Kornimate/medical-research-clean huggingface dataset:
study to evaluate qr-110 in leber's congenital amaurosis (lca) due to the c.2991+1655a>g mutation (p.cys998x) in the cep290 gene

Conditions: Leber's Congenital Amaurosis

Summary: the purpose of this study is to evaluate the safety and tolerability of qr-110 administered via intravitreal injection in subjects with lca due to the cep290 p.cys998x mutation.

the purpose of this study is to evaluate the safety and tolerability of qr-110 administered via intravitreal injection in subjects with lca due to the cep290 p.cys998x mutation. subjects will receive qr-110 in one eye every 3 months, for a maximum of 4 doses. up to 3 dose levels of qr-110 will be evaluated.

Eligibility criteria:
inclusion criteria: * male or female, ≥ 6 years of age at screening with a clinical diagnosis of lca and a molecular diagnosis of homozygosity or compound heterozygosity for the cep290 p.cys998x mutation. * best-corrected visual acuity greater than or equal to light perception in both eyes and equal to or worse than logmar +1.0 (snellen notation 20/200) in the worse eye and equal to or worse than logmar +0.7 (snellen notation 20/100) in the contralateral eye. * detectable outer nuclear layer (onl) in the area of the macula. * an electroretinogram (erg) result consistent with lca. * clear ocular media and adequate pupillary dilation to permit good quality retinal imaging. exclusion criteria: * syndromic disease. * pregnant or breast-feeding female. * any clinically significant cardiac disease or defect. * one or more coagulation parameters outside of the normal range. * any ocular disease or condition that could compromise treatment safety, visual acuity or interfere with assessment of efficacy and safety. * prior receipt of intraocular surgery or intravitreal injection within 3 months prior to study start or planned intraocular surgery or procedure during the course of the study. * use of any investigational drug or device within 90 days or 5 half-lives of day 1, whichever is longer, or plans to participate in another study of a drug or device during the pq-110-001 study period. * any prior receipt of genetic therapy for lca

Keywords: cep290 p.cys998x c.2991+1655a>g rna therapy antisense oligonucleotide leber's congenital amaurosis
rhomboid intercostal and subserratus plane block vs erector spinae plane block in video-assisted thoracoscopic surgery

Conditions: Video Assisted Thoracoscopic Surgery; Regional Block for Pain Control; Regional Blocks; Pulmonary Functions

Summary: to compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.

video-assisted thoracoscopic surgery (vats) can be very painful and may lead to complications such as prolonged stays in intensive care, thromboembolic complications due to lack of early mobilization, chronic acute pain, and delirium if adequate analgesia is not provided. therefore, using thoracic epidural, paravertebral, or regional blocks as part of multimodal analgesia is recommended to provide effective pain relief. this study aims to compare the effects of the erector spinae plane block (esp) and rhomboid intercostal subserratus plane block (riss) on postoperative analgesia and the improvement of respiratory parameters in patients undergoing vats. the primary objective is to evaluate total analgesic consumption in the first 24 hours postoperatively. secondary objectives include assessing active and dynamic pain scores, triflow performance, complications, and the length of hospital stays.

Eligibility criteria:
inclusion criteria: * patients who will undergo vats * who agrees to participate * american society of anesthesiologists (asa) physical status i, ii, and iii * elective surgery * age between 18 and 80 years exclusion criteria: * local anesthetic allergy * who disagrees to participate * asa physical status iv and v * emergency surgery * hemorrhagic disease * thoracic vertebrae deformity * thoracic vertebrae surgery
a clinical study to assess the plaque and gingivitis effects of a stannous fluoride dentifrice

Conditions: Gingivitis

Summary: the objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in general good health as determined by the investigator based on a review of the health history/update for participation in the trial; * have at least 16 gradable teeth; * agree to return for scheduled visits and follow the study procedures; * agree to refrain from use of any non-study oral hygiene products for the duration of the study; * agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. exclusion criteria: * having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the baseline visit; * have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; * removable oral appliances; * fixed facial or lingual orthodontic appliances; * self-reported pregnancy or lactation; * any diseases or condition that might interfere with the safe participation in the study; and * inability to undergo study procedures.
coseal for hemostasis of aortic anastamoses

