cyrilzakka/clinical-trials huggingface dataset:
Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.

This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure.

The main question it aims to answer is:

• Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?

The study aims to determine whether coordinated care in the form of administering protective vaccinations affects the prognosis of patients with chronic heart failure. The study will involve analyzing epidemiological data for each participant, followed by randomization into two treatment paths: receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits) versus following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). All vaccinations will be administered using vaccines registered with the appropriate authorities and approved for use in the EU and Poland.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Willingness to provide informed consent for participation in the study
* Diagnosis of heart failure
* No previous vaccination against RSV or influenza

Exclusion Criteria:

* History of an anaphylactic reaction to vaccination
* Hypersensitivity to any component of the vaccine
* Receipt of vaccination against RSV or influenza in the current infectious
* Active infection
* Pregnancy
Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders

The purpose of this study is to examine the effectiveness of group psychoeducation for the psychological distress of mothers with the children of high-functioning pervasive developmental disorder and for their behavior based on disorder traits.

Pervasive Developmental Disorder (PDD) is defined by its unique symptoms such as qualitative impairment in social interaction and communication and restricted repetitive and stereotyped patterns of behavior and interests. Recently, studies have been conducted on PDD without mental retardation, and have reported that the morbidity of PDD is 0.6%-1.7％． Several studies have focused on distress of the mothers of PDD facing atypical development of their children. Some of them have indicated the associations between depression and family history of PDD. Therefore it is important to pay attention to parental mental health.

In Western countries, researchers have investigated the effectiveness of various psychotherapeutic techniques such as childcare counseling and education for mothers about how to treat their children with PDD. It has been reported that one of them which innovates pragmatical methods to manage their children and parental educational programs made improvement in parental adaptation to their children and parental mental health.

However, to the best of our knowledge, few studies have shown the effectiveness of family intervention about PDD in Japan, despite widely implementation of family psychoeducation with various approaches in medical center, public health department. New research may be needed to establish rigorous evidence base for improvement of parental mental health and of behaviors of their children with PDD.

The investigators hypothesized that psychoeducation programs for mothers in addition to treatment as usual to their children would be more effective for parental mental health and behaviors of their children with PDD than treatment usual to their children alone.

The purpose of this study is to examine the effectiveness of psychoeducation to the psychological distress of mothers with the children of high-functioning PDD and to behaviors of the children affected by disorder traits, in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Mothers whose children have been diagnosed with any disorders by DSM-Ⅳ-TR as: 1) Autistic disorder and not mental retardation; 2) Asperger disorder; or 3) Pervasive developmental disorder not otherwise specified and not mental retardation
2. Children were diagnosed at more than 3 months before allocation
3. Children were between 2 and 6.5 years and have more than 6 months as pre-school period at allocation
4. Mothers who are native speakers of Japanese.
5. Mothers who are biological mother of and actually bringing their children.

Exclusion Criteria:

1. Mothers who are at risk of taking an emotional toll and unable to understand the contents of psychoeducation for any reason.
2. Mothers who are not allowed to participate in this study judged by the doctors of the children for any reason.
Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.


Eligibility Criteria:
Principal Inclusion Criteria:

* Medical record diagnosis of COPD, emphysema or bronchitis
* Post-bronchodilator FEV1 / FVC \< 70% or post-bronchodilator FEV1 / slow VC \< 70%
* Post-bronchodilator FEV1 \< 80% predicted
* Age ≥ 40 years on day of first dose of IMP
* Smoking history ≥ 15 pack-years
* If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
* Able to give written informed consent to participate

Exclusion Criteria:

* Current diagnosis of asthma
* Known clinically significant bronchiectasis
* Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
* Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose of IMP
* Treatment with any investigational medical product or device up to 4 months before first dose of IMP
* Breastfeeding, pregnant or planning a pregnancy
* Baseline corrected serum calcium \> 2.65 mmol/L
* Baseline serum creatinine \> 125 micromol/L
Patient-reported Outcome After Sling Insertion Using the Incontinence Outcome Questionnaire (IOQ)

Midurethral tapes are by now standard procedure in the surgical treatment of women with stress urinary incontinence. While the retropubic TVT is well documented with long-term results up to 11 years and continence rates of 90 %, the published data for the transoburator tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was constructed to assess patient-reported outcome and quality of life after insertion of a midurethral tape and validated for the German language. The aim of this study was to evaluate patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape, inside-out (TVT-O).


Eligibility Criteria:
Inclusion Criteria:

* incontinence sling
* time frame 1/1999 - 12/2007
Quality of Life in Elderly Patients After Pancreatic Cancer Surgery

Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men.

Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied.

The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires.

It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen
* Operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021
* 70 years of age or older at the time of surgery.

Exclusion Criteria:

* Patients who have expressed their opposition to the study
* Patients under curatorship, guardianship or legal protection
* Patient unable to express non-opposition
* Patient unreachable after 4 attempted calls over 3 consecutive weeks
* Patient deceased at the time of the telephone call
* Persons deprived of their liberty by a judicial or administrative decision
* Persons under compulsory psychiatric care
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)

The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects of any age
* Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP
* Require substitution with vWF/FVIII complex due to a surgery

Key Exclusion Criteria:

* Known significant hemostatic disorder other than vWD
* Acquired vWD
* Known antibodies to FVIII or vWF
* Known platelet type vWD
* Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol
* History of allergic reaction to Humate-P®
* Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents)
* Progressive fatal disease/life expectancy of less than 6 months
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment
* Pediatric patients of insufficient body weight to permit PK sampling
* Woman in the first 20 weeks of pregnancy
Evaluating an Internet-based Program for Anxious Adolescents

Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by adolescents, parents and health care providers. Even if anxiety disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if their anxiety is not treated properly. The investigators will carry out research to test Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can use this treatment from home via the computer. Breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com

This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives:

1. To determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage.
2. To explore mediators and moderators of the Internet-based CBT program.
3. To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention.
4. To determine adherence to a self-guided Internet-based CBT program.
5. To determine the cost-effectiveness of the Internet-based CBT program.

