Kornimate/medical-research-clean huggingface dataset:
investigating safety, tolerability, pk and pd for multiple doses of nnc9204-0530 in combination with liraglutide in male and female subjects being overweight or with obesity

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america. the aim of this trial is to investigate safety, tolerability, pk (the exposure of the trial drug in the body) and pd (the effect of the investigated drug on the body) for multiple doses of nnc9204-0530 in combination with liraglutide in male and female subjects being overweight or with obesity


Eligibility criteria:
inclusion criteria: * body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. * male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent exclusion criteria: * any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening * any prior obesity surgery or currently present gastrointestinal implant. * thyroid-stimulating hormone (tsh) values outside 0.4-6.0 miu/l * glycosylated haemoglobin (hba1c)above or equal to 6.5% or in système international (si) units 48 mmol/mol * abnormal ecg (electrocardiogram) results including 2nd or 3rd degree av-block, prolongation of the qrs complex above 120 ms, or the qtcf interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator * a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalaemia, family history of long qt syndrome) * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) * calcitonin above or equal to 50 ng/l * history of pancreatitis (acute or chronic)
nesa microcurrents on quality of life in geriatric patients

Conditions: Aging

Summary: in recent years, the population of older adults (ma) in the world has been increasing, due to the increase in life expectancy and the decrease in the fertility rate. the united nations (un) places spain as the most aged country in the world in the year 2050, with 40% of its population over 60 years of age. there is evidence that quality of life in the elderly is associated with variables linked to physical and psychological health. thus, for example, previous research indicates that perceived health and cognitive functioning influence the perception of quality of life. the nesa xsignal® device is a low-frequency, non-invasive neuromodulation device that uses microcurrents to restore electrical balance in the body. this technology is approved as medical equipment and is ce marked. this non-invasive neuromodulation equipment is starting to have promising results in patients with sleep disorders. so it can be a useful tool to reduce the impact on the geriatric patient's quality of life.

the main objective will be to evaluate the efficacy of the application of non-invasive neuromodulation in the treatment of geriatric patients for the improvement of health-related quality of life. for this purpose, the investigators propose to carry out an interventional study with a sample of approximately 40 participants. data will be recorded for 1 month and a half for each participant. it is estimated 7 months from the design, management and development of the project, and it does not have sources of financing.

Eligibility criteria:
inclusion criteria: * patients residing in the social-health care center under study. * stable medical and pharmacological condition. * no cognitive impairment or mild cognitive impairment. exclusion criteria: * patients with some of the contraindications for treatment with nesa device: pacemakers, internal bleeding, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity, * not having signed the informed consent form. * patients with severe cognitive impairment, patients with severe cognitive impairment.

Keywords: physical therapy modality sleep disorders quality of life
trial of endocrine against locoregional therapy first in postmenopausal women with early breast cancer

Conditions: Operable Breast Neoplasms

Summary: the hypothesis to be addressed in this randomized phase iii trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.


Eligibility criteria:
inclusion criteria: * informed consent * age 60 years or older * measurable non-metastatic and non-inflammatory breast cancer * tumor of 2 cm or larger * er and/or pgr positive tumor * co-morbidity index 0 - 3, e.g., no other serious medical condition exclusion criteria: * prior medical therapy for a malignant disease, including aromatase inhibitors * distant metastasis * need for chemotherapy * past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri) * treatment with a non-approved drug within 30 days

Keywords: breast neoplasms randomised trial aromatase inhibitors preoperative care age 60 or older hormone receptor positive tumor tumor lager than 2 cm no distant metastasis
augmented endobronchial ultrasound (ebus-tbna) with artificial intelligence

Conditions: Artificial Intelligence; Endobronchial Ultrasound; Lung Cancer

Summary: to evaluate the usefulness of deep neural network (dnn) in the evaluation of mediastinal and hilar lymph nodes with endobronchial ultrasound (ebus). the study will explore the feasibility of dnn to identify lymph nodes and blood vessel examined with ebus.

multi-center prospective feasibility study. the dnn model will be trained on ultrasound images with annotation to identifies lymph nodes and blood vessels examined with ebus. the ability of the dnn to segment lymph nodes and vessels based on postoperative processing and static ebus images will be evaluated in the first part of the study. in the second part of the study real-time use of dnn in ebus procedure will be evaluated.

