cyrilzakka/clinical-trials huggingface dataset:
Personality Profile of Children and Adolescents With ADHD and With or Without Emotional Dysregulation

Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli.

According to research, there are strong correlations between personality traits and psychiatric disorder as ADHD. In a longitudinal study, the persistence of ADHD symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. Studies show that these personality traits are factors of vulnerabilities for comordities associated with ADHD and are predictive of overall functioning difficulties. Studies show correlations between ADHD in childhood and personality disorders at adulthood .

ADHD is frequently associated with emotional dysregulation (ED) that is characterized by an inability to modulate emotional responses in a given context . ED is observed in 24% to 50% children with ADHD . Children with ADHD and ED are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ED. To date, there would be no studies which would have been interested in personality traits in children with ADHD and ED.

The main objective is to determine if children with ADHD and ED present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. It would involve earl identification of children at increased risk of pejorative developmental trajectories.

The second objectives are:

* Improve understanding of the heterogeneity of ADHD symptom expression;
* Have a better understanding of the child's personalit and temperament traits to identify riks and protective factors;
* Identify children with ADHD with profiles at risk of personality disorders in order to adapt the care according to the child's needs.


Eligibility Criteria:
Inclusion criteria:

* Children and adolescents aged 7-12 years followed at Montpellier University Hospital ;
* Children and adolescents with a diagnostic of ADHD (diagnostics criteria from DSM-V);
* Children and adolescents benefiting from a multidisciplinary evaluation or therapeutic group at the child psychiatry unit of Montpellier University Hospital

Exclusion criteria:

- Family non-french speaking
Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule

This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Granule.

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Granule.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals in accordance with indications for XLGB Granule, including osteoporosis, fracture, osteoarthritis, aseptic necrosis of bone and climacteric;
2. The age range of 18 to 70 years;
3. Individuals taking XLGB Granule over 2 weeks;
4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for XLGB Granule;
2. Unconformity to the XLGB Granule drug label;
3. Individual taking XLGB Granule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with XLGB Granule, simultaneously;
5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Incentives for Preventative Health Care: Increasing Completion of Health Risk Assessments

The purpose of this study is to understand using incentives to encourage employees to increase participation in an aspect of a corporate wellness program - filling out health risk assessments. This study will test whether lottery-linked incentives are more effective than guaranteed incentives in encouraging people to fill out health risk assessments.

This study will be run in an employer setting in which rates of health risk assessment completion are suboptimal. This study would be conducted within a workplace setting in which the firm is divided into a number of geographically situated and functionally related subunits. The investigators will run a "complete your health risk assessment now!" program for 4 weeks. Each work unit will obtain a symbol. Every week, one symbol will be randomly drawn, publicly announced, and anyone in that work unit at the firm who has received their preventive screening would receive a $100 prize. In addition, if all of employees in that unit have completed their forms, then the prize will be increased to $125.

The investigators expect this condition to result in greater compliance compared to a control condition in which employees would receive weekly reminders and a direct payment of a $25 gift card for completing the form at anytime during the 4 weeks of the study. This is analogous to direct payments that have been used by insurers to encourage completion of such forms in other contexts.

The purpose of this study is to apply concepts from behavioral economics to increase the effectiveness of incentives for preventative health care.

Health risk assessments are an important part of preventative healthcare. Employees fill out these forms and are given feedback about their health risks and steps they can take to improve their health. This study will be run in an employer setting in which rates of health risk assessment completion are suboptimal. This study would be conducted within a workplace setting in which the firm is divided into a number of geographically situated and functionally related subunits. We will run a "complete your health risk assessment now!" program for 4 weeks. Each work unit will obtain a symbol. Every week, one symbol will be randomly drawn, publicly announced, and anyone in that work unit at the firm who has received their preventive screening would receive a $100 prize. In addition, if all of employees in that unit have completed their forms, then the prize will be increased to $125.

This program plays on a number of psychological factors: 1) avoidance of regret, which one will experience if the number/symbol of the unit one is a member of is drawn and one does not win a prize because one is not participating in the wellness program 2) amplification of such regret by social means - because other people around you who are participating will receive cash prizes 3) mild social pressure, because high enrollments will yield benefits for all participants.

