Kornimate/medical-research-clean huggingface dataset:
helios-a: a study of vutrisiran (aln-ttrsc02) in patients with hereditary transthyretin amyloidosis (hattr amyloidosis)

Conditions: Amyloidosis, Hereditary; Transthyretin Amyloidosis

Summary: the purpose of this study is to evaluate the efficacy and safety of vutrisiran (aln-ttrsc02) in participants with hereditary transthyretin amyloidosis (hattr amyloidosis). participants will receive vutrisiran subcutaneous (sc) injection once every 3 months (q3m) or the reference comparator patisiran intravenous (iv) injection once every 3 weeks (q3w) during the 18 month treatment period. this study will use the placebo arm of the apollo study (nct01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 month treatment period. following the 18 month treatment period, all participants will be randomized to receive vutrisiran 50 mg sc injection once every 6 months (q6m) or vutrisiran 25 mg q3m in the randomized treatment extension (rte) period. upon implementation of amendment 6, participants receiving vutrisiran sc 50 mg q6m will transition to vutrisiran sc 25 mg q3m at their next scheduled dosing.


Eligibility criteria:
inclusion criteria: * male or female of 18 to 85 years of age (inclusive); * has a diagnosis of hattr amyloidosis with transthyretin (ttr) mutation; * has adequate neurologic impairment score (nis); * has adequate polyneuropathy disability (pnd) score; * has adequate karnofsky performance status (kps). exclusion criteria: * had a prior liver transplant or is likely to undergo liver transplantation during the study; * has known other (non-hattr) forms of amyloidosis or leptomeningeal amyloidosis; * has new york heart association heart failure classification \>2; * clinically significant liver function test abnormalities; * has known human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) infection; * received an experimental drug within 30 days of dosing; * received prior ttr-lowering treatment; * has other known causes of neuropathy.
an observational study on theaccuracy of whole-body magnetic resonance imaging (wb-mri) screeningto predict clinically significant diagnoses in general population subjects interested in proactive and advanced general preventive healthcare.

Conditions: Cancer; Metabolic Disease; Aneurysm; Neurologic Disorder

Summary: this is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (wb-mri) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites within the united states. study subjects must meet a set of inclusion and exclusion criteria. potential subjects arriving at the study sites will be evaluated for enrollment. it is the principal investigator's (pi) responsibility to enroll only subjects who satisfy the inclusion/exclusion criteria. recruitment can occur by subject presentation at the sites for elective standard screening, word-of-mouth, flyers, healthcare professional (hcp) referrals, advertisement online, or any other means, subject to approval by the associated institutional review board (irb) or ethics committee (ec) when applicable.


Eligibility criteria:
inclusion criteria: * each subject must: * be\>=18 years of age at the time of enrollment. * be able to read and understand provided procedural information for the study; * be able and willing to follow all study procedures including proper breathing and body movement minimization while within the wb-mri system; * be willing and able to provide required clinical, demographic, medical history, and concomitant medications information; * be able to provide financial payment in advance for reimbursement of the cost of the wbmri acquisition procedure and interpretation; * complete all required consent procedures. exclusion criteria: * harbor within their bodies contraindicated medical devices including, but not limited to, implanted pacemakers, intracranial aneurysm clips, cochlear implants, drug infusion pumps, neurostimulators, bone growth stimulators, certain intrauterine contraceptive devices, non- mri safe metals, etc.; * self-certify that they are pregnant; * be seeking to undergo wb-mri as a subject in this study in lieu of other covered dedicated diagnostic imaging evaluations when such covered procedures represent more appropriate or standard-of-care procedures by context-specific clinical indication; * be an employee of the study site or the sponsor; * have a medical condition or serious intercurrent illness, or other circumstance that, in the investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
a pilot c11-choline pet-ct imaging study in patients with locally advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11c-choline pet-ct images of esophageal cancer.


Eligibility criteria:
inclusion criteria: * newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology. * ability to tolerate pet imaging * prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer. exclusion criteria: * pregnant or lactating females are not eligible for this pilot study. * patients having received chemotherapy in the 3 months prior to registration for any reason * patients with metastatic disease requiring chemoradiation for palliation are not allowed.

