cyrilzakka/clinical-trials huggingface dataset:
Quantitative US for Hepatic Steatosis

The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers
* Signed informed consent

Exclusion Criteria:

* chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation)
* chronic alcoholics
* serum alanine transaminase (ALT)\>5 times the upper limit of normal within 3 months
* previous liver surgery
* acute hepatitis or bile duct obstruction
Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin


Eligibility Criteria:
Inclusion Criteria:

* Normal subjects who are sensitized to nickel, neomycin, or fragrance mix.

Exclusion Criteria:

* Under 18 years of age.
A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD


Eligibility Criteria:
Inclusion Criteria:

* GOLD criteria 2 to 4
* 10 pack year history of smoking

Exclusion Criteria:

* Women of child bearing potential
BIOSURE™ RG Knee Safety & Performance Study

Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction

This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following:

Knee repair:

* ACL repair Posterior cruciate ligament (PCL) repair
* Extra-capsular repairs
* Medial collateral ligament (MCL)
* Lateral collateral ligament (LCL)
* Posterior oblique ligament (POL)
* Patellar realignment and tendon repairs
* Vastus medialis obliquus advancement
* Iliotibial band tenodesis

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent for study participation.
2. Subject is eighteen (18) years of age or older at the time of enrollment in the study.
3. Subject requires one of the following knee procedures:

   * Anterior cruciate ligament (ACL) repair
   * Posterior cruciate ligament (PCL) repair
   * Extra-capsular repair - Medial collateral ligament (MCL), Lateral collateral ligament (LCL), Posterior oblique ligament (POL)
   * Patellar realignment and tendon repair Vastus medialis obliquus advancement Iliotibial band tenodesis
4. Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.

Exclusion Criteria:

1. Subject has Body Mass Index (BMI) \> 40.
2. Subject has had total knee arthroplasty (TKA) in the study knee.
3. Subject has conditions that may interfere with graft survival or outcome (e.g. Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
4. Subject has a known allergy to the study device or any of its components.
5. Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse, subject is pregnant, or plans to become pregnant during the study.
6. Subject is entered in another investigational drug, biologic, or device study, or has been treated with an investigational product in the past 30 days.
7. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
Patient Satisfaction After Ingrown Toenail Surgery

In this study, demographic characteristics (age, gender, which toe is involved, family history) of the patients who were operated because of ingrown nails were examined, and the post-operative satisfaction score of the patients was noted, and the recurrence rate and complications were recorded.

The study was designed as single-center, single-surgeon observational study. Approximately 4000 patients who were operated on by the same surgeon between 2015-2020 due to ingrown nails were reached by phone, and patients' satisfaction was assessed by using the Surgical Satisfaction Questionnaire (SSQ-8). Outcomes such as retrospective treatment processes and complications were asked using a questionnaire, and patients' demographic characteristics were also recorded.

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent ingrown toenail surgery Patients who could be reachable by phone over contact details on medical records

Exclusion Criteria:

Patients who were not reachable Patients who underwent another surgery on the targeted foot rather than ingrown toenail surgery Patients who had fractures on the targeted foot Clinical diagnosis of Alzheimer disease or patients who have lost their cognitive functions.
The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients

Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate.

Using anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.


Eligibility Criteria:
Inclusion Criteria:

1. cataract candidates treated (in the present or in the past) with tamsulosin
2. aged 55 or more
3. candidates for topical anesthesia
4. no allergy to anticholinergic or adrenergic drugs
5. able to understand and sign an informed consent

Exclusion Criteria:

1. history of uveitis
2. iris neovascularization
3. s/p iris surgery
4. traumatic/uveitis induced cataract
5. dialysis / abscence of zonules
Deportalization, Venous Deprivation, Venous Congestion

Patients with multiple primary or secondary liver tumors have a low survival rate unless they can benefit from curative extended hepatic resections with R0 or R1 marge resection. Post-operative acute liver failure may occur after such surgery when the remnant liver is insufficient, leading to high morbimortality.