Conditions: Surgical Bleeding; Aneurysms; Aortic Dissection

Summary: surgery on the aorta can be associated with significant blood loss. most commonly this is due to bleeding at the site of aortic anastomosis. surgical bleeding is associated with significant morbidity. one way to prevent bleeding is to use a special glue (sealant) after performing large connections on the aorta. the goal of this study is to compare the different methods surgeons use to stop/prevent bleeding. the study team will collect medical information about patients before, during, and after surgery on their aortas, including the methods used to prevent bleeding. this information may help doctors improve the way that they care for these patients.

bleeding is a major complication of cardiac surgery, and a significant cause of morbidity and mortality \[1-4\]. hemostasis can be challenging during complex cardiac surgery, particularly due to friability of the tissue, coagulopathy, poor visualization of the surgical field, and limited accessibility to bleeding sites \[5\]. failure to achieve and maintain hemostasis and reinforce fragile tissue may result in additional bleeding, which can further reduce visualization, increase operative blood loss, lengthen surgery, increase the use of blood products, and contribute to postoperative complications and reoperation \[1-4\]. postoperative bleeding is a significant concern in cardio-thoracic surgery. bleeding, either intraoperative or postoperative, has been associated with extended in-hospital length of stay, reoperations, severe morbidity and death \[12\]. in addition to surgical technique, a variety of therapeutic agents are available to assist in hemostasis. surgical sealants are used to prevent suture line bleeding when ligation or conventional methods are ineffective or impractical \[13\]. coseal® surgical sealant (coseal®, baxter, westlake village, ca) is a synthetic polyethylene glycol (peg) polymer \[11, 13\]. the polymers cross-link with proteins in the tissue and begin to gel in approximately 5 seconds and set within 60 seconds, forming a strong, flexible, clear, degradable hydrogel that adheres to both tissue and synthetic graft surfaces \[11, 13-14\]. a secure seal is maintained through covalent tissue bonds even under high pressures in vessels, such as the aorta \[15\]. the gel is completely resorbed within 30 days \[14\].

Eligibility criteria:
inclusion criteria: * the study will include all patients undergoing cardio-thoracic surgery requiring a large aortic anastomosis. exclusion criteria: * patients with severe preoperative coagulopathy, connective tissue disorders and disseminated intravascular coagulopathy (dic) will be excluded.

Keywords: coseal surgical bleeding hemostasis aortic anastamoses bleeding cardiac surgery aneurysms aortic dissection
feasibility of cell-free dna liquid biopsy in screening high-risk patients for lung cancer

Conditions: Lung Carcinoma

Summary: this clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (dna) liquid biopsy is in screening high-risk patients for lung cancer. currently, a low dose computed tomography (ct) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. liquid biopsy utilizes technology that can detect small amounts of dna shed by cancer cells and may be able to spot lung cancer at an earlier stage. if a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose ct (ldct) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.

primary objective: i. to determine the feasibility of lung cancer screening using liquid biopsy in a community setting. secondary objectives: i. to determine screening follow-through rates in those who agreed to undergo screening by preferred modality (liquid biopsy versus \[vs\] ldct). ii. to determine the rate of ldct following liquid biopsy (in those who underwent liquid biopsy) after stratifying by test result (negative versus positive). iii. to compare participant sociodemographic factors (age, sex, race/ethnicity, educational background) and survey scores across screening preference (liquid biopsy vs. ldct). outline: participants choose 1 of 2 cohorts. cohort a: participants undergo collection of blood sample (liquid biopsy), with option to undergo ldct if liquid biopsy results are positive. cohort b: participants undergo low dose ct with optional liquid biopsy on the same day as ldct. after completion of study, patients are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * documented written informed consent of the participant. * age 50-80 years. * smoking history of \>= 20 pack-years and if quit, quit within 15 years. * received referral for counseling for lung cancer screening and would qualify for ldct. * health insurance that will pay for a ldct for lung cancer screening at either city of hope duarte, newport beach (newport diagnostic imaging), or lancaster (renaissance imaging/antelope valley outpatient imaging center). * willingness to provide blood sample. * english speaking. * consent to undergo lung cancer screening with either liquid biopsy (lb) or ldct. exclusion criteria: * symptoms of lung cancer. * chest ct scan or chest positron emission tomography (pet)/ct within 12 months. * any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer. * unable to undergo ldct at either city of hope duarte, newport beach, or lancaster.
lifestyle-related health outcomes in prediabetes and diabetes

