cyrilzakka/clinical-trials huggingface dataset:
Prospective Monocentric Study on the Efficacy of Lidocain Spray for Patient Comfort During Nasogastric Tube Insertion in Enteral Nutrition

Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT) is although a common act. Unfortunately, this procedure can be painful. Also, many patients will need many NGT re-insertion. Therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during NGT passage. Professionals guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using local anesthesic without ordering their use. However, NGT tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these studies have been done in the emergency room with NGT of a bigger gauge and for many reasons except enteral nutrition.

The investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of NGT insertion using Likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray.

The study will be held in CHU Nice at nutrition unit support. After signed consentment, patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient will have to answer a questionnaire. Pain will be grade using visual analogue scale immediately after the procedure. Demographic data and complications will be note by the investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be 34 patients by group. If the investigators find a benefit, this can change their practice and guidelines.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Patient needing enteral nutrition by NGT
* Signed consentment
* Affiliation to securite sociale

Exclusion Criteria

* Lidocaine allergy
* Severe demencia
* Non cooperating patient
* Facial trauma and basal skull fracture
* Reflex deglutition problem
* Pulmonary illness like severe asthma
* Hemodynamic instability
* Pregnancy and nursing
* Patient on guardianship
Implications of Self-weighing During Weight Loss Treatment

This study aims to analyze the effectiveness of introducing behavioral elements in a weight loss program, in this case, comparing the difference between self-weighing versus not doing so.


Eligibility Criteria:
Inclusion Criteria:

* Having a IMC \>25,
* Being sedentary and
* Have not been submitted to a restrictive diet in the 6 months preceding this study

Exclusion Criteria:

* Suffered from type 2 diabetes or renal conditions
* Being pregnancy or attempt at pregnancy,
* Undergoing antidepressant pharmacological treatment
Effectivness of Active Office Intervention

The Active Office study is focusing on interventions with potential to reduce sedentary behavior and increase physical activity in office workers. The participants will be devided in two groups, the experimental and the control group. The participants in the experimental group will use active office (sit-to-stand desk, bike desk, seddle chair and active breaks) for one week, whereas the control group will remain in the conventional sitting-desk office. All the participants will wear ActivePal for 5 consecutive day and complete the measurements (heart rate, blood pressure). The goal of the study is to evaluate the effects of active office on sedentary behavior and physical activity levels in office workers.

Sedentary behavior is racognised as an independent risk factor for the development of non-communicable diseases. It is estimated that office workers spent up to 80 % of their working time sedentary and do not compensate by sitting less in their leisure time. Therefore, interventions with potential to reduce sedentary behavior and increase phyical activity levels are of increasing interest. The aim of this study is to evaluate the effects of active office, including sit-to-stand desk, bike desk, seddle chair, and active breaks, on sedentary behavior, physical activity levels, and cardio-vascular parameters. The study design will be randomised control trial with one experimental and one control group. The participants in the experimental group will use active office for one week whereas the control group will use the conventional office. All the participants will wear ActivePal for 5 consecutive day and complete the measurements (heart rate, blood pressure). The participants will also complete quastionaires about the sedentary behavior and physical activity levels (Sedentary Behavior Questionnaire, Global Physical Activity Questionnaire). Moreover, at the baseline and on the last day of measurements the investigators will measure the work environment factors (light, noise, air flow, temperature). The goal of the study is to evaluate the effects of active office on sedentary behavior and physical activity levels in office workers.

Eligibility Criteria:
Inclusion Criteria:

* office workers spending at least 70 % of their working time sedentary
* aged between 18 and 65

Exclusion Criteria:

* body mass index \> 30kg/m2
* pain presence in any musculokeletal part \> 3 on 10-level scale
* presence of any non-communicable chronical diseases
* pregnancy
Clinical Applications of a Joystick in Femoral Shaft Fractures

This study will use a new "H" joystick for reduction on patients with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

This study will design a new "H" joystick for reduction (which has received the national utility model patent) and will use this equipment on 80 patients (55 males, 25 females) with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Eligibility Criteria:
Inclusion Criteria:

* Femur shaft fractures

Exclusion Criteria:

* Not suitable to receive intramedullary nail treatment
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients who start or are on treatment with Adempas
* Written informed consent

Exclusion Criteria:

* Patients currently participating in an interventional clinical trial
Sex Differences in Oral Bacteria

Females have a lower incidence of hypertensive and cardiovascular disorders that may relate to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled with the help of oral bacteria to nitric oxide which is protective against vascular disorders. This study will test the hypothesis that females have different numbers and species of these nitrogen-oxide reducing bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form

Exclusion Criteria:

1. Healthy subjects unwilling to consent
2. History of hypertension, diabetes or hypertensive on BP measurement
3. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
4. History of any serious illnesses, including recent infections or trauma
5. Subjects taking systemic medication (other than the oral contraceptive pill)
6. Subjects with self-reported use of mouthwash or tongue scrapes
7. Subjects with recent or current antibiotic use (within 3 months)
8. Subjects with a history, or recent treatment of (within last 3 months) of any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
the Impact of Physical and Mental Fatigue on Balance

Mental and physical Fatigue and overall fatigue will be collected based on Fatigue assessment scale while balance data will be obtained by recording mobile sensors in X, Y and Z directions when mobile placed on COG of the participants.


