cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Characteristics of Patients With SARS-CoV-2

The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been declared a public health emergency of international concern. Hospitalized COVID-19-positive patients requiring ICU care is increasing along with the course of epidemic. A large number of these patients developed acute respiratory distress syndrome (ARDS) according to current data. However, the related hemodynamic characteristic has so far been rarely described.

The outbreak of COVID-19 is a worldwide concern. To our knowledge, the details of the hemodynamic characteristics of COVID-19 patients have not yet been well described. Besides, the cardiac injury was reported in about 7-17% of hospitalized patients with COVID-19 in previous Chinese publications and is much more common in patients admitted to ICU and non-survivors. However, no systematic assessment, including echocardiography evaluating the left ventricular function of these patients has been declared. In addition, extravascular lung water (EVLW) and pulmonary capillary permeability are two hall markers in ARDS patient's management, and transpulmonary thermodilution is a validated method to provide these values at the bedside. However, no study has reported the characteristic profile of these variables during ARDS caused by SARS-Cov2. A better knowledge of these characteristics would also be helpful in guiding their management.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or suspected SARS-Cov2 cases
* Patients admitted to ICU, defined as a unit in which patients can receive vasopressors.
* Monitored by a transpulmonary thermodilution system (PiCCO2 (Pulsion Medical Systems, Feldkirchen, Germany) or EV1000 (Edwards Lifesciences, Irvine, United States of America).

Exclusion Criteria:

* SARS Cov-2 Negative
* Refusal to participate in the study
Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models

Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.

Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each,in patients submitted to long-term outpatient nutritional support. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.This study is important because tube dysfunction and unscheduled changes are expensive troubles that disrupt the nutritional protocol and are responsible for multiple inconveniences to the patient and the caretaker.

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia.
* registered at the outpatient endoscopy service
* clinical stable and with the possibility of returning for scheduled visits
* expected duration of enteral feeding \> 6 months

Exclusion Criteria:

* Sepsis,
* shock,
* coma,
* other types of digestive access (surgical gastrostomy, jejunostomy)
* terminal disease,
* lack of cooperation,
* refusal to participate in the protocol
Emergency Psychological Intervention With Children: Alex Storm

Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.

Alex storm hits France from September 30, 2020 to October 3, 2020. On October 2, several valley in the Nice hinterland were devastated by this natural disaster. Nine people died during this storm and hundreds of families were affected (house washed away or uninhabitable). This led to emergency evacuations on October 3 of several families. The inhabitants of some villages have been subjected to prolonged stress (lack of water and electricity, difficulty in supplying food, fear of another storm). These villages were isolated for a period varying from fifteen days to over three months. These people are particularly exposed to psychological consequences.

Between October 3 and October 30, the CUMP (medico-psychological emergency unit) was mobilized to provide psychological first aid to these families. Among those seen in emergency 116 children were taken care of. In order to assess the immediate symptoms of the children, the investigators used an assessment sheet specific to the developmental ages of the children.

All children seen in an emergency between October 3 and October 30, 2020 were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma.

Eligibility Criteria:
Inclusion Criteria:

* children impacted by the Alex storm
* children seen in an emergency between October 3 and October 30, 2020
* children were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma

Exclusion Criteria:

* children whose parents refused to the processing of their data
PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients

This six-arm study is being conducted to measure the effect of a combination of paroxetine and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology) PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of paroxetine alone after one or eight weeks of treatment will also be measured.

A double-blind, double dummy, placebo-controlled, randomised, parallel group positron emission tomography study to investigate the effects of a 8 week administration of vestipitant and paroxetine in combination or paroxetine alone on regional cerebral blood flow during a public speaking test in subjects affected by social anxiety disorder.

Eligibility Criteria:
Inclusion criteria:

* Social phobic ambulatory subjects, defined according to DSM-IV criteria.
* Must be capable of giving informed consent and can comply with the study requirements.
* Women of childbearing potential must agree to acceptable method of birth control.

Exclusion criteria:

* Primary diagnosis within the past 6 months of other psychiatric conditions such as major depression or another anxiety disorder.
* Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
* Subjects who, in the investigator's judgement pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
* Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
* Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG) findings.
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.

