Kornimate/medical-research-clean huggingface dataset:
effect of ocrelizumab on choroid plexus changes in patients with ppms

Conditions: Primary Progressive Multiple Sclerosis

Summary: the goal of this non-interventional, observational study is to learn if cortical plexus enhancement in patients with primary progressive multiple sclerosis occurs in response to the autoimmune inflammatory process.

to study the effect of ocrelizumab on choroid plexus changes in patients with primary-progressive multiple sclerosis participating in the oratorio: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study

Eligibility criteria:
inclusion criteria: * patient participating in the oratorio study * mri scans available at baseline * presence of t2-weighted image (wi) (flair, t2/pd), and 3d t1-wi at baseline exclusion criteria: - none
a phase i study to evaluate pharmacokinetics, efficacy and safety of ct-p13 subcutaneous in patients with active crohn's disease and ulcerative colitis

Conditions: Crohn's Disease; Ulcerative Colitis (Part 2 Only)

Summary: phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between ct-p13 subcutaneous (sc) and ct-p13 intravenous (iv) in patients with active crohn's disease (cd) and active ulcerative colitis (uc).

a new subcutaneous infliximab formulation is developed by celltrion, inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. the availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. this phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between ct-p13 sc and ct-p13 iv in patients with active cd and active uc.

Eligibility criteria:
inclusion criteria: * patient has active crohn's disease with a score on the crohn's disease activity index between 220 and 450 points. * patient has active ulcerative colitis as defined by a total mayo score between 6 and 12 points (part 2 only). exclusion criteria: * patient who has previously received a biological agent for the treatment of cd and uc and/or a tumor necrosis factor-alpha (tnfα) inhibitor for the treatment of other disease * patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product * patient who has a current or past history of infection with hiv, hepatitis b, or hepatitis c (carriers of hepatitis b and hepatitis c are not permitted to enrol into the study, but past hepatitis b resolved can be enrolled) * patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug * patient who has an indeterminate result for interferon-γ release assay (igra) or latent tuberculosis (tb) at screening. for part 2, if igra result is indeterminate at screening, 1 retest will be possible during the screening. if the repeated igra result is negative, the patient can be included in the study.
transversalis fascia plane block in caesarean section patients

Conditions: Pain, Postoperative

Summary: transversalis fascia plane block is a regional anesthesia technique described ten years ago. its use for many indications has been identified by case reports in the literature. as the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. the main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane block in cesarean section.


Eligibility criteria:
inclusion criteria: * patients undergoing cesarean section under general anesthesia asa i-ii exclusion criteria: * patients undergoing cesarean section under neuraxial anesthesia morbidly obesity asa iii - iv infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs
study of surgical technique with use of single-radius prosthesis in total knee replacement

Conditions: Arthritis of Knee

Summary: the purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing).


Eligibility criteria:
inclusion criteria: * scheduled to undergo primary total knee arthroplasty performed by the principal investigator * use of a single radius posterior-stabilized tka prosthesis is planned * spinal anesthetic is planned * diagnosis of osteoarthritis * has normal knee ligaments with no history of previous injury or surgery to ligaments, or other pathologic condition * has at least 100 degrees knee flexion preoperatively (measured by long goniometer) * gives valid informed consent * age 18 years or older exclusion criteria: * patient receives general anesthetic * diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis, post-traumatic arthritis) * history of any prior knee ligament injury, or any surgery to ligaments * any connective tissue disease affecting integrity of the ligaments (must have normal ligaments) * history of long bone fracture in the affected leg * flexion contracture that would interfere with ability to establish extension gap reliably (judgment of investigator) * maximum pre-operative knee flexion is less than 100 degrees. * patient is non-ambulatory * any preclusion or inability to use navigation * treatment with single radius posterior stabilized tka prosthesis is not indicated * participation is not in best interest of patient for any reason * cannot or does not give valid informed consent * female patient who is currently pregnant * age less than 18 years * body mass index greater than 40 kg/(m\*m) * incarcerated
to evaluate the efficacy of mobile applications in tailoring and enhancing rehabilitation interventions for pediatric cp