Eligibility Criteria:
Inclusion Criteria:

* patients from 18 to 24 years old

Exclusion Criteria:

* free of any mental disorders or major health issues in last year
Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support

Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. The patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using Intrapulmonary Percussive Ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Bronchiolitis
* PICU patients
* Non Invasive Pressure Support Ventilation
* Age \< 24 months

Exclusion Criteria:

* Age \> 24 months
* Invasive Ventilation
* No parental consent
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)

The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \<3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).


Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants \<3 months of age
* Patient has a body weight greater than or equal to 500 grams
* Patient has documented or highly suspected Candida infection

Exclusion Criteria:

* Patient is greater than 3 months of age
* Patient has a body weight of less than 500 grams
* Patient does not meet certain laboratory testing criteria
* Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
* Patient has documented HIV infection of any stage
* Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class
Polycystic Kidney Disease Data Repository

Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. Over half of all PKD patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family.

Despite the fact this is a relatively common problem, relatively few patients have been studied for a sufficient period of time to fully understand how patients are affected over the course of their lifetime. The reason for creating this repository is to collect information about PKD so that the investigators may fully understand its complications, including high blood pressure, heart attack, and stroke. This information may also aid in the development of improved treatment strategies.

Visit #1:

* An initial detailed history, physical examination, and laboratory evaluation
* An extensive family history of PKD will be obtained from the patient.

Follow-up Study Visits:

- Patients will return to the outpatient facility for detailed follow-up examinations every other year after Visit 1.

Eligibility Criteria:
Inclusion Criteria:

* Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate.

Exclusion Criteria:

* Inability to provide informed consent.
Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed presence of familial hypercholesterolemia
* Women must be sterilized or post-menopausal

Exclusion Criteria:

* Smoking an average of greater than 10 cigarettes per day
* History of cardiac events
* Very low or high body weight
* Treatment with fibrates or niacin
* High blood triglyceride levels

Other protocol-defined inclusion/exclusion criteria may apply.
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain

This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.


Eligibility Criteria:
Inclusion Criteria:

* Main complaint of Neck Pain for at least six (6) months;
* Score of at least 10 points in NDI (Neck Disability Index);
* Pain and / or restriction of cervical movements;
* Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
* The definition of the term Neck Pain follows the classification of TFNP.

Exclusion Criteria:

* Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
* History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
* Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
* Red flags contraindicating spinal manipulation.
Expanded Access Study of UC-MSC in DMD Patients

The primary objective of this study is to provide UC-MSC treatment to patients with DMD.

Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testing/assessments, blood laboratories, and inflammation related biomarker levels over time.

The study will enroll ambulatory male participants between the ages of 5 and 10, who will receive four, 3-day intravenous dose cycles of UC-MSC treatment, each administered every three months. Participants will be closely monitored throughout the study period for treatment-related adverse events and changes in DMD-related functional assessments at specific follow-up intervals through 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male sex by birth with a genetically confirmed diagnosis of Duchenne Muscular Dystrophy (DMD).
2. Age is greater than or equal to 5 and less than or equal to 10 years.
3. Has a North Star Ambulatory Assessment (NSAA) score greater than 13 and less than 30.
4. Demonstrates the ability to perform the "time to rise" test in under 10 seconds.
5. Is up-to-date on immunizations.
6. Is on a stable dose of glucocorticoids for at least 12 weeks prior to study participation, except for weight-based or toxicity-related adjustments.
7. Is on a stable dose of supplements for at least 12 weeks prior to study participation.
8. Has the ability to comply with the requirements of the study and the ability to understand and provide written informed assent and a guardian's consent.
9. Patient must be either a non-responder to or a poor candidate for treatment with another established therapy.

Exclusion Criteria:

1. Active cancer or prior diagnosis of cancer within the past year (patients with basal and squamous cell cancer of the skin will not be excluded).
2. BMI \> 45 kg/m².
3. Any other condition (including concomitant treatment) that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration (e.g., known hypersensitivity to dimethyl sulfoxide (DMSO), Human Serum Albumin (HSA), or PlasmaLyte), or follow-up.
4. Treatment with an exon skipping therapy within 3 months of study start.
5. Cognitive delay or impairment that can confound motor development in the opinion of the investigator.
6. Major surgery within 3 months prior to Day 0 or planned surgery or procedures that could affect the conduct of the study.
Stay Well at Home: a Text-messaging Study Social Distancing

The investigators have developed supportive text-messages in English and Spanish to help people cope with the stress and anxiety of COVID-19 social distancing. The purpose of this study is to examine if automated text-messages will improve depression and anxiety symptoms and enhance positive mood.

