Kornimate/medical-research-clean huggingface dataset:
acceptability and feasibility of apollo in veterans with a history of ptsd

Conditions: PTSD

Summary: the proposed investigation is an open label pilot study intended to establish the acceptability and feasibility of the apollo in a population of veterans. exploratory data regarding biological signatures will also be collected.

evaluation of apollo requires a stepwise process in which initial aims are geared towards identifying biological signatures versus diagnosing, treating, mitigating or curing any conditions. towards the end of identifying potential biological signatures, we hypothesize the following. 1) participants who use the apollo will have an attenuated physiological stress response as measured by improved heart rate variability (hrv) compared to baseline. 2) participants who use apollo will have attenuated perceived psychological stress measured by lower scores on psychological correlates of acute stress when compared to baseline

Eligibility criteria:
inclusion criteria: 1. veterans eligible to receive care by a va provider 2. history of at least one deployment in support of operation enduring freedom (oef), operation iraqi freedom (oif), and operation new dawn (ond) 3. current diagnosis of ptsd per the clinician administered ptsd scale-5 (caps-5) 4. willingness to wear the apollo daily and to comply with study protocol 5. android or apple smart phone on which the participant can download the apollo mobile app 6. age between 18 and 65 7. ability to provide informed consent exclusion criteria: 1. inability to adequately respond to questions regarding the informed consent procedure 2. currently involved in the criminal justice system as a prisoner or ward of the state 3. current (past month) alcohol or substance abuse or dependence 4. lifetime history of bipolar disorder, psychosis, or delusional disorders 5. lifetime history of oppositional defiant disorder or anti-social personality disorder 6. pregnancy 7. recent medication changes in the past 4 weeks 8. a current beta blocker prescription (other than prazosin) 9. active untreated visual impairment

Keywords: stress heart rate variability microbiome
treatment of respiratory tract infection and/or acute bronchitis with ectoin inhalation solution

Conditions: Bronchitis; Cough; Sputum, Cellular Atypia; Dyspnoea

Summary: this observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between ectoin inhalation solution and pari nacl (0.9%) inhalation solution

the assessment focuses on the bronchitis severity score (bss) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea

Eligibility criteria:
inclusion criteria: * according to instruction for use exclusion criteria: * according to instruction for use

Keywords: inhalation isotonic saline nacl solution 0.9 % ectoin bronchitis respiratory tract infection
cefepime vs. carbapenems for treating ampc β-lactamase-producing enterobacteriaceae bloodstream infections

Conditions: Bacteremia

Summary: recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. as cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years of age) * managed within a study center for high-grade cephalosporinase-producing bacteremia * not objecting to the reuse of their health data for scientific research purposes. exclusion criteria: * patient who has expressed opposition to the reuse of their data for scientific research purposes. * resistance to cefepime or carbapenems * multiple bacteremia * treatment with a molecule other than cefepime or carbapenem.

Keywords: bacteremia cefepime carbapenems ampc β-lactamase enterobacteriaceae bloodstream infections
dapagliflozin for long covid syndrome

Conditions: COVID - 19; Long COVID Syndrome

Summary: this is a randomized, placebo-controlled study. patients with long covid will be randomized to receive dapagliflozin or placebo for 12 months.

this is a multi-centre, randomized, placebo-controlled trial (figure 4). we will randomly assign patients with long covid to 12 months of dapagliflozin 10 mg or placebo daily. the 10 mg daily dose of dapagliflozin was used in large clinical trials (44,48) and is the health canada approved dose for heart and kidney disease. additionally, this dose was used in the mri study of body composition (58) and the rct in patients with acute covid-19 (54). eligible patients with long covid will be recruited from post covid programs or advertisement through-multi-media. a total of 192 participants will be enrolled and this is anticipated to take 3 years. participants will be followed for the entire duration of the study. based on a study duration of 5 years (3-year recruitment, 2-year follow-up), patients will be followed for a median of 3.5 years.

