Kornimate/medical-research-clean huggingface dataset:
real-world effectiveness study of long-term treatment with dupilumab in participants ≥6 years with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a prospective, non-interventional (nis) observational study in patients (≥6 years) with atopic dermatitis (ad) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. the aim of this nis is the characterization of the ad patient population in germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing ad treatments. in addition to the therapeutic response rate at month 6, the long-term efficacy of dupilumab at month 12 and month 24 will be assessed by additional outcomes by measuring disease control in ad patients using questionnaires such as atopic dermatitis control tool (adct) and recap of atopic eczema (recap). in addition, this nis aims to assess the dosing pattern of dupilumab for ad, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. in addition, the effect of dupilumab in adult and pediatric ad patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. finally, this nis aims to collect long-term safety data in adult, adolescent and pediatric ad patients treated with dupilumab. individual observation period is 2 years or until dupilumab is discontinued. visits will be scheduled according to standard of care.


Eligibility criteria:
inclusion criteria: - patients are at least 6 years of age at the baseline visit. - initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe ad, or in children 6 to 11 years of age with severe ad according to the summary of product characteristics. - patients or their guardians are able to understand and complete the study-related questionnaires. - signing a written informed consent form by the patients before the initiation of documentation within the framework of this nis or informed consent of parents/guardian, if applicable. exclusion criteria: - patients who have a contraindication for dupilumab based on the current summary of product characteristics. - patients who have already been treated with dupilumab for more than 7 days. - any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results. - participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study. "the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."
benefit of left atrial roof ablation in paroxysmal atrial fibrillation

Conditions: Drug-refractory Paroxysmal Atrial Fibrillation

Summary: the aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.


Eligibility criteria:
inclusion criteria: * drug-refractory paroxysmal atrial fibrillation exclusion criteria: * hypo or hyperthyroidism * implantable defibrillation or pacemaker implanted * moderate or severe mitral valve disease or mitral prosthetic valve * ejection fraction less than 30% * left atrial anteroposterior diameter more than 50 mm. * previous atrial fibrillation ablation * left atrium thrombus * current infective disease or sepsis * pregnant women * current unstable angor * acute myocardial infarction in last 3 months * atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease * reduced expectancy of life (less than 12 months) * patient participating in another clinical study that investigates a drug or device * psychologically unstable patient or denies to give informed consent
pharmacologic response and safety of inhaled insulin in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study was to compare the pharmacokinetic (pk) response after inhaled insulin administration with 3 different inhalation regimens and with subcutaneous insulin administration.

this first-in-human trial investigated the optimal particle size for absorption of dance-501, an aerosolized liquid human insulin for inhalation (inh). twelve subjects with type 1 diabetes received an inh dose (50 iu) using an inhaler on 4 visits and 6 u insulin lispro (lis) sc on a separate visit to assess relative bioavailability (frel) of inh. the inhaler was configured to generate insulin aerosol particles sized 3.5-4.0 μm (low output mesh; lom), 4.3-4.8 μm (medium output mesh; mom) or 5.0-5.5 μm (high output mesh; hom) during low inspiratory flow. to assess within subject variability, mom was used twice. pharmacokinetics (pk) were measured up to 8 hours after dosing.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus treated with multiple daily insulin injections or continuous subcutaneous insulin infusion and total daily insulin dose less than 1.2 units/kg/day. * body mass index 18.0 - 28.0 kg/m2. * hemoglobin a1c less than or equal to 9%. * forced vital capacity and forced expiratory volume in one second at least 75% of predicted normal values for race, age, gender and height. * fasting c-peptide less than 0.3 nmol/l. exclusion criteria: * subjects with any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke. * active or chronic pulmonary disease. * any clinically significant major disorders other than diabetes mellitus. * decompensated heart failure at any time or angina pectoris within the last 12 months or acute myocardial infarction at any time. * proliferative retinopathy or severe neuropathy.
multiparametric approach to identify a cmr-based tricuspid regurgitation classification

