Kornimate/medical-research-clean huggingface dataset:
dyevert™ system for contrast monitoring in at-risk patients undergoing angiography: a real-world registry

Conditions: Patients at Risk for Developing Contrast-induced Nephropathy

Summary: the purpose of this registry-based study is to evaluate the ongoing, real-world clinical performance and safety of commercially available dyevert systems during typical clinical use for patients undergoing coronary or peripheral angiography for diagnostic and/or interventional procedures.

contrast-induced acute kidney injury (ci-aki) occurs in 3-19% of patients undergoing coronary angiography and is associated with increased morbidity, mortality, and healthcare costs. patients with chronic kidney disease have greater odds of developing ci-aki. guidelines for ci-aki prevention include screening for risk, volume expansion, and minimizing contrast media volume (cmv) to the patient during angiography; however, hospitals face barriers to implementation in the real-world setting and therefore consistent care delivery for at-risk patients remains a modern clinical challenge. dyevert systems provide real-time cmv monitoring and minimization during angiography procedures thereby reducing total cmv to the patient and total cmv relative to baseline renal function, two known risk factors for ci-aki. the dyeminish registry is designed to evaluate ongoing real-world clinical performance and safety of commercially available dyevert systems among a large, real-world population of patients undergoing coronary and peripheral angiography.

Eligibility criteria:
inclusion criteria: * dyevert group patients: patient underwent a diagnostic and/or interventional angiography procedure in which the dyevert system was used in a majority of the case * patient is willing and able to provide appropriate informed consent (if required) exclusion criteria: * required data was not collected or is not available * in the investigator or sponsor's opinion, the patient is not considered to be suitable
randomized fixed bearing vs mobile bearing cruciate retaining tka

Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Juvenile Rheumatoid Arthritis; Avascular Necrosis of Bone

Summary: the purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. outcome scoring and radiographic assessment will be the methods used to evaluate performance.

this study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. this will be done by obtaining a series of primary total knee replacements. patients will receive either the p.f.c.® sigma™ rotating platform cruciate retaining knee system or the p.f.c.® sigma™ fixed cruciate retaining knee system and assignment is randomized.

Eligibility criteria:
inclusion criteria: * osteoarthritis * rheumatoid arthritis * other inflammatory arthritis * avascular necrosis of bone exclusion criteria: * prior ipsilateral tka * metabolic disorders * joint replacement due to autoimmune disorders
odontoid fracture study treated with pulsed electromagnetic fields

Conditions: Odontoid Fracture Type II

Summary: the hypothesis of this study is that pemf treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with type ii odontoid fractures, and this effect will be evident by 6 months post-injury. subjects will be assessed for the presence of a type ii odontoid fracture by x-ray, mri and ct scan. subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. x-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. a ct scan will be performed at 6 months to confirm healing. quality of life measures (sf-36, vas neck pain scale, ndi) will be collected at all visits (6 weeks, 3, 6 and 12 months). study subjects will receive either an active orthofix cervical-stim model 2205od or an inactive (placebo) orthofix cervical-stim model 2205od device.


Eligibility criteria:
inclusion criteria: * subjects must be 50 years of age or older at the time of consent * subject must have radiographic evidence (x-ray , mri and ct scan) of a type ii odontoid fracture * subject must have mri evidence that the fracture occurred within 30 days of study enrollment * subject must have vas neck pain score of greater than 4 (\>4) * subject must have radiographic evidence that the fracture is displaced ≤ 5 mm in any direction and/or have a fracture gap of ≤ 3 mm due to angulation * subject must use a rigid cervical collar (miami j, philadelphia or aspen) for a minimum of three months post-injury * subject must have a dexa scan within 6 months prior to enrollment (can be done within one week of baseline visit) * subject must be willing and able to follow all study procedures and return for all study visits * subject must be willing to sign an informed consent document exclusion criteria: * subject has undergone systematic administration, within 30 days prior to the fracture, of any type of corticosteroid, antineoplastic, immunostimulation or immunosuppressive agents * subject is on chronic anticoagulation, or has a bleeding disorder * subject is pregnant, nursing or plans to become pregnant during the study * subject has a chronic type ii odontoid fracture that occurred more than 21 days prior to enrollment * subject has a type ii odontoid fracture displaced \>5 mm * subject has a mental or physical condition that would prevent him from complying with the study protocol, including the physician obtaining an accurate neurologic exam * subject was recommended for surgery to treat the fracture but subject refused surgery * subject is a prisoner * subject has participated in another clinical trial within the last 90 days

