cyrilzakka/clinical-trials huggingface dataset:
Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders

The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety.

Cognitive and Behavioral Therapy (CBT) is today the reference treatment recommended by the "Haute Autorité de Santé" and the American College of Physicians for chronic insomnia. Today, however, few patients use CBT treatment due to the lack of trained practitioners, the cost of non-reimbursed sessions and the time and involvement that these sessions require.

Several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. The hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in patients suffering from insomnia disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Patient suffering from insomnia as defined in the Diagnostic and Statistical Manual of Mental Disorders V (DMS-V) and the International Classification of Sleep Disorders.

Exclusion Criteria:

1. Patient who, in the judgment of the investigator, has a disease that may preclude participation in study procedures.
2. Minor subject
3. Subject under judicial protection, guardianship or curatorship
4. Inability to give informed information about the subject: demented patients, psychotic patients or follow-up for a psychiatric pathology
5. Unbalanced epilepsy
6. Hearing and/or visual disorders that contraindicate the use of virtual reality headphones
7. Patient with a language barrier
8. Pregnant or breastfeeding patient
9. Subject in period of exclusion (determined by a previous or current study)
10. Patient Refusal
11. Patient currently being treated for depression, alcoholism or drug addiction.
12. Patient using drug treatment for insomnia not stabilized within 2 weeks prior to the start of the study.
13. Patient starting psychological, complementary or alternative medicine treatment for insomnia within 2 weeks prior to the start of the study, or during the study.
14. Patient receiving or having received CBT treatment for insomnia within the last 6 months.
15. Patient diagnosed with sleep apnea, involuntary limb movement, restless legs syndrome.
16. Patient with diagnosed medical conditions that cause insomnia: psychotic disorder, bipolar disorder, dementia, generalized anxiety disorder, panic disorder, manic disorder, schizophrenia, cancer.
Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities

The purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic abnormalities.

The purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic syndrome.

This study is a 24 week follow up randomized prevention trial. Participants visit for a screening test, then eligible participants are randomly assigned for one of the following arms; 1 intervention group using a mobile application to monitor their life style behaviors, 1 intervention group using a mobile application for personal coaching on purpose of improving their life style behavior, and 1 control group providing education about managing life style behaviors.

Eligibility Criteria:
Inclusion Criteria:

* "Etiologic study on cardiovascular and metabolic diseases: prospective cohort study (Severance Hospital IRB No. 4-2013-0661)" participants
* Smartphone user
* Metabolic abnormality. Having 2 or more components of metabolic syndrome described below:

  1. Central obesity : waist circumference ≥ 90cm in male, ≥ 80cm in female
  2. Systolic/diastolic blood pressure ≥ 130/85 mmHg
  3. Serum triglyceride ≥ 150 mg/dL
  4. Serum high density lipoprotein cholesterol \< 40 mg/dL in male, 50 mg/dL in female
  5. Fasting glucose ≥ 100mg/dL

Exclusion Criteria:

* Presently or planning for pregnant/breastfeeding during the study. Or confirmed pregnancy by a urine test.
* Currently taking medication (including insulin injection) for hypertension, dyslipidemia, or diabetes.
* Presently using a mobile application for lifestyle modification
Immunogenicity and Safety Study of NBP606 in Healthy Infants

This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
* The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Known hypersensitivity to any components of the pneumococcal vaccine
* Any confirmed or suspected immunosuppressive or immunodeficient conditions
* Coagulation disorder contraindicating IM(intramuscular) vaccination
* Subject has received any licensed vaccine(not including BCG and Hepatitis B)
* Participation to another study
A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)

This study will examine whether fasudil is effective and safe in treating patients with amyotrophic lateral sclerosis (ALS).

This is an open labeled, single center clinical study with placebo of historical researches as control. 10 patients will be enrolled in the study. The basic treatment is riluzole, 50mg twice a day. For the procedure, patients will take fasudil treatment for 14 days (30mg twice a day, intravenous). 3 months later, patients will repeat the fasudil treatment. All the patients will be followed up for 6 months. The primary outcome was the decline rate of ALSFRS-R. The secondary outcomes are the survival time, endpoint time(death, tracheotomy and continuous ventilator-dependent), forced vital capacity (FVC), the short form health survey (SF-36), evaluation of cognitive function (verbal fluency and Frontal Behavioral Inventory Scale) and safety.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
* Age: 18-70 years
* Disease duration: 3-36 months
* Forced vital capacity: at least 60% of predicted
* ALSFRS-R: at least 30, respiratory items: at least 10
* Decline of ALSFRS-R in the last 3 months before enrollment: 1-8
* Must take riluzole, on a stable dose for at least 30 days prior to baseline visit with no serious side effects. They must continue the riluzole treatment for at least 6 months after enrollment.
* Patients of childbearing potential must be using an effective method of birth control
* Willing and able to give informed consent