Eligibility Criteria:
Inclusion Criteria:

* Full time employees
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction

The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.

Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.

In this multicenter study we prospectively evaluate the technique.

Inclusion criteria:

All patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.

Exclusion criteria:

Treatment of open abdomen with other techniques.

Method:

* The first period of 2-5 days only the abdominal VAWC dressing is applied.
* On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
* The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
* Finally the mesh is removed and the fascia is closed.
* At closure the wound to suture length is registered.

Primary endpoint:

Frequency of primary fascial closure.

Secondary endpoints:

* study of factors associated with failure of fascial closure and in-hospital mortality,
* abdominal pressure variation attributable to the use of the technique,
* duration of treatment with open abdomen,
* frequency of incisional hernia after one and five years.

Duration of the study:

3-5 years. Enrollment of open abdomen cases.

Follow-up schedule for patients:

* Clinical evaluation at 1 and 5 years.
* CT-examination at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable

Exclusion Criteria:

* open abdomen patients treated otherwise
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old Chinese;
* Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
* Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.

Exclusion Criteria:

* Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
* Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
* gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
* The investigator considers that it is not suitable for this test.
Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age inclusive
* Type 1 or type 2 diabetes mellitus
* History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
* Documented delayed gastric emptying
* Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
* Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.
* Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception

Exclusion Criteria:

* Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
* Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
* NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
* Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
* Active gastric pacemaker within 3 months prior to the Screening Visit
Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Diabetes

Racial and ethnic minorities with type II diabetes in the US are more likely to develop complications and die from the disease than the general population. The foreign-born subset of this population is less likely to adhere to diabetes care recommendations than US-born patients, thereby placing them at higher risk for complications. In our previous pilot project, eight stories were assessed through preliminary multi-site intervention for acceptability and efficacy in diabetes management among Latino and Somali patients with poorly controlled type II diabetes. The goal of this project is to evaluate a new format for delivery of a culturally tailored digital storytelling intervention by incorporating a facilitated group discussion following the videos, for management of type II diabetes in Latino communities.


Eligibility Criteria:
Inclusion criteria:

1. Self-identify as Hispanic/Latino
2. Are Spanish-speaking
3. Receive primary care at one of the participating clinical sites
4. Self-reported diagnosis of type II diabetes

Exclusion criteria:

1. Not able to give informed consent
2. Not able to participate in a group discussion
Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health

Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status.

Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status. Key Stage 1 and 2 pupils will be recruited from 15 primary schools in the North West of Northern Ireland and will be randomised to one of four intervention arms: i) 'Engage', ii) 'Nourish', iii) 'Engage' and 'Nourish' and iv) Delayed of duration up to 6 months. Study outcomes include food knowledge, attitudes, trust, diet, behaviour, health and wellbeing and will be collected at baseline and six months.

Eligibility Criteria:
Inclusion Criteria:

* Mainstream primary schools willing to be randomly assigned to an intervention,
* Mainstream primary schools willing to engage with the intervention and implement it with their pupils,
* Mainstream primary schools willing to facilitate pre and post-test data collection in their setting,
* Mainstream primary schools within the North West region of Northern Ireland.
* Pupils in Primary 3 (Key Stage 1) and Primary 7 (Key Stage 2) of participating schools were eligible to take part.

Exclusion criteria

* Secondary schools
* Non-mainstream schools
* Schools not in the North West region of Northern Ireland
Robotic Cardiac Surgery Wet Lab Simulation Study

The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.


Eligibility Criteria:
Inclusion Criteria:

* Experienced robotic cardiac surgeons: robotic surgeons with total volume \> 50 robotic cardiac operations and at least 20 robotic cases annually
* Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency
* Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery)

Exclusion Criteria:

* Robotic novices with \> 5 hours experience of any robotic system
Implementing Evidence-Based Mental Health Practices in Primary Care