Conditions: Obesity; Prediabetic State; Type 2 Diabetes

Summary: this study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.

this study aims to do the following: 1. to evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning. 2. to evaluate whether a health education and coaching strategy in obese adolescents with diabetes (type 1 or type 2) is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of diabetes control), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning. 3. at baseline, before the interventions described in aims 1 and 2, to identify key diet and physical activity factors, patient characteristics, or biomarkers which are predictive of diabetes risk. 4. at baseline, before the interventions described in aims 1 and 2, can associations between glycemia, cardiometabolic risk factors, and diet and physical activity behaviors in overweight and obese adolescents who are at risk for type 2 diabetes be identified using the bright futures questionnaire, a survey for lifestyle behavior which is normally used in the clinic setting.

Eligibility criteria:
inclusion criteria: 1. male and female adolescents/young adults, 2. age 10-21, 3. tanner stage ii-v, 4. overweight or obese (body mass index ≥85th percentile for age and sex). exclusion criteria: 1. pregnancy, 2. use of medications that adversely affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics), and 3. syndromic obesity (such as prader willi, hypothalamic obesity, or laurence- moon-biedl).

Keywords: at risk for type 2 diabetes currently has type 2 diabetes
carotid intima-media thickness (imt) and large-vessel atherosclerosis by multidetector computed tomography (mdct)

Conditions: Type 2 Diabetes

Summary: the aim of this study was to investigate whether carotid imt can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by mdct and whether mdct could be useful next step for more aggressive treatment modality in korean type 2 diabetic patients.

we evaluated mean/maximal carotid imt in seventy-one type 2 diabetic subjects, and defined increased carotid imt as maximal imt ≥ 1.0 mm. multidetector ct (mdct) and pulse wave velocity (pwv) were taken to evaluate carotid artery stenosis (cs), coronary artery disease (cad), intracranial arterial lesion (ica), and peripheral artery disease (pad). we compared prevalence of large artery stenosis according to carotid imt group and evaluated whether maximal imt ≥ 1.0 mm could predict for significant cad by mdct. we performed invasive coronary angiography in some patients (n=14) and analyzed association for degrees of cad between two angiographic methods.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients who had multiple cardiovascular risk factors were recruited. * patients who had atypical chest pain, ekg abnormality (ischemic st-t changes or abnormal q-wave), or history of previous cardiovascular disease were also included. exclusion criteria: * acute coronary sd, serum cr\>1.4 mg/dl, history of allergy to iodinated contrast dye were excluded.

Keywords: atherosclerosis carotid imt multidetector ct type 2 diabetes
clinical pharmacology study of chf1535 pmdi 50/6 µg versus the free combination in asthmatic children 5-11 years old

Conditions: Asthma

Summary: the rationale is to investigate the systemic availability of bdp/b17mp and formoterol after single oral inhalation of chf 1535 50/6 pmdi vs the free combination of approved bdp and formoterol pmdis, in asthmatic children (5 to 11 years old).


Eligibility criteria:
inclusion criteria: * male/female children aged 5-11 years * written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting). * children with stable asthma on regular treatment with ics or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms * forced expiratory volume in one second (fev1) \> 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period. 6. a cooperative attitude and ability to be trained about the proper use of pmdi with a spacer device and compliant to study procedures. exclusion criteria: * past or present diagnoses of cardiovascular, renal or liver disease * known hypersensitivity to the active treatments * exacerbation of asthma symptoms within the previous 4 weeks * inability to perform the required breathing technique and blood sampling * hospitalization due to exacerbation of asthma within 1 month prior to inclusion * lower respiratory tract infection within 1 month prior to inclusion * disease (other than asthma) which might influence the outcome of the study * obesity, i.e. \> 97% weight percentile by local standards

Keywords: asthma ics+laba children inhalation pmdi
escitalopram (lexapro) for the treatment of postpartum depression

Conditions: Postpartum Depression

Summary: the purpose of this study is to determine whether women with postpartum major depressive disorder (mdd) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (lexapro). also, to determine whether women with postpartum mdd will experience a significant decrease in anxiety symptoms.


