Kornimate/medical-research-clean huggingface dataset:
open label extension study of ht-100 in patients with dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this study is designed to provide 6-months continuous dosing with the study medication, called ht-100, on participants who successfully completed the predecessor study (halo-dmd-01). the main purpose of this study is to assess chronic safety, tolerability, pharmacodynamic activity (testing the drug's effect on dmd) and population pharmacokinetics (measuring how much drug is in the bloodstream) in participants with a broad spectrum of duchenne muscular dystrophy (dmd).


Eligibility criteria:
inclusion criteria: * completed both the single ascending dose (sad) and multiple ascending dose (mad) phases of predecessor study halo-dmd-01 * maintained the same corticosteroid therapy from the predecessor study halo-dmd-01 * ability to provide written informed consent * ambulatory or non-ambulatory exclusion criteria: * recent, substantial change in use of cardiac medications or medications affecting muscle function * clinically significant major disease, not related to dmd * significantly compromised cardio-respiratory function * history of severe allergic or anaphylactic reactions * prior treatment with another investigational product in past 6 months * inability to undergo magnetic resonance imaging (mri) * current drug or alcohol abuse or prior treatment for abuse

Keywords: duchenne muscular dystrophy halofuginone hydrobromide anti-fibrotic anti-inflammatory muscle regeneration protein synthesis inhibitor
ibi322 monotherapy or combination therapy in subjects with advanced malignant tumors.

Conditions: Advanced Solid Tumor

Summary: the phase ia study was designed to evaluate the tolerability, safety, pk, pd, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. phase ib study was designed to evaluate the safety and initial efficacy of ibi322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. investigators and sponsors determine the recommended dose of ibi322 for phase ib based on pk, pd, safety and efficacy data obtained during phase ia.


Eligibility criteria:
inclusion criteria: 1. histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors. 2. per recist1, at least one evaluable or measurable lesion. 3. male or female subject above 18 years old, no more than 75 years old. 4. eastern cooperative oncology group performance status (ecog ps) performance status 0 or 1. 5. must have adequate organ function exclusion criteria: 1. previous exposure to any anti-cd47 monoclonal antibody, sirpα antibody, or cd47/sirpα recombinant protein. 2. direct coombs test was positive or have history of hemolytic anemia. 3. subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies. 4. patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. patients with a history of a bleeding diathesis (von willebrand disease, end stage liver disease, hemophilia, etc.) 5. subjects who have a history of blood transfusion within 2 weeks prior to the study.
randomized controlled rsa study comparing the taperloc complete versus the taperloc complete microplasty.

Conditions: Hip Osteoarthritis; Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Correction of Functional Deformity; Rheumatoid Arthritis

Summary: this is a single center, prospective, randomized controlled study. the primary objective of this study is to measure migration over two years with rsa. patients will be randomized in two arms, receiving a taperloc complete reduced distal or a taperloc complete microplasty hip stem.

a total of 50 patients will be enrolled into the study, randomized 1:1. all patients will receive a g7 limited hole acetabular cup with e1 liner. all potential study subjects will be required to participate in the informed consent process.

Eligibility criteria:
inclusion criteria: * non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis. * correction of functional deformity. * male or female -≥ 18 and ≤ 70 years of age * subjects willing to return for follow-up evaluations. * subjects able to read and understand dutch language. exclusion criteria: * active infection (or within 6 weeks after infection) * sepsis * osteomyelitis * uncooperative patient or patient with neurologic disorders who are incapable of following directions * diagnosed osteoporosis or osteomalacia * metabolic disorders which may impair bone formation * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy or neuromuscular disease.

Keywords: total hip arthroplasty medical device performance safety hip prosthesis roentgen stereophotogrammetric analysis
end tidal carbon dioxide in minimal sedation

Conditions: Complication of Anesthesia

Summary: this randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.


Eligibility criteria:
inclusion criteria: * pediatric patients undergoing minimal sedation for procedure. exclusion criteria: * none
time spent in target glucose range in women with t2d diabetes in pregnancy

Conditions: Diabete Type 2; Pregnancy in Diabetic

Summary: prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard cgm measures and functional data analysis


Eligibility criteria:
inclusion criteria: 1. women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a hba1c of \>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g ogtt. to make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above. 2. ≤14 weeks gestation, 3. age ≥18 years 4. willingness to use the study devices a minimum of 10 days per trimester 5. able to provide informed consent 6. have access to email exclusion criteria: 1. non-type 2 diabetes 2. current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids 3. known or suspected allergy against insulin 4. women with nephropathy (egfr\<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results 5. severe visual or hearing impairment, as judged by the investigator to impact treatment compliance 6. unable to communicate effectively in english as judged by the investigator 7. any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results

Keywords: glucose range neonatal outcomes glycemic control hypoglycemia insulin resistance preganant pregnancy cgm continuous glucose monitoring dexcom maternal outcomes pregnancy in diabetes
validation of ejection fraction and cardiac output using biostrap wristband

