Kornimate/medical-research-clean huggingface dataset:
woe of anti-cd20 therapies

Conditions: Multiple Sclerosis

Summary: the nature, intensity, and prevalence of this wearing-off effect remain poorly understood. to our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. the current study will explore the wearing-off effect associated with ocr and omb, using a variety of validated scales assessing ms symptoms (i.e., fatigue, mobility, pain, depression, cognition), as well as some global questions on wearing-off. in addition, impact of worsening of ms symptoms on patients' health-related quality of life (hrqol) and their work productivity will be assessed using relevant ms-specific validated scales

this will be a non-interventional, primary data collection study in patients with ms treated with an established anti-cd20 treatment regimen (ocr or omb) in the united states. patients who satisfy the inclusion criteria and consent to participate in the study will be surveyed at four timepoints at the beginning and the end of ocr or omb treatment cycles according to the following assessment schedule: * assessment 1. 0-10 days before 1st dose post-enrollment (index dose) * assessment 2: 5-14 days after index dose * assessment 3: 0-10 days before 2nd dose post-enrollment (follow-up dose) * assessment 4: 5-14 days after follow-up dose dose

Eligibility criteria:
inclusion criteria: ocr sample: * self-reported diagnosis of rms, spms or cis * ≥21 years old at the time of initial contact * under treatment with ocr at the time of initial contact * have been on ocr for ≥ 1 year at the time of initial contact (i.e., prevalent users) * able to answer the questionnaires in english omb sample * self-reported diagnosis of rms, spms or cis * ≥21 years old at the time of initial contact * under treatment with omb at the time of initial contact * have been on omb for ≥6 months at the time of initial contact (i.e., prevalent users) * able to answer the questionnaires in english exclusion criteria: ocr sample: * currently participating in a clinical trial involving ms drugs * last ocrevus infusion was less than 3 months back omb sample: currently participating in a clinical trial involving ms drugs

Keywords: nis anti-cd20 therapies multiple sclerosis ocr ocrevus omb kesimpta
bursa augmentation in arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Summary: the aim of this first study is to investigate in a case series through sequential sonographic imaging, using doppler ultrasonography, the postoperative morphology, especially vascularity and findings of neovascularity, after bursa augmentation in arthroscopic rotator cuff repair.

the outcome of rotator cuff (rc) reconstruction with and without bursa augmentation, considering also the inflammatory status of the bursa, will be systematically investigated for the first time. the influencing role of the inflammatory status of the bursa, of the rc tendon and the synovial membrane at the time of the operation on the tendinous healing rate, the patient-relevant outcome factors and the revision rate will be assessed. in a further approach, basic knowledge about the role of bursa inflammation and its influence in the development and regeneration of tendon pathologies shall be gained. the findings of the whole project could lead to improve tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.

Eligibility criteria:
inclusion criteria: * patient aged 18 years and older * patient with c-shaped posterosuperior rotator cuff tear (ssp / ± isp, ± scp tear lafosse ≤ 1 (scp no repair, only debridement)) * retraction ≤ 2 according to patte * fatty infiltration ≤ 2 according to goutallier * eligible for arthroscopic double row rotator cuff repair in suture bridge technique. * written informed consent exclusion criteria: * legal incompetence * last subacromial cortisone infiltration ≤ 6 months * systemic rheumatologic-inflammatory disease * diabetes mellitus * smoker

Keywords: arthroscopic rotator cuff repair bursa augmentation neovascularization doppler ultrasonography
clinical trial to evaluate the efficacy of bifidobacterium bb-12® in the treatment of infantile colic

Conditions: Infantile Colic; Colic, Infantile

Summary: this is a single-center, randomized, double blind controlled study to investigate the effects of bifidobacterium, bb-12® versus placebo in a study group of pediatric patients with infantile colic.


