cyrilzakka/clinical-trials huggingface dataset:
Mental Health Training for Elementary Teachers Through Tele-education and Its Impact on the School Atmosphere

The purpose of this study is to create a web-based interactive educational environment to train elementary teachers, to identify children and adolescents in need of specialized mental health care and give them some advises in managing problematic children in class. After the creation of such an educational environment the psychoeducational project was tested in order to verify it's effectiveness.

Objectives: To develop and test the efficacy of a computer-based training to elementary school teachers of the most common mental health problems.

Outcomes: (a)early identification of the most common mental health problems among children and adolescents, (b)teacher's acquirement of manage skills to better deal with behavior problems and (c)teacher's acquisition of important knowledge to refer students to treatment when necessary.

Method: This research includes two steps: a pilot project (already implemented, whose data will be presented here) and a randomized clinical trial intervention (that will be implemented in a few months).

1. Pilot project, without control group - Comprehended six sessions of educational videos covering basic concepts of mental health stigma and the main disorders that affects children and adolescents followed by discussion forums, quizzes and a conclusion web conferencing with a specialist.
2. A randomized controlled trial with a sample of 176 teachers from nine elementary schools were randomly divided in three groups: a web-based interactive educational group (WBIE), a text and video-based educational group (TWBE) and a waiting list group (WL).

Outcome measures: knowledge, beliefs and attitudes of teachers in mental health and satisfaction with the training received.

Results: The results show that there was an increase in knowledge, attitude changes in mental health and reducing stigma among teachers of web-based interactive educational group. Indeed, comparing the three groups of study participants (WBIE, TVBE and WL), was verified that TVBE group compared with WL group did not show a significant statistical difference (B = 0.957, p = 0.127). Comparing WBIE with WL group, the WBIE answers correctly 1:44 (B = 1.44, p = 0.015). Regarding beliefs and attitudes, WBIE group increased significantly in the ability to identify children with mental health problems, search for mental health information, the ability to recognize colleagues with mental health problems. The average confidence in helping a student with mental health problems also showed increased after psychoeducational intervention in WBIE group.

Discussion: After adjusting educational tools, the methodology and with a bigger sample it's expected to have greater positive results. It's very important to offer teachers a basic apparatus so that they will be able to deal with mental health issues in schools.

Eligibility Criteria:
Inclusion Criteria:

* Primary Public Schools of Campos do Jordão City
* Internet Access

Exclusion Criteria:

* none
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).


Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of allergic asthma, uncontrolled on current medication.
* History of at least 2 asthma exacerbations during the last 1 year
* Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator.

Key Exclusion Criteria:

* Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
* Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Duet TRS Used in Pulmonary Resections

The objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as \> 5 days by the Society for Thoracic Surgery) when using the ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs) buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy or segmental resection. Results of the study will be compared to contemporary literature for a similar population.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be 18 years of age or older
* The patient must be scheduled to undergo segmentectomy or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer
* The patient must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure
* The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.

Exclusion Criteria:

* The patient is pregnant or breastfeeding
* The patient is scheduled to undergo sleeve lobectomy, wedge resection, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease
* The patient has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected
* The patient is scheduled to receive intra-operative brachytherapy
* The patient has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months
* Re-operative surgery is excluded if it is on the same side as the previous surgery
* The patient requires chest wall reconstruction
Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block in Hip and Proximal Femur Surgeries

Multimodal analgesia is used to control postoperative pain in hip surgery. Quadratus lumborum block is an effective regional anesthesia technique for hip and proximal femur surgery. The erector spinae plane block applied to the lumbar region was also reported to provide effective analgesia in these surgeons. In this study, we aimed to determine and compare the effects of quadratus lumborum block and lumbar erector spinae plane block on postoperative pain in hip and proximal femur surgeons.


Eligibility Criteria:
Inclusion Criteria:

- Hip joint and proxiaml femur surgery, ASA 1-2-3

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
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa

The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in South Africa. To do this, the investigative team will analyze PrEP initiation and retention data from the study's implementing partner, TB HIV Care, a non-profit organization providing PrEP to marginalized young women in South Africa. The effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (CRT).

The cluster randomized trial (CRT) will not engage in PrEP provision to individuals, but instead employs geographical regions to serve as units of randomization where social media content and community engagement will be targeted. TB HIV Care employs a large team to provide routine service delivery while the CRT tests strategies including a social media campaign and community engagement that may amplify PrEP uptake and persistence among the community, leveraging the programme infrastructure to actually provide services as it is already doing. Embedding strategies within the programme ensures that the existing results come from real world contexts and focuses on implementation of support strategies rather than clinical care provision. The CRT will be implemented across 10 districts, with 5 districts serving as control sites and 5 as intervention sites.