Conditions: Heart Failure

Summary: in this study, the investigators will compare the accuracy of the biostrap wristband, a wearable device with a clinical-grade photoplethysmography (ppg) sensor, to measure ejection fraction and cardiac output in patients undergoing a cardiac ultrasound and pulmonary arterial catheterization, respectively.

this in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac icu patients with pulmonary arterial catheters featuring biostrap wristband. this is a single site, non-blinded, non-randomized study. the wristband is a wearable device that contains a clinical-grade photoplethysmography (ppg) sensor which will measure parameters quasi-continuously and non-invasively. the device, biostrap wristband, will measure cardiac ejection fraction (ef) and cardiac output (co). we will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days. the investigators will perform a retrospective analysis comparing the accuracy of ef and co measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. cardiac ultrasound and pulmonary arterial catheters are standard of care procedures.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age. 2. subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1 or are scheduled for/completed a pilmonary arterial catheterization for group 2. 3. written informed consent obtained from subject and ability for subject to comply with the requirements of the study. exclusion criteria: 1. subject is unable or unwilling to wear the wristband for the required duration.

Keywords: ejection fraction cardiac output
social cognition in dystrophinopathies and neurodevelopmental disorders

Conditions: Duchenne / Becker Muscular Dystrophy; Osteogenesis Imperfecta (OI); Social Cognition

Summary: the primary aim of this observational study is to investigate specific aspects of social cognition in dystrophinopathies. body awareness, interpersonal distance and emotional processing will be measured in a sample of patients affected by becker (bmd) and duchenne (dmd) muscular dystrophy, compared with a sample of patients affected by osteogenesis imperfecta (oi), and both compared with a control sample with typical development. the secondary aim is to study cortical activity at rest, by means of electroencephalography (eeg), to explore frequencies and time course of eeg responses. moreover, the relationship between eeg activity and neuropsychological, dispositional and subjective measures will be explored through correlational analyses.

study procedure includes: 1. eligibility assessment according to inclusion and exclusion criteria. 2. administration of questionnaires and scales for the characterization of cognitive and psychological features related with bmd/dmd and oi : wechsler intelligence scale for children 4th edition (wisc-iv), raven's progressive matrices; nepsy-ii; the child behavior checklist (cbcl); pedsql; toronto alexithymia scale (tas-20); emotion regulation questionnaire (erq); emotion regulation questionnaire for children and adolescents (erq-ca); multidimensional assessment of interoceptive awareness (maia); body shape questionnaire (bsq-14); and the autism spectrum quotient (aq, adult or child version) 3. administration of experimental tasks. the comfort-distance task (cdt) to measure the interpersonal comfort distance, the task will be implemented in immersive virtual reality by means of head-mounted displays (oculus ©2024 meta). interoceptive accuracy will be measured through a modified version of the heartbeat counting task. an emotional priming task will be administered in order to measure emotion processing, participants will be asked to detect trial by trial the target emotion which could be preceded by a congruent or incongruent visual priming. all the tasks will be performed in a counterbalanced order, for an overall duration of about 40 minutes. 4. recording of resting state eeg will be collected.

Eligibility criteria:
inclusion criteria: * patients diagnosed with duchenne and becker muscular dystrophy (genetic and histological diagnosis and clinical diagnosis) (ambulant and non-ambulant). * patients diagnosed with osteogenesis imperfecta. * control group: participants without any neurological or psychiatric disorder exclusion criteria: * presence of comorbid diagnoses, * sensory deficit * specific condition that could prevent the application of the tests and tasks under study, such as: a) the need for peg; b) the need for tracheostomy; c) the need for assisted ventilation. * cognitive level lower than 60.

Keywords: social cognition duchenne / becker muscular dystrophy osteogenesis imperfecta (oi) eeg interpersonal distance interoception
vibration response imaging (vri) in children with acute respiratory symptoms

Conditions: Pneumonia

Summary: the vri device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.

this study is a prospective, single center study to determine the value of vri images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints. study participants will be children, selected from the emergency department (ed), who were designated to undergo a pa and left lateral cxr because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever. patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the vri device. a technician will perform a cxr on the enrolled patients. the cxr and the vri will be performed on the same day within 6 hours of each other. vri readers, who are blinded to the patient's cxr, history, and physical exam, will evaluate the vri recording. the vri reader will review the vri images and, using the lexicon of images supplied by deep breeze, determine whether the vri is normal or abnormal. certified radiologists will review the patient's cxr and will determine whether the cxr is normal or abnormal based solely on the cxr. the vri readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal cxr for each subject.

Eligibility criteria:
inclusion criteria: 1. subject's parent or legal guardian, is able and willing to read the informed consent, understands the informed consent, and provides written informed consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian. 2. boy or girl in the age range of 3-18 years. 3. patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever. 4. patient referred by ed physician and presented for cxr. exclusion criteria: 1. body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture); 2. potentially contagious skin lesion on the back; 3. subject has had lung surgery; 4. subject was prescribed the cxr for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.

