cyrilzakka/clinical-trials huggingface dataset:
Serotonin, Serotonin Genetics(TPH2) and Emotion and Interference Processing

The study aims to explore whether acute tryptophan depletion can affect the emotion and interference processing whether this effect is moderated by the TPH2 genotype

Based on previous studies suggesting that serotonin, a neurotransmitter, is associated with social \& emotional behavior, including emotional reactivity and emotion regulation, the present study aims to explore effects of acute tryptophan depletion (ATD) on emotion processing and emotional interference processing within a randomized double-blind, with-subject, placebo-controlled pharmaco-fMRI experiment. To further examine the potential moderating effects of the genetic makeup of the serotonin system the present study will include a pharmacogenetics imaging approach. Given that TPH2 is the key regulator of the serotonergic signaling pathway, we therefore assessed whether such the effects of tryptophan depletion vary according to the TPH2 genotype. To this end, healthy male TPH2-GG or TPH2-TT carriers will be recruited and will receive ATD (100g) and placebo (102.3g) in a within subject design. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness

Exclusion Criteria:

* History of head injury;
* Medical or psychiatric illness.
* High blood pressure, general cardio-vascular alterations
* History of drug or alcohol abuse or addiction.
* Allergy against medications or general strong allergies
* Sleep disorders.
* Visual or motor impairments
Repetitive Position Change Improves Gastric Cleanliness for MCE

By comparing dimethicone administration with/without subsequent repetitive position change before magnetically controlled capsule endoscopy (MCE) examination, the investigators aim to determine the efficacy of repetitive position change in improving gastric cleanliness for MCE examination.

This is a single-blind, randomized controlled trial. Subjects receiving magnetically controlled capsule endoscopy at the institution will be randomly allocated into positional change group and conventional group before the procedure. Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination. Gastric cleanliness will be rated by two physicians independently.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged more than 18 years, who were scheduled to undergo a magnetically controlled capsule endoscopy, were eligible for this study.

Exclusion Criteria:

* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
* Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
* Pregnancy or suspected pregnancy;
* Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
* Currently participating in another clinical study.
Patient Anxiety Reduction in Children by Using Simple Explanation Videos

The reduction of preoperative anxiety in children and adolescents before an elective surgical procedure is an important clinical question in perioperative care. Adequate, age-appropriate patient information about the processes of the inpatient stay plays an important role in order to address possible worries and fears to reduce.

The medium video is popular with children and adolescents today and offers the possibility of an easily understandable and vivid presentation of information.

Studies by the health insurance companies, scientific publications and economic papers show that in times of increasing economic interests of the hospitals and the resulting necessity of economic working methods in the medical system, less time remains for human interaction. This creates areas of conflict, such as the patient's right to information regarding the time available to medical personnel. This in turn leads to significant stress factors in patients who are involved in the treatment and mostly on the communication level, such as "Missing information", "misunderstood visit", "missing partnership relationship" refer to what is reflected in patient satisfaction and fears. Studies show how important good perioperative psychosocial care is for reducing these circumstances in children, also and especially in the context of further development. The drug options for calming and reducing anxiety are already known, but there are also increasing numbers of non-drug approaches to reducing anxiety and stress in the literature. Painting therapy and clinic clowns are examples. However, access to such resources is limited and costs are permanently high. New technologies, e.g. mobile phones and tablets, with the associated media, increasingly finding their way into our society, are now inexpensive to buy and have become an integral part of most households. Such devices and media are increasingly used in clinical studies and patient care. Their use is tested extensively in modern medicine, e.g. to avoid unnecessary postoperative consultations in the emergency room or to increase cognitive learning for children. Even small children can use and understand these media early on. Videos are one of the most common media already understood by the smallest patients.

Eligibility Criteria:
Inclusion Criteria:

1. All patients (children) who present themselves planned in the Altona Children's Hospital or in the University Clinic Hamburg Eppendorf in the course of an upcoming elective operation.
2. The surgical intervention must take place in one of the following body regions: thorax, abdomen and / or extremities (incl. Head and neck)
3. A signed declaration of consent from the parents or legal guardians is available
4. The patient has given a declaration of consent
5. No mental illnesses may be diagnosed
6. No chronic pre-existing conditions may be diagnosed
7. Age of the patients is between 6 and 17 years

Exclusion Criteria:

1. No signed declaration of consent from the parents or legal guardians available
2. There is no signed declaration of consent from the patient
Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine

Primary objective:

\* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

* Immunogenicity

  * To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
  * To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
* Safety

  - To describe the safety profile after vaccination in each group
* Acceptability

  * To describe the pain at the injection site
  * To describe the comfort of the injection


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older on the day of inclusion

Exclusion Criteria:

* Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
* Unstable chronic illness
* Congenital or acquired immunodeficiency,
* Any blood or blood-derived product in the past 3 months
* Current abuse of alcohol or drug addiction
* Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
* Any vaccination against influenza in the past 6 months
* Subjects who previously received a vaccination against influenza by intradermal route
Framingham Offspring Study: Psychosocial Risk Factors

To examine the relationship between psychosocial characteristics, health behaviors, and the development of coronary heart disease among participants in the Framingham Offspring Study.

