Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of drotrecogin alfa (activated) in adult patients with septic shock

Conditions: Sepsis

Summary: the purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. this study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein c deficiency.


Eligibility criteria:
inclusion criteria: * must be 18 years or older * must have evidence of infection * must have systemic inflammatory response syndrome (sirs) * must have vasopressor-dependent septic shock exclusion criteria: * have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug * have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion * have single organ dysfunction and recent surgery (within 30 days of study entry) * have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period * are not expected to survive 28 days given their preexisting uncorrectable medical condition

Keywords: sepsis septic shock
pvri godeep global deep phenotyping meta-registry for pulmonary hypertension

Conditions: Pulmonary Hypertension; Global Health

Summary: pvri-godeep is a ph meta-registry, run under the umbrella of the pulmonary vascular research institute (pvri). it merges anonymized ph patient related data from various local registries around the world run under the responsibility of pvri members. it will be operated under the auspices of the university of giessen/giessen ph center. combining deep phenotyping with worldwide outreach, pvri-godeep aims to offer insights into specific geographical and ethnical profiles of ph, to deepen the epidemiological, clinical and molecular understanding of this disease and to promote strategies for improved individualized treatment of ph patients.

pvri-godeep is a ph meta-registry, run under the umbrella of the pulmonary vascular research institute (pvri). it merges anonymized ph patient related data from various local registries around the world run under the responsibility of pvri members. it will be operated under the auspices of the university of giessen/giessen ph center. combining deep phenotyping with worldwide outreach, pvri-godeep aims to offer insights into specific geographical and ethnical profiles of ph, to deepen the epidemiological, clinical and molecular understanding of this disease and to promote strategies for improved individualized treatment of ph patients. the data provided by pvri-godeep will support academia to perform scientific projects in the field of ph. pharmaceutical / commercial companies will be charged fee for access to pvri-godeep data and / or analysis, thereby creating revenues exclusively devoted to support the pvri mission and the registries entering their data into pvri-godeep. all requests from academia or commercial companies are to be decided by the pvri-godeep consortium, serving as use and access committee.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pulmonary hypertension exclusion criteria: * none

Keywords: pulmonary hypertension data integration standardization global health quality indicators
prediction of sphenoid septation in mri compared with ct and intraoperative findings during endoscopic pituitary adenoma surgery

Conditions: Pituitary Adenoma

Summary: to investigate whether mri is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where ct yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.

the current research project addresses the question whether mri alone is sufficient for preoperative planning and computer-assisted surgery (cas) during standard trans-sphenoidal pituitary surgery and if situations can be identified, where additional ct yields more information for the surgeon. a comparison of mri with ct of the skull base or paranasal sinuses and intraoperative video documentation of the anatomical site will be used. 50 patients operated the university hospital of basel \[usb\] (centre a) are consecutively included into the prospective part of the study. mri is used to assess the standardized variables, confirmed by ct. additionally, for the 50 prospectively collected patients, neuroimaging results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery. between 20-50 patients operated at the university of malaya medical centre \[ummc\] and specialist centre \[umsc\] (centre b)will be included retro- and prospectively . mri is used to assess the standardized variables and the results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

Eligibility criteria:
inclusion criteria: * lndicated trans-nasal trans-sphenoidal surgery for an anterior skull base tumour with preoperative baseline mri (centre a and b) and baseline ct (centre a). exclusion criteria: * previous trans-sphenoidal surgery * patients without ct, mri or intraoperative endoscopic video

Keywords: pituitary adenoma surgery endoscopic transsphenoidal surgery sphenoid septation
effects of neurocognitive training on chronic ankle instability

Conditions: Chronic Ankle Instability; Balance; Neurocognitive

Summary: aim: this study aimed to investigate the effects of neurocognitive training on pain, proprioception, injury-related fear, functional, and neurocognitive performance in athletes with chronic ankle instability (cai). materials and methods: a total of 30 athletes with cai, with a mean age of 11.10±1.06 years and residing in balıkesir, were included in the study. participants were randomly assigned into two groups using simple randomization: the intervention group (n=15) and the control group (n=15). two participants from the control group were excluded from the final analyses due to missing post-intervention assessments. the intervention group received a neurocognitive training program conducted twice a week for four weeks, following an initial familiarization week. the training was progressively administered on flat ground, balance mat, bosu, and inverted bosu. both groups were evaluated before and after the 4-week intervention using the following measures: the identification of functional ankle instability (idfai), the cumberland ankle instability tool (cait), pain intensity, proprioception, fear of re-injury, y balance test (ybt), side hop test, reactive balance test (rbt), and upper extremity choice reaction time test. results: the results were analyzed.


