cyrilzakka/clinical-trials huggingface dataset:
A Dissonance-Based Obesity Intervention

This project will examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention, and whether this intervention results in significantly greater reductions in weight and improvements in lifestyle behaviors than an assessment only condition. Participants will be young adults enrolled in college.

Approximately 34% of college students are overweight/obese. However, few behavioral weight loss (BWL) interventions have been developed for young adults in college. Research suggests that standard BWL interventions are not addressing the needs of young adults as they have shown poorer retention rates and weight loss compared to older adults in BWL trials. Standard BWL interventions are also time-intensive and are not conducive to inexpensive dissemination.

The primary aim of this project is to examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention for young adults enrolled in college. Enhanced Project Health is based on Project Health, a dissonance-based obesity prevention program, which has been shown to significantly decrease weight gain and future overweight/obesity onset compared to a matched intervention and minimal intervention control condition in young adults. The current intervention was expanded to consist of eight weekly group sessions and to address sleep, in addition to diet and physical activity. The secondary aim is to test the hypothesis that Enhanced Project Health will result in significantly greater reductions in weight and improvements in lifestyle behaviors compared to an assessment only condition.

Eligibility Criteria:
Inclusion Criteria:

1. Young adults of ages 18 to 25.
2. Enrolled as a college student.
3. Body mass index of 25 or more (overweight/obese) based on measured height and weight.

Exclusion Criteria:

1. Diagnosis of bulimia nervosa according to DSM-5 criteria.
2. Diagnosis of obstructive sleep apnea.
3. Participation in interventions for weight loss or disordered eating behaviors.
4. Current use of prescription drugs for weight loss or disordered eating behaviors.
Long Term Excess Mortality of Acute Myocardial Infarction in Patients With and Without Diabetes: A Population-based Cohort Study

Diabetes is key risk factor for death following acute myocardial infarction. However, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. Investigators aimed to determine the long-term excess risk of death associated with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction
* Both sex
* 18 years

Exclusion Criteria:
Greater Occipital Nerve Injection Study

This study is designed to answer the question of whether injection of the greater occipital nerve at its proximal origin, near the C2 vertebrae, using ultrasound guidance is effective in improving pain in human subjects.

HYPOTHESES

1. Ultrasound (US) guided greater occipital nerve (GON) injections are effective at a novel, proximal C2 location in live, human subjects, measured by improvement in visual analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection, and 1-month post-injection .
2. Ultrasound (US) guided injection of the greater occipital nerve (GON) at a novel, C2 location is effective at improvement of both occipital neuralgia and cervicogenic headache demonstrated by improvement in visual analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection, and 1-month post-injection. We further hypothesize that the mean improvement in VAS scores at 1-month post injection will be greater than 2 units.
3. Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel, proximal C2 location in live, human subjects appears safe.

Patients must be referred to Pain Clinic for occipital nerve injection.

Patients are responsible for all clinical costs associated with the injection.

There is no remuneration offered for participation in this study.

Eligibility Criteria:
Inclusion Criteria:

Subjects must be referred to the Pain Clinic for an occipital nerve injection.

* Must have Occipital Neuralgia and/or Cervicogenic Headache

Exclusion Criteria:

* Bilateral GON symptoms and/or cervicogenic headache symptoms
* History of cervical spine surgery/procedure or trauma in past 6 months that may have caused or contributed to the occipital pain or cervicogenic headache, excluding Occipital Nerve Blocks (ONB).
* Evidence of impaired sensation in the GON dermatome region
* Evidence of cranial defect/abnormality near target injection site
* Untreated cutaneous infection, systemic illness, or immunocompromised state
* History of bleeding tendency or use of anticoagulants
* History of adverse reaction to anesthetic agents or corticosteroids
* Occipital nerve block in past 3 months
Comparative Motility of Alloplastic Orbital Implants

This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .

Evisceration allows removal of the intraocular contents while preserving the sclera and normal extraocular muscle attachments. It is more advantageous than enucleation in patients in whom intraocular tumor is rules out.

Maximizing orbital volume and restoration of movement are important aspects of a successful surgical outcome.

Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm which don't adequately replace the volume leading to postevisceration socket syndrome. Therefore, various techniques have been described to expand the scleral cavity and allow placement of a large implant including anterior sclerotomies, posterior sclerotomies, and disinsertion of optic nerve.

Implant exposure is a terrible complication of evisceration with reported rates as high as 67%. Exposure of the implant can lead to infection, which usually mandates removal of the implant. Trying to minimize this risk, physicians intentionally place the implants posterior to the normal position of the globe. Some authors described placement of the implant posterior to posterior sclera which totally eliminated the risk of exposure.

However, this deep seating of the implant may have deleterious effects on its motility. It can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the implant moves it posterior to the pulleys that serve as the functional origins of rectus muscles. This relationship would be expected to alter the pulling directions of the rectus muscles after evisceration hindering effective implant motility.