Conditions: Tricuspid Regurgitation Congenital

Summary: the aims of this study are: 1. to explore a novel 2d-cardiovascular magnetic resonance (cmr) indirect method for tricuspid regurgitation (tr) quantification (atrial method) relying on right atrium variables, and assess its agreement with the traditional indirect method (involving right ventricle variables) and the direct method (based on through-plane phase contrast (pc) sequences on the tricuspid valve); 2. to assess the agreement of tr volume (rvol) and regurgitant fraction quantification from 2d-cmr methods with transthoracic echocardiography and 4df-cmr methods; 3. to assess the diagnostic performance of 2d-cmr in classifying tr, in terms of rvol and regurgitant fraction, with respect to echocardiographic transthoracic echocardiography grades.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with the diagnosis of al least mild-degree tricuspid regurgitation, who: * patients that are scheduled for a cardiovascular magnetic resonance examination in our institution exclusion criteria: * patients with previous surgical or transcatheter interventions on the tricuspid valve * patients with ebstein's disease * subjects with pace-maker or intracardiac defibrillator * subjects with intrabody ferromagnetic material precluding patient's safety * patients with claustrophobia or breath-holding precluding an adequate cmr images quality * pregnant women
precision vaccine promotion in underserved populations

Conditions: Influenza; Vaccine Hesitancy

Summary: previous studies have shown that low-cost, behavioral nudges through texting can increase influenza vaccination uptake compared to usual care. however, there are limited studies that evaluate the effect of decreasing barriers to scheduling, especially within safety net populations. the setting for this study, dhs, is the second largest public delivery system in the country and serves approximately half a million diverse patients that are eligible for vaccinations annually. this pilot study (one arm in a larger randomized controlled trial) will examine the effect of text messages highlighting medical health plan transportation resources (vs standard text messaging) on influenza vaccination rates in adults during the 2022-2023 flu season.


Eligibility criteria:
inclusion criteria: * los angeles county department of health services (lacdhs) primary care patients over 6 months of age exclusion criteria: * lacdhs patients less than 6 months of age
stable coronary artery diseases registry

Conditions: Chronic Ischemic Heart Disease

Summary: observational, prospective multicentric, national study, evaluating the diagnostic and therapeutic pathways of patient with cronic coronary artery disease followed in italian cardiology centers.

coronary heart disease is still highly prevalent in the world, and chronic stable angina is one of the most common clinical presentations of this disease. the objectives of chronic stable angina treatment include the reduction of symptoms, the inhibition or slowing of the progression of the disease, the prevention of associated cardiovascular events such as myocardial infarction, and the possible improvement of survival.the results of courage study and of meta-analysis of more recent studies demonstrate that patients in optimized medical therapy (omt) (aspirin, beta-blocker and statin in association with an ace-inhibitor and strict control of risk factors). ) the percutaneous coronary revascularization procedure (pci) did not lead to an improvement in the cardiovascular prognosis. these data led the groups in charge of drafting the guidelines to recommend omt as an initial treatment of stable angina, reserving the revascularization procedure for those patients with symptoms not adequately controlled by medical therapy. it is therefore considered appropriate to plan a registry in patients with stable coronary artery disease that has the ability to describe in the heterogeneity of italian cardiological centers the current characteristics of these patients, their treatment modalities, adherence to the current guidelines both as regards invasive therapy that the optimized medical, the use and the total cost of the resources needed to manage this pathology, the clinical course one year after entering the register. consecutive patients discharged (after an ordinary or day hospital admission) or managed as outpatient at cardiology department participating in the project with a diagnosis of stable coronary artery disease will be included in the register. enrollment will last 3 months in each center, starting with the first enrolled patient, or up to 50 patients enrolled.

Eligibility criteria:
inclusion criteria: * patients aged \>/= 18 * patients discharged from hospital or ambulatory visit with a diagnoses of stable heart disease; * written informed consent exclusion criteria: * acute coronary syndrome within 30 days from enrollment * ccs angina class iv * angina probably not for coronary artery disease
accuracy of two methods of making impressions for complete-arch implant supported fixed prosthesis

Conditions: Edentulous Jaw

Summary: to compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis

the intraoral scan is digital optical scan method, that has advantages such as being more comfortable, easy to transfer, and full digital workflow. conventional impression using silicon rubber and gained stable accuracy of impression. this study aims to compare the accuracy of two methods.

