cyrilzakka/clinical-trials huggingface dataset:
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery.

Co-primary endpoints are

* Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
* CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin \<0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge))
* No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
* Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3.
* No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation
* Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment
* No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization
* Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve.
* No colonic strictures or severe diverticulosis.
* No prior CRC
* No other malignant disease which is not deemed cured
* No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
* No inflammatory bowel disease
* Written informed consent provided by before enrolment

Exclusion Criteria:

* all who do not fulfill inclusion criteria
Freedom Inguinal Hernia Repair System Study

The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.

The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo routine inguinal hernia repair
* Competent to give consent
* Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
* Defect size at operation is between 5mm and 35mm
* Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
* Primary hernia at the operative site
* Male or female
* Life expectancy of at least 12 months
* At least 18 years of age

Exclusion Criteria:

* Signs of obvious local or systemic infection
* Any previous surgery on the hernia operative site
* Hernia is not in the inguinal area
* Hernia is not identified as indirect or direct
* Femoral hernias
* Known collagen disorder
* Presenting with unstable angina or NYHA class of IV
* Known Pregnancy
* Active drug user
* Recurrence of a repair by any method
* Patients with giant inguinoscrotal hernia or abdominal wall defect \>35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
* Immunosuppression, prednisone\>15 mg/day, active chemotherapy
* End stage renal disease
* Abdominal ascites
* Skin infection in area of surgical field
* BMI \>35
* Peritoneum cannot be closed
Clareon Toric vs Eyhance Toric

The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.

This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits. The expected individual duration of participation in the study is 3 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Planned bilateral cataract removal by routine small incision phacoemulsification surgery;
* Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism;
* Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential Best Corrected Distance Visual Acuity (BCDVA) to a level worse than 0.2 logarithm minimum angle of resolution (logMAR);
* Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome;
* History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK));
* Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame;
* Other protocol-specified exclusion criteria may apply.
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery

The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.

This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.

Eligibility Criteria:
Key Inclusion Criteria:

* Female and male subjects with an age ≥18 years
* Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)
* Subject has at least ONE of the following risk factors for AKI at screening:

  * History of LVEF \<35% for at least 3 months prior to screening assessed by either echocardiography, cardiac MRI or nuclear scan.
  * History of previous open chest cavity cardiac surgery with or without CPB
  * Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug
  * Age ≥70 years
  * Documented history of heart failure NYHA class II or higher for at least 3 months or longer at screening
  * Documented history of previous AKI before date of screening independent of the etiology of AKI
  * Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least 3 months prior to screening
  * Documented history of albuminuria, defined as UACR \>30 mg/g or \> 30 mg/24 hour in a 24-hour urine collection.
  * eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation

Key Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) is \<30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline
* Subject has surgery scheduled to be performed without CPB ("off-pump")
* Subject has surgery scheduled for aortic dissection
* Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation
* Subject is scheduled to undergo trans catheter aortic valve implantation (TAVI) or trans catheter aortic valve replacement (TAVR), or single vessel off-pump surgeries or left ventricular device (LVAD) implantation
* Subject has a requirement for any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary)
Long-term Experience With Abatacept SC in Routine Clinical Practice

The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old at treatment initiation
* Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Rheumatoid Arthritis Classification Criteria
* Patients naïve of Abatacept IV and who at their physician's discretion are initiated with Abatacept SC. In countries where required (e.g. Germany and Spain), patients naïve of Abatacept IV and who at their physician's discretion have been initiated with Abatacept SC at least 1 month prior to enrollment visit up to 6 months if baseline and disease characteristics data are available
* For Spanish pharmacogenomic sub-study:
* Caucasian patient and from European ancestry
* Patient for whom a collection of blood sample before the initiation of abatacept is possible or available (blood sample was taken in routine practice before the study enrolment)
* Patient who agreed to participate in this substudy and provide a specific signed Pharmacogenomic Blood RNA informed consent
* In the UK, the ART substudy will be proposed to all patients enrolled in ASCORE from amendment approval and application date

Exclusion Criteria:

- Patients who are currently included in any interventional clinical trial in RA
Thickness of Retinal Layers in Amblyopia

The purpose of this study is to examine retinal layer thickness in amblyopia.

