cyrilzakka/clinical-trials huggingface dataset:
Skhokho Supporting Success: A Cluster RCT of a Multi-faceted, School-based IPV Prevention Intervention in South Africa

Development and evaluation of a multi-faceted school-based intervention to prevent intimate partner violence among Grade 8 high school students in South Africa

Primary prevention of intimate partner violence among young men and women requires an intervention which addresses the underlying driving factors of such violence operating at different ecological levels.That is, interventions need to address factors impacting directly on youth and their family relationships, school as an institutional setting. In the school, holistic interventions strengthen the curriculum and teaching, but also the broader environment of learning, including addressing positive discipline and the culture of the school. In order to prevent violence, interventions need to build gender equality, challenge the normative use of violence in schools and homes (e.g., corporal punishment), strengthen teen-adult relationships and communication, and build negotiation and conflict resolution skills, as well as addressing stress and coping.

A three-arm, cluster randomised controlled trial based in high schools in Gauteng, South Africa is evaluating such a multi-faceted primary prevention intervention. This intervention includes school strengthening components for learners and educators, which includes providing a teaching materials for the grade 8 life orientation (LO) curriculum (which covers gender and violence), training teachers in LO teaching, training staff on positive discipline and establishing learner clubs. A second intervention seeks to strengthen families and is a workshop based intervention delivered over 4 day long sessions for a parent or caregiver and their grade 8 adolescent.

The intervention is being evaluated in a three arm randomised controlled trial, with school-level randomisation involving 24 schools. One is a delayed intervention control arm, two arms have the school strengthening intervention and one arm additionally have the family strengthening intervention.

The outcomes will be addressed using qualitative and quantitative methods with data collected from Grade 8 learners (the primary outcome group), school educators and administrators, and parents/caregivers of Grade 8s. These measures will be conducted pre-intervention and at 6, 12, and 18 month follow up periods. In addition, an economic costing evaluation will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* LEARNER/TEEN PARTICIPANTS: enrolled in Grade 8 in one of the study schools; informed consent from parent/guardian to participate in study
* EDUCATOR PARTICIPANTS: currently employed/working as an educator (of any group of learners) at one of the study schools
* PARENT/CAREGIVER PARTICIPANTS: the male or female parent/caregiver/guardian of a Grade 8 learner in Arm 2 schools

Exclusion Criteria:

NONE
7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream

The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.

In this study we will compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal. Patients will be asked to fill in questionnaires to:

* assess the severity of pain experienced (VAS score) during laser treatment,
* evaluate whether the pain relief is adequate and,
* evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief.

One week after the visit the patient will have a telephone consultation. The patients will be asked if they experienced any symptoms, which will be recorded as adverse events.

Eligibility Criteria:
Inclusion Criteria:

* • Subject has provided written informed consent;

  * Subject is ≥ 18 years of age at time of screening;
  * Group A: subjects with acne keloidalis nuchae;
  * Group B: subjects with an uniform, black, professionally placed tattoo

Exclusion Criteria:

* • Known sensitivity to any components of the test materials;

  * Pregnant or breast-feeding women;
  * Use of any other pain medication during past 24 hours prior to the laser treatment;
  * Damaged skin at the designated treatment site;
  * Blister formation and/or scar formation after test-treatment with standard laser settings;
  * Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Treatment Plan for ADHD With Indifferent Traits

For children with ADHD aged 4-10 at the time of enrollment, starting from preschool, focusing on apathy and emotional control, using psycho-behavioral measurements, EEG experiments, and eye tracking technology to evaluate and implement targeted Sexual intervention and six-month follow-up. Establish a diagnosis and treatment decision analysis model and psychological treatment plan for ODD/CD.

