cyrilzakka/clinical-trials huggingface dataset:
Non-contact Proactive Remote Monitoring of COPD Exacerbations

The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are:

* Can an exacerbation be detected before the person recognizes they are unwell?
* What are the biological signals which provide the best indication of decompensation?
* How does this indication of decompensation compare to a daily CAT?

Participants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of COPD
2. 1 or more exacerbation in the last year
3. Aged over 18 years
4. Willing to use monitoring devices and complete study questionnaires
5. Adequate English
6. Signed consent form

Exclusion Criteria:

1. Pregnancy
2. BMI greater than 45 kg/m2
3. Nil other, provided inclusion criteria are met.
Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop due to long-term pressure application of the intubation tube to the tongue, in patients hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by submental ultrasonography (USG) method.

Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop due to long-term pressure application of the intubation tube to the tongue, in patients hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by submental ultrasonography (USG) method.

Eligibility Criteria:
Inclusion Criteria:

Patients aged between 18-65 years Patients who underwent endotracheal intubation and were admitted to the intensive care unit on the 0th day of intubation and patients who underwent endotracheal intubation during follow-up in the intensive care unit and were followed up on a mechanical ventilator -

Exclusion Criteria:

Patients under the age of 18 and over the age of 65 Patients who had a history of maxillofacial trauma, tongue surgery, head and neck malignancy, radiotherapy to the head and neck region, congenital anomalies of the tongue base and floor of the mouth Patients who were admitted to the intensive care unit due to allergy-anaphylaxis

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Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU

Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in ICU
* under mechanical ventilation
* presenting an ARDS according to the Berlin definition
* induced by either influenza or SARS CoV 2

Exclusion Criteria:

* pregnant women
* mechanical ventilation\>48 hours before admission
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.

The treatments are

Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46

Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33

* first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
* second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)

Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
* Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
* Not resectable
* Karnofsky PS \>= 70
* Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
* Informed consent signed

Exclusion Criteria:

* Distant metastasis
* Contra-indication to concomitant chemotherapy
* History of cancer
* History of head and neck radiotherapy
S90652 in Paediatric Hypertension

The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive children, who have been treated for four months at least with S90652, with safety and efficacy

Exclusion Criteria:

* Poorly controlled hypertension
* Girls with signs of pubescence
Assessment of Food Practices by Residents in Nursing Homes

Nutrition is an essential component of health and a key determinant of aging and quality of life of individuals. Malnutrition in the elderly is now recognized as a public health problem affecting nearly half of residents in nursing homes. The fight against malnutrition requires to rethink the meal in all its dimensions, beyond the nutritional needs. In order to improve practices of care at the elderly, the impact of environmental and social aspects of food in nursing homes has been assessed. The social environment and interactions during the meals are now identified as effective ways to stimulate food intake and increase feelings of well-being in the elderly.

The objectives of the study are to characterize the appreciation of food and social interactions during the meals and to study the relationships between the quality of food practices and nutritional status of the residents in nursing homes to improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Men or women living in nursing homes
* Person able to consent and understand the study
* Person able to converse in French, answer to a questionnaire
* Person feeding orally with or without assistance
* Person having lunch in community
* Availability of assessment criteria in the medical file

Exclusion Criteria:

* Person with cachexia syndrome
* Person with severe dementia (MMS \<20)
* Dependent person (GIR score 1 and 2)
* Person with severe disorders of neurological origin swallowing
* Person under artificial nutrition (enteral, parenteral)
* Person with acute infectious disease
* Person with unstable medical or psychological conditions that could lead to be non receptive or uncooperative during the study or could compromise the security or the participation of the subject in the study
* Person under trusteeship or deprived of their liberty by judicial or administrative decision
* at the end of life
Motivations, Obstacles and Opportunities for Using a Health Application to Encourage Physical Activity in People With Chronic Low Back Pain