Eligibility criteria:
inclusion criteria: * subjects referred to thoracic department in any of the participating hospitals with undiagnosed enlarged mediastinal and hilar lymph nodes. * subjects have to be ≥ 18 years of age exclusion criteria: * pregnancy * any patient that the investigator feels is not appropriate for this study for any reason.
efficacy of stellate ganglion block in dysphagic patients with bulbar palsy after ischemic stroke

Conditions: Bulbar Palsy

Summary: this is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in china. all patients are randomly allocated to the observation group or the control group. both groups are provided with comprehensive rehabilitation. besides, the observation group additionally undergoes the stellate ganglion block. at admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, functional oral intake scale, flexible laryngoscope are used to assess swallowing function.

palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.this is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in china. all patients are randomly allocated to the observation group or the control group. both groups are provided with comprehensive rehabilitation. besides, the observation group additionally undergoes the stellate ganglion block. at admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, functional oral intake scale, flexible laryngoscope are used to assess swallowing function.

Eligibility criteria:
inclusion criteria: * diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy. * upper esophageal sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by videofluoroscopic swallow study. * age \>18 years. * first-time stroke. * steady vital signs, * transferred or admitted to the department of rehabilitation medicine within 15d after onset. exclusion criteria: * the bulbar palsy caused by other diseases, such as neurodegenerative diseases. * pseudobulbar palsy. * complicated with other neurological diseases. * tracheostomy tube inserted. * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. * dysphagia caused by other possible diseases. * pregnant females.
a study to estimate the relative bioavailability of pf-00258210 administered alone or in combination with pf-00610355

Conditions: Asthma

Summary: the purpose of this study if to investiagte the time course of pf-00258210 plasma concentration in the presence or absence of pf-00610335 administered via oral inhalation using dry powder inhalers


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) * a positive urine drug screen * pregnant or nursing females

Keywords: healthy
assessment of the ace program for rehabilitation in hearing loss

Conditions: Hearing Loss

Summary: * introduction: hearing loss is a prevalent condition in elderly population. however, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. in 2007 there was designed a rehabilitation program called ace, which aims to improve rehabilitation directed to hearing aids users. the study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population. * objective: to evaluate the utility of a standardized counselling program in patients with hearing loss. * material and methods: a before/after trial will be carried out, approved by the hospital ethics - committee. patients with 65 years and older with hearing loss diagnosed by pure tone audiometry will be included. to assess adherence we will use the ioi-ha scale.

* introduction: hearing loss is a prevalent condition in elderly population. however, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. in chile, hearing aids are provided by the state for elderly population. in 2007 there was designed a rehabilitation program called active communication education (ace), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution. * the study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population. * objective: to evaluate the utility of a standardized counseling program in patients with hearing loss. * material and methods: a before/after clinical trial will be carried out, approved by the hospital ethics - committee. patients with 65 years and older diagnosed by pure tone audiometry who are beneficiaries of the public ges hearing loss programme and receive a hearing aid will be included. the subjects will be randomized in two branches: active branch, subject to the rehabilitation program; and passive branch, which was control, with usual management (no intervention). to assess adherence we will use the ioi-ha scale.

