cyrilzakka/clinical-trials huggingface dataset:
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients

This study comparing both of the investigational device and reference device to gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each the overall mean root mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor are evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.

The testing will be conducted in three periods. In the Accuracy Tests (periods

1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being compared with the Patient Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.

The primary hypotheses for HR, are as follows:

Adults HO: μ = 3.25 vs. HA: μ \< 3.25, Children HO: μ = 3.5 vs. HA: μ \< 3.5,

The primary hypotheses for RR, are as follows:

Adults HO: μ = 2.25 vs. HA: μ \< 2.25, Children HO: μ = 2.5 vs. HA: μ \< 2.5, where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contact-free devices will be performed on the recorded results via statistical analysis.

The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion on or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years old and above.
2. Provide written informed consent.
3. Weight ranging from 20 to 150 kg inclusive.
4. Are located in a non-ICU hospital setting.
5. Agree to not eat during the testing period.
6. Agree to keep still.

Exclusion Criteria:

1. Are connected to a device which may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. Sleep apnea.
4. Pregnant or breastfeeding.
5. A likely need to receive or undergo a procedure during the testing period.
6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
7. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
8. Are wearing pacemaker or defibrillator.
Pragmatic Randomised Controlled Trial Evaluating Effectiveness of a Smoking Cessation e- Intervention " Tabac Info Service "

Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs).

Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR \[95% confidence interval\] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results.

Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.


Eligibility Criteria:
Inclusion Criteria:

* adult smokers
* with an information and consent form completed
* agreed to participate in the study
* get a Smartphone and be willing to use applications
* wanting stop smoking (in short, medium or long terms).

Exclusion Criteria:

* refusal to participate in the study
Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.

The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.


Eligibility Criteria:
Inclusion Criteria:

* HEV-infected patients, with hepatitis and/or neurological and/or renal symptoms

Exclusion Criteria:

* Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (hepatitis B, hepatitis C, hepatitis A ...)
Pubertal Development in Patients with RASopathies

Retrospective, single-centre, non-profit, observational study on pubertal development in patients with RASopathies.

Literature data shows that puberty can be delayed by about 2 years in patients with RASopathies and this has been associated with a reduced peak growth rate. To date, only a few numerically limited case series without molecular characterisation have been published.

This descriptive study should improve knowledge of pubertal development and its influence on growth and final stature. The primary aims are to describe the age of onset and progression of pubertal development in the cohort of patients with RASopathies, both male and female, and to describe the influence of pubertal development on statural growth and final stature in the same cohort.

The study enrolls patients with molecularly confirmed RASopathy and completed pubertal development who referred to the Centre for Rare Congenital-Malformative Diseases of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy, between 01/01/2001 and 31/12/2023. Being a Regional Centre, it is possible to enrol a significant number of patients.

The primary aims of the study are to describe the age of onset and progression of pubertal development in this cohort of patients, and to describe the influence of pubertal development on statural growth and final stature. The secondary aim is to compare the trends of pubertal development and statural growth at puberty in GH-treated and untreated patients with RASopathies.

The study consists of the retrospective collection and analysis of anthropometric data on growth and pubertal development of the cohort of patients enrolled by consulting their medical records. More in detail, for each patient will be collected demographic data, prenatal data, personal medical history, pubertal history, organ involvement data, outpatient clinical evaluation with height, weight, and growth rate, data on GH therapy, if any, radiological assessments and laboratory tests, and the molecular RASopathy diagnosis by NGS panel and/or Sanger sequencing of target genes.

Due to the observational nature of the study, enrolled patients are treated according to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment between 8 and 35 years, extremes included;
* Molecularly confirmed clinical diagnosis of RASopathy;
* Complete pubertal development;
* Obtaining informed consent for participation in the study and processing of personal data.

Exclusion Criteria:

• None.
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)

The majority of head and neck cancer patients do not respond to immunotherapies, and clinical responses are often not durable. However, targeting tumors with stereotactic radiation in combination with immunotherapy while sparing draining lymphatics enhances anticancer immunity, resulting in dramatic response in HPV (Human Papilloma Virus) virus related cancers of the throat. This trial will leverage targeted tumor radiation and immunotherapy in advance of standard surgical therapy to improve the response of HPV (Human Papilloma Virus) throat cancer to radiation and immunotherapy.

