Kornimate/medical-research-clean huggingface dataset:
early intervention based on neonatal crawling in very premature infants without major brain damage

Conditions: Prematurity

Summary: extreme prematurity is constantly increasing according to the world health organization. however, methods to train premature infants at risk of disability is sorely lacking. the goal of this project is to overcome this problem. in our previous studies, we discovered that promoting the crawling of typical newborns on a mini skateboard, the crawliskate (a new tool that we designed and patented ep2974624a1), is an excellent way to stimulate infants' motor and locomotor development. this method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants. the specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as median risk for developmental delay. methodology: we will study and follow three groups of very premature infants born between 24 and 32 weeks of gestational age without major brain lesions. these infants will be recruited before their hospital discharge at the nicu. after their discharge from the hospital, one group of infants will be trained at home by physiotherapists to crawl on the crawliskate every day for 2 months (crawli group), one group of infants will be trained at home by physiotherapists positioned prone on a mattress (mattress group) and one group of infants will receive regular medical care (control group). all infants will be tested for: 1) their crawling proficiency on the crawliskate at term-equivalent age (just before training for the trained groups) and at 2 months corrected age (ca, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 24 months ca (2d and 3d recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 24 months ca : bsid iii edition, asq-3, amiel-tison's neurological assessment, prechtl assessment of general movements. one more asq-3 questionnaire will be provided at five years. expected results: our first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the nicu) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive mattress training or no training.


Eligibility criteria:
inclusion criteria: * term between 24-32 ga * parental consent * family living in intervention area * good tolerance on the first crawliskate trial exclusion criteria: * no bronchodysplasia define by oxygen dependency after 36 ga * no medical disease * no limb deformity * no karyotype anomaly * no visual or auditory inpairment
b2-adrenergic receptor polymorphisms

Conditions: Status Asthmaticus

Summary: beta(2)-adrenergic receptor (bar) agonists are the most important group of drugs used in the treatment of asthma. in children unresponsive to inhaled bar agonist therapy, higher dose systemic bar agonist therapy is frequently the next step in treatment. despite the widespread use of intravenous bar agonist therapy for pediatric status asthmaticus, there is controversy regarding the efficacy of this therapy. a number of studies have established that genetic variations of the bar have important effects in modulating responses to bar agonist therapy for asthma. in particular, changes in amino acid position 16 of the bar gene are thought to be the most functionally important. patients encoded for two glycine amino acids, rather than arginine, at this position appear to have more severe asthma and to respond differently to acute bar agonist therapy. our hypothesis is that genotypic differences may contribute to poor response to acute bar agonist treatment. we propose to conduct a prospective observational study to determine the influence of a patient's bar genotype on the response to acute bar agonist therapy. our specific hypothesis is that children with genetic polymorphisms of the gene encoding the bar will have a decreased response to acute high-dose continuous bar therapy (both inhaled and intravenous) compared to other children. our primary outcome is icu length of stay. secondary outcomes are 1. to assess the rate of improvement in clinical asthma score based on genotype, and 2. to attempt to correlate asthma phenotype with genotype by comparing demographic data and hospital course.

this study has both a prospective and a retrospective arm. in the retrospective arm, patients with a history of admission to the icu with a severe asthma exacerbation are contacted by phone and mail and dna samples are obtained via saliva. in the prospective arm, patients admitted to the icu are contacted prospectively and dna is obtained either via saliva or blood.

Eligibility criteria:
inclusion criteria: * (1) admission to the ccmc picu with a primary admission diagnosis of status asthmaticus. (2) age between 2 years and 18 years. exclusion criteria: * pre-existing chronic disease (other than asthma)

Keywords: pediatric
a study of jab-3312 in adult patients with advanced solid tumors in china

Conditions: Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Carcinoma; Esophageal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Breast Cancer; Other Solid Tumors

Summary: this is a phase 1, open-label dose-escalation study to determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) and assess the dlt of jab-3312. it is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. jab-3312 will be administered orally once daily (qd) in 21-day treatment cycles.


