cyrilzakka/clinical-trials huggingface dataset:
The Value of Near-infrared Spectroscopy and Blood Pressure Measurements in Estimating Future Fall Risk in Older Adults

The investigators aim to study which measurements/definitions from continuous blood pressures measurements (using a Finometer) and from cerebral oxygenation measurements (using near-infrared spectroscopy (NIRS)) are associated with future fall incidents in older adults at risk of falls.

Patients aged 65 years and over with a fall in the last 12 months are eligible for inclusion. After being informed about the study, all participants giving written informed consent will perform the active stand procedure (5min lying, 5 min standing). The hemodynamic measurements that will be performed during this procedure simultaneously consist of:

1. Volume-clamp photoplethysmography on the finger in the digital artery (Finapres medical systems, Enschede, The Netherlands) for continuous blood pressure measurements.
2. PortaLite MKII (Artinis medical systems, Elst, The Netherlands) for continuous cerebral oximetry (NIRS).

After completing the measurements, participants will receive a falls calendar and will be instructed to record falls, fall-related injuries, and fall-related healthcare use on a weekly basis for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* History of a fall (in the past year)
* Ability to perform supine-to-stand manoeuvres.
* Ability to sign informed consent.
* a Mini-Mental State Examination (MMSE) score of 21 points or higher or a Montreal Cognitive Assessment (MOCA) - Dutch score of 16 points or higher.
* Sufficient command of the Dutch language

Exclusion Criteria:

* Physically not able to perform sit-to-stand and supine-to-stand manoeuvres.
* Estimated life expectancy of less than one year.
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy

Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Already have an indication for coronary angiography
* Previous diagnosis of hypertrophic cardiomyopathy (unless control)

Exclusion Criteria:

* Fractional flow reserve found to be significant (FFR \< 0.8)
* Already have a condition associated with or likely to be associated with an elevated IMR (diabetes, cardiac syndrome X, takotsubo cardiomyopathy, hypertensive cardiomyopathy, severe aortic stenosis, STEMI)
Comparison of Cardiac Output With LiDCO Rapid and TEE Against Thermodilution Technique in Cardiac Surgery

Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output. Investigators would like to compare the most popular minimally-invasive devices used to measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution method at various phases of the cardiac surgery.

Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output, however over the past 10 to 15 years it has been questioned about its safety and efficacy. There has been a surge in recent years of less invasive devices capable of measuring cardiac output by various means, including bioimpedance, transpulmonary thermodilution, transthoracic and transesophageal echocardiography, and arterial waveform analysis.

There is a variety of devices currently available for cardiac output measurement by arterial-waveform analysis. These devices have been compared to each other, and to the pulmonary artery catheter as the gold standard. However, the companies manufacturing these devices have made software upgrades that they believe improves their performance. No studies have been performed comparing the uncalibrated arterial waveform based cardiac output measurement device,LiDCORapid since the software upgrades. In addition to baseline cardiac output measurements, Investigators intend to study the effect of volume loading (by trendelenburg position), sympathetic stimulus (incision), a vasodilated state (15 minutes after separation from CPB) and chest closure on cardiac output measured by the three different techniques.

In addition to cardiac output the investigators would like to measure stroke volume ,Systemic Vascular Resistance, stroke volume variation with LiDCO . The main purpose is to validate the accuracy of measurements by these two minimally-invasive methods in comparison with thermodilution method in various hemodynamic states.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac procedures other than those specified in the exclusion criteria

Exclusion Criteria:

* All emergency cardiac procedures, prisoners and pregnant women, patients who are scheduled for ventricular assist devices and those with severe aortic, mitral and tricuspid insufficiency will be excluded.
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
* MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
* Meet 18F flortaucipir PET scan eligibility criteria.
* Meet 18F florbetapir PET scan (central read) eligibility criteria.

Exclusion Criteria:

* Have a history of long QT syndrome.
* Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
* Contraindication to MRI.
Discard:Characterisation of Colonic Polyps in Vivo

Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age, assessed as fit for routine colonoscopy
2. Patients attending for screening or surveillance colonoscopy meeting the following criteria:

   * Polyp surveillance with at least 3 adenomas or 1 adenoma\>10mm at previous colonoscopy
   * Surveillance post colorectal cancer resection
   * Screening with positive faecal occult blood test

Exclusion Criteria:

1. Patients with known colitis or polyposis syndromes
2. Unable or unwilling to give informed consent
Cognitive Leisure and Preclinical Alzheimer's Disease: Exploring Neural Mechanisms

The goal of this clinical trial is aims to:

1. Translate and culturally adapt the Cognitive Leisure Activity Scale (CLAS) into Chinese and Conduct reliability and validity tests for the Chinese version of CLAS.
2. Investigate the correlation between cognitive leisure activity levels and cognitive function in the preclinical stage of Alzheimer's Disease (AD).
3. Clarify the regulatory mechanisms of cognitive leisure activity levels on the neural circuits of patients in the preclinical stage of AD.