Exclusion Criteria:

* Familial ALS
* Pregnant or nursing women
* Patients after tracheotomy or continuous ventilator-dependent (time with non-invasive ventilator more than 22 hours per day for 7 consecutive days.)
* After percutaneous endoscopic gastrostomy
* Alanine Transaminase (ALT) or Aspartate Transaminase (AST): at least 3 times the upper limit of normal
* Abnormal creatinine or urea nitrogen
* Severe cardiac disease, pulmonary disease, hematic disease, autoimmune disease, mental disease, dementia and substance abuse
* History of malignancy
* History of intracranial hemorrhage
* History of severe bleeding of digestive tract, lungs, nose and skin
* Allergic to fasudil
* Participating in other clinical studies or using other investigational drugs at present
Lavender During Intrauterine Insemination

The Researchers hope to learn if by using lavender aromatherapy during an intrauterine insemination patients have decreased anxiety and pain at the time of the procedure.

Infertility patients have a high level of anxiety before and during infertility treatments due to anticipated discomfort of a procedure and anticipation of a long awaited pregnancy. Aromatherapy with lavender, an essential oil, has been shown to be effective in reducing anxiety and pain in a variety of procedures such as Botox injections, cesarean delivery and intrauterine device placement.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing intrauterine insemination
* English speaking

Exclusion Criteria:

* Allergy to lavender oil or its components
* Currently using aromatherapy
* Contraindication to intrauterine insemination
* Contraindication to pregnancy
Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block

The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.

Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) grade I or II patients
* both sexes
* scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .

Exclusion Criteria:

* with pre-existing peripheral neuropathy of upper limb.
* Bleeding disorders.
* Infection at injection site.
* Untreated pneumothorax.
* Patients on adrenoreceptor agonist or antagonist therapy.
* History of severe cardiac,.respiratory, hepatic, or renal disease.
* pregnancy and known hypersensitivity to the study drugs.
BioXmark, Rectal Feasibility Trial

To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.

This study is a prospective non-randomized open label trial.

A total of 20 patients who will undergo neo-adjuvant chemo-radiotherapy for rectal cancer will be included in this study upon informed consent.

During an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).

Participants will undergo standard treatment for their rectal cancer.

As part of standard patient set-up directly before each radiotherapy treatment, kilovoltage (KV) cone-beam computed tomography (CBCT) will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe (this probe will be positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum). Moreover, for patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device.

As part of standard clinical practice an Magnetic resonance imaging (MRI) of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.

As part of standard clinical practice patients whose tumor has not responded completely will be operated on 8-12 weeks after the end of neoadjuvant chemo-radiotherapy. Patients with a complete response will be follow-upped according to the "wait-and-see" protocol.

Cone-beam CT and MR images which are obtained as routine practice during treatment of the participants will be compared with images of 20 non-participating patients treated at our institute in the same period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy
* Age \> 18 years
* Have given written informed consent before patient registration

Exclusion Criteria:

* Patients using anticoagulants: platelet aggregation inhibitors or coumarines
* Iodine allergy
Comparison of Two Different Alveolar Ridge Preservation Techniques

The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket preservation procedures, both when the socket is filled and overfilled with freeze dried bone allograft (FDBA).

This single-blind, randomized clinical trial aims to compare two different, commercially available materials to assess their relative efficacies in socket preservation procedures after tooth extraction. Patients presenting with single teeth deemed clinically hopeless and treatment planned for removal in the normal course of clinical dentistry will be considered for this study. If eligible, a ridge/socket preservation procedure will be performed at the time of extraction. Periodontics residents will perform the procedure under the supervision of board certified staff. Patients will be randomized via concealed random number sequence into one of four groups, based on a combination of materials and graft placement techniques. Patients will be equally distributed into the following groups: (1) dense polytetrafluoroethylene (Cytoplast) (2) Cytoplast with additional buccal augmentation/onlay graft, (3) human amniotic-tissue derived membrane (BioXclude), and (4) BioXclude with additional buccal augmentation/onlay graft. All four treatment groups are consistent with the current standard of care, and this study seeks to compare techniques and materials as part of routine, clinical/periodontal therapy in order to determine superiority. Approximately 150 patients will be enrolled and distributed equally among the four groups. Any post-operative complications will be managed and documented during follow-up appointments at 1, 2 and 4 weeks. Cone beam computed tomography (CBCT) will be used as the primary assessment tool, and scans will be compared between a pre-operative baseline time point and a scan taken after 4 months of healing to prepare for implant placement. The primary dependent variables will be (1) percent of baseline alveolar ridge changes (both horizontal and vertical) and (2) whether or not the anticipated dental implant could be placed appropriately. Secondary outcomes include ease of use, perceptions of pain, complications, cost-effectiveness, and changes in keratinized tissue.