Keywords: pemf odontoid fracture ide prospective
prediction of survival in children with cystic fibrosis using the multiple-breath washout

Conditions: Cystic Fibrosis; Death; Lung Transplantation

Summary: retrospective cohort study using routinely collected annual data on lung clearance index (lci) in combination with clinical data to predict survival in patients with cystic fibrosis. the primary study endpoint is the association of lci with the compound outcome survival or lung transplantation in patients with cf.

retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with cf aged 3 years or more between 01.01.1980 and 31.12.2005. the overall aim of this project is to retrospectively assess whether lci measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. for this, the investigators will assess in a systematic way clinically measured lci and relate them with the compound outcome survival or lung transplantation retrospectively.

Eligibility criteria:
inclusion criteria: * patients treated at the children's hospital bern * confirmed cf diagnosis * age \>= 3 years exclusion criteria: * uncertain diagnosis of cf according to current standards * existing written or otherwise documented refusal to participate in research

Keywords: multiple-breath washout, mbw lung clearance index, lci prediction survival cystic fibrosis, cf
the indian polycap study (tips)

Conditions: Cardiovascular Diseases

Summary: study title a randomized double-blind controlled trial of the efficacy and safety of the polycap® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor. study objectives this study is designed to assess the efficacy and safety of the polycap®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ace inhibitor, a diuretic and a statin. study design randomized controlled double-blind trial of the polycap® versus its components in eight formulations. study population subjects between 45 and 80 years of age, with at least one additional cvd risk factor. investigational products composition polycap® and its comparators follow up the total duration of follow up will be 4 months, from the start of study medication.. subjects will take study medication for 3 months. there will be a final follow up visit 1 month after stopping the study medication. there will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment. outcome measures mean difference of change in bp, ldl and urinary thromboxane at the end of the three month period. statistical issues non-inferiority evaluation of the polycap in modifying bp, lipids and platelet activity \[as measured by urinary thromboxane\] when compared with its different components in eight different formulations.


Eligibility criteria:
inclusion criteria: * age between 45 and 80 years * at least any one of the following cvd risk factors: * stable type 2 diabetes mellitus or * hypertension or * current smoker or * a waist to hip ratio \> 0.85 for women and \>0.9 for men or * elevated lipids. * informed consent. exclusion criteria: * on any of the study medications, * uncontrolled blood pressure, * symptomatic hypotension, * any clear indication or a contraindication to the use of any of the study medications, * history of coronary/cerebrovascular events, * pregnancy or lactating or women of child-bearing potential with inadequate contraception and / or an inability to attend follow up visits.

Keywords: polycap, primary prevention,cvd
a two-session exposure treatment and parent training for arfid

Conditions: Avoidant Restrictive Food Intake Disorder

Summary: this study aims to assess the acceptability, feasibility, and preliminary efficacy of a two-session, virtual parent-training exposure protocol for children ages 5-12 who experience picky eating consistent with an avoidant-restrictive food intake disorder (arfid) diagnosis.

potential subjects aged 5 to 12 years with picky eating symptoms consistent with an arfid diagnosis, as determined by the pica, arfid, rumination disorder interview, a semi-structured diagnostic interview, will be recruited via social media and local doctor's offices. eligible subjects will complete informed consent and an intake session. participants will then be randomized to an immediate treatment group, in which they will begin treatment the following week, or a 4-week waitlist condition, in which they will wait four weeks to begin treatment. all participants will have the opportunity to receive the treatment, arfid parent training program or "arfid-ptp." arfid-ptp was adapted from a seven-session parent-training for extremely picky eating behaviors to examine the efficacy of a two-session, virtual protocol on increasing food intake and decreasing selective eating. the two virtual treatment sessions will include psychoeducation, parent-training skills, and exposure protocol. there will be 5 major assessment time points: intake, end of treatment, 4-weeks post-treatment, 3-months post-treatment, and 6-months post-treatment.

