cyrilzakka/clinical-trials huggingface dataset:
Meta-cognitive Functional Intervention for Adults With ADHD: A Pilot Efficacy Study

The purpose of this study is to examine the initial efficacy of a psycho-social, metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit Hyperactivity Disorder (ADHD).

It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate improvements in measures of executive functioning, occupational performance and quality of life.

The Cog-Fun - A is a structured occupational therapy intervention for promoting self management in adults with ADHD. The protocol comprises three central treatment modules: Adaptive self awareness, executive strategies and skill implementation and multi-context transfer of strategies and skills.

The intervention is administered by occupational therapists on an individual basis, once a week, over 3-4 months.

20 participants will be recruited through community advertising. Sample size was determined based on expected moderate effect sizes. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.

Adverse events if occur will be reported to supervising psychiatrist and the Helsinki Committee.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosed by certified medical practitioner
* Adult ADHD Self Report Scale (ASRS) score above cutoff
* BRIEF-A score above cutoff

Exclusion Criteria:

* Diagnoses of severe neurological or psychiatric health condition.
* Instability in pharmacological treatment
* Brief Symptom Inventory (BSI) above cutoff according to Israeli adult norms
The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy. Unfortunately, fear of IUD insertion in women who have not had children is common among health care providers and women alike, and this limits IUD use. To increase acceptance of this highly effective contraceptive, there is need to investigate novel, low cost, easily applied and accessible techniques to improve the insertion experience. This is a pilot study to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.

Subjects who are have already scheduled an IUD insertion will be asked to join this study assessing whether or not nitroprusside gel helps with IUD insertion process. Only healthy, nulliparous women between the ages of 18 and 45 will be recruited. Nulliparous women report much more pain associated with IUD insertion than parous women so the possibility of being able to measure the effect of nitroprusside vs placebo is more likely. The primary outcome, pain with IUD insertion, and the secondary outcomes, such as satisfaction and provider ease of IUD insertion, will be compared between the study groups as well.

Eligibility Criteria:
Inclusion Criteria:

* age 18-45,
* Generally Healthy.
* requesting LNG-IUS for contraception as the primary indication

Exclusion Criteria:

* previous pregnancy beyond 20 weeks,
* previous IUD placement or attempted placement,
* allergy to nitroprusside,
* history of migraines,
* history of heart disease.
Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.

Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. It occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia, mental retardation and short stature are very common features of children with down's syndrome. Children with down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills and , under-development of fine motor skills. Active video gaming used different games that involve interactive session that can enhance cortical recognition, motor learning and functional profile of children with DS. The objective of this study is to determine the effects of active video gaming on pre-hand writing skills of children with down's syndrome. This will be a RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years both male and female patients are randomly selected and children with poor pre-hand writing skills. And the exclusion criteria for this study is children with any other neurological condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and hearing loss. Two groups were randomly assigned and equally divided patients into each group. Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling, coloring, painting, and group B received active video gaming and prehandwriting skills. For measuring each group developmental coordination

disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for (8consecutive weeks). Data collected from different centers, Raising sun institute of special education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game, Fine motor skills, Pre-hand writing skills, Virtual reality gaming.

To determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age 5 to 14 years.
* Both male and female patient diagnosed with down syndrome.
* Able to understand and follow verbal command.
* Down syndrome children with pre-hand writing skills are not good.
* Difficulty in fine motor skills.

Exclusion Criteria:

* Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss.
* Musculoskeletal and mobility disorder.
Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.

The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.

Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.

At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months. Home oral care will be performed with different products, containing lactoferrin (group 1) and probiotics (group 2). The control group (Group 3) will use normal products.

The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.

Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.

At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months.

Home oral care will be performed as follows:

* Group 1: patients will use 2 Forhans GengiFor tables (between foods) and Forhans Scudo Naturale toothpaste containing lactoferrin.
* Group 2: patients will use Biorepair Peribioma chewing-gum for 10 minutes/day and Biorepair Peribioma toothpaste containing probiotics.
* Group 3: patients will choose the best product for their home oral care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with black stains
* Patients with high compliance

Exclusion Criteria:

* Patients suffering from psychological, neurological or psychiatric disorders
* Pregnant or breastfeeding women
* Patients undergoing anti-cancer therapy
* Patients with low compliance
The Novel Addiction Assessment Study in Synthetic Drugs Addiction

The purpose of this research is to develop an objective assessment based on the virtual reality techniques which is used for evaluate addiction severity.

In order to evaluate the addiction severity and the effect of rehabilitation objectively, this study develops a virtual environment model based on the virtual reality technique, making the subjects in a drug related or neutral scene , at the same time recording the physical signs and eye movements index. Reliability and validity of this system will also be tested in this study. And we will construct the norm of addiction assessment system in Shanghai .The evaluating system will be very beneficial to develop novel and practical assessment for synthetic durg related disorder, and provide a reference for other drug dependence diagnosis.

