cyrilzakka/clinical-trials huggingface dataset:
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery

A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase the postoperative IL-6/Il-10 ratio.

Cardiac surgery associated systemic inflammatory response syndrome (SIRS) plays an important pathophysiological role in the development of AKI in patients after cardiothoracic surgery.

Previous studies have shown that the elimination of inflammatory mediators can be either achieved by Continuous Venous Venous Hemodialysis(CVVHD) or Continuous Venous Venous Hemofiltration (CVVH) by using a high-cutoff (HCO) membrane with a cut-off 45kD. Data from patients treated with HCO-CVVHD during septic shock show a reduction in systemic cytokines and improved hemodynamics.

No data about the effects of early HCO-CVVH in cardiac surgery patients with a high risk of Cardiac Surgery associated AKI and consequently a high rate of postoperative renal replacement therapy (RRT) are available.

It is of note that patients with Euroscore \> 6 are on high risk to develop SIRS associated AKI.

No pharmacological anti-inflammatory approach has convincingly shown to prevent renal dysfunction in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Scheduled for complex / prolonged cardiac surgery (i.e.combined CABG+ valve surgery, Redo surgery) with an anticipated CPB time \> 120 min
* CKD with an e GFR \< 50ml/min/m2
* Euroscore \> 6

Exclusion Criteria:

* End stage CKD (dialysis dependent) renal failure before surgery
* Radiocontrast exposure within 24 hours before surgery
* Active endocarditic with antibiotic treatment
* pulmonary disease with chronic hypoxia
* Clinically significant liver dysfunction (bilirubin \> 1.8mg/dl (30µmol/L))
* Known HIV, HCV infection
* Alcoholism
* Active uncontrolled infection
* Pregnancy or lactation
* Inability to give informed consent to participate in the study
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.

Exclusion Criteria:

* Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.
A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects

This trial is conducted in China. The aim of the trial is to investigate the influence of IBI362 on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin, metformin, warfarin, atorvastatin, digoxin in overweight or obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, age between 18 and 45 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 24 and 30 kg/m\^2 (both inclusive) and weight≥50kg
* The subject has no birth plan and voluntarily takes effective contraceptive measures within 6 months after signing the informed consent form to the last medication

Exclusion Criteria:

* Cardiovascular, respiratory, hepatic, digestive (including digestive diseases that significantly affect gastric emptying or gastric motility, such as severe gastric spasticity or pyloric stenosis), endocrine (including but not limited to history of thyroid cancer or precancerous lesions), hematological and neurological disorders, or muscle degenerative disorders
* Drug or alcohol abuse
* Have dysphagia or any history of gastrointestinal diseases that affect drug absorption.
* Medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
* Have a history of acute and chronic pancreatitis or serum amylase and/or lipase ≥ upper limit of normal value (Upper Limit of Normal value, ULN) at the time of screening.
* Those with a history of hypoglycemia.
* Previous or current mental illness.
Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery

This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.

Prostate cancer is one of the most diagnosed cancer in men. Several treatments are available depending on patient's clinical features. When the cancer is localised or locally advanced, one of the possible treatment is Radical Prostatectomy. A risk of that procedure is the incomplete removal of cancer tissues due to the presence of cancer cells within the resection margin. A histological analysis of the resected prostate allows to assess surgical margins. If cancer cells comes out to the edges of the removed tissue, it is called Positive Surgical Margin (PSM). Several studies showed that PSMs are more frequent in case of extra-prostatic extensions of the cancer and are correlated with biochemical recurrence.

A study conducted on 21 patients scheduled for Robotic-Assisted Radical Prostatectomy has already demonstrated the feasibility of the intra-operative observation of microscopic features of prostatic and periprostatic tissues in vivo and ex vivo with the Cellvizio® 100 Series system combined with the CelioFlex™ probe.

The main objective of the study is to assess the feasibility and safety of pCLE technology during radical prostatectomy (RP) and to assess the diagnostic performance of pCLE technology for the definition of the resection margins.

This method could be used to guide surgeons during nerve sparing surgery and provide real-time feedback for adequate dissection of NVB. As well, ex vivo characterisation of benign and cancerous glandular structures could provide an efficient and rapid method for intra-operative surgical margin assessment

The study is divided in 2 parts:

1. Ex vivo study

   An ex vivo study will be carried out on 15 firsts prostate specimens for pathologist training and generation of ex vivo pCLE images atlas.
2. In vivo study

Prior to pCLE analysis, a contrast agent (Fluorescein) will be administered:

* by intravenous injection in each prostatic pedicles before their ligation
* topically, after NVB dissection, in a spray solution through a catheter inserted in an assistant trocar or with a soaked gauze.