Eligibility Criteria:
Inclusion Criteria:

* Eligible to take PrEP per TB HIV Care programmatic criteria
* Engaged in TB HIV Care HIV prevention program

Exclusion Criteria:

* Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria
HIV Patients Cohort

The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it.

Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory chronic pathology centred on a long term care taking into account the complication of long-term treatment as well as the arisen of new problem bound to a prolonged survival and ageing. So the care is more and more in a prevention and screening approach with in particular the care of metabolic and cardiovascular complication due to antiretroviral treatment.

As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu Hospital it thus seems important to double this care optimization with a clinical research side. This will be done in constituting an HIV patient cohort including a blood sample collection to contribute to the vigilance of the complication to due the infection.

Our ultimate objective is to optimize the selection of the treatment. It is important to do it to be able to have, on many years duration, precise clinical information and biological sample allowing to realize later some assay and analyse the influence of some genetic markers.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years old,
* Patients with an HIV infection
* patients having given their written informed consent.
Oral Health and Risk Factors for Oral Disease

Oral health has improved considerably in recent decades in Sweden, as well as in other countries. However, despite great improvements with regard to periodontal disease and dental caries in recent decades, global problems still persist, and as a consequence of retaining natural teeth high up in age, the risk for oral disease increases.

Traditionally, the number of teeth has been a measure of good oral health, and the World Health Organization (WHO) stipulated goals of a minimum of 20 functional teeth at the age of 80 years have been reached in some industrialized countries. Oral Health means more than good teeth and is integral to general health. The relationship between oral and general health has been recognized. For example, periodontal disease is associated with diabetes and rheumatoid arthritis. The severity of periodontal disease and number of teeth have been associated with an increased burden of cardiovascular disease.

There is a lack of longitudinal studies of oral Health and risk factors for oral disease.

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* None
Evaluation of Zapperclick Device for Relief From Mosquito Bites

Mosquito bites commonly result in redness, swelling and itching. This study will determine if a device that emits a small piezo-electrical impulse can provide relief from these symptoms. Volunteers entering the study will have a mosquito bite on one forearm. Redness and irritation will be recorded periodically for 24 hours. Comparing data from subjects randomised to the treatment or a placebo device will be analysed to determine effectiveness of the product. We will also ask the subjects their view on how easy the product is to use and clarity of instructions provided.


Eligibility Criteria:
Inclusion Criteria:

* known rection to mosquito bites
* willing to attend clinic for 2 hours during measurements
* informed written consent

Exclusion Criteria:

* hypersensitivity to bites or stings
* atopic allergy
* pacemaker
* pregnant / breast feeding
* use of other medication including pain killers
Open Label Study of OTO-104 in Subjects With Meniere's Disease

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject has a diagnosis of definite unilateral Meniere's disease.
* Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

* Subject has an infection in the ear, sinuses, or upper respiratory system.
* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.
Misoprostol Dosing in BMI Greater Than 30

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

As of 2019, almost 1 in 4 women in the United States had their labor induced with almost 9 in 10 women requiring different methods to prepare their cervix for induction. There have been several research studies in the past designed to look at the fastest and safest method for labor induction, however very few studies have been done in women with a Body Mass Index (BMI) greater than or equal to 30 kg/m2.

Women with a BMI greater than or equal to 30 kg/m2, also classified as Obesity, are known to have longer labor induction times and experience more "failed" labor inductions requiring cesarean delivery (C-Sections). Obese women are also at a higher risk of developing complications during labor and postpartum such as excessive vaginal bleeding and infections.

Due to limited information, the American College of Obstetricians and Gynecologists (ACOG) currently recommends a standard dosing of 25 or 50 micrograms of vaginal misoprostol for labor induction in all women. However, there are studies which specifically compared the 25 microgram and 50 microgram misoprostol doses and found that women have significantly shorter time to deliveries without any harmful effects to mother or baby.

