cyrilzakka/clinical-trials huggingface dataset:
Surgical PA-LAA Shunting: a Feasibility Study

Atrial fibrillation is common and increases the risk of stroke. Traditionally patients are treated with blood thinning medications or at the time of surgery the part of the heart where blood clots form is cut out. Surgically cutting out the left atrial appendage can be difficult and complications can occur. An alternative strategy is to create a tunnel to increase blood flow and wash out the part of the heart where clots form.

This strategy has not been previously studied. The purpose of this study is to determine if creating a tunnel to increase blood flow is feasible and safe.

The goal is to understand the potential avenues to increase Left Atrial Appendage (LAA) flow in patients with Atrial Fibrillation (AF) to minimize systemic embolization risk. Flow modeling demonstrates that the anatomy of the LAA results in decreased velocities in the LAA apex. Introduction of a 3-4mm shunt in the apex can result in increased velocity, less stasis and a lower propensity for thrombus formation. Small (\<8mm) inter-chamber shunts can exist in humans with no long term hemodynamic consequences in otherwise structurally normal hearts - making a strategy of pulmonary artery (PA) to LAA shunt an attractive potential therapy given anatomic proximity and gradient differential between the cardiac chambers.

This will be a 5 patient first-in-human feasibility study. The population will include patients undergoing CABG or other cardiovascular surgery with AF and a CHADS2 score \>1 in whom the treating team deems traditional therapy with anticoagulants is prohibitive or ineffective (dialysis or EGFR preoperatively \<15, previous bleeding with non-reversible pathology, clinically deemed contraindicated to oral anticoagulant). The intervention will be PA-LAA shunt creation at the time of surgery. As this is a single arm study there will be no comparison group.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years undergoing CV surgery
* History of AF with a CHADS2 score \>1
* Relative contraindication to OAC as determined by the heart team

  1. Dialysis or preoperative eGFR of \<15
  2. Bleeding on DOAC/Coumadin with non-reversible pathology
  3. Other medical condition that makes the patient ineligible for OAC
* Anatomic proximity of LAA and PA on preoperative CT scan suitable for shunt creation

Exclusion Criteria:

* LVEF \<40%
* History of VTE - either DVT or PE
* Resting baseline preoperative O2 sats \<98%
* Inability of the patient to provide written informed consent
* Greater than moderate valvular heart disease which is not to be addressed during surgical intervention
* Documented mPA to PCWP \<5mmHg
Comparison of Two Methods for Bowel Preparation in Patients With Constipation

Constipation is a common high risk factor for inadequate bowel preparation. The bowel cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated patients. The investigator hypothesized that compared with the standard preparation regime, the split-dose with three times of 4L PEG may be superior in BP quality.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 with constipation.

Exclusion Criteria:

* History of colorectal surgery BMI\>30 Suspected colonic stricture or bowel obstruction Use of purgatives within 3 days Pregnancy or lactation Unable to give informed consent Haemodynamically unstable
The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium (ALT-711) improved cardiac function and symptoms in experimental and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial.

This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 100 patients (2x50) with stable CHF. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 9 months. Efficacy measurements will be performed at baseline, and at the end of the study, and include aerobic capacity (VO2max) exercise testing, echocardiography, Minnesota Living with Heart Failure score, AGEs measurements in blood and skin, NYHA heart failure class, patient's and physician's global assessment, and levels of NT-pro-BNP. Safety visits are performed at 3 months intervals. In addition, one safety visit will be performed 2 weeks after the randomization visit and 1 month after the last treatment visit. A total of 8 visits will be performed during the entire study.