The future remnant liver (FRL) preoperative evaluation is then the key consideration before performing extended liver resection. The FRL volume measurement on computed tomography (CT) imaging is the most widespread method of FRL evaluation. Threshold values of acceptable FRL volume depend on the underlying liver function, it ranges from 20-30% in healthy liver to 40% in cirrhotic liver. However, it recently appeared that the FRL function would be more valuable in predicting post-operative liver failure. 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) combined with SPECT/CT enables reliable FRL function measurement with a threshold value calculated at 2.69%/min/m2, to predict post-hepatectomy liver failure.

When the FRL evaluation does not reach the acceptable threshold values to avoid liver failure, portal vein embolization (PVE), consisting of portal branches occlusion of the future removed liver, can be performed. It is now the standard of care to induce FRL regeneration before surgery. Right PVE induces right hemiliver (S5-8) deportalization (portal input deprivation with hepatic venous drainage preservation) leading to left hemiliver (S2-4) regeneration.

To optimize PVE results, recent effective techniques have been developed such as the simultaneous embolization of the right portal branch and the right hepatic vein (HV), and the right accessory HV if so, which is called liver venous deprivation technique. Additional simultaneous embolization of the middle HV defined the extended liver venous deprivation (ELVD) technique. ELVD induces right liver (S5-8) venous deprivation (deprivation of both portal input and venous drainage) and leads to rapid increase in FRL function. After ELVD, segment IV (S4) portal input from left portal branch is preserved while its venous drainage through the middle HV is disrupted, resulting in venous congestion.

The aim of this study is to analyze the volumetric and functional evolutions after embolization procedures in deportalized liver (S5-8 after PVE), vein-deprived liver (S5-8 after ELVD) and congestive liver (S4 after ELVD).


Eligibility Criteria:
Inclusion criteria:

* Age \> or = 18 years
* primary or secondary liver tumor(s)
* major hepatectomy approved by multidisciplinary tumor meeting
* small FRL (baseline FLR \<2.69%/min/m2)

Exclusion criteria:

* liver fibrosis / cirrhosis
* biliary obstruction
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy

The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.

The main questions it aims to answer are:

* silicone chest drains are less painful compared to standard PVC drains?
* is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.


Eligibility Criteria:
Inclusion Criteria:

* primary lung cancer eligible for VATS lobectomy by tumor board meeting

Exclusion Criteria:

* age under 18 years
* high risk of post-operative complications (ASA \> 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) \< 15 ml/kg/min)
* tumors growing in parietal pleura
* extended lung resection diffuse
* previous surgery in the same hemithorax
* chronic pain
* chronic use of analgesics or sedatives
* surgical revision
* inability to participate in the study.
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy

The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.

Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP develop colorectal cancer at a median age of 35-45 years. To prevent colorectal cancer in patients with FAP, prophylactic colorectal surgery is performed. The preferred surgical procedures for FAP are a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) or a subtotal colectomy with ileorectal anastomosis (IRA) or ileosigmoidal anastomosis (ISA).

After both types of prophylactic colorectal surgery, subtotal colectomy with IRA/ISA or proctocolectomy with IPAA, patients will require life-long surveillance because disease progression and development of new adenomas in retained rectum, pouch or residual rectal cuff will occur.

The 10-years risk of developing one or more adenomas in the rectum after IRA is 100% compared to 33% in the pouch after IPAA. The risk of developing rectal cancer after IRA was found to be 9% and 11% in two large studies with a median follow-up of 12.8 and 15 years, respectively. One study showed that the 10-years risk of developing a carcinoma in the pouch was 1%. As patients are usually operated at a young age, and nowadays have a long life-expectancy, the actual cumulative life-time risk will presumably be higher.

The recently published ESGE (European Society of Gastrointestinal Endoscopy) polyposis guideline recommends a one to two yearly endoscopic surveillance interval after prophylactic colorectal surgery in FAP, both for patients that underwent IRA/ISA and IPAA, with removal of all polyps \>5mm. This recommendation is based on expert-opinion, since no studies have been reported comparing the efficacy and safety of different surveillance intervals. No advices are provided on which patients will benefit from which surveillance interval.