Eligibility criteria:
inclusion criteria: 1. subject must be ≥18 years-of-age at the time of signature of the informed consent form (icf). 2. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 3. subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. 4. subjects with life expectancy ≥3 months. 5. patients must have at least one measurable lesion as defined by recist v1.1. 6. patients who have sufficient baseline organ function exclusion criteria: 1. severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent). 2. known malignant central nervous system disease other than neurologically stable, treated brain metastases. 3. history or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. 4. history of seropositive status for hepatitis b, hepatitis c and human immunodeficiency virus (hiv). 5. history or evidence of active infections (grade ≥2). 6. history or evidence of significant inflammatory or vascular eye disorder. 7. history of an allogeneic bone marrow or solid organ transplant. 8. use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of jab-3312. 9. history of radiation therapy ≤28 days prior to the first dose of jab-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of jab-3312. 10. history of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. 11. subjects experiencing unresolved grade \>1 toxicity before the start of treatment

Keywords: src homology phosphatase 2 (shp2) ptpn11 kirsten rat sarcoma (kras) proto-oncogene, gtpase epidermal growth factor receptor (egfr)
effects of core stabilization and inspiratory muscle training in patients with copd

Conditions: Copd

Summary: in chronic obstructive pulmonary disease (copd), a mismatch develops between the respiratory system's demand and the functional capacity of respiratory muscles due to the combination of local and systemic factors increasing the respiratory workload. this results in impaired coordination of muscle groups, leading to muscle dysfunction. respiratory muscle dysfunction is a significant determinant of life expectancy in copd. additionally, respiratory muscles unable to cope with increased workloads lead to impaired respiratory functions and reduced exercise capacity. it is widely accepted that appropriate training of respiratory muscles can increase their strength, endurance, and their close relationship with lung volume capacities. besides their role in respiration, respiratory muscles also contribute to postural function and core stabilization. studies on respiratory muscle training in copd have primarily focused on inspiratory muscle strength training, neglecting the core stabilization function of respiratory muscles. however, optimal gains in a muscle can only be achieved with training tailored to its functional characteristics. therefore, a comprehensive training program should be developed considering the multifunctional nature of respiratory muscles. studies published in healthy individuals and different patient populations demonstrate that core training can improve lung functions. the aim of this study is to compare the effects of inspiratory muscle training and core stabilization training on diaphragm activation, inspiratory muscle strength, functional capacity, respiratory functions, physical activity, and quality of life in individuals with copd.


Eligibility criteria:
inclusion criteria: * being over 18 years old * having a diagnosis of copd according to the gold criteria and being at stage 3 or lower * not being in an acute exacerbation period and having at least one month since the last exacerbation * being able to walk independently * having sufficient mental capacity to understand the tasks in the study (mini-mental test \>24) * being willing to participate in the study exclusion criteria: * being a stage 4 copd patient according to the gold criteria * having a diagnosis of lung cancer, pulmonary hypertension, and heart failure * being in a copd exacerbation period * scoring below 24 on the mini-mental test * having any other disease that affects respiratory functions * having undergone pulmonary surgery
uab 2419-cd34 selection using the automated clinimacs prodigy

Conditions: AML; ALL; Lymphoid Malignancies; Myelodysplastic Syndromes; CML; Primary Myelofibrosis

Summary: patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. in such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. therefore those patients are at increased risk of graft versus host disease, and the infusion of a cd34 selected graft would reduce such a risk. the infusion of cd34 selected graft using clinimacs plus is currently fda fda-approved indication for acute myeloid leukemia. however, the use of the prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. this procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a cd34 selected stem cell boost for graft failure or low graft function (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).

Eligibility criteria:
inclusion criteria: 1. aml in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2 2. all in morphologic remission with high-risk features or relapsed disease 1 or 2 3. lymphoid malignancies in cr or pr (e.g. non-hodgkin's lymphoma, prolymphocytic leukemia, cll) 4. myelodysplastic syndromes with \<=10% blasts 5. cml in morphologic remission after blast phase or accelerated phase 6. primary myelofibrosis with \<=10% blasts \^morphologic remission is defined as \<5% blasts on the bone marrow biopsy. negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol. exclusion criteria: 1. non-compliant patients. 2. no appropriate caregivers identified. 3. uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician). 4. patients with known allergy to dmso. 5. pregnant or breastfeeding women

Keywords: hematologic malignancies graft failure
efficacy and safety study of combined oral and injection therapy for erectile dysfunction

