Kornimate/medical-research-clean huggingface dataset:
amyloid prediction in early stage alzheimer's disease through speech phenotyping - future extension

Conditions: Alzheimer Disease; Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer's Disease (Incl Subtypes); Mild Cognitive Impairment

Summary: the primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in preclinical alzheimer's clinical composite with semantic processing (pacc5) between baseline and +12 month follow up across all four arms, as measured by the coefficient of individual agreement (cia) between the change in pacc5 and the corresponding regression model, trained on baseline speech data to predict it. secondary objectives include (1) evaluating whether similar algorithms can predict change in pacc5 between baseline and +12 month follow up in the cognitively normal (cn) and mci populations separately; (2) evaluating whether similar algorithms trained to regress against pacc5 scores at baseline, still regress significantly against pacc5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (cia) between the pacc5 composite at +12 months and the regression model, trained on baseline speech data to predict pacc5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal arms (arm 3 + 4), and fast vs slow decliners in the mci arms (arm 1 + 2), as measured by the area under the curve (auc) of the receiver operating characteristic curve, sensitivity, specificity and cohen's kappa of the corresponding binary classifiers. secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.


Eligibility criteria:
inclusion criteria: * subjects are fully eligible for and have completed the amypred-us (amyloid prediction in early stage alzheimer's disease from acoustic and linguistic patterns of speech) study. (see https://clinicaltrials.gov/ct2/show/nct04928976) - subject consents to take part in future extension study. exclusion criteria: * subject hasn't completed the full visit day in the amypred-us study.

Keywords: alzheimer's disease preclinical alzheimer's disease prodromal alzheimer's disease mild cognitive impairment normal cognition amyloid speech acoustic language linguistic machine learning artificial intelligence
computerized lung sound analysis

Conditions: Pneumothorax; Pulmonary Fibrosis

Summary: this clinical trial is conducted within the research project 'computerized lung sound analysis'. the research goal is the development of a system enabling the automatic classification of lung sounds, which will result in a decision support system for physicians. the objective of this trial is to create a small lung sound corpus, enabling the development of a prototype of the described system. therefore, investigators record lung sounds with several lung sound transducers distributed on the posterior chest of human test subjects.

in this clinical trial investigators record lung sounds over the posterior chest of human test subjects. the subjects are either lung-healthy (control group) or subjects with pneumothorax condition or pulmonary fibrosis. the lung sounds are recorded in supine position on an examination table. a foam pad with several lung sound transducers is placed under the back of the subjects. during the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. the subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. for each subject investigators simultaneously record 30 seconds of the airflow signal and the lung sounds from 16 lung sound transducers.

Eligibility criteria:
inclusion criteria: general: * smoker and non-smoker * 'lung-healthy' subjects (control group), subjects with pneumothorax or subjects with pulmonary fibrosis additional for 'lung-healthy' subjects: * copd \< 3 (gold criteria) exclusion criteria: general: * body mass index \> 30 * preceding thoracic surgery * non-cooperation of the subject * intubated or tracheostomized subjects additional for 'lung-healthy' subjects: * disease of the respiratory system * taking medication influencing the respiration
new screening and diagnostic cut-off points of pa patients

Conditions: Primary Aldosteronism

Summary: this study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay.

primary aldosteronism (pa) is the most common causes of secondary hypertension. the diagnostic workup for pa is composed of multiple steps and requires measurement of both plasma aldosterone and renin. in terms of assay of aldosterone, most of currently available chemiluminescence assays are based on competitive methods. what is actually detected is the sum of aldosterone and its metabolite aldosterone 3c glucuronide, which causes the value to be about 50%\~100% higher than the actual value. this study aims to establish a new arr (aldosterone/renin ratio) cutoff point for pa screening and a new cutoff point for pa diagnosis, using a recently developed two-site sandwich chemiluminescence method (snibe, china) for aldosterone and renin assay. hypertensive patients referred to hospitals for screening of pa will be included. all the participants proceed to seated saline infusion test (sit) and captopril challenge test (cct) for confirmation. aldosterone and renin will be measured using chemiluminescent immunoassay on the liaison analyzer (diasorin, italy) and maglumi x8 (snibe, china), as well as liquid chromatography-tandem mass spectrometry (lc-ms/ms) platform. according to the experience of fuwai hospital, the following diagnosis criteria are proposed: based on the results of currently used (diasorin, italy), aldosterone \> 8.5ng/dl and renin \< 15μiu/ml after sitting saline infusion conform pa, and aldosterone ≤ 8.5ng/dl excludes pa. the total number of cases to be enrolled in this study is planned to be 770, including at least 77 positive subjects and at least 406 negative subjects. by drawing the roc curve, the point corresponding to the maximum value of the youden index will be selected as the cutoff value, and the corresponding sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, etc. will be calculated.

