cyrilzakka/clinical-trials huggingface dataset:
Effects of Combined High Intensity Interval Training and Resistance Training

Background: Hypertension has long been considered as a major risk factor for cardiovascular disease representing a high public health concern.

Objectives: the purpose of this study is to evaluate the effects of combined HIIT and resistance training on body composition, blood pressure, and cardiorespiratory fitness in obese hypertensive men.

Methods: This study will make use of sixty obese hypertensive men aged 40 to 60 years. All participants meeting the eligibility criteria will be assigned to one of three groups; combined HIIT and resistance group, HIIT only group or control group. Combined exercise group subjects will undergo weekly three sessions of both HIIT and resistance training for sixteen weeks. The HIIT session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the HRmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the HRmax. The resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-RM. The HIIT only group perform 12 weeks of HIIT only. The control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. Body composition measures, blood pressure and VO2peak will be assessed at baseline and at the end of the study period.

Results: All the outcome variables will be assessed at baseline and 12 weeks following the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* men aged between 40 and 60 years old,
* have been diagnosed with clinical stage 1 or 2 hypertension,
* being obese with body mass index more than 30 kg/m2
* physically inactive

Exclusion Criteria:

* musculoskeletal problems that may limit their ability to participate in resistance or HIIT programs
* diabetes mellitus
* a history of respiratory or chronic heart disease
Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients

Participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.

In all patients, 12 ml of blood sample will be collected in EDTA tube for analysis of biological biomarkers in different time points.

Participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.

Group 0 (set-up): blood sampling and rectal swab will be collected at a single time-point during the PC treatment. No follow-up is required.

Group 1a (control): the first blood sampling will be performed within 4 weeks since the negative biopsy; subsequent samplings will be done according to a schedule comparable to that of Group 1 up to 1 year or evidence of tumor, whichever occurs first.

Group 1, Group 2 and Group 3: the first blood sampling will be performed before radical treatment or HT start or CT start, on the basis of the planned antitumor therapy; subsequent sampling will be done after radical intervention at 4 weeks (only for Group 1) and then every 3 months (or more frequently if clinically indicated), up to 3 years or evidence of tumor recurrence/progression (radiological or biochemical), whichever occurs first.

At the time of recurrence/progression, patients of Group 1 could become part and could be followed as per Group 2, and patients of Group 2 could become part and could be followed as per Group 3.

Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria (for entering all groups)

* Age ≥ 18 years
* Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated
* Written Informed Consent

Inclusion criterion only for entering Group 0

• Patients with a known diagnosis of CSPC or CRPC

Inclusion criterion only for entering Group 1a

• Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer

Exclusion Criteria:

General exclusion criteria (for entering all groups)

* Active infection requiring treatment
* Decrease of general condition
* Concomitant severe comorbities
* Difficult socioeconomic conditions making regular follow up unfeasible.
* Need of concomitant steroids at study entry and during the study
* Diagnosis of second tumor in the previous 5 years

Exclusion criterion only for entering Group 0

• No antibiotic treatments in the previous 2 months before enrollment

Exclusion criteria only for entering Group 1

* Previous radical surgery and / or radical radiotherapy
* Previous hormonal treatments

Exclusion criteria only for entering Group 2

* No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics)
* Previous hormonal treatments for advanced disease

Exclusion criterion only for entering Group 3

• No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)
Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools

Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.


Eligibility Criteria:
Inclusion Criteria:

* Boy or girl between 6 and 15 years old
* Confirmed diagnosis of cerebral palsy
* GMFCS class\> 3
* Parents and child agreement

Exclusion Criteria:

* Pharmacological treatment of sleep disorders
* Diurnal and / or nocturnal ventilatory support
* Difficulty understanding and / or participation
* Subjects under 6 and over 15
* Refusal to participate
* Not affiliated with and not a beneficiary of a health insurance plan
Montessori Based Activities for Dementia

The objectives of this study are to examine the feasibility of a culturally-adapted group-based Montessori Method for Dementia program in Chinese community and examine its effects on engagement and affect in community-dwelling people with dementia.

People who were aged 60 years or over and with mild to moderate dementia were recruited from six community centres and three care homes. Participants were randomly assigned to either the intervention group to attend the Montessori-based activities or the comparison group to attend the conventional group activities for one hour twice per week over eight weeks. All sessions were videotaped to facilitate analysis. Observations of engagement and affect were conducted for each intervention session on the individual participant for a ten-minute period at the beginning, middle, and end of the activity in order to have observations from multiple time points. The Menorah Park Engagement Scale and the Apparent Affect Rating Scale were used to assess the engagement and affect during the activities based on observations.

