cyrilzakka/clinical-trials huggingface dataset:
Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. There has been a great deal of research on different approaches to optimize post-operative insulin sensitivity including hormonal and nutritional interventions, minimally invasive surgical techniques and epidural anesthesia. However, the correlation between insulin resistance and body protein loss is not well understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection patients; 2) investigate whether the post-operative metabolic state can be improved by the pre-operative administration of metformin; and assess the impact of metformin on surgical complications and hospital length of stay. The results of this study will provide insight into the relationship between insulin resistance and post-operative adverse events and potentially suggest a novel approach to improve outcomes using Metformin, a drug already in wide clinical use.


Eligibility Criteria:
Inclusion Criteria:

1. Elective open anatomic lung resections: segmentectomy, lobectomy, bi-lobectomy
2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
3. Primary or secondary lung cancer
4. At least 18 years of age with
5. HbA1c 5.7- 6.5 %
6. Not receiving any kind of glucose lowering medication.

Exclusion Criteria:

1. Already diagnosed with diabetes (Hb A1c \> 6.5%)
2. Are pre-diabetic receiving glucose lowering intervention ( any glucose lowering medication)
3. Have renal or liver dysfunction (serum creatinine above 124 micromol/L in women and 133 micromol/L in men, bilirubin \>50 micromol/L)
4. will undergo extended resection of adjacent organs, chest wall resections, bronchoplasty, non-anatomic lung resections
5. Will undergo Pneumonectomy
6. Non-elective operations
7. Have mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis),
8. Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), Chronic obstructive pulmonary disease(COPD), sepsis, morbid obesity (BMI \>40 kg/m2), anemia (hematocrit \< 30 %, hemoglobin \<100g/L albumin \< 25mg/dl)
9. Have received steroids for longer than 30 days
10. Have poor English or French comprehension.
ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

We aim to understand the mechanism of olfactory dysfunction in COVID-19.

In December 2019, a new coronavirus causing severe acute respiratory syndrome was described in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health Organization.

By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a frequent association between coronavirus disease 2019 (COVID-19) and smell disorders.

In the present study, the investigators wish to begin to understand the pathogenesis of olfactory dysfunction in COVID-19.

Eligibility Criteria:
Inclusion Criteria:

- Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively

Exclusion Criteria:

* none
Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design

A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique)

In This study investigators compare a novel sperm processing and selection method which is (fast, cheap and safe) with the well known processing method of sperm "Density gradient (DG)"

The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10 μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid with mineral oil.

Control group : Oocytes will be injected using sperm after processing with DG and will be selected from control PVP microdroplets

Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP microdroplets is prepared on "H" Pattern and will be selected from the far point from the deposition point and will be injected into the oocytes from the sample group All injected MII oocytes from both groups will then be cultured, with each group demarcated in separate place in the culture dish then according to the randomisation embryo transfer will be selected from one of both groups then the quality of the embryos will be reported and the pregnancy rate

Eligibility Criteria:
Inclusion Criteria:

* The normal \& high responders were selected according to :

  * age: 18 - 40 years
  * anti-Müllerian hormone (AMH): \> 1.0 ng/ml
  * number of aspirated oocytes:more than or equal 8
  * BMI \< 34

Exclusion Criteria:

* Age \> 40 years;
* AMH \< 1.0 ng/mL;
* aspirated oocytes \< 8.
* severe male factor
* Testicular aspirated sperm
A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet

This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.

The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.

Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the combined administration of solifenacin and tamsulosin given as combination tablet EC905.

Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and verapamil.

On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is obtained.

Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.

Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18.5 and 30.0 kg/m2, inclusive

Exclusion Criteria:

* Known or suspected hypersensitivity to EC905 or any of the components of the formulation used
* Known or suspected hypersensitivity to verapamil or any of the components of the formulation used
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
Intermittent Normoxia Reduces Myocardial Reperfusion Injury

This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass (CPB) on inflammatory response, oxidative stress and myocardial reperfusion injury in adult patients undergoing valve replacement. The investigators hypothesized that nuclear factor kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.