Eligibility criteria:
inclusion criteria: * women ages 18 to 45 years old * subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth * subjects must present within six months of childbirth * madrs score \>15 * bai score \>10 * subjects will be able to be treated on an outpatient basis * subjects will be able to provide written informed consent exclusion criteria: * subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc) * suicidal ideation with active plan or intent, as determined by the investigator * presence of psychotic symptoms or homicidal ideation * history of mania or hypomania * pregnant or breastfeeding * presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator * active alcohol/substance abuse currently or within the past year * abnormal tsh, severe anemia, or uncontrolled hypertension

Keywords: women postpartum depression anxiety
normal human immunoglobulins (ivig) in patients aged 75 years and over, covid-19 with severe acute respiratory failure

Conditions: Sars-CoV2

Summary: according to recent data, death rate is more than 20% for 75 years old hospitalized patients and older. in case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity. apart from an increase in oxygen therapy, no specific treatment is currently proposed. the control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution. polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for covid patients. this study objective is evaluation of the efficacy of polyvalent ivig in combination with the standard management of patients aged 75 and over with sarscov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy\> 5 l / min (i.e. patients considered as moderate to severe ards according to the berlin definition, pa02 / fi02≤200) and disqualified from a care in the icu.


Eligibility criteria:
inclusion criteria: * man or woman aged 75 and over * sars-cov2 infection confirmed by rt-pcr or thoraco-pulmonary ct * hospitalized in the acute general geriatrics unit of the versailles hospital center * patient rejected from resuscitation * saturation ≤ 95% under oxygen therapy\> 5 l / min (i.e. pao2 / fio2≤200mmhg according to the berlin definition of ards) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution exclusion criteria: * patient under palliative care * patient with contraindication to iv polyvalent ig 1. . hypersensitivity to the active substance or to any of the excipients (l-proline) 2. . hypersensitivity to human immunoglobulins, especially when the patient has anti-iga antibodies, 3. . patients with type i or ii hyperprolinemia * patient under guardianship or curatorship * patient receiving another experimental treatment as part of an interventional study * moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an mmse \<20/30 or a neuropsychological assessment with a diagnosis made. * patient not affiliated with a social security system in france * adl patients \<4/6 and / or iadl \<6/8
pain neuroscience education for middle school students

Conditions: Pain; Pediatrics; Neuroscience Pain Education; Physical Activity

Summary: this project was designed as a single-blind, randomised controlled, prospective intervention study. the research question of the project is 'is pain neuroscience education an effective method to improve various aspects of child health, conceptualise pain and change pain-related behaviours in middle school children?'. in other words, the aim of this project is to investigate whether pain neuroscience education (pne4kids) is an effective method for improving various aspects of child health, conceptualising pain and changing pain-related behaviours in middle school children. for this purpose, it is planned to implement pne4kids based power point presentation and interactive game training. it is aimed to evaluate children in terms of physical activity level, sleep quality/habits, pain conceptualisation level and participation in leisure time activities. physical activity levels will be assessed with actigraph gt3x+ accelerometer device and 'physical activity scale for older children'. sleep quality/ habits will be assessed with actigraph gt3x+ accelerometer and 'children's sleep habits scale-short form'. knowledge of pain conceptualisation will be assessed with the 'conceptualisation of pain' scale. children's level of participation in leisure time activities will be assessed through the participation section/domain of the participation environment measure for children and youth (pem-cy). after the baseline measurements of the individuals included in the study and who volunteered will be completed, they will be randomly assigned to the control or intervention group. participants in the intervention group will receive 'turkish pne4kids programme'. individuals in the control group will not receive any intervention. all evaluations will be repeated before the training, immediately after the training and at the end of the 3rd month after the training.


Eligibility criteria:
inclusion criteria: * being actively educated at midschool level, * having sufficient reading and understanding skills in turkish. exclusion criteria: * chronic pain (pain in ≥1 anatomic region that persists or recurs for longer than 3 months, * chronic illness (e.g. cancer, diabetes, asthma, juvenile rheumatic arthritis), * being diagnosed with a specific learning disability, * being diagnosed with attention deficit hyperactivity disorder, * being diagnosed with autism spectrum disorder, * not being willing to participate in the study by oneself or one's parents.

Keywords: pain pediatrics neuroscience pain education physical activity sleep