Kornimate/medical-research-clean huggingface dataset:
single-file pulpectomy in primary molars

Conditions: Pulpal Necrosis

Summary: the current study evaluates the rotational one shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars. this randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. the teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. group i: 47 primary molars were instrumented with one shape rotational single-file system. group ii: 47 primary molars were instrumented with stainless steel k-files. all teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.


Eligibility criteria:
inclusion criteria: * children categorized as class i or ii according to american society of anesthesiologists (asa). * children aged between 4 and 6 years with at least one necrotic primary second mandibular molar. * history of dull toothache over an extended period of time * history of spontaneous pain or pain at night * swelling adjacent to tooth with or without a sinus tract * abnormal tooth mobility * presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed * interruption of lamina dura or thickening of periodontal ligament space * furcational radiolucency did not surpass half of the distance between the furcation and permanent successor * negative findings of internal root resorption * external root resorption confined to the apical third and with at least two-thirds of the root length was intact exclusion criteria: * uncoperative children or parents/legal guardians * sever intellectual, behaviour or emotional problems * non-restorable tooth crowns * root canal obliteration * presence of underlying dentigerous or follicular cysts

Keywords: pulpectomy pediatric dentistry
pharmacokinetic profile and safety of fluticasone propionate and albuterol sulfate in combination when compared to fluticasone propionate multidose dry powder inhaler (fp mdpi) in children aged 4 to 11 years old

Conditions: Asthma

Summary: the primary objectives of this study are: * to determine the pharmacokinetic (pk) profile of fluticasone propionate (fp) and albuterol sulfate (abs), delivered in combination, from a single dose of tev-56248 (fp and abs multidose dry powder inhaler with e-module \[fp/abs emdpi\]) in participants with asthma * to compare the pk profiles of fp for 2 different dose strengths of tev-56248 to that of fluticasone propionate multidose dry powder inhaler (fp mdpi) * to compare the pk profiles of abs between the 2 different strengths of tev-56248 the secondary objective is: • to evaluate the safety of a single dose of tev-56248 and a single dose of fp mdpi

the planned duration for this trial is approximately 1.5 to 3 months. the trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.

Eligibility criteria:
inclusion criteria: * participant has a diagnosis of asthma as defined by the global initiative for asthma guidelines (gina 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the screening visit * has persistent asthma, with a forced expiratory value (fev1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the screening visit * demonstrate acceptable inhalation technique with the training inhaler * able to stop (as judged by the investigator) his or her rescue medication, for approximately 6 hours before the screening visit and for approximately 4 hours before training sessions in periods 1-3 * has body mass index (bmi) within the 3rd and 97th percentiles for the participant's age and gender. the participant must have a weight of ≥18 kilograms (kg) * able to achieve a peak inspiratory flow (pif) rate of at least 60 liters per minute (l/min) on an inhaler training device note- additional criteria apply, please contact the investigator for more information exclusion criteria: * participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures * has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the screening visit or plans to participate in another investigational drug trial at any time during this trial * known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product * asthma exacerbation requiring systemic corticosteroids within 30 days of the screening visit, or has had any hospitalization for asthma within 2 months of the screening visit note- additional criteria apply, please contact the investigator for more information
open label study of sargramostim among patients receiving myelosuppressive induction chemotherapy for acute myelogenous leukemia

Conditions: Acute Myeloid Leukemia NOS

Summary: primary objective: measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy. secondary objectives: * assess the time after treatment at which the antibodies develop and the level of antibodies is measured after the first dose. * measure the levels of immunoglobulin protein. * assess the impact of any immune response on safety and the duration of low white blood cell count.

the total study duration for a participant is up to 6 months from 1st dose of sargramostim or until the antibodies level return to baseline or up to 24 months if antibodies test is positive at month 6.

Eligibility criteria:
inclusion criteria : * able to provide informed consent. * newly diagnosed acute myeloid leukemia (aml) to be treated with standard of care induction chemotherapy as per local policy. * patients 55 to 70 years of age (inclusive). * negative serum pregnancy test within 30 days prior to receiving the first dose of induction chemotherapy in female participants who are \<2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception. exclusion criteria: * prior treatment with sargramostim or any leukocyte growth factor (lgf) product. * prior myelodysplastic syndrome (mds). * known central nervous system (cns) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (ct) or magnetic resonance imaging (mri). * out of range (\>2x normal) laboratory values. * clinically important medical conditions unrelated to aml as determined by the investigator. * eastern cooperative oncology group (ecog) performance status \>2. * bone marrow blasts ≥5% on marrow examination following induction or reinduction chemotherapy. * history of allergy to yeast products, recombinant human granulocyte/macrophage-colony-stimulating factor, or any component of sargramostim. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the dutch-geraf study

Conditions: Atrial Fibrillation; Frailty; Major Bleed

Summary: geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients. this study applies opportunistic screening for atrial fibrillation as advised in the latest esc guideline on the diagnosis and management of atrial fibrillation. furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.


