Kornimate/medical-research-clean huggingface dataset:
smart watch insights for prevention of exacerbations and enhance rehabilitation - movement study

Conditions: Cardiovascular Diseases; Non-Alcoholic Fatty Liver Disease; Respiratory Disease; Diabetes

Summary: aims of the study: 1. to deliver a scalable wellbeing programme to the local population of imperial college healthcare nhs trust, focusing on movement. 2. to describe the natural history of long-term conditions using digital data from a smartwatch. 3. to identify digital information that is routinely collected by a smart watch that can be used to predict outcomes in patients with long term conditions. 4. to identify factors that determine whether participants engage with and improve in a movement programme. adult patients who are registered to the imperial nhs care information exchange (cie), an nhs patient-facing electronic health record, are eligible to participate in the study. participants will receive a smart watch for self-monitoring of their movement and wellbeing and be asked to wear the device as much as possible. they will be asked to download a smartphone application called connected life, which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). participants will receive secure login details for the connected life application from the research team, to ensure data privacy. the research team will look at participants' health records, and attempt to identify associations between the digital data and clinical information. this will allow the research team to identify digital data that predicts the onset and natural history of long term conditions, which may potentially allow for earlier diagnosis for future patients. the primary outcome of the study is the identification of trends in movement based on step-count data recorded by the smartwatch.


Eligibility criteria:
inclusion criteria: * aged over 18 years * registered with the patient-facing electronic health record (care information exchange) exclusion criteria: * unwilling or unable to provide informed consent * arm or wrist injury or condition prohibiting the safe use of a smartwatch * any visual impairment preventing the use of the smartwatch or smartphone application.

Keywords: digital health smart wearable population health digital biomarkers
secondary ear reconstructions based on nagata method

Conditions: Secondary Ear Reconstructions Based on Nagata Method

Summary: the goal of this observational study is to provide a feasible surgical strategy based on nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. the main question it aims to answer is: • whether ear reconstruction surgery based on nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? participants who had accepted secondary ear reconstruction based on nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (cnn) models we previously developed.


Eligibility criteria:
inclusion criteria: * chest circumference larger than 60cm at the lowest sternum level; * willingness to participate long-term follow-ups; * ability to correctly understand the questionnaire(\>8 years old). exclusion criteria: * patients with damaged superficial temporal artery (sta); * patients with poor condition of rib cartilage; * patients with active inflammation in auricular area; * patients who refuses surgical approach.
quantitative ultrasound to assess steatotic liver disease in children

Conditions: MASLD; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Summary: this research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. the investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver mri. the investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices. our goals are: * to assess the accuracy of the advanced ultrasound analysis techniques in children * to implement and assess these advanced technique on small handheld ultrasound devices, if possible

our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (masld), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat. our study aims to develop advanced quantitative ultrasound (qus) analysis models for use with full-size us and, if possible, inexpensive point-of-care ultrasound (pocus) systems in children at risk for masld to estimate liver fat fraction and classify presence/absence of fatty liver. we anticipate the models will incorporate technical innovations to improve qus accuracy and efficiency. to develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or pocus devices. we plan to compare the performance of our qus models with liver mri.

Eligibility criteria:
inclusion criteria: * age 9 to 18 years * presence of risk factors for having masld * ability and willingness of participant or legal guardian/parent to give written informed consent * participant is willing to give written assent * able and willing to undergo all study procedures exclusion criteria: * known liver disease other than masld * pregnant or trying to become pregnant * inability to undergo an mr study: weight exceeding scanner table limit, waist circumference \> 140 cm, claustrophobie, and/or metal implants.

Keywords: masld steatosis quantitative ultrasound quantitative mri fat fraction pdff
to evaluate pharmacokinetics of lff269 in healthy volunteers and patients with hypertension

Conditions: Part 1 - Healthy Volunteers; Part 2 - Patients With Hypertension

Summary: this study is designed to enable optimal dose selection of lff269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.


Eligibility criteria:
inclusion criteria: part 1 - healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. part 2 * hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive. * patients with mild-to-moderate uncomplicated essential hypertension exclusion criteria: part 1 * history of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes. * a history of clinically significant ecg abnormalities. * known history or current clinically significant arrhythmias. * history of hypertension, adrenal or endocrine disease. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. * smokers (use of tobacco products in the previous 3 months). * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. * a positive hepatitis b surface antigen or hepatitis c test result. part 2 * pregnant or nursing (lactating) women. * women of child-bearing potential. * known history or evidence of a secondary form of hypertension * type 1 or type 2 diabetes mellitus. * history of heart diseases * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. other protocol defined inclusion/exclusion criteria may apply

Keywords: healthy volunteers, hypertension
braf-/mek-inhibition with dabrafenib and trametinib in melanoma patients

Conditions: Melanoma

Summary: adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the ema (european medicines agency). the purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.