Conditions: Cerebral Palsy

Summary: the world of technology is changing and becoming more advanced. children with cerebral palsy can benefit from the technology to enhance their mobility, balance, and coordination through mobile applications. a lot of applications are made to offer games and interactive therapy activities that focus on balance, coordination, and motor skills.

they may find these activities entertaining as well as helpful, which makes their rehabilitation more pleasurable. this work builds on previous studies by making a mobile application that may be accessed from any location, giving therapeutic treatments more distribution flexibility. this is especially helpful for those with cerebral palsy who might have mobility issues that make it challenging to consistently attend in-person therapy sessions. cerebral palsy children can perform organized exercises at home with the help of mobile application made for therapeutic activities and rehabilitation. therapeutic activities may be customized to meet the unique demands of each patient, guaranteeing that the treatment plan is in line with their capabilities and objectives. caregiver's involvement in the treatment process is a common element of app created specifically for people with cerebral palsy. this might involve providing tools to enhance home-based care, educating caregivers through resources, and monitoring progress in order to promote a team-based approach to treatment.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy * children aged between 5 to 16 years exclusion criteria: * children with unstable epilepsy, chronic heart abnormalities , asthma , anemia and other medical conditions * undergone botulinum neurotoxin a (bont-a)injections or surgery in the previous 2 months or 6 months respectively. "
validating the safety and effectiveness of endoangel upper gastrointestinal endoscope image auxiliary diagnostic software

Conditions: Gastric Cancer

Summary: the upper gastrointestinal endoscope image auxiliary diagnostic software developed by wuhan endoangel medical technology co., ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. the aim of this study is to evaluate the safety and effectiveness of the software in clinical use.


Eligibility criteria:
inclusion criteria: 1. age ≥18, male or female； 2. cases with complete, clear imaging data, including images under white light and magnified stained images； 3. complete pathological diagnosis of upper digestive tract lesions; 4. the included cases were excluded from the software development. exclusion criteria: 1. cases whose image data did not meet the evaluation requirements; 2. the investigator considered the case unsuitable for the clinical trial.
clinical trial to evaluate the efficacy and safety of tenofobell® tablet in chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: this study was designed to evaluate the rate of subjects with hbv dna less than 20 iu/ml after taking tenofobell® tablet for 48 weeks


Eligibility criteria:
1. inclusion criteria: 1. patients who show positive hbsag 2. patients who show positive or negative hbeag 2. exclusion criteria: 1. patients who have hepatitis c(hcv), hepatitis d(hdv) or human immunodeficiency virus(hiv) 2. patients with a history of allergic reaction to tenofovir 3. patients who are unable to participate in clinical trials based on investigator's decision.
an open-label, non-randomized, parallel group study in subjects with mild, moderate, severe, or no renal impairment

Conditions: Renal Impairment

Summary: multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the pk of deferiprone and its 3-o-glucuronide metabolite following a single oral dose of 33mg/kg ferriprox®.

post-marketing study to evaluate the effect of impaired renal function on the pharmacokinetics (pk) of deferiprone and its 3-o-glucuronide metabolite and on the safety of ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy volunteers.

Eligibility criteria:
main inclusion criteria: all subjects: 1. adult males or females, 18 - 75 years of age (inclusive); 2. body weight ≥ 45 kg; 3. body mass index (bmi) range of approximately 18.5-32 kg/m\^2 (inclusive); 4. absolute neutrophil count (anc) of \>1.5x10\^9/l; healthy volunteers: 1. medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination); 2. egfr ≥ 90 ml/min/1.73m\^2; renally impaired subjects: 1. considered clinically stable in the opinion of the investigator; 2. subjects with mild renal impairment (egfr 60-89 ml/min/1.73m\^e2) or moderate renal impairment (egfr 30-59 ml/min/1.73m\^2) or severe renal impairment (egfr 15-29 ml/min/1.73m\^2). main exclusion criteria: 1. history of renal transplant; 2. subjects undergoing any method of dialysis; 3. history or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; 4. disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pk of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.); 5. clinically significant abnormalities on 12-lead ecg (e.g., qtcf≥430 ms in males or ≥450 ms in females); 6. evidence of liver damage: hepatitis b and c; aspartate aminotransferase (ast), alanine aminotransferase (alt) that is considered clinically significant by the investigator; 7. participation in another clinical trial within 28 days prior to the study drug administration;