DESIGN NARRATIVE:

Unique data sets of social, psychological, and behavioral measures were collected at the third examination of the Offspring Study from 1984 through 1987 (which results in 14 to 17 years of follow-up). Hypotheses for this research are focused toward understanding the sex and age differences in the effects these variables have on health endpoints. The research questions involve the prediction of three separate endpoints: incidence of coronary heart disease; the incidence and prognosis of atrial fibrillation; and total mortality. The analyses of psychosocial predictors for these outcomes are divided into four conceptual areas: 1) occupational status and strain, income, and employment status; 2) type A behavior, expressions of anger, hostility, and rate; 3) symptoms of depression, tension, anxiety, and feelings of aloneness; and 4) marital relationships and marital strain. These psychosocial variables will be analyzed jointly with the physiological risk factors collected at the same time to assess independence and interaction of effects. To date these psychosocial data have not been analyzed or published.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Mucoadhesive Film With/without Acmella Oleracea &amp; Triamcinolone Acetonide for Aphthous Ulcers

The purpose of this study is to evaluate the effectiveness of mucoadhesive film with or without Acmella oleracea extract compared to standard treatment by using 0.1% triamcinolone acetonide in pain relief, promoting wound healing, healing time and satisfaction in 3 aspects included taste, product used and quality of life after using the product.

Participants who consent and meet the inclusion criteria will be allocated into 3 groups using block randomization: group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy participants aged 18-50 years without any underlying diseases.
2. Participants are voluntary and have signed the informed consent.
3. Participants are literate.
4. Participants can follow the treatment guidelines and follow up.
5. Participants have one untreated oral ulcer lesion.

   * An ulcer has occurred within 48 hours.
   * The ulcer size is less than 10 mm.
   * The ulcer is clearly visible and located on non-keratinized oral mucosa such as buccal mucosa, labial mucosa, alveolar mucosa, or buccal vestibule.
   * The ulcer must be painful.
6. If an ulcer is caused by a denture or orthodontic appliance, the cause must be eliminated before participation.
7. Participants must not be currently participating in any other clinical studies about oral ulcer

Exclusion Criteria:

1. Participants with allergies to herbal extracts, Acmella oleracea, or steroids.
2. Participants with chronic underlying diseases.
3. Participants with underlying diseases that may affect wound healing.
4. Participants receiving anti-analgesic drug, systemic steroids, antibiotics, hormones, NSAIDS, or any drugs that affect the oral mucosa.
5. Oral ulcer lesion larger than 10 mm or lesions resembling herpetic form of aphthous ulcers.
6. Oral ulcers are caused by infection or associated with systemic diseases.
7. Participants with poor oral hygiene requiring emergency treatment.
8. Participants who smoke or consume alcohol regularly.
9. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.


Eligibility Criteria:
Inclusion Criteria:

* Children with OSDB-symptoms referred to ENT-clinics
* Age between 18 months and 15 years old.
* Good knowledge of the Swedish language

Exclusion Criteria:

* Craniofacial abnormalities
* Mb Down
* neuromuscular disorders
* do not understand swedish
Epidemiological Study to Assess the Prevalence of Lung Cancer

Lung cancer is the main cause of mortality by cancer in France. The lung cancer stage at time of diagnosis is a major determinant of survival. To date, 75% of lung cancer are diagnosed at an advanced stage with worse survival). Lung cancer screening is based on low dose CT scan which allows to decrease lung cancer related mortality of 20% in patients aged 55-74 years-old with a history of tobacco consumption ≥ 30 PY active of who quite \< 15 years. These criteria for eligibility for lung cancer screening lead to 1 to 2% of lung cancer diagnosis at the first CT scan. In our experience regarding 1 year of lung cancer surgical resection, only 45% of the patients presented criteria for lung cancer screening. Moreover, the duration of tobacco consumption would provide a better stratification of lung cancer risk compared to only PY. Therefore, other criteria for lung cancer screening eligibility could be proposed. Currently, 9 out of 10 lung cancer is linked with tobacco consumption which is also a major risk factor for atherosclerosis-associated cardiovascular events. Around 40% of patients with a lung cancer have a history of atherosclerosis-associated cardiovascular event, mainly coronary artery diseases and peripheral artery diseases. Main Objective: The objective is to compare the observed rate of lung cancer prevalence in our study to the rate of around 2 % observed in lung cancer screening trials in south Europe (France and Italy).

The investigators hypothesize that the population of patients with a history of atherosclerotic cardiovascular event associated with tobacco consumption present a higher prevalence of lung cancer compared with the population of patients eligible for lung cancer screening program which is defined by age and history of tobacco consumption.


