cyrilzakka/clinical-trials huggingface dataset:
A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

Intravenous and inhalation combined anesthesia is a commonly used method for maintaining general anesthesia in clinical practice. This study aims to explore the interaction between ciprofol and sevoflurane. By employing response surface methodology, we constructed a three-dimensional pharmacodynamic interaction surface for various dose combinations of ciprofol and sevoflurane. This approach allows us to determine the nature of the interaction between the two drugs at any given level, thereby providing a ciprofol understanding of the dose-response relationship when ciprofol and sevoflurane are used in combination. This knowledge will serve as a theoretical basis for rational drug administration during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective general anesthesia and non-cardiac surgery;
* Age 18-60 years old, gender is not limited;
* ASA I or II level;
* Body mass index (BMI) 18-30 kg/m2

Exclusion Criteria:

* Preoperative assessment of potential difficult airway risk;
* Airway hyperreactivity;
* There is disease of the central nervous system or cardiovascular system;
* Currently using drugs that may alter the pharmacokinetics and pharmacokinetics of the drug under study;
* Known or suspected allergy or contraindication to the components or regimens of the investigational drug;
* A history of drug or alcohol addiction;
* Patients with gastroesophageal reflux disease;
* Severe liver and kidney dysfunction.
Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.


Eligibility Criteria:
A. Hemodilution Test Procedure

Inclusion Criteria:

* Weight of more than 110 lbs and less than 220 lbs.
* Physical status of ASA I of II
* Able to read and communicate in English
* Has signed written informed consent
* Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion Criteria

* Age less than 18 yrs and greater than 35 years
* Weight of less than 110 lbs or more than 220 lbs.
* Hemoglobin less than 12 g/dL
* ASA physical status of III. IV, V.
* Pregnant
* Subject has known drug or alcohol abuse
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
* Subject has experienced a head injury with loss of consciousness within the last year
* Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
* Hypertension: Systolic BP \>140 mmHg or Diastolic BP \> 90 mmHg.
* Baseline heart rate \< 50 bpm.
* Inability to tolerate sitting still or minimal movement for up to 90 minutes
* Discretion of investigator

B. Blood Draw Test Procedure

Inclusion Criteria:

-Subjects must understand and consent to be in the study.

Exclusion Criteria

* Subjects less than 18 years of age.
* Subjects who do not understand the study and the risks involved.
* Anyone deemed ineligible by test personnel.
The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus

Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.

83 diabetic patients with severe coronary artery disease were enrolled in the study. These patients were investigated according to their collateral development. Monocytes and their subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups

Eligibility Criteria:
Inclusion Criteria:

* presence of \> 95% stenosis of at least one major coronary artery in their first coronary angiogram.

Exclusion Criteria:

* Patients experiencing acute coronary syndrome either with or without ST elevation in the last one month
* Evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease
Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions

The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.

This is a prospective, multi-center, single-arm observational registry trial planned to enroll 800 subjects. All 800 subjects enrolled will receive CRE8 stents. Clinical follow-up will be performed at 1 month, 6 months,12 months and annually up to 5 years after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤ 75 years, male or female without pregnancy;
* Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
* De novo lesions of native coronary arteries;
* Target vessel diameter between 2.25mm and 4.5 mm, and target lesion length ≤ 60mm by visual estimation;
* Target lesion diameter stenosis ≥ 70% by visual estimation;
* Each target lesion must be implanted the same stent (CRE8);
* Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
* Patients with left ventricular ejection fraction ≥40%;
* Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consents.

Exclusion Criteria:

* Patients with acute myocardial infarction (AMI) within 72 hours;
* Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment;
* Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
* In-stent restenosis;
* Thrombotic lesions;
* Patients who had received any other stent in the past one year;
* Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
* Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
* Patients who allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, polymer, Co-Cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor;
* Patients with life expectancy less than 1year;
* Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
* Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol;
* Patients who had underwent heart transplant surgery.
The Predictive Capacity of Machine Learning Models for Progressive Kidney Disease in Individuals With Sickle Cell Anemia

This is a multicenter prospective, longitudinal cohort study which will evaluate the predictive capacity of machine learning (ML) models for progression of CKD in eligible patients for a minimum of 12 months and potentially for up to 4 years.

Sickle cell disease (SCD) is characterized by a vasculopathy affecting multiple end organs, with complications including ischemic stroke, pulmonary hypertension, and chronic kidney disease (CKD). Albuminuria, an early measure of glomerular injury and a manifestation of CKD, is common in SCD and predicts progressive kidney disease. Kidney function decline is faster in SCD patients than in the general African American population. The prevalence of rapid decline, commonly defined as an estimated glomerular filtration rate (eGFR) decline of \>3 mL/min/1.73 m2 per year, is \~ 31% in SCD, 3-fold higher than in the general population. Furthermore, high-risk Apolipoprotein 1 (APOL1) variants are associated with an increased risk of albuminuria and progression of CKD in SCD. It is well recognized that kidney disease, regardless of severity, is associated with increased mortality in SCD. The investigators have recently observed that rapid eGFR decline is also independently associated with increased mortality in SCD. Early identification of patients at risk for progression of CKD is important to address potentially modifiable risk factors, slow eGFR decline and reduce mortality.