Eligibility criteria:
inclusion criteria: * 18-75y; * persistent hypertension (bp \>150/100 mm hg), or drug-resistant hypertension; * newly diagnosed hypertension; * hypertension and spontaneous or diuretic-induced hypokalemia; * hypertension with adrenal incidentaloma; * hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (\<40 years); * status as a hypertensive first-degree relative of patients with pa; * patients with hypertension and obstructive sleep apnea. exclusion criteria: * age \<18; bmi ≤ 18.0kg/m2 or ≥ 35.0 kg/m2; * a diagnosis of secondary hypertension other than pa; * chronic cardiac dysfunction (nyha iii-iv); * medium and several kidney dysfunction (ccr\<30ml/min); * liver cirrhosis; * terminal malignant tumor; * recent use of steroids or oral contraceptives; * pregnancy or lactation.

Keywords: aldosterone renin primary aldosteronism cut-off value diagnosis
routine irrigation with ropivacaine vs. lidocaine vs. saline of surgical bed in sleeve gastrectomy

Conditions: Overweight and Obesity

Summary: the aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at the surgical bed on postoperative pain relief and breathing parameters in laparoscopic sleeve gastrectomy.

as in any other surgery, postoperative pain control after bariatric procedure should provide comfort and early mobilisation as well as enable adequate respiratory effort. early ambulation is thought to reduce the risk of pressure ulcers, deep vein thrombosis and respiratory complications. in contrast, early inadequate postoperative pain management can lead to hypoxemia, hypercarbia and atelectasis. however, the use of opioids for pain control is limited in bariatric surgery due to sedative effect which might worsen obstructive sleep apnoea (osa), a common comorbidity amongst morbidly obese patients and opioid-sparing techniques might help avoid respiratory complications. methods of regional analgesic are limited and might be challenging in the obese patient and although techniques such continuous epidural analgesia is possible it is not the common practise. the use of patient-controlled i.v. analgesia of opioids is limited owed to increased risk for hypoxemia and other practises such as routine local anaesthetic port site wound infiltration and systemic non-steroidal drugs are warranted. the benefit of intra-peritoneal irrigation with local anaesthetic for abdominal pain relief after laparoscopic procedures was established in few studies. the aim of this study is to evaluate the effect its' effect on postoperative pain relief and breathing parameters in laparoscopic sleeve gastrectomy.by pain score

Eligibility criteria:
inclusion criteria: * patient admitted to sleeve gastrectomy exclusion criteria: * second bariatric procedure patients younger than 18 years patients who have drug allergy to lidocaine or ropivacain patients who suffer a cardiac arrhythmia pregnant patients mentally challenged patients patients who refuse to participate in the study

Keywords: sleeve gastrectomy lidocaine ropivacaine
pathways relating amnestic mci to a mild traumatic brain injury history

Conditions: Mild Cognitive Impairment; Amnestic Mild Cognitive Disorder; Amnestic Mild Cognitive Impairment; Mild Traumatic Brain Injury; Concussion, Brain

Summary: this study will probe if the biological changes in amnestic mild cognitive impairment (amci) are related to a history of mild traumatic brain injury (mtbi) using high definition transcranial direct current stimulation (hd-tdcs) and blood-derived biomarker tools. participants who do as well as those who do not have a history of mtbi will be enrolled in the study.

ten study visits will be completed by each participant. the initial visit will include a blood draw and a baseline memory evaluation. afterwards, participants will be randomized to begin with one of 3 conditions of hd-tdcs. the three conditions are sham-control, active stimulation to frontal region, and active stimulation to left temporal region. all participants will be expected to completed each hd-tdcs condition, which will be counterbalanced and separated by 14 days. active hd-tdcs will be applied at 2 ma for 30 minutes over 3 consecutive daily sessions while sham stimulation will be applied for the same duration and timespan. all subjects will complete memory assessments again immediately following each hd-tdcs condition for a total of four test sessions.