Eligibility criteria:
inclusion criteria: * 18 years of age or older and willing and able to provide informed consent * patients with a history of positive covid-19 test (polymerase chain reaction or rapid test) or have been diagnosed with covid-19 by a health care provider. * new or persistent symptoms at least 12 weeks from infection and present for at least 8 weeks that is not explained by an alternative diagnosis (64). * women of childbearing potential (wocbp) who, if sexually active, are willing to use to use at least one highly effective methods of contraception throughout the study. exclusion criteria: * history of diabetes * prior heart failure * weight loss treatment with glucagon-like peptide-1 receptor agonists (e.g. liraglutide, semaglutide) * pregnancy or planned pregnancy in the next 12 months. we will ask wocbp about the possibility of pregnancy at the time of screening and if so, then pregnancy testing will be offered. if testing is declined in this instance, then they will be excluded from the study. * women who are breastfeeding * severe renal impairment (egfr\<30ml/min1.73m2) * known history of allergy or hypersensitivity to dapagliflozin exclusion for optional mri portion of the protocol: - any contraindication to mri

Keywords: covid-19 long covid syndrome sars cov-2
a study to describe the real-world treatment patterns and associated outcomes in patients of china with her2-positive unresectable or metastatic breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this is a multicenter, non-interventional, retrospective, real-world study that enrolled patients diagnosed with her2-positive unresectable or metastatic breast cancer. this study will be conducted to understand the treatment pattern and sequencing of therapies, survival outcomes, and associated burden of toxicities with line of treatment in the real world.

the treatment landscape has changed dramatically with the lack of real-world evidence for usage and the efficacy of newly approved drugs in china. this multicenter, retrospective, non-interventional study will include patients newly diagnosed with her2-positive unresectable or metastatic breast cancer, or first recurrent from early breast cancer. the primary objective of this real-world study is to describe the treatment patterns of her2-positive unresectable or metastatic breast cancer in china. secondary objectives will include describing the demographic and clinicopathological characteristics of patients, efficacy of different treatment regimens, treatment options and efficacy of brain metastases, and safety and tolerability of different treatment regimens in patients with her2-positive unresectable or metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age at the time of diagnosis of unresectable or metastatic breast cancer * participants with first diagnosis of unresectable or metastatic breast cancer, or first recurrence of her2-positive breast cancer since january 1, 2020. participants were eligible if they were her2-positive in the early operable stage and her2-negative in the advanced stage. her2 positive was defined with the reference to the chinese guidelines for her2 positive breast cancer at the time of testing * participants have received at least one systemic therapy for advanced breast cancer exclusion criteria: * participants with concomitant cancer at the time of diagnosis of her2-positive unresectable or metastatic breast cancer, except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of her2-positive breast cancer diagnosis. * participants who are/were currently/previously enrolled in a clinical trial and have not been unblinded during the data collection interval of the study * participants with critical missing data from their medical records or other patients deemed by the investigator to be ineligible for inclusion

Keywords: her2-positive breast cancer real-world study treatment patterns
study evaluating temsirolimus (cci-779) in breast neoplasms

Conditions: Breast Neoplasms

Summary: to evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered temsirolimus (cci-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. all patients must be appropriate to receive endocrine therapy as treatment for advanced disease.


Eligibility criteria:
inclusion criteria: * postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast. * must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted). * women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen. exclusion criteria: * patients having known central nervous system (cns) metastases. * prior therapy with temsirolimus (cci-779) or aromatase inhibitors. * tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1 week prior to day 1 of treatment on study.

Keywords: breast neoplasms
sulforaphane in a new jersey (nj) population of individuals with autism

Conditions: Autism; Autistic Disorder; Autism Spectrum Disorder; Autistic Behavior

Summary: this study is a double blind treatment trial that will test if sulforaphane improves core symptoms in autism. the investigators expect to see clinical improvement in some of these areas. sulforaphanes come from eating certain vegetables such as broccoli. the investigators will be using a preparation that gives specific and reproducible amounts. the investigators will also test specific chemicals and genes needed for sulforaphane usage to try to understand differences in response.

