cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Social Status and Use of Healthcare Services During the Confinement Period Linked to the COVID-19 Epidemic

Epidemics have always affected the most disadvantaged social categories more intensely. This social inequality is expressed in the use of care and emergencies: greater frequency but also greater seriousness. Our hypothesis is that, during a period of confinement, the most disadvantaged populations are more affected by the COVID-19 infection than the rest of the population. The number of remedies is greater, as is the severity of the forms of infection.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or over
* Calling center 15 from March 17 at noon and until the end of the confinement period (May 31, 2020) for one of the following reasons that may be related to COVID-19: cough, fever, rhinitis, diarrhea, pain thoracic, odynophagia, diarrhea, anosmia, ageusia, whose calling address belongs to Bas-Rhin Or
* Supported (consultation or hospitalization) at the HUS for a COVID-19 infection and included in the COVID-HUS base and residing in the Bas-Rhin.

Exclusion Criteria:

* Patient under the protection of justice
* Patient under guardianship, curatorship
* Patient taken care of at the screening center
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)

Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).

The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.

Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥50 years.
* Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy
* Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye

Key Exclusion Criteria:

* History and/or evidence of exudative age-related macular degeneration in either eye
* History and/or evidence of diabetic retinopathy in either eye
* Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
* Central chorioretinal atrophy in the study eye
* Glaucoma in the study eye
Postop Pain Management in Pituitary Tumour Patients

To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.

To further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (SPG) block (SPGB) for pain management in the context of an enhanced recovery after surgery (ERAS) protocol for minimally invasive (MIS) endoscopic transsphenoidal pituitary surgery. The SPG is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of SPGB following sinus surgery and showed positive results for endoscopic sinus surgery. However, there is limited research on the use of SPGB in the context of pituitary surgery.

In this randomized placebo-controlled trial, the investigators aim to assess the benefit of SPGB with bupivacaine in addition to multimodal general anesthesia on pain management, after MIS pituitary surgery. The results of the trial will provide valuable insights into the potential benefits of SPGB and its optimal use for pituitary surgery.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (18 yrs or older)
* undergoing endonasal pituitary adenoma resection

Exclusion Criteria:

* Patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs
* contraindications to the performance of SPGB such as known allergy to used medications
* chronic alcohol abuse
* uncontrolled systemic arterial hypertension
* severe kidney or liver diseases
* cardiomyopathies or sustained cardiac arrhythmias (permanent paroxystic atrial fibrillation or other sustained supraventricular rhythmic anomalies)
Speech Motor Learning and Retention (Aim 2)

The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well. The strategy for the proposed research is to identify individual brain areas that contribute causally to retention by disrupting their activity with transcranial magnetic stimulation (TMS). Investigators will also use functional magnetic resonance imaging (fMRI) which will enable identification of circuit-level activity which predicts either learning or retention of new movements, and hence test the specific contributions of candidate sensory and motor zones. In other studies, investigators will record sensory and motor evoked potentials over the course of learning to determine the temporal order in which individual sensory and cortical motor regions contribute. The goal here is to identify brain areas in which learning-related plasticity occurs first and which among these areas predict subsequent learning.

The focus of this registration is Aim 2. Specific Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning. Plasticity is assessed using measures of cortical excitability. Specifically, auditory, somatosensory and motor evoked potentials are elicited using single pulse TMS (motor), pure tone bursts (auditory), and mentalis nerve stimulation (somatosensory). Tests of cortical excitability are interleaved with trials involving speech motor adaptation. Cortical excitability is also measured using these same measures 24 hours after learning to assess retention.

The Speech Motor Learning and Retention Master Protocol is NCT06467292.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speakers
* Right-handed
* Normal hearing
* No speech disorder or reading disability

Exclusion Criteria:

* Cardiac pacemaker
* Aneurysm clip
* Heart or Vascular clip
* Prosthetic valve
* Metal implants
* Metal in brain, skull, or spinal cord
* Implanted neurostimulator
* Medication infusion device
* Cochlear implant or tinnitus (ringing in ears)
* Personal and/or family history of epilepsy or other neurological disorders or history of head concussion
* Psychoactive medications
* Pregnancy
Evaluation of Dental Caries Using Caries Assessment Spectrum and Treatment Need (CAST) Index, International Caries Detection and Assessment System (ICDAS) Index and World Health Organization (WHO) Index

This study goals is to compare the three indices in Egyptian children aged 4 to 6 years in caries detection and time needed for the assessments which will contribute to valuable data for pediatric oral health assessments both locally and globally.

This study will ensure that patients receive precise evaluations and guide early, appropriate preventive measures or treatments. Over time, this will contribute to reducing caries progression and related complications.

Also, Parents become more aware of their children's dental health status, emphasizing the importance of early detection and intervention.Furthermore , Comparing the indices will provide insights into which tool is most efficient and reliable for detecting caries in preschool children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-6 years.
* Written consent from parents or guardians for participation.
* Children who are cooperative during clinical examinations.

Exclusion Criteria:

* Children with systemic and mental diseases that might affect dental health.
* Teeth with developmental anomalies that interfere with caries assessment.
* Teeth with extensive restorations.
Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms

The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

Massage therapy (in the form of manual lymph drainage \[MLD\]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development.

Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Lymphedema (5% to 20% increase in volume) after breast cancer treatment

Exclusion Criteria:

* Physically unable to perform massage or bandaging during home program
Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study

COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective study will assess the use and frequency of SMBG and blood glucose control and its influencing factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus who have received more than 3 months of insulin therapy are eligible to participate in this study. The anticipated duration of the study is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus patients who have received insulin treatment for more than 3 months
* Patients willing to sign written informed consent form
* Patients who meet the criteria for the first cross-sectional investigation and have an HbA1c \< 7% will receive the second cross-sectional investigation

Exclusion Criteria:

* Patients unable or unwilling to comply with the requirements of the protocol
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)

The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.

Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
* Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
* Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
* Subjects must use continuous positive airway pressure (CPAP).
* Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

Exclusion Criteria:

* Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
* Subject has a history of, or current malignancy except for non melanomatous skin cancer.
* Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
* Subject is known to be seropositive for human immunodeficiency virus (HIV).
Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females

it is a cross-sectional study conducted in female patients attending outpatient clinc in our university hospital to assess their awareness regarding the symptoms of premenstrual dysphoric disorders.

this study will be conducted on females in the reproductive age attending the gynecological outpatient clinic to assess the prevalence of premenstrual dysphoric disorder(eeiPMDD) and their awareness regarding the symptoms of PMDD and the impact of these symptoms on their quality of life using questionnaire including ( knowledge , attitude and practice) of those Egyptian females.

Eligibility Criteria:
Inclusion Criteria:

females in reproductive age

history of regular menstruation

Exclusion Criteria:

history of any psychological disorders

history of chemotherapy in last 6 months
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate

The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).

Primary outcomes This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from gastroesophageal reflux (GER) the effectiveness of magnesium alginate. The clinical improvement of the patient will be evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated questionnaire on symptoms of GER (I-GERQ Annex A).

Secondary outcomes To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance, basing on questionnaire results.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 1 year
* Suggestive symptoms of gastroesophageal reflux (I-GERQ score \> 7)
* Absence of clinical evidence of allergy to cow milk protein or other allergic disorder
* No previous intake of thickened formulas, acid suppressants or drugs
* All parents or guardians must sign a document of informed consent
* Patients affected by chronic disease
* Patients affected by hepatic or renal diseases
* Patients affected by cardiac diseases

Exclusion Criteria:

* Patients affected by chronic disease
* Patients affected by hepatic or renal diseases
* Patients affected by cardiac diseases
* Inability or unwillingness to give informed consent
* Patients wth severe neurologic disease
* Patients affected by cow milk protein allergy
* Previous or ongoing intake of thickened formulas, acid suppressants or drugs
Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy

The primary role of anesthesia is to provide unconsciousness, amnesia, immobility, and pain control. Other important roles include maintaining stable vital signs and tissue perfusion, preventing and management of organ failure.

Emergency laparotomy represents a major surgical procedure which is usually performed in patients with acute and chronic comorbidities and is associated with several surgical and medical complications with post-induction hypotension being one of the common and serious complication. Thus, it is essential to provide a balanced and safe protocol for anesthesia which maintains adequate hypnosis and antinociception besides vital stability and adequate perfusion.

Opioid drugs are commonly used within the context of balanced general anesthesia primarily for their antinociceptive effects. Opioid drugs had been a basic component of perioperative care for providing analgesia and decreasing the requirements of other hypnotic drugs. However, there are several short- and long-term adverse effects for opioid drugs such as pruritus, postoperative nausea and vomiting, respiratory depression, dependence, and development of chronic pain. Furthermore, opioid drugs are claimed to have cardiovascular depressant effects which increases the risk of hypotension if they were used routinely in patients with borderline hemodynamic profile. Therefore, there is an increased interest in opioid-sparing and opioid-free anesthesia and several international consensus statements were released to regulate and suggest protocols for opioid-sparing anesthetic regimens.

Lidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. The investigators hypothesize that lidocaine-based induction of anesthesia would provide superior hemodynamic profile compared to conventional opioid-based induction of anesthesia in emergency laparotomy.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Both gender
3. American Society of Anesthesiologists (ASA) class I-III undergoing emergency laparotomy.

Exclusion Criteria:

1. Patient refusal
2. Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions)
3. Baseline mean arterial pressure \<75 mmHg
4. Patients on vasopressor infusion,
5. Patients with high shock index (heart rate / systolic blood pressure \>1)
6. Pregnant or lactating women,
7. Allergy of any of the study drugs
8. Hypertensive patients and patients on beta blockers.
9. Uncontrolled hypertensive patients or patients receiving angiotensin converting enzyme (ACE) inhibitors preoperatively.
10. Opioid drug abusers.
11. Patients with increased intracranial tension.
Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease

The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.


Eligibility Criteria:
* Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol
The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.


Eligibility Criteria:
Inclusion Criteria:

* Female 18 and older
* IBS-C patients diagnosed on the basis of Rome II criteria
* Ability to comply with the requirements of the entire study

Exclusion Criteria:

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions.
* Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy.
* Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study

Other protocol-defined inclusion/exclusion criteria may apply.
rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.


Eligibility Criteria:
Inclusion Criteria:

* signed patient informed consent;
* primary obsessive compulsive disorder;
* YBOCS score at least 20;
* males/females 18-65yrs;
* treated with adequate dose of SSRI at least 8 weeks at some stage of illness;
* currently using adequate, stable dose of SSRI at least 4 weeks but not responding.

Exclusion Criteria:

* schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (HDRS(17)\>18, substance/alcohol dependence within last 6 months;
* severe axis II;
* suicidal score\>=6 on MINI;
* metallic implant in cranium;
* severe/unstable medical conditions;
* not responding to ECT or had TMS in last 6 months;
* history epilepsy;
* neurological disorder leading to increased intracranial pressure;
* severe cardiac disorder/intracardiac lines, pacemakers;