Methods:Patients meeting the requirement will be randomized into 2 groups: the control group received hyperoxic reperfusion (PaO2 180-250 mmHg) throughout CPB as routine; the treatment group underwent 3 cycles of 5/5 min normal/high oxygenation (PaO2 80-150/180-250 mmHg) during cardioplegia arrest, and maintained the same hyperoxia as the control group in the rest time of CPB. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), tumor necrosis factor-α , interleukin-6, 10, and malondialdehyde (MDA). Atrial biopsies will be removed before cardioplegia arrest and 30min after aortic de-clamping to determine the extent of neutrophil infiltration (myeloperoxidase activity), NFkB binding DNA activity, and gene expression of inflammatory factors (TNF-α, IL-6, 10).

Statistical analysis:A sample size of at least 32 patients in each group was needed to have a power of 90%, significance at the two-side 5% level, on the basis that a SD of 0.2 ng/ml and a difference in peak serum cTnI release of about 0.15 ng/ml between control and conditioned patients was determined.

Expected Results: The treatment group will have significantly lower release of cTnI, inflammatory factors, and MDA during CPB and afterwards. Intermittent normoxia may be related to less myocardial inflammation characterized by decreased myeloperoxidase activity, gene expression of inflammatory factors, the later may result from reduced activity of NFkB binding to DNA after reperfusion.

Eligibility Criteria:
Inclusion Criteria:

* rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

Exclusion Criteria:

* infective endocarditis congenital valve disease previous cardiac surgery complicated with diabetes, coronary artery disease, hypertension or peripheral vascular disease.

receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma

The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin 20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven days in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study of oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-70
* male and female
* signed the informed consent form.
* Diagnosis:Gastrointestinal cancer diagnosed by imaging,cell and pathology report.
* Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months.
* Indication for Chemotherapy,no contraindication.
* First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
* At least 8 weeks after last biotherapy.
* Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

* Chemotherapy is contraindicated.
* Have the primary disease can cause the neuropathy.
* A history of other malignant tumor in recent 5 years.
* Less than 6 months after last chemotherapy or radiotherapy.
* Less than 8 weeks after last biotherapy.
* Cinobufotalin allergy.
* Had received transplantation surgery,less than 2 weeks after last major surgery.
* Other researchers think is not suitable for this clinical trail.
Intravitreal Bevacizumab for Inflammatory Neovascular Membranes

Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous Choroidopathy and 1 patient with Multifocal Choroiditis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnose
* Patient Consent
* Chronic stage of inflammation

Exclusion Criteria:

* only eye
* age lower than 30 yo.
* Systemic condition
The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)

The study aims to improve the safety of the electroporation ablation (PFA) procedure by using muscle relaxants to reduce skeletal muscle damage during the procedure. It will also assess myocardial damage to improve the procedure's quality and speed up recovery after the procedure.

The procedure of electroporation (PFA) is a method of atrial fibrillation ablation introduced in Poland in 2022. A biphasic high voltage current (2000 volts) is applied to the electrode placement site. Local coagulation of the site is followed by myocardial scarring and interruption of the pathological conduction pathway of premature electrical impulses in the heart. The patient, once qualified by the cardiologist for the procedure of electroporation ablation (PFA), will undergo a standard anaesthetic qualification process with assessment of basic demographics, comorbid conditions, medications taken, determination on the surgical risk scale.

Participants will be randomized into 2 groups. Group I will consist of patients undergoing general anaesthesia without the muscle relaxant rocuronium. Group II will consist of patients undergoing general anaesthesia with the muscle relaxant rocuronium. A total of 32 patients were initially planned for the study (16 patients in each of the two groups). Before the procedure, the anaesthetist will be given a sealed envelope by a person unrelated to the project (hospital administration staff) with a randomised method of anaesthesia based on simple randomisation. Before the procedure, each patient will have a transthoracic ultrasound of the heart (TTE). The patient will not know which study group he/she has been assigned to. The operator performing the procedure will not be informed about the type of anaesthesia used \[double blind randomisation\].

Eligibility Criteria:
Inclusion Criteria:

* Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation

Exclusion Criteria:

* Patients with allergies to the general anaesthetics used, genetic diseases of the neuromuscular plateau - e.g. Duchenne dystrophy, myasthenia gravis - and patients who do not gived informed consent to participate in the study will be excluded from the study.
Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery

The purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with written informed consent
* Male and female subjects
* Subjects scheduled for an elective and urgent CABG surgery that includes saphenous vein harvesting.

