Kornimate/medical-research-clean huggingface dataset:
the effects of a multidomain lifestyle intervention on brain functioning and its relation with immunometabolic markers in ageing

Conditions: Life Style; Risk Reduction; Cognitive Decline; Aging

Summary: heli is a multicenter, randomised controlled trial in two dutch research centres (donders centre for cognitive neuroimaging, nijmegen, and the department of human nutrition \& health at wageningen university) among 104 older adults aged 60-75 years who are at risk for cognitive decline with an intervention duration of 26 weeks (roughly 6 months). participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and guidance (high-intensity intervention group) versus online access to general lifestyle-related health information in the form of biweekly leaflets (low-intensity intervention group).


Eligibility criteria:
inclusion criteria: * written informed consent; * age between 60-75 years (at pre-screening); * fluency in dutch (speaking, reading and writing); * lives near study centres in nijmegen and wageningen (max. 50 kilometers of travelling, to ensure study centre visits are possible without excessive travel burden); * presence of ≥2 self-reported risk factors for cognitive decline (bmi of 30 or higher, physical inactivity according to world health organization guidelines, hypertension \[not using hypertensive drugs counts as an additional risk factor\], hypercholesterolemia, diabetes type-ii, non-symptomatic cardiovascular disease). exclusion criteria: * concurrent participation in other intervention trials; * technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, etc.); * no internet access from home; * clinical diagnosis of ≥1 of the following: vascular event (cva), neurological pathology (e.g. mild cognitive impairment, dementia, multiple sclerosis, parkinson's, epilepsy), current malignant disease(s) (with or without current treatment), current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), revascularisation surgery in the last 12 months at pre-screening, inflammatory bowel disease (characterised with diarrhoea), visual impairment (e.g. blindness), hearing or communicative impairment; * unable to undergo mri (e.g. metal objects in upper body, past brain surgery, active implants, claustrophobic); * cognitive impairment as determined by the telephone interview for cognitive status (tics-m1), performed during pre-screening before inclusion.
echocardiographic changes during adjuvant therapy in hispanic women with her-2 neu expressing breast cancer

Conditions: Breast Cancer

Summary: this study retrospectively looks at changes in echocardiographic parameters while using transtuzumab

transtuzumab based chemo-immunotherapy is commonly administered to patients diagnosed with early stage her-2 expressing breast cancer, because it decreases the risk of relapse. transtuzumab affects cardiac function and potential benefits in decreasing cancer recurrence have to be balanced against short and long term toxicity. we have previously identified a high prevalence of metabolic syndrome and type ii diabetes mellitus in our patients with breast cancer. these patients may be particularly susceptible to cardiotoxic effects of transtuzumab based therapy. aim of this study is to assess the changes in the cardiac function of women who are undergoing transtuzumab based therapy for early stage breast cancer.

Eligibility criteria:
inclusion criteria: * stage 1,2,3 breast cancer * her2+ exclusion criteria: * stage 4 cancer
acrysof toric clinical results

Conditions: Cataracts; Astigmatism

Summary: this study is an evaluation of visual outcomes of subjects implanted with the acrysof toric intraocular lenses (iols) models sn60t3, sn60t4, and sn60t5.


Eligibility criteria:
inclusion criteria: * diagnosed with cataracts; has astigmatism falling in range of acrysof toric lens as assessed by the acrysof toric calculator exclusion criteria: * ocular comorbidities affecting visual outcome data, * prior refractive surgery, * irregular astigmatism

Keywords: toric intraocular lens (iol)
families, children and teachers thriving together

Conditions: Social Anxiety; Emotional Stress

Summary: the current study examines the impact of parentcorps in high-poverty district schools in new york city (nyc). the study is conducted within the context of the nyc department of education (doe) pre-k thrive initiative. as part of this initiative, the center for early childhood health and development (cehd) at nyu langone health is implementing services to strengthen family engagement and support parents and teachers in creating safe, nurturing and predictable environments for young children. all parents of pre-k students in the 81 district schools will be invited for them and their pre-k children to participate in the study, which includes 2 school-based assessments in pre-k over a 10-month period and 1 school-based assessment at the end of kindergarten, and teacher ratings of children in pre-k and kindergarten. additionally, parents will be invited to consent to the use of their children's nyc doe administrative records from pre-k through grade 5 for the purposes of this study. parents will also be invited to participate by completing surveys with nyu study staff. parents will be consented to complete two surveys when their child is in pre-k. parents may be randomly selected to complete a third survey when their child is in kindergarten or to participate in a focus group with other parents.