Eligibility Criteria:
Inclusion Criteria:

* with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (GDS)

Exclusion Criteria:

* were joining any other dementia training activities
* would highly likely present a hazard to others through disruptive behaviors
* proxy consent could not be obtained
Comparion of Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoskopic Cholecystectomy

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Quadratus Lumborum block (QLB) type 2 is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and QLB in laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic Cholecystectomy, ASA status 1-2

Exclusion Criteria:

* Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders
Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients

This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.

Exposure to sufficient daylight indoors is a novel and potentially effective nonpharmacological treatment option for reducing depression and other neuropsychiatric symptoms for people living with dementia in long term care facilities. However, there are currently no minimum requirements for daylight access in care facilities. In urban settings, it is common for residents to spend the majority of the day indoors, illuminated by electrical light sources that deliver light with significantly lower intensities and reduced spectrum compared with daylight.

A 12-week pilot study was conducted in 8 dementia care facilities involving (n = 83) participants addressing the hypothesis that an intervention increasing indoor exposure to daylight will reduce depression and other neuropsychiatric symptoms. At 4 facilities, staff was enlisted to increase daylight exposure by taking participants to a perimeter room with daylight exposure for socialization in the morning (8:00 - 10:00 AM) each day. At the other 4 facilities, a control group were taken to a similar sized area without daylight for socialization under typical electrical lighting conditions. Outcome measures for depression and other neuropsychiatric symptoms were taken at the beginning and end of the 12-week study.

Eligibility Criteria:
Inclusion Criteria:

* Residents were recruited according to the trial inclusion criteria: 1) Alzheimer's disease and related dementias (ADRD) diagnosis, 2) no physical co-morbidities that precluded participation in the daily group intervention, and 3) a Mini-Mental State Exam (MMSE) score of 10 or higher

Exclusion Criteria:

* physical co-morbidities that precluded participation in the daily group intervention
Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track

To compare mobile sperm extraction rate between microTESE and conventional TESE in 18-50 years-old men with non obstructive azoospermia.

About one in ten couples cannot have children without medical assistance. Male factors for infertility are identified in half cases with 10% azoospermia, non-obstructive in most cases. Up to date, testis surgical sperm retrieval for use in ICSI-IVF is the only possibility for those men to have children with their own sperm. Several options are available for surgically retrieving sperm from testis: During conventional testicular sperm extraction (cTESE), the testis is exposed through a small incision, then 1 or more biopsies are randomly made. Up to date, cTESE is considered as the gold-standard for sperm extraction in this population.

However, the success of surgical sperm extraction concerns a man out of two having cTESE for non-obstructive azoospermia.

On the other hand, Schlegel showed in 1997 that cTESE induces a significative loss of testicular tissue with possible impact on male endocrine balance with occurence of hematomas, inflammatory reshuffles and ischaemic lesions, compromising some regions in the testicular parenchyme. Another option for surgical sperm extraction is micro-surgery called microTESE (or µTESE). It consists in examining the testicular parenchyme under a high-power microscope (up to 25 magnification), screening for white opaque tubules with higher diameter which indicates possible active spermatogenesis. The benefits of µTESE are: (1) a better identification of sites of sperm production in the testis, (2) a better preservation of testicular vasculature decreasing the risk of postoperative hematoma or tissue ischemia and (3) excision of 3 to 10 times less tissue.

Nevertheless, no randomized studies have compared both techniques to validate such an assumption. In 2014, the results of a meta-analysis performed by Deruyver showed that, among the 7 original articles comparing cTESE to µTESE, 3 were retrospective studies and the remaining 4 prospective studies were not randomized.

It is highly unlikely that this better outcome is related to patient selection. Nevertheless, the relatively small number of studies comparing both methods makes it difficult to draw definitive conclusions This study is based on the hypothesis that µTESE is a superior technique than cTESE with a difference of 20% like observed in Deruyver's meta-analysis.

The principal objective is to compare motile sperm extraction rate between μTESE and cTESE in 18-50 years-old men with NOA.

Eligibility Criteria:
Inclusion Criteria:

* 2 consecutive spermograms (with ±3 months interval) confirming absence of sperm (azoospermia)
* diagnosis of non-obstructive azoospermia on the basis of a complete history, physical examination, endocrine profile, ultrasound and chromosomal analysis

Exclusion Criteria:

* History of previous testicular surgery, except orchiopexy for undescended testis.
* Monochordy
* Ultrasound revealed testicular nodule
* Y chromosome microdeletions type AZFa and b.
CUIDA-TE, an APP for the Emotional Management

The aim of this study is to develop and validate an Ecological Momentary Intervention APP for healthcare workers, in order to face of work-related stresses generated by the COVID-19 pandemic.