In this trial the investigators will try to study the effect of posterior placement of the implants on its motility after evisceration.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for evisceration

Exclusion Criteria:

* Inability to provide independent, informed consent
* Significant preoperative motility abnormalities
Role of Vitamin E in Gaucher Disease Patients

gaucher disease (GD) can be classified into three clinical types .type 1,the most common type ,is the chronic non neuronpathic form of the disease,which shows gighly variable signs and symptoms and variable course,with visceral,skeletal and hematologic involvement among others.the neurologocal involvement can be observed in types 2 and 3

enzymatic defeciency in gaucher disease patients may induce a cascade of events that result in side effects, such as the production of reactive oxygen species(ROS) and reactive nitrogen species(RNS) that can then generate the oxidative stress whereas in body of healthy individuals,the production and degradation of ROS and RNS are generally balanced.

neurochemical abnormalities in patients with gaucher disease might be related to oxidative stress and inflammation in the brain.

oxidative stress induces peroxiredoxin-2 as cytoprotective response against RNS .it is able to detoxify a vast range of organic peroxides.

vitamin E well accepted nature most effective lipid soluble chain breaking antioxidant .

Eligibility Criteria:
Inclusion Criteria:

children and adolescents aged fron 2 to 18 years old with gaucher disease both type 1 and type 3 diagnosed clinically and confirmed by laboratory analysis patients who are on stable enzyme replacement therapy for at least 6 months -

Exclusion Criteria:

patients with infection or another inflammatory condition patients on multivitamin therapy known chronic liver disease (viral hepatitis,HIV) patients with renal impairement defined as creatinine level greater 1.2 for female and greater than 1.4 for male.

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Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal cord injury erectile dysfunction. The study has the characteristics of a non- inferiority, randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile Function Domain questionnaire of the International Index of Erectile Function IIEF).

This is an interventional study


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury
* Erectile dysfunction
* No Medical Contraindication to use Avanafil and/or Sildenafil
* Able to provide informed consent
* Able to complete questionnaires

Exclusion Criteria:

* Medical Contraindication to use Avanafil and/or Sildenafil
* No spinal cord injury
* Congenital spinal cord injury
* Not able to provide informed consent
* Not able to complete questionnaires
Influence of Peer Mentoring on Adolescent Contraceptive Decision Making

This is a prospective, randomized-controlled trial in which subjects will be randomized to receive either routine contraceptive counseling or peer mentoring plus routine contraceptive counseling.

Unintended adolescent pregnancy continues to be a significant public health problem in the United States. While the use of highly effective forms of birth control, such as the long-acting, reversible contraceptives (LARC) have been found to be more effective in decreasing pregnancy rates than non-LARC methods of birth control, knowledge and use of LARC has been shown to be low in this vulnerable population. We are interested in better understanding the influence peers may have on contraceptive decision making among adolescents. The purpose of this study is to evaluate the impact of a peer mentoring intervention on adolescent contraceptive decision making, specifically with regard to increasing long-acting, reversible contraceptive uptake. The main study intervention will consist of randomization to usual contraceptive counseling versus peer-mentoring plus usual contraceptive counseling. Pre- and post-intervention questionnaires will be used to better understand peer influence on contraceptive decision making, and to assess the peer mentor-teen intervention interaction.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Female
* Age 13-21 years old at enrollment
* Desiring contraception; either currently not taking any method of contraception, or not satisfied with current method, and not desiring pregnancy in the next 12 months
* Willing and able to follow the study protocol

Exclusion Criteria:

* Male gender
* Younger than 13 years old, older than 21 years old
* Pregnant or desiring pregnancy within the coming year
* Issues or concerns in the judgement of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial

Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.

This is a three-centre randomised controlled trial in which 200 patients with symptomatic lumbar spinal stenosis will be randomised into one of two treatment arms. The patients in the surgical arm will undergo decompression of the neural structures by use of any open or minimally invasive (MIS) technique with or without fusion; the patients in the non-surgical arm will undergo imaging assisted percutaneous interspinous spacer insertion with fusion.

The primary outcome of the study will be the Oswestry Disability Index. Secondary outcomes will include motor amplitude and degree of denervation activity obtained by means of nerve conduction studies and electromyography.

Patient-reported outcome measures will be also used as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50-85 years.
2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3.
3. MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75 mm2 or degree of stenosis C or D according to Schizas's classification.34
4. The patient has given oral and written informed consent to participate.

