cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Integrating Physically Active Learning Through Co-teaching in Extremadura: ACTIVA-MENTE Project

Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents.

Activamente is a quasi-experimental study coordinated by fully qualified researchers in physical activity and sport sciences from the University of Extremadura (UEX), Spain. This study is aimed at students from 1st to 4th year of Secondary Education (11-16 years old), belonging to 10 schools in the Autonomous Community of Extremadura. Each school will have five experimental groups and five control groups. Thus, there will be 50 experimental groups (n=1100) and 50 control groups (n=1100). The intervention will last 8 months, and will consist of one component, which is the inclusion of one physically active class per week.

Before and after the intervention, physical activity and sedentary time will be assessed by activity bracelets, health-related fitness levels by field tests, body composition parameters by anthropometry, academic performance by school grades, positive health (quality of life and self-perception of health) by questionnaire, and cognitive parameters (executive functions) by specific cognition tests. In addition, two intermediate measures of physical activity levels and sedentary time will be measured.

At the end of the intervention the investigators will determine changes in the main outcome variables. Also, the main hypotheses raised will be:

1. Students belonging to the experimental group will improve physical activity and decrease sedentary time during the school day when compared to students belonging to the control group.
2. The students belonging to the experimental group will improve in the markers of physical and psychological health when compared to the students belonging to the control group.
3. Students in the experimental group will improve their academic and cognitive indicators when compared to students in the control group.
4. Students belonging to the experimental group will improve school climate and motivational variables in academic classes when compared to students belonging to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents in 1st, 2nd, 3rd and 4th year of ESO.
* Adolescents with informed consent signed by the family/guardian.
* Schools with at least 210 students enrolled in 1st, 2nd, 3rd and 4th year of ESO.
* Schools belonging to the Autonomous Community of Extremadura.

Exclusion Criteria:

* Adolescents with any physical disability or health condition that may limit physical activity levels.
* Schools participating in any other physical activity or health promotion program.
Use of Facilitated STAIR Coach in Kenya

The specific aim of this project is to examine the feasibility of using a low cost, low intensity, mobile app-based intervention teaching emotion regulation and interpersonal skills to improve general well-being for those with probable post-traumatic stress disorder (PTSD) in Kenyan clinics.

The aim of the present study is to examine the feasibility of the use of the Skills Training in Affective and Interpersonal Regulation (STAIR; Cloitre et al., 2020) Coach mobile app delivered through a mobile app for individuals with probable post-traumatic stress disorder (PTSD) in Kenya. This pilot study will recruit a total of 10 participants with probable PTSD. Participants will complete 10 modules focused on learning skills to improve interpersonal functioning and emotion regulation. The sessions will be facilitated by a mental health worker trained in STAIR. Participants will complete baseline (week 0), mid-treatmnet (week 5), post-treatment (week 11), one-month (week 15) and 3-month (week 23) follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* criteria

  1. 18 years of age or older
  2. ability to complete the study in English
  3. agreed to be contacted for follow-up studies when consenting to the parent study
  4. not currently enrolled in another form of psychotherapy
  5. if currently prescribed medications, participants must be on a stable dosage of psychotropic medications (i.e., prescribed on stable dose for 1 month or more)
  6. have a score of 33 or higher on the PCL-5 lifetime score in the parent study

     Exclusion Criteria:

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  1. less than 18 years of age
  2. unable to complete the study in English
  3. did not agree to be contacted for follow-up studies when consenting to the parent study
  4. diagnosed with a psychotic disorder, unmedicated bipolar disorder, or severe substance-use disorder
  5. experiencing ongoing long-term trauma as it is a contraindication for trauma focused treatment
  6. experiencing acute levels of alcohol or is under the influence of an illegal substance, demonstrated by inpatient medical care for alcohol or substance abuse
  7. participant is not competent to consent to the study as measured by the UBACC in the parent study
  8. During parent study assessment (IRB23-0211), the participant receives a PCL score less than 33
  9. Participant is receiving inpatient psychiatric care at the time of the study or experiencing involuntary detention
Results of Cold Stored Allografts in Vascular Access

Vascular access creation in patients with renal failure requiring long-term hemodialysis can be a challenge when there is no more autologous material or in case of infection, in a population undergoing long term dialysis with a longer life-expectancy. Many types of grafts have been used, with its advantages and drawbacks, such as prosthetic grafts (PTFE). Over the past decade, surgeons have used cold stored venous allografts as a biological conduit for hemodialysis, with the idea of avoiding most of major complications including a lower incidence of infection and steal syndrome, with patencies at least equivalent to PTFE. There is only a few data in the litterature, but many surgical teams use it when there is no autologous material or in case of infection.

The aim of the study is to give the primary patency of vascular access with this technique, and to assess its long term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* End stage renal failure patient requiring hemodialysis
* With the placement of a venous allograft for a hemodialysis approach
* Who underwent a surgery between January 1, 2014 and December 31, 2018 in a vascular surgery department participating in our study

Exclusion Criteria:

* Patient \<18 years old, or under guardianship / curatorship
* Patient objecting to the use of his personal data in the context of research
Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas

Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important components in decision making and follow-up of patients diagnosed with this disease.