Eligibility criteria:
inclusion criteria: patients are included in the study if they meet all the following criteria: * exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks. * diagnosis of ic according to rome iii criteria. * written informed consent of the parent/tutor. exclusion criteria: patients are excluded from this study if they meet any of the following criteria: * birth weight \< 2500 g. * gestational age \< 37 weeks. * apgar 5 minutes \< 7. * formula feeding. * stunting/loss of weight (\< 100 g/weeks from birth to the last reported weight). * neurological diseases. * known or suspected food allergy. * gastroesophageal reflux disease. * use of substances that alter gut microbiota (probiotics, prebiotics, antibiotics, gastric acidity inhibitors) in the last 2 weeks prior the enrollment. * history of fever and/or infectious diseases in the last 2 weeks prior to enrollment. * ongoing systemic infections. * history of congenital infections. * chronic intestinal diseases (cystic fibrosis or other forms of primitive pancreatic insufficiency) * primitive or secondary malformations of the gastrointestinal tract (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation). * metabolic diseases. * genetic diseases and chromosomal abnormalities. * primary or secondary immunodeficiencies. * not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the protocol. * previous participation in this study.

Keywords: bifidobacterium
effects of monounsaturated fatty acids on intestinal lipid metabolism in insulin resistant subjects (mufa )

Conditions: Metabolic Syndrome

Summary: the overaccumulation of apolipoprotein (apo)b-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (cvd) risk. therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins à (trl) levels of intestinal origin appears to be crucial to improve cvd risk associated with insulin-resistance. in this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (sfas) by monounsaturated fatty acids (mufas) reduces cvd risk in the general population. although the beneficial impact of pufas on cvd risk has been related primarily to favorable changes in plasma ldl-cholesterol levels, recent data suggest that chronic mufa consumption may also exert beneficial effects on cvd risk by reducing postprandial lipemia. the impact of substituting sfas by mufas on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal trls represent a large proportion of the atherogenic lipoproteins. the general objective of the proposed research is to investigate how dietary mufas in place of sfas modify intestinal lipoprotein metabolism in men and women with dyslipidemia associated with insulin-resistance. the investigators hypothesize that the intestinal secretion of apob-48-containing lipoproteins will be lower following a diet rich in mufas than after consuming a diet rich in sfas. the investigators also hypothesize that substitution of sfas by mufas will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.


Eligibility criteria:
inclusion criteria: * men and women aged between 18-60 years * waist circumference \> 102 cm (men) and \> 88 cm (women) * hdl-cholesterol \< 1.1 mmol/l (men) and \< 1.3 mmol/l (women) * triglycerides \> 1.7 mmol/l * fasting blood glucose \> 6.1 mmol/l * normal blood pressure (\<130/85) exclusion criteria: * men and women \ 60 years * smokers (\> 1 cigarette/day) * body weight variation \> 10% during the last 6 months prior to the study baseline * subjects with a previous history of cardiovascular disease * subjects with type 2 diabetes * subjects with a monogenic dyslipidemia * subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa * subjects with endocrine or gastrointestinal disorders * history of alcohol or drug abuse within the past 2 years * subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
stratifying critically ill patients for novel ferroptosis or pyroptosis intervention strategies

Conditions: Sepsis; Trauma Related Injuries; Subarachnoid Haemorrhage (SAH)

Summary: in order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (icu) , one has to determine which underlying mechanism is causing this organ falure. we will determine levels of so called "biomarkers" for ferroptosis (a mechan ism of iron-related cell death) in the peripheral blood and biological fluids of criticaly ill patients admitted to the icu with a catastrrophy (severe infection, trauma ...) . why ? if it turns out that this ferroptosis plays a role in the ocurrence of organ failure in the critially ill, this will lead to new therapies in the future as drugs become more and more available which can influene this biochemical "pahway". of iron-relatd death.


Eligibility criteria:
inclusion criteria: * admitted to the icu of uza * critically ill and predicted to be hospitalised in the icu for \> 48 hours (i.e. mostly patients admitted for sepsis, trauma, haemorrhagic shock, neurological catastrophe ... which means at risk to develop mono-or multiple organ failure) * with arterial line in place (for blood sampling) exclusion criteria: * refusal of consent by patient or closest relative * postoperative patients after major surgery in whom prolonged icu stay is not foreseen (i.e. elective cardiac surgery
efficacy of bromfenac ophthalmic solution in patients undergoing cataract surgery

Conditions: Pain; Inflammation; Cataract

Summary: this is an efficacy study of bromfenac ophthalmic solution in cataract surgery.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age who are scheduled for unilateral cataract surgery exclusion criteria: * have known hypersensitivity to bromfenac or to any component of the investigational product

