cyrilzakka/clinical-trials huggingface dataset:
Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. The investigators hope to compare the hemodynamic and pulmonary effect in children after surgical repair of congenital heart disease with right ventricular hypertrophic ventilated with Pressure control ventilation (PCV), Pressure support ventilation (PSV), and NAVA by a crossover study.

In the patients suffered from congenital heart disease with right ventricular hypertrophy, the preload of the heart will be influenced by the variation of the intrathoracic pressure. The cardiopulmonary interaction during mechanical ventilation will be an important influence factor on hemodynamics after surgical repair for these patients. As a new mode of mechanical ventilation, NAVA delivers ventilatory assist in proportion to patients' neural effort avoiding over ventilation.

The investigators designed a crossover study to evaluate the cardiopulmonary effect in patients with congenital heart disease with right ventricular hypertrophy when ventilated with NAVA postoperatively, compared with the conventional mode of pressure control ventilation and pressure support ventilation. Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform.

Data are expressed as mean ± standard deviation. Datas from the three registrations will be compared using a repeated-measures ANOVA. The comparison of each mode will be assessed by the SNK methods post hoc test. A p value of less than 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease
2. Obtain informed consent signed by parents

Exclusion Criteria:

1. Significant residual shunt (more than 2mm), residual obstruction of right ventricular outflow tract (RVOT) or A-V valve insufficiency.
2. Hemodynamic instability (whose inotropic score more than 20);
3. Significant bleed (whose chest drainage more than 5ml/kg/h);
4. Failed to insert the PiCCO catheter
5. Dysfunction and abnormal of esophage;
6. Inclusion in other research protocol
A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma

This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.

The protocol specifies rules for dose-limiting toxicity and a maximum tolerated dose (MTD). To gain further experience with the MTD, and/or at some lower optimal biologic dose level, an expansion cohort (Part B) enrolled patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histological or cytological documentation of an advanced solid tumor
* Subject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remission
* Subject must have evaluable, progressive, and measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1
* Adequate bone marrow, liver, and renal function
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

For Part B (expansion) in subjects metastatic urothelial carcinoma:

* The patient's tumor has been evaluated and prospectively identified as having FGFR 1, 2, 3, or 4 genetic alterations.

Exclusion Criteria:

* Patients who have received adequate prior treatment with a highly selective FGFR inhibitor
* Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis
* Patients who have received prior systemic anticancer therapy ≤ 3 weeks prior to study start (6 weeks for nitrosourea, antibodies, or mitomycin-C)
* Patients diagnosed with another primary malignancy within 3 years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervix
* Patients with glioblastoma multiforme
* Patient has a primary neoplasm of the brain or known uncontrolled metastases to the central nervous system (CNS).
A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
* Women must be of non-childbearing potential.
* Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -7.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Neural Correlates of Intern Speech

The goal is to define what is the nature of intern speech, how it manifests itself, who deal with agency in intern speech and finally what is the role of intern speech in attention tasks.

Intern speech has a main goal in memory, thinking and self-awareness. So this study might bring information in order to better understand any potential adverse effect on depression or anxiety disorders for example.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years
* Right-handed
* French as mother tongue
* Visual acuity that allow to read stimulis (contact lens authorized)
* Healthy subject

Exclusion Criteria:

* Respiratory or cardio-vascular pathology
* Claustrophobia
Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm

This study evaluates the effects of an eHealth tool and psychosocial support on anxiety, depression and health-related quality of life in patients undergoing surgical treatment for abdominal aortic aneurysm (AAA). Participants in the intervention group will receive access to the eHealth tool and structured follow-up with a contact nurse, the control group will receive standard of care.

Abdominal aortic anuerysm (AAA) is associated with a decreased health-related quality of life (HRQoL) both at diagnosis and during surgical treatment, although recent studies report somewhat contradictory results. In qualitative research, it has been shown that the health care system fails to meet the patients' information need, as well as their need for psychosocial support during the care process. The aim of this study is therefore to evaluate the effects of an intervention comprising an eHealth tool with individualized information in combination with structured follow-up with a contact nurse on anxiety, depression and HRQoL in patients undergoing surgical treatment for AAA.