Eligibility Criteria:
Inclusion Criteria:

* NYHA II-IV heart failure
* Echocardiographic ejection fraction ≤ 40%
* Duration of heart failure \> 3 months
* Stable heart failure medical therapy for \> 1 months

Exclusion Criteria:

* History of myocardial infarction in previous 6 months
* History of stroke in previous 6 months
* Clinically significant renal, liver, pulmonary,or hematological disease
* Active and or treated malignancies within 12 months
* Uncontrolled diabetes mellitus
Validation Study of the Korean Version of the EORTC QLQ-HDC29

The aim of this study is to evaluate the reliability and validity of the Korean version of the European Organization for Research and Treatment of Cancer High-dose Chemotherapy module (EORTC HDC-29).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged more than 18 years
* Patients who are diagnosed with hematologic malignancies and who are planned to receive high-dose chemotherapy followed by allogeneic or autologous stem cell transplantation (SCT)
* Patients who agree with the informed consent

Exclusion Criteria:

* Patients who are unable to complete the questionnaire due to the serious physical or psychological morbidity
A Study Investigating Routine Practice of Chronic Thromboembolic Pulmonary Hypertension Management in EMEA Countries

The aim of the registry is the assessment of the diagnosis and treatment of CTEPH (Chronic Thromboembolic Pulmonary Hypertension) in EMEA (Europe/Middle East/Africa) countries.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 18 years of age, diagnosed with CTEPH regardless of the current treatment
* Availability of a signed informed consent
* WHO Pulmonary Hypertension clinical classification Group IV (CTEPH):

  1. Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels:

     * Mean pulmonary arterial pressure (PAP) ≥ 25 mmHg at rest
     * Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg
  2. Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines:

     * At least 1 (segmental) perfusion defect(s) in ventilation/perfusion (V/Q) scan or
     * Pulmonary artery obstruction seen by MDCT (multidetector computed tomography) angiography or
     * Pulmonary artery obstruction seen by conventional pulmonary cineangiography (In case of suspicion/diagnosis of 'sub-acute' Pulmonary Embolism: Patients who are treated with anti-coagulation for at least 3 months before diagnosis of CTEPH)

Exclusion Criteria:

* Patients with an underlying medical disorder with an anticipated life expectancy less than 6 months
* Any medical condition which, in the opinion of the investigator, could jeopardize the safety of the patient or his/her compliance in the study, or otherwise make the patient inappropriate for study participation
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia

The study aims to determine whether 30 minutes of treatment playing an interactive computer game weekly for 6 weeks, improves visual acuity. The game has been specially configured to ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses which manipulate the image seen by each eye in order to provide more information to the amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM technology, play the computer game but without the I-BiTTM technology, or watch a DVD using the I-BiTTM technology.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of Anisometropic, Strabismic or Mixed Amblyopia as made by an Orthoptist
* Male or Female
* Aged 4 - 8 years inclusive.
* Participant's parent or guardian is willing and able to give informed consent for participation in the study

Exclusion criteria:

* Stimulus deprivation amblyopia.
* Organic lesions of the eye preventing the establishment of good vision (e.g. media opacities, abnormalities in the fundus or optic nerve).
* Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment).
* Patients diagnosed with Photosensitive Epilepsy
* Patients diagnosed with or suspected of having Conjunctivitis
* Loss of suppression at filter 4 or less as measured with the Sbisa Bar
* Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
* Inability to comply with the follow up visits required
* Refusal to accept randomisation
* Have participated in a previous study examining I-BiT treatment
A Study of the Safety and Pharmacokinetics of MINT1526A, Administered Intravenously As a Single Agent and in Combination With Bevacizumab to Patients With Advanced Solid Tumors

This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A administered alone and in combination with bevacizumab by IV infusion every 3 weeks to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit
* Adequate hematologic and end organ function
* Evaluable disease or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0; prostate cancer patients with nonevaluable or nonmeasurable disease if they have an increase in prostate-specific antigen (PSA); ovarian cancer patients with nonevaluable or nonmeasurable disease if they have an increase in cancer antigen 125 (CA-125)
* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for 6 months after discontinuation from the study

Exclusion Criteria:

* Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy within a specified timeframe prior to initiation of study treatment.
* Leptomeningeal disease
* Active infection requiring intravenous antibiotics
* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or prednisone
* Bisphosphonate therapy for symptomatic hypercalcemia
* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
* Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
* Pregnancy, lactation, or breastfeeding
Comparison of Ideal vs. Actual Weight Base Factor Dosing

This is a randomized, prospective, multicenter study to examine whether or not the current recommended factor dosing strategy - i.e., dosing by actual body weight - in overweight and obese patients with Hemophilia A may deliver excessive clotting factor to achieve the desired result of bleeding prevention and cessation. This study also examines ways to prevent delivering excessive factor by using a patient's ideal body weight as a new dosing strategy compared to the current dosing strategy. The hypothesis being tested is that factor dosing based on ideal body weight will result in protective factor levels.