This is a prospective, multi-center, open-label, one-arm, two-stage, Phase II study to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) in patients with stage I HPVOPC (Human Papilloma Virus Oropharynx Cancer) amenable to surgical resection, including AJCC (American Joint Committee on Cancer) VIII T1-2N1M0 HPVOPC (Human Papilloma Virus Oropharynx Cancer) and excluding patients with solitary lymph nodes less than 3 cm. A Simon's two-stage optimal design is used for this study. We will test the hypothesis that neoadjuvant stereotactic tumor targeting radiation along with CD47 inhibition (evorpacept) and PD-1 inhibition (pembrolizumab) provides pathologic response compared to current standard of care rates of locoregional control.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of Stage I T1-2N1M0 HPVOPC (Human Papilloma Virus Oropharynx Cancer)
* Amenable to surgical resection
* Are able to safely receive neoadjuvant radiation and Evorpacept/Pembrolizumab

Exclusion Criteria:

• Patients with solitary lymph nodes less than 3 cm
Human Amniotic Membrane Plug for Large Macular Holes

This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.

This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.

Included participants with large macular holes will undergo complete vitrectomy is performed with an accurate vitreal base shaving (Constellation; Alcon Surgical). A human amniotic membrane hAM plug is taken from the hAM patch, and the final dimensions are adjusted with vitreoretinal scissors before insertion into the vitreous. The hAM plug is rolled inside the vitreoretinal forceps and inserted through the trocar into the vitreous. Then the human amniotic membrane is transplanted through macular hole into the subretinal space; it is then spread to cover the entire portion of the hole. Afterward, perfluorocarbon is injected to a complete overfilling of the break to permit good adhesion of the hAM plug to the underlying RPE and the overlying retina. Fluid-air exchange and an endotamponade injection is performed at the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* large macular hole confirmed by optical coherence tomography

Exclusion Criteria:

* patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy
Airway Reactivity in Children Before and After BMT Bone Marrow Transplantation

Background: Stem cell transplantation (SCT) is associated with pulmonary complications and may lead to high morbidity and mortality. We encountered several children post-SCT with a clinical picture suggestive of airway hyper-reactivity (AHR) and evidence of reversible airway obstruction that was not reported pre-transplant. Our aim was to determine if SCT induced AHR as assessed by methacholine challenge test (MCT) and to determine any correlation between AHR and pulmonary complications.

Methods: Prospective study evaluating consecutive patients referred for SCT to the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital. Evaluation included pulmonary function test and methacholine challenge test before and after the transplantation, and assessment of pulmonary complications.

We encountered several children post SCT with clinical picture suggestive of airway hyper-reactivity (AHR) by spirometric evidence of reversible airway obstruction that was not reported pre transplantation. Our question was if AHR is present but undiagnosed pre BMT or AHR is developed post transplantation.

Our aim was to determine if BMT induces AHR as assessed by methacholine challenge test (MCT) and to determine a possible correlation between AHR and pulmonary complications. The study was Prospective. Subjects: consecutive patients were referred for pulmonary function tests (PFT's); MCT and clincical evaluation before SCT and were followed after transplantation for at least a year. The study was approved by the ethics committee and parental consent was obtained. Clnical evaluation included medical history: type of disease, previous chemo/radiotherapy. Type of SCT was recorded (allogeneic/ autologous). respiratory evaluation included: Respiratory history; previous asthma medications; allergy/ parental smoking; Physical exam; CXR O2-Sat. on rest and exercise. PFT's included: Spirometry, lung volumes, diffusion capacity; MCT prior and 2-6 months post SCT; Follow-up: 6-12 months post SCT. Pulmonary complication: Any respiratory symptoms or signs: cough, SOB, hemoptysis, hypoxemia; New chest radiological finding; Number of hospitalizations due to pulmonary complications.

Statistics: Sample size-26 patients to detect an increase of 0.5SD in AHR with a power of 80%. No. of children with AHR before and after SCT.; Pulmonary complications and AHR: hospitalizations for pulmonary complications and AHR.

Eligibility Criteria:
Inclusion Criteria:

* age 4.5-20 years
* ability to perform spirometry consistently
* FEV1\>70% predicted

Exclusion Criteria:

* FEV1\<70%
* inability to perform methacholine challenge test before and after stem cell transplantation.
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia

The postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks. In addition, it could potentiate the generalisation of effects to verbal and non-verbal communication skills, having a direct impact on patients' quality of life. This research is a prospective, randomized controlled, open-label, single-centre study. It is part of the management of patients with aphasia who have suffered a cerebral infarction and aims to evaluate the effect of combined language semantics/metacognition rehabilitation.

Vascular aphasia occurs after 20 to 25% of strokes and leads to anomia or word-finding difficulties in many patients. Speech therapy, which is the standard treatment, notably employs Semantic Feature Analysis (SFA). SFA aims to teach patients a strategy that helps activate semantic links strongly associated with the target word, thereby facilitating word retrieval.

