cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.

Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications.

Two types of treatments are validated : serotoninergic antidepressants (SSRI) and psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies also emphasize the important proportion of non-responders to SSRI, few of them analyze the reasons for this non-answer.

To better understand the mode of action of SSRI, we should analyse the serotonergic activity in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor ligands (\[18F\] MPPF or \[11 C\] WAY-100635), were used in positron emission tomography (PET) to characterize the serotonergic abnormalities of bulimic patients. The ligand \[18F\] MPPF has the feature to be sensitive to the level of endogenous serotonin.

A first pilot study using PET with \[18F\] MPPF realized between the University Hospital of Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of \[18F\] MPPF in bulimic patients, suggesting a decrease in serotonin activity.

The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse, taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity of cortical binding of \[18F\] MPPF.

In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic activity, it seems necessary to continues investigations, to determine if there is a link between brain serotonin profile and responding to SSRI in bulimia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Bulimic patients according to DSM-IV TR: minimum 2 bulimic crises (compulsive eating followed by compensatory behavior) / week for 3 weeks
* Patients who signed informed consent to the study
* BMI greater than or equal to 18.5 kg / m²

Exclusion Criteria:

* Against-indication to the SSRI or fluoxetine
* SSRI consumption in the previous three months
* Other addiction (except tobacco, for reasons of feasibility)
* Diagnosis of binge eating disorder or EDNOS (DSM-IV-TR)
* Patients with heart failure
* Against-indication for PET and / or MRI: pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia
* Subjects with suspected pregnancy or in the second half of their menstrual cycle in the absence of oral contraceptives; positive Β-HCG test before the exam
Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease

Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface disease is helpful.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.

Exclusion Criteria:

* Subjects who are elderly (≥80 years old) or have an autoimmune disease (e.g., Sjögren's syndrome and systemic lupus erythematosus) are excluded.
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children

Children experience numerous painful experiences from nursing procedures: peripheral venous access placement is the main cause of procedural pain.

As much as pharmacological and nonpharmacological tools are known, their application during venipuncture is not systematic by children's hospitals.

Among pharmacological tools, the Equimolar Mixture of Nitrogen Protoxide and Oxygen (EMONO) provides adequate protection from procedural pain through inhalation of the gas mixture at least 3 minutes before the procedure.

Literature reports that the combination of nonpharmacological distractive tools and pharmacological interventions increases their analgesic effect.

The aim of the study is to measure children's cooperation during procedure (primary outcome), pain perception and side effects when EMONO is combined with audiovisuals compared with EMONO alone in peripheral venous access placement.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 years and 5 years and 364 days
* Prescription for peripheral venous access placement
* Parental consent for participation in the study
* Presence of at least one parent in possession of a smartphone/tablet with the ability to connect to the Internet through Wi-Fi available to users
* Absence of contraindications to the administration of EMONO reported in health records
* Absence of facial pathology
* Presence on duty of at least one experimental nurse trained in the use of EMONO

Exclusion Criteria:

* Age less than 2 years and more than 5 years and 364 days
* No parental consent to participate in the study
* Parents not in possession of a smartphone/tablet with the ability to connect to the internet through Wi-Fi available to users
* Presence of contraindications to EMONO administration
* Presence of facial pathology
* Oxygen therapy
* Presence of tracheostomy
* Absence on duty of at least one experimental nurse trained in the use of EMONO
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

The purpose of this survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.

This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

The survey will enroll approximately 1,000 participants.

- Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a history of gastric or duodenal ulcer

Exclusion Criteria:

* Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
* Participants with active upper gastrointestinal hemorrhage at initiation vonoprazan therapy
* Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
* Participants receiving atazanavir sulfate or rilpivirine hydrochloride
Role of Airway Hyperresponsiveness on Performance in Elite Swimmers.

The prevalence of airway hyperresponsiveness (AHR) is very high in elite swimmers, reaching 80% in certain studies. Repeated Chlorine-derivatives exposure may be a major causative factor for its development. Asthma diagnosis is generally made on the basis of clinical characteristics. The demonstration of a variable bronchial obstruction through positive expiratory flow reversibility to a bronchodilator, spontaneous variations of airway obstruction or a positive provocation test (methacholine, eucapnic voluntary hyperpnoea...) is necessary to avoid false diagnosis. Currently asthma treatment in swimmers is the same as in the general population. A short-acting bronchodilator is often prescribed to avoid occasional symptoms, combined with an inhaled corticosteroid or an antagonist of Leukotriene if asthma symptoms are persistent. Previous studies have shown a reduced efficiency for asthma medication in elite athletes compared with non-athletes. The specific response to different medications remains to be studied in athletes. The effects of a short-acting bronchodilator in swimmers with AHR, especially when asymptomatic, on pulmonary function and performance have not yet been studied. Moreover, the significance of a positive bronchial provocation test remains to be studied in asymptomatic swimmers with AHR.