Eligibility criteria:
inclusion criteria: * children ages 5-12 * child meets criteria for arfid using the pica, arfid, rumination disorder interview * established care with a primary care provider * not engaging in other medication or psychotherapy for arfid during this treatment trial * fluently speak and read english exclusion criteria: * child or parent experiencing suicidal thoughts * child or parent experiencing psychotic symptoms * child has a cognitive functioning disability

Keywords: parent training exposure arfid picky eating brief intervention virtual intervention
chinese alliance for type 1 diabetes multi-center collaborative research

Conditions: Type 1 Diabetes Mellitus

Summary: the china alliance for type 1 diabetes (cat1d) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.

1. through the cat1d, expand the cohort construction of type 1 diabetes patients and first-level relatives in china, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in china. 2. observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in china, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications. 3. through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for chinese people and medical background. 4. by using mobile health (mhealth) and artificial intelligence (ai) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with type 1 diabetes according to the 1999 world health organization report * written informed consent from the patient or family representative; * individuals who own smartphone and are capable of using wechat or apps exclusion criteria: * non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (aps) are the first disease * with mental disorders * have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
the efficacy of treatment for helicobacter pylori infection in preschooler by yoghurt with lg21

Conditions: H. Pylori Infection

Summary: the goal of this randomized, open-label, interventional trial is to study the efficacy of treatment for helicobacter pylori infection in preschooler aged 4-6 by meiji yoghurt with lg21. the main question it aims to answer is: - whether the treatment by meiji yoghurt lg21 is effective by stool antigen (hpsa) test 140 qualified participants will be enrolled and randomized into 2 groups of the same size (product study group and blank control group). participants of the product study group will need to eat assigned meiji yoghurt for 12 weeks, one bottle each day, while participants of the blank control group won't receive any intervention during the study. four visits will be made for all participants, and relevant clinical data will be captured and recorded into ctms (clinical trial management system) for statistical analysis and reporting.


Eligibility criteria:
inclusion criteria: * preschooler aged 4-6 years * h. pylori positive * drink milk or milk beverages regularly (more than three times a week) before joining the study * icf signed * parents or guardians agree not to participate in other interventional clinical studies during this study exclusion criteria: * has potential metabolic class or chronic disease * use of antibiotics within 7 days before randomization (as judged by the trial responsible physician) * people who have been treated for eradication of helicobacter pylori * pharmaceuticals, medicinal skin care products (medical external products) and health foods that may affect gastric symptoms have been commonly used since more than one month ago * already under digestive system treatment * has lactose intolerance or protein allergy * those whose families had plans to leave jinhua city during the study period * fails to comply with the provisions of the protocol * those who are deemed unsuitable as subjects by the physician

Keywords: meiji yoghurt lg21 helicobacter pylori stool antigen test preschooler
compassionate use of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this program is designed to provide access to pozelimab and cemdisiran and document the long-term safety of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria (pnh). pnh is a rare immune disease that causes red blood cells in your body to break apart.