This is a randomized, prospective, multicenter, open-label, crossover study to examine whether or not the current recommended factor dosing strategy, i.e., dosing by actual body weight in overweight and obese patients, may deliver more clotting factor than necessary to cause bleeding to stop in participants with Hemophilia A who use Factor VIII (FVIII). This study also examines ways to prevent delivering too much factor by using a participant's ideal body weight as a new dosing strategy compared to the current dosing strategy. The hypothesis being tested is that factor dosing based on ideal body weight will result in hemostatic factor levels.

The study will be conducted at the Washington Center for Bleeding Disorders (WCBD) at Bloodworks Northwest, Oregon Health \& Science University (OHSU), Seattle Children's Hospital (SCH), and Providence Sacred Heart Children's Hospital (SH). Cumulatively across the four sites, up to 20 participants will be enrolled. Randomization will be performed centrally at WCBD.

Participants will provide their own factor. Prior to the first study-related dose, participants will stop taking any FVIII products for either 48 hours if currently using a short-acting FVIII product or 72 hours for a long acting FVIII product. Factor levels will be measured immediately before and at multiple points after two different factor doses. Subjects will be randomized to start their dosage based either on actual body weight or ideal body weight first and then crossover to receive dosage based on the other category.

Eligibility Criteria:
Inclusion Criteria:

* Hemophilia A
* Able and willing to comply with pharmacokinetic testing schedule
* Either overweight or obese BMI using CDC definitions by age

Exclusion Criteria:

* Inhibitor of \> 0.6 BU twice in the past, or documented abnormal recovery of less than 66% (of expected) in the past
* Known other bleeding disorder
* Known other prolongation in aPTT (lupus anticoagulant, FXII deficiency)
* Female
A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.

In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF \< or = 40%) and NT-proBNP level \> or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent and accept study procedures and time schedule.
* Age ≥ 18 years.
* Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history).
* Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.

Exclusion Criteria:

* Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study.
* Cancer or other significant co-morbidities implying that the patient's condition is unstable.
* Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR \< 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
* Patients who are primarily managed and regularly followed-up by a cardiologist for their HF
* Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.
High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema

The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.

Prospective multicenter study including ED patients with a suspected diagnosis of acute hypercapnic pulmonary edema with respiratory failure who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care.

Patients will be randomly assigned to NIV or high flow nasal oxygen therapy, with stratification on center and severity of hypercania.

Assigned Treatment will be administered during at least one session of 1hr and resumed as needed based on the patient's signs of respiratory distress and blood gas results Repeat evaluation of arterial blood gases, clinical parameters and dyspnea will be performed before and after the first and second hour of treatment according to current recommendation from the French society of anesthesia and intensive care medicine (SFAR).

Eligibility Criteria:
Inclusion criteria:

* Asuspected diagnosis of acute pulmonary edema presenting with any of the following criteria:
* Dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)-Respiratory rate \>20 b/min
* Bilateral crepitant rales at pulmonary auscultation
* Pulmonary infiltrate on chest X-ray
* Signs of respiratory failure or any of the following clinical, laboratory or or radiology signs:

  * Use of accessory respiratory muscles
  * Paradoxical abdominal movement
  * Cardiomegaly (cardiothoracic ratio \>0.5)
  * Hypertensive crisis
  * PaO2/FiO2 \<= 300 mmHg breathing O2\> 8L/min or PaO2 \<= 63mmHg breathing room air.
* Hypercapnia (PaCO2\>45)

Exclusion criteria:

* Chronic respiratory disease or associated dyspnea from non cardiac origin,
* Fever (\>38,5°), sepsis or ongoing infection,
* Contra-indication to NIV,
* Treatment with NIV or CPAP prior to inclusion, including prehospital treatment
iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

The purpose of this study was to clarify the possible mechanism of hypoxemia after surgical treatment of type A acute aortic dissection and the possible mechanism of the treatment role of inhaled nitric oxide in refractory hypoxemia.