Our hypothesis is that swimmers with a positive bronchial provocation challenge have not necessarily an exercise-induced bronchoconstriction during swimming and the use of a bronchodilator will be unnecessary. Chlorine-derivatives exposure may be responsible for a weakness of the epithelium layer but warm and humid atmosphere of the swimming-pools may be protective for the development of a bronchoconstriction. Thus we also hypothesis that during a field test outside the swimming pool, swimmers will develop an exercise-induced asthma, and will need to take a bronchodilator in prevention.

Eligibility Criteria:
Inclusion Criteria:

* Swimmer (at least 10h/week) aged from at least 14 years.

Exclusion Criteria:

* Smoker, obese or other disease which may interfere with the study. Some parts of the study may exclude swimmers taking inhaled corticosteroids.
Immun Response in Children With MIS-C

Multi-system inflammatory syndrome in children (MIS-C) is a post-viral inflammatory vasculopathy of children and adolescents following Covid-19 infection. It affects one of 1000-5000 children. Latency between mild or asymptomatic Covid-19 infection and MIS-C is 4-6 weeks. The immune response in MIS-C seems to be dysregulated and different from that during acute SARS-CoV-2 infection.

The investigators are planning to investigate the immune response in children with MIS-C.

RNA and protein expression of cytokines and immune cell-related markers will be determined via multiplex ELISA, FACS, quantitative PCR, RNAseq, and Western blot.

The use of highly sensitive multiplex methods will allow for the analysis of a large number of parameters in the smallest possible amount of sample. Sample preparation and analysis will be performed in close collaboration with the Centre for Molecular Medicine Cologne (CMMC) and the Institute of Virology.

With this project the investigators hope to identify risk factors for developing MIS-C and extend the knowledge on therapeutic options for the treatment of this condition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MIS-C (WHO criteria)
* \<18 years
* Hospitalized in the Children´s University Hospital of Cologne

Exclusion Criteria:

* no informed consent
The Influence Of Physiological And Psychological Factors On Fall Syndrome

Most of previous studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, we hope to find out what changes in the elders' physiological and psychological functions after a fall.

Falls are the main cause of accidental injuries that are common among the elderly. In Taiwan, the incidence of falls is about 15% to 34%. Falling can cause subsequent serious injuries and post-fall syndromes. Post-fall syndrome is common after a fall. The symptoms of self-restricted activity for fear of falling again affect about one-fifth of older fallers. This syndrome develops within a short period of time after a fall, which not only causes serious problems but also affects psychological symptoms and dependence on daily life functions. All of these reduce the function of movement and increase the chance of falling again. However, most of the past studies are cross-sectional studies, and rarely explore the changes in physical activity, mental state, cognitive and motor functions over time after a fall. Therefore, the study will investigate the changes in physiological and psychological functions after a fall among older adults who experiences a recent fall within 2 months. Additionally, the physiological and psychological functions will be compared between older adults with and without a history of falls.

Eligibility Criteria:
Inclusion Criteria:

1.60 years to 99 years old 2.Fall experiences within two months 3.Can understand and answer the questions 4.Can give their informed consent

Exclusion Criteria:

1.Serious fracture or head trauma caused by a fall, 2.Unable to perform a walking test, 3. Neurological diseases
Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.

Two theory-based, task-oriented approaches are distributed CIT (dCIT) and robot-assisted Bilateral training(BAT). CIT/dCIT involves massed practice of the affected arm and restraint of the unaffected arm. BAT involves repetitive practice of symmetrical bilateral movements on robot. Both are evident to improve motor performance, motor control or daily function in high functioning patients. These dCIT and BAT have their own limitations for motor-deficit rehabilitation after stroke, i.e. only appropriate for high-functioning or mildly motor impaired patients. Functional electrical therapy, an innovative technology, is proposed as an adjunct to these behavioral approaches to assist in movement execution. Functional electrical therapy is used to increase the electric activity of muscles for movement and the active range of motion in low functioning patients. Combining functional electrical therapy into CIT or BAT may extend the utility of these two behavioral approaches beyond patients with mild motor deficits and could expedite the progress of motor recovery. This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with dCIT or with BAT.

Eligibility Criteria:
Inclusion Criteria:

* The onset duration more than 6 months
* An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
* No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
* The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
* No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
* Considerable nonuse of the affected upper extremity (an AOU score \< 2.5 of Motor Activity Log)

Exclusion Criteria:

* Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
* Excessive pain in any joint that might limit participation
Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden

Caregivers are also faced with multiple stress factors. Autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. Although there are various studies on this subject (Chegeni et al. 2018, Seo and Kim 2019, Ramiraz-Garcia et al. 2020, Wang et al. 2021, Bagheri et all 2021, Ozhanlı and Akyuz 2022), there is no study on caregivers as far as we could reach. As a result of this study, nurses will help caregivers, whom they work one-on-one in most areas, to relax, thus helping to increase the quality of patient care in home environments and contributing to the increase in the quality of life of the caregiver. Thus, caregivers will be able to manage care more actively and effectively both at home and in clinics.