Eligibility criteria:
inclusion criteria: * age 18-70 years old (including 18 and 70 years old); * the patient's maxilla or mandible cannot be preserved due to missing teeth or remaining teeth proposed for implant-retained restoration; * the patient's missing teeth area is available for placement of 4-6 implants; * completion of osseointegration of the patient's implants after implant surgery; * the patient has at least 2 mm width of keratinized mucosa in the remaining alveolar ridge; * the patient voluntarily participates in the trial and signs an informed consent form exclusion criteria: * the patient has a severe gag reflex; * the patient has an intermaxillary distance of less than 20 mm in the posterior region; * the distance between the two implants is less than 10 mm; * implants fitted with composite abutments with the abutment screw holes penetrating at an angle greater than 60 degrees to the alveolar ridge; * other patients judged by the investigator to be unsuitable for inclusion
one year clinical evaluation of white spot lesions treated with newly introduced resin modified glass ionomer in comparison to resin infiltration in anterior teeth split mouth technique

Conditions: White Spot Lesions

Summary: the aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases

roles and responsibilities: * shaimaa mohammed (sh.m.): operator and author.specialist in air-force specialized hospital. * mohamed riad (m.r.): main supervisor, data monitoring and auditing, professor, conservative dentistry department,cairo university. * asma harhash(a.h.):co-supervisor, outcome assessor and data collection, associate professor, russian university. * omnia magdy moustafa (o.m.): baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: assistant lecturer, conservative dentistry department , faculty of oral and dental medicine cairo university. * ghada ahmed (g.a.): data entry and auditing; assistant lecturer, conservative dentistry department, faculty of oral and dental medicine, russian university. intervention: a- preoperative clinical assessment: 1. explain patient need toward aesthetic needs 2. digital photos for white spot lesions 3. recording number of white spot lesions and site. (sh.m.) will apply both materials at the same patient mouth (split mouth technique) according to the manufacturer's instructions. * intervention: resin modified glass ionomer cement varnish: vanish™ xt extended contact varnish (3m espe dental) * comparator: resin infiltration (dental milestones guaranteed, germany). (a.h) and (sh.m) will assess the outcome measures through the follow up time: immediately after,1 day, 1 week,1 month,3 months, 6 months, 12 months

Eligibility criteria:
inclusion criteria: 1. post-orthodontic patients included in this clinical trial toll age of 35 years. 2. patients with good general health. 3. patients who will agree to the consent and will commit to follow-up period. 4. fully erupted anterior teeth with no cavitated lesions. 5. at least one spot lesion on each side in the same jaw exclusion criteria: 1. patients with any systemic disease that may affect normal healing. 2. patient with bad oral hygiene. 3. tetracycline or fluorsis staining. 4. patients who could/would not participate in all times of follow-up. 5. untreated periodontal disease was not allowed. 6. active caries or defective restorations in 6 anterior teeth. 7. bleaching history 8. patients participating in more than 1 dental study. 9. patient received fluoride varnish during orthodontic treatment.
efficacy of a novel walking assist device with auxiliary laser illuminator on stroke patients

Conditions: Stroke

Summary: many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs. ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke. walking assist device with auxiliary laser illuminator during ambulation training could correct gait parameters, improve balance and basic activity of daily living among stroke patients.

facilitation of normal gait is a primary goal of rehabilitation on patients with stroke. the investigators aimed to investigate whether walking assist device with auxiliary lser illuminator (laser quad-cane) providing visual feedback during ambulation could improve parameters of gait cycle and function among patients with chronic stroke. methods: this was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. patients in the experimental group (eg) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). patients in the control group (cg) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. the rehabilitation lasted for 4 weeks, twice per week. gait parameters were measured by rehab watch as primary outcomes and berg's balance scale (bbs), timed-up-and-go test (tug), and barthel index were used as secondary outcomes. both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.