Amblyopia is a visual disorder characterized by a reduction of vision that cannot be immediately improved by refractive correction or accounted for by clinically determined anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the postnatal maturation of the retina including the postnatal reduction of retinal ganglion cells. However, although some studies have found incrased retinal nerve fiber layer thickness in amblyopic eyes, others have found no significant differences. This sutdy will examine the retinal layer thickness in amblyopia and compare the retinal layer thickness between amblyopic eyes and nonamblyopic fellow eyes.

Eligibility Criteria:
Inclusion Criteria:

* Amblyopia

Exclusion Criteria:

* Other retinal disease
* Anisometropia
* Neurologic abnormalities
TRANexamic Acid to Reduce Bleeding in BURN Surgery

Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered.

Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2).

Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

The first aim of the study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

Secondary objectives are to evaluate impact of tranexamic acid on mortality, success of skin grafts and occurrence of deep vein thrombosis or myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing burn excision surgery for standard of care purposes
* Male or female \>= 18 years of age
* Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion Criteria:

* Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
* Renal impairment
* Subjects with known hypersensitivity to tranexamic acid
* Consecutive fibrinolytic states to coagulopathy
* History of convulsions
TELI COM - Telithromycin in Children With Otitis Media

This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \<72 months \[\< 6 years of age\]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for enrollment into the study:

* Subjects ≥6 months and \<72 months (\< 6 years) of age;
* Recent (within the last 72 hours) and rapid onset of AOM symptoms and signs;
* The presence of MEF on otoscopy indicated by a bulging tympanic membrane;
* Otalgia or ear tugging or touching within the last 24 hours that interferes with or precludes normal activity or sleep;
* At least 1 of the following clinical findings not specific to AOM: fever, vomiting, diarrhea, anorexia, sleep disturbance, or irritability;
* Caregiver-reported AOM symptoms sufficient for entry according to protocol criteria.
* Caregiver-reported AOM symptoms diary
* Tympanometry exhibiting:

  * Type B curve or positive pressure peak curves.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Uncertain diagnosis of AOM or mild to moderate symptoms and signs of AOM that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days.
* Otorrhea or tympanostomy tube present in the ear to be evaluated;
* Otitis externa;
* Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with \<25% CD4 count or requiring prophylaxis for Pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection;
* Known congenital long QT syndrome;
* Known or suspected uncorrected hypokalemia (≤3 mmol/L \[mEq/L\]), hypomagnesemia, bradycardia (\<50 bpm);
* Myasthenia gravis;
* Known impaired renal function, as shown by creatinine clearance ≤25 mL/min;
* History of hypersensitivity or intolerance to macrolides or azithromycin;
* Previous enrollment in this study or previous treatment with telithromycin;
* Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients

The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with systolic heart failure;
* New York Heart Association (NYHA) class II-III;
* Left ventricular ejection fraction less than 40%;
* Peak Oxygen Consumption less than 20 ml/Kg/min;
* Stable Clinical Status.

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease;
* Neuromuscular Diseases;
* Orthopedic Diseases;
* Neurologic Diseases;
* Neoplastic Diseases;
* Recent myocardial infarction or cardiac surgery (less than 6 months);
* Unstable angina pectoris;
* Atrial Fibrillation;
* Pacemakers users;
* Changing medication or hospital admission.
A Study to Evaluate the Effect of Bexarotene on Beta-Amyloid and Apolipoprotein E Metabolism in Healthy Subjects

The primary objective of this proof of mechanism pilot clinical trial is to determine if the RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the clearance of Amyloid-Beta

This is a double blinded, investigational drug study designed to measure the effect of bexarotene on the clearance of Aβ total and production of apoE in the human brain of young, healthy individuals with the APOE3/3 genotype. From the date of initial subject recruitment to the issuance of a final study report and closeout activities, the expected total study duration is 6 to 10 months.