Conditions: Erectile Dysfunction

Summary: erectile dysfunction (ed or impotence) is a common medical condition affecting many men world wide. the most commonly used treatment for ed are oral medications like viagra (sildenafil), levitra (vardenafil) and cialis (tadalafil). if these are not effective the use of an injection into the penis (intracavernosal injection or ici) is necessary. however in some men neither of these therapies is successful. hypothesis: an adequate erection may be achieved in men with difficult-to-treat erectile dysfunction, when they are treated with a therapy of combination of tablet and penile injection, when a single treatment therapy has failed for these men. aim of the study is to test the safety and efficacy of a combination of viagra and caverjet impulse in a group of men who had failed to achieve an adequate response to the maximum recommended dose of either viagra, cialis or levitra and caverjet impulse, when these treatments were used alone. 20 men with difficult to treat ed will be given oral medication, intracavernosal therapy or the combination in a single-blind randomised study. informed consent will be signed prior to any study procedures being carried out. all participants are 'blinded' to their study treatments. participants who have satisfactory response to any of the tablets or penile injections, will be excluded from the study.


Eligibility criteria:
inclusion criteria: * men aged 20 years and over * history of ed for at least 6 months * iief score \<26 * failure to achieve an adequate response to the maximum recommended therapeutic dose of an approved ed treatments, when either of these treatments was used alone. exclusion criteria: * concurrent treatment with nitrate-containing medications * significant cardiac, hepatic, renal or respiratory dysfunction * systolic blood pressure of less than 100mm hg * myocardial infarction, serious cardiac arrhythmia, cardiac surgery, or stroke within the last 6 months * significant penile fibrosis, curvature or infection * reported significant side effects of using pde5 inhibitors or alprostadil * hypersensitivity to pde5 inhibitors or alprostadil
incidence, prevalence and overall risk of esophageal cancer in achalasia: a propensity-matched population-based study from a large multicenter database

Conditions: Achalasia Cardia; Esophageal Cancer (EsC)

Summary: esophageal achalasia has been investigated as a potential risk factor for esophageal cancer (ec). longstanding disease, repeated treatment, age and male sex seem the most relevant risk factors, but no clear effect size estimation from large sample cohorts has been provided so far. the aim of the investigators is to estimate ec risk in large sample-size population, and to provide sub-analyses per cancer type and treatment impact on ec risk.

achalasia is a chronic idiopathic condition characterized by the absence of esophageal peristalsis and reduced relaxation of the lower esophageal sphincter, causing progressive dysphagia and weight loss. achalasia has been investigated as a potential risk factor for esophageal cancer (ec); squamous cancer due to chronic inflammation related to stasis due to poor esophageal emptying and adenocarcinoma due to uncontrolled gastroesophageal reflux after treatment. longstanding disease, repeated treatment, age and male sex have been addressed as the most relevant risk factors, but no clear effect size estimation from large sample cohorts has been provided so far. the authors conducted a retrospective cohort study, accessing the global federated health research network "trinetx", that provides access to electronic medical records from approximately a hundred million patients across large healthcare organizations (hcos). the analysis will be performed on achalasia patients, based on the icd-10 code (k22.0), from january 1st 2000 until may 31st 2025. the incidence rate (cases/1000 persons-year) and cumulative prevalence of ec in an achalasia cohort in a span of 25 years will be firstly assessed. then the absolute and time-to-event risk of ec, by comparing the achalasia cohort with control cohort, after propensity score nearest neighbor greedy matching, for relevant covariates. kaplan-meyer (km) analysis with censoring, hazard ratios (hrs) and risk ratio (rr) and risk difference (rd) estimation for ec risk will be calculated. log rank test will be used to compare km curves. further sub-group analysis will be implemented between two population of achalasia patients, treated (with endoscopic/surgical myotomy or pneumatic dilation) and treatment-naïve. further in-depth analyses between histologic type of ec, esophageal localization and comparing different achalasia treatment (myotomy vs pneumatic dilation) will be performed, in order to categorize the risk of ec, if more linked to treatment and therefore to the development of reflux, barrett esophagus eventually leading to adenocarcinoma, or towards squamous cell cancer driven by chronic stasis and degeneration of the squamous esophageal epithelium