This research study will examine the effectiveness of a brief, computerized motivational intervention plus treatment-as-usual to treatment-as-usual alone for treating alcohol misuse in Veterans presenting to primary care. The investigators aim to recruit 162 Veterans screening positive on the AUDIT-C to participate in this study. Participants will be randomly assigned to one of the two intervention conditions and be asked to complete a baseline assessment and two follow-up assessments conducted at three and six months post treatment. Baseline assessments will be conducted in person by a trained research assistant, while all follow-up interviews will be conducted over the phone. The primary outcome for this clinical trial is the reduction in the number of heavy drinking days. Several secondary outcomes will be collected including health status, depressive symptoms, consequences of drinking, pain symptoms, and distress tolerance. The findings from this study may have large scale implications for how alcohol misuse is treated in primary care. In addition, this study will provide evidence for the feasibility of using the computer as a method for delivering evidence-based mental health interventions in primary care.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age,
* speak and read English,
* U.S. Veteran status,
* screen positive on the AUDIT-C

Exclusion Criteria:

* the presence of any cognitive difficulties that interfere with one's ability to consent to study participation
Virtual Reality in Chronic Neck Pain

The purpose of this study is to compare the effects of virtual reality, which encourages active neck movements, in individuals with chronic neck pain, with the control group receiving only neck exercises. Participants will be randomly divided into two groups; Half of them will be given only a neck exercises program, and the other half will be given neck exercises and virtual reality.

Individuals with chronic neck pain tend to have low levels of endurance in deep neck flexor muscles. Conservative treatments for neck pain, including posture education, strengthening, range of motion, motor control, flexibility, and proprioceptive training, are recommended in clinical guidelines. Virtual reality has been shown to be beneficial in the treatment of various issues related to pain in previous systematic reviews. Distracting attention is one of the mechanisms explaining the impact of virtual reality on pain. It is believed that virtual reality reduces pain perception by influencing pain pathways.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 45
* Having a history of non-traumatic neck pain persisting for more than three months
* Having a Neck Disability Index score greater than 5 points
* Not having participated in a physiotherapy program for at least 3 months
* Being able to read and write in Turkish to understand, interpret, and respond to the questionnaires

Exclusion Criteria:

* Having a surgical history in the neck region
* Having cervical spine flexion, extension, and rotation range of motion \<10 degrees
* Having a history of rheumatologic, vestibular, neurological, or cardiopulmonary diseases
* Vertigo associated with neck pain
* Osteoporosis, vertebral fractures,spinal tumors
* Presence of radiculopathy or myelopathy
* Traumatic spinal cord injury
* Neck pain associated with progressive neurological deficits or loss of strength
Life Enhancing Activities for Family Caregivers (LEAF 2.0)

The goal of the proposed intervention, called LEAF (Life Enhancing Activities for Family Caregivers) is to reduce burden and increase well-being in Alzheimer's Disease caregivers through the practice of positive emotion skills. We will evaluate two methods of online delivery of LEAF: facilitated and self-guided and compare them to an emotion-reporting waitlist control condition. If effective, the LEAF program can be disseminated to Alzheimer caregivers nation wide.

LEAF 2.0 is a 3-arm, technology-based, randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's Disease (AD) are randomly assigned to 1) the LEAF intervention facilitated remotely via web (N = 200), 2) the LEAF intervention self-guided online (N = 200), or 3) an emotion reporting control (N = 100) which will then cross over to the intervention after approximately 7 months, half to the facilitated arm and half to the self-guided arm. Participants will complete a program that teaches them eight positive emotion skills which aim to reduce stress and burden, and increase positive affect. All aspects of the study (recruitment, consent, intervention, and assessments) are conducted online.

To be eligible for participation in LEAF 2.0, participants must identify as the primary family caregiver of someone with Alzheimer's disease or Alzheimer's-related dementia, and whose care recipient is not living in a care facility at the time of enrollment. "Primary family caregiver" is defined as the person who spends the most time caring for the individual with Alzheimer's disease in a non-professional capacity. Participants must also be able to speak and read English, live in the United States, be at least 18 years of age, and have access to a reliable Wi-Fi connection. Respondents are ineligible if they have already participated in a prior version of LEAF.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 and over who identifies as the primary caregiver of a family member with Alzheimer's disease or probable Alzheimer's
* Care recipient does NOT reside in care facility
* Speaks and reads English
* Has access to high speed internet connection at home or a location where they can speak privately with a facilitator

Exclusion Criteria:

* Care recipient lives in care facility
* Does not speak/read English
* Does not have access to internet
* Care recipient does not have Alzheimer's disease