The investigators have previously reported that machine learning (ML) models can identify patients at high risk for rapid decline in kidney function. In this study, the investigators propose the conduct of a prospective, multi-center study to build a ML-based predictive model for progression of CKD in adults with SCD. A model with high predictive capacity for progression of CKD not only affords risk-stratification, but also offers opportunities to modify known risk factors in hopes of attenuating kidney function loss and decreasing mortality risk.

The overall hypothesis is that ML models utilizing clinical and laboratory characteristics, additional biomarkers and genetic assessments have a higher predictive capacity for progression of CKD than persistent albuminuria alone in adults with sickle cell anemia.

Eligibility Criteria:
Inclusion Criteria:

1. HbSS or HbSβ0 thalassemia, 18 - 65 years old;
2. non-crisis, "steady state" with no acute pain episodes requiring medical contact in preceding 4 weeks;
3. ability to understand the study requirements.

Exclusion Criteria:

1. pregnant at enrollment;
2. poorly controlled hypertension;
3. long-standing diabetes with suspicion for diabetic nephropathy;
4. connective tissue disease such as systemic lupus erythematosus (SLE);
5. polycystic kidney disease or glomerular disease unrelated to SCD;
6. stem cell transplantation;
7. untreated human immunodeficiency virus (HIV), hepatitis B or C infection; h) history of cancer in last 5 years; i) End-stage renal disease (ESRD) on chronic dialysis; j) prior kidney transplantation.
China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD

This is a single group, 52-week treatment, Phase 4, open-label, single-arm study to assess the safety and efficacy of avalglucosidase alfa IV infusion in male and female Chinese participants with IOPD who are treatment-naïve or were previously treated with ERT.

Study details include:

* The study duration: total study duration is approximately 64 weeks.

  * Screening period of up to 8 weeks
  * Treatment period of 52 weeks
  * Follow-up period of 4 weeks.
* The number of visits will be 30, including 29 site visits and 1 phone call follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be \<18 years of age, at the time of signing the informed consent.
* Participants have documented onset of Pompe disease symptoms before 12 months of age (corrected for gestation if born before 40 weeks); and diagnosis of IOPD is confirmed by GAA enzyme deficiency from any tissue source and GAA gene pathogenic mutations.
* Participants must have documented cardiomyopathy at the time of diagnosis.
* Contraceptive use should be consistent with local regulations Participant's parent/legally authorized representative (LAR) must be capable of giving signed informed consent.

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

* Participants with major congenital abnormality that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival.
* Participants with clinically significant organic disease (with the exception of symptoms relating to Pompe disease).
* Participants who have received an ERT other than alglucosidase alfa or avalglucosidase alfa, or any other treatment for Pompe disease, including gene therapy prior to the enrollment.
* Participants who have received alglucosidase alfa or avalglucosidase alfa less than 1 week prior to the first dose of avalglucosidase alfa given as IMP Participants who are anticipated to take prohibited therapy (ie, any other treatment for Pompe disease) during this study.
* Participants who have taken other investigational drugs (not Pompe disease specific) within 30 days or 5 elimination half-lives in blood of that drug before enrollment, whichever is longer, or are anticipated to take any other concurrent investigational treatments.
* Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Kinetics of the Finasteride Prostate Induced Apoptosis

The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a surgical procedure because of low tract urinary symptoms are randomly attributed to one of five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of the procedure. Prostate histological fragments are conditioned for molecular and histologic studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with low tract urinary symptoms needing a surgical procedure
* No previous treatment with finasteride
* No androgen deficiency; no prostate cancer suspected.
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy

This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.

PRIMARY OBJECTIVE:

I. Determine if micro-ultrasound (US) can be used to identify prostate cancer foci with equivalent (non-inferior) performance relative to multiparametric magnetic resonance imaging (mpMRI).

SECONDARY OBJECTIVE:

I. Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.

TERTIARY OBJECTIVE:

I. Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images.

QUATERNARY OBJECTIVE:

I. Determine if micro-US can be used to evaluate suspicion of extracapsular extension (ECE) with equivalent (non-inferior) accuracy to mpMRI.

OUTLINE:

Patients may undergo transrectal micro-ultrasound scan (TRUS) prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Standard-of-care mpMRI within the past 12 months
* Biopsy-proven prostate cancer, Gleason grade \>= 3+3
* Maximum posterior-to-anterior prostate dimension of =\< 6 cm
* Scheduled to receive standard-of-care radical prostatectomy

Exclusion Criteria:

* Maximum posterior-to-anterior prostate dimension greater than 6 cm
* Prior radiation or focal treatment for prostate cancer
* Inability to have a transrectal ultrasound scan
* Prostate biopsy \< 4 weeks prior to surgery
Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy

This research study is testing whether an experimental drug, called SRD-001, is safe and helps the weakened heart of patients with Duchenne muscular dystrophy (DMD) regain its ability to effectively pump blood to the rest of the body. SRD-001 is a form of gene therapy. The goal of SRD-001 gene therapy is to provide the heart muscle cells with extra copies of the SERCA2a gene so that they can produce more SERCA2a protein to help the heart muscle cells squeeze/contract better. Researchers will compare SRD-001 treated participants with no-treatment participants; all participants will continue to take their current heart medications. All participants will be followed very closely for 2 years and undergo cardiac magnetic resonance imaging of their heart at baseline, year 1 and year 2 along with assessment of upper limb function and lung function. After the 2 years of close follow-up, all participants will roll over into long-term follow-up where they will be called biannually for information on their current medical status.