These tumor markers were found to be elevated not only in the serum but also in other body fluids in patients with malignant lesions of the parotid gland and the urinary tract. The authors have described in a previews small preliminary study a positive and a strong linear correlation between the levels of CA19-9 in urine and saliva with those presented in the serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to enlarge the study population to confirm the previous results and standardize the measured levels of CA19-9 in these body fluids.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Proven diagnosis of ductal adenocarcinoma of the pancreas
* elevated levels of CA19-9
* possible elevated levels of CEA

Exclusion Criteria:

Controls:

* Previous diagnosis of malignancy
Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)

The hypothesis of this study is to show that after laparoscopic digestive surgery in obese patients (BMI\>30kg/m2), the wearing of an abdominal support belt is an effective treatment for the Incisional Hernia and feasible in terms of compliance, quality of life and patient satisfaction

The study will be conducted at the Institut Mutualiste Montsouris, it is planned to include 350 patients in 12 months, the duration of participation of each patient is 24 months.

An orthopaedist will see patients in consultation to take their measurements, patients complete a quality of life questionnaire (the SF 36), when they are admitted for surgery.

After surgery, patients begin wearing their belts according to the instructions given by the surgeon during hospitalization:

* Start wearing the belt as soon as possible.
* wear it according to its recommendations: all day, every day of the week and for two months.

Patients should record the number of hours they would have worn their belts in the EVINOV logbook each day.

The studu Co will contact patients by phone every two weeks for the 2 months they will be wearing the belt.

At the one-month post-operative consultation, the patient will complete a quality of life questionnaire again (the SF 36).

Two months after surgery, patients receive a final SF 36 questionnaire by mail, with a satisfaction scale to evaluate their overall feeling around the period of wearing the abdominal belt. Patients are asked to return these two documents, as well as the EVINOV logbook.

The latest health data collection is the imaging data from the abdominal CT scan at 24 months, which will show the presence or absence of an incisional hernia.

Eligibility Criteria:
Inclusion Criteria:

* Must be ≥18 years of age.
* Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study.
* Having a BMI \>30kg/m2.
* Affiliated to health insurance regimen.
* Having undergone laparoscopic digestive surgery

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Patient under guardianship or unable to give consent.
* People particularly protected by French law.
* Having undergone laparoscopic digestive surgery with ileostomy or ostomy closure.
Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Eligibility Criteria:
Inclusion Criteria:-

* Be between 16 and 45 years of age (inclusive)
* Adapted soft contact lens (CL) wearers (i.e. \> 1 month)
* Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
* Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
* Correctable to 6/9 (20/30) in both eyes
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
* Have read, understood and signed the informed consent
* Willing to comply with the wear schedule (at least 40 hours per week)
* Willing to comply with the study visit schedule

Exclusion Criteria:-

* Any active corneal infection, injury or inflammation
* Systemic or ocular allergies, which might interfere with CL wear
* Systemic disease, which might interfere with CL wear
* Ocular disease, which might interfere with CL wear
* Strabismus, amblyopia
* Subjects who have undergone corneal refractive surgery and any anterior segment surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant or lactating
* Use of systemic/topical medication contraindicating CL wear
* Use of gas permeable contact lenses within the last month
* Employees of the investigational site or immediate family members of Investigators
* Participation in any concurrent clinical trial or in the last 30 days
Validation Of Cambodia Version of Five Minutes Hearing Test

Seek the simple tool as questionnaire for screening hearing loss. The FMHT was developed by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). It is a standard hearing questionnaire. So, we plan to translate the FMHT into Cambodian language and validate by comparing its result with those of audiometry.

Primary Objective:

To assess sensitivity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Secondary Objective: To assess

1. Specificity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
2. Likelihood ratio of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
3. Predictive value of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old
* Able to read and understand Khmer language
* Volunteer to participated

Exclusion Criteria:

* Aphasia patients
* Patients with severe mental disability
* Patients with other conditions that preclude audiometry
The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section

Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.

To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.

Eligibility Criteria:
Inclusion Criteria:

* pregnant 37-41 weeks
* one fetus
* scheduled for C/S under spinal anesthesia
* accepting to participate

Exclusion Criteria:

* Emergency surgery
* placenta previa
* preeclampsia
* cardiovascular and cerebrovascular comorbidities
* morbid obesity (BMI\>40)
* pregnancy weeks \<36 and \> 41
* The use of vasoconstrictors
* Severe Anemia ( Hb \<9 g/dl)
* Refusal or known contraindication for spinal anesthesia
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
* Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
* Eastern cooperative oncology group performance status of 0 or 1
* Women of childbearing potential must agree to follow methods of contraception

Exclusion Criteria:

* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Uncontrolled or significant cardiovascular disease
* History of or with active interstitial lung disease or pulmonary fibrosis
* Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
* History of allergy or hypersensitivity to study drug components

Other protocol-defined inclusion/exclusion criteria apply
Study on Clinical Program Optimization of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs)

A multicenter, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml) to enter this study, and to compare the feasibility, effectiveness and safety treated with Pegylated Interferon α2b Continuous therapy or Pulse therapy in immune-controlled chronic hepatitis B patients.