Destructive, conduct disorder children have emotional processing defects, including apathy and ruthless traits, emotional disorders, may be early diagnosis of conduct disorder (Conduct Disorder, CD) or attention deficit hyperactivity disorder (Attention Deficit Hyperactivity Disorders, ADHD) comorbid CD sensitivity Sexual indicators, systemic psychotherapy for these children's indifference characteristics and emotional disorders will improve related symptoms. This study will start with preschool children with ADHD, design evaluation indicators for emotional traits for children aged 4-10, combined with various psychological evaluations, and use advanced brain electricity combined with eye tracking research technology to provide candidate indicators for evaluation; and On the basis of previous research, establish a treatment plan to improve pathological emotional characteristics and emotional disorders; establish a predictive intervention decision model from preschool to school-age ADHD comorbid CD to provide methods for precise diagnosis and treatment options. The early prevention and intervention of ADHD and CD has practical significance and maneuverability.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 years, 0 months and 10 years old and 11 months old, who have been diagnosed by a doctor who is at least the attending physician in the pediatric psychiatric department and meet the American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) ADHD diagnostic criteria, have a total IQ higher than 80, and the subjects are doing this The baseline level of the study has not received any medical treatment before.

Exclusion Criteria:

* Attention deficit disorder caused by organic diseases of the nervous system, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; exclude parents or guardians from suffering Severe mental illness, such as schizophrenia, mood disorders (onset period), etc., and a degree below junior high school.
Impact of Another Person's Presence on Brain and Behavioral Performance

In a recent study, investigators provided the first neuroscientific data on social facilitation. This neuroimaging study, performed in the macaque monkey, shows a marked improvement in performance in a simple task when a congener is present compared to when the animal performs the task alone. This social facilitation is accompanied by a significant increase in brain activity within the fronto-parietal network of attention. No variation in activity, however, is observed in the cerebral network of motivation. These results argue in favor of the implication of attentional processes in the phenomenon of social facilitation. The challenge now is to determine whether social facilitation is always based on the attention network (whatever the task) or, alternatively, whether it increases activity in any cerebral circuit involved depending on the task performed and the population studied. This hypothesis, which the investigators have named the "multi-mediator model of social facilitation", has the advantage of reconciling the attentional and motivational theories of social facilitation, which are not mutually exclusive. This hypothesis also provides an explanation for the pervasiveness (across species and different ages for humans) of social facilitation. The main objective of SOFEE is to gather neuroscientific evidence to support the multi-facilitator model of social facilitation.

The main objective is to study the effect of the presence of others on cognitive performance and its evolution during development by behavioral and neural measures. The secondary objective is to identify factors (psychological characteristics such as personality traits) explaining individual, behavioral and neural differences, sensitivity to the presence of others.

Eligibility Criteria:
Inclusion Criteria:

* Girl or boy aged ≥ 8 years and ≤ 12 years old for children,
* Girl or boy aged ≥ 13 years and ≤ 19 years old for teenagers,
* Woman or man age ≥ 20 years and ≤ 35 years old for young adults,
* French mother tongue,
* With the right to a social security scheme or similar,
* With informed consent form signed by the legal representatives and the subject, for minors,
* Has signed the informed consent form, for adults.

Exclusion Criteria:

* Known acquired neurological disorders, including epilepsy,
* Known psychiatric disorders,
* Complications at birth requiring admission to neonatal intensive care unit,
* Ongoing treatment with drugs affecting the central nervous system,
* Significant hearing impairment,
* Uncorrected visual inadequacy,
* Left manual preference,
* Contraindications to the MRI examination (people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects),
* Refusal of the subject or parents of the subject to be informed of any anomalies detected on the MRI,
* Pregnancy for women of childbearing age: the possibility of pregnancy will be ruled out on questioning for inclusion,
* Protected persons other than children
Changes in PPV Induced by PLR Test to Predict Fluid Responsiveness in ICU

The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time.

In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence.

Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (\<8 mL/kg of ideal body weight).

Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients
* Patients in whom the physician decides to perform a fluid challenge based on the presence of one of the following criteria:

  (1) systolic arterial pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or the need for vasopressor infusion; (2) skin mottling; (3) urine output \<0.5 mL/Kg/h for more than or equal to 2 hours; (4) lactate concentrations \> 2 mmol/L
* Patients in whom the physician decides to perform a PLR test to predict fluid responsiveness
* Arterial catheter should be in place for invasive monitoring of arterial pressure and PPV

Non inclusion Criteria:

* Age \<18 yrs
* Pregnancy
* Moribund patients
* Risk of fluid loading induced pulmonary edema
* Cardiac arrhythmias
* Contraindication to perform PLR (intracranial hypertension, pelvic fractures)

Exclusion Criteria :

* Changes in vasopressor and sedation agents dosages during the protocol
* Changes in ventilatory parameters during the protocol
Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic

Background The significant risk of transmission of SARS-CoV-2 to healthcare staff mandated changes to Basic and Advanced Life Support (BLS and ALS) guidelines. As advised by the European Resuscitation Council (ERC), healthcare staff should put on airborne-precaution personal protective equipment (PPE) before starting chest compressions and/or airway interventions, as a minimum an FFP3 mask (FFP2 or N95 if FFP3 not available), eye and face protection and long-sleeved gown. However, wearing FFP3 masks has been shown to highly impair cardiopulmonary exercise capacity and the effect of wearing PPE on the quality of cardiopulmonary resuscitation is not known. The aim of this project is therefore to to investigate whether wearing PPE has an effect on the quality of chest compressions.

Methods The study forsees a simulated CPR scenario on manikins. Study participants are lay rescuers and members of the rescue organization Croce Bianca. Each participant will perform 5 sequences consisting of 2 min of chest compressions altered by 2 min of no chest compressions (break), as recommended by the current ERC guidelines. The participants will perform the described CPR sequence two times in a cross-over design with randomized order, once while wearing PPE and once without wearing PPE. Between the two CPR sequences (i.e. with and without PPE) a break of 60 min for recovery will be given. During both CPR sequences, the quality of chest compressions will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Member of the rescue organization "Croce Bianca"
* Aged 18-60
* Certified in basic life support (BLS)
* No current COVID-19 symptoms, not being tested positive for COVID-19, no COVID-19 symptoms in the 4 weeks before the tests, no quarantine or unprotected contacts with COVID positive patients in the last 4 weeks, body temperature ≤ 37.5°on test days.
* Obtained informed consent.

Exclusion Criteria:

* Age \<16 or \>60 years,
* No informed consent
* Current COVID-19 symptoms, being tested positive for COVID 19 or symptoms in the 4 weeks before the tests, quarantine or unprotected contacts with COVID-19 positive patients in the last 4 weeks, body temperature ≥ 37.5°on test days.
The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis

Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive Periodontitis patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with aggressive periodontitis in maintenance that had completed orthodontic treatment
* age 13-40
* with full records of periodontal treatment
* with full records of orthodontic treatment

Exclusion Criteria:

* smoking over 10 cigarets/day
* non controlled diabetes
* pregnancy
* alcohol consumption
Accuracy of Continuous SpO2 Measurement in Adults

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.

SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
* Subject is willing and able to participate in the measurement period for up to two hours.

Exclusion Criteria:

* Subject has a carboxyhemoglobin level (COHb) ≥3%.
* Subject has a MetHb level ≥2%.
* Subject has a ctHb value ≤10g/dl.
* Subject is in another clinical study that may interfere with the results of this study.
* Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
* Subject is deemed by the Investigator to be medically unsuitable for participation in this study.
Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial

Chronic nonspecific low back pain is a major health and socioeconomic responsible for a high rate of employee absenteeism and reduced functional performance. The use of acupuncture as an alternative therapy in the treatment of low back pain and electroacupuncture to enhance the treatment has been effective; however, there is little evidence of the effectiveness of one over the other.