Eligibility criteria:
inclusion criteria: * site selection criteria a total of 81 of these district schools with pre-k programs in high poverty nyc neighborhoods were selected for the study in late spring 2017 by the nyc department of education (doe), following a detailed methodology developed collaboratively by the nyc doe and nyu investigators. schools must meet the following criteria: 1. have 2 or more pkfa classrooms; 2. serve a high-need population and 3. leaders ranked thrive or inspire as a first or second preference for the school. sites that were currently implementing parentcorps at the time of the randomization were not eligible for the study. participant selection criteria * pre-k students and families who are in the schools in 2018-2019. * only parents and students who are english or spanish speaking will be eligible for participation in the study. exclusion criteria: * families in sites other than the 81 district schools randomized to this study are excluded. * parents or students who do not speak english and/or spanish will not be eligible to participate. * teachers and principals from the 81 sites are not considered participants in the study of student and family outcomes.
the effects of core stability training in children with adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: adolescent idiopathic scoliosis (ais) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a cobb (method for measuring spinal curvature) angle of 10° and above. ais is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. children with ais have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. lack of core stability might be causing these problems. core stability training may have a positive effect for these problems experienced by children with ais. pathologies that cause the disease may originate from the nervous system and musculoskeletal system. in this study, the investigators will evaluate these systems objectively with emg biofeedback and isokinetic testing. the aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. in addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.


Eligibility criteria:
inclusion criteria: * diagnosed with ais between the ages of 10-20 * cobb angle is between 15-40 degrees * the child's and family's consent to participate in the study * the child does not receive any other treatment that will affect his scoliosis. exclusion criteria: * surgical operation in the last 3 months * presence of an orthopedic, neurological, systemic disease that will prevent him from exercising * having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises * exercising 3 or more days a week.

Keywords: isokinetic testing emg biofeedback core stability
treatment of miller class i and ii gingival recession using non- pedicled buccal fat pad graft as compared to subepithelial connective tissue graft

Conditions: Gingival Recession

Summary: this randomized controlled single blinded parallel clinical trial is held to monitor if the use of the non pedicled buccal fat pad graft will result in post operative pain as a primary outcome compared to that occurs with the use of the sub epithelial connective tissue graft in treating miller class i and class ii gingival recession


Eligibility criteria:
inclusion criteria: 1. patients are systemically healthy based on questionnaire dental modification of cornell index. 2. patients are periodontally healthy with no contraindication for periodontal surgery. 3. all patients are not using any kind of medications that could interfere with the health of gingiva or periodontal tissues. 4. o'leary index is less than 10% ( the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation) 5. buccal recession defects are classified as miller class i or ii. 6. presence of identifiable cej. 7. the papilla fill the interdental spaces as far as the contact area 8. clinical indication and/or patient request for recession coverage. exclusion criteria: 1. miller class iii or iv recession defects 2. pregnant female. 3. smokers as smoking is contraindicated for any plastic periodontal surgery 4. patients with special needs or with any mental problems. 5. patients undergoing radiotherapy 6. teeth with carious or non-carious lesion or cervical restorations 7. rotated teeth and tooth extrusion with or without occlusal abrasion 8. patient undergone any prior periodontal surgery in the relevant region.

Keywords: buccal fat pad graft sub-epithelial connective tissue graft
a trial of shr-1905 in healthy subjects

Conditions: Asthma

Summary: this is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. the objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered shr-1905 in healthy subjects.