Keywords: cataract surgery
sonodynamic therapy manipulates atherosclerosis regression trial on patients with carotid atherosclerotic plaques

Conditions: Carotid Atherosclerosis

Summary: sonodynamic therapy (sdt) is a new treatment for carotid atherosclerotic plaque. the aim of this study is to assess the safety and efficacy of this technique.

carotid atherosclerotic plaque is an important cause of ischemic stroke, causes about 30% stroke/tia attacks. patients with carotid stenosis face an escalated risk of mi, pad, and death. treatments for patients with carotid plaque include lifestyle changes, medical management(such as control of hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid endarterectomy or carotid artery stenting). studies have suggested that plaque morphology and composition are important determinants of plaque stability, using serial mr imaging of the carotid artery allowed observation of changes in plaque composition. contrast enhanced ultrasound (ceus) is a well accepted technique for detection of intraplaque neovascularization(ipn) in carotid atherosclerotic disease. the aim of this trial is to assess the safety and efficacy of sdt. the sdt can induce macrophage elimination and inhibiting matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction. an estimated 80 eligible patients will be randomly divided into two groups: optimal medical care (omc) combined with pseudo-sdt and omc combined with sdt. recruitment will be performed over 1 year and patients will be followed for 3 months; the anticipated total study duration will be 2 years.

Eligibility criteria:
inclusion criteria: * age 18- 80 years * carotid artery with 30%\~70% stenosis by ultrasound and plaque thickness\>2.5mm * patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months * patients' ldl-c level below 100 mg/dl(2.6mmol/l), well-controlled blood pressure(systolic bp\<140 and diastolic bp\<90 under resting conditions) and diabetes(hba1c\<7%) * written informed consent exclusion criteria: * non-atherosclerotic carotid artery stenosis * contraindication to mri( uses pacemaker, has metallic implants, claustrophobia) * acute mi, acute coronary syndrome or stroke within 4 weeks prior to visit or during run-in * severe cerebral artery stenosis, atrial fibrillation or mri detected thrombosis that would cause stroke * previous significant adverse reaction to a statin * systemic disorders such as hepatic, renal, hematologic, and malignant disease * medical history that might limit the individual's ability to take trial treatments for the duration of the study * allergic to dvdms or sonovue * diagnosis of porphyria * pregnant women and nursing mothers * history of bilateral carotid endarterectomy or has immediate plans for carotid endarterectomy * not willing to be randomized into the 3 months trial * patient who is attending other clinical trial
virtual parental presence on induction of anesthesia vs premedication with midazolam

Conditions: Anxiety; Surgery

Summary: this multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. the primary objective of this study is to assess the modified yale preoperative anxiety scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. patients will be randomized to one of two groups by block randomization.


Eligibility criteria:
inclusion criteria: * children from ages 4 years to 8 years old undergoing outpatient surgery * children identified as needing premedication * asa physical status i, ii or iii * planned inhalational induction * children presenting from home prior to surgery (not an inpatient) * english speaking parents and child exclusion criteria: * children with developmental delay * children with psychological / emotional disorders * children with altered mental status * children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team * children with language barrier * children who are not accompanied by someone able to consent (ie legal guardian) * children who are inpatient prior to surgery * children with expected difficult intubation/airway * children presenting for emergency surgery * family history or personal history of malignant hyperthermia / risk of mh * consent not obtained or withdrawal of consent * children with past history of violent behaviors during induction of anesthesia * cancellation of surgery * patients with a diagnosis of covid-19 or a patient under investigation for covid-19, including patients being treated with airborne precautions in the operating room * receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.
ovarian cancer risk estimation in patients with pelvic mass

Conditions: Adnexal Mass; Ovarian Cancer

Summary: the purpose of this study is to determine whether the risk of ovarian cancer algorithm (roma) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass. after informed consent is obtained, an initial cancer risk assessment will be made. a blood sample will be collected within 30 days of the surgical procedure. results of the surgical procedure will be collected and analyzed against the ca125 and he4 results used in the calculation of the roma.


