bf-200 ala and placebo in seven centres in germany. a total of 94 patients were screened in this study; 87 were randomized (55 patients received bf-200 ala, 32 received placebo). patients received one pdt. if residual lesions remained at 3 months after treatment, pdt was repeated. illumination was performed with the pdt lamp bf-rhodoled.

Eligibility criteria:
inclusion criteria: * males or females between 18 and 85 years of age (inclusive) * presence of 4 to 8 clinically confirmed actinic keratosis (ak) target lesions of mild to moderate intensity within 1-2 fields exclusion criteria: * history of hypersensitivity to 5-ala or any ingredient of bf-200 ala * current treatment with immunosuppressive therapy * presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (bcc) or squamous cell carcinoma (scc)) within the last 4 weeks * confirmed diagnosis of scc for the representative lesion by screening biopsy

Keywords: photodynamic therapy field-directed treatment
intravesical ozone therapy for interstitial cystitis/bladder pain syndrome

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Summary: this randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (ic). participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. the primary outcome was the change in o'leary-sant icsi score. secondary outcomes included vas pain score, sf-36 physical health, and urinary frequency.

patients received either 50 ml ozonated saline (20-40 µg/ml), normal saline (placebo), or continued standard care twice weekly for 3 weeks. assessments were conducted at baseline, week 3, and week 6. the study aimed to determine if ozone therapy reduces interstitial cystitis symptoms compared to placebo and standard care.

Eligibility criteria:
inclusion criteria: * age 18-65 years * histopathologically or clinically confirmed ic (per aua guidelines) * symptoms for at least 6 months * willing to provide informed consent exclusion criteria: * active urinary tract infection * bladder malignancy * pregnancy or breastfeeding * known ozone allergy * intravesical therapy within 3 months * g6pd deficiency

Keywords: interstitial cystitis bladder pain syndrome ozone therapy intravesical ozone
optimal predilatation technique for bvs implantation

Conditions: Coronary Artery Stenosis

Summary: the purpose of this study is to determine the optimal way of predilatation for bvs implantation.

randomized, single-center study. forty-five patients with intended bvs implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/emerge nc™, boston scientific, cutting balloon/flexitome™, scoring balloon/scoroflex™,orbus). predilatation is intended to be done in a vessel:balloon ratio of 1:1. if the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) after a successful predilatation, the bvs (absorb™, abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (emerge nc™, bsci). the mla of the absorb stent will be evaluated with optical coherence tomography (optis, st.jude).

Eligibility criteria:
inclusion criteria: * patients undergoing percutaneous coronary intervention (pci) * lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment exclusion criteria: * patients with acurate myocardial infarction (stemi) * patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, chronic total occlusion)

Keywords: pci, bioabsorbable scaffold
prevalence of molar incisor hypomineralization among a group of egyptian children in fayoum governorate schools

Conditions: Molar Incisor Hypomineralization

Summary: determining the prevalence of molar incisor hypomineralization among a group of egyptian children in fayoum governorate schools via clinical examination. participants from primary and preparatory schools in fayoum governorate will be included in the study and clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders. teeth will be cleaned gently using gauze and wet with saliva during examination. a disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. no diagnostic radiographs will be taken. the results of the study will be regularly monitored by the supervisors who will have full access to these results.


Eligibility criteria:
inclusion criteria: * acceptance for participation in the study. * eruption of four first permanent molars. * eruption of four permanent maxillary and mandibular incisors. * both genders. exclusion criteria: * uncooperative children. * children with orthodontic appliances. * children with systemic diseases which may affect teeth development. * children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.

Keywords: mih
haelo: a phase 3 study to evaluate ntla-2002 in participants with hereditary angioedema (hae)

Conditions: Hereditary Angioedema

Summary: this phase 3 study aims to evaluate the efficacy and safety of ntla-2002 compared to placebo in participants with hae.

this is a multinational, multicenter, double-blind, placebo-controlled study in which approximately 60 participants will be randomized in a 2:1 ratio to receive a single iv infusion of ntla-2002 or placebo. after the primary observation period (week 1 through week 28), participants will have the option to receive a blinded, single iv infusion of the opposite treatment. following the primary observation period, participants will enter the long-term observation period (76 weeks), for a total of 104 weeks. including the screening and run-in period, prior to the first blinded dosing, the total study duration is approximately 28 months.

Eligibility criteria:
inclusion criteria: 1. age ≥16 years 2. clinical history consistent with hae-c1inh-type 1 or -type 2 3. ability to provide evidence of hae attacks (confirmed by the investigator) to meet the screening requirement 4. must agree to refrain from the use of long-term prophylactic therapies from the start of the screening period through the end of the primary observation period. pi must be in agreement that it is medically acceptable for the participant to do so. 5. must have access to, and the ability to use, on-demand medication(s) to treat potential angioedema attacks 6. adequate chemistry and hematology measures at screening 7. must agree not to participate in another interventional study for the duration of this trial. 8. must be capable of providing signed informed consent. participants 16 to \< 18 years of age, whose legal guardian provides informed consent, must provide assent. 9. must agree to follow contraception requirements exclusion criteria: 1. concurrent diagnosis of any other type of recurrent angioedema or hae with normal c1-inh 2. have known negative reaction or hypersensitivity to any lipid nanoparticles (lnp) component. 3. any condition that, in the investigator's opinion, could adversely affect the safety of the subject. 4. unwilling to comply with study procedures.