With the proposed study, the investigators aim to provide evidence for personalized endoscopic surveillance for patients with FAP that have undergone (procto)colectomy with construction of an IRA/ISA or IPAA with the goal to prevent development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (\>100 colorectal adenomas in combination with a positive family history of FAP)
* Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA
* Age 18 years or older

Exclusion Criteria:

* Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
* Cancer at baseline endoscopy
* Need for surgery
Perpetual Observational Study - Ventilator Associated Pneumonia

Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics.

Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials.

The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.

Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).

Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).

RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.

These trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population.

Through a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.

Eligibility Criteria:
Inclusion criteria:

* Age≥18 years
* At risk of acquiring VAP during ICU stay, defined as:
* Requiring admission or being admitted to the ICU.
* Expected or documented to be under IMV for more than 48 hours.
* Consent, either a written informed consent given by the study patient in full medical, psychological, cognitive, social or legal capacity to give an informed consent, or, if not possible, by a Legally Authorized Representative of the study patient OR any applicable locally accepted form of consent OR consent waiver allowing data collection and sharing of data according to ECRAID's principles

Exclusion Criteria:

* Death is deemed to be imminent or inevitable during this hospital admission AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.

OBJECTIVES:

Primary

* Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.

Secondary

* Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
* Determine the treatment impact on tumor growth (e.g., objective response, time to progression).

OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.

Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.

After completion of study treatment patients are followed every 2 months for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma

  * Stage IV disease (M1a and M1b only)
* Measurable disease according to RECIST criteria
* HLA-A2 positive
* Must have IgA in serum (any concentration)
* No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 75,000/mm\^3
* AST ≤ 5 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to provide informed consent
* Agrees to return to Mayo Clinic Rochester for follow-up
* Agrees to participate in the mandatory translational research component of the study
* No uncontrolled or current infection
* No known immune deficiency
* No B or AB blood grouping

PRIOR CONCURRENT THERAPY:

* More than 4 weeks since prior chemotherapy and recovered
* More than 4 weeks since prior biologic therapy
* No concurrent immunosuppressive therapy
Effect of a Therapeutic Exercise and an Education Program on Sexual Function and Experience in People With Endometriosis

This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program.

The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after 4 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). Objective and subjective data of the participants will be evaluated. T1 will be assessed with a sociodemographic questionnaire and the FSFI and MSSCQ surveys. T2 and T3 will assess blood pressure, heart rate, variability of the autonomic system, the ability to dissociate the lumbopelvic movement from the thoracolumbar, measurement of the muscles of the transverse, internal and external obliques, the distance between the rectus abdominis and the pelvic floor, subjective perception of effort during exercise and subjective perception of orgasmic intensity.


Eligibility Criteria:
Inclusion Criteria:

* People of legal age (over 18 years old)
* Not older than 50 years old
* Currently residing in Spain
* Spanish speakers
* With a medical diagnosis of endometriosis
* Without any other associated gynecological pathology

Exclusion Criteria:

* Minors
* People over 50 years old
* Those with cognitive limitations that prevent them from completing the different questionnaires used
* People who are involved in litigation processes
* People with gynecological pathologies other than endometriosis
Rhinosinusites Chroniques

To analyse and describe sinus microbiota, during hard to treat (or refractory) rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA contained in samples).

Samples are middle meatus swabs or pus aspiration, done during usually patient following.


Eligibility Criteria:
Inclusion Criteria:

* \>18 year old
* chronic refractory rhinosinusitis
* to require middle meatus swab or other sinus sample
* absence of opposition

Exclusion Criteria:

* \<18 year old
* pregnant women
* breastfeeding
* under trusteeship
* under guardianship
First-in-man Sirolimus-eluting Prolim® Stent Registry

The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.

Investigators prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome, treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15% of patients (randomly chosen) underwent optical coherence tomography analysis. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old,
* stable coronary artery disease (SCAD) or acute coronary syndrome (unstable angina - UA, non-ST elevation myocardial infarction - NSTEMI or ST-elevation myocardial infarction - STEMI) and
* signed informed consent

Exclusion Criteria:

* inability to take dual antiplatelet therapy for 12 months,
* left ventricular ejection fraction ≤ 30%,
* chronic total occlusions, and
* in-stent restenosis