Eligibility Criteria:
Inclusion Criteria:

* Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED)
* Ability to read and write English
* Regular access to a telephone and a computer system with high speed Internet service
* Ability to use the computer to interact with web material

Exclusion Criteria:

* Positive screen on the Ask Suicide-Screening Questionnaire (ASQ)
* Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI; modified version)
* Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale (AUDIT-C)
* Residence outside of Canada
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.

This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented rheumatoid arthritis by ACR criteria
* Disease duration \< 5 years
* May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
* Tender joint count \>= 6, swollen joint count \>= 6, and one must be a knee
* Corticosteroids \<= 10 mg per day permitted on stable doses for at least 4 weeks
* Patients must consent to 2 arthroscopic synovial biopsy procedures

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to monoclonal antibodies
* Previous treatment with Rituximab
* Previous treatment with Arava
* Injected with steroids within 4 weeks of day 1 of study
* Treatment with any investigational agent within 4 weeks of day of study
* Any severe or significant medical condition or disease or known active infection
* Pregnancy or nursing at present
Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)

The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.


Eligibility Criteria:
Inclusion Criteria:

* Ocular surface disease index, OSDI \> 12 points.
* Non-invasive breakup time, NIBUT \< 11 seconds.

Exclusion Criteria:

* Ocular surface disease index, OSDI \< 12 points.
* Non-invasive breakup time, NIBUT \> 11 seconds.
Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂

the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. Two groups of patients are likely to participate in this study: Patient hospitalized in intensive care for a septic shock = Primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. The clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. To predict the unfavorable evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2) is performed. the investigators analyzed mortality at day 28 in patients with increased P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted according to good clinical practice. An information will be distributed to patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of septic shock
* Initial lactate in patients should be≥ 2 mmol / L.
* The presence of circulatory insufficiency defined by a systolic blood pressure ≤ 90 mmHg (or a drop in blood pressure≥ 50 mmHg in hypertensive patients)
* One or more of the following: oliguria defined as diuresis≤ 0,5 mL/ kg / h for at least two hours; the presence of signs of cerebral hypoperfusion; the highlighting of mottling
* The presence of a femoral arterial catheter and a central venous line in the superior vena cava position
* Hemodynamic monitoring with semi-invasive monitoring of cardiac output with thermodilution

Exclusion Criteria:

* Patient no longer in the initial phase of septic shock
* Absence of semi-invasive cardiac monitoring with thermodilution
* Vulnerable people
* Absence of informed consent
Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR

During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR.

During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR. This study may provide information if paramedics in an emergency should ventilate as they do traditionally with bag-valve mask ventilation or if they should ventilate with a laryngeal tube.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest

Exclusion Criteria:

* Paramedic does not want to use laryngeal tube
* Physician on site before paramedic
* Foreign body airway obstruction
Can we Predict COronary Resistance By EYE Examination ? (COREYE)

Prospective interventional study, open, non-comparative and non-randomized. The research concerns physiological parameters of the coronary and ocular blood circulation.

At the coronary level, the curves of pressure and Doppler flow will be extracted from ComboMap® (Philips). The coronary microvascular resistances, basal and hyperemic, will be determined by the average ratio of the distal pressure and flow.

At the ocular level, a fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed. The measures of the FFR and the coronary microvascular resistance will be determined by a guidewire allowing measures of pressure and by a guidewire allowing measures of Doppler flow (ComboWire®, Volcano), in 123 patients with intermediate stenosis of the left anterior descending artery (LDA). Topological parameters characterizing the retinal area and choriocapillaries will be determined by statistical approaches and mathematical morphology.

To establish a predictor of the coronary microvascular resistance from the eye vascular parameters, we shall use a non-linear regression by supervised machine learning. The main cardiovascular risk factors (hypertension, diabetes, dyslipidemia, age, sex) will be part of predetermined input features for the machine learning.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patient's ≥18 years of age with coronary arterial indication as usual and with proximal and / or mean IVA stenosis ≥ 50%.
2. Signed informed consent
3. Affiliation to the social security system

Exclusion Criteria:

1. Unstable Coronary Artery Disease
2. Atrial fibrillation
3. History of myocardial infarction \<6 months in the territory of the proximal and / or mean IVA.
4. Asthma
5. Aortocoronary bypass surgery.
6. Collateral development at the level of the proximal and / or mean IVA.
7. Allergy to iodine, severe renal insufficiency.
8. Ametropia\> = 6 diopters.
9. History of retinal ocular pathologies other than uncomplicated diabetic retinopathy and hypertensive retinopathy.
10. History of ophthalmic treatments such as macular or panretinal laser photocoagulation, intravitreal injection of anti-VEGF or cortisone.
11. Chronic glaucoma
12. Patients under guardianship or curators.
13. Pregnant or lactating women.
14. Patient's not affiliated to the French social security.
15. Persons placed under the protection of justice,
16. Subject participating in another research including an exclusion period still in progress at pre-inclusion
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC

The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
* Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to \< 50% of the ipsilateral lung volume.
* Patients with Zubrod performance status 0-1
* Adequate hematologic function
* FEV1 with ≥ 1200 cc or ≥ 50% predicted

Exclusion Criteria:

* Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
* Exudative, bloody, or cytologically malignant effusions
* Prior therapy with any molecular targeted drugs (for lung cancer)
* Active pulmonary infection not responsive to conventional antibiotics
* Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease \>2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
* Patients with \> grade 1 neuropathy