Keywords: renal impairment kidney impairment kidney disease ferriprox deferiprone dfp (deferiprone) l1
effect of a low glycemic index on metabolic syndrome

Conditions: Metabolic Syndrome X

Summary: metabolic syndrome (mets) is a cluster of multiple risk factors of metabolic origin associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. there has been an increased interest of researchers in the relationship between mets and diet and, specifically, mediterranean diet would be beneficial for people with high risk of developing mets or individuals with established mets.

metabolic syndrome (mets) is a cluster of multiple risk factors of metabolic origin, associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. the national cholesterol education program's adult treatment panel iii (ncep-atp iii) defines mets the presence of at least three of five diagnostic criteria consisting in the measure of waist circumference, fasting glucose, systolic pressure and/or diastolic blood pressure, serum triglycerides and hdl cholesterol. the level of physical activity, smoking habits, low social class membership as well as low level of education and even a mild degree of chronic inflammation have been associated with an increased risk of mets. recently, there has been an increased interest of researchers in the relationship between mets and diet, and more specifically mediterranean diet (md). a problem of the contemporary md is the quality of carbohydrates as the foods rich in carbohydrates consumed actually, such as white bread and some type of pasta, are produced with refined flour, at high glycemic index (gi) and load (gl). there are numerous studies showing that taking large amounts of high gi and gl foods is a risk factor for coronary heart disease and type 2 diabetes. to our knowledge there is no diet trial that compared the health effects of mediterranean diets with different quality of carbohydrates. objective of this study was to compare, in a randomized clinical trial, the effects of a simple md, a low glycemic index diet (lgid), and a low glycemic index md (lgimd) on mets, mets components and other metabolic variables. for this reason, after a baseline examination, participants were randomly divided into three groups, each receiving a specific dietary intervention, and all the parameters measured at the first visit were examined again at months third and sixth.

Eligibility criteria:
inclusion criteria: * mets, subject enrolled in the micol study in 2005-2006 exclusion criteria: * insulin treatment, not enrolled in the micol study

Keywords: metabolic syndrome x low glycemic index mediterranean diet low glycemic index diet randomized clinical trial
the hunt for heart failure" risk score

Conditions: Heart Failure

Summary: in this population study aim is to evaluate risk factors for heart failure and combine these into a new heart failure risk score. secondly, the heart failure risk score will be internally and externally validated, and compared with established heart failure risk scores. additionally, the prevalence of heart failure as well as the distribution of the heart failure risk score in the general population will be evaluated.

explore which clinical risk factors or patient characteristics in a general population that are associated with increased risk for heart failure events and combine these into a new population-based heart failure risk score ("the hunt for heart failure risk score") for predicting heart failure risk validate the newly developed heart failure risk score internally in the hunt2 database compare the predictive ability of the new heart failure risk score with established heart failure risk scores (the abc health hf risk score, the framingham hf risk score) and an established norwegian cardiovascular risk score (norrisk 2) estimate the prevalence of likely ("undiagnosed") heart failure , i.e., patients at high risk of hf, in a general population by using both the established heart failure risk scores and the newly developed heart failure risk score, and compare the heart failure event rate between those at high risk of heart failure and those with established heart failure.

Eligibility criteria:
inclusion criteria: * participation in the third or second wave of the hunt study exclusion criteria: * not willing to participate * missing vital data

Keywords: risk factor population diagnosis prognosis
epidemiological investigation of helicobacter pylori-infected patients and the effect of eradication treatment on dyspepsia symptoms

Conditions: Helicobacter Pylori Infection; Dyspepsia

Summary: the objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with helicobacter pylori (h. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after h. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with h. pylori infection and dyspeptic symptoms.