Eligibility criteria:
inclusion criteria: all newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including fall clinic, memory clinic, pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician). exclusion criteria: * the patient has a pacemaker or implantable cardioverter defibrillator. * the patient is known with a severe dementia, moca ≤ 15 points. * the patient has a severe tremor, from whatever cause, and thus is unable to use the ppg based smartphone af detection algorithm.

Keywords: atrial fibrillation frailty major bleed intra cranial haemorrhage cognitive disorder ehealth
megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy

Conditions: Anorexia; Weight Changes

Summary: rationale: megestrol acetate may help improve appetite and lessen weight loss caused by cancer. purpose: this clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.

primary objectives:proportion of patients who maintain weight or experience weight gain. secondary objectives:bmi trends, caloric intake, weight maintenance over time, toxicity profile as assessed by nci common toxicity criteria for adverse effects (ctcae) v.4. outline: patients are randomized to 1 of 2 treatment arms. arm a: patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. arm b (control): patients are observed for weight loss and gain for 4 weeks. after completion of study treatment, patients are followed up for 12 weeks.

Eligibility criteria:
inclusion criteria: * any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas) * ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy or ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy * negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only exclusion criteria: * receiving tube feedings or parenteral nutrition * evidence of ascites * current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol) * known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (\> 5 episodes/week) * history of unresectable brain tumor or cancer metastatic to the brain * history of thromboembolic disease * insulin-requiring diabetes * congestive heart failure and/or uncontrolled hypertension * anticoagulation * previous history of thrombosis (personal and immediate family) * concurrent corticosteroid therapy (except as an antiemetic)
evaluation of morphology abnormal cornea stability with corneal biomechanical

Conditions: Keratoconus, Stable

Summary: to evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.


Eligibility criteria:
inclusion criteria: 1. best corrected visual acuity (bcva) ≥ 20/20; 2. no other eye diseases except myopia and astigmatism; 3. the cornea was transparent, and there was no cloud or pannus; 4. no clinical manifestation of keratoconus（corneal stromal thinning, cone-shaped anterior protrusions, fleischers ring, vogts striae, epithelial or subepithelial scarring） exclusion criteria:1) corneal disease; 2) ocular trauma; 3) patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 4) pregnant and lactating women;
a study of fitusiran (aln-at3sc) in severe hemophilia a and b patients with inhibitors

Conditions: Hemophilia A; Hemophilia B

Summary: the purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. in addition, the study assessed safety, quality of life, pharmacodynamics (pd), and pharmacokinetics (pk).

the duration of treatment with fitusiran was 9 months. the estimated total time on study, inclusive of screening, for each participant was up to 11 months for all participants who enroll in the extension study and participants in the on-demand arm who did not enroll in the extension study. the estimated total time on study was up to 17 months in fitusiran treatment arm participants who did not enroll in the extension study due to the requirement for up to an additional 6 months of follow-up monitoring for antithrombin levels.

Eligibility criteria:
inclusion criteria: * males, greater than or equal to (\>=) 12 years of age. * severe hemophilia a or b with inhibitors. * (severity confirmed by a central laboratory where coagulation factor viii (fviii) level was less than (\ =0.6 bethesda units per milliliter \[bu/ml\] or as evidenced by medical records). * a minimum of 6 bleeding episodes requiring bpa treatment within the last 6 months prior to screening. * willing and able to comply with the study requirements and to provide written informed consent and assent. exclusion criteria: * known co-existing bleeding disorders other than hemophilia a or b. * antithrombin (at) activity \<60% at screening. * co-existing thrombophilic disorder. * clinically significant liver disease. * active hepatitis c virus infection. * hiv positive with a cluster of differentiation-4 count of \<200 cells/microliter. * history of arterial or venous thromboembolism. * inadequate renal function. * history of multiple drug allergies or history of allergic reaction to an oligonucleotide or n-acetylgalactosamine. * history of intolerance to sc injection(s). * any other conditions or comorbidities that would make the participant unsuitable for enrollment or could interfere with participation in or completion of the study, per investigator judgement.

Keywords: rnai therapeutic hemophilia a hemophilia b hemophilia a, severe hemophilia b, severe blood coagulation disorders, inherited blood coagulation disorders hematologic diseases coagulation protein disorders hemorrhagic disorders genetic diseases, inborn genetic diseases, x-linked factor viii factor ix inhibitor bypassing agents coagulants fitusiran
achieving control of asthma in children in africa

Conditions: Asthma

Summary: the main aim of the study is to identify altogether 3000 children aged between 12 and 16 years old with asthma symptoms in six sub-saharan african countries. the study furthermore aims to assess their asthma control, current treatment, knowledge of and attitudes to asthma, as well as the barriers to achieving good asthma control.