Additionally, the investigators will compare the effectiveness of sending messages on a random schedule (using a micro-randomized trial design) or sent by a reinforcement learning policy on overall change in depression and anxiety symptoms and daily mood during the 8-week study.

The investigators will send participants supportive text-messages for a period of 2 months. These text-messages will include tips about behavioral activation and coping skills to deal with worries and stress. The investigators generated a message bank balanced such that 50% of all messages are related to behavioral activation (BA) and 50% messages involve different coping skills. Participants will receive one of these messages per day between 9:00 am and 6:00 pm. Participants will also receive a message asking them to rate their mood on a scale of 1-9 once a day 3 hours after the BA or coping message.

Participants will be randomized to:

1. a uniform random messaging group (micro-randomized trial design).
2. a reinforcement learning group with a learned decision mechanism for the timing and type of text-message. The algorithm learns from previous data (which messages were sent, what was the participants' mood) to maximize an increase in participants mood. No other data are collected from participants' phones.

The investigators will compare the effect of sending text-messages by a random schedule, and text-messaging chosen by the RL algorithm. This allows to both evaluate the effect of the individual intervention components over time within a micro-randomized trial design, and assess the added value of using RL to adapt the messaging scheme.

The investigators hypothesize that:

* Participant will show improvements in depression, anxiety symptoms and mood during the 60 day study.
* The participants in the group receiving reinforcement learning will have a greater improvement in depressive symptoms, anxiety and positive mood during the study than participants in the micro-randomized group.
* The investigators will find differential effects on mood ratings for the two categories of messages

Eligibility Criteria:
Inclusion criteria:

* Over 18 years old
* Own a mobile phone
* Speak English or Spanish

Exclusion criteria:

* Not owning a mobile phone
* Under 18 years old
Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

The use of Neuromodulators is now recognized by international consensus as effective in improving Disorders of Gut-Brain Interaction (DGBIs). However, the digestive mind-body concept of therapeutic drugs is still in the experience-based treatment stage, and there is a lack of clinical studies in the field of DGBIs. Although numerous studies have been conducted to confirm the safety of Neuromodulators for the treatment of DGBIs, the current functional dyspepsia (FD) treatment is still awaiting further explorations and accumulations. In addition, neuromodulators, like Flupentixol-Melitracen (FM), are often used as a second-line treatment option for FD after the failure of acid-suppressive therapy with proton pump inhibitors, etc. However, the efficacy of conventional drugs for FD is mediocre, which often leads to recurrent and prolonged symptoms, seriously affecting patients' confidence in treatment and their quality of life, and the repeated visits to the clinic also create a huge economic burden for the society. Therefore, we conducted a clinical trial to verify whether FM can be used as the first-line therapy to improve the efficacy of FD patients.


Eligibility Criteria:
Inclusion Criteria:

1. adult patients with primary FD who meet the diagnostic criteria for Roman IV;
2. able to complete the questionnaire, trial evaluation and sign the written informed consent.

Exclusion Criteria:

1. organic gastrointestinal diseases by gastroenteroscopy within 6 months;
2. severe insufficiency of heart, liver, kidney, lung and other important organs and with congenital diseases;
3. allergic to the drugs used in this study
4. being pregnant, lactating or planning to become pregnant;
5. are taking or have taken monoamine oxidase inhibitors within the past 5 weeks;
6. have a known risk of narrow angle glaucoma.
Regulation of HIIT Combined with IET on Vascular Function in Young Women with Normal Weight Obesity

Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women.

This is a randomized clinical trial of single-blind with 3 arms (control group , HIIT group and IET with HIIT group), in which a pre-treatment-posttest design has been used.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged between 18 and 30 years old;
* BMI between 18.5 and 24.9 kg/m2 with a BF% \> 30% (normal weight obesity determination criteria);
* exercise capacity to complete the exercise programme.

Exclusion Criteria:

* Acute or chronic musculoskeletal disorders, cardiovascular diseases, etc. that prevented training;
* other diseases (such as diabetes, etc.) that had a great impact on physical condition;
* bad habits (such as smoking, drinking, etc.);
* and unstable body weight (up and down fluctuations of more than 2.5 kg) in the 3 months before the experiment.
Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT

Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer. Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy. The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments. Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.

Potential cases will be identified at the multidisciplinary head and neck group meeting. If the case meets eligibility an informed consent will be presented to the patient. Interested participants will be scheduled for baseline assessment before the beginning of treatment (M0). At the end of CRT patients will be submitted to a second assessment (M1). Follow-up assessments will occur 16th to 18th weeks after the treatment is completed (M2). Patients proposed to surgery or induction chemotherapy will also be submitted to an additional assessment before the beginning of CRT (Mc / Mic).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Diagnosis of locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx), stage III-IVB.
* Proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.

Exclusion Criteria:

* Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
* Inability to provide informed consent.
* Expected inability to fulfil the propose schedule and follow-up.