melanoma is a disease of significant metastatic potential if not detected very early. oncogenic mutations in braf (b-raf proto-oncogene, serine/threonine kinase) are found in approximately 40% of melanomas and result in constitutive activation of the mapk (mitogen-activated protein kinase) pathway. treatment with the braf inhibitor dabrafenib plus the mek (mitogen-activated protein kinase kinase) inhibitor trametinib showed improved overall survival in patients with unresectable or metastatic braf v600e/k-mutant melanoma (combi-d and combi-v studies). in an adjuvant setting treatment with dabrafenib and trametinib significantly reduced the risk of melanoma recurrence in patients with high-risk, stage iii braf v600-mutant melanoma, with improvements in os (overall survival), dmfs (distant metastasis free survival), and ffr (freedom from relaps) (combi-ad study). based on these results, adjuvant dabrafenib plus trametinib therapy was approved in 2018 by the ema. compared to the metastatic situation, issues of compliance and treatment adherence may be more relevant in adjuvant treatments, as patients are free of disease and potentially cured even without adjuvant treatment. as the routine administration of drugs including dosing, treatment interruptions, and early termination in clinical practice may vary from procedures defined in clinical trials, this study aims to assess the usage of adjuvant dabrafenib and trametinib in the routine clinical setting.

Eligibility criteria:
inclusion criteria: * patients with complete surgical resection of histologically confirmed ajcc (american joint committee on cancer) (8th edition) clinical stage iii (iiia, iiib, iiic, iiid) melanoma, for whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study. * v600e/k mutation-positive cutaneous melanoma * adjuvant treatment with combination therapy of dabrafenib (tafinlar®) and trametinib (mekinist®) as indicated in the smpc (summary of product characteristics) and by prescription, that has been started no longer that 4 weeks before inclusion of the patient into the study or which will be initiated directly after inclusion * age ≥ 18 years * signed written informed consent exclusion criteria: * lack of basic demographics and staging information * current or planned participation within a clinical trial. the participation in a follow-up phase of a clinical trial without active intervention is allowed. * current or planned treatment of another tumor disease except keratoacanthoma, squamous cell or basal cell carcinoma of the skin
study on the biomarker of first-line immunotherapy combined with chemotherapy in advanced esophageal cancer

Conditions: Advanced Esophageal Cancer

Summary: this study intends to explore the predictive biomarkers by next-generation sequencing (ngs) and multiple immunohistochemistry (mihc) for the treatment of shr-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.


Eligibility criteria:
inclusion criteria: * unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology; * not received any previous systematic antitumor therapy. * eastern cooperative oncology group (ecog) fitness status score was 0 or 1 within 3 days before the first administration of the intervention. * 8-10 tumor tissue samples can be provided. * demonstrate good organ and bone marrow function. * consent to participate in the contraceptive methods related to clinical research. exclusion criteria: * have a history of allergy to monoclonal antibodies, any component of shr-1210, albumin-paclitaxel, carboplatin, and other platinum drugs; * weight loss \> 20% in the past 3 months. * major surgery within 28 days prior to enrollment. * have received systemic chemotherapy or radiation therapy for esophageal cancer. * had a myocardial infarction within the past 6 months. * have any medical history or current evidence, treatment, or laboratory abnormalities that prevent the subject from participating fully in the study with the investigator's opinion. * prior treatment with immunotherapy drugs. * received live vaccine within 30 days prior to initial administration of the investigational drug. * have been diagnosed with immunodeficiency or are receiving immunosuppressive treatment. * another malignancy is known to exist. * have active infections that require systemic treatment. * pregnant or lactating, or planning to become pregnant or become a father during the study period (180 days for lactating subjects receiving carboplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.
adrenal function in ghd children

Conditions: Growth Hormone Treatment; Adrenal; Functional Disturbance

Summary: to evaluate in children affected by idiopathic ghd the adrenal function both at baseline and after 6 and 12 months of gh treatment.

the relationship between the growth hormone (gh)-insulin like growth factor (igf)-i system and the hypothalamic-pituitary-adrenal (hpa) axis is complex and not univocal. both a stimulatory and neutral effect of igf-i on hpa axis has been demonstrated in in vitro models and in healthy subjects, respectively. the effect of gh on the 11beta-hydroxysteroid dehydrogenases (11beta-hsd) isozymes is always to be considered in patients affected by ghd both at diagnosis and during gh treatment. indeed, in peripheral tissues, corticosteroid hormone action is partially determined by the activity of 11beta-hsd, two isozymes of which interconvert hormonally active cortisol and inactive cortisone. 11beta-hsd2 inactivates cortisol to cortisone in the kidney, whilst 11beta-hsd1 performs the reverse reaction activating cortisol from cortisone in the liver and adipose tissue. for these reasons, many data are available about the evaluation of adrenal function in patients affeceted byghd, but most of them come from patients with organic ghd or adult patients, while few and discordant data are available on pediatric ghd patients. we aimed to evaluate, through insulin tolerance test, the adrenal function in about 30 children with overt diagnosis of idiopathic ghd both at baseline and after 6 and 12 months of gh treatment.