asthma prevalence in young people has been rising in several african countries during the last decade, reaching between 10% and 20% in central africa, and up to 20% in south africa. in addition, asthma related mortality in many african countries is high. south africa has the third highest asthma related mortality rate in the world. yet to date, a lack of asthma research and research infrastructure means that we do not have the evidence to either inform advocacy or to develop interventions that improve asthma outcomes. this study aims to collect data about asthma prevalence and to identify existing barriers to effective asthma management of young people in 6 sub-saharan countries: malawi, south africa, zimbabwe, uganda, ghana, and nigeria. each of these countries identifies 500 young people with asthma between 12 and 16 years of age through a screening questionnaire in schools. these 3000 young people with asthma symptoms fill in a survey about asthma, including questions around asthma control, current treatment and access to care, asthma knowledge, asthma attitudes, smoking and environmental influences. some of the participants also discuss asthma related topics in focus groups. a subset of the participants furthermore do spirometry and feno testing. in addition to the data collection, the study develops and tests options for an intervention aimed at improving asthma control, including the adaption of a united kingdom - based theater play about asthma awareness. the development of wifi infrastructure and it solutions is promoted by the study, where appropriate.

Eligibility criteria:
inclusion criteria: * aged between a minimum of 12 years, and * a maximum of 14 years exclusion criteria: * age less than 12 years * age more than 14 years

Keywords: feno africa spirometry asthma control act prevalence
overminus lens therapy in intermittent

Conditions: Intermittent Exotropia; Myopia Overcorrection; Over-minus Therapy; Myopia Progression

Summary: in this prospective study, entitled "the long-term efficacy of overminus lens therapy in intermittent exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (ixt), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.

purpose: to evaluate the long-term impact of overminus lenses in intermittent exotropia (ixt), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia. materials and method: sixty-five consecutive cases of ixt followed for at least 48 months were included. patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (\>-5.0 d), severe hyperopia (\>+5.0 d), moderate or severe amblyopia and poor compliance with spectacles were excluded. data was collected including near stereoacuity, ac/a ratio, control of ixt measured with newcastle control score (ncs) at baseline and in all follow-up visits. baseline values without overminus threapy were compared with postintervention values at every visit.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ixt * prescribed overminus lenses exclusion criteria: * a history of previous surgery, ocular pathology * convergence insufficiency type ixt * presence of any type of ocular deviation except ixt * presence of severe myopia (greater than -5.0 d) * presence of severe hyperopia (greater than +5.0 d) * presence of moderate or severe amblyopia * poor compliance with overminus spectacles * follow up period of \<48 months after intervention.

Keywords: intermittent exotropia overminus lens therapy myopic overcorrection
e-biomatrix postmarket registry

Conditions: Coronary Artery Disease

Summary: the purpose of this registry is to capture clinical data of the biomatrix™ and biomatrix flex™ (biolimus a9™-eluting) stent systems in relation to safety and effectiveness.

prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. all patients will be followed for up to 3 years.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. patients that need a treatment with either a biomatrix™ or a biomatrix flex™ drug-eluting stent 3. presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents 4. no limitation on the number of treated lesions, and vessels, and lesion length exclusion criteria: 1. inability to provide informed consent 2. patients needing additional stent not of the biolimus a9™-eluting stent type 3. patients receiving next to the biolimus a9™-eluting stent also other coronary vascular interventions, for example dilation 4. patients receiving both the biomatrix™ and the biomatrix flex™ stent during index and/or staged procedure
arginase inhibition in type 1 and type 2 diabetes mellitus

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: to evaluate the efficacy of arginase inhibition on endothelial function in patients with type 1 diabetes and type 2 diabetes.

detailed description: the study is performed on one group of patients with type 1 diabetes and one group of patients with type 2 diabetes. forearm blood flow is determined by venous occlusion plethysmography. endothelium-dependent vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and 210 ng/min). endothelium-independent vasodilatation is determined by infusion of sodium nitroprusside (snp; 1, 3 and 10 µg/min). each dose is given for 2 min at a rate of 2.5 ml/min. data are expressed as percentage change in forearm blood from baseline flow. twelve subjects are included in each group. on the day of the study the subject arrives to the laboratory after having a light breakfast. forearm vessels of the non-dominant arm are cannulated and forearm blood flow is determined as described above. baseline endothelium-dependent and endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin and snp, respectively. thereafter an intra-arterial infusion of the arginase inhibitor n-omega-hydroxy-nor-l-arginine (nor-noha) is administered as an intra-arterial infusion at a rate of 0.1 mg/min and is maintained for 120 min. the dose is based on a previous study by our group demonstrating improved endothelial function. endothelium-dependent and -independent vasodilatation is reassessed at 120 min of infusion.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * type 2 diabetes exclusion criteria: * age \>80 years * acute coronary or ischemic event during the last three months * vascular surgery of the arm * peripheral vascular disease affecting the arm * ongoing anticoagulant medication * any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.