The investigators will conduct a randomized controlled trial to determine if 50 micrograms of vaginal misoprostol, when compared to the standard 25 micrograms, reduces the time from the start of labor induction to delivery in obese women. Women who are admitted to Labor \& Delivery for the purposes of labor induction will be randomized to undergo either 25 micrograms or 50 micrograms of vaginal misoprostol for cervical ripening. Women and their infants will be followed until the time of their discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton gestation
2. Age 18 years or older
3. Gestational age \>= 36 weeks
4. BMI \>= 30 kg/m2 at time of labor induction
5. Cephalic presentation (including successful external cephalic version)
6. Cervical dilation \<= 3cm
7. Intent to proceed with cervical ripening

Exclusion Criteria:

1. Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.)
2. Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.)
3. Multiple gestations
4. Gestational age \< 36 weeks
5. Non-reassuring fetal heart tracing
6. Evidence of clinical chorioamnionitis
7. Significant vaginal bleeding with concern for abruption
8. Prior cesarean delivery or uterine surgery
9. Major fetal anomaly or demise
10. Cervix \>3cm
11. No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.)
12. Uterine tachysystole (defined as \>= 5 contractions within a 10m period)
13. Fetal Growth Restriction (EFW \<= 5% or elevated/absent/reversed Umbilical Artery dopplers)
14. Inability to give consent (inability to read/write in English or Spanish)
The Aortic Valve DECalcification (AVADEC) Trial

Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps. A few attempts with medical preventive treatment have failed, thus presently the only effective treatment of aortic stenosis is surgery. This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). The investigators hypothesize that MK-7 supplementation will slow down the calcification process.


Eligibility Criteria:
Inclusion Criteria:

Participants in the Danish Cardiovascular Screening Trial (Trials. 2015 Dec 5;16:554) with an aortic valve calcification score above 300, but without aortic valve stenosis are eligible.

Exclusion Criteria:

* Known aortic valve disease (peak velocity ≥3.0 m/s)
* History of venous thrombosis or other coagulation disorders or use of vitamin K antagonists
* Disorders of calcium and phosphate metabolism
* A life-expectancy \< 5 years
Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.

IC = informed consent

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.

Eligibility Criteria:
Inclusion Criteria:

* For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
* Had to be undergoing pediatric endoscopy.
* English speaking

Exclusion Criteria:

* None.
Assessment of the Prognostic Value of the Thickness of the Quadriceps and Abdominal Muscles Measured by Ultrasound for 28-day Mortality in Postoperative ICU Patients

Ultrasound measurement of muscle thickness, particularly of the quadriceps, can be used to highlight a reduction in lean mass. Sarcopenia is annvoluntary loss of lean mass, and it is a frequent and major problem in the intensive care unit (ICU). Sarcopenia is associated with significant morbidity and mortality, as previously demonstrated by CT scan measurements.

Nevertheless, due to its nature and cost, it does not appears reasonable to perform CT sarcopenia evaluation in all ICU patients. Described in the literature as evolving rapidly upon admission to ICU, accurate assessment of this loss of muscle mass would allow early detection of sarcopenia and adaptation of therapeutic management, particularly nutritional and rehabilitative.

There are many advantages to evaluating sarcopenia by ultrasound measurement: simple, rapid, achievable at the patient's bedside, no exposure to radiation, non-invasive, and low cost. The abdominal muscles (external oblique, internal oblique, transverse) constitute the accessory respiratory muscles. Easily accessible by ultrasound, they are a potential target for the evaluation of sarcopenia, which could be responsible for ventilatory withdrawal failures, prolonged stays in intensive care and associated complications. The combined ultrasound measurement of the quadriceps and accessory respiratory muscles in ICU patients therefore appears to be an innovative approach. Considering the ease of implementation, the validity of ultrasound (confirmed in the literature), and the safety of the technique, we wish to evaluate the link between the muscle mass at arrival in the postoperative Intensive Care Unit of the Dijon University Hospital by ultrasound measurement of the quadriceps and accessory respiratory muscles, and: mortality, duration of mechanical ventilation, length of stay and occurrence of intercurrent events.


Eligibility Criteria:
Inclusion Criteria:

* Person who has not opposed (or non-opposition of health care proxy for patients who are comatose or under the influence of sedative drugs) after receiving information about the study
* All adult patients admitted to the postoperative intensive care unit.

Exclusion Criteria:

* Protected adult or minor
* Pregnant or breastfeeding woman
* Lower limb amputation
* Refusal to participate of the patient or health care proxy
* Patient with pre-existing neuromuscular condition, tetra or paraplegia
* Morbid obesity as defined by BMI ≥ 40
* BPCO stage ≥ 3; heart failure with LVEF \< 50%; patients with symptomatic valvulopathy
Toxoplasmic Encephalitis in Patients With AIDS. Treatment and Prevention of Relapse

To compare pyrimethamine and intravenous (IV) clindamycin vs. pyrimethamine and sulfonamides in the treatment of AIDS patients with central nervous system (CNS) Toxoplasma gondii.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Opportunistic infection (Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis) or other conditions (brain abscess) which would make treatment results difficult to interpret due to concurrent infection, disease, or therapy.

Patients with other opportunistic infections or brain diseases are excluded.

Patients with AIDS and cerebral toxoplasmosis.