Moreover, a growing number of studies suggest combining metacognitive strategy training with language rehabilitation in brain-injured patients, particularly in reading comprehension, communication skills, and anomia, could improve cognitive and language recovery outcomes. In rehabilitation, metacognitive strategy training can be used to enhance and/or compensate for cognitive function deficits. Patients are repeatedly exposed to discrepancies between the patients performance evaluations and expectations. Findings indicate improvements in trained tasks and transfer effects to similar tasks.

While studies have examined the effects of linguistic training on one hand and the impact of metacognitive abilities on the other, to the investigators knowledge, no study has assessed the effect of a combined linguistic and metacognitive training approach in post-stroke aphasic patients on behavioral and imaging variables. This study postulates that rehabilitation combining linguistic and metacognitive training will lead to a significant improvement in language performance, correlated with changes in functional brain connectivity networks. Furthermore, it may enhance the generalization of effects to both verbal and non-verbal communication skills, directly impacting patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* First cerebral infarction
* Chronic phase (\> 3 months)
* Patient affiliated to a health insurance scheme
* Usual french language
* Severity score measures using the Boston Diagnostic Aphasia Examination battery scale corresponding to the mild or moderate level (score greater than or equal to 2)

Exclusion Criteria:

* Contraindication to undergoing brain MRI
* Cognitive impairment pre-existing stroke (CQI code \> 3.4) (Law et al., 1995)
* Chronic alcohol or drug abuse
* Unstabilised psychiatric illness
* Uncorrected sensory deficits
* Diagnosed as having a progressive general pathology
A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

* To compare the overall survival in the 2 treatment arms
* To compare the objective response rate in the 2 treatment arms
* To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
* To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.


Eligibility Criteria:
Inclusion criteria:

* Histologically proven soft tissue sarcoma
* Unresectable locoregional recurrent or metastatic soft tissue sarcoma
* Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy

Exclusion criteria:

* Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
* Brain metastases and carcinomatous leptomeningitis
* Uncontrolled hypertension
* Known platinum hypersensitivity

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
FSH Doser for Controlled Ovarian Stimulation

The study aims to evaluate the effectiveness of an individualized FSH dosing model called IDoser in controlled ovarian stimulation (COS) for assisted reproduction. The randomized, controlled, multicenter trial involves 236 first cycle IVF patients, who will be assigned to either the intervention arm (using the IDoser model) or the control arm (standard clinician-determined dosing). The primary outcome is the number of mature oocytes retrieved, with the hypothesis of non-inferiority for the intervention arm. Secondary outcomes include cycle cancellations, risk of ovarian hyperstimulation syndrome (OHSS), and pregnancy and live birth rates.


Eligibility Criteria:
Inclusion Criteria:

* First IVF cycles
* Use of autologous oocytes
* Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH).

Exclusion Criteria:

* Natural ovarian stimulation cycles (without Controlled ovarian stimulation)
* Cycles where FSH is not measured in International Units (IU).
ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years

Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy.

The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.


Eligibility Criteria:
Inclusion Criteria:

Patients can be included if ALL the following criteria are met:

1. Provide written informed consent prior to participation
2. Female or male adult patients aged ≥ 20 years and \< 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment.

Exclusion Criteria:

Patients should not be included if ANY ONE of the following criteria is met:

1. Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran \[e.g., anaphylactic reaction or anaphylactic shock\], severely impaired renal function \[Creatinine clearance rate (Ccr) \< 30 mL/min\], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole)
2. Participate in other interventional trials currently or in the past 30 days
Properties and Clinical Performance of Zirconia-based Dental Ceramics

The objectives of this study are to determine the clinical performance of zirconia-based dental prostheses and their related properties.

Zirconia has been used in dentistry since 2000 for constructing fixed partial denture. Its advantages are high fracture resistance, excellent biocompatibility, moderate opacity, etc. Because the increase in demand for more esthetic restoration, zirconia becomes more popular for use as a core material for all-ceramic systems. Its properties have been investigated extensively in many in vitro studies. However, clinical performance of zirconia-based restorations would require a period of time before the results can be assessed. Currently, there are not much results regarding clinical performance of zirconia-based prosthesis and more information are required for future research.

Eligibility Criteria:
Inclusion Criteria:

* Occlusion: At least 20 remaining teeth for each patient, and at least one posterior endodontically treated tooth with natural opposing teeth
* Bruxism: No evidence based on an intraoral exam
* Dental history: No evidence of either moderate or severe periodontal disease
* Medical history: Good to excellent general health

Exclusion Criteria:

* Periodontal status: Pocket depth greater than 4 mm
* Occlusion: Evidence of bruxism or excessive clenching force, Abutment tooth that opposes a removable partial denture, Abutment teeth for fixed partial dentures, Gingival recession of an abutment tooth more than 1 mm from the cementoenamel junction, Tooth with first or second degree of tooth mobility, Tooth with extensive carious lesions