OBJECTIVE: To compare the effect of acupuncture and electroacupuncture as an alternative therapy in patients with chronic low back pain to be able to identify whether electroacupuncture has more benefits than just acupuncture in the treatment of low back pain to be more widespread with scientific.

METHOD: Sixty subjects will be randomized into two groups: Group Acupuncture treatment of low back pain (AG) and Group Acupuncture with the use of electroacupuncture (EG). The primary clinical outcomes will be pain, assessed with the numerical pain scale and McGill Pain Questionnaire and disability assessed with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with global perception scale of global perceived effect, quality of life using the Short-Form Health Survey questionnaire (SF-36), Beck Depression (Beck Depression Inventory BDI), Flexibility, kinesiophobia and through bank Wells. The groups will be treated with two weekly sessions lasting about an hour, 6 weeks, totaling 12 sessions. The outcomes will be achieved in the final and initial ratings after six months of treatment completion. Data will be collected by a blinded examiner who also has made the allocation of patients to groups.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain (pain for more than three months)
* Be between 20-60 years

Exclusion Criteria:

* Patients with severe spinal
* Previous surgeries or scheduled
* Herniated Disc
* Rheumatic disease or infection
* pregnancy
* metal implants
Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients

IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

This study will compare the effect of low FODMAPs diet and usual diet instruction on Intestinal flora, intestinal short chain fatty acids and quality of life by two groups.The results will answer the effect and long-term safety of Low FODMAPs diet.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria for Rome Ⅲ
* IBS patients with diarrhea type
* By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease
* Patients be able to communicate well with the researchers and be willing to participate in the study

Exclusion Criteria:

* Stomach, small intestine, colon surgery history
* irritable bowel disease (IBD) active period, celiac disease
* Alcoholics or drug abuse
* Pregnant or lactating women
* Recent drug users who use defecation
* Have a special diet
Efficacy Albendazole and Levamisole Against STH on Unguja

Field epidemiological studies undertaken during 2005 in four village locations in Northern Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections.

The prevalence of Ascaris lumbricoides was found to have remained relatively high despite community-wide treatment with the mass administration of Albendazole (a WHO recommended de-wormer) in coordination with community vitamin A supplementation.

One hypothesis for this is that the children and mothers had Ascaris infections more tolerant to Albendazole that subsequently failed to clear. It is necessary to compare the present drug efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on STH infections such patients a case-control setting to shed light on the putative resistance of local Ascaris/Trichuris to albendazole.

In so doing, this should clarify whether there is resistance developing towards Albendazole and have possible implications for introducing combination therapies of Levamisole and Albendazole for first line de-worming mothers and their children in the future.

The study was conducted in 10 villages on Unguja Island representative of urban, semi-urban and rural environments. After liaison with the local Shehia (the elected community leader) mothers and their children aged between 6 months and 5 years old were invited to attend a walk-in mobile clinic. In accordance with WHO sample size recommendations of 30 individuals per site and to cater for drop-out/non-compliance, target enrolment was about 50 mother and child pairs at each study village.

Stool specimens were transported to the Helmtin Control Laboratory Unguja laboratory for visual inspection of stool consistency and presence of blood, after which a single Kato-Katz thick smear (41.7mg) was prepared. Eggs of all STH species were counted by inspection at 100x microscopy and expressed as a tally of eggs per gram (EPG). To ensure consistency of egg counts, slides were read by the same two technicians for each study village.

10 Mother and child pairs found positive for Ascaris and/or Trichuris were randomised, by coin tossing, to receive either a single tablet of ALB (400mg) or an appropriate dose of LEV (2.5 mg/kg). A parasitological follow-up took place 18 days after treatment where a requested stool sample was analyzed by a single Kato-Katz thick smear for assessment of STH clearance. In accordance with WHO's 'no survey without service' all attendees were given an additional ALB tablet.

Eligibility Criteria:
Inclusion Criteria:

* Presently with soil-transmitted helminthiasis

Exclusion Criteria:

* absence of soil-transmitted helminthiasis