cyrilzakka/clinical-trials huggingface dataset:
Effect of Two Different Plane Blocks on Post-thoracotomy Pain

Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery.

In this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective thoracotomy surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects who:
* received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225
* understand the nature of the study, agree to its provisions and provide written informed consent
* are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial)
* have a negative pregnancy test result at the first medical examination (if female and capable of bearing children)
* agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
* agree to keep a Subject Diary

Exclusion Criteria:

Subjects who:

* have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225
* have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)
* have had an allergic reaction to one of the components of the vaccine since participation in Study 225
* suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions
* have a known or suspected problem with drug or alcohol abuse (\>4 liters wine/week or equivalent doses of other alcoholic beverages)
* have donated blood or plasma within 30 days of study entry
* have received a blood transfusion or immunoglobulins within 30 days of study entry
* are known to be HIV positive (an HIV test is not required specifically for this study)
* are simultaneously participating in another clinical trial including administration of an investigational product
* have participated in any other clinical study within 6 weeks prior to study start
* have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)
* For female subjects: pregnancy or lactation
Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface between the body and its outside environment. Its strategic position confers it a crucial role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is slower in elderly comparatively to young subjects.

The purpose of this study is to investigate, by characterizing molecular events, the effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier function after acute disruption of stratum corneum in ederly subjects.

10 male volunteers aged from 60 to 75 years are randomized to receive topical application of ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential selloptape strips, epidermal samples of treated and control skin are removed under local anesthesia, using a dermatome. Differential gene expression analysis is performed using micro array techniques and quantitative RT-PCR.

treatment, randomized on the location, double blind, placebo control, internal control subject, prospective study.

Structural modifications of the superficial dermis during the aging process associated to alterations in the GAG- and PG profile appear to impact the quality of the dermal epidermal junction (DEJ). Previous biological and clinical evaluations of ER4017, a C-glycoside biomimetic of xylose, showed its capacity to stimulate GAG- and PG synthesis and to improve morphogenesis of the whole DEJ.

The aim of the study is to investigate the gene expression in human epidermis treated with ER4017 following sequential sellotapes strips after a 3 months ER4017 topical application. For this purpose, the modulation of gene expression is determined using a cDNA microarray technology. Stratum corneum disruption is performed following 3 months topical application on skin inner forearms. All the experiments are performed in 10 elderly healthy men. Volunteers are clinically and biophysically evaluated at baseline and then at monthly intervals or at 3 months respectively.

Eligibility Criteria:
Inclusion Criteria:

* Phototype I to III
* Healthy skin on studied skin areas
* Subject having freely given his informed written consent.
* Cooperative subject, aware of the necessity to attend all the scheduled appointments during the study.
* Negative serology for HIV, hepatitis B and hepatitis C
* No past or present history of allergy linked either to one of the ingredients of the study cosmetic cream tested or to xylocaïne (anesthesia).

Exclusion Criteria:

* Cutaneous disease or previous malignant cutaneous lesion on the tested zones.
* Any treatment able to act on blood coagulation and homeostasis.
High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis

Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis.

However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.

Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions )
* aged 7 days- 6 months
* transcutaneous SpO2 in room air \< 95%
* modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5
* agreement of at least one of the parents or legal tutor for his child to participate in biomedical research
* affiliation to social security (beneficiary or entitled), except beneficiary of State medical help

Exclusion Criteria:

* Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route
* Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP)
* Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy
* Inclusion in other observational study.
Evaluation of Block Duration in Type 2 Diabetes Patients

Diabete animal studies demonstrated a longer period recovery after local anesthetic injection (perineural administration). No clinical study demonstrated a prolonged nerve block duration in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that block recovery is delayed in diabetic patients.

For diabetic patients, peripheral nerve block is an interesting alternative to general anesthesia because it provides effective analgesia and may decrease haemodynamic complication. The fear of nerve injury after regional anaesthesia in diabetic patients is a concern that has neither been confirmed nor refuted by current literature. As a matter of fact, diabetic patients with neuropathy may be considered at increased risk because of the possibility for double crush syndrome when a chronic axon lesion related to diabetes is associated with an unexpected distal nerve injury related to regional anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* age (50 80 yrs) with monofilament test 10 g (\> 4/8)

Exclusion Criteria:

* refusal of sciatic nerve block,
* age \< 50 yr or \> 80 yr,
* American Society of Anesthesiologists state \> IV,
* presence of contraindications to local anaesthesia (known allergy to local anaesthetics, sepsis),
* emergency surgery,
* patients unlikely to be fully cooperative during the study,
* psychiatric disorders, or
* those abusing alcohol or drugs, and
* participation in another study within the previous 30 days. Moreover, patients with preoperative estimated values of creatinine clearance \< 50 mL min-1 (Cockroft and Gault Formula) or with glycosylated hemoglobin (A1c) level \> 8 % or with type 1 diabetes mellitus (insulin therapy)
Development and Testing of a Sports Intervention to Promote Physical Activity in Rural Girls

The goal of this study is to examine the impact of a 12-week sports sampling and physical literacy program on rural girls' physical activity.