Exclusion Criteria:

* Known allergy or intolerance to triclosan
* Different surgical prophylactic antibiotic regimen than common in the department.
* Continuous preoperative and predicted postoperative antibiotic treatment.
Starting Pediatric Obesity Prevention in Pregnancy

The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors during pregnancy to prevent excessive gestational weight gain.

The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to support women in gaining weight during pregnancy within their clinically recommended weight gain target.

Eligibility Criteria:
Inclusion Criteria:

* any race/ethnicity
* speak Spanish or English
* ≥16 years
* \>10 and \<28 weeks pregnant
* in prenatal care
* anticipating remaining in Middle Tennessee for their full gestation
* willing to sign a medical information release form so that we can abstract weight measures from their obstetric and pediatric records

Exclusion Criteria:

* speak neither Spanish or English
* \<16 years
* \< 10 weeks or \>28 weeks pregnant
* not in prenatal care
* anticipating leaving Middle Tennessee before full gestation
* unwilling to sign medical information release form
* current or past (within last 12 months) enrollment in another research program that targets weight, physical activity, nutrition
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent.

Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission.

Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants.

The study team hypothesizes that:

* Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts.
* Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.

The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.

As sites are activated the registration will be updated.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)
* Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan
* Access to means of communication with the study team (email, text messaging, and/or telephone)
* Adequate independent cognitive function and English language proficiency to complete study surveys
* Written informed consent

Exclusion Criteria:

* Planned bilateral ureteroscopy
* Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
* Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
* Anatomic or functional solitary kidney
* Planned secondary or staged ureteroscopy
* Planned use of ureteral access sheath
* Pregnancy
* Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Second Stage Exclusion Criteria:

* ureteral perforation
* unanticipated anatomic abnormality
* greater than expected bleeding
* ureteral dilation greater than 12 French
* ureteral access sheath utilized
* failed ureteroscopy
* no or incomplete lithotripsy performed
* unable to complete case due to medical or anesthetic event.
Regional Native American Community Networks Program (RNACNP)

Aim: Determine the overall effectiveness of a targeted digital messaging intervention at improving colorectal cancer (CRC) screening rates compared to care as usual.

Hypothesis: Screening rates will be higher for patients who receive the digital messaging intervention, compared to the control group in which patients receive care as usual.

Native People for Cancer Control is one of the projects under Partnerships for Native Health, and is 1 of 23 Community Networks Programs funded by the National Cancer Institute. The aim of Native People for Cancer Control is to reduce cancer health disparities by conducting training, research, education and outreach, in collaboration with American Indian and Alaska Native communities. We do this work in partnership with Native people, communities, and organizations in an 8-state area, including: Alaska, Washington, Wyoming, Oregon, Idaho, Montana, North Dakota, and South Dakota. Our program consists of 4 cores:

Administrative Core: assists with grant administration, budgeting, sub-contracts with Tribes, program planning, and reporting.

Outreach/Education Core: assists with cancer education, outreach, health promotion, and cancer prevention activities among urban and rural AI/AN people.

Training Core: builds capacity for Native faculty-level investigators, and students, to conduct research.

Research Core: conducts community-based participatory research on colorectal cancer screening, health literacy, health communication, and cancer risk factors among American Indian and Alaska Native people.

The main research project under Native People for Cancer Control is titled, "Innovations in Enhancing Colorectal Cancer Screening". The goal of this project is to develop, implement, and evaluate a community wide, multi-media campaign to improve colorectal cancer screening among American Indians and Alaska Natives in 3 communities.

Eligibility Criteria:
Inclusion Criteria:

* AI/AN
* Age 50-75
* Active clinical patient

Exclusion Criteria:

* Not AI/AN
Effect of Remimazolam and Propofol on Postoperative Delirium

Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.


Eligibility Criteria:
Inclusion Criteria:

* elderly patients undergoing hip or knee arthroplasty under general anesthesia.
* body mass index \>30 kg/m2

Exclusion Criteria:

* moderate to severe liver dysfunction
* moderate to severe renal dysfunction
* unable to extubate in the operation room after operation
* benzodiazepine dependence
* sensitivity to anesthetic drugs used for study (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Sugammadex, Flumazenil)
* acute angle glaucoma
* received (benzodiazepine, antianxiety drugs, antidepressant, antipsychotic drugs) within 24 hours.
* acute psychotic depression
* history stroke or cerebrovascular disease