Eligibility criteria:
inclusion criteria: * esophageal achalasia diagnosed according to guidelines (icd-10-k22.0) exclusion criteria: * primary esophaeal and pharyngeal motility disorders (icd-10-j39.2)

Keywords: achalasia esophageal cancer
postoperative analgesic efficacy of modified tapa and ql blocks in laparoscopic cholecystectomies

Conditions: Postoperative Pain Management; Postoperative Pain; Analgesia; Nerve Blocks; Cholecystectomy

Summary: comparison of postoperative analgesic effects of m-tapa and anterior quadratus lumborum blocks in laparoscopic cholecystectomies.

in trunk blocks, the interfascial area between the anterior abdominal wall or back muscles is targeted. local anesthetics are used for this purpose. since there is no blood circulation and vascularization in the interfascial areas, the absorption of local anesthetics is slow, providing long-lasting analgesia. therefore, they are used as a part of multimodal analgesia. the effectiveness of trunk blocks can vary depending on the patient's anatomical differences and previous surgeries, but on average, analgesic effectiveness lasts for 8-12 hours. sometimes analgesic effectiveness extending up to 24 hours has been reported. in laparoscopic cholecystectomy operations, pain plays a role in postoperative atelectasis, pneumonia due to atelectasis, prolonged hospital stay, and discharge. to reduce the use of opioids due to their side effects such as nausea, vomiting, itching, constipation, and addiction, opioid-free analgesia is applied, and regional techniques are used. quadratus lumborum blocks and m-tapa blocks have been safely and easily applied in abdominal surgery in recent years thanks to developments in trunk blocks and ultrasound technology, and they are frequently preferred.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists physical statusⅰ-ii exclusion criteria: * inclusion criteria: * 18-65 years of age * american society of anesthesiologists physical statusⅰ-ii exclusion criteria: * local anesthetic allergy * infection at the procedure site body mass index \>35 kg/m2 anticoagulant use with bleeding disorder chronic analgesia and opioid use with mental and psychiatric disorders contraindications to regional anesthesia several lung and heart disease

Keywords: postoperative pain laparoscopic cholecystectomy quadratus lumborum block m-tapa block abdominal wall blocks postoperative analgesia
a network intervention for prevention of hiv infection in chennai, india - 1

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate a peer-based hiv prevention intervention that targets active injection drug users and their drug and sex partners in chennai india.

the intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Eligibility criteria:
inclusion criteria: * drug users * network members

Keywords: hiv injection drug use social networks
comparative efficacy and safety study in patients with active ulcerative colitis

Conditions: Active Ulcerative Colitis

Summary: to demonstrate that import mesalazine (asacol®) is non-inferior to the reference drug, marketed mesalazine, regarding the primary endpoint (reduction of uc-dai score)in patients with active ulcerative colitis (uc) treated for 8 weeks.


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis (uc) at active phase who are defined to show ulcerative colitis-disease activitiy index (uc-dai) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher exclusion criteria: * patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course
short duration high intensity intrapleural alteplase with pulmozyme in pleural infection management

Conditions: Loculated Empyema

Summary: the aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (actilyse, boehringer ingelheim) with 5mg dnase (pulmozyme hoffmann-la roche ltd) in patients with pleural infection.

the regimen 10 mg alteplase and 5 mg dnase twice daily that was used in mist-2 trial is still an empiric choice. the rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg dnase) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.

Eligibility criteria:
inclusion criteria: * adult patient with age more than 17 year old * evidence of complex parapneumonic effusion or empyema; with poor pleural fluid drainage of ≤150 ml after 24 hours of insertion of chest drain * clinical evidence of infection such as fever and or elevated c-reactive protein (crp) or white-cell count * complex pleural effusion proven by ultrasound * pleural fluid analysis that fulfilled at least one of the characteristics: frank pus, exudative nature (according to light's criteria), gram stain or culture positive, lactate dehydrogenase (ldh) \> 1000 u/l, ph \< 7.2 and/or glucose level \< 3.3mmol/l exclusion criteria: * known allergy to pulmozyme or alteplase * acute stroke, active bleeding diathesis * major surgery in past 5 days * previous pneumonectomy on the infected side * bronchopleural fistula * pregnancy * coagulopathy (inr \> 2, aptt \>100, platelet count \< 50,000 cells)

Keywords: intrapleural fibrinolysis, pleural infection