the study will consist of one dose esclation part with a total of 5 dose levels. the subjects will be randomized to receive shr-1905 as reflected by the guiding principle for the dose esclation/expansion phase. each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial. 2. male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 3. total body weight ≥45 kg at screening, and body mass index (bmi) between 18 and 28 kg/m2 (inclusive). 4. for healthy subjects, no clinically significant abnormalities. 5. men and women of childbearing potential (wocbp) must agree to take effective contraceptive methods exclusion criteria: 1. known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc. 2. severe injuries or major surgeries within 6 months before screening. 3. subjects with infecious disease. 4. hyper/hypotension at screening and at check in. 5. clinically significant abnormalities in 12-lead ecg 6. more than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening 7. positive urine drug screen . 8. subject who cannot perform venous blood sampling. 9. known history or suspected of being allergic to the study drugs and their excipients. 10. use of any medicine within 4-weeks or within 5 half-lives 11. history of alcohol abuse within 3 months prior to the ip administration . 12. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening 13. in the investigator's judgment, may increase the risk to the subject
a study in male and female adolescent participants with severe uncontrolled asthma starting treatment with dupilumab injection (dupixent®)

Conditions: Asthma

Summary: primary objective: - describe the characteristics of enrolled severe asthma patients secondary objectives: * assess the control of asthma under dupilumab (dupixent®) treatment until 1 year * assess the clinical objectives of the asthma care * assess comorbidities associated with type 2 inflammation * assess safety during the year of treatment

52 weeks

Eligibility criteria:
inclusion criteria: * adolescents, for whom initiation of dupilumab (dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study * adolescents ≥ 12 and \< 18 years of age at the time of the initiation of dupixent® treatment exclusion criteria: - adult participants ≥ 18 years of age the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
a study of tor kinase inhibitor in advanced tumors

Conditions: Solid Tumors

Summary: the purpose of the study is to assess the safety, tolerability and pharmacokinetics of azd8055 and determine the maximum tolerated dose to take into phase ii trials.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma part a only) * cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to recist criteria) can be recruited to part a * evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients exclusion criteria: * patients with severe laboratory abnormalities for haematology, liver or renal function. also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug. * patients with abnormal fasting glucose, have type i or ii diabetes or have uncontrolled blood fats and cholesterol * patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded * patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Keywords: cancer advance solid tumours dose escalation preliminary efficacy azd8055 tor kinase inhibitor oral administration
effectiveness of sequential eustachian tube maneuvers in hyperbaric oxygen conditions

Conditions: Barotrauma;Ear; Tympanum; Perforation

Summary: middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation. several pressurization protocols have been proposed to reduce the incidence of this trauma, but barotrauma is still the main cause of poor adherence to hyperbaric therapy. therefore, this study aims to evaluate the effectiveness of serial tubal opening maneuvers to prevent barotrauma in patients undergoing treatment in a hyperbaric chamber.


Eligibility criteria:
inclusion criteria: * patient undergoing the first hyperbaric session. * understanding and properly carrying out equalization maneuvers exclusion criteria: * patients who did not understand the equalization maneuvers * patients with specific contraindications to hyperbaric therapy * patients with acute middle ear or tympanic membrane disease

Keywords: barotrauma tympanic membrane perforation eustachian tube hyperbaric oxygenation
erlotinib and momelotinib for the treatment of epidermal growth factor receptor (egfr) mutated egfr tyrosine kinase inhibitor (tki) naive metastatic non-small cell lung cancer (nsclc)

Conditions: EGFR Mutated EGFR TKI Naive Metastatic NSCLC

Summary: this study will evaluate the safety, preliminary efficacy, and pharmacokinetics (pk) of momelotinib (mmb) and erlotinib, as well as define the maximum tolerated dose (mtd) of momelotinib (mmb) combined with erlotinib in adults with epidermal growth factor receptor (egfr)-mutated, egfr tyrosine kinase inhibitor (tki) naive metastatic non-small cell lung cancer (nsclc). participants will be sequentially enrolled to receive progressively increasing doses of momelotinib (mmb) in combination with erlotinib. escalation of momelotinib (mmb) doses will proceed to the mtd, defined as the highest tested dose associated with dose-limiting toxicities (dlt) during the first 28 days of combined erlotinib and momelotinib (mmb) treatment. there will be four dose levels and each treatment cycle will consist of 28 days.