Eligibility criteria:
inclusion criteria: * bilateral hearing loss equal or higher than 40 decibels * age 65 years old or more * agree to be included in the study * have a relative to go to the intervention with the subject exclusion criteria: * severe organic brain impairment * physical or mental incapacity to understand the study questionnaires * structural pathology of the ear that produces hearing loss as chronic otitis media, ear canal tumor, or tumor of the cerebellopontine angle

Keywords: hearing loss, rehabilitation programs, adherence to hearing aids.
tracking triple-negative breast cancer evolution through therapy

Conditions: Triple-Negative Breast Neoplasm

Summary: a prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ith) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (tnbc) who are eligible for neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: 1. age 18-years or older 2. patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator 3. estrogen receptor (er)- and progesterone receptor (pr)-negative as defined by ≤1% of positive staining on immunohistochemistry 4. human epidermal growth factor receptor 2 (her2)-negative as defined by american society of clinical oncology / college of american pathologists guidelines 5. t1c-4 tumours (including inflammatory cancers), with any nodal status non candidate for conservative surgery upfront. bilateral or multifocal cancer is permitted provided that all sites are her2-negative and at least one site is er- and pr-negative. 6. provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses 7. patient with social insurance coverage exclusion criteria: 1. confirmed metastatic disease at initial presentation 2. any contraindication to the biopsy procedure 3. previous or current malignancies of other origin within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin 4. any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol 5. individuals deprived of liberty or placed under the authority of a tutor
liquid biopsy with pet/ct versus pet/ct alone in diagnosis of small lung nodules

Conditions: Lung Cancer; Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Summary: the purpose of this study is to determine if a liquid biopsy, a method of detecting cancer from a blood draw, combined with a pet/ct scan, a type of radiological scan, is better at determining whether a lung nodule is cancerous when compared to a pet/ct scan alone. a pet/ct scan is already used for diagnosis of lung nodules, but its efficacy is uncertain in nodules 6-20 mm in size. therefore, the pet/ct will be evaluated for its diagnostic ability in lesions this size alone and in combination with a liquid biopsy. secondarily, a machine learning model will be created to see if the combination of the pet/ct imaging data and the liquid biopsy data can predict the presence of cancer.


Eligibility criteria:
inclusion criteria: * over 18 years of age * ecog performance status of 0,1, or 2 * newly discovered lung nodule with: 1. at least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening ct 2. no single lesion larger than 20 mm in greatest diameter when multiple nodules present 3. high- or intermediate-risk nodules per american college of chest physician (accp) guidelines * able to provide informed consent exclusion criteria: * prior cancer of any type for the previous 3 years * prior organ, bone marrow, of hematopoietic stem cell transplant * contraindication to administration of \[18f\]fdg * inability to undergo a pet/ct scan * ongoing infection, either acute or subacute * severe copd or lung disease requiring home oxygen use * pregnancy

Keywords: pet-ct scan liquid biopsies
evaluation of the effects of bradykinin antagonists on pulmonary manifestations of covid-19 infections (antagobrad-cov study).

Conditions: Covid19

Summary: the main objective of this study is to evaluate the efficacy of human c1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin b2 receptor antagonist) on the pulmonary manifestations of covid-19 infections.

prospective, prospective, multicentre, double-blind, randomised, multi-centre study of three parallel groups of patients: * group 1 (n=15): standard of care + c1 inhibitor * group 2 (n=15): standard care + icatibant + c1 inhibitor * group 3 (n=15): standard support + placebo the study has two parts: * a 4-day (96-hour) therapeutic part during which the patient will be evaluated nine times (h0, h4, h12, h24, h36, h48, h60, h72 and h96). * a follow-up part of 6 days with at least two assessments (d7 and d10). the maximum duration of patient participation in the study will be 10 days.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age, having read and signed the consent form for participation in the study after the reflection period (≤ 15 minutes) * patient screened for covid+ by rt-pcr on nasopharyngeal swab * patient with at least three of the following respiratory signs: * temperature \>38° c * non-productive dry cough * presence of crackling rales on auscultation * respiratory discomfort felt by the patient * heart rate \> 90/min * respiratory rate \>20/min * o2 saturation ≤ 93% * patient whose clinical condition, in the opinion of the investigator, requires hospital monitoring. * patient who would have been monitored and treated outside of study participation, including prevention of thromboembolic risk with lmwh. exclusion criteria: * patient with pre-existing respiratory disease (cancer, copd, asthma, emphysema) or smoking history of \> 25 years) * patient with a known allergy to one of the study products * patient treated with anti tnf, il1 or il6 * patient requiring immediate intubation * patient on a low sodium diet * patient under protective custody, guardianship or trusteeship * patient not affiliated to the french social security system * patient participating in another therapeutic protocol * pregnant or likely to become pregnant (woman of childbearing age without effective contraception and without hcg dosage) * patient unable to understand informed information and/or give written informed consent: dementia, psychosis, consciousness disorders, non-french speaking patient
clinical trials for the optimal dosage of tang ning tongluo capsule

