cyrilzakka/clinical-trials huggingface dataset:
Effect of Immersive Virtual Reality Reminiscence Versus Traditional Reminiscence Therapy on Cognitive Function and Psychological Wellbeing Among Institutionalized Older Adults: A Randomized Controlled Trial

Cognitive function and psychological wellbeing are basic determinants of successful ageing that enable older adults to maintain their health, independence, and autonomy. Reminiscence therapy (RT) is one of the most prevalent evidence-based psychosocial interventions that can enhance older adults' cognitive function and maintain their psychological health. Virtual reality (VR) reminiscence is an innovative strategy that has the advantage of integrating technology in to the care of institutionalized older adults. However, limited researches have been conducted to compare the role of VR reminiscence versus traditional RT on improving older adult's cognitive and psychological wellbeing.

The aim of this study is to determine the effect of virtual reality reminiscence versus traditional reminiscence therapy on cognitive function and psychological wellbeing among institutionalized older adults.

Eligibility Criteria:
Inclusion Criteria:

* their age is 60 years and above, capable of communicating clearly, free form hearing or vision impairments that might hinder RT, and being able to tolerate using the Head Mounted Display(HMD) headset.
Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension

This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe hypertension

Exclusion Criteria:

* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.
Exercise and Arterial Modulation in Youth

The project is designed as a large scale, cross-sectional study. The aim of the study is to investigate the association of micro- and macrovascular function with physical fitness and body composition in primary school children.

The investigators will examine whether physical fitness, body composition and blood pressure differently affect large and small arteries in young children. Furthermore, the investigators will examine whether pulmonary dysfunction is associated with vascular disorders and if subcutaneous advanced glycation endproducts (AGE's) mediate some of the vascular alterations observed.

Eligibility Criteria:
Inclusion Criteria:

* primary school children aged 6-8 years who can participate in physical education lessons with written consent from their parents.

Exclusion Criteria:

* children with a medical certificate that prohibits physical exercise with no consent from their parents.
Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

  1. Coverage of the body surface area (BSA) of 10% or more with plaques
  2. A score of 3 or more on the IGA scale
  3. A PASI score of at least 12 at baseline

     Exclusion Criteria:
* Have forms of psoriasis other than the required "plaque psoriasis"
* Women of childbearing potential
* Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
* Previous treatment with this investigational drug
* Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities;

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Aquatic Therapy Versus Neuro-dynamic Technique for the Treatment of Carpal Tunnel Syndrome Patient

Carpal Tunnel Syndrome (CTS) is a common neurological disorder due to entrapment of median nerve which runs from the forearm into the hand through a tunnel, compressed or pinched due to anatomical factors, such as a narrow carpal tunnel. Widespread condition that affects 3-6% of the general population worldwide. Carpal Tunnel Syndrome (CTS) a prevalent and debilitating condition leading to disability despite optimal interventions to rehabilitation that aimed to reducing pain and improving neural function status in Carpal Tunnel Syndrome Patients .

This study investigates the additional benefits of Aquatic Therapy and Neuro-dynamic Technique in Carpal Tunnel Syndrome Patients .The researcher employs a randomized controlled trial methodology. Participants are divided into two groups: one receiving Aquatic Therapy, and the other receiving Neuro-dynamic Technique.

Outcomes are assessed over an 8-week period, focusing on pain levels and neural function restoration and grip strength. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, intervention to alleviate symptoms and improve the quality of life, neural restoration for those suffering Carpal Tunnel Syndrome (CTS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild-to-moderate carpal tunnel syndrome by Neuromuscular Physician
* Participants who presented with unilateral CTS with symptoms reported up to 3 months
* Male and female
* Aged 18 years or older

Exclusion Criteria:

* Patients with non-specified stage of CTS,median nerve entrapment in TOS, Cervical Radiculpathy
* Participants presents with co-morbidities,Hx of CTS (e.g., pregnancy, diabetes, trauma, congenital disorders, obesity, post-surgical release, and hypothyroidism)
* Cardiovascular disease, thenar muscle atropy"
Ursodeoxycholic Acid in Chronic Heart Failure

This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA on peripheral blood flow and immune function in patients with stable chronic heart failure (CHF). Sixteen patients with CHF will be recruited from the heart failure clinic at the Royal Brompton Hospital. Following baseline evaluation, patients will be randomised to receive either placebo or UDCA at a dose of 1000 mg/day for a period of four weeks. They will then undergo repeat evaluation (peripheral blood flow and immune function). A four week washout period will then take place before the patients cross-over to receive the respective other therapy for a further four weeks (i.e. those first receiving placebo will go onto receive UDCA and vice versa). The study will be completed after a total of twelve weeks, with a final assessment (peripheral blood flow and immune function).