Alzheimer's disease (AD), also known as senile dementia, is the most common neurodegenerative disorder characterized by progressive decline in cognitive function and behavioral impairment. It is estimated that there are approximately 9.83 million AD patients in China, with an average annual treatment cost of about $19,144 per person, accounting for 1.47% of the national gross domestic product, surpassing the global average. This not only severely affects the quality of life for elderly patients but also imposes a heavy economic and caregiving burden on families and society.

Due to the limitations of AD treatment and the irreversibility of its progression, early detection and intervention have become the focus of AD prevention and control efforts. Increasingly, scholars propose shifting the diagnosis and intervention of AD to the preclinical stage, particularly the mild cognitive impairment (MCI) phase and even earlier stages characterized by subjective cognitive decline (SCD). Cognitive leisure activity, as one of the potentially modifiable factors in the preclinical stage of AD, understanding its impact on cognitive function and the neural circuitry regulation mechanisms in this stage is of significant importance. This knowledge can contribute to the development of early targeted intervention measures, preventing or delaying the onset and progression of AD, and promoting healthy aging.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD)
* Age ≥ 60 years
* Capable of normal communication in Mandarin，possesses a certain level of comprehension and judgment.

Exclusion Criteria:

* Individuals with severe hearing or language impairments, or with severe physical illnesses that are unable to cooperate with the survey
* Individuals with pacemakers, metallic implants, cochlear implants, claustrophobia, and other contraindications for MRI examination.
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to angiography unit
* over 18
* informed consent

Exclusion Criteria:

* acute renal failure before 7 days
* spironolactone contraindications
* hyperkalemia (S.K. \>5.5 mEq/L)
* documented tumor
* actively taking NSAIDs, Ciclosporin, Cisplatin,
Effectiveness of the Quotient® ADHD Assessment in a System of Care

The study goal is to examine whether the use of an objective computerized neuroassessment (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to improved outcomes among pediatric patients being assessed and treated for ADHD.

This study is a randomized, controlled trial using a 2-phase data collection. The first phase is the initial assessment for ADHD and includes all patients eligible to be assessed for ADHD as determined by their clinician in the course of usual care. The baseline measurements will be used to compare groups at baseline, and also for longitudinal analyses of medication management. Patients are randomized at this point. Patients in both treatment arms who then receive an ADHD diagnosis and who start medication for ADHD will be eligible for the second phase of the study: three follow-up assessments over six months. Patients who do not have an ADHD diagnosis will not continue in the study, and will be treated by their clinician as usual.

Eligibility Criteria:
Inclusion Criteria:

* All patients within the specified age range who are English speaking and who are presenting for ADHD assessment are eligible. An additional criterion is consent to be randomized.

Exclusion Criteria:

* Non English speaking
* Refusal to participate
FBY PET/CT in Patients With Brain Tumors

This study is an open-labeled phase II diagnostic clinical trial to explore the safety and clinical value of FBY in suspected adult brain tumor patients. The investigation regarding the clinical value of FBY includes 1) the metabolic characteristics of FBY in suspected malignant brain tumors; 2) role of FBY to differentiate tumor progression from pseudoprogression. A single dose of 0.10 mCi/kg FBY will be intravenously injected for PET examination. Quantitative features will be extracted to analysis the PET images. Cranial MRI (with contrast enhancement) will also performed as diagnostic comparison with FBY. For patient who took surgery after multiple examination, histopathology, molecular pathology and LAT-1 immunohistochemistry will also be obtained.

FBY is a new PET tracer derived from tyrosine, with the carboxyl group replaced by boron trifluoride, and is transferred across cell membrane through LAT-1. LAT-1 is a sodium independent amino acid transporter and is highly expressed in tumor cells. Considering the significant role in cancer development as well as in nutrient delivery, FBY could be a promising PET tracer to reflect altered metabolism in tumors.

