cyrilzakka/clinical-trials huggingface dataset:
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements

TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME study (NCT03541577). This study will further evaluate the safety and efficacy of the physiological indices measured by the TruePhysio pressure microcatheter, including resting and hyperemic indices, with respect to the physiological indices measured by the Pressure Wire.

This study will evaluate the safety and efficacy of the constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, in both binary and hybrid strategy, with respect to its own fractional flow reserve (FFR) and the FFR or resting full-cycle ratio (RFR) by the Pressure Wire. And the safety and efficacy of the FFR measured by the TruePhysio pressure microcatheter in patients with a border range of diameter stenosis also be validated with respect to the FFR by the Pressure Wire.

The diagnostic accuracy of cRR by the TruePhysio pressure microcatheter system is evaluated, using FFR measured by both systems as reference;

Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire is evaluated, using FFR measured by Pressure Wire as the reference;

The diagnostic accuracy of the hybrid cRR-FFR scheme by the TruePhysio pressure microcatheter is evaluated, using its own FFR as reference;

The diagnostic accuracy of the hybrid RFR-FFR scheme by the Pressure Wire system is evaluated, using its own FFR as reference.

The hybrid scheme for cRR-FFR (pressure microcatheter system), or RFR-FFR (pressure wire system), is defined as following:

* the gray zone is defined as where the sensitivity and specificity are equal, shown as \[A, B\].
* if cRR or RFR of the target vessel is \<A, it is diagnosed as functionally positive in myocardial ischemia;
* if cRR or RFR of the target vessel is \>B, it is diagnosed as functionally negative in myocardial ischemia;
* if cRR or RFR of the target vessel is between A and B (including A and B), the diagnostic criterion is superseded by that of FFR, which is:

  * if FFR of the target vessel is \> 0.80, it is diagnosed as functionally negative in myocardial ischemia;
  * if FFR of the target vessel is ≤ 0.80, it is diagnosed as functionally positive in myocardial ischemia.

A total of 487 patients are anticipated to be recruited from 11 centers in China.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old;
* Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
* Clinically indicated to physiological assessment.

Exclusion Criteria:

* Unable to comprehend, or unwilling to sign the informed consent form;
* Contraindicated to the procedures of invasive coronary angiography or percutaneous coronary intervention;
* Clinically diagnosed with severe coronary artery vasospasm;
* Other operator-discerned facts that will make enrollment or the procedure impossible to complete.
Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes

The purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.


Eligibility Criteria:
Inclusion Criteria:

1. \> 65 years of age
2. male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization \> 24 hours
3. able to read and write in English
4. discharged to home environment

Exclusion Criteria:

1. a cardiac transplant candidate
2. experienced an acute coronary event within the previous 30 days of index hospitalization
3. experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization
4. end stage renal disease/hemodialysis
5. have a left ventricular assist device
6. \> 400 lbs
7. unable to stand for 90 seconds independently
The Effect of Watching Relaxing Video During Cystoscopy

The cystoscopy procedure may cause pain and anxiety in patients. Since cystoscopy causes more pain in men, studies on pain and anxiety during cystoscopy are more common in men than women. The aim of this study was to evaluate the effect of watching relaxing video during cystoscopy on the pain and anxiety levels of female patients.

Cystoscopy is a safe procedure with low risk of morbidity commonly used to evaluate lower urinary tract symptoms such as hematuria, voiding disorders, irritant bladder symptoms, anatomical disorders. Patients experience pain and anxiety when cystoscope is inserted into the bladder. The various methods (drug or non-drug) are used for pain and anxiety during the cystoscopy. Although there are a lot of studies on male patients, there are limited studies evaluating pain severity in the female patients during urological procedures. In addition, there wasn't found any randomized controlled study for video use from non-drug methods to distract attention in these patients. Based on the study results in the literature, investigators aimed to evaluate the effect of watching relaxing video on the pain and anxiety levels of female patients during rigid cystoscopy.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* female gender
* rigid cystoscopy for the first time

Exclusion Criteria:

* presence of any contraindication for cystoscopy (such as lidocaine allergy, urinary tract infection, and urethra-related anatomical disorders)
* any analgesic used 24 hours before cystoscopy
* manipulations such as Double-J stent placement or removal, and/or bladder biopsy.
Performance of New Diagnostic Methods in Older Adults With Pneumonia

Create a clinical diagnostic pathway for older ED adults with pneumonia and its subgroups (bacterial, viral, and co-infection) and determine whether novel biomarkers improve diagnostic accuracy. The investigators will conduct a prospective observational trial of 250 ED patients ≥65 years old with suspected pneumonia. The investigators will perform analyses overall and by subgroups, seeking common models to ease adoption.


