cyrilzakka/clinical-trials huggingface dataset:
Post Prandial High Resolution Impedance- Manometry

Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome...). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.

The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Patient of both gender older than 18 years
* Patient referred for post prandial esophageal high resolution manometry combined with impedance and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor
* Heartburn and/or regurgitation despite double dose proton pump inhibitor therapy
* Proven Gastro-esophageal reflux disease off proton pump inhibitor (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure \> 5% on esophageal pH monitoring off proton pump inhibitor)
* Absence of major esophageal motility disorders (achalasia, esophago-gastric junction outflow obstruction, esophageal spasm, jackhammer esophagus, absent contractions)
* Patient who does not decline to participate to the study

Exclusion Criteria:

* Patient younger than 18 years
* Pregnancy or breast feeding
* Previous history of esophago-gastric surgery ( including anti-reflux surgery, Heller myotomy, bariatric surgery)
* Patient with severe renal insufficiency
* Patient with severe cardiac insufficiency
* Patient legally incompetent or unable to give consent
* Patient who declines to participate to the study
* Participation to another study at the same time
Effect of Thoracic Mobilization on Lumbar Radiculopathy

The purpose of the study will be to:

* To investigate the effect of thoracic mobilization on back and leg pain in patients with lumbosacral radiculopathy.
* To investigate the effect of thoracic mobilization on functional disability in patients with lumbosacral radiculopathy.
* To investigate the effect of thoracic mobilization on proprioception in patients with lumbosacral radiculopathy.

To investigate the effect of thoracic mobilization on back and leg pain, functional disability and proprioception in patients with lumbosacral radiculopathy.

1-Thirty four patients of both sexes with unilateral chronic lumbar radiculopathy at L4-L5 or/ and L5-S1 levels will participate in this study. The patients will be diagnosed as having lumbar radiculopathy based on careful clinical examination by neurologist . The diagnosis will be confirmed by CT scan or MRI.

Patients will be recruited from the outpatient clinic of Faculty of Physical Therapy, Cairo University and private clinics. Patients in this study will be randomly divided into two groups.

* Group (I) which will include 17 patients who will receive manual mobilization exercises in addition to selected physical therapy .
* Group (II) which will include 17 patients who will receive selected physical therapy.

The treatment will conducted 3 sessions per week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral chronic lumbosacral radiculopathy at L4- L5 or / and L5-S1 levels confirmed by MRI.
2. The age of patients will be ranged from 30 to 45 years.
3. Duration of pain will be more than 12 weeks.
4. Patients with a positive straight leg raising (SLR) test.
5. Patients with sufficient cognitive abilities that enables them to understand and follow instructions .
6. Patients had to report an average pain level of more than five on the Visual Analogue Scale (VAS) and a lumbar spine range of motion (ROM) of at least 50% of the accepted normal range.
7. Patients with body mass index\< 30kg/m2

Exclusion Criteria:

1. Cauda equina syndrome.
2. Ankylosing spondylitis, thoracic deformities (pectus carinatum, excavatum), spina bifida, fractures, postoperative spinal conditions, diabetes, inflammatory processes.
3. Previous inner ear infection or vestibular disorder with unresolved balance disturbance, history of head trauma with residual neurological deficits.
4. Spinal tumor.
5. Previous lumbar surgery.
6. Sever musculoskeletal disease.
7. Peripheral mononeuropathies or polyneuropathy.
8. Obesity .
9. Pregnancy.
An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)

This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.

The duration of treatment is 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Males and females (ages 25-75)

Exclusion Criteria:

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults

The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhino laryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally form the ENT department e.g. in the emergency department (ED), intensive care unit (ICU), ward etc., i.e. consults.

The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhinolaryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally from the ENT department e.g. in the emergency department, intensive care unit, ward etc., i.e. consults.

The study will be prospective and randomised until 13 procedures have been performed in each group followed by an assessment of the organisational impact and cost comparison of the two technologies. The investigator will track the time and evaluate the device after each procedure. The organisational impact will be accessed by a questionnaire following the study period. A cost comparison will be enabled via tracking all the processes associated with the rhinolaryngoscopes. After tracking all equipment, time, and utilities will be ascribed a cost.

Eligibility Criteria:
Inclusion Criteria:

* The investigator has been trained and conducted at least 5 successful training procedures with both the aScope 4 RhinoLaryngo and the reusable rhinolaryngoscope systems.
* The investigator on call for consults must be available to fill out the CRF immediately before and after the procedure.
* The investigator must be dedicated to the study while on call for consults
* Clinical indication and eligible for a rhino laryngoscopy, as judged by the physician
* Patients ≥18 years

Exclusion Criteria:

* If the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.
Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction

The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

1. Signed ICF (Informed Consent Form)
2. Subject-reported history of Drye Eye Disease (DED) in both eyes
3. Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

1. clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
2. Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
3. underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
4. received or removed permanent lacrimal plug within 3 months before baseline;
5. DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
6. ocular or periocular malignancy;
7. active ocular allergies, or allergy to the study drug or its components;
8. ongoing ocular or systemic infection;
9. use of contact lenses within 1 month before screening;
10. intraocular surgery or ocular laser surgery within 6 months before enrollment;
11. uncontrolled systemic disease or history of herpetic keratitis;
12. use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;
13. used any known oral drugs that could have caused eye dryness within 1 month before screening;
14. participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
15. inappropriate to participate for other reasons judged by the investigators.
Topical Metformin Versus Topical Ketotifen in Melasma Treatment

The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.