Patients who are planned for elective surgical treatment, fulfil the inclusion criteria and none of the exclusion criteria will fill out questionnaires. The control group will receive information and follow-up per institution's standard of care. The intervention group will be given access to the eHealth tool, containing individualized information about the condition, surgical procedure and self-care. They will also receive structured follow-up by a contact nurse at discharge, 3 and 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Ability to speak and understand Swedish
* Planned for elective surgical repair of an abdominal aortic aneurysm

Exclusion Criteria:

* Severe visual impairment or blindness
* Severe hearing impairment or deafness
* Diagnosed dementia
* Medical condition with a suspected life expectancy of \< 1 year.
Fiberoptic Bronchoscopy and Bronchoalveolar Lavage in Critically Ill Ventilated Patients

Fiberoptic bronchoscopy (FOB) is widely used as a diagnostic or therapeutic procedure in intensive care units. Patients with ARDS or COVID-19 disease often undergoes to these procedures. However, intensive care patients might suffer from serious side effects such as prolonged oxygen desaturation and adverse change in lung compliance and resistance. This study aims to evaluate these changes and determine their impact on patient stability.

Fiberoptic bronchoscopy (FOB) is widely used in intensive care units as a diagnostic or therapeutic procedure. FOB in respiratory failure patients supported by mechanical ventilation may worsen hypoxemia and hypercapnia, therefore FOB requires careful consideration in this patient population. The generally accepted indications for FOB in ventilated patients are removal of retained secretions, resolution of atelectasis and evaluation of hemoptysis. A diagnostic indication is the bronchoalveolar lavage (BAL), to sample the lower respiratory tract without contamination. Studies of FOB performed in mechanically ventilated patients suggest an acceptable safety profile, except for the occurrence of hypoxemia as the main adverse event. Bronchoalveolar Lavage (BAL) in normal volunteers is reported to be safe and does not lead to measurable changes in pulmonary function parameters. However, in intensive care patients may suffer from serious side effects such as prolonged oxygen desaturation. Moreover, reductions in arterial oxygen tension (PaO2) have been reported to persist in some patients for 4 h and more after the procedure. Authors reported the BAL procedure is associated to a worsening of PaO2/FiO2 ratio, in several ARDS patients the drop in PaO2 was higher than 30%. Moreover a physiological study in patients undergoing FOB and BAL showed adverse change in lung compliance and resistance.

The purpose of this prospective study is to determine the alterations in respiratory mechanics (regional compliance and resistance) and gas exchange induced by FOB and BAL up to 6 hours after the procedure. The lung regional ventilation evaluation will be made by electrical impedance tomography (EIT).

Eligibility Criteria:
Inclusion Criteria:

Mechanically ventilated ICU patients requiring a FOB or FOB + BAL

Exclusion Criteria:

* PaO2/FiO2 ratio \<100
* Age \< 18 years
* Pregnancy
* Unstable angina and recent (less than 1 week) myocardial infarction
* Uncontrolled cranial hypertension
* Major hemodynamic instability
* Any previous lung surgery (except for lung transplantation)
* Obesity (BMI \> 50)
* Chest circumference \> 150 cm
* Electronic implanted device (pacemaker, neurostimulator, etc.)

Patients who had undergone several bronchoscopy procedures could not be included twice.
Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?

Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.

The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.

Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.


Eligibility Criteria:
Inclusion Criteria:

* Programmed Cholecystectomy
* Laparoscopy
* Man and woman
* ≥ 18
* ASA 1 or 2
* Not living alone
* Patient receiving social security coverage
* Signature of Informed Consent Form

Exclusion Criteria:

* Cholecystectomy emergency
* Patient minor
* Pregnant woman (pregnancy test) or during breastfeeding
* Conversion to laparotomy
* Patient anticoagulant curative dose
* Living alone
* Patient addict
* Peptic Ulcer
* Refusal to enter the protocol
* Chronic requiring analgesics long-term
* Immunosuppression
* Long-term Treatment with corticosteroids
* Discovery intraoperative calculation in the bile duct
* Contraindication to ropivacaine (see cons-indications to ropivacaine)
* Hypersensitivity to study treatment or concomitant medications anesthesia
* Cardiac or unbalanced epileptic patients (due to the risk of cardiovascular and neurological local anesthetics)
* Patients ASA ≥ 3
* Patient \<50 kg
Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents

This research was planned to evaluate the effectiveness of the technology-based psychosocial empowerment program for home care for children aged 8-18 years with cancer and their parents as a parallel-group randomized controlled study design.The required institutional permission and ethics committee approval was received.The study group of the study consisted of 72 children and parents (intervention group \[n=36\], control group \[n=36\]). Data were collected using the descriptive features form, the General Self-Efficacy Scale-Pediatric Cancer Version, the State-Trait Anxiety Inventory for Children, the Pediatric Cancer Coping Scale, the General Self-Efficacy Scale for parents, the Problem Solving Inventory, and the Psychological Resilience Scale for Parents of Children with Cancer. The data were stored in the SPSS 25 program.

The incidence of childhood cancers has become an important health problem increasing all over the world. Children and parents are affected in many dimensions physically, psychologically, and socially during this experience. The needs of the child and parents are not limited to the treatment period in the hospital. They also need to be supported and strengthened during the home care process. The required institutional permission and ethics committee approval was received. The study group of study consisted of 72 children and parents (intervention group \[n=36\], control group \[n=36\]).The technology-based program was applied to children and families for 4-6 weeks through modules on the website. In addition, at the end of each module, online interviews or telephone counseling will be applied.Children and parents in the control group will follow the standard care procedures included in the treatment process. At the end of the study, it was planned to apply website modules to the children and parents in the control group. The research is based on the Psychological Empowerment Theory.

Eligibility Criteria:
Inclusion Criteria:

* For children's:
* Children between the ages of 8-18,
* Those receiving cancer treatment (leukemias and solid tumors) and completing the first 2 months of the treatment process,
* Children with tablets, android phones and internet access
* Children whose parents and themselves agree to participate in the study,
* Children who can continue the study for 4-6 weeks,
* For primary care parents,
* Parents who can speak Turkish,
* Parents who can use computers and android mobile phones,
* Parents who agreed to participate in the study,
* Parents who can continue the study for 4-6 weeks,

Exclusion Criteria:

* Newly diagnosed children (in induction phase),
* Children who are in the terminal period or who are treated for relapse,
* Presence of another important disease (such as chronic disease, psychiatric diagnosis) in the family that may prevent coping, other than the child followed up with the diagnosis of cancer
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis

Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.

A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).

This study will be conducted at about 40 study centers in central and eastern European countries. A contract research organization, will oversee operational aspects of this study on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians Global Assessments (sPGA) ≥ 3 (moderate) at Screening and at BL.
* Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
* Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).

Exclusion Criteria:

* Patient has prior use of 2 or more biologics for treatment of PsO.
* Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), or other systemic autoimmune disorder inflammatory disease at the time of the Screening visit that would interfere with evaluations of the effect of the study drug on psoriasis.
* Patient has prior use of any of the following medications within specified time periods or will require use during the study:

  1. Topical medications within 2 weeks of BL (Week 1).
  2. PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
  3. Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit.
  4. Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
  5. Any systemic steroid in the 4 weeks prior to BL.

Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol
Self-Centering Guide Catheter Feasibility Study

An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.

A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.

Exclusion Criteria:

* Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).
* Subject has a pre-existing prosthetic aortic valve.
The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease.

Chronic Obstructive Pulmonary Disease (COPD) has a significant impact on one's quality and quantity of life resulting in increased morbidity and mortality. In Ireland, COPD has the highest hospital admissions in comparison to other countries within the organisation for economic cooperation and development (OECD). There is a need to improve knowledge and self-management behaviour in order to improve recognition of early signs of an exacerbation thereby seeking early treatment from the general practitioner (GP) thus reducing hospital admissions among this cohort . There are limited studies pertaining to the use of a comprehensive self-management programme via a smartphone app for people with COPD on a longitudinal basis.The aim of this study is to investigate the effectiveness of a smartphone application self-management programme on clinical health outcomes in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years of age
* Confirmed COPD diagnosis defined as the presence of post- bronchodilator FEV1/FVC \<0.70.
* COPD category GOLD A, B, C \& D.
* Those who are able to give informed consent
* Has a smart phone and is capable of using a smartphone app to input data?
* Good dexterity to use the spirometer and pulse oximeter

Exclusion Criteria:

* n/a