this study is a double blind randomized treatment trial that will test if sulforaphane improves core symptoms in autism. it is designed to try to replicate a previous trial (clinicaltrials.gov identifier nct01474993) which reported that the isothiocyanate, sulforaphane treatment led to improvement by multiple metrics. significant improvement was seen in behavior as measured by the aberrant behavioral checklist (abc) and by the social responsiveness scale (srs). in addition a significantly greater number of participants receiving sulforaphane had improvement in social interaction, abnormal behavior, and verbal communication as per the clinical global impression (cgi). in addition the investigators will attempt to account for some variability in response to sulforaphane treatment by testing alleles of genes that are relevant in sulforaphane metabolism. the investigators will also measure glutathione levels, which are also important in sulforaphane metabolism and are in part regulated by sulforaphane.. sulforaphane is the most potent naturally occurring inducer of mammalian cytoprotective enzymes known. therapeutic potential is based at least in part on their ability to up-regulate genes responsible for alleviation of oxidative stress and to regulate both the immune system and the inflammatory response 40 males with autistic disorder will be randomly selected to receive either sulforaphane or placebo. seven visits are required by the subjects including enrollment ,screening, baseline, weeks 4, 10 and 18 and a follow up visit at seek 22.

Eligibility criteria:
inclusion criteria: * autistic disorder diagnosis. * age between 13-30 years. * male gender. exclusion criteria: * absence of a parent or legal guardian and consent, * those that can not or will not complete all visits and adherence to study regimen. * seizure within 2 years of screening, * impaired renal function (serum creatinine\> 1.2 mg/dl). * impaired hepatic function (\> 2x upper limit of normal). * impaired thyroid function (tsh outside normal limits). * current infection or treatment with antibiotics. * chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment. * less than 13 years or more than 30 years of age. * female gender. * a diagnosis of autism spectrum disorder other than autistic disorder, for example, asperger, pervasive developmental disorder not otherwise specified (pdd-nos) etc.
evaluation of the efficacy of diagnostic support algorithms in chest x-rays- luana trial

Conditions: Consolidation; Lung Injury; Pleural Effusion; Pneumothorax; Cardiomegaly; Edema Lung

Summary: this study aims to evaluate whether the use of ai as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without ai support. this is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the standard protocol items: recommendations for interventional trials (spirit). in this study, the diagnostic support solution for chest x-rays - lunganalysis (luana), developed by the hospital israelita albert einstein (hiae) within the proadi-sus banco de imagens, was used. the clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. the expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest x-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other ai applications in imaging diagnostics.

imaging diagnostic aid tools that use ai and facilitate the identification of findings on chest x-rays can contribute to doctors' care routines and clinicians' and radiologists' reporting routines, as these tools can allow the organization of care queues according to priorities, in addition to identifying subtle findings on the image, thereby reducing errors in reading the rxt and benefiting patients with greater agility in care and a shorter time until diagnosis. however, for reliability, these tools must undergo rigorous validation processes in large populations before implementation.

Eligibility criteria:
inclusion criteria: * non-reported chest x-rays (xrts) of individuals aged over 18 years. * individuals images with respiratory complaints. * chest x-rays taken during the presence of these respiratory symptoms or while being followed up for respiratory disease. * chest x-rays taken on any x-ray machine. * chest x-rays that include at least one frontal view of the chest. exclusion criteria: * those whose chest x-ray was performed due to a history of trauma, pre-operative risk assessment, lung cancer screening, or exclusively for verifying the correct positioning of a peripheral intravenous catheter (picc). * chest x-rays with technical quality below the minimum required for proper interpretation and diagnosis. * cases without at least one frontal view. * x-rays printed on regular paper.

Keywords: artificial intelligence chest x-ray stepped wedge trial
mobile application of seizure diary (brain4u) in epilepsy care

Conditions: Epilepsy

Summary: the study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.

investigators assess the general and personal knowledge of epilepsy, compliance of antiepileptic drugs (aed), and self efficacy scale. participants be asked to use the mobile application (brain4u) and record seizure type, frequency of seizures, aggravating factors, and adverse events related to antiepileptic drugs for 2 month period.

Eligibility criteria:
inclusion criteria: * participants must be between the ages of 1-99. * participants must attend seoul national university bundang hospital pediatric neurology outpatient clinic. * participants under age 18 must have an adult guardian give informed consent. * participants must have a functioning smartphone (ios or android) which can download the and perform brain4u application. * participants must be able to use mobile application skillfully. exclusion criteria: * person who does not have smartphone nor restricted to use mobile application can not participate this study. * person with intellectual disability or unable to use mobile application can not participate this study.