Eligibility criteria:
inclusion criteria: 1. active diagnosis of amnestic mild cognitive impairment 2. presence of an mtbi history for the mtbi+ group; absence of an mtbi history for a control sample 3. female and male subjects 4. all races/ethnicities 5. age 55 years and older 6. fluent in english exclusion criteria: 1. mild traumatic brain injury within past year 2. lifetime history of moderate or severe brain injury 3. lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor) 4. lifetime major cardiovascular conditions (e.g., heart attack, heart failure) 5. current substance use disorder 6. current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder) 7. current vision or hearing impairment that interferes with testing 8. any electronic and or metallic implants in the skull or brain 9. current medication use known to alter hd-tdcs reactivity

Keywords: mci tbi memory biomarker alzheimer
behavioral and immunological factors in coronary disease

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression

Summary: to explore the immune/inflammatory processes as pathways between depression/exhaustion and coronary artery disease (cad) progression.

background: recent studies demonstrate that the immune system plays an important role in coronary artery disease (cad). research also shows that psychological factors such as major depression and acute mental stress are involved in the clinical progression of cad. depression is associated with higher levels of immune parameters that play a role in cad (cytokines, markers of low grade inflammation, infectious pathogen burden, and adhesion molecules), and most of these measures also increase in response to acute physical and mental stress. the pathophysiological mechanisms linking depression and mental stress with adverse cardiovascular outcomes may therefore be mediated by immunological factors. design narrative: the study examines clinical outcomes in patients who undergo percutaneous coronary revascularization, because a major problem remains the frequent (20 percent-40 percent) occurrence of coronary restenosis and new cardiac events in the six months after the intervention. these adverse outcomes have substantial impact on the costs of medical care and patients' quality of life. since previous research has not examined the role of behaviorally-induced changes in immune parameters in the prediction of cad progression, the following immunological measures will be examined: cytokines (il-1b, il-4, il-6, ifny, tnfa), acute phase proteins (crp, fibrinogen), lymphocyte counts and differential, adhesion molecules (icam-1, lfa, l-selectin), and a composite measure of pathogen burden (cmv, h. pylori, c. pneumoniae). using a longitudinal design, this project will determine the time course of changes in depression and changes in immune parameters. moreover, the present study will determine the contribution of behavioral and immunological factors in the clinical progression of coronary disease following coronary angioplasty. these data may therefore improve the identification of patients at risk for recurrent cardiac events and restenosis after coronary angioplasty, and provide further understanding of the pathophysiological mechanisms involved in coronary disease progression.

Eligibility criteria:
no eligibility criteria
imaging study of neurovascular coupling in cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (cadasil)

Conditions: CADASIL

Summary: the aim of this study is to investigate using fmri methods, eeg and dedicated mathematical models, the potential alterations of neurovascular coupling in cadasil.

comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fmri (bold signal, asl and eeg).

Eligibility criteria:
inclusion criteria: * cadasil group: typical notch3 mutation, age less than 60 years, rankin score at 0-1, active social insurance exclusion criteria: * mri contra-indications and use of any treatment known to interfere with neurovascular coupling, pregnancy, lack of informed consent
studies of disorders and mechanisms related to atrial fibrillation before and after dc-conversion.

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to investigate if breathing disorders are related to atrial fibrillation and if it is possible to predict recurrence of atrial fibrillation after dc-conversion by changes in heart rate variability and 24 hour ecg.


Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation * scheduled for electrical cardioversion exclusion criteria: * known obstructive sleep apnea

Keywords: atrial fibrillation
antiplatelet therapy guided by thrombelastography in patients with acute coronary syndromes (tegcor study)

Conditions: Thrombosis; Coronary Artery Disease

Summary: personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. this study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting


Eligibility criteria:
inclusion criteria: * patients admitted with acute coronary syndrome (unstable angina, non-st elevation myocardial infarction) and referred for coronary angiography. * current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for \>5 days) * age range 21-75 years. exclusion criteria: * unable to give consent * age younger than 21 years, greater than 75 years * history of stroke * body weight \<60 kg * acute stemi, * thrombocytopenia\<100'000, * requirement for chronic warfarin therapy
discontinuation of antiretroviral therapy in patients with asymptomatic hiv infection