The COVID-19 pandemic has had a very high emotional impact on healthcare workers. Ecological momentary interventions (EMI) can offer an intervention in real time, when the emotion arises. CUIDA-TE is an EMI APP based on principles of different transdiagnostic cognitive behavioral interventions focused on emotion regulation. The effectiveness of CUIDA-TE will be investigated in the current study. A two-arms randomized controlled trial (RCT) will be conducted. At least 182 healthcare workers will be randomly assigned to a 2-month immediate intervention group (CUIDA-TE APP, n= 91), or a control group (no assessment or intervention, n=91). The CUIDA-TE consists of an app-based EMI that estimates and intervenes based on ecological momentary assessment data of five emotional states: joy, fatigue, sadness, anxiety, anger, as well as sleep quality, sleep quantity, burnout, perceived stress, and self-perception of coping skills. The primary outcome is the PHQ-9. Secondary outcomes include ERQ, DERS, OASIS, BRS, SUS, and ProQOL questionnaires. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at 3-month follow-up measurement.

Eligibility Criteria:
Inclusion Criteria:

* to be a healthcare worker in active (from 18 until 67 years)
* to have a smartphone with Internet access and Android operating system.

Exclusion Criteria:

* to be in psychological treatment at the time of the recruitment
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy

The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline
* Agree to use a double-barrier method of contraception during their participation in this study

  * condoms (with spermicide) and hormonal contraceptives OR
  * condoms (with spermicide) and intrauterine device OR
  * intrauterine device and hormonal contraceptives OR
* Abstains from sexual intercourse during their participation in this study
* Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
* Have a full-thickness trauma wound that is between 1.2cm2 and 24cm2 at initial screening
* Be able to apply study drug to their wound, or have a reliable and capable caregiver do it
* Subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (TcpO2) of \>30mmHg recorded over intact epidermis at the wound margin.

Exclusion Criteria:

* Less than 18 years of age
* Pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
* Allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
* Tested positive for a doxycycline-resistant infection
* Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months
* Currently undergoing dialysis for renal failure
* Have participated in another clinical research trial within the last 30 days
* Subject has wounds resulting from any cause other than trauma (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult)
* Active or previous (within 60 days prior to the study screening visit) chemotherapy
* Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo
* Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits
* The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
* History of sickle cell anemia
* History of infection with Human Immunodeficiency Virus
* History of other immunodeficiency disorders
* Severe anemia - Hgb \< 7 g/dl (males) or \< 6.5 (females)
Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial

The goal of this clinical trial is to learn if Computer Controlled Local Anesthetic Delivery (CCLAD) results in lower pain during local anesthesia administration for infiltration in the buccal region of the upper jaw in patients between 6 and 16 years old who will receive a dental treatment.

The main questions it aims to answer are:

* Does CCLAD result in lower self-reported pain (Visual Analogue Scale (VAS) and Face Pain Scale-Revised (FPS-R)) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment?
* Does CCLADD result in lower observed pain (Sound Eye Motor Scale (SEM)) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment?
* Does CCLAD result in lower hearth rate (HR) and galvanic skin response (GSR) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment? Researchers will compare CCLAD (Dentapen, Septodont, France) to conventional local anesthesia infiltration with a metallic syringe to see if the infiltration is less painful in patients between 6 and 16 years old who will receive a dental treatment.

Participants will receive local anesthesia either with the Dentapen or metallic syringe.

* GSR and heart rate are measured before anesthesia, during needle insertion, at 0.3 - 0.6 - 0.9ml, and after anesthesia.
* Post-injection, the child provides VAS scores (if 8 years or older) and FPS-R (all patients).
* A researcher not administering the injection determines the SEM score.


Eligibility Criteria:
Inclusion criteria:

* Patients between the ages of 6 and 16 years
* Requiring a buccal injection with local anesthesia for dental treatment, bilaterally in the upper jaw
* Treatments: restorative filing, pulpotomy, extraction or a steel crown placement
* At least one week between both treatments
* Complying with the criteria of ASA I (ASA classification of The American Society of Anaesthesiologists, 1963)
* Fluent in Dutch
* Children who had a score of 3 or higher on the Frankl scale

Exclusion criteria:

* Contraindications to inject Local anesthesia (allergy to the liquid, ...)
* Patients referred because of needle phobia or behavior management problems
* Refusing to sign the informed consent
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Histological diagnosis of cancer
* Locally advanced or metastatic, biopsiable disease
* ECOG Performans Status ≤2
* Affiliation to social security
* Signed informed consent.

Exclusion Criteria:

* Emergency, Individually deprived of liberty or placed under the authority of a tutor
* Patients with symptomatic or progressive brain metastasis
* Patients who have only bone and/or brain metastases
* Pregnant or breastfeeding women