This phase 1b, multi-center, non-randomized, open-label, ascending dose escalation, no-intervention-control trial will assess the safety and explore the efficacy of SRD-001 administered as a one-time antegrade epicardial coronary artery infusion for the treatment of participants with cardiomyopathy secondary to DMD. SRD-001 is an AAV1 vector expressing the transgene for SERCA2a. Twelve participants will be assigned to either active treatment with SRD-001 or no-intervention based upon their neutralizing antibody status. The objectives of the trial are (1) to evaluate the safety of a one-time intracoronary administration of SRD-001 in participants with cardiomyopathy due to DMD; and (2) to explore the impact of SRD-001 on heart and skeletal muscle function and quality of life. After screening to determine eligibility, participants will be sequentially assigned to low dose SRD-001, high dose SRD-001 or no-intervention. Participants assigned to active treatment with SRD-001 will under cardiac catheterization and angiography just prior to the intracoronary infusion of SRD-001 and spend overnight int he hospital for observation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DMD with confirmatory genetic testing
* Cardiomyopathy with left ventricular scar in at least 3 of 16 segments
* Left ventricular ejection fraction \< 40%
* Individualized, optimized cardiac medical therapy and glucocorticoid treatment for at least 12 months prior to enrollment
* Willing and able to provide informed consent

Exclusion Criteria:

* Abnormal blood pressure
* Non-DMD-related liver function test elevations
* Cystatin C ≥ 1.2 mg/L
* Thrombocytopenia
* Anemia
* Inadequate pulmonary function
Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended.

Aims of the study:

1. To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):

   * in reducing the number of urinary tract infection episodes during prophylaxis
   * in reducing the number of urinary tract infection episodes after prophylaxis
   * in improving the patient's quality of life .
2. To assess :

   * Tolerability of antibiotic prophylaxis
   * The incidence of resistance to antibiotic therapy


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age over 18 years old
* No allergies to the drugs to be prescribed
* No counter-indications to this drug therapy
* Urine culture shows responsiveness to drugs at recruitment of patient
* History of urinary tract infections with at least three episodes in the previous year or two in the past six months

Exclusion Criteria:

* Lack of tolerability of prescribed drugs
Teaching the Getting Up From the Floor Among Long-Term Care Facility Residents

The aim of this study is to determine the effect of teaching the getting up from the floor using the Backward Chaining Method on functional mobility, muscle strength, fear of falling, and life-space mobility among among long-term care facility residents.

Methods: Randomized controlled trial of a teaching the getting up from the floor using the Backward Chaining Method for older people living in long-term care facility. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and after the 20-session intervention (post-test). After baseline assessments is completed, participants will be randomly allocated to intervention or control groups using stratified randomization based on the use of walking aids and baseline values of FES-I.

The BCM sessions will be provided in a community room situated in the nursing home and will be led by a physiotherapist with extensive experience in geriatric physiotherapy with assistance of 2 physiotherapist student.

Only stable chairs provided for supporting and safety, wedge pillows, and training mats are required during practicing.

Expected results Improvement in functional mobility of the IG Improvement in lower and upper limb muscle strength Improvement in fall efficacy Improvement in life-space mobility


Eligibility Criteria:
Inclusion Criteria:

* • aged 65 years or older,

  * living in the nursing home for at least 2 months,
  * being able to walk at least 6 meters with or without walking aids

Exclusion Criteria:

* • being physically unable to be taught how to get up from the floor.

  * lower limb endoprosthesis implanted within 6 months
  * severe pain (VAS\> 7/10)
  * cognitively unable to co-operate (based on psychiatrist's judgement)
  * planned moving away from the nursing home during the study period.
Shockwave Phonophoresis on Calcaneal Spur Patients

The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Therefore, the present study might help in the treatment of calcaneal spur patients and also might improve the quality of life in a fast and efficient way.


Eligibility Criteria:
Inclusion Criteria:

* Heel pain with a calcaneal spur.
* Calcaneal spur in a lateral calcaneal x-ray.
* Patient's age ranged from 30 to 65 years.
* Patients with a calcaneal spur.
* Patients with intact sensory perception.
* At least 6 weeks from last corticosteroid injection; 4 weeks from the last local anaesthetic injection, iontophoresis, ultrasound, and electrotherapy

Exclusion Criteria:

* History of fracture or surgery of the heel or ankle.
* Presence of inflammatory joint disease.
* Marked osteoporotic patient.
* Presence of ankylosing spondylitis or other inflammatory joint diseases.
* Heart pacemaker use.
* Patient on anticoagulant and coagulation disease.
* Skin wound or ulcers.