cyrilzakka/clinical-trials huggingface dataset:
Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity

The aim of this study is to analyse explicit and implicit emotional information processing abilities in children with attention deficit disorder with or without hyperactivity

The main symptoms of Attentional Deficit Hyperactivity Disorder (ADHD) are inattention, motor agitation and impulsivity. However, other dysfunctions affecting the quality of life remain poorly studied: lack of understanding and management of emotions, focus on the local aspects of a visual scene limiting the ability to assign a general meaning to the scene and alteration of long-term memory encoding. This study aims to analyse these difficulties using different tasks requiring processing of rich and varied everyday images, having high ecological validity. It involves the participation of 56 boys and girls with ADHD, aged 7 to 12 years. A first phase examines the immediate understanding of images using two tasks: semantic categorization (Experiment 1) and emotional evaluation (Experiment 2) of images with positive, negative or neutral emotional valence, and depicting real environments (natural vs. manufactured contexts) or foreground objects pasted into a noise background (inanimate objects vs. animals vs. people. In each trial, one context image and one object image are presented briefly and simultaneously, one in each visual field. In order to be appropriately understood in both their semantic and emotional contents, context images will require more global processing, while object images will require more local, detailed processing. Their semantic (Exp. 1) and emotional (Exp. 2) consistency is manipulated. A week later, the participants have to perform a memory task requiring old/new recognition in a two-alternative forced choice (2AFC) paradigm that presents in each trial a pair of images (one old, one new) having the same emotional valence (Exp. 3). The study will characterize the specificities of processing and representing visual emotional information in ADHD children. The results will be compared with those from a previous study we conducted with the same methodology on neuro-typical children (controls).

Eligibility Criteria:
Inclusion Criteria:

* Children between 7 and 12 years old..................................
* Normal or corrected visual acuity .....................................
* ADHD diagnostic given by a doctor according to DSM 5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
* Free from drug treatment until 24 hours before the experiment session............................
* Affiliation to a social security system.........................
* Signature of the authorization documents from one parent or the holder of parental authority

Exclusion Criteria:

-History of neurological troubles, dysphasia, autistic spectrum disorder, intellectual disabilities
Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution

The aim of this study is to know the characteristic of "one-per-mil" tumescent solution in regards of the optimal time delay to achieve optimal visualization of operation field in hand and digit surgery.

Hypothesis:

1. Epinephine in "one-per-mil" concentration by tumescent injection technique will provide faster decrease in oxygen saturation compared to normal saline solution injected by tumescent technique.
2. Epinephrine in "one-per-mil" concentration by tumescent injection technique will provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.
3. Epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.

This is a prospective, randomized, double-blind study to measure the optimal time delay of 1:1,000,000 epinephrine in saline solution injected by tumescent technique until maximum vasocontriction in the distal finger is achieved.

Subjects will be injected in both his ring fingers(distal phalanges, volar side) with randomized solutions, one containing "one-per-mil" tumescent solution and the other containing only normal saline solution; information which both the injector and examiner are blinded from. Maximum vasoconstriction of the finger injected is depicted by the lowest oxygen saturation (recorded every minute until 45 minutes using pulse oxymeter).

Eligibility Criteria:
Inclusion Criteria:

* Willing to join the research
* BMI 18.5-23
* Healthy individual, no history of blood or coagulation disorders

Exclusion Criteria:

* BMI \<18.5 or \>23
* History of blood or coagulation disorder, diabetes mellitus, heavy smoker
The Effects of CBT and tDCS on Fibromyalgia Patients

Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.

Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
2. Between the ages of 21 and 85

Exclusion Criteria:

1. Other chronic pain conditions
2. on chronic opioid therapy
3. history of seizures
4. are or might be pregnant
5. metal/electronic implants or devices above the waist
6. moderate to severe depression (HDRS \>19)
7. moderate to severe anxiety (BAI \>16)
8. Latex allergy
9. Psychiatric illness other than mild depression or anxiety
10. on medications that lower seizure threshold
Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Prospective observational interventional study , The study done in two phases:

1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.

Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.

Patients and Methods: The study done in two phases:

1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.

Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis

Exclusion Criteria:

* patients wishing future fertility
* endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume
Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility

Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

The first group includes non active ectopic pregnancies defined by score or algorithm. In this case, we propose a randomized controlled trial between medical and conservative surgery. In all others clinical situations, we proposed surgery treatment. In a randomized controlled trial we compare conservative versus radical treatment. The patients are followed-up during 2 years with phone contact every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis by ultra sound of ectopic pregnancy (EP)
* Patients aged \> 18 years old
* Desire of future pregnancy

Exclusion Criteria:

* EP by failure of contraception
* EP associated with in vitro fertilization (IVF)
Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil

The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS).