Eligibility criteria:
inclusion criteria: aged between 10 and 18 years at least 2 years of active athletic participation history of ankle sprain with at least 2 inflammatory symptoms (e.g., pain, swelling) the most recent sprain occurred at least 3 months prior to the study start date a score of 11 or above on the fabit (simon et al., 2012) a score of ≤27 on the cait (yin et al., 2022) willingness to participate in the study exclusion criteria: history of hip/pelvis, knee, or ankle surgery within the past year history of ankle fracture diagnosis of a neurological disorder presence of vestibular disorders

Keywords: cognitive load ankle instability rbt
first safety study in humans of a single dose of cpg 52364

Conditions: Healthy Volunteers

Summary: determine the safety and tolerability of the study drug, cpg 52364, when given as liquid or capsule. another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.


Eligibility criteria:
inclusion criteria: * normal body mass index and weight * no significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram exclusion criteria: * current illness or history of medical condition affecting the body's function * use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days * use of any medications during the study * positive tb test * smoking within 6 months * pregnancy or risk of pregnancy * alcohol or drug misuse within 60 days * sensitivity to quinazolines

Keywords: treatment, parallel assignment, double blind, randomized, placebo control, safety study,sle (systemic lupus erythematosus)
effects of remote ischemic preconditioning with postconditioning on neurologic outcome

Conditions: Moyamoya Disease; Remote Ischemic Preconditioning

Summary: in the present study, we evaluated whether ripc with ripostc reduce the major neurocomplication in patients undergoing sta-mca anastomosis.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists 2. adults 18 to 65 years of age 3. in patients with planned mca-sta anastomosis under general anesthesia 4. patients who pre-agreed to the study exclusion criteria: 1. if there is a history of peripheral vascular arterial or venous disease 2. if there is a previous history of peripheral nerve disease 3. other brain or cerebrovascular disease 4. in case of serious cardiovascular disease, pulmonary disease, kidney disease 5. patients who do not agree with the test
relationship between hip extensor strength and gait speed in diplegic cerebral palsy

Conditions: Diplegic Spastic Cerebral Palsy

Summary: the hip extensors are essential for upright posture and forward propulsion during gait. children with diplegic cp often demonstrate reduced muscle strength, which impacts their gait speed and overall mobility. understanding the relationship between hip extensor strength and gait speed could provide a basis for targeted interventions. this feasibility study will establish whether the handheld dynamometer can reliably measure hip extensor strength and if this strength correlates with gait speed in children with diplegic cp.


Eligibility criteria:
inclusion criteria: * • diagnosed with diplegic cp * ages 6 - 8 years * gmfcs levels i-ii (indicating they are ambulatory) * able to follow instructions and participate in strength and gait assessments exclusion criteria: * • severe cognitive or behavioral impairments affecting participation * musculoskeletal conditions or recent orthopedic surgery that could interfere with hip function * use of assistive devices for ambulation
assessment of prolonged safety and tolerability of in migraine patients in a long-term open-label study

Conditions: Migraine; Migraine Disorders; Migraine Headache

Summary: this is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.

this was an open-label, multi-center, single arm study with flexible dosing allowing both dose adjustment and one drug holiday per patient. the study design consisted of 3 parts: * screening epoch (0 - 2 weeks): required for all patients to assess initial eligibility. eligible patients came from study camg334ade01 (nct03828539). * open-label treatment epoch (128 weeks): individual patients were treated for 128 weeks. in this open-label treatment phase, the erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit. additionally, a voluntary single treatment interruption ('drug holiday') of up to 24 weeks (approximately six months) could be introduced after at least 12 weeks of treatment in the open-label treatment epoch. * follow-up epoch (4 weeks): a follow-up visit 4 weeks after the last regular study visit (8 weeks after last investigational medicinal product \[imp\] application) was required as part of routine safety monitoring.