Eligibility criteria:
key inclusion criteria: 1. patients who have completed either the end of treatment visit of the open-label treatment period or open-label extension period in one of the following parent studies: * an open-label extension study to evaluate the long-term safety, tolerability, and efficacy of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria (r3918-pnh-2050 \[nct05744921\]) * a randomized, open-label, two-arm study to evaluate the safety, efficacy, and pharmacodynamic effects of pozelimab and cemdisiran combination treatment in patients with paroxysmal nocturnal hemoglobinuria who have received pozelimab monotherapy (r3918-pnh-2092 \[nct04811716\]) * a single arm, open-label study to assess the safety, efficacy, and pharmacodynamic effects of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria who switch from eculizumab therapy (r3918-pnh-20105 \[nct04888507\]). note: in some countries, patients that would normally enter into the r3918-pnh-2050 (nct05744921) parent study before entering this expanded access program, may be given the opportunity to skip r3918-pnh-2050 (nct05744921) and go straight into this expanded access program, with regeneron's permission 2. patients who have been enrolled in r3918-pnh-2022 (nct05131204), with regeneron's permission 3. willing and able to comply with clinic visits and related standard-of-care procedures 4. with regeneron's permission, patients who have been enrolled in other pnh studies as appropriate key exclusion criteria: 1. significant history or concerns of non-compliance that could impact the patient's safety per the treating physician 2. any new condition or worsening of an existing condition which, in the opinion of the treating physician, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the program note: other protocol defined inclusion / exclusion criteria apply
optimal timing of postoperative magnetic resonance imaging (mri) in patients with extradural spinal

Conditions: Spinal Tumor

Summary: this research study is evaluating suitability of a delayed magnetic resonance imaging (mri) in management of spine tumors. currently the standard of care is obtaining an mri scan in the early postoperative period (within 72 hours after surgery). the purpose of this study is to see if delayed mri (2 to 3 weeks after surgery) is similar in quality to the earlier mri. in this study patients will undergo 2 mris after the surgery instead of one mri. patients will have one mri about 3 days after the surgery and one mri about 2-3 weeks after surgery.

primary aim: assess if magnetic resonance imaging (mri) at 2 to 3 weeks after surgery leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative mri. secondary aims: investigate the differences between early and late mri by comparing: * size of tumor in three dimensions; * extent of edema; * presence and extent of fluid collection; * spine oncology study group score; * involvement of adjacent levels; * progression of tumor; * patient's preference/performance scale right after each image had taken: level of discomfort at around the time each mri was performed. study design: this is a prospective diagnostic study for which no standard of care currently exists.

Eligibility criteria:
inclusion criteria: * metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space * operated for debulking, decompression or separation surgery; * a magnetic resonance imaging (mri) scan performed within 72 hours after surgery is needed; * image quality acceptable for comparison with later mri as read by a neuroradiologist; * karnofsky score of 60 or higher; * able to consent for the study. exclusion criteria: * any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes. * intradural extension of the tumor. * patients, whose mri at post operative 48-72 hours are not readable due to artifacts or disease process shall not be included in the study. * patient not able to tolerate mri scan due to claustrophobia or severe pain or allergic reaction to contrast. * patients with an estimated glomerular filtration rate (egfr) \< or = to 30 will be excluded to avoid issues related to contrast administration in such patients. this glomerular filtration rate (gfr) threshold cutoff level is chosen per institutional policy, because below that level other measures would be required (hydration or no contrast administration). in order to keep the imaging information as uniform as possible in such a small study group, patients with a low gfr will not be enrolled in the study.

Keywords: magnetic resonance imaging
the effect of pregabalin on pain of propofol injection

Conditions: Pain

Summary: pain is a common side effect of propofol injection. the purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.

in a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group l), oral pregabalin 75 mg (group lp), and oral pregabalin 150 mg (group hp) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).

Eligibility criteria:
inclusion criteria: * patient underwent elective dental surgery. exclusion criteria: * patient with a history of adverse response to lidocaine or pregabalin, * patient with cardiovascular or respiratory disease, * patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.

Keywords: propofol lidocaine pregabalin
ipti in mozambican infants for malaria prevention

Conditions: Malaria

Summary: to evaluate if intermittent preventive treatment in infants (ipti) consisting of sp \[fansidar\] given through the epi scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age

the study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the epi scheme at the time of routine immunisations. children will be randomized into placebo and sp treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group. doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (sp) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those \ 10 kg). the tablets will be crashed and diluted with water for their administration.

Eligibility criteria:
inclusion criteria: * children from study area * signed informed consent exclusion criteria: * history of drug allergies