In industrialized countries, low back pain can be considered a priority health issue. Some studies define it as one of the leading causes of disability in people under 45, or the leading cause of musculoskeletal disorders, with a prevalence of 26.9%. Chronic forms account for less than 10% of acute episodes, but represent around 85% of costs. It has been recognized that rest and physical inactivity are not beneficial in the treatment of low back pain, and worse, increase the risk of chronicity. Functional Restoration of the Spine (FRS) programs have been introduced in rehabilitation centers, and have proved to be effective both physically and psycho-socially. Patients generally adhere well to this type of program during in-center treatment. The effects obtained tend to fade rapidly on discharge, due to a lack of adherence to what can be offered conventionally (exercise sheets, oral advice). The development of connected tools (smartphones, tablets, etc.) could be a lever in this respect, as it would enable better patient support. In 2022, 84% of the population will own a smartphone. The content offered would be of higher quality, and would enable regular remote monitoring of the patient. The effects of the initial intensive treatment would be maintained by this new interactive, fun tool.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Chronic non-specific low-back pain.
* Diagnosis confirmed according to HAS definition (i.e. pain located between the thoraco-lumbar hinge and the lower gluteal fold. It may be associated with radiculalgia corresponding to pain in one or both lower limbs at the level of one or more dermatomes). Patients included in the study must have given written informed consent.

Exclusion Criteria:

* Patients not meeting HAS diagnostic criteria
* Patients with comprehension difficulties (making it impossible to fill in questionnaires)
* Patients with medical contraindications to physical exercise
* Patients under guardianship, curatorship or safeguard of justice.
* Patients without a smartphone
Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

Design: randomized clinical trial. Objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (FMS).

Background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with FMS are controversial. Descriptive data and intervention studies are still scarce.

Methods and measures: sixty patients will be randomly assigned to experimental or control group. The experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). Pain levels, impact of FMS symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups independent Student t-test for continuous data and χ2 tests of independence for categorical data. Separate 2x2 mixed model ANCOVAs with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia syndrome.
* Agreement to attend evening therapy sessions.
* A chief complaint of acute pain (duration \<6 months) in the temporomandibular joint on at least one side.
* The presence of joint clicking during jaw opening that was eliminated on protrusive opening.

Exclusion Criteria:

* History of recent trauma.
* Therapeutic co-interventions during treatment.
* Indication for surgical treatment of temporomandibular joint.
* Edentulism.
* Physical or mental illness that precludes attendance at therapy sessions.
The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine.

The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.


Eligibility Criteria:
Eligibility Criteria:

* You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate.
* You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine.
* You must be able to visit the doctor's office as scheduled for the next 4 months.

Exclusion Criteria:

* You have a history of an illness that would cause weight loss or gain in the near future.
* You have taken remoxipride within the past 6 months.
* You are allergic to olanzapine or Anti-obesity Agent.
* You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke.
* You have a serious medical illness, such as heart, liver, or kidney disease.
* You are pregnant or breast feeding.
Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed.

Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate.

The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial


Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥ 18 years old)
2. Admitted in the ICU for ≤ 24 hours
3. De novo hARF defined by the three following criteria:

   1. Respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration
   2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered.
   3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan
4. Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent

Exclusion Criteria:

1. Refusal of study participation by the patient or the proxy
2. Anatomical factors precluding the use of a nasal cannula or CPAP
3. Long term oxygen
4. Home CPAP or NIV
5. Hypercapnia indicating NIV (PaCO2 \> 45 mmHg)
6. Isolated cardiogenic pulmonary oedema indicating NIV
7. Known pregnancy or breastfeeding
8. Absence of coverage by the French statutory health care insurance system
9. Surgery within the last 6 days
10. Use of vasopressors (norepinephrine\>0.3 mcg/kg/min)
11. Glasgow coma scale \< 13
12. Urgent need for endotracheal intubation
13. Patients at an end-of-life stage receiving compational oxygenation
Virtual Reality Based Vision Test in Patients With AMD

To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

In order to bridge the gap between the existing functional measures and AMD lesions, researchers are considering the use of VR tools.