Keywords: hereditary angioedema ntla-2002 hae hae-c1inh-type1 or -type 2
specific use-result of spiriva respimat® in asthmatics

Conditions: Asthma

Summary: the study objective is to investigate the safety and effectiveness of spiriva respimat in patients with mild to moderate persistent asthma under real-world use

the study is post-marketing surveillance on the long-term use of spiriva respimat in japanese patients with mild to moderate persistent asthma. the patient population who receive spiriva respimat and the safety profile is not expected to change. this study can investigate the safety and effectiveness of spiriva respimat in patients with mild to moderate persistent asthma under real-world use

Eligibility criteria:
inclusion criteria: * patients diagnosed with mild to moderate persistent bronchial asthma * patient aged ≥ 15 years * patients who are naive to spiriva respimat and receive spiriva respimat for the first time for treatment of bronchial asthma on top of at least ics treatment. exclusion criteria: * patients who have a contraindication to spiriva respimat defined in the package insert for spiriva respimat * patients who have been enrolled in this study before.
gall bladder bed infiltration analgesia

Conditions: Pain, Acute

Summary: early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. this pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. hypothesis: laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. this combination can give the maximum analgesia after laparoscopic cholecystectomy.

bladder bed irrigation with bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. the intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. in order to allow the sprayed solution to diffuse under the diaphragmatic space, the trendelenburg position will be maintained for 2 minutes. in the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. co2 will be humidified and wormed.

Eligibility criteria:
inclusion criteria: * scheduled to undergo elective laparoscopic cholecystectomy. * american society of anesthesiologists physical status (asa) i or ii. exclusion criteria: 1. patient in receipt of analgesics or sedatives 24 h before scheduled surgery. 2. patient with spillage or cholelithiasis with known common bile duct pathology. 3. body mass index \> 40 kg/m2. 4. patient underlying severe systemic disease. 5. patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.

Keywords: cholecystectomy; analgesia; gallbladder; infiltration; visceral pain
the safety and efficacy of daclatasvir and asunaprevir with chronic hcv genotype 1b infection and chronic renal failure

Conditions: Hepatitis C

Summary: safety and efficacy of daas (daclatasvir+asunaprevir) in patients with chronic hepatitis c and chronic renal failure will be assessed.


Eligibility criteria:
inclusion criteria: * hcv rna positive and genotype 1b * no history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months * a patient who is on dialysis, or if not mdrd egfr\<30ml/min * hcv treatment history: hcv treatment-naive participants, defined as never having received hcv treatment with any approved or investigational drug (including vaccines); or hcv treatment-experienced, defined as having received previous hcv treatment with any (pegylated) interferon (\[peg\]ifn)-based drug regimen (with or without ribavirin \[rbv\] and not including a direct-acting antiviral agent \[daa\]). last dose in this previous hcv treatment course should have occurred at least 2 months prior to screening * no baseline mutation ns5a polymorphism including l31f/i/m/v and y93h exclusion criteria: * a patient who having received daclatasvir or asunaprevir * pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study * evidence of a medical condition contributing to chronic liver disease other than hcv or seropositive for hiv * diagnosed or suspected hepatocellular carcinoma or other malignancies * any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage) * received solid organ or bone marrow transplant * current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance * significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator * known hypersensitivity to study drugs, metabolites, or formulation excipients * who has taken investigational drugs within 2 months.
heart rate variability in children with traumatic brain injury

Conditions: Traumatic Brain Injury; Child Development

Summary: using a prospective cohort of children admitted to the picu, the investigators will determine hrv monitoring is feasible, if a decreased hrv in the 7 days following moderate or severe tbi in children is associated with a worse outcome 6 months post-tbi and investigate hrv as a tool that can predict adverse events (neurological crisis) within 2 days following tbi.

this is a single center prospective cohort study of 15 children \<18 years, admitted to the picu at the chu sainte-justine (chusj) with moderate or severe tbi (\<24 hours). neurodevelopment outcome of children will be evaluated 6 months post tbi.

Eligibility criteria:
inclusion criteria: * \<18 years * admitted to the picu at the chusj * moderate tbi (glasgow coma scale (gcs): 9-12) or severe tbi (gcs ≤8) as - - assessed 30 minutes after tbi or upon arrival in the emergency room * written parental consent. exclusion criteria: * children fulfilling brain death criteria at the time of picu admission (gcs 3 and loss of all brain stem reflexes) * children with a pacemaker or with previously diagnosed arrhythmia (hrv monitoring not reliable) * inflicted trauma (different underlying pathophysiology) * patients or parents who do not speak or read english or french.