Eligibility criteria:
inclusion criteria: * female, age ≥ 18 years * adnexal mass present documented by imaging * scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis) * able to understand and willing to provide informed consent exclusion criteria: * previous history of ovarian cancer * previous history of bilateral oophorectomy * currently known to be pregnant * unable to provide informed consent

Keywords: pelvic mass ovarian cancer adnexal mass ca125 he4
patient -ventilator interaction in chronic respiratory failure

Conditions: Chronic Hypercapnic Respiratory Failure; Obesity Hypoventilation Syndrome; Neuromuscular Disease; Chronic Obstructive Pulmonary Disease

Summary: to evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (niv) in neuromuscular disease (nmd), chest wall disease (cwd), chronic obstructive pulmonary disease (copd) and obesity hypoventilation syndrome (ohs) patients. by enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. we aim to incorporate this technology into routine clinical practice.


Eligibility criteria:
inclusion criteria: 1. patients over the age of 16 years. 2. patients with confirmed diagnosis of duchenne muscular dystrophy or chronic obstructive pulmonary disease or obesity hypoventilation syndrome. 3. patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of \>6.0 kpa in the morning. 4. patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of \>6.0 kpa during the day. 5. no prior domiciliary ventilation. exclusion criteria: 1. patients with other co-morbidities e.g. cancer or cardiac failure. 2. patients with muscular weakness but an unconfirmed diagnosis of duchenne muscular dystrophy, obesity hypoventilation syndrome or chronic obstructive pulmonary disease. 3. patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation. 4. patients who have an abnormal bleeding tendency (inr or apttr \>1.4 or platelets \<100). 5. patients with a psychological, social or geographical situation that would impair compliance with the project.
effects of sensory stimulation versus sensorimotor therapy on spasticity, motor function and daily activities in stroke

Conditions: Stroke, Ischemic; Proprioceptive Disorders; Sensory Defect

Summary: to compare effects of exteroceptive and proprioceptive sensory stimulation versus sensorimotor therapy on spasticity, motor function and activities of daily living in patients with stroke

it will be a randomized clinical trial in which total 42 stroke patients will be recruited through non probability convenience sampling techniques. data will be collected from gujranwala medical college teaching hospital and riphah rehabilitation center lahore. the patients who are fulfilling the inclusion criteria will be randomly assigned to either group a (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation or to group b (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks. baseline treatment will be given to both groups. conventional therapy will be given for 20 minutes per session, 03 times a week, for 06 weeks. data collection tools will be fugl-meyer assessment, modified barthel index and modified ashworth scale.

Eligibility criteria:
inclusion criteria: * the patients with chronic stroke (6 months to 2 years) * patient 's muscular activity on stage 3 or higher according to the brunnstrom's stages of stroke recovery. * patients having mini mental state examination score \> 24 exclusion criteria: * significant musculoskeletal impairments (e.g., arthritis, joint contractures). * any other neurological disorders like multiple sclerosis, parkinson 's disease. * history of orthopaedic surgery. * unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease). * severe visual or vestibular impairments. * lower limb prosthesis.

Keywords: stroke, ischemic proprioceptive disorders sensory defect
xishui project for idm of copd and comorbidities

Conditions: Chronic Obstructive Pulmonary Disease; Comorbidities and Coexisting Conditions

Summary: study population: 4000 stable copd patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications. design: cohort study primary objectives: the primary objective of this study is to access the effectiveness of idm on changes in fev1 from baseline to the 24th week visit in patients with copd. statistical analysis: we plan to compare demographic differences between groups based on whether the data conformed to normal distribution and satisfied variance chi-square, and proposed to calculate p-values using the t-test or non-parametric test for continuous data and person's χ² or non-parametric test for categorical data. a two-sided p-value \< 0.05 is considered statistically significant.


Eligibility criteria:
inclusion criteria: * aged ≥40 years; * stable copd patients with post-bronchodilator fev1/fvc \<70% or previously diagnosed of copd by physicians and confirmed by pft; * with/without diabetes and/or hypertension; * permanent resident of xishui (not expected to leave the area within 1 year). exclusion criteria: * suffering from severe cognitive disorders or total loss of ability of daily living. * death.

Keywords: effectiveness of integrated disease management multimorbidity management prosepective cohort study