Eligibility Criteria:
Criteria for synthetic drug abusers:

Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-4) for methamphetamine (MA) use disorders;
* Education level equal or more than 9 years;
* Have normal or corrected-to-normal vision;
* Have normal or corrected-to-normal hearing;
* Less than 3 months before last drug use;

Exclusion Criteria:

* Current substance use (except nicotine or caffeine) ;
* History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、 head injury or other severe medication conditions;
* Intelligence quotient less than 70.

Criteria for healthy control:

Inclusion Criteria:

* Without schizophrenia family history;
* Without history of drug abuse;
* Education level equal or more than 9 years;
* Have normal or corrected-to-normal vision;
* Have normal or corrected-to-normal hearing.

Exclusion Criteria:

* History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
* Intelligence quotient less than 70.
Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients ( PRESDIE)

Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

* inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
* 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
* return visit : device return, agenda return, skin control, seat-pressures control

Eligibility Criteria:
Inclusion criteria :

* Patient is male or female, aged ≥ 18
* Patient accepting the initial assessment and the following visits during the protocol
* Written informed consent has been obtained
* Patient having a social assurance
* Spinal cord injury ≤ C6 stable Spinal cord trauma \> 1 an
* Main mode of ambulation : own manual wheelchair

Exclusion criteria :

* Aged ≤ 18
* Adults under guardianship
* Patients do not speak French, refusing or unable to be followed
* Pregnant or lactating women
* Person deprived of their liberty by judicial or administrative decision
* Person hospitalised without consent
* Pelvic pressure ulcer ongoing
* Cognitive disorder incompatible with the use of the device, understanding and conduct of the study
Which Approach to Favor for Ultrasound-guided Lumbar Plexus Block (BPLE). Comparative Study.

Lumbar plexus block is described as a difficult block, thus requiring experienced practitioners. Many techniques have been used to date, notably anatomical landmarks, neurostimulation, and ultrasound-guided techniques. Among ultrasound-guided techniques, the "Trident" technique was described in 2006, while the "Shamrock" technique was described in 2013. Trident consists in putting the probe sagittally next to the lumbar spine and injecting local anesthetic around the lumbar plexus inside the psoas muscle at the level of L4. It is an out-of-plane puncture.

Shamrock puts the probe transversely on the iliac crest. Authors of the 2013 article said the image obtained with this technique was an image of L4. This technique allows an in-plane puncture, which is a safe technique.

This study aims at describing the level obtained with Shamrock, as well as at comparing depth of lumbar plexus, image quality and presence of vessels between the two techniques.

Eligibility Criteria:
Inclusion Criteria:

* Adult with indication of lumbar echography

Exclusion Criteria:

* Antecedent of spine surgery or spinal malformation
The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum

The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.

In pregnant women(11-14 week) admitted to our hospital between the ages of 15-49; After the healthy eating index scores were made face to face by the dietician, it was planned to measure the maternal thyroid volume by the radiologist.Our hypothesis in our study is to determine whether healthy eating index has effects on thyroid volume and blood parameters.

Eligibility Criteria:
Inclusion Criteria:

* 15-49 years old pregnant women
* 11-14 Gestational week of pregnancy
* Do not use medication,
* have no history of illness,
* who participated in face-to-face meetings with a dietician,
* who want to be included in the study,
* No smoking or alcohol consumption
* Patients with a BMI between 15-25

Exclusion Criteria:

* Pregnant women who are not between 15-49 years old,
* patients with chronic disease such as heart disease, diabetes,
* Patients who do not agree to meet with a dietician, patients who do not agree to be included in the study,
* smoking and alcohol use --Morbid-obese patients (BMI greater than 25)
Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

The study period per patient will include 62 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up performed in the form of a phone interview at 3, 6, 12, 18 and 24 months from the last administration of the study medication.

Eligibility Criteria:
Inclusion criteria:

* Patients with Ulcerative Colitis (UC) who were previously randomized and have completed the 8-week treatment in ACT12688 study with an acceptable safety profile. Patients who for administrative reasons could not be enrolled in the LTS12593 study right after completion of the 8-week treatment in the ACT12688 study must be enrolled within 3 months from the end of the ACT12688 study
* Signed written informed consent for Study LTS12593

Exclusion criteria:

* Patient with any adverse event leading to study drug (active or placebo) treatment discontinuation from ACT12688 study.
* Patient with any abnormalities or adverse events that per investigator judgment would adversely affect patient's participation in the long-term extension study.
* Use of any immunosuppressant (if patient is on immunosuppressant he or she must discontinue immunosuppressant before starting the LTS12593).
* If the patient started biological treatment for UC while waiting to be enrolled in the LTS12593, then he or she must stop the biological treatment and must have 8 weeks of wash out period before starting treatment with SAR339658 (only anti-tumor necrosis factors (TNFs) are allowed)
* Patients exposed to an anti-integrin or any investigational drug administered after the end of treatment in ACT12688
* Positive pregnancy test
* Breast feeding woman
* Women of childbearing potential not protected by highly effective contraceptive method of birth control and/or who are unwilling and unable to be tested for pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Survey of Knowledge and Attitude of Pain in Anesthesia Residents of Thailand

This study is a prospective descriptive cross-sectional survey using the modified Knowledge and Attitudes Survey Regarding Pain (KASRP) in English via an online google form.