Eligibility criteria:
inclusion criteria: * male or female patients aged 18-80 years * h. pylori infection diagnosed by 13c/ 14c-ubt (\> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive) * treatment-naive patients with helicobacter pylori * ability and willingness to participate in the study and to sign and give informed consent exclusion criteria: * under 18 or over 80 years old * organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc. * combined with melena, hematemesis, anemia, emaciation and other alarm symptoms * pregnant and lactating women * history of cancer * history of subtotal gastrectomy * severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade iv heart failure, liver failure, uremia, respiratory failure, hemophilia, wilson's disease, etc.

Keywords: helicobacter pylori infection dyspepsia
identification of the clinical specificities of complex posttraumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: identification of the clinical specificities of complex post-traumatic stress disorder post-traumatic stress disorder

in general, the current state of the literature in the field the lack of data on elements of characterization of ptsd compared to simple ptsd, which are which are essential for deciding on the discriminatory validity of discriminative validity of ptsd as a disorder in its own right disorder in its own right. the challenge of defining the nosographic scope of this disorder is twofold, since the links between diagnosis and treatment are decisive for developing treatments adapted to the treatments adapted to the psychopathology of the patients. these characterization elements are therefore crucial in order to improve the perspective of improving the effectiveness of future treatment which are currently lacking in tsptc.

Eligibility criteria:
inclusion criteria patient : * age ≥ 18 years * free, informed and signed consent * affiliated to a social security scheme inclusion criteria volonteer : * age ≥ 18 years * free, informed and signed consent * affiliated to a social security scheme exclusion criteria (patient and volonteer): * under legal protection (curatorship, guardianship, safeguard of justice) * present a former or current psychotic disorder, a former or current neurological disease, a history of head trauma (loss of consciousness of more than 10 minutes)
the efficacy of oxaliplatin plus s-1 for treatment of gastric cancer

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

there was no evidence of standard chemotherapy for advanced gastric cancer (agc) in china. fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of agc. capecitabine/cisplatin combination therapy showed an overall response rate (orr) of 41- 55%, a median time to progression/progression free survival (ttp/pfs) of 5.6-6.3 months, and a median overall survival (os) of 10.1-10.5 months. though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both s-1 and capecitabine appear to be comparable in terms of efficacy and safety. the investigators conducted a phase ii trial of oxaliplatin combined with s-1 in the treatment of first-line agc.

Eligibility criteria:
inclusion criteria: * histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma * measurable lesion and/or non-measurable lesion defined by recist * ecog performance status ≦ 1 * hgb ≧ 8g/dl, wbc 4000-12000/mm3, platelets ≧ 100,000/mm3 * creatine ≦ upper normal limit (unl) * total bilirubin ≦ 1.5 x unl * ast, alt and alp ≦ 2.5 x unl * subjects must be able to take orally * no prior chemotherapy * life expectancy estimated than 3 months * written informed consent exclusion criteria: * pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * known brain metastases * history of hypersensitivity to fluoropyrimidines, oxaliplatin * active double cancer * treatment with any investigational product during the last 4 weeks prior to study entry * symptomatic peripheral neuropathy ≧ garde 2. by nci-ctcae ver.3.0 * any previous chemotherapy or radiotherapy for agc

Keywords: stomach neoplasms drug therapy oxaliplatin s1
energy load in patients with acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: the investigator would assess if there is an incremental energy load during mechanical ventilation in acute respiratory distress syndrome (ards) patients.

the investigator would study the inspiratory and expiratory pressure volume curve in ards patients and investigate if there is a correlation between the energy loss (hysteresis curve) and the severity of disease.

Eligibility criteria:
inclusion criteria: * ards patients exclusion criteria: * pediatric population * chronic obstructive pulmonary disease (copd) * patients with hemodynamic instability