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether patients who have asymptomatic hiv infection can discontinue antiretroviral therapy (art) without adverse clinical, virologic, or immunologic consequences. this study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart art.

patients who can discontinue art without a significant loss of virologic or immunologic control and without an increase in clinical events may be spared the expense and adverse effects of treatment. however, the consequences of treatment discontinuation in patients with asymptomatic hiv infections are not well understood. this study will follow the clinical and immunologic progression of hiv infection in patients who have low hiv viral load and preserved cd4+ cell counts at the time art is stopped. patients will fast for at least 8 hours prior to the first study visit. at this visit, blood will be drawn and body measurements will be taken. patients will then discontinue their art. patients taking nonnucleoside reverse transcriptase inhibitors (nnrtis) will stop taking nnrtis 48 hours before withdrawing their other art drugs. study visits will occur every 4 to 8 weeks for the first year, then every 12 weeks for the second year. blood will be taken at most visits, and patients will be asked to fast for at least 8 hours prior to week 12 and 24 visits and again every 6 months. patients who reinitiate art for any reason will be registered to step 2 and followed for 24 weeks.

Eligibility criteria:
inclusion criteria: * hiv infection * art with 2 or more drugs for 6 or more months * cd4+ cell count(s) \> 350 cells/mm3 immediately prior to initiation of first art * cd4+ cell count \> 350 cells/mm3 within 45 days prior to study entry * plasma viral load \< 55,000 copies/ml within 45 days prior to study entry * willingness to discontinue art at study entry * negative serum or urine pregnancy test within 14 days prior to study entry exclusion criteria: * pregnancy or breast-feeding * systemic cancer chemotherapy, systemic investigational agents, or immunomodulators within 30 days prior to study entry * drug or alcohol use or dependence that would interfere with adherence to study requirements * illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or has been clinically stable on therapy for at least 30 days prior to study entry * chronic medical condition that would have a negative impact on the participation of the patient or would be expected to result in significant use of the medical care system * history of an hiv-related illness or complication in cdc categories b and c * nonadherence to art * active infection with hepatitis b and currently taking adefovir at doses \> 10 mg or 3tc and/or tdf

Keywords: treatment experienced disease progression anti-hiv agents treatment interruption
agile development of a digital exposure treatment for youth with chronic musculoskeletal pain

Conditions: Chronic Pain; Exposure; Adolescent Behavior; Child Behavior

Summary: this project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (sced). sced provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. development of iget living will be based on a series of short iterations, with alpha testing (aim 1) on a small sample of adolescents with chronic pain (n = 15). for aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for aim 1. aim 2 will involve a sample (n = 20 youth) of naïve end-users. participants will be enrolled in a baseline period ranging from 7-25 days (done to support sced methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.


Eligibility criteria:
inclusion criteria: * youth ages 10-18 * have diagnosis of chronic musculoskeletal pain (\>3months) * have moderate to high pain interference (promis pain interference ≥ 61) * english literate * have access to computer, smartphone, or tablet with internet connection exclusion criteria: * significant cognitive impairment (e.g., brain injury) * significant medical or psychiatric problems that would interfere with treatment
safety, tolerability, pharmacokinetic and pharmacodynamic study of mbx 1416 in healthy subjects

Conditions: Postbariatric Hypoglycemia

Summary: the purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and drug drug interaction of mbx 1416 in healthy volunteers this study includes 3 parts. part a involves a single dose of mbx 1416 or placebo taken as a subcutaneous injection (sc). part b involves repeat doses of mbx 1416 or placebo taken as a subcutaneous injection (sc). part c involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of mbx 1416.


Eligibility criteria:
part a/b/c inclusion criteria: 1. female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (bmi) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose \< 100 mg/dl and hba1c \< 5.7%. 2. female subjects of childbearing potential (wocbp) and male subjects must use highly effective contraception. part a/b/c exclusion criteria: 1. pregnant, lactating or intending to become pregnant during the study. 2. use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug. 3. presence of clinically significant ecg findings 4. subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to glp-1 receptor agonists, study drug or drug components. 5. abnormal laboratory results at screening. 6. history of renal disease or abnormal kidney function tests at screening 7. presence of any clinically significant physical exam, ecg, or laboratory findings at screening.