Setting of the study/Trial site This study will be conducted via google form survey.

Target population (Provide a complete description of your target population in the study) Anesthesia residents of all levels throughout Thailand.

Study population (Provide details of your population in the study) Anesthesia residents of all levels throughout Thailand.

Inclusion criteria Anesthesia residents of all levels throughout Thailand.

Exclusion criteria Anesthesia residents who do not want to participate in this study.

Withdrawal criteria (e.g. research participant withdrawal, adverse outcome during participating the study) Anesthesia residents can stop answering the questionnaire survey at any time.

Termination criteria (e.g. terminating investigational product treatment/trial treatment) Not relevant

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia residents of all levels throughout Thailand.

Exclusion Criteria:

* Anesthesia residents who do not want to participate in this study.
Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum

This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the third trimester of pregnancy and again postpartum.

This is a prospective cohort study to evaluate the presence or absence of OSA in the third trimester of pregnancy and again postpartum. The investigators will use the Watch-PAT200® device as their accepted standard for diagnosis of obstructive sleep apnea.

When enrolled, women will be taught how to use the Watch-PAT200® via a company produced video that will be shown in the clinic and will be available via YouTube for review later if needed. They will also complete the Berlin Questionnaire. The patient will then use the Watch-PAT200® device overnight to evaluate for obstructive sleep apnea. This will be performed between 32-36 weeks gestation. Apnea-hypopnea indices (AHI) will be calculated and an AHI\>5 will be considered diagnostic for OSA.

The next morning when the patient returns the Watch-PAT200® device they will exhale into the NIOX MINO® to assess their exhaled nitric oxide levels. This will be performed between 800-1000 am by one of the study personnel.

The patient will also wear the Watch-PAT200® device the first postpartum night. The entire process will be repeated between 6-8 weeks postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Female (\> or equal 18 year of age)
* Pregnant between 32 0/7 prior to 35 6/7 weeks gestation
* Anticipated delivery at Forsyth Medical Center: Winston Salem, North Carolina

Exclusion Criteria:

* Illicit drug/Alcohol abuse
* Current treatment for obstructive sleep apnea
* Age \<18 years
* Inability to speak/read English proficiently enough to give informed consent
* Usage of alpha blockers or short acting nitrates
* Permanent pacemaker
* Sustained non-sinus cardiac arrhythmias
Images in Extracranial Artery Stenosis

The goals of this trial are:

1. To compare the sensitivity and specificity of various tools including Doppler and magnetic resonance imaging (MRI) for diagnosing vertebral artery stenosis and carotid artery stenosis. The positron emission tomography (PET)/MRI fusion imaging will be a promising tool to provide both anatomical and functional imaging for vulnerable plaques.
2. To identify patients at high risk of plaque rupture by image studies, biomedical profile, and gene expression of circulating monocytes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic extracranial atherosclerosis who are going to receive angiography and possible intervention.

Exclusion Criteria:

* Acute systemic illness
* Creatinine \> 3 mg/dl
* Unable to tolerate the tests (including MRI and PET/computed tomography \[CT\] scans)
Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study

A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the heart sounds data recorded by an FDA-cleared device AUDICOR AM device.

To conduct a prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). To show equivalence, these data will be compared with the heart sounds data recorded by an FDA-cleared AUDCIOR AM device .

The study will enroll a minimum of 27 and a maximum of 35 subjects.

Participants will be adult patients (age ≥ 18 years) with at least seven patients over the age of 40 years. In addition, at least five patients with a history of heart failure will be included.

First, participants will wear the AUDICOR-AM device for 15 minutes while sitting quietly. Then, the AUDICOR device will be removed and the participants will wear the WCD for 15 minutes while sitting quietly. Next, while wearing the WCD, participants will perform various activities of daily living, including at least 6 hours of overnight wear. Finally, the WCD will be removed and the participants will wear the AUDICOR again for 15 minutes while sitting quietly.

This is a single center, prospective, observational study. This is a non-significant risk device study as all biological study parameters will be measured noninvasively with the WCD defibrillation capability disabled. In addition, the study device will not be used as a replacement for regularly prescribed therapies or diagnostics.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers who are able to fit in the WCD garment (26 to 56 inches measured circumferentially at the level of the xiphoid process).
* Included in this group are at least five healthy subjects with a self-reported history of heart failure.
* The subject must be 18 years of age or older on the day of screening, with at least 7 subjects 40 years of age or older on the day of screening.

Exclusion Criteria:

* Mental, visual, physical, literacy, and auditory limitations that prevent interaction with the WCD equipment.
* Any acute medical conditions that prevent the following maneuvers: lying on back, lying on the right and left side, standing, sitting, and/ or leaning forward when sitting.
* Any self-reported shortness of breath, fatigue, swelling of feet, ankles, or legs, and/or chest pain
* Employees or family members of the sponsor.
* Unable or unwilling to provide written informed consent.