cyrilzakka/clinical-trials huggingface dataset:
Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer

This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.

This study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. Descriptive analysis will include incidence, type of cardiovascular adverse events.

We will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. This will provide information about the individual drug safety profiles.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

Exclusion Criteria:

* Minors \< 18 year old
* Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients

Malnutrition is seen frequently in hemodialysis units in most developing countries. Malnutrition increases morbidity and mortality in this population and its treatment improves patient survival and health status The purpose of this study is to compare two strategies to improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml) versus egg albumin-based protein supplement (30 g) on a daily basis.

This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment (SGA) in addition to most used biochemical markers to determine nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease in Hemodialysis

Exclusion Criteria:

* Infection
* Liver insufficiency
* Cancer or neoplasia
* Acquired immunodeficiency syndrome
* Intestinal malabsorption syndrome
Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.

To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (Sham).


Eligibility Criteria:
Inclusion Criteria:

* MRI diagnosis of rotator cuff tear
* Persistent symptoms despite a minimum of 6 months of failed non-operative management
* Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule).
* Age 40 to 80 years
* Able to read and complete English-language surveys
* Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
* Willingness and ability to comply with study product and methods

Exclusion Criteria:

* Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis
* Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
* Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer
* Chronic narcotic pain medication dependency
* Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion
* Worker's compensation claimant
* Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment
* Use of oral prednisone in the past 30 days
* Use of any investigational drug or participation in another research study within the past 30 days
* Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)
REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients.

The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017 American Society of Echocardiography (ASE) guidelines for noninvasive evaluation of native valvular regurgitation.
2. Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.

Exclusion Criteria:

1. Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
2. Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture.
3. Age \< 18 years.
4. Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team.
5. Need for a concomitant surgical procedure, excluding Coronary artery bypass grafting (CABG), tricuspid valve repair, Patent foramen ovale (PFO) closure, Atrial septal defect (ASD) closure and Maze procedure.
6. Prior mitral valve repair procedure (percutaneous or surgical).
7. Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip.
Effects of Probiotics in Immune System of Healthy Adults

The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable conditions, with a positive contribution to health and wellbeing of healthy individuals.

Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036), increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular intake has positive effects on the gastrointestinal and immune system.

The project will be based on a double-blind, randomized, and placebo-controlled clinical trial. It will be multi-Centre, with four groups plus a control group.

The colonization performed by the strains and the modification of the intestinal microbiota will be evaluated by means of strain identification with RT-PCR equipped with specific primers, and bacterial population counting with in situ immunofluorescence techniques.

The safety of strain intake will be evaluated with physical examination, blood parameters, and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora.

Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the record of aspect and frequency of faeces.

The effect on the systemic and adaptive immune system will be measured by means of lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC on faeces.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Age: 18-50 years
* Normal defecation
* Normal blood parameters
* Body Mass Index: 18-30

Exclusion Criteria:

* Pregnancy
* Lactation
* Antibiotic treatment
* Gastrointestinal disease
* Diarrhoea
* Constipation
* Diabetes
* Abnormal blood pressure
* Allergy
* Smoker
Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs).

This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs). Participants will be followed for 6 months post-study procedure. This study will be conducted at up to 12 clinical sites in the United States. A total of one-hundred and fifty (150) participants will be enrolled and randomized.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 18 years of age
2. Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure
3. For this patient, the current plan of the operator must be to pursue a catheter ablation target in the left ventricular endocardium that can be accessed by either a transseptal puncture or retrograde aortic approach
4. Life expectancy of at least 1 year
5. Willing and able to undergo pre- and post-ablation MRIs
6. Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up)
7. Willing and able to provide written informed consent

Exclusion Criteria:

1. Planned epicardial ablation that would include a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure)
2. Any contraindication to MRI (as defined by the institution performing the MRI)
3. Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including:

   1. Severe aortic stenosis
   2. Mechanical aortic valve
4. Clinical contraindication to a transseptal puncture as determined by the treating physician, including:

   1. Severe Mitral valve stenosis
   2. Mechanical Mitral valve
   3. Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture
   4. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture
5. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
6. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)
7. Current mental impairment or other diagnosis which precludes accurate assessment of neurocognitive function or which may not allow patient to understand the nature, significance and scope of the study
8. Inability to perform neurocognitive function testing after \> 24 hours free of sedating medications
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged greater than or equal to (\>/=) 50 years
* Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye

Exclusion Criteria:

Ocular Exclusion Criteria, Study Eye:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
* Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria (Both Eyes):

* GA in either eye due to causes other than AMD
* Evidence of prior or active CNV
* Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months
Baseline Performance and Fitting Parameters for Sonova Products

The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide Informed Consent/Assent
* Adults (age +18 years) and children (8-17 years) can be enrolled in this study

  * If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
* Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
* English language proficiency as determined by the investigator

Exclusion Criteria:

• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
HIV Physician's Survey

This is a survey study to assess the variability in the current management of pregnancy, reproductive care and assisted reproductive technologies for HIV-positive individuals in Canada to estimate interest for further projects.


Eligibility Criteria:
Inclusion Criteria:

* any HIV health care provider

Exclusion Criteria:

* none
Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding

The purpose of this multicenter, two component observational and standardized case-control study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective 3-month and 12-month follow-up to examine outcomes and their possible causes.