The investigators' previous study has stressed that inhaled nitric oxide therapy might play an ameliorative role in patients with refractory hypoxemia after surgical treatment of type A acute aortic dissection. The possible reason might be the decreasing of intrapulmonary shunt because previous studies showed that inhaled nitric oxide could decrease intrapulmonary shunt by selectively dilating the pulmonary vessels in ventilated areas. As a result, the investigators designed this observational study to calculate the intrapulmonary shunt before and after inhaled nitric oxide therapy. Intrapulmonary shunt was calculated from oxygen content (CO2) of different sites ( artery, mixed venous, alveolar capillary) by Fick equation:(CaO2-CcO2)/(CvO2-CcO2). A FiO2 of 1.0 and tidal volume of 6\~8 ml/kg were chosen. Oxygen content was calculated from hemoglobin (Hb), oxygen saturation (SO2) and oxygen partial pressure (PO2) by the following equation: CO2 = 1.34\*Hb\*SO2 + 0,0031\*PO2. PaO2, SaO2, PvO2 and SvO2 were measured from arterial and mixed venous blood samples taken from the radial arterial catheter and from the pulmonary artery catheter. ScO2 was estimated to be 1.0 with a FiO2 of 100%. PcO2 was considered to be the same as PAO2 (partial pressure of oxygen in the alveoli), and was calculated from the alveolar gas equation with PAO2 = \[(atmospheric pressure - 47) \* (FiO2)\] - PaCO2/0.8.Other variables such as hemodynamic variables from pulmonary artery catheter were also collected.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Type A aortic dissection;
* After surgery;
* P/F ratio ≤ 200mmHg

Exclusion Criteria:

* Intracardiac shunt;
* Contradiction of PAC;
* Chronic pulmonary diseases before surgery;
* ECMO;
* Anticipation of death within 48 hours after operation;
Ophtalmological Characteristics of Patients With Craniosynostosis Followed at the Amiens University Hospital

Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births. In the vast majority of cases, craniosynostoses are isolated (non-syndromic) and their origin is not always known. On the other hand, 20% of these deformations are said to be syndromic.

Craniosynostosis has morphological (associated dysmorphism) and functional (growth conflict between the skull and the brain) repercussions. Ophthalmological disorders are frequent: refractive disorders, oculomotor disorders, optic nerve damage, sensory damage.

This study aims to describe the ophthalmological clinical characteristics associated with craniosynostosis in patients followed at the Amiens University Hospital. This is a retrospective study based on the analysis of patient records followed in our center.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of craniostenosis

Exclusion Criteria:

* Posterior plagiocephalia
Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV

The purpose of the study is to evaluate prospectively the outcome of treatment interventions of knee osteochondral lesions Outerbridge grade III and IV.

The main purpose of the study is to prospectively evaluate the outcome of treatment interventions with replacement, repair and regenerative approaches, of osteochondral articular lesions or defects, Outerbridge grade III and IV, in terms of symptomatic and functional recovery 12 months after surgery.

Eligibility Criteria:
Inclusion criteria:

patients referred to the participating centers for symptomatic treatment of degenerative lesions of the knee, which meet the following inclusion criteria:

* symptomatic osteochondral lesions of grade III or IV (according to classification of Outerbridge;
* Axial deviation with chondral damage, correct or not;
* Consent to the processing of personal data, signed and dated by patient;
* Patients of both sexes and aged between 30 and 60 years;
* Patients willing to participate actively in the rehabilitation program and to attend post-operative follow-up visits.

Exclusion criteria:

* Patients with synovitis;
* BMI\> 30;
* Allergy to collagen or calcium phosphate;
* Patients with neoplastic disease;
* Patients with metabolic disorders, thyroid diseases, immune system disorders.