Eligibility criteria:
the study population consisted of patients with a documented history of episodic (4 - 14 baseline migraine days) or chronic migraine (≥15 baseline headache days), who had been successfully randomized to clinical trial camg334ade01. key inclusion criteria: * signed informed consent must be obtained prior to participation in the study * patient is capable of understanding the nature, significance and implications of the clinical trial. * adults ≥18 years of age upon entry into screening key exclusion criteria: * use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the open-label treatment epoch. this exclusion criteria does not apply to erenumab or topiramate administered within clinical trial camg334ade01 * any prior exposure to (investigational) prophylactic migraine products targeting the cgrp pathway, other than erenumab.

Keywords: migraine episodic migraine chronic migraine headache erenumab amg334 aimovig monoclonal antibody cgrp-receptor antibody
atelectasis after inhalation or intravenous induction in pediatric anesthesia

Conditions: Atelectasis; Pediatric Anesthesia

Summary: children have a highly compliant chest wall and atelectasis formation occurs often during pediatric anesthesia. inhalation induction is commonly performed in pediatric anesthesia but it is still unclear if this can have an effect on the development of atelectasis. aim of this study is to investigate the impact of inhalation versus intravenous induction on atelectasis formation during anesthesia induction in children. atelectasis will be evaluated with lung ultrasound before induction and right after induction.

respiratory complications, among which atelectasis, are a common cause of adverse events in pediatric anesthesia. lung ultrasound (lus) examination is a point of care, non-invasive, radiation-free tool with high sensitivity and specificity for the identification of anesthesia-induced atelectasis in children. inhalation induction is commonly performed in pediatric anesthesia to avoid pain at venipuncture or to facilitate vein cannulation. this technique has been associated with a higher rate of respiratory adverse events but no study has investigated the role of inhalation or intravenous induction on lung atelectasis development in pediatric anesthesia. the investigators will perform this study aiming to describe the impact of inhalation versus intravenous induction technique on atelectasis formation during anesthesia induction in children of different ages.

Eligibility criteria:
inclusion criteria: * scheduled for elective surgery under general anesthesia * parental consent exclusion criteria: * american society of anesthesiologists (asa) physical status iii-vi * neuromuscular disease * chronic lung disease * cardiopathy * thoracic cage malformations * chronic home ventilation (either invasive or non-invasive) * positive history of foreign body inhalation * required immediate life-saving procedures * lack of parental consent
tissue alterations in aggressive and chronic periodontitis

Conditions: Localized Aggressive Periodontitis; Chronic Periodontitis

Summary: present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals. the investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased fibroblast cell counts and increased inflammatory cell counts. investigators also suggest that a possible mechanism which might play a role in the disease progression might occur via a disbalance between matrix metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.

periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. the etiology and pathogenesis of chronic periodontitis are mostly revealed however, there are many dark points in the etiopathogenesis of aggressive periodontitis. the existence of periodontal destruction at even one tooth in the mouth increases the risk of further periodontal destruction. however, the incidence of progression of the disease to the unaffected teeth was not demonstrated. yet, the progression of the disease from diseased sites to healthy sites is likely to occur but no evidence is present comparing healthy and diseased sites of chronic and aggressive periodontitis. present study aimed to evaluate the histological changes in both diseased and healthy sites in both localized aggressive periodontitis (lagp) and chronic periodontitis (cp) patients by determining fibroblast and inflammatory cell counts in histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to better understand the dimensions of this demolition in periodontal disease.