Keywords: pet positron emission tomography ct x-ray computed tomography patients with locally advanced esophageal cancer
study to evaluate the efficacy of a probiotic in infantile colic symptoms relief

Conditions: Infantile Colic

Summary: this study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.


Eligibility criteria:
inclusion criteria: * gestational age of minimum 37 weeks. * birthweight of minimum 2500 g (5.5 lb.). * age of greater than 3 weeks and less than 12 weeks at enrolment. * confirmed infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording \>3 hours of crying in a 24-hour period (ediary app completed daily during run-in period \& for duration of study). * participant informed consent form signed by parent or legal guardian. * infant is considered healthy following physical exam. * parents/caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits exclusion criteria: * use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial. * use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics). * need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery). * congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract. * failure to thrive. * known lactose or gluten intolerance. * known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo. * known other causes for abdominal pain (e.g., pyloric stenosis). * participation in any other interventional clinical study. * immuno-compromised participant or participant with other severe chronic disorder. * use of probiotic supplements by breastfeeding mother from child's birth to enrolment. * use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial. * any participant/parent/caregiver who is an employee of the investigational site or an atlantia clinical trials employee or their close family member or a member of their household.

Keywords: probiotic bifidobacterium colic cry
impact of starting a dolutegravir-based regimen on hiv-1 proviral dna reservoir of treatment naïve and experienced patients

Conditions: HIV-1 Infection

Summary: this is a multi-center prospective study. the primary objective of drone study is to investigate the change of the size of hiv-1 dna reservoir in blood from baseline to week 48 (w48) in participants treated by dtg-based regimen. secondary objectives include: dtg pharmacokinetic and analysis of biomarkers of immune activation from baseline to w48.


Eligibility criteria:
inclusion criteria: * male or female aged from de 18 to 80 years * patient starting a dtg-regimen * patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping dtg treatment * signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening exclusion criteria: * women who are pregnant or breastfeeding * hbv or hcv coinfection * participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted * an active aids-defining condition at screening * documented resistance to dtg * allergy or intolerance to the study drugs or their components or drugs of their class * any acute or verified grade 4 laboratory abnormality (with the exception of grade 4 lipids) at screening. * coadministration with dofelitide

Keywords: dolutegravir proviral hiv-1 dna reservoir
stop sepsis through home monitoring cooperative

Conditions: Sepsis; Home Monitoring Follow-up; Infection; Innovativeness

Summary: in this study, patients presenting with acute infections at risk of developing sepsis will be followed in their home setting using wearables that provide (semi-)continue monitoring of vital signs as well as through follow up using a designated smartphone application. this is an innovative pilot study that will examine the potential of transmural care through telemonitoring for the first time in patients at risk for developing sepsis. by allowing for active follow-up of vital parameters in a transmural setting, this project aims to reduce the number of hospitalizations as compared to current practice. furthermore, we aim to the number of patients referred to the emergency department after a visit at their primary care physician. thereby, we aim to reduce the healthcare burden, yet providing the ability for rapid intervention in case of detarioration of patients, thereby reducing morbidity and mortality as well as associated costs.


Eligibility criteria:
inclusion criteria: * this study will include patients aged 18 years or older, capable of giving informed consent, presenting with signs of severe acute infection with a risk of developing sepsis at the emergency department or at their primary care physician. exclusion criteria: * patients that are severely ill and require immediate hospitalization qucik sepsis related organ failure score (qsofa) ≥ 1 national early warning score (news) ≥ 5 * patients that demonstrate confusion, changes in mental state and/or an mini-mental state examination (mmse) below 26 * presence of neuropenic fever * patients currently undergoing immunosuppressive therapy or chemotherapy * patients with human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids) * suspicion of appendicitis, suspicion of meningitis or meningeal irritation, suspicion of or high risk of developing endocarditis * complicated operation wounds at the time of screening * proven pneumonia (curb 65 score ≥ 1) * emphysema, chronic obstructive pulmonary disease (copd) gold \>1 or interstitial lung disease * patients with oxygen at home \> 2 l/min on a chronic basis (severe underlying lung disease?) * severe cardiovascular disease including: * severe heart failure new york heart association (nyha) class \> 1 * endoprosthesis * cardiac arrhythmia including atrial fibrillation * severe heart valve abnormalities * mechanic valve replacement * recent acute myocardial infarct or coronarography (less than 1y ago) * severe peripheral vascular morbidity * acute chest pain (suspicion of acute coronary pathology) * suspicion of/chance of septic arthritis
quantifying disease progression in lbsl