Eligibility Criteria:
Inclusion Criteria:

- Adults aged 65 and older presenting to the ED with suspected pneumonia defined as (1) either a physician order for CXR OR CT OR a chief complaint consistent with dyspnea; AND (2) physician suspicion of pneumonia prior to ED testing (score of 2-5 on Likert scale)

Exclusion Criteria:

* inability to obtain consent from the patient or an LAR
* active cancer
* organ transplant
* immunosuppression
* trauma activation
* suicidal ideation
* incarceration
* antibiotics in the last 14 days
* a separate episode of lower respiratory illness in the last 30 days
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages 18-70, inclusive.
* Availability for the three (3) week duration of the study.
* Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
* Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for three months prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria:

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination.
* Sensitive teeth with mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
* Current participation in any other clinical study.
* Pregnant or lactating subjects.
* Allergies to oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.
Evaluation of Colorectal Cancer Screening Strategies in China

A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.


Eligibility Criteria:
Inclusion Criteria:

* 50-74 years old
* Informed consent is available

Exclusion Criteria:

* Previous colorectal cancer
* Previous colorectal resection
* Previous received cancer-related treatment (except non-melanoma skin cancer)
* Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
* Fecal occult blood or fecal DNA was performed within one year
* Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight - Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)
Thorough QT Assessment of Cedazuridine in Healthy Subjects

This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study duration per participant is approximately 20 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female who is not of childbearing potential
* Body mass index of 18.0 to 32.0 kg/m\^2, inclusive

Exclusion Criteria:

* QTcF \>450 msec at screening
* Clinically relevant abnormalities in conduction parameters; or if PR interval \> 200 msec, QRS duration \> 110 msec, or bradycardia or tachycardia (HR \<45 bpm or \>100 bpm)
* History or presence of hypokalemia, hypomagnesemia, or hypocalcemia
* Risk factors for Torsades de Pointes (TdP) (eg, congenital deafness, heart failure, cardiomyopathy, concomitant medications known to cause QTc prolongation) within a washout of at least 30 days
* Family history of Long QT Syndrome or family history of TdP
* Sick sinus syndrome, atrioventricular block (any degree)
* Myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities
* Repeated or frequent syncope or vasovagal episodes
* Resuscitated arrest possibly due to TdP; hypertension, angina, or severe peripheral arterial circulatory disorders
* Use of concomitant medications that prolong the QT/QTc interval
Using Exhaled Air to Determine Changes in Nutritional Status of Patients on Intravenous Nutrition

Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath. Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects who were in negative energy balance then fed a positive energy balance meal. Measuring one liter of exhaled breath daily may be a more convenient way to measure negative or positive energy balance in patients receiving intravenous nutrition.

This is a prospective, pilot study to determine if there is change in the 12C/13C BDV between days 0-7 in patients who receive parenteral nutrition. Investigators will recruit subjects from inpatient units at the University of Wisconsin Hospital and Clinics whose primary team consult the Nutrition Support Team to institute parenteral nutrition for clinical reasons. Subjects with clinical indications for parenteral nutrition are moderately to severely malnourished due to little to no nutrition by other means (oral nutrition or nutrition per tube) for a period of time (0-10 days based on state of nourishment prior to admission).

Investigators will record baseline nutritional status from the medical record notes (dietitian, Nutrition Support Team, etc.), as well as medication, demographic information and medical history. Investigators will take a baseline exhaled CO2 measurement and then a daily measurement at approximately the same time daily (+/- an hour).

The daily exhaled 12C/13C breath delta value will be matched with the subjects' daily caloric intake from parenteral nutrition (and oral nutrition and nutrition per tube, if applicable). The breath delta value, the caloric intake, plus the subjects' degree of malnourishment will be parameters with which to build further research. Investigators hypothesize that the breath delta value will increase from baseline and then stabilize after the patient reaches goal energy needs as defined by the Nutrition Support Team.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Anticipated start of parenteral nutrition
* Expected duration of stay at least 5 days from enrollment
* Subject speaks English
* Subjects with inability to take adequate oral nutrition who are developing or have developed malnutrition who require parenteral nutrition

Exclusion Criteria:

* Subjects unable to coordinate well enough to give a 1 liter breath sample
* Subjects receiving parenteral nutrition prior to admission
* Subjects who are pregnant
* Subjects who are prisoners
* Subjects who are pharmacologically sedated or with altered consciousness
* Subjects who are mechanically ventilated
* Subjects admitted for bone marrow or stem cell transplants
* Known participation in another interventional research study within 30 days prior to enrollment (note: to be eligible, any interventional treatment must have ended at least 30 days ago)
* Subjects with disease states or clinical conditions that do not make them study candidates, per the primary investigator's discretion
Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression

A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.

This study is expected to be completed in a period of 4 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 20 years to 80 years.
2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible" or "probable" PD1.
3. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent)

Exclusion criteria:

1. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
2. Alcohol or substance abuse.
3. History or presence of QTc prolongation. (\>500msec)
4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
5. Unable to stay still in the MRI or PET scanner for 30 minutes.
6. Pregnancy and breast feeding.
7. Hepatic dysfunction with liver function test (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) of \> 3x the upper limit of normal
A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants

RATIONALE: Studying samples of blood and urine from healthy participants receiving antioxidant nutritional supplements may help doctors identify changes in biomarkers related to oxidative stress.

PURPOSE: This clinical trial is studying how well a nutritional supplement capsule containing curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract works in healthy participants.