The Cellvizio will be used during the NVB dissection to acquire in vivo images and sequences of prostatic tissues.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Localised or locally advanced prostate cancer
* Agreement given for Radical Prostatectomy
* Not eligible or refusing an active surveillance protocol
* having given its signed informed consent

Exclusion Criteria:

* Under 18 years
* Previously treated for PCa (hormones, EBRT, focal treatments)
* Surgical history of BPH treatment
* Known allergy to Fluorescein
Podcasting Cervical Cancer Prevention for AAW

For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. While previous research has identified only a few social determinants that are specifically related to cervical cancer, there may be a host of additional social and cultural factors that contribute to a lack of preventative behavior. The overall objective of the proposed study is to gather preliminary data to determine whether the use of concept mapping methodology is useful in identifying unique sociocultural determinants of cervical cancer prevention behavior, and to pilot test the feasibility of a podcast video developed using the information garnered from the concept mapping procedure. It is hypothesized that the resulting podcast video will increase HPV knowledge and behavioral intentions. Proof of concept and feasibility are needed first, in determining the utility of both the methodology and media development procedures, as well as data on preliminary effect outcomes, before further investigation and program development.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American
* biological female sex
* speak and read English
* 18 years old or older
* not currently or previously diagnosed with cervical cancer or cervix dysplasia

Exclusion Criteria:

• history of hysterectomy
Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

This study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

Ovarian clear cell carcinoma (OCCC) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. Previous studies indicate that PD-1 inhibitors may have clinical benefits for OCCC patients. This single-arm, single-center, pilot study evaluates the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years to ≤ 75 years
* Pathologic confirmed ovarian clear cell carcinoma
* Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy
* According to the definition of RECIST1.1, the patient must have measurable lesions
* PD-L1 Combined Positive Score ≥ 1
* ECOG performance status of 0 to 2
* Adequate bone marrow, liver, and renal function to receive combined immunotherapy
* Written informed consent

Exclusion Criteria:

* Histological evidence of non-ovarian clear cell carcinoma
* Lack of tumor samples (archived and/or recently obtained)
* Previous administration of immunotherapy
* Patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration
* An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) within 2 years before the first administration
* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity) Symptomatic or uncontrolled visceral metastases that require simultaneous treatment
* Patients are known to be allergic to the active ingredients or excipients of zimberelimab or metformin
* Known human immunodeficiency virus (HIV) infection history (HIV 1/2 antibody positive).
* Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center)
* Contraindications to metformin: kidney dysfunction or abnormal creatinine from any cause; acute or metabolic acidosis
Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma

Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.

Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.

Eligibility Criteria:
Inclusion Criteria:

* glaucoma patient
* over 18 years
* needs further intraocular pressure regulation

Exclusion Criteria:

* age under 18 years
* debilitated
* no glaucoma
Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer

This is a prospective, single-center, non-randomized validation study being conducted under a non-significant risk study design with the primary aim to evaluate PWV, PR, and BW accuracy in a sample of subjects representative of the US general adult population. The primary study objective is to demonstrate equivalency when measuring: Pulse Wave Velocity (PWV) and Pulse Rate (PR) between the PhysioWave Cardiovascular Analyzer (CA) and AtCor Medical SphygmoCor® XCEL PWA \& PWV (XCEL), and Body Weight (BW) between the CA and the Detecto Solo Digital Healthcare Scale (Detecto).


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>18 years old
* Subject signs a written Informed Consent form to participate in the study, prior to any study procedures

Subgroup Inclusion Criteria

* Subject has been taking ACE Inhibitors or Angiotensin Receptor Blockers for at least 30 days

Exclusion Criteria:

* Known significant carotid or femoral artery stenosis
* Non-palpable (non-detectable) arterial pulse at the sites of measurements
* Pacemaker, defibrillator, or other cardiac stimulator
* Erratic, accelerated or mechanically controlled irregular heart rhythm, or an arrhythmia
* History of cardiac valve disorder or cardiac valve disease
* History of venous disease, including venous insufficiency or deep vein thrombosis
* History of peripheral artery disease
* Requirement for supplemental oxygen
* Neuromuscular disorders that cause shaking or tremors (such as Parkinson's disease or Multiple Sclerosis), or other disease or condition affecting balance
* Amputation or malformation of any limb or extremity (foot, leg, or arm) which would impede the placement of blood pressure cuffs or standing on the scale with two feet.
* Known or suspected pregnancy
* Inability to provide informed consent
* Mental incompetence or a prisoner status
* Current participation in a clinical trial of another investigational drug or device in which the study endpoint has not been met
* BMI \> 40
* Subjects \> 400 lbs
* Subjects on strong vasoactive drugs, such as those used to control high blood pressure, for \<30 days
* Blood loss or blood donation of ˃ 550 mL within 30 days before study procedure
Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females

Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.