Eligibility criteria:
inclusion criteria: age range from 30 to 45, the existence of at least 20 functioning teeth, no history of smoking, systemical health, no antibiotic use within 6 months, no periodontal therapy within 6 months, no pregnancy or lactation, no drug use, in addition; for healthy individuals, the existence of oral health * for localized aggressive periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient. * for chronic periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient. exclusion criteria: * patients younger than 30 older than 45 years old, the absence of occlusion, drug use, pregnancy/lactation, smoking, previous antibiotic use, previous periodontal therapy, the existence of any systemical disease.
transient and immediate motor effects of exercise in progressive multiple sclerosis

Conditions: Multiple Sclerosis, Chronic Progressive; High-Intensity Interval Training; Motor Symptoms

Summary: endurance training is a cornerstone of rehabilitation in multiple sclerosis (ms) due to its beneficial effects on multiple ms-related symptoms, such as health-related quality of life, aerobic capacity (vo2peak), functional mobility, gait, depressive symptoms, and fatigue. persons with progressive phenotypes of ms, namely primary progressive ms (ppms) and secondary progressive (spms), represent a minor proportion of the total ms population, thus having been underrepresented in previous studies. the generalizability of existing evidence may be compromised by differences in symptom expression between ms phenotypes, with a dominance of motor symptoms (i.e., paraspasticity and/or paraparesis) in ppms and spms. adding up to this, clinical experiences of neurologists and sports scientists reveal that the effects of endurance exercise are characterized by a distinct time course, firstly inducing a minor and transient deterioration of motor symptoms that is followed by motor symptom alleviation beyond baseline level. this phenomenon was mainly related to the performance of high-intensity interval training (hiit), but not to moderate-intensity continuous training (mct). therefore, this pilot study aims to systematically investigate the time course of acute motor effects on spasticity, functional mobility, gait, and dexterity in persons with ppms and spms following two different endurance training protocols, that are hiit and mct.


Eligibility criteria:
inclusion criteria: * adult age (≥ 18 years) * definite ms diagnosis according the 2017 revised mcdonald criteria * ppms/spms phenotype according to the 2013 revised lublin criteria * expanded disability status scale (edss) score ≤ 6.0 * informed consent as documented by signature of participants and pi exclusion criteria: * severe lower extremity spasticity or severe concomitant disease states (i.e., orthopaedic, cardiovascular, metabolic, psychiatric (e.g., substance abuse), other neurological, other serious medical conditions) impairing the ability to participate * inability to follow study procedures (e.g., due to language barriers) * suspected non-compliance * previous enrolment into the current study * enrolment of the investigator, his/her family members, employees, and other dependent persons

Keywords: multiple sclerosis, chronic progressive physical conditioning, human paraparesis gait dexterity
gestational weight gain criteria for pregnant women with gestational diabetes mellitus in china

Conditions: Gestational Weight Gain

Summary: appropriate gestational weight gain (gwg) is a key factor in balancing maternal and neonatal needs of nourishment and health, which is especially important in women with gestational diabetes mellitus (gdm). however, there are no specific guidelines for gwg in chinese pregnant women and even for gdm pregnant women.this project intends to fill in the gaps of this field through multi-center large sample prospective cohort study.

inappropriate gestational weight gain (gwg) is an important risk factor affecting adverse pregnancy outcomes. however, the current guidelines for gwg are based on american population and may not apply to pregnant women in china, especially for those with gestational diabetes mellitus (gdm) who have high risk factors. the big gaps in academic-related fields need to be filled. our research group has previously found the heterogeneous relationships between gwg and adverse outcomes in gdm women with different abnormal glucose metabolism. therefore, based on the principles of precision medicine, this project intends to establish for the first time the gwg standard for chinese pregnant women to optimize the gwg management through a multicenter prospective cohort study. at the same time, specific gwg guidelines applicable to gdm women with different glucose metabolism abnormalities were innovatively constructed. our study will provide strong evidence for stratified management and precise intervention of gdm pregnant women, which is of great significance to ensure health of both mothers and their offspring.

Eligibility criteria:
inclusion criteria: * maternal age: 20-49 years; * natural conception; * single pregnancy; * plan to have routine prenatal examinations and give birth in the research center; * no plan to move within two years; * no second pregnancy within two years; * willing to cooperate with the hospital to follow up after childbirth. exclusion criteria: * have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, aids, etc.; * assisted reproduction; * multiple pregnancy; * fetus has a known deformity or genetic defects; * incomplete clinical data.

Keywords: gestational weight gain gestational diabetes mellitus