Eligibility criteria:
key inclusion criteria: * metastatic nsclc with documented egfr exon 19 deletion or exon 21 (l858r) substitution mutation * treatment naive or one prior standard chemotherapy that is platinum-based * adequate organ function defined as follows: * hepatic: total bilirubin \< upper limit of the normal range (uln); aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x uln * hematological: absolute neutrophil count (anc) ≥1500 cells/mm\^3, platelet ≥ 100,000 cells/mm\^3, hemoglobin ≥ 9.0 g/dl * renal: serum creatinine \< uln or calculated creatinine clearance (clcr) of ≥ 60 ml/min * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 key exclusion criteria: * known positive status for human immunodeficiency virus (hiv) * chronic active or acute viral hepatitis a, b, or c infection (testing required for hepatitis b and c) * presence of \> grade 1 peripheral neuropathy * symptomatic leptomeningeal, brain metastases, or spinal cord compression. * history of interstitial pneumonitis note: other protocol defined inclusion/exclusion criteria may apply.
long-pulsed 1064 nm nd-yag laser versus tca 20% in treatment of keratosis pilaris

Conditions: Keratosis Pilaris

Summary: keratosis pilaris (kp) is a common disorder of keratinization. there are different treatment modalities for kp with variable results. nd:yag laser and chemical peels are among these treatment modalities, however, there is no enough evidence in the literature regarding their efficacy. the aim of this study is to assess and compare the efficacy of long pulsed nd:yag laser and trichloreacetic acid 20% in treatment of keratosis pilaris.

keratosis pilaris (kp) is a genetic disorder of keratinization of hair follicles of skin. it's a very common benign condition that manifests as small, rough folliculocentric keratotic papules, often described as chicken bumps, chicken skin or goose-bumps, in characteristic areas of body, particularly the outer upper arms and thighs. trichloreacetic acid (tca) is a type of chemical peels that is derived from acetic acid by the chlorination of 3 hydrogen ions. it can induce coagulative necrosis of proteins and cells. the depth of action depends on various factors e.g the number of layers applied and its combination with substances that potentiate its action. nd: yag laser is a type of hair removing devices that operates at wave length of 1064nm. this wave length allows for less absorption at the epidermis. it is less absorbed by melanin, which leads to lower side effect and better tolerance but less efficacy in dark skinned patients.

Eligibility criteria:
inclusion criteria: * patients above 18 years with kp. * patients with kp affecting back of the trunk, arms, thighs, forearms, legs and buttocks. exclusion criteria: * pregnant or lactating females. * patients who had performed any laser treatment for kp within 6 months prior to the study. * patients with history of oral retinoids within 3 months prior to the study. * patients with history of hypertrophic scars or keloids. * patients who used any topical treatment one month prior to the session. * patients with acne affecting the same sites of keratosis pilaris. * patients with active skin diseases affecting the area involved with kp e.g. folliculitis and eczema.
bioavailability study of pf-06651600 formulations in healthy participants

Conditions: Healthy Volunteers

Summary: the study will be conducted as a phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. participants will be randomized into 1 of 4 sequences of treatment.


Eligibility criteria:
inclusion criteria: * participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes bp and pulse rate measurement, clinical laboratory tests, and 12 lead ecg. * participants with body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). exclusion criteria * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * known immunodeficiency disorder, including positive serology for human immunodeficiency virus (hiv) at screening, or a first degree relative with a hereditary immunodeficiency. * infection with hepatitis b or hepatitis c viruses

Keywords: pharmacokinetics jak inhibitor pf-06651600
evaluation of the allergenicity of amphadase injection (hyaluronidase injection usp)

Conditions: Allergic Skin Reaction

Summary: this study is designed to evaluate the allergenicity of amphadase® in healthy volunteers using an intradermal skin test.


Eligibility criteria:
inclusion criteria: healthy volunteers of either gender; those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, assessed according to the judgment of the principal investigator. a non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are: * hypothyroidism, * stable hypertension except those subjects on beta blockers including ocular preparations, * seasonal/perennial allergic rhinitis if able to wash out of antihistamines, * stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage), * migraine if not taking excluded medications, * mild anxiety/depression if not taking excluded medications, and * mild arthritic conditions if not taking excluded medications. * willingness and ability to sign an informed consent document; * 18 - 80 years of age; * intact skin at the forearm ; * female participants are currently practicing effective birth control methods or abstinence. exclusion criteria: * known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal, edetate disodium (edta); * use of medications within a duration considered to interfere with skin testing. * known dermographism which may interfere with skin testing. * pregnant or lactating women.

Keywords: hyaluronidase enzymes with tissue spreading activity allergic reaction intradermal skin testing