Fewer than 30% of elementary-aged youth meet physical activity guidelines, with lower activity levels found among girls, racial minorities, and those living in rural areas. Sport is one of the best strategies for promoting physical activity, yet girls, Hispanics, and rural populations participate in youth sport at lower numbers and drop out at a higher rate. In line with Self-Determination Theory, commonly cited barriers include lack of competence, autonomy, and relatedness. Physical literacy and sport sampling have also been identified as key determinants of youth sport participation. Developing interventions around physical literacy and sport sampling, with intervention delivery grounded in Self-Determination Theory principles, is a promising strategy for promoting youth sport. However, the few existing interventions aimed to promote girls' physical activity through sport were developed outside the United States, focused on adolescent (versus younger) girls, and/or conducted among urban or suburban youth, limiting generalizability. Rural, Hispanic girls face unique challenges around sport that should be identified and addressed, yet there remains a paucity of information on determinants of sport participation among this population.

This study aims to to develop, tailor, and examine the impact of a tailored Boys \& Girls Clubs (BGC) sport sampling and physical literacy program on rural girls' physical activity levels. BGC is an organization that provides learning and leadership programs to millions of rural youth nationwide, about half of whom are girls.

This study will enroll Hispanic girls ages 8-10 living in rural Imperial County, California. The first aims are to develop and refine a 12-week sport sampling and physical literacy intervention entitled "Girls Positive Learning Activities for Youth", or "Girls PLAY". The Girls PLAY intervention will be delivered as Boys \& Girls Clubs programming, and intervention delivery will be grounded in Self-Determination Theory. We will then examine the feasibility of the 12-week Girls PLAY intervention. Secondary outcomes of physical activity levels, physical literacy, Self-Determination Theory constructs, and sports participation will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* living in Imperial County, California
* identify as female
* aged 8-10 years old
* enrolled at a participating Boys \& Girls Club site

Exclusion Criteria:

* has a sibling enrolled in the study
* physical or mental impairment that would preclude physical activity or protocol compliance
Efficacy of Combined Interferential Therapy and Electronic Cupping Therapy for Chronic Constipation Management

Constipation is a common gastrointestinal issue affecting individuals worldwide. Interferential therapy, a form of electrotherapy, has been suggested to have potential benefits in improving gastrointestinal motility and relieving constipation symptoms. Introducing of a new method like electronic cupping therapy with interferential therapy may optimize the therapeutic outcomes by potentially increasing bowel movements and improving overall gastrointestinal function.

Objective: The purpose of this study was to assess the effectiveness of a combined treatment regimen that includes interferential therapy and electronic cupping therapy on the symptoms of chronic constipation, as well as gastrointestinal health outcomes.

Methods: This study involved 110 patients with chronic constipation, consisting of 60 females and 50 males, ranging in age from 20 to 40 years. Each participant underwent evaluations using Abdominal Ultrasonography and a standardized constipation scoring system. All participants were allocated into three groups; Group (A) received interferential therapy with aerobic exercises, Group (B) received electronic cupping therapy and aerobic exercise in the form of treadmill exercise and stationary bicycle 3 sessions/week for four weeks, and Group (c) received interferential therapy, electronic cupping therapy in addition to aerobic exercises.

Eligibility Criteria:
Inclusion Criteria:

* history of Chronic Constipation (CC), as defined by either experiencing two or fewer Complete Spontaneous Bowel Movements (CSBMs) per week for a minimum of 6 consecutive months before the screening visit
* Reporting a sensation of incomplete evacuation or straining during at least a quarter of their bowel movements (according to the generally accepted definition of constipation).
* Patients must have had CC persisting for more than 6 months, failed to respond to or be intolerant of medical treatment for at least 3 months

Exclusion Criteria:

* pregnant or lactating women
* Chronic Constipation (CC) resulting from anorectal malformations such as colorectal or anal organic lesions, pelvic floor disorders requiring surgical intervention as determined by the investigator (such as rectal prolapse, rectocele, or enterocele)
* presence of implanted electronic devices like cardiac pacemakers, defibrillators, cardiac pumps, or spinal stimulators
* CC attributable to medications or neurologic, endocrine, or metabolic conditions
* prior history of partial colectomy; conditions like megacolon, megarectum, or colonic inertia
* skin abnormalities that hinder the placement of electrodes
* women lacking adequate contraception (hormonal or intrauterine device).
Stem Cell Transplantation for Patients With Multiple Myeloma

The purpose of this study is to test whether regulatory T-cell reduction is possible and safe in myeloma subjects undergoing autologous stem cell transplantation (ASCT).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic multiple myeloma of any subtype in any disease stage, providing that patient does not have smoldering myeloma.
* Patient must otherwise be a candidate for ASCT as determined by treating physician.
* No current CNS Myeloma at time of enrollment.
* Life expectancy greater than 12 weeks.
* Age greater than or equal to 21 and less than or equal to 70 years old.
* EGOG performance status less than or equal to 2.
* No cardiac, pulmonary, hepatic, or renal contraindications for high dose chemotherapy.
* HIV Negative.
* No active Hepatitis B or C.
* Patients must be able to provide written informed, consent.

Exclusion Criteria:

* Pregnant or nursing women. Women of child-bearing age must be tested for pregnancy.
* Use of systemic immunosuppressive medications, including corticosteroids, tacrolimus, mycophenolate mofetil, sirolimus or cyclosporine A.
* Psychiatric illness which may make compliance to the clinical protocol unmanageable or which may compromise the ability of the patient to give informed consent.
* Active autoimmune disease including but not limited to: rheumatoid arthritis inflammatory bowel disease, celiac disease, systemic lupus erythematosis, scleroderma or multiple sclerosis.
A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+

The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage.

This was a single center, single-cell, 12-week clinical trial on female subjects (Fitzpatrick Skin Type I-VI, evenly distributed) between 35-60 years of age with moderate to severe overall facial photodamage. All subjects were provided Revision Skincare Gentle Foaming Cleanser and Facial Moisturizer (Goodier Cosmetics) at the Screening visit after eligibility was confirmed. These products were used twice daily as instructed for a minimum 3 days prior to the Baseline visit (washout phase). At Baseline, subjects were given Sunscreen Moisturizer SPF 50+ to replace their Facial Moisturizer morning application. Subjects continued to use the Facial Moisturizer given at Screening in the evening.

Clinical grading assessments, full face images, Corneometer, Ultrasound, and subject self-assessment questionnaires were completed at each study visit (Baseline, Week 4, 8, and 12). Full face images were also completed post-application at Baseline.

A total of 34 subjects completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 35 and 60 years
* Women with Fitzpatrick skin type I-VI
* Subjects must have moderate to severe overall facial photodamage
* Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria:

* Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients in the study product(s).
* Subjects who are currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response.
* Subjects who are nursing, pregnant, or planning a pregnancy during this study
* Subjects who have a health condition and/or pre-existing or dormant dermatologic disease on the face
* Subjects who are not willing to avoid daily sun exposure on their face and the use of tanning beds or sunless tanning products during the duration of the study.
* Is currently taking or have taken within the listed time frame prior to the start of the study: Oral isotretinoin (Accutane®) within the last 6 months; Avita®, Differin®, Renova®, Retin-A®, Retin-A Micro®, Soriatane®, or Tazorac® within 3 months; Prescription-strength skin-lightening products within 4 months; Any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within 2 weeks; Had a non-ablative laser (Including IPL) or non-ablative fractional laser resurfacing of the face and neck within 6 months
* Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.
Expanded Access for Anti-IL8

This is an expanded access designed to provide access to Anti-IL8 for eligible participants.


Eligibility Criteria:
Diaphragm Training Post-Cardiac Surgery

Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both.

Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases.

Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung function tests.

Eligibility Criteria:
Inclusion Criteria:

* post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement

Exclusion Criteria:

* heart failure
* COPD
* neuromuscular disease
Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID-19.

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.

The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.

This include both children and adult subjects, subject without social security, and healthcare workers.

Procedures added by the research:

Blood sampling for determination of the presence of SARS-CoV-2 type M immunoglobulins or type G immunoglobulins.

Blood sampling for whole exome sequencing

Eligibility Criteria:
Inclusion Criteria:

* High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
* Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
* Obtaining informed consent.

Exclusion Criteria:

* Subject included in the CoV-CONTACT study
* Subject deprived of freedom
* Subject under a legal protective measure