This study aim to observe the safety of FBY, and investigate the diagnostic value of FBY in the patient with suspected brain tumors. Patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition, explaining the benefits and risks of clinical trials, clarifying the patient's willingness to include the clinical trial, and signing informed consent. The cohort number, FBY administrative dose, imaging protocols are decided based on the investigators' preliminary data. The diagnosis and post-examination treatment are based on the recommended guideline, combined with the subject's own situation for standardized diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Have suspected diagnosis of brain tumors, based on clinical performance and MRI results.
* 2. Meet the indications for PET examination, show a clear indication and no contraindications;
* 3. Have a performance status of score ≥70 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
* 4 Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
* 5. Be ≥ 18 years of age on day of signing informed consent.
* 6. Be willing and able to understand the research content and provide written informed consent/assent for the trial.

Exclusion Criteria:

* 1. Have a history of imaging agent allergies;
* 2. Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination;
* 3. Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
* 4. Unable to adhere strictly to protocol requirements.
Major Depressive Disorder With Mixed Features - Extension

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.


Eligibility Criteria:
Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).

Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)

This is a first in human, Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL).

This is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.

In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive RNK05047 at the starting dose of 0.75 mg/kg.

In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the study. Tumor types for these cohorts will be determined based on data from the dose-escalation phase of the study and emerging results from preclinical studies or other scientific data. These dose expansion cohorts in all groups may be done concurrently.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented locally advanced or metastatic solid tumor
* Refractory or intolerant to all available standard-of-care therapies for advanced disease
* Measurable disease
* Archived tumor tissue collected
* ECOG Performance Status of 0 or 1
* BMI ≥ 18 kg/m2
* Adequate liver, renal, hematologic, and coagulation parameters
* Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion
* Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.
* Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.

Exclusion Criteria:

* Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1
* Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia
* Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
* Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
* Known active infection with HIV, HTLV-1, hepatitis B or C
* Women who are pregnant or breastfeeding
* History of another malignancy unless the subject has been treated with curative intent for this malignancy
Tibial Nerve Stimulation for Post-BPH Overactive Bladder

A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline

Exclusion Criteria:

-
A Machine Learning Approach to Continuous Vital Sign Data Analysis

Study hypothesis: Machine Learning algorithms and techniques previously developed for use in the robotics field can be applied to the field of medicine. These state-of-the-art, feature extraction and machine learning techniques can utilize patient vital sign data from bedside monitors to discover hidden relationships within the physiological waveforms and identify physiological trends or concerning conditions that are predictive of various clinical events. These algorithms could potentially provide preemptive alerts to clinicians of a developing patient problem, well before any human could detect a worrisome combination of events or trend in the data.

Specific aims:

1. Collect physiological waveform and numeric trend data from patient vital signs monitors in ICUs at the University of Colorado Hospital and Children's Hospital Colorado.
2. Combine the physiological data from patient monitors with clinical data obtained from patient Electronic Medical Records including IV fluids, medications, ventilator settings, urine output, etc. for use in developing models of various clinical conditions.
3. Apply Machine Learning techniques to these models to identify physiological waveform features and trend information, which are characteristic and predictive of common clinical conditions including but not limited to:

   * Post-operative atrial fibrillation and other cardiac dysrhythmias
   * Post-operative cardiac tamponade
   * Tension pneumothorax
   * Optimal post-operative and post-resuscitation fluid needs
   * Intracranial hypertension and cerebral perfusion pressure


Eligibility Criteria:
Inclusion Criteria:

1. Age: 0 days - 89 years
2. Admitted to the surgical intensive care unit (SICU) at the University of Colorado Hospital or to the pediatric intensive care unit (PICU) or children's intensive care unit (CICU) at Children's Hospital Colorado or patients in the Childrens Hospital Colorado (CHC) emergency room with the following conditions

   1. Hemodynamic instability
   2. Febrile \>38.5
   3. Respiratory distress
   4. Requiring mechanical ventilation
   5. Requiring central access
   6. Requiring vasoactive medications As well as the time that any of these patients might be in the operating rooms at Children's Hospital Colorado.

Exclusion Criteria:

1. Pregnant
2. Incarcerated
3. Limited access to or compromised monitoring sites for non-invasive finger and forehead sensors
4. Brain death (GCS 3 with fixed, dilated pupils)), unless patient is actively being resuscitated (see CPR specific details in protocol and application)