Conditions: LBSL; Leukoencephalopathies

Summary: leukoencephalopathy with brain stem involvement and lactate elevation (lbsl) is a genetic disorder caused by biallelic mutations in the dars2 gene that encodes mitochondrial aspartyl trna synthase.(1, 2) it is characterized by typical abnormalities on mri of the brain and spinal cord.(3) clinically, the disorder is heterogeneous and can present in the neonatal period, later in childhood or even in adults.(3) in general it can be stated that the earlier presentations are characterized by rapid progression leading to severe disability and death. presentation at a later age is typically characterized by a more benign disease course, although considerable disability is common. clinically, the disease presents as a slowly progressive myelopathy with mainly involvement of the corticospinal tracts and the dorsal columns. although the natural history has been studied in large cohorts, the rate of progression has not been systematically studied with clinimetric outcome scales or potential surrogate outcomes for spinal cord disease.


Eligibility criteria:
in order to be eligible to participate in this study, a subject must meet all of the following criteria: * age \> 16 years * definite diagnosis of lbsl confirmed by dars2 mutation analysis. * able to understand dutch or english and provide informed consent. * no contra-indications for mri of brain and spinal cord. subjects eligible to participate as healthy controls must meet all of the following criteria: * willing to visit the hospital * 16 years or older * provision of written informed consent to participate in the study obtained from the participant for the mri controls: - no contra-indications for mri of the brain and spinal cord a potential subject (patient or healthy control) who meets any of the following criteria will be excluded from participation in this study: * unable to visit the hospital for the follow-up visits * co-existing neurological disease that can cause pyramidal tract signs making interpretation of acquired data difficult (for instance, multiple sclerosis, stroke, etc)
variation of atelectasis score after high-frequency percussions in severe acquired brain injury

Conditions: Atelectasis; Acquired Brain Injury; Respiratory Rehabilitation

Summary: investigators conduced in the neurological rehabilitation unit of the irccs "s.maria nascente - fondazione don gnocchi", (milan) a retrospective study on 19 patients hospitalized between september 2018 and february 2021, with the aim of comparing the efficacy of the two devices, metaneb® and intrapulmonary percussion ventilation (ipv®). the efficacy was evaluated considering the change of various measures after two weeks of treatment. the main outcome considered is the atelectasis score, assigned by two radiologists who blindly and retrospectively evaluated it on high-resolution computed tomography (hrtc) images

patients with severe acquired brain injury (sabi) frequently exhibit pulmonary complications, with atelectasis and/or consolidation of the lower lobes. the atelectasis in critically ill patients is a risk factor for pneumonia and increase the possibility to develop dysventilation syndrome with consequent negative impacts on gas exchanges. to the best of our knowledge, there is no study investigating the use of the two devices for the treatment of atelectasis in the specific population of non-cooperative tracheostomized patients with sabi who had been spontaneously breathing with no mechanical ventilation support.