Exclusion Criteria:

1. Degenerative deformity with Cobb angle \>20°.
2. Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
3. Arterial insufficiency (claudication intermittent).
4. Former lumbar surgery other than disc hernia.
5. Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases.
6. Heart and lung diseases presenting a significant risk for surgery or making it impossible for the patient to take part in a percutaneous arm of treatment (American Society of Anesthesiologists (ASA) score \>3).
7. Polyneuropathies.
8. Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).
Ridge Splitting With Simultaneous Implant Placement Using i-PRF

Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period. The present study was conducted to evaluate the clinical and radiographic outcomes following the application of the alveolar ridge splitting in combination with the use of guided bone regeneration (GBR) with or without i-PRF (sticky bone), associated with immediate implant placement in patients with horizontally atrophic jaw bones.


Eligibility Criteria:
Inclusion Criteria:

* good general health at the time of surgery.
* at least 3 months of healing after tooth extraction.
* horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

Exclusion Criteria:

* a vertical bone defect in the edentulous ridge.
* thick cortex in the labial/buccal with less cancellous bone inside
* obvious undercut on the labial/buccal side.
* uncontrolled periodontal conditions or other oral disorders.
* history of radiotherapy in the head and neck region.
* uncontrolled diabetes mellitus or other systematic disorders.
* smokers.
* Pregnancy.
* non-compliant patients.
* allergic reaction to the medications used
Evaluation of the Videodrama Therapeutic Device for Children with Autism Spectrum Disorders

Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).

Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 15 years.
* Clinically confirmed ASD by a psychiatrist.
* Parental or legal guardian consent for participation.
* Child showing a strong interest in screens and/or video content.
* Ability to tolerate the presence of other children.
* Minimum of 18 video drama sessions.
* Not having benefited from disease care in the past.
* Affiliation to a social security system

Exclusion Criteria:

* No ASD diagnosis.
* Younger than 3 or older than 15 at the study start.
* No interest in screens or video content.
* Parental or legal guardian refusal for participation.
* Dropping out before completing 18 sessions.
* Patient having benefited a disease care in the past
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed inoperable biliary tract cancer
* Age: 18 \~75 years old
* Performance status: ECOG 0-2
* Hematopoietic:

  * Granulocyte count at least 1,500/mm3
  * Platelet count at least 100,000/mm3
* Hepatic:

  * Bilirubin No greater than 2 fold the upper normal limit
  * AST/ALT : No greater than 3 fold the upper normal limit
* Renal:

  * Creatinine - no greater than 1.5 mg/dL
* Not pregnant
* No other serious medical or psychiatric illness that would preclude giving informed consent or limit
* No prior chemotherapy within 6 months
* No other concurrent anticancer radiotherapy within 6 months
Impact of IPE in Multidisciplinary Primary Care Centres on Collaborative Competency of Healthcare Students (FLIRT-MSP)

The aim of our study is to evaluate the impact of interprofessional education program (IPEP) for healthcare students in clinical placement in MPCC on interprofessional collaboration (IPC), comparing the acquisition of interprofessional collaboration skills in students receiving IPEP during their MPCC placement with those in their MPCC placements without this IPEP.

The IPEP will be delivered by trainers (health professionnals from the MPCC) who receive a train the trainer program.

For the intervention group, 12 MPCC will be recruited. 3 professionals from each MPCC will be trained and will be responsible for implementing the IPEP for their students.

For the control group, 12 MPCC will be recruited. Students will carry out their clinical placement as usual.

Study method : A multimodal study with a quasi experimental multisite study before and after the IPEP and a qualitative study to explore students' perceptions of the IPC will be conducted.

Eligibility Criteria:
Inclusion Criteria :

MPCC signatories to the interprofessional conventional agreement with the French national health insurance system.

Volunteer to take part in the FLIRT MSP Study. MPCC with GPs who are habilitated to supervise internship family medicine students.

MPCC volunteer to receive healthcare students from different professions including at least one GP intern.

Volunteer to form an interprofessional training team.

Exclusion Criteria:

MPCC who are unable to form an internship training team or to commit to IPE as stipulated in the protocol will not be included in the MSP intervention group.

For the qualitative study, students who do not volunteer or are unavailable for interview will not be included in the FLIRT qualitative component.
Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents

This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.

Despite increased use of insulin pumps and continuous glucose monitors (CGM) for pediatric type 1 diabetes (T1D) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with T1D has worsened in recent years. Although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in T1D. Psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal T1D management approaches. There are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. The development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of T1D.

Interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and CGM. These results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with T1D. Finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.

Eligibility Criteria:
Inclusion Criteria:

1. child 8-12 years of age with a diagnosis of T1D ≥ 6 months
2. currently using insulin pump( IP) and CGM ≥ 1 month \[including Hybrid Closed Loop (HCL) systems\]
3. participation of primary diabetes caregiver
4. English fluency
5. mean A1c \>7.5% over the past 6 months (Aim 3 only)

Exclusion Criteria:

1. major illnesses other than T1D in the child
2. significant cognitive limitations or major psychiatric disorders in the child or parent
3. the use of medications other than insulin to control blood glucose levels.