Based on this purpose, the aim of the study is to reduce the anxiety level of caregivers, increase the quality of life and reduce the burden of care after autogenic relaxation therapy to be applied to caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Being able to answer data collection forms
* Being able to speak Turkish
* Being able to provide continuous or partial care to a patient for at least 3 months
* Being able to communicate

Exclusion Criteria:

* Having epilepsy
* Not speaking or understanding Turkish
* Having a neurological disability
* Having had an acute myocardial infarction
* Being diagnosed with schizophrenia and major depression
* Being addicted to alcohol or drugs
* Having a history of loss of consciousness
Needle-Aspirated Compression Dressing Following Ostomy Reversal

Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections. This study studies the effect of a low cost needle-aspirated negative pressure compression dressing on rates of wound infection at prior ostomy site in patients undergoing ostomy reversal surgery.

Negative Pressure Wound Therapy (NPWT) will be studied in colorectal surgery patients undergoing ostomy reversal surgery. The immediate goal is to compare primary wound closure against primary closure with needle-aspirated compression dressing, and determine if risk of potential ostomy site wound infections is decreased. The investigators would also like to evaluate if this compression dressing can increase prevalence of complete wound closure by 12 weeks (last planned clinic visit). NPWT using a continuous suction device was shown to decrease surgical site infection (SSI) at ostomy reversal sites undergoing primary closure. There is a lack of published literature studying NPWT dressings without an associated suction device. The investigators will be using a low-cost simple needle-aspirated suction technique to provide negative pressure under a tegaderm/gauze dressing, at the time of placement. Patients will be consented and randomized into a negative pressure group, or a control group consisting of the same dressing under normal pressure. All adult patients undergoing ostomy reversal surgery who consent to the study will be included. Exclusion criteria include prior recurrent skin infections, prior stoma-site infection, or large parastomal hernia. Patients in the negative pressure group will have the pressure under the dressing measured immediately prior to removal on post-operative day 2.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* presence of a loop or end colostomy or ileostomy
* consenting to study and to ostomy reversal

Exclusion Criteria:

* altered mental status or patients unable to sign the informed consent form
* vulnerable patient populations such as prison and ward patients
* patients who are discovered before or during surgery as unable to undergo placement of compression dressing will be excluded.
* Patients with visible protrusion/evidence of large parastomal hernia
* history of recurrent skin \& soft tissue infections
* history of previous stoma site infection or complications
* patients with extensive comorbidities (such as cancer involving stoma site, uncontrolled diabetes, etc), Crohn's patients and abdominal wall fistula patients
* patients in who primary closure of wound is deemed inappropriate by the operating surgeon, requiring a different method of stoma site wound management
Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
* American Society of Anesthesiology (ASA) Class I and II

Exclusion Criteria:

* Conversion from laparoscopic to open surgery
* History of Chronic pain or ongoing treatment for chronic pain
* Age less than 18 yrs
* Allergy to local anesthetics
Duke Spine Outcome Study (DSOS)

The primary goal of this registry is to increase the knowledge about spine tumors and other spine disorders to guide appropriate management strategies for the future. This registry will include the review of medical records, data collection for health related quality of life questionnaires, and collected tissues and samples.

The study will require obtaining spinal lesions (tumor, etc.), blood, and bone marrow samples (from non-lesional bone) from selected patients, which will be collected during your surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years.
* Able to read and write local language at an elementary level.
* Diagnosis of primary or metastatic tumor of the spine ); or
* Infection of the spine; or
* Instability of the spine; or
* Injury of the spine.
* Accessibility for treatment and follow up.
* Patient consent obtained according to Duke institutional policy.

Inclusion criteria for spine surgery (control population for bone marrow specimens)

* Age between 18 and 85 years.
* Spine surgery to be performed at Duke University Medical Center (DUMC) under the auspices of the neurosurgery program.
* No concurrent cancer diagnosis.
* Accessibility for treatment and follow up.
* Patient consent obtained according to Duke institutional policy.

Exclusion Criteria:

* History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening
* Is a prisoner.
* A disease or condition that would, in opinion of the investigator, preclude accurate evaluation

  (e.g. significant psychiatric disease), or that would impair the ability of the patient to receive protocol treatment or comply with protocol.
* Pregnant or breast feeding during the study period (women of child-bearing potential will require a negative serum pregnancy test within 30 days of enrollment).
* Active infection, or fever of unknown origin.
* Inflammatory bowel disease.
* Systemic lupus erythematosus.
* Rheumatoid arthritis, or other autoimmune disease.
* History of or active hematologic or bone marrow diseases, including but not limited to diagnosed lymphomas, leukemias, sickle cell or other anemias not associated with their current condition.
* Polycythemia vera.
* Known or suspected immunodeficiency or Human Immunodeficiency Virus (HIV).
* Hematocrit \< 24% pre-operatively.