Eligibility Criteria:
Inclusion Criteria:

* age \>21 years
* of either sex
* the patient is willing and capable of complying with the requirements of this protocol
* the patient has provided written informed consent
* the patient has clinical evidence of chronic heart failure:

  * reduced ejection fraction (≤40%) or left ventricular impairment on echocardiography (LVEDD ≥60mm)
  * stable clinical condition and medication for at least 1 month prior to the study (New York Heart Association class II-IV).
  * the patient is receiving appropriate conventional medical therapy for heart failure (ACE inhibitor or angiotensin II blocker, diuretics, beta-blocker as indicated and tolerated).

Exclusion Criteria:

* congenital heart disease
* any life-threatening disease, other than heart failure
* active malignancy of any type, or history of a malignancy within previous 5 years. Patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrolment are acceptable.
* previous heart transplant
* severe neuro-muscular disease
* history of unstable angina, myocardial infarction or stroke within 3 months prior to the study
* pregnancy or women of child-bearing age
* treatment with immunosuppressive therapy e.g. steroids for rheumatoid arthritis or obstructive lung disease
* significant renal dysfunction (serum creatinine \>250mmol/l), severe liver disease (liver function tests \> 3 times normal)
* unable to understand and comply with protocol or to give informed consent
Impact of PREMs in the Shared Decision Process for Renal Replacement Treatment Methods.

The French "my health 2022" plan is the first bundled payment initiative for stage 4 and 5 chronic kidney disease (CKD) pathway with the aim to improve the quality of care and promote a multi professional collaboration for a more holistic approach of healthcare. Renal Replacement therapies (RRT) have a significant impact on the quality of life and autonomy of patients and their caregivers. The transition to these treatments is a critical point in the pathway, involving a complex choice for patients that cannot be based solely on medical considerations but requires to assess the needs and preferences of patients and their caregivers in order to improve their experience and the quality of care. The investigators propose to conduct a prospective cohort study aimed at 1/ describing the patient and caregiver experience, patient related outcome measures (PROM) and the quality of life in relation to the decision-making process 2/ identifying the individual factors (socio-cultural, health literacy) associated with the patient experience, 3/ assessing the expectations and needs of patients regarding the information and support received during the process, and 4/ describing the perceptions of caregivers and professionals regarding the information provided and the decision-making process. The assessments will be conducted by questionnaires before, 3 months after the information on RRT and 3 months after the initiation of RRT or 24 months after the initial information for patients and caregivers and at the time of information on RRT for professionals. The data from the questionnaires will be further explored by a qualitative survey in a subgroup of patients and caregivers. The results of this study will help identify the factors determining the choice and satisfaction of patients and their caregivers in order to adapt the decision making support and thus have a patient-centered approach.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Stage 4-5 chronic kidney disease not on dialysis with a nephrologist follow up \>3 months
* Glomerular filtration rate estimated by the CKD EPI formula \< 20 ml/min/1.73 m2,
* Referred for consultation and information on renal replacement therapies.
* Age \>18 years old.
* Patient with a sufficient level of oral comprehension of French, able to understand the research

Exclusion Criteria:

* significant cognitive disorders preventing decision making
* patients under guardianship, or legal protection
* referred for ultrafiltration in the context of cardio renal syndrome
GM-CSF With Post-Transplant Cyclophosphamide

Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.


Eligibility Criteria:
Inclusion Criteria:

* Availability of 5/10 to 8/10 matched related donor
* KPS \>/= 70%
* CML, AML, MDS, ALL, CLL, HD, NHL, MPS/CMML, MM, any other hematologic condition deemed an eligible indication for allogeneic transplant by the treating center

Exclusion Criteria:

* Poor cardiac, pulmonary, liver, and renal function
* HIV-positive
* Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent
* History of severe or serious allergic reaction to human GM-CSF or yeast-derived products
Botox or Botox With Esophageal Dilation in Patients With Achalasia

Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.


Eligibility Criteria:
Inclusion Criteria:

* Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM
* Patient undergoing routine care upper endoscopy for achalasia

Exclusion Criteria:

* Less than 18 years old
* Previous surgery for reflux or peptic ulcer disease
* Significant medical conditions possibly placing subjects at risk to undergo endoscopy
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma

The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent for the trial.
2. Age ≥ 18 years of age
3. Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.

   1. Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.
   2. Cohort B: all other patients with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type \[non-mutated\] tumors)
4. Unfit for or intolerant to standard platinum-based chemotherapy.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
6. Adequate organ function.
7. Have a measurable disease per RECIST 1.1

Exclusion Criteria:

1. Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.
2. History and/or current evidence of any of the following disorders:

   1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.
   2. Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.
   3. Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.
3. Has received a live vaccine within 30 days prior to the first dose of study drug.
4. Have an active autoimmune disease that has required systemic treatment in the past 2 years.
5. Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
6. Have had an allogenic tissue/ organ transplant.
7. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA.
8. Have known active central nervous system metastases and/or carcinomatous meningitis.
9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease

A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known.

The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form.