Patients:chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml). The study patients were divided into two groups.Group A (PEG IFN α- 2b continuous group): PEG IFN was injected subcutaneously once a week from the first day of baseline α- 2b 180 μg. The total course of treatment should not exceed 96 weeks.Group B (PEG IFN α- 2b pulse group): from the first day of baseline, PEG IFN was injected subcutaneously α- 2b 180 μg. Every 8 weeks of injection, stop for 4 weeks, and conduct it periodically.Two groups at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72weeks, 84 weeks, 96 weeks and the 12th and 24th weeks after drug withdrawal, and corresponding examinations were carried out at each follow-up.Check and record adverse events and concomitant medication in detail, and evaluate the compliance of subjects; Blood samples were retained and transported to the laboratory for HBV at baseline, 24 weeks, 48weeks, 72, 96, and 12 and 24 after drug withdrawal.DNA quantification and detection of hepatitis B virus markers.The efficacy and safety were evaluated after the study.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years, both male and female (including 18 and 65 years old);
* HBV DNA≤2000 IU/ml and HBeAg negative;
* HBsAg positive for more than 6 months, and HBsAg≤1000 IU/ml;
* ALT≤ULN at screening (discontinue liver-protecting enzyme-lowering drugs for at least 2 weeks);
* A negative urine or serum pregnancy test (for women of childbearing age) within 24 hours before the first dose;
* B-ultrasound or fibroscan suggest no liver cirrhosis;
* Willing to accept treatment and sign informed consent.

Exclusion Criteria:

* Participants with other hepatotropic viruses or human immunodeficiency virus co-infection;
* other chronic non-viral liver diseases or decompensated liver diseases;
* tumours;
* drug abuse;
* severe psychiatric disease;
* uncontrolled thyroid disease or diabetes;
* pregnancy or lactation.
The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment

Efficacy of Ivermectin in larger doses in COVID-19 treatment

Clinical Study Evaluating the Efficacy of Ivermectin in higher doses in COVID-19 treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients with covid 19

Exclusion Criteria:

* Allergy or side effects to treatment
Gene-by-Stress Interactions in Intervention Studies Significance

The purpose of this study is to identify gene variants that increase risk of cardiovascular disease (CVD) and type 2 diabetes, particularly genes related to stress factors.

In Aim 3, 100 subjects who participated in previous studies will be recruited to test the ability of a 5HTR2C agonist (lorcaserin) to increase and antagonist (ziprasidone) to reduce cortisol response to mental and metabolic stress in men carrying the rs6318 C allele and women in the rs6318 CC genotype of 5HTR2C. Lorcaserin is serotonin receptor agonist indicated for use as a weight loss drug. Ziprasidone is an antipsychotic indicated for treatment of bipolar disorder. Subjects will be treated with a single dose of each drug, 1 to 2 weeks apart, followed by a mental stress test and an oral glucose tolerance test with multiple blood draws. Each subject will also receive a placebo drug during one of the study visits.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who have been enrolled in the STRRIDE, ENHANCED, and/or REMIT studies age 18 years or greater.
* Ability and willingness to provide informed consent.
* Individuals with specific genotypes as determined from our previous work on their samples through Aim 1 of this project.

Exclusion Criteria:

* Women who are known to be pregnant, intend to become pregnant, or breast-feeding will be excluded. Women who are of child bearing potential (under age 55) will be informed that they will need to have their urine tested for pregnancy and that they should not participate in the research if they are not willing to have the Investigators provide them with information on positive pregnancy test results. Subjects will be informed that the pregnancy testing is not being performed for clinical purposes and that the testing is not a substitute for their regular medical care if they need to know whether or not they may be pregnant.
* History of Type II diabetes mellitus.
* History of prolonged QT interval.
* Participation in an investigational drug trial within the last 30 days.
* Already taking either ziprasidone or lorcaserin or any potential confounding medications, for example, other weight loss medications or psychotropic medications.
* Unwillingness to fast for at least 6 hours prior to the research study visit.
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness\>350 μ ) were entered in the study. One eye went randomly under PRK with mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC. UCVA,BCVA, refractory error after the operation and the number of endothelial cells before and after the surgery would be compared in 6 months.


Eligibility Criteria:
Inclusion Criteria:

* 19 \< age \< 60
* Refractory error stabled for at least one year
* No corneal pathology
* -3 \< bilateral myopia and astigmatism \< -5 with no difference more than 0.75 between 2 eyes

Exclusion criteria:

* Keratoconus
* Ectatic corneal disease
* Glaucoma
* Corneal dystrophy
* Lens changes affecting the visual acuity
* Anterior or posterior uveitis
* Corneal scar