Keywords: to acquire database of pneumonia cases in children
asterix: low dose asa and nexium

Conditions: Gastroesophageal Reflux

Summary: the purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose asa.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose asa, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week). * age \>= 60 years. * no gastric and/or duodenal ulcer at the baseline endoscopy. * h. pylori negative by serology test at screening. exclusion criteria: * upper gi symptoms * erosive oesophagitis * malignancy

Keywords: prevention of gastroduodenal lesions erosive oesophagitis upper gi symptoms
ovarian reserve after ovarian hemostasis by floseal matrix

Conditions: Ovarian Cysts

Summary: laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of the ovarian wound ground using bipolar coagulation. however, the hemostasis with bipolar coagulation could result in the damage of ovarian reserve and decrease the response of the ovaries to hormonal stimulation for assisted reproductive technologies. the possible mechanism may contribute to thermal destruction of ovarian follicles by excessive use of bipolar coagulation for hemostasis purposes. to avoid additional ovarian tissue damage by conventional bipolar coagulation being potentially important ovarian reproductive function, hemostasis using various topical hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. among them, floseal (baxter healthcare corporation, deerfield, il, usa) is a hemostatic matrix sealant composed of a gelatin-based matrix and thrombin solution. on coming into contact with blood after application at a bleeding site, the gelatin particles swell and tamponade bleeding. the bulk of the gelatin matrix-thrombin composite has the effect of slowing blood flow and providing exposure to a high thrombin concentration, thus hastening clot formation. therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where there is superficially pervasive focus of bleeding. ovarian reserve is defined as the functional potential of the ovary, which reflects the number and quality of antral follicles left in the ovary, and is correlated with the response to ovarian stimulation using exogenous gonadotropin. serum anti-müllerian hormone (amh) has been accepted as the most reliable and easily measurable marker for postoperative assessment of ovarian reserve. the investigators conducted a multicenter, large-scale, randomized controlled trial to investigate whether hemostasis by floseal was superior to that by bipolar coagulation in preserving ovarian reserve by assessing serial amh levels in patients undergoing laparoscopic ovarian cystectomy for benign ovarian cysts.


Eligibility criteria:
inclusion criteria: * age between 18 and 45 years * maximum diameter of the cyst between 3 and 10 cm * regular menstrual bleeding (defined as cycle length less than 21 or more than 45 days) * appropriate medical status for laparoscopic surgery (american society of anesthesiologists physical status classification 1 or 2). exclusion criteria: * any suspicious finding of malignant ovarian diseases * postmenopausal status * baseline serum amh \< 0.50 ng/ml * pregnancy * lactation * any other endocrine diseases (such as thyroid dysfunction, hyperprolactinemia, or cushing's syndrome) * use of hormonal treatments in the 3 months before enrollment
thalidomide versus infliximab in new onset crohn's disease with poor prognostic factors

Conditions: Crohn Disease

Summary: crohn's disease (cd) is a life-long inflammatory bowel disease disease with an unknown pathogenesis. the ultimate goal of therapy is to modify the natural history of cd thus reducing complications. thalidomide is a small molecule with immunomodulatory and anti-angiogenetic properties. it is currently approved for the treatment of erythema nodosum leprosum, an immunological complication of leprosy and multiple myeloma. it has also been used in several other inflammatory diseases of the skin and of the mucosal membranes, such as behcet disease, oropharyngeal ulcers in aids, cutaneous lupus, and graft versus host disease. many case series and one pediatric randomized controlled trial proved the efficacy of thalidomide in the treatment of children with cd refractory to standard treatments. in these patients, clinical remission was achieved in about 50% of the cases and was maintained for a mean time superior of 3 years. mucosal healing after 52 weeks of treatment was observed in 40% of the patients in clinical remission. moreover, thalidomide was found to have a steroid-sparing effect and to decrease the need for surgical interventions. the clinical and endoscopic efficacy of thalidomide was also observed in children with failure to respond or intolerance to anti-tnf biological drugs. the aim of this multicentric prospective randomized controlled is to evaluate the efficacy and safety of thalidomide vs infliximab in changing the natural history of cd in patients with poor prognostic outcome. moreover, the study will evaluate the immunological and genetical mechanisms of cd, the mechanisms of action thalidomide in cd and will the pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on thalidomide safety and effectiveness.


Eligibility criteria:
inclusion criteria: * age at diagnosis \ =6 years * new diagnosis of cd based on porto criteria * cd with inflammatory phenotype (non-penetrating, non-fistulizing) and with no need for surgery except for perinal fistulas * presence of at least one of the following risk factors for poor prognosis: * fistulizing perianal disease * pan-enteric disease * disease extension \> 60 cm * severe growth delay (height z-score \< -2 ds) * severe osteoporosis (z score \< -2 ds) * hypoalbuminemia (\< 3g/dl) or high c-reactive protein (2 times higher the normal range) * acceptance of the risk evaluation and mitigation strategy (rems) program for reducing the teratogenic risk. exclusion criteria: * ongoing pregnancy * presence of peripheral neuropathy * hiv * patients with transplanted organs * ongoing major infections or other severe diseases * participation to other experimental studies.

Keywords: children crohn disease thalidomide mucosal healing