Eligibility criteria:
inclusion criteria: * spontaneous breathing 24h/24h * presence of tracheostomy cannula * presence of atelectasis diagnosed through high resolution computed tomography * levels of cognitive functioning (lcf) ≤ 5 * no pneumothorax * consent signed exclusion criteria: * age under 18 years old
efficacy of glp-1 infusion in comparison to an insulin infusion protocol to reach normoglycemia type 2 diabetic patients

Conditions: Diabetes Mellitus Type 2; Hyperglycemia

Summary: the aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered glp-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia. in addition, hypoglycaemia is a frequent and important side effect. glucagon-like-peptide 1 (glp-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia. the aim of our study was to compare for the first time efficacy and safety of intravenously administered glp-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * fasting glycemia above 150 mg/dl * signed informed consent exclusion criteria: * patients with heart failure \> nyha ii * uncontrolled hypertension * impaired kidney function (creatinine \> 3 mg/dl) * acute infection

Keywords: diabetes mellitus type 2, glp-1, insulin infusion
pharmacological preparation of the cervix for hysteroscopy

Conditions: Uterine Polyp; Uterine Bleeding; Endometrium; Senility

Summary: pain accompanying office hysteroscopy is the most common reason for its discontinuation. urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. the aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.

a prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). the following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the numeric rating scale (nrs).

Eligibility criteria:
inclusion criteria: * age 45-90 years * uterine cavity focal lesion, abnormal uterine bleeding exclusion criteria: * drug allergy * no consent to the procedure or participation in the study
multicentric, prospective, randomized, comparing trial between bypass of the femoropoplitea by ptfe and heparin bounded ptfe

Conditions: Peripheral Vascular Diseases

Summary: comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: ptfe with or without bounded heparin

comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: ptfe with or without bounded heparin. evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

Eligibility criteria:
inclusion criteria: * patients with peripheral vascular diseases with complaints of invalidating claudication, rest pain, ucera or gangrene * patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm * reasonable outflow arteria * informed consent * patient able to take part in all follow-up examinations exclusion criteria: * acute ischemia of the leg * patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery * \< 18 years * pregnancy * recent heart attack (\< 1 month) * life expectancy less than 12 months * known allergy to heparin * known contrast allergy * known bleeding or coagulation disorder
antibiotic education for children in an emergency care unit

Conditions: Otorhinolaryngologic Diseases; Respiratory Tract Infections; Pyelonephritis; Urinary Tract Infections

Summary: the purpose of this study is to determine if a patient education in acute condition about the intake of oral solution antibiotic in children under 6 year-old are effective to improve the satisfaction about the therapeutic education, the knowledge about antibiotics among the patients' families and thereby decrease the misuses of antibiotics.

adherence to antibiotic regimen for common childhood illnesses, such as otitis media and streptococcal pharyngitis, is related to a variety of outcomes such as illness' remission, prevention of recurrent infections, maintaining of cost-effectiveness, and prevention of the growth of antibiotic-resistance. a patient and family 's therapeutic education about the intake of an oral solution of antibiotic should decrease the misuses of antibiotic, improve the family 's knowledge and the satisfaction of the patient and his family. those factors are related to the understanding and adherence to the antibiotic prescription.

Eligibility criteria:
inclusion criteria: * french-speaking patients seen at the emergency department and discharged with a diagnosis of bacterial infections (urinary and respiratory tract infections, streptococcal pharyngitis, acute otitis media) requiring 5 to 10 days of an oral solution of antibiotic. * under 6 year-old. * no opposition of the parents to be included in the study. * personal health insurance. exclusion criteria: * chronic pathology such as: sickle cell disease, aids. * parents with insufficient knowledge of french. * family not reachable by phone. * antibiotic's suspected allergy.

Keywords: patient education antibiotic child respiratory tract infection patient satisfaction parental knowledge adherence
monitoring and evaluation of the levothyroxin replacement therapy in pregnant women with hypothyroidism

Conditions: Hypothyroidism

Summary: the aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range? a retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the endocrinology unit, herlev hospital, denmark during 2012. patients selected through electronic medical system. blood tests for the the hormone levels drawn from the laboratory of clinical biochemical department, herlev hospital


Eligibility criteria:
inclusion criteria: * consecutive pregnant women with l-t4 treated hypothyroidism followed at the outpatient clinic at the endocrinology unit, herlev hospital, denmark during 2012

Keywords: hypothyroidism pregnancy