Conditions: Accidental Exposure While Preparing Drug for Administration

Summary: treatment of diabetes mellitus with traditional chinese medicine has a long history. aim： --establish the optimal dosage of traditional chinese medicine tang ning tongluo capsule to treat type ii diabetes mellitus. ---preliminary evaluate the clinical efficacy and safety of tangning tongluo capsule in the treatment of type ii diabetes

preliminary evaluation on the clinical efficacy and safety of tangning tongluo capsule in the treatment of type ii diabetes, and provides basis for determining optimal dosage of tangning tongluo capsule.

Eligibility criteria:
inclusion criteria: 1. fulfilled diagnostic criteria for type ii diabetes and tcm syndrome diagnostic criteria. 2. age between 18-70 years. 3. the blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/l, ≤ 13 mmol/l and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/l, ≤ 16 mmol/l; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%. 4. traditional chinese medicine symptom score ≥ 4 points. 5. participated in the experiment voluntarily, and signed the informed consent form. exclusion criteria: 1. durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity. 2. secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, bernard glenn nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional chinese medicine. 3. within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders. 4. alt is 2 times higher than the upper limit of the normal value, cr is higher than the upper limit of normal persons. 5. has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients. 6. pregnant, lactating women and prepare for pregnancy. 7. the allergic constitution and the drug allergy known composition. 8. for nearly a month with severe infection or other emergency state, such as trauma, operation etc.. 9. within the past 3 months, participated in the other drugs.
micro-ultrasound/magnetic resonance imaging 001

Conditions: Diagnoses Disease

Summary: micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (cspca) to mri. this prospective trial aims to compare micro-ultrasound to mpmri in detection of cspca in the biopsy naïve.

evidence from a large randomized clinical trial (clinical trials.gov id nct02079025), suggests that micro-ultrasound system is more sensitive than conventional transrectal-ultrasound (trus) to detect prostate cancer (pca). the pri-mus (prostate risk identification using micro-ultrasound) scoring system was developed and validated to assess the risk of prostate cancer for targeted biopsy with the micro-ultrasound platform, similar to the pirads scoring system for suspicious areas on mpmri. this project will compare micro-ultrasound imaging modality to the current gold-standard imaging for prostate cancer, mpmri. by applying both modalities to the same patients, the investigators will provide a direct comparison of their screening abilities in terms of sensitivity, specificity, negative predictive value and positive predictive value. it will build evidence to demonstrate that micro-ultrasound may replace mri/fusion biopsy in these patients.this project aims to demonstrate that the micro-ultrasound 1) provides more sensitive initial biopsy, reducing the need for repeated procedures, thus lowering the rate of severe sepsis and the number of cancers found after local or regional progression, and 2) reduces the need for mpmri following initial biopsy.

Eligibility criteria:
inclusion criteria: * men with indication for a prostate biopsy will be offered inclusion in the study. indications for biopsy include clinical suspicion of prostate cancer due to elevated psa or abnormal digital rectal exam (dre) exclusion criteria: * patients with history of prostate cancer * patients with prior prostate biopsies * patients who are unwilling or unable to give informed consent * patients with contraindication to mri (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to mri contrast agent)

Keywords: prostatic disease diagnostic imaging micro-ultrasound