Primary outcome is the percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive an authorized second-line systemic treatment.
2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
3. For children, parent/legal guardian must provide written informed consent. If age \>11 years old, the minor must give assent.
4. Participant is willing and able to adhere to the procedures specified in this protocol.

Cohort 2:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are already receiving authorized second-line systemic therapy at the time of selection.
2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
3. For children, parent/legal guardian must provide written informed consent. If age \>11 years old, the minor must give assent.
4. Participant is willing and able to adhere to the procedures specified in this protocol.

Exclusion Criteria:

1. Any investigational drug within 60 days prior to study drug administration.
2. Any condition or situation precluding or interfering the compliance with the protocol.
3. Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
4. Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
Palliation of Dyspnea With Mouth Piece Ventilation

An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and from oncology ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
* incurable advanced disease
* able to understand the study and to give informed consent
* would not gain from intensive care or resuscitation according to the treating physician

Exclusion Criteria:

* unable to participate and use MPV due to e.g. delirium or lack of co-operation
* the cause of the dyspnea can be succesfully treated
* unable to give informed consent
Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes

There are only very few data about the prevalence of CA-MRSA in France and no in athletes. In USA, the clone USA300 is widely disseminated and in Europe the clone ST80 predominates. The aim of the study was to study the carriage of S. aureus in athletes in a French county (Limousin) and to evaluate the proportion of CA-MRSA. The athletes will be met during their training, each one will fill-in a clinical information questionnaire. Nasal, throat, inguinal and skin lesions swab samples will be performed. The antibiotic susceptibility profile of the Staphyloccocus aureus strains isolated will be performed as well as the detection of the PVL gene. Strains will also be typed by different molecular methods (PGFE (Pulsed Gel Field Electrophoresis), SCCmec type (Staphylococcal Chromosome Cassette mec), and MLST (MultiLocus Sequence Typing)). The CIC (Clinical Investigation Center) of the Limoges University Hospital will be in charge of the inclusions of the athletes. The sample analysis will be centralized and performed at the Laboratory of Bacteriology of the Limoges University Hospital. A Clinical Research Officer of the Limoges University Hospital will be in charge of the survey of the study and will organize monthly meetings with all the participants of the study.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (over 18),
* belonging to a sport club of Limousin, practicing rugby, wrestling, basket-ball, volley-ball, hand-ball, fence, martial art, football, weight lifting, and base-ball.
* Patient having signed in a free way and lit his consent to participate in this study

Exclusion Criteria:

* clinical information questionnaire not possible to fill,
* swab sample not possible to realize.
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)

The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent.
* Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening.
* Must qualify for ATC opioid therapy for treatment of CLBP.
* Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score.
* Female subjects of childbearing potential will use an acceptable method of birth control.
* Must be in general good health based on screening physical examination.
* Must be willing and able to comply with all study procedures and visit requirements.

Exclusion Criteria:

* Known to be refractory or intolerant to the analgesic effects of opioids or have failed previous opioid therapy.
* A medical condition that would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug, including (but not limited to) intractable nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having paralytic ileus.
* A surgical procedure for back pain within 6 months prior to the Screening Visit.
* Any other chronic pain condition other than CLBP that would interfere with the assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches requiring opioid therapy).
* Known history of major depressive disorder that is not controlled with medication or has other conditions that produce significant cognitive or emotional disability.
* Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems.
* Known history of alcohol and/or drug abuse.
* Positive urine drug screen for illegal or non-prescribed drugs
* Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the subject's life except pediatric febrile seizures.
* Known history of head injury within 6 months of Screening Visit.
* Current malignancy or a history within past 2 years of malignancy, with the exception of basal cell carcinoma or cervical carcinoma in situ that have been successfully treated.
* Positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or hepatitis C antibody
* Subject is not able or is unwilling to meet the study attendance requirements.

Other protocol specific inclusion and exclusion criteria may apply.
Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects

This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent has been obtained.
* Healthy Japanese male subjects.
* Aged 20 to 40 years inclusive.

Key Exclusion Criteria:

* Body Mass Index outside the range 18-25 kg/m²
* Use of any medication (systemic or topical) within 2 weeks of Day 1.
Migraine STImulation Crisis of Migraine

Migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. Currently, there is no treatment for migraine.

Millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain.

MISTIC is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.

MISTIC is a multicenter, controlled, randomized, double-blind study. Eligible patients will have to report their migraine crisis in a diary during a one month pre-selection phase. Then, patients will be randomized into one of two treatment groups :

* active millimeter wave emission bracelet
* or placebo bracelet

Patients will have to use the medical device twice a day for 3 months. The investigators will follow them for an additional 3 months to assess the persistence of the effect.

Throughout the follow-up, patients will report their migraines crisis in a journal.

The primary outcome will be the impact of wearing a millimeter wave bracelet for 3 months, on the number of days with migraine headaches.

Eligibility Criteria:
Inclusion Criteria:

* Patient with episodic migraine without aura (according to ICDH3 classification criteria)
* Patient with at leat 4 migraine days per month and no more than 8 migraine days per months
* Background treatment (or not) stable for at least 1 month
* Drug management of migraine stable for at least one month
* Non-drug management of stable migraine at least 1 month prior to the study
* Patient affiliated to social security or beneficiary of such a scheme

Exclusion Criteria:

* Patients with chronic migraine (defined according to IHS criteria)
* Patients already included in an interventional clinical research protocol
* Patients with chronic headache due to drug abuse (according to IHS criteria)
* Patients with only migraine crisis with aura
* Wrist size \< 14.5 and \> 21 cm
* Situations of dermatological pathologies on pre-existing wrists (oozing dermatosis, hyper sweating, eg.) or unhealed lesions on both wrists.
* Presence of metallic object (bracelet, watch, piercing...) on both wrists.
* Presence of a tattoo on both wrists
* Allergic reactions on contact with silicone or metal
* Persons referred to in Articles L 1121-5 to L 1121-8 of the CSP (corresponds to all protected persons) pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
* Women of childbearing age with a short-term pregnancy project
Gene Therapy for Gaucher's and Fabry Disease Using Viruses and Blood-Forming Cells

Gaucher's disease is a lysosomal storage disease resulting from glycocerebroside GLUCOCEREBROSIDE (1) accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in patients of all ages. The most severe form, Type 2 Gaucher's Disease occurs in infants who die in the first years of life (with rapidly progressive neurologic deterioration). The condition is passed from generation to generation through autosomal recessive inheritance.

Fabry's disease isa genetic disorder (X-linked recessive) due to the absence of the enzyme a-galactosidase A. The disease is characterized by abnormal collections of glycolipids in cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia(2) decreased sweating, tingling sensations in the extremities, and cataracts. Patients with Fabry's disease die from complications of the kidney, heart, or brain.

Both conditions are caused by the absence of specific enzymes (3). Patients with these conditions are missing (3) or have defective genes needed for the normal production of these enzymes. Studies on the blood-forming cells in bone marrow have lead to gene therapies using retroviruses as vehicles to carry and insert working genes into abnormal or diseased cells.

This study is designed to measure the safety and effectiveness of transferring working copies of genes responsible for making missing enzymes into the cells of patients with Gaucher's or Fabry disease.

This protocol was developed in order to obtain bone marrow stem cells for ex vivo transduction with retroviruses containing the human glucocerebrosidase gene. We continue to enter a small number of patients to this protocol each year. Studies with the bone marrow hematopoietic progenitor cells have enabled us to identify the most effective retroviral construct currently available in order to carry out gene therapy trials in patients with Gaucher's disease. The data revealed that a comparatively simple retroviral construct containing human glucocerebrosidase cDNA driven by the MoLV promoter is highly effective. We have obtained approval and initiated a Phase I safety and gene marking investigation in patients with Type I Gaucher's Disease.

Eligibility Criteria:
Normal and patient volunteers.

Individuals with platelet counts less than 40,000/ul, PT greater than 15 seconds, or PTT greater than 40 seconds will not undergo bone marrow aspiration.

Individuals with hematologic disorders other than Gaucher Disease, Fabry Disease, or mild iron deficiency will not undergo bone marrow aspiration.

HIV positive individuals will be excluded from participating.