Keywords: epilepsy seizure diary mobile application
milk thistle in body dysmorphic disorder

Conditions: Body Dysmorphic Disorder

Summary: the proposed study will consist of a 9 week double-blind cross-over study trial of milk thistle in 15 people (ages 18-65). the study will be divided into an initial 4 week phase, a one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting of active treatment with milk thistle, and the other 4 week phase consisting of inactive placebo treatment. participants will be randomized to receive either milk thistle or placebo during the first 4 week phase on a 1:1 basis. this blinding will be maintained by the ids pharmacy at the university of chicago.

the goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in adults with body dysmorphic disorder. the hypothesis to be tested is that silymarin will be more effective and well tolerated in adults with body dysmorphic disorder compared to placebo. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment. the primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using silymarin (milk thistle) in 15 participants with body dysmorphic disorder. the study will consist of three phases: a 4 week active treatment phase with milk thistle, a 4 week placebo phase, and a one week wash out phase between the active and placebo phases. the subjects will be randomized to either receive active or placebo treatment in the first 4 weeks, and the other during the remaining 4 week phase. this will be one of few studies assessing the use of pharmacotherapy for the treatment of body dysmorphic disorder in adults. assessing the efficacy and safety of silymarin (milk thistle), will help inform clinicians about additional treatment options for adults suffering from this disorder.

Eligibility criteria:
inclusion criteria: * males and females age 18-65 * diagnosis of current body dysmorphic disorder (bdd) based on dsm-5 criteria and confirmed using the clinician-administered structural clinical interview for dsm-5 (scid) * able and willing to provide written consent for participation exclusion criteria: * unstable medical illness as determined by the investigator * history of seizures * clinically significant suicidality (defined by the columbia suicide severity rating scale) * baseline score greater than or equal to 17 on the hamilton depression rating scale (17-item hdrs) * lifetime history of bipolar disorder type i or ii, schizophrenia, autism, any psychotic disorder, or any substance use disorder * initiation of psychotherapy of behavior therapy within 3 months prior to study baseline * previous treatment with milk thistle * any history of psychiatric hospitalization in the past year * currently pregnant (confirmed by urine pregnancy test)
benidipine-based comparison of angiotensin receptors, β-blockers, or thiazide diuretics in hypertensive patients

Conditions: Cardiovascular Disease

Summary: a number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control. there is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events. the cope trial is planned to investigate, in patients with hypertension, which combination of the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse drug effects.


Eligibility criteria:
inclusion criteria: * outpatients who are required a combination therapy with sitting systolic blood pressure ≥ 140 mmhg or diastolic blood pressure ≥ 90 mmhg. * outpatients aged over 40 years and less than 85 years (inclusive), regardless of sex. * previously untreated patients or patients who are on other therapy, which can be converted to 4mg of benidipine. * patients who can be treated with benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics. exclusion criteria: * seated systolic blood pressure ≥ 200 mmhg or seated diastolic blood pressure ≥ 120 mmhg. * secondary hypertension. * type i diabetes mellitus or type 2 diabetes on insulin treatment. * history of cerebrovascular disorder, myocardial infarction, angina pectoris, coronary angioplasty or coronary artery bypass graft surgery within 6 months prior to enrolment in the study. * heart failure (new york heart association \[nyha\] functional classification ii, iii or iv). * chronic atrial fibrillation or atrial flutter. * congenital heart disease or a history of rheumatic heart disease. * severe peripheral arterial disease (fontaine class ii, iii or iv). * serious liver dysfunction (ast or alt ≥100 iu / l). * serious renal dysfunction (serum creatinine ≥ 2mg/dl). * history of malignancy 5 years prior to study entry. * pregnancy. * compliance rate \< 70% assessed by a patient interview. * known hypersensitivity or contraindication to benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics. * other serious illness or significant abnormalities that the investigator judges inappropriate for the study

Keywords: hypertension multicenter clinical trial probe combination therapy benidipine essential hypertension