Eligibility Criteria:
Inclusion Criteria:

* Age 45 - 75 years old
* Patient who has signed an informed written consent
* Daily smoking for at least 10 years
* History of cardiovascular disease:

Exclusion Criteria:

* History of active cancer \< 5 years (except in situ cervical carcinoma and basal cell carcinoma of the skin)
* Lung cancer symptoms (involuntary weight loss \> 6.8 kg in 1 year, hemoptysis)
* Treatment or bleeding risk syndrome contraindicating an invasive diagnostic procedure within 3 months.
* Active pulmonary parenchymal infection
* Severe cardiac or respiratory insufficiency (resting dyspnea)
The Relation Between Pregnancy,Birth Outcome, Feeding , Oral Hygiene Habits and Early Childhood Caries Development.

* 200 children between ages 36 to 48 months will be invited for a regular dental examination
* Parameters to be investigated

  1. Pregnancy history
  2. Birth outcome
  3. Child's general health
  4. Feeding habits
  5. Oral hygiene habits
  6. Dmft caries index
  7. Congenital enamel defects

Severe Early Childhood Caries is a condition whereby very young children suffer multiple caries. The value of a pre- perinatal preventive approach is currently being examined in the dental literature. At Hadassah, a Pilot Study is currently underway to test the feasibility of a comprehensive Baby Clinic designed to prevent Severe Early Childhood Caries. The pilot study in cooperation with the Woman's Health Center and with the midwives and the breastfeeding counselors of the maternity unit. Lectures are given by pediatric dentists to parents of firstborn children attending Hadassah's Birth Preparation Class, emphasis is given to the importance of breastfeeding and other feeding habits in the emotional, physical, nutritional and immunological development of the future baby. In addition the effect of these feeding habits on the dental/oral aspects, relevant for the developing dentition.

After birth the parents are invited to come with their babies around 12 months for the first dental examination and follow up according to individual risk for caries development. The current proposed study will be a control group from offspring of women who have participated previous Sessions Hadassah's Birth Preparation Class ("Historical Controls" before the Baby Clinic project)

Eligibility Criteria:
Inclusion Criteria:

* children born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)

Exclusion Criteria:

* children not born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)
Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* Possible autoimmune encephalitis
* Patients who have been diagnosed and treated for encephalitis for more than 4 weeks
* Patients with epilepsy (EEG finding or clinically)

Exclusion Criteria:

* septic shock, fever \>38.5 ℃, O2 saturation \<90%, respiratory rate \>25, HR \>120
* previously, mRS=3 or mRS\>3
* MMSE\<20
* Patients who have terminal disease
* eye problem
* pregnancy
Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

The investigators propose to explore the hypothesis-supported by limited data-that a contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing, will enhance women's genital and reproductive health. The investigators propose that this CVR will increase the bacteria that help the vaginal environment protect against infection by HIV and other STIs, and that in women who already have HIV, use of the CVR will lower the quantity of HIV that is shed in the female genital tract.

The investigators objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. The investigators will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in \>50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone-commonly used throughout Africa-may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). The investigators propose NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. Sustained vaginal delivery of contraceptive and ARV PrEP as "multicomponent prevention" is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation.

Total duration of follow up is no more than 8 months, with 5 months of CVR usage.

Eligibility Criteria:
Inclusion Criteria:

* BV+ by Amsel Criteria
* Not intending to become pregnant over the course of the study
* If HIV infected, not taking ART
* Capable of providing written informed consent

Exclusion Criteria:

* Current pregnancy
* Desire/intent to become pregnant over the course of the study
* Contraindications to hormonal contraceptive use
* Current cigarette smoking if age is older than 35 years
* Unable to comprehend consent material because of language barrier or psychological difficulty
Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile

Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in children and it's considered as a public health problem.

ADHD is frequently associated with a new diagnostic entity " Disruptive Disorder with Emotional dysregulation ". This disorder is characterized by crisis of anger with verbal or physical aggression, intensity disproportionate to the context and developmental age.

Few studies have examined the elements of emotional dysregulation in ADHD in children. Many studies have shown the interest of CBT in multimodal management of ADHD symptoms and associated disorders.

The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after intervention. Secondary objectives are to evaluate the impact of this program, at short-term (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities, quality of life, children's functioning and parental stress.

It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels, with an evaluation of the criteria of blind judgment.

68 patients (parents and children) will be recruited within Montpellier University Hospital. They will be divided into a CBT group and a control group (body mediation).

The CBT group benefits from an intervention based on the program "Better manage its anger and its frustrations" of 15 sessions for the children.

The control group participates in an intervention of body mediation (theatre) of 15 session for the children.

The parents of CBT and Control groups participate in an CBT intervention of 8 sessions every 15 days.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 7-13 years ;
* Children with a diagnostic of ADHD (diagnostics criteria from DSM-V);
* Score CBCL-DP ≥ 180 (" Aggressive behavior ", " Anxious-depression " and " Attention problems ") ;
* Children follow-up in Montpellier University Hospital ;
* Parents and children benefit of social security.

Exclusion Criteria:

* Children with a developmental delay or severe language disorder ;
* Families non-french speaking ;
* Absence of consent signed by parents and child ;
* Children not living with at least one parent.