Antithrombotic therapies are effective for prevention of cardiovascular (CV) events but cause bleeding. Emerging evidence indicates that extra-cranial bleeding is just as important as myocardial infarction as a marker of risk for subsequent non-fatal and fatal CV events, but this issue has not been prospectively studied. If the association between bleeding and CV events is causal, prevention of bleeding, by targeting the risk factors, and prevention of the complications of bleeding, by targeting the causal pathways, could substantially reduce the burden of bleeding-related CV events. Progress in developing these approaches has been limited by a knowledge gap. Known risk factors do not fully explain bleeding risk and the investigators do not understand the mechanisms linking bleeding with adverse outcome and whether the association is causal.

One-half of bleeds that lead to CV events in patients receiving antithrombotic therapy arise in the GI tract. INTERBLEED plans to explore risk factors for GI bleeding, and outcomes after GI bleeding, in this well-circumscribed and important group using a case-control design with prospective 3 month and 12 month follow-up.

Specific objectives are to: (1) identify risk factors for GI bleeding and estimate their population attributable risk; (2) determine the risk of non-fatal and fatal CV events and functional outcomes after GI bleeding; and (3) explore the possible mechanisms linking GI bleeding with CV outcome.

INTERBLEED will recruit 2500 case-control pairs from centres in Argentina, Belgium, Brazil, China, Ireland and the Netherlands. Data will be collected on patient characteristics, medical history and, in cases, the work-up, management and outcomes after bleeding. The INTERBLEED results will help to develop new approaches to reducing the burden of bleeding-related CV events.

Eligibility Criteria:
Inclusion Criteria:

Cases

* Age ≥ 18 years at enrollment
* Written informed consent
* Confirmed cardiovascular disease
* Present to the hospital with GI tract bleed or develop GI tract bleed in hospital

Controls

* Age ≥ 18 years at enrollment
* Written informed consent
* Confirmed cardiovascular disease
Effects of High-Flow Nasal Cannula Therapy Assessed by Electrical Impedance Tomography

This study aimed to determine the effects of HFNC therapy on lung recruitment and lung strain change assessed by electrical impedance tomography (EIT)


Eligibility Criteria:
* Inclusion Criteria:
* Patient who received a HENC therapy within 24 h after the extubation

Exclusion Criteria:

* Aged \<18 years
* Pregnancy
* Body mass index (BMI) over 50 kg/m2
* ribcage malformation .any contraindication of using EIT monitoring (automatic implantable cardioverter defibrillator, chest skin injury, etc.).
Effects of Alpha-acid Lipoic in PCOS Women

The aim of our study is to investigate the effects of six months treatment with alpha-lipoic acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral glucose tolerance test and hormonal assays are evaluated before and after therapy.


Eligibility Criteria:
Inclusion Criteria:

* women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

* pregnancy
* past history of cardiovascular diseases
* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal)
* neoplasms.
Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia

This clinical trial aims to evaluate the non-inferiority of Aliskiren compared to Losartan in the treatment of hypertension combined with hyperuricemia. Hypertension and hyperuricemia often coexist and may exacerbate each other, increasing the risk of cardiovascular and renal complications. Both Aliskiren and Losartan are widely used for managing hypertension, but their effects on serum uric acid levels and renal function are not well understood in this patient population.

This study will involve 66 participants, randomly assigned to receive either Aliskiren (240 mg daily) or Losartan (100 mg daily) for a treatment period of 3 months. The primary outcome will be the change in serum uric acid levels before and after treatment. Secondary outcomes include changes in blood pressure, kidney function (measured by creatinine levels, eGFR), and adverse events.

The primary objective is to demonstrate that Aliskiren is non-inferior to Losartan in lowering serum uric acid levels. Additionally, the study will assess whether Aliskiren, while effectively managing blood pressure, has a lesser impact on kidney function compared to Losartan.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Hypertension
2. Diagnosed with Hyperuricemia
3. Serum uric acid levels between 420 μmol/L and 700 μmol/L
4. Age between 18 and 80 years
5. Able to provide informed consent
6. No history of gout
7. No serious comorbidities such as severe kidney, liver, or cardiovascular diseases

Exclusion Criteria:

1. Diagnosis of Gout
2. History of secondary hypertension
3. Severe organ dysfunction, including liver, kidney, or heart failure
4. History of malignant tumors
5. Severe cognitive disorders or mental illness
6. Pregnant or breastfeeding women
7. Allergy to study medications (Aliskiren or Losartan)
8. Participation in other clinical trials during the study period
Reconstruction of Digital Nerve Lesions With Muscle-in-Vein Conduits

Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. Low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of proper palmar digital nerves were retrospectively enrolled. Primary repair by MVCs was performed in 22 cases while 21 underwent secondary reconstruction. Recovery of sensibility was assessed by static and moving two-point discrimination (2PDs, 2PDm) and Semmes-Weinstein monofilaments (SWM). Results were compared with contralateral side serving as intraindividual control. Outcome data were stratified according to international guidelines and evaluated for differences in terms of age, gap length, time of reconstruction and concomitant injuries.


Eligibility Criteria:
Inclusion Criteria:

- Patients with reconstruction of digital nerves with muscle-in-vein conduits

Exclusion Criteria:

* Subtotal or total amputations
* pre-existing neurological disorders (e.g. polyneuropathy)
* symptoms of nerve entrapment