OBJECTIVES:

Primary

* To assess the effect of a specific combination nutritional capsule containing curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract on a specific biomarker of relevance to oxidative stress (NF-κB).
* To estimate the mean change in blood lymphocyte NF-κB level before and after 2 weeks of consumption of the nutritional agent under study.

OUTLINE: Participants receive oral curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule twice daily for 2 weeks. Participants are asked to keep a pill diary to track compliance.

Blood and urine samples are collected from participants at baseline and after completion of study. Lymphocytes and serum from the blood samples are isolated and analyzed for NF-κB biomarker levels. Urine samples are also tested for oxidative stress marker levels. Samples are analyzed using an electrophoretic mobility shift assay (EMSA).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy volunteers who are employees of Karmanos Cancer Institute, Wayne State University, or Detroit Medical Center

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
COVID-19 Hyper Coagulability Care by LLLT

COVID-19 clotting Safety

Covid-19 patients have liability for hyper coagulability, low level laser Therapy improve circulation and decrease liability for hyper coagulability accompanied with circulatory exercises .

Eligibility Criteria:
Inclusion Criteria:

* BMI from 18.5 to 29.9 kg/m2
* Moderate elevated percentage of coagulative factors for COVID-19 Diagnosis:
* Nasopharyngeal swab
* Sepsis induced coagulopathy score\>4
* D_dimer≥0,5mg/L
* Fibrinogen\>2,5gm/L
* C_reactive protein≥10mg/L
* Lymphocyte count\<1,500mm3
* Platelet count\<150,000mm3
* Prothrombin time increase\>3sec
* Activated partial thromboplastin time increase\>5sec
* Same level of physical activity
* Patients can swallow tablets
* CT scan screening method for COVID-19 Diagnosis
* Physical examination

Exclusion Criteria:

* hyper tension
* Cognitive impairment e.g (delirium)
* Diabetes mellitus both types dependant or non
* Disabled musculoskeletal Disorders e.g hemi paresis
* Coronary artery diseases and heart failure
* DVT
* Stroke, bone disease, renal failure, pulmonary embolism
* Vitamins deficiency
* 6 months post large surgeries
* Alcohol intake and smokers
* Thyroid diseases
Genetic and Environmental Risk Factors for Hemorrhagic Stroke-GERFHS III

The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH). ICH, a type of bleeding into brain tissue, is a type of stroke that can result in death or disability in a large number of people. Our study hopes to identify a specific genetic risk factor that will help identify at risk individuals and target treatment strategies.

Our case-control study will enroll subjects with a spontaneous ICH in the Greater Cincinnati region. For each subject enrolled we will also enroll a healthy control subject(matched by age , race and gender). Both the cases and control will undergo the same interview and have blood drawn for genetic analysis. The cases will have a chart abstraction done on their event medical record and be contacted for 3 and 6 month follow up(short interview). The genetic sample will be genotyped using the Affymetrix 6.0 gene chip looking for SNPs of interest and to identify genetic variants associated with ICH. The most promising SNPs identified through this process will be replicated in the external cohort from Massachusetts General Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Resident (6 months or longer) within 100 miles of University of Cincinnati.
* Fulfillment of the criteria for spontaneous ICH
* No evidence of trauma, brain tumor/metastases, hemorrhagic transformation of ischemic stroke or infectious processes as a cause of the hemorrhage.
* Ability of the patient or legal representative to provide consent for an interview, blood pressure determinations and DNA sampling.

Exclusion Criteria:

* N/A
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery

To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery and the following 24 hours or placebo (0.9% saline infusion). Study hypothesis is that nifedipine has a prophylactic effect on decline in renal function.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of either gender above 18 years of age.
2. Patients with significant coronary stenosi(e)s (≥ 75% coronary artery lumen surface stenosi(e)s and / or aortic- or mitral valve vitriuim that are accepted for coronary artery bypass surgery and/or valve replacement surgery.
3. Patients with impaired renal function, defined as increased serum- creatinine. Men: ≥ 150 µmol/l and Women: ≥130 µmol/l.

Exclusion Criteria:

1. Patients on maintenance hemodialysis
2. Renal transplant patients
3. Patients with ejection fraction ≤ 35%
4. Patients with unstable angina pectoris
A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes

The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).


Eligibility Criteria:
* Eligible patients must have a diagnosis of myelodysplastic syndrome
* Life expectancy of at least 6 months.
* Patients must be able to adhere to the study visit schedule and other protocol requirements.
* Patients must understand and voluntarily sign an informed consent document.
* Women of childbearing potential (WCBP) must agree to practice abstinence or to use TWO methods of contraception beginning 4 weeks prior to the start of study medication and throughout the course of treatment.
* Males must use barrier contraception when engaging in reproductive sexual activity with women of childbearing potential.
Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

Principal hypothesis:

A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.

Secondary's hypothesis:

* It don't expect differences in:

  1. Incidence of hematomas
  2. Incidence in surgery wound infection
  3. Time of immobilization
  4. Duration of hospitalization
* The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)

Eligibility Criteria:
Inclusion Criteria:

* Adult knee replacement patients who agreed to participate in the study

Exclusion Criteria:

* People that not accomplished the inclusion criteria