Eligibility Criteria:
Inclusion Criteria:

* All active duty military patients (age 18-65) referred to the investigators' facility's periodontics department for diagnosis of "hopeless" tooth with documented confirmation of diagnosis by periodontal staff
* Eligible for extraction and ridge preservation (adequately healthy and not otherwise disqualified)

Exclusion Criteria:

* Pregnant or breastfeeding
* History of allergy to involved products
* Current acute infection at the site (chronic periapical infections will not exclude the patient)
* Elian Type 3 extraction sockets
* Sites not treatment planned for implant therapy
* Third molar sites
* American Society of Anesthesiology Category III patients (medically compromised)
* Active duty military patients in a student status
Activities of Daily Living Participation Characteristics Among School-Aged Children With Autism Spectrum Disorder

This study aimed to investigate the performance of activities of daily living (ADL) among 53 children ages 6-10 years: 17 with high-severity ASD (HS-ASD), 16 with low-severity ASD (LS-ASD), and 20 controls with typical development. Methods: The assessment combined a parent-reported questionnaire (the Participation in Childhood Occupation; PICO) alongside the Pediatric Evaluation of Disability Inventory (PEDI self-care) and Performance-based task, the Washing Hands Structured Observation (WashHO).

study objectives were to:

(a) Examine participation characteristics in self-care and daily activities of school-age children with HS-ASD and LS-ASD compared to children with typical development, based on the parent-reported Participation in Childhood Occupation Questionnaire (PICO-Q) for ASD and PEDI (b) Establish the validity and reliability of the WashHO assessment.

The research hypotheses were (A) Significant differences will be found among children with HS-ASD, children with LS-ASD, and children with typical development in results of the PICO-Q and the PEDI self-care subtest of independence.

(B1) The internal consistency of the WashHO assessment will be at a Cronbach alpha level equal to or greater than 70.

(B2) Significant differences will be found among children with HS-ASD, LS-ASD, and typical development in the WashHO assessment performance criteria, thus establishing the WashHO's discriminate validity.

(B3) Significant correlations will be found among the four PICO-Q ADL items, which involve performing a sequence of actions (bathing, hygiene, clothing, and washing hands) and the WashHO assessment performance scores, establishing its convergent validity.

(B4) Significant correlations will be found among the WashHO performance and degree of independence scores and the PEDI independence subtest in self-care, establishing the WashHO's concurrent validity.

Eligibility Criteria:
Inclusion Criteria:

Hebrew speakers

* study groups- ASD diagnosis provided by pediatricians or clinical psychologists according to DSM-5 criteria (APA, 2013).

Exclusion Criteria:

* without ASD formal diagnosis
Qualitative Interview Study Regarding Dentists' Repair Behaviour

The aim of the present study is to determine dentists' barriers and facilitators for performing repairs on partially defective dental restorations.

Potential barriers and facilitators for treating partially defective dental restorations by repair instead of complete replacement are going to be assessed by interviewing German dentists.

Eligibility Criteria:
Inclusion Criteria:

* Dentists who are working in dental offices in Germany and who are able to give written consent

Exclusion Criteria:

* Non-fulfillment of the inclusion criteria
* Lack of capacity to consent
* No German language skills in written and spoken language
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.

This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 4 through 17 years
* History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms
* Positive SPT for peanut
* Positive serum IgE to peanut
* Written informed consent from the subject's parent/guardian
* Written assent from the subject as appropriate
* Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

* Uncertain clinical diagnosis of peanut allergy
* History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* Severe persistent asthma or uncontrolled mild or moderate asthma
* History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
* History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids

Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique.

This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months.

The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old.
* Non-pregnant patient
* A patient who had an ultrasound confirming the presence of a uterine fibroid to be treated less than 6 cm.
* Patient who had a diagnostic hysteroscopy confirming the presence of a uterine fibroid to be treated of type 0, 1 or 2 according to the FIGO classification.
* Patient presenting an indication for intra uterine fibroid resection (bleeding, fertility problems) by operative hysteroscopy.
* Patient having agreed to participate in the study and having signed an informed consent.

Exclusion Criteria:

* Minor patient
* Patient not affiliated to a social security system
* Persons benefiting from special protection: by virtue of articles L1121-5 to L1121-8 of the Public Health Code: pregnant or breast-feeding women, minors, adults under guardianship or curatorship, persons deprived of liberty.
* Patient refusing to sign the consent or unable to receive the information necessary to give informed consent.