This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years of age
* Diagnosis of CoVid-2 SARS infection retained (from clinical presentation, radiological and CoVid-19 positive microbiological specimen).
* Hospitalisation in the conventional medical sector for "respiratory" reasons (= severe form of CoVid-19) in the Nancy-Brabois hospital and Metz-Thionville Hospital between 02/03/2020 and 15/06/2020.

Exclusion Criteria:

* Diagnosis of SARS-CoV-2 infection not retained
* Refusal of the patient to participate in the study
* Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: o Pregnant woman, parturient or breastfeeding mother o Minors (not emancipated) o Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) - Persons of full age unable to express their consent Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.
Ultrastructure of Atrial Myocytes in Patients in Sinus Rhythm and With Atrial Fibrillation

The aim of this work is to study the prevalence of T-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. Furthermore, since current information is lacking on the key Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it will be investigated whether a regulation of these proteins could be an underlying cause of the disease. Mitochondrial function will also studied.

1. The investigators hypothesize that both structure of sarcolemma and localization of key Ca2+-handling proteins are altered in patients with atrial fibrillation compared with patients in sinus rhythm.
2. The investigators hypothesize that mitochondrial function is altered in patients with atrial fibrillation compared with patients in sinus rhythm.


Eligibility Criteria:
Inclusion Criteria:

* sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation
* selected for open heart surgery
* informed consent

Exclusion Criteria:

* not given informed consent
Do Your Genes Put You at a Higher Risk of Developing Mesothelioma

The purpose of this research study is to investigate the possibility that a person's genes put a person at a higher risk of developing mesothelioma. The investigators will examine genes from DNA (genetic material) isolated from blood. This study will also examine the impact of environmental and work exposures and family history of common cancers on the development of mesothelioma. The genetic markers in this study will basically identify how a person's body processes frequently encountered environmental pollutants and will not tell about chromosomes, specific diseases, or other potential health problems.

Mesothelioma is a cancer that develops from serosal surfaces usually in response to prior asbestos exposure. A history of asbestos exposure can be elicited in more than 80% of mesothelioma victims. However, asbestos exposure alone is not sufficient to cause the development of mesothelioma. Nearly 27 million individuals in the US, were exposed to asbestos in the work place between 1940 and 1979 but just 3,000 new cases of mesothelioma are diagnosed each year. Therefore, the investigators hypothesis is that genetic variation in addition to asbestos exposure, and host factors contribute to the development of mesothelioma. It is estimated, based on the investigators preliminary studies, that a population in excess of 1,000 subjects with mesothelioma is required to perform a valid GWAS.

Therefore a multicenter approach is necessary to collect data and DNA on sufficient numbers with mesothelioma to adequately evaluate genetic risk. It is the aim of this proposal to develop a consortium of mesothelioma investigators to share phenotypic data and DNA samples and to perform genome wide association scanning (GWAS).

Eligibility Criteria:
Inclusion Criteria:

* Subjects able to provide informed consent who suffer from mesothelioma

Exclusion Criteria:

* Inability to provide informed consent
* Absence of mesothelioma in self
Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation

Home ergometer training combined with online monitoring and regular telephone support could prove to be a cost-effective method to improve physical performance and quality of life in COPD patients.

The primary objective of the study is to demonstrate a significantly higher daily workout time in patients that are monitored during home ergometer training with telephone support compared to conventional home ergometer training. Consequently we expect an increased quality of life related to the illness and a decreasing BODE-Index. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

Hypothesis: There will be an increased prevalence, morbidity and mortality of COPD during the next decades. On the other hand there is a clear correlation between life expectancy and physical activity in this disease. Telemedicine concepts promise new treatment strategies with favourable impact on the long-term process of COPD.

Eligibility Criteria:
Inclusion Criteria:

* COPD

Exclusion Criteria:

* tumor diseases
* unstable coronary heart disease
* untreated cardiac valve disease
* incapable of giving consent
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method

Surfactant administration via thin catheter using a specially adapted video laryngoscope - a prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video Surfactant Administration Laryngoscopy).

The study will search for the number of attempts until surfactant is administrated, assessment of the infants' stability during the procedure, duration of the entire procedure, form laryngoscope insertion to surfactant administration.

In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.).

The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel.

Primary Endpoints

1. - Number of attempts until surfactant is administrated
2. - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
3. - Duration of the entire procedure, form laryngoscope insertion to surfactants administration.

4. Secondary Endpoints

1. - Need of invasive mechanical ventilation in the next 24 hours.
2. - Complications reports
3. - Subjective procedure scale of assessment
4. - Unexpected pitfalls reports
5. - Safety assessment of the procedure

Eligibility Criteria:
Inclusion Criteria:

1. - Premature infants with gestational age 30-36 weeks.
2. - Diagnosis of respiratory distress syndrome
3. - Spontaneously breathing with non-invasive positive pressure ventilation.
4. - Maximal age 3 days.

Exclusion Criteria:

1. - Apgar score at 5 min \< 5
2. - Need for chest compressions or medication upon delivery.
3. - Evident major congenital malformation, metabolic or genetic disorders.
4. - Clinical evidence of sepsis.