Each participant will be screened for eligibility and randomized to receive either oral bexarotene or placebo control ("Test Article").The study has the potential to demonstrate the pharmacodynamic properties of a novel treatment approach to Alzheimer's disease. The primary biomarker measurements obtained from this study are believed to be highly dynamic and able to provide a rapid read-out of the biologic activity of the candidate therapeutic under study. In addition, exploratory analysis will involve a proteomics-based screen to identify proteins within both blood and CSF that are induced by the Test Article, thereby potentially identifying new biomarkers that can be used in future clinical trials to demonstrate bexarotene action and target engagement.

Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults (age 21-50)
* APOE3/3 genotype

Exclusion Criteria:

* Contraindications for blood or CSF sampling
* Bleeding disorder or taking anticoagulants/antiplatelets
* Chronic active infection
* Blood donation within the past month
* Active drug/alcohol dependence or abuse history with in the last 12 months
* Thyroid dysfunction
* High triglycerides (\>3.5 mmol/L)
* High cholesterol (\>4.0 mmoL/L)
* Leukopenia, including low neutrophil count (\<3 x 10\^9/L)
* Neurological or psychiatric disorders
* Homeless or prisoner
* Pregnancy
* Incapable of self-informed consent
* Blood borne disease (HIV, Hepatitis)
* Actively smoking and incapable of using nicotine patches
* Known drug allergy to pain medication or local anesthetic
* Subjects that have participated in another study in the last 30 days
* Abnormalities in lumbar spine previously known within 12 months
* APOE2 or APOE4 allele
* Abnormal EKG
Traditional Bed Baths Versus Disposable Wet Wipes

The Purpose of the study is to compare the effectiveness on microbiological counts from skin swaps after wash with water and soap or wet wipes.

The study is a crossover clinical trial where the effect of two interventions is compared on the same subject.

The two interventions are:

* Intimate hygiene with water and soap
* Intimate hygiene with prepackaged disposable wet wipes

Null hypothesis: Same effectiveness to reduce microbiological counts on skin

Alternative hypothesis: Significant different effectiveness to reduce microbiological counts on skin

Each individual receives the two interventions in random order. The effect of the interventions on microbiological counts on the patients skin is evaluated on the same patient.

A crossover trial requires half the number of participants and reduces confounding factors.

All participants receive a sequence of the two different interventions. But there is a sufficient gab between the two interventions to ensure a washout period and avoid a crossover effect. In this study this is 12-24 hours.

The study uses block randomization, without intra block correlation to achieve allocation balance over time.

Furthermore it may prevent some predictable allocation.

Microbiological sampling with moistened swaps and aseptic techniques, sterile equipment and sterile recovery medium (Stewarts Medium) are used to obtain skin samples from the patients before and after intimate hygiene with water and soap and wet wipes.

Differences in microbiological skin counts will be compared (delta values) before and after the two interventions and between interventions.

Data will be blinded during microbiological count and statistical analyses.

Analyses:

Data are structured in CASTOR and will be stored in a secure Team Collaboration Software Tool (SharePoint).

Descriptive analysis including mean, median, confidence interval, standard deviation, and standard error.

Statistical analyses will be performed using STATA. Test of differences will be performed by simple t- test or Wilcoxon sign rank test, depending on the distribution of the data. A multiple regression analysis including possible confounders will be considered.

Inclusion of 68 patients

Eligibility Criteria:
Inclusion Criteria:

* Patients who need intimate hygiene
* Admitted for minimum two days
* Understand oral information
* And apple to sign written consent

Exclusion Criteria:

* Diarrhea
* Dementia
* Dying