Eligibility criteria:
inclusion criteria: * prepubertal children with overt idiopathic growth hormone deficiency exclusion criteria: * children with organic growth hormone deficiency or under treatment with glucocorticoids

Keywords: growth hormone children adrenal function
indoor air and children health study

Conditions: Cardiopulmonary Disease

Summary: the objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in beijing.

this randomized, double-blind crossover study was conducted to explore the cardiopulmonary effects of ionization air purification among 48 children in beijing. real or sham purification was performed in classrooms for 5 weekdays in a random order with a 2-month wash-out period. during the study periods, different indoor environmental factors were monitored including size-fractionated particulate matter (pm), black carbon (bc), ozone, carbon dioxide (co2), negative air ions (nai), noise, temperature and relative humidity, which were controlled as confounders in the analysis of the effects of indoor air purification. in addition, we analyzed the cardiopulmonary effects of those environmental factors on the children.

Eligibility criteria:
inclusion criteria: * living in beijing for more than two consecutive years; * living in school dormitories from monday to friday. exclusion criteria: * suffering any health condition; * having asthma or thoracic surgery history.
a phase 2 study of standard chemotherapy plus bsi-201 (a parp inhibitor) in the neoadjuvant treatment of triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: this study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and bsi-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery. based on data generated by bipar/sanofi, it is concluded that iniparib does not possess characteristics typical of the parp inhibitor class. the exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-h2ax (a marker of dna damage) in tumor cell lines, induces cell cycle arrest in the g2/m phase in tumor cell lines, and potentiates the cell cycle effects of dna damaging modalities in tumor cell lines. investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility criteria:
inclusion criteria: * invasive breast cancer * stage i-iiia disease * er, pr, her2/neu-negative status * no prior treatment for breast cancer * age 18 years of greater * normal renal, liver function * normal hematologic status * ecog performance status 0, 1 * evaluation by a surgeon to determine breast conservation eligibility * women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * metastatic breast cancer * inoperable breast cancer, including stage iiib and iiic * tumor size less than 1 centimeter * prior surgery, systemic therapy, or radiotherapy for the current cancer * hormone receptor-positive breast cancer * her2/neu-positive breast cancer * any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol * pregnant or nursing women * receipt of any investigational agents within 30 days prior to commencing study treatment

Keywords: triple negative breast cancer
therapeutic optimization study based on mr enterocolonography in patients with crohn's disease

Conditions: Crohn Disease

Summary: this randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with magnetic resonance enterocolonography (mrec) active. in addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and mrec remission. the primary endpoint is the rate of clinical remission at 104 weeks.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of crohn's and proven history of disease with clinical remission (cdai\<150) * signed written consent form to enroll the study (need agreement from deputy for patients under 20years old) exclusion criteria: * contraindication for infliximab, adalimumab, or azathioprine * lactating woman * presence of malignancy * within 3 month from intestinal surgery * presence of an end stoma * planned surgery

Keywords: crohn disease inflammatory bowel diseases disease attributes
effectiveness of association mometasone furoate 0.1% and salicylic acid 5% compared with mometasone furoate

Conditions: Plaque Psoriasis

Summary: the aims is to evaluate the efficacy and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate produced by the laboratory glenmark pharmaceuticals ltd. in patients of both sexes, patients with plaque psoriasis grade mild to moderate.

the specific objective is to evaluate through analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. the study will be conducted with 40 patients who will deal with two symmetrical lesions of his body being identified by the clinician that a party should be treated in a double-blind only with mometasone furoate cream containing 0.1% and another with the combination of furoate of mometasone 0.1% + salicylic acid 5%. the group of patients to be treated must be adults of both sexes, aged 18-70 years with good mental and physical health to sign the informed consent and who are clinically assessed by dermatologists in the study as having mild plaque psoriasis and moderate. the association made a proposal of effectiveness was developed and is produced by the laboratory glenmark pharmaceuticals ltd., as well as its isolated version of the pilot (mometasone furoate 0.1%). this study should be characterized as phase ii multicenter not.

Eligibility criteria:
inclusion criteria: * adults of both sexes, regardless of color or social class; * age 18 or older, with good mental health; * patients with plaque psoriasis of mild to moderate; * patients who agree to participate and sign the informed consent and * clarified (appendix); * patients who agree to return for follow-up visits. exclusion criteria: * patients who are making use of biologics, steroids or steroidal anti-inflammatory and non-steroidal or who made use of these topical medications until 15 days ago 30 days ago or when occurred in oral administration; * patients who are exposing themselves to the sun 15 days before the study began or during the course of the same. * patients who are making use of acetaminophen; * patients who do not agree to the terms described in the informed consent informed consent; * patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics; * lions and other types of skin damage than those psoriasis; * pregnant and nursing women; * patients using oral anticoagulants.

Keywords: psoriasis