Eligibility Criteria:
Inclusion Criteria:

* hyperandrogenemia
* informed consent to participate
* female sex
* age 18-40 years old

Exclusion Criteria:

* male sex
* no consent given
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation

The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the quality and quantity of the education that is provided to patients listed for lung transplantation. We propose to change the method and timing of our transplant patient education. The objective of this prospective data collection will be to collect and analyze pre and post test scores of patients when patient education is provided via compact disc as compared to individualized teaching.


Eligibility Criteria:
Inclusion Criteria:

* Age- 18-75

Exclusion Criteria:

* None
End Nicotine Dependence Clinic

The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.

Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the opportunity to receive a CBT-based tobacco intervention delivered several possible formats (face-to-face, telephone, video-counseling) based on availability and participant preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse prevention strategies, and discuss barriers to cessation, previous quit attempts, risky situations, and benefits observed after quitting. Participants may also complete exercises designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine replacement therapy and text-messaging support.

Objective 2: To examine the rates of smoking abstinence across intervention formats. Investigators will attempt to follow-up with participants for a 6-months after program completion. Investigators will assess point prevalence abstinence for each intervention delivery method.

Objective 3: To assess individual difference variables that influence outcomes. Investigators will examine individual-difference predictors of outcomes, such as readiness to quit, social support, distress, and environmental factors.

Eligibility Criteria:
Inclusion Criteria:

* Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a breath carbon monoxide (CO) reading of ≥ 8 ppm)
* Able to speak and read English
* Able to engage using at least one of the intervention formats.

Exclusion Criteria:

* Enrollment in another cessation program
* Do not speak and read English
* Do not have access to at least one intervention format
* Have contraindications for NRT
* Do not have contact information (e.g., address, telephone number)
* Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse)
* They endorse active addiction to another substance (e.g., illicit drugs or alcohol).
* People who self-report having a severe mental illness
Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients

Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. The objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. Body composition was assessed by computed tomography (CT) and bioelectrical impedance test was conducted to evaluate the phase angle. Handgrip strength was used to determine functionality. The percentage of weight loss in relation to usual weight was the anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis. Postoperative complications were classified according to the Dindo and Clavien classification. Overall time survival was the period between the first assessment of the patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and the Log Rank test and regression analysis will be used (p \<0.05).


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic cancer confirmed
* Over 18 years old
* Accepted the terms of survey

Exclusion Criteria:

* Tumor synchronic
* Inflamattory disease
* Under 18 years old
* No accepted the terms of survey
A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants

The main goal of this trial is to learn about the effect of Lu AG06474 on a battery of Evoked Pain Tests when a single dose is given to healthy adult participants. The effects of Lu AG06474 will be compared with 2 approved pain-relieving medications (ibuprofen and pregabalin) and with a placebo (a treatment that looks like the trial treatment but does not have any medicine in it). Each participant will receive 1 dose of each of these treatments during the trial (Lu AG06474, ibuprofen, pregabalin, and placebo), with 1 week between treatments. All treatments will be taken orally (by mouth), either as a liquid or a capsule.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤32 kilograms per meter squared (kg/m\^2) at the Screening Visit and at the Trial Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
* The participant has Fitzpatrick skin type IV, V and VI, wide-spread acne, tattoos, or scarring interfering with the area of interest (that is, upper back).
* The participant is currently enrolled in another clinical trial or used any investigational drug or device within 3 months (or \<5 half-lives of that product, whichever is longer) prior to dose of investigational medicinal product (IMP), or has participated in more than 4 investigational drug studies within 1 year prior to Screening.
* The participant takes any disallowed medication within 14 days from first dose of trial drug.
* The participant has been vaccinated ≤14 days prior to the first dose of IMP.
* The participant is pregnant, breastfeeding, intends to become pregnant, or is of child bearing potential and not willing to use adequate contraceptive methods.
A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle

The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.


Eligibility Criteria:
Inclusion Criteria:

* positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study