Eligibility criteria:
inclusion criteria: * stroke patients at subacute (stroke symptoms between three months to one year) or chronic stage (stroke symptoms more than 1 year) * with hemiplegia * with sufficient cognition that could follow the instructions and procedure * walk independently for a distance of more than 20 meters with or without the use of a walking aid. exclusion criteria: * stroke patients with other neurological diseases like parkinsonism, * myopathy * multiple sclerosis * spinal cord injury that might interfere with walking ability

Keywords: gait stroke walking assist device auxiliary illuminator visual feedback
use of allocetra-ots in end stage knee osteoarthritis - assessment of safety

Conditions: Knee Osteoarthritis

Summary: this is a pilot study to assess safety and possible efficacy of allocetra-ots in end-stage knee osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. age 18 or older. 2. diagnosed with end-stage knee osteoarthritis and are scheduled or offered surgery. 3. x-ray positive for knee osteoarthritis. 4. pain and functional disability from osteoarthritis. 5. accetable blood workup results (cbc, electrolytes, kidney and liver function) from up to three months before treatment. 6. mentally and physically able to fully comply with the study protocol. 7. signed informed consent form. exclusion criteria: 1. evidence of active local infection in the vicinity of the knee joint. 2. previous surgery of total or partial knee replacement in the injected knee. 3. patients unable to provide informed consent due to language barrier or mental status. 4. patients with a major medical condition that would affect quality of life and influence the results of the study. 5. patients unwilling to be followed for the duration of the study. 6. acute infection requiring intravenous antibiotics at the time of screening. 7. other limb pain of unknown etiology. 8. pain in the limb clinically assessed to arise from an origin which is not the affected knee joint. 9. known neurological disease or rheumatic condition other than osteoarthritis. 10. bleeding disorders. 11. known cognitive disorder. 12. concurrent participation in any other clinical study. participation in an interventional investigational study within 30 days prior to enrollment. 13. physician objection. 14. positive pregnancy test.
study to test the safety and tolerability of pf-07062119 in patients with selected advanced or metastatic gastrointestinal tumors.

Conditions: Gastrointestinal Tumors; Colorectal Adenocarcinomas; Gastric Adenocarcinomas; Esophageal Adenocarcinomas

Summary: a phase 1, open-label, dose escalation and expansion study of pf-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

this is a phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of pf-07062119 administered as a single agent in sequential dose levels and then in combination with anti-programmed cell death -1 protein (anti-pd-1) and in combination with an anti-vascular endothelial growth factor (anti-vegf). in part 1a, successive cohorts of patients will receive escalating doses of pf-007062119 and then in dose finding (part 1b) with pf-07062119 in combination with anti-pd-1 and in combination with anti-vegf. this study contains 2 parts, dose escalation with single agent (part 1a) and then dose finding with pf-007062119 in combination with ant-pd-1 and in combination with anti-vegf (part 1b) followed by dose expansion arms as a single agent and pf-07062119 in combination with anti-pd 1 and in combination with anti-vegf (part 2).

Eligibility criteria:
inclusion criteria: * for part 1 and part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit. * for part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (part 1) * measurable disease as defined by recist 1.1 is required (part 2) exclusion criteria: * known active uncontrolled or symptomatic central nervous system (cns) metastases * other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * major surgery or radiation within 3 weeks prior to study entry * last anti-cancer treatment within 4 weeks prior to study entry * active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication * active or history of clinically significant gastrointestinal disease * participation in other studies involving investigational drug(s) within 2 weeks prior to study entry * pregnant or breastfeeding female patients

Keywords: gastric cancer esophageal cancer colorectal cancer advanced esophageal cancer metastatic esophageal cancer advanced colorectal cancer metastatic gastric cancer advanced gastric cancer metastatic colorectal cancer gucy2c anti-pd1 anti-vegf measurable disease pf-07062119 pf-06801591 bevacizumab