This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.


Eligibility Criteria:
COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19

Inclusion Criteria:

* Age ≥18 years;
* Hospitalization due to COVID-19;
* Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
* Diagnosis of ARDS during hospitalization according to the Berlin definition;
* Expected to survive and be discharged directly home from the hospital.

Exclusion Criteria:

* Severe comorbidity with life expectancy less than 3 months;
* Unavailability to attend the study follow-up appointment;
* Death during hospitalization;
* Absence of proxy for patients with communication difficulties;
* Refusal or withdrawal of agreement to participate.

COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19

Inclusion Criteria:

* Age ≥18 years;
* Hospitalization;
* Diagnosis of ARDS during hospitalization according to the Berlin definition;
* Expected to survive and be discharged directly home from the hospital.

Exclusion Criteria:

* Severe comorbidity with life expectancy less than 3 months;
* Unavailability to attend the study follow-up appointment;
* Death during hospitalization;
* History of SARS-CoV-2 infection within the last 12 months;
* Absence of proxy for patients with communication difficulties;
* Refusal or withdrawal of agreement to participate.

FAMILY CONTROLS

Inclusion Criteria:

* Age ≥18 years;
* Family member of a enrolled participant (either from the COVID-19 ARDS cohort or from the non-COVID-19 ARDS cohort)

Exclusion Criteria:

* Severe comorbidity with life expectancy less than 3 months;
* Unavailability to attend the study follow-up appointment;
* History of SARS-CoV-2 infection within the last 12 months;
* History of non-elective hospitalization due to medical condition within the last 12 months;
* Refusal or withdrawal of agreement to participate.
Clinical Intramuscular Gene Transfer Trial of rAAVrh74.MCK.Micro-Dystrophin to Patients With Duchenne Muscular Dystrophy

The proposed phase I clinical trial is a pilot study to evaluate safety and biological activity of the rAAVrh74.MCK.micro-Dystrophin vector administered by an intramuscular route. This study will evaluated the micro-Dystrophin vector as a potential dystrophin replacement mechanism for Duchenne Muscular Dystrophy. Two cohorts will undergo gene transfer in a standard three-six dose escalation scheme to establish maximum tolerated dose (MTD) using toxicity. A minimum of three subjects will be enrolled into each cohort. The first cohort will receive a total dose of 3E11 vg. The second cohort will receive 1E12 vg total dose.

The primary objective of this study is the assessment of the safety of an intramuscular administration of rAAVrh74.MCK.micro-Dystrophin to the Extensor Digitorum Brevis (EDB) muscle of patients with Duchenne Muscular Dystrophy (DMD). Safety will be assessed by changes in hematology, serum chemistry, urinalysis, immunologic response to rAAVrh74 and micro-Dystrophin protein, and reported history and observations of symptoms. Subjects will be evaluated at baseline, injection visit (days 0-2), and return for follow up visits on days 7, 14, 30,60, 90, and 180 and at the end of 1st and 2nd years. On Day 180, subjects will undergo a muscle biopsy on the injected muscles in one foot compared with placebo-treatment in the opposite foot to establish transgene expression and any potential toxicity from gene transfer.

Eligibility Criteria:
Inclusion Criteria:

* Age 7 or older; must be wheelchair-dependent
* Confirmed Dystrophin mutations based on mutation compatibility with micro-dys cDNA based on previously published methods.
* Males of any ethnic group will be eligible.
* Ability to cooperate with muscle testing.
* Willingness of sexually active subjects with reproductive capacity to practice reliable method of contraception (If appropriate).

Exclusion Criteria:

* Active viral infection based on clinical observations.
* Symptoms or signs of cardiomyopathy, including:

  * Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales at the base of the lungs
  * Echocardiogram with ejection fraction below 40%
* Serological evidence of HIV infection, or Hepatitis A, B or C infection
* Diagnosis of (or ongoing treatment for) an autoimmune disease
* Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer.
* Subjects with AAVrh74 binding antibody titers ≥ 1:50 as determined by ELISA immunoassay.
* Abnormal laboratory values in the clinically significant range as defined in protocol or based upon normal values in the Nationwide Children's Hospital Laboratory.
Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg

The investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.