This study is designed to assess the contrast sensitivity function mapping test (CSF radial sweep) in an elderly population with AMD.

The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

The secondary objective of this study is to assess the relationship between the metrics generated by VR-based functional tasks and the metrics derived from conventional clinical measurements of retinal anatomy and visual function.

The primary efficacy endpoint is the Contrast sensitivity function (CSF) area under curve (AUC) correlation to Snellen BCVA.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years of age diagnosed with AMD
2. Subject Snellen BCVA score is 20/100 or better
3. Ability to undergo quality optical coherence tomography (OCT) imaging
4. Willing and able to give written informed consent

Exclusion Criteria:

1. Unwilling to use headset
2. Previous negative experience with a VR headset (eg, motion sickness, discomfort)
3. Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
4. Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
5. Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)
Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms

Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs.


Eligibility Criteria:
Inclusion Criteria:

* HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium

Exclusion Criteria:

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Clinical Impact of 16S rDNA PCR

The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management.

The secondary objectives of the protocol are:

* to evaluate bacterial identification performance
* to evaluate the effect of previous antibiotic therapy
* to analyze the management of discordant results between 16S PCR and culture identification


Eligibility Criteria:
Inclusion Criteria:

* Patients that had a 16S rDNA PCR positive result in Strasbourg University Hospital laboratory from 2014 to 2018
* Patients consent for this analysis of their past medical history
* Legal guardians consent for the analysis of their children's medical history

Exclusion Criteria:

* Patients who express opposition for this study
* Incomplete clinical record
COPD on Primary Care Treatment (COOPT)

The aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.

Chronic obstructive pulmonary disease (COPD) is a disorder characterised by symptoms and abnormal tests of expiratory flow that do not change markedly over periods of several months observation. COPD includes chronic bronchitis and emphysema. It is not fully clear which medication is the most efficacious in the long-term treatment of COPD. In contrast to asthma, the efficacy and therefore the precise role of inhaled corticosteroids is less clear in the treatment of patients with COPD. The same applies to another (much less investigated) possibility in the treatment of COPD, the anti-oxidant agent N-acetylcysteine. N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions, such as acute and chronic bronchitis and cystic fibrosis. The aim of this study, which is performed in family practices, is to determine the 3-year treatment effects and cost-effectiveness of oral N-acetylcysteine versus an inhaled corticosteroid (fluticason propionate) in modifying the course and progression of COPD.

Comparisons: N-acetylcysteine (oral, 600 mg o.d.) and fluticason propionate (dry powder inhalation, 500 mcg b.i.d.) are compared with placebo

Eligibility Criteria:
Inclusion Criteria:

* age between 30 and 75 years
* being a smoker or ex-smoker
* post-bronchodilator FEV1/FVC ratio is \<88% of the predicted value in case of men or \<89% of the predicted value in case of women
* post-bronchodilator FEV1\>=40% and \<90% of the predicted value
* subjects have a GP diagnosis of COPD or had increased cough, sputum and/or dyspnea on most days for 3 or more months a year, for at least the last 2 years
* able to provide a written informed consent
* expected to be able to comply with the study protocol
* able to communicate with the study personnel and to understand and read instructions
* females of childbearing potential should use an acceptable method for birth control

Exclusion Criteria:

* a known history of intolerance or allergy for N-acetylcysteine or fluticason
* use of long-term oxygen therapy or expected to be in need of oxygen therapy within the next 3 years
* registered asthma, allergic rhinitis, and/or allergic eczema as an active problem in the GPs records within the last 12 months
* alpha1-antitrypsin deficiency
* cystic fibrosis
* active infection due to Mycobacterium tuberculosis
* status post-lobectomy
* clinically proven gastric or duodenal ulcer in the previous six months
* non-compensated severe chronic congestive heart failure
* life expectancy reduction (e.g. malignancies)
* evidence of illicit drug use or abuse of alcohol intake
* expected not to be compliant in taking medications in general
* being pregnant or giving breastfeeding
* not complying with the inclusion criteria