SEVICONTROL-2:

Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial

Eligibility Criteria:
Inclusion Criteria:

* male or female patients \>= 18 years of age
* essential hypertension, i. e. systolic office bp \>= 140 mmHg for pre-treated patients or \>= 160 mmHg for untreated patients at screening visit and \>= 160 mmHg at end of wash-out
* signed IC

Exclusion Criteria:

* systolic office bp \> 180 mm Hg at screening visit
* known hypertensive retinopathy GIII or IV
* recent (\< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
* type I diabetes or poorly controlled (HbA1c \>= 8) type II diabetes
* chronic heart failure NYHA III or IV
* prior stroke or TIA
* creatinine clearance \< 60 ml/min or condition after kidney transplant
* moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
* women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
* concomitant therapy with lithium
* hemodynamically relevant mitral or aortic valve stenosis (\>= II°) or hypertrophic obstructive cardiomyopathy
* concomitant therapy with strong CYP3A4 inhibitors or inductors
* african patients
* concomitant severe psychiatric condition that might impair proper intake of study medication
* life expectancy \< 6 months
* night shift workers
* known other mandatory indication for treatment with antihypertensive medications
* parallel participation in other clinical trials
Orthodontic Retention In France - ORIF

The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.

Questionnaire aggregating 27 questions on orthodontic retention strategies, was sent to a professional list of French orthodontists from health authorities. The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All French Specialist orthodontists trained in France who answer the survey

Exclusion Criteria:

* Non-specialist orthodontists, not trained in France
Saccadic Eye Movements Are Impaired In Glaucoma

The purpose of this study is to determine whether rapid eye movements called saccades are impaired in glaucoma, a neurodegenerative disease of visual pathways.

Eye movements that quickly scan a visual scene are critical to a number of daily activities including driving. It is not known whether rapid eye movement called saccades, are altered in glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Ages from 40-80 years. Primary open angle glaucoma is defined by characteristic glaucomatous optic nerve head findings and the presence of corresponding visual field deficits in one or both eyes. All control subjects will be age-matched, with no ocular medical or surgical history, and a completely normal eye examination. Age-matched controls will be recruited from local hospital personnel and accompanying relatives.

Exclusion criteria:

* Any patient with a history of other eye disease, neurological disease or neurodegenerative disorder, or history of incisional ocular surgery within the previous month will be excluded.
To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions

To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence
* Female subjects who are pregnant or lactating
The Comparison of Microbial Adherence to Various Sutures in Patients Undergoing Oral Surgery

The final stage of any surgical procedure is suturing. Sutures have a vital rule in wound healing- they are responsible for flaps approximation, hemostasis and restoring function and esthetics.

Choosing the right suture is crucial especially in oral sites because of its unique anatomical features: the presence of saliva and the patient's everyday function- swallowing, talking, eating etc.

Sutures require certain physical properties such as tensile strength, dimensional stability, lack of memory, knot security and elasticity. One highly important quality is the ability to prevent or reduce bacterial adhesion and by that to prevent secondary infection. There are many kinds of sutures in the market- none of which contains all the ideal features.

The aim of the study is to compare the amount of bacterial adhesion to different kinds of sutures in patients undergoing periodontal surgery.

The participates in the study are scheduled to go oral surgery: dental implantation, Guided bone regeneration, resective periodontal surgery, sinus elevation (both crestal or lateral).

All participates will sign an informed consent form and under the institutional ethics committee approval will go to through the operation.

Each surgery will include at least 4 Simple Interrupted Suture with even spacing of 5 mm from each other in the scheduled for operation and without changing the original treatment plan. Incision location is in the area of surgery and not in a distinct location. The four sutures that will be used are: silk, vicryl, nylon and polypropylene.

At suture removal, after 10 days, all sutures will be collected in a sterile tube containing PBS solution. Within 3 hours, the samples will be sowed on two blood agar media plates. One plate will be aerobic condition and the other in an-aerobic condition. After one week, the number of colonies will use to calculate the CFU- colony-forming units.

Eligibility Criteria:
Inclusion Criteria:

* Patients designated for oral surgery with the possibility to perform at least 4 sutures, 5mm apart. The surgery will take place at the periodontology department, Dental faculty, Hadassah medical center.
* Patients willing to participate in the study and sign an informed concerned form
* Patients without systemic illness

Exclusion Criteria:

* Diabetes, heart disease, immune deficiency, thrombocytopenia\\ coagulation enzymes deficiency
* Chronic alcohol consumption\\ drug user
* Pregnancy