This research investigates the therapeutic effects of two nanoparticle-based topical treatments-metformin and ketotifen-on melasma. The study employs a split-face design where each patient receives different treatments on each half of their face. Patients are divided into two groups:

Group 1: Undergoes micro-needling sessions for the entire face, followed by the application of topical ketotifen on one half and topical metformin on the other half.

Group 2: Receives only topical applications of ketotifen on one half of the face and metformin on the other half without micro-needling.

The study includes detailed pre-procedure preparation (cleaning and anesthetizing the face) and post-procedure care (application of SPF 50+ sunblock). Clinical assessments include photographic documentation, H-MASI and mH-MASI scoring for melasma severity, patient satisfaction surveys, MELASQOL questionnaires to assess quality-of-life impacts, and monitoring for side effects. Assessments are conducted at baseline, monthly during treatment, and one month after the final session.

Eligibility Criteria:
Inclusion Criteria:

* Female adults of 18 years and above with bilateral melasma .
* Clinical diagnosis of melasma.
* Mental capacity to give informed consent.

Exclusion Criteria:

* Pregnant or nursing women.
* Current use of hormonal birth control medication or any hormonal therapy.
* Current or previous treatment by depigmenting agents within 3 months
* History of laser or MN to the face within 3 months of study enrollment.
* Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids.
* Photosensitivity.
* Patients with unrealistic expectations.
A Study to Evaluate a Modified Contact Lens

This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be free of any anterior segment disorders.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
* Subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses.
* Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study.
* Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment.
* Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog).
* Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience.
* Subjects must have access to an internet connection and be able to send and receive email.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
* Subjects who are allergic to any component in the study care products.
A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 and less than or equal to 80
* Diagnosis of Rheumatoid Arthritis for at least six weeks
* Taking an NSAID
* If female: using adequate contraception
* Willingness to stop current NSAID until criteria reached to begin study drug
* Able to provide written informed consent

Exclusion Criteria:

* Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
* Pregnancy, lactating
* Use of investigational drug within 30 days prior to entering the trial
* History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
* History of cerebrovascular or other bleeding disorder
* Severe hypertension
* Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
* RA of functional class IV
* Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
* Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
* DMARDs initiated within past three months or dose changed less than two months before entering the trial
* Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
* Concomitant therapy with ACTH within past month before entering the trial.
* History of narcotic or alcohol abuse (past 12 months)
* Abnormal laboratory values
* Previous participation in the present trial
Low-dose Tolvaptan for Inpatient Hyponatraemia.

This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management.

Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to Accident \& Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: \<125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management.
* Patients of all genders aged 18-90 y.o

Exclusion Criteria:

* Pregnant women and patients aged \< 18y.o
* Hyponatraemia not associated with SIADH
Clinic and Neurophysiology of Aphasia Treatment

In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated.

Clinical neurorehabilitation faces a major challenge of functional recovery in aphasia, i.e. guiding the structural and temporal dynamics of reorganization within responsible neural networks. Here, according to current research, relevant neural factors affecting the treatment and thus the functional recovery of aphasia patients after stroke are of interest, highlighting structural as well as functional neuroanatomical features. Of particular interest are not only the functional localization of affected cerebral regions, but more the clinical and neurophysiological patterns which might help to factorize and predict the therapeutic outcome. In the planned study, the clinical and neurophysiological characteristics of the dynamics of language function recovery in relation to the intensity of professional speech therapy (constraint induced aphasia therapie - CIAT) will be recorded in 40 patients with aphasia resulting from a cerebrovascular event. The aim of this study is to test the value of neurophysiological aspects based on electroencephalographic (EEG) parameters such as event-related potentials (N400, P600, theta band activity) for the identification of specific neuronal markers, which in turn support predictive statements for individual therapy planning of logopedic treatment in neurorehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* patients with a cerebrovascular event

Exclusion Criteria:

* premorbid brain disorder
The Healthy Families Project

A primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( PDAs). The impact on the content and quality of clinician counseling will be assessed in exit survey prior to and after implementation. Among families interested in making a change to address nutrition or activity risk reported on the screener a cohort with children \> BMI 85% will be recruited. They will be randomized to mailed tailored supports to level of readiness to change versus a single generic informational mailing. The hypotheses are that 1)families that receive the enhanced office visit with screening will be more likely to plan to make changes compared to usual care; and 2) families receiving the tailored post visit supports will be less likely to gain weight than controls after 6 months.

1. Using hand held PDAs, we will develop an obesity risk screening and counseling system for 4 through 10 year olds attending primary care well child visits. Screening results will be summarized immediately by the PDA and will prompt the clinician to provide brief counseling messages tailored to each childís obesity screening results, including the familyís and the childís readiness to change behavior
2. We will evaluate the specific content and quality of clinician obesity counseling provided at the well child visit through parent surveys before and after implementation of the PDA screening and counseling program.
3. To support action by families after the office visit, we will develop a post-visit intervention package of newsletters and materials that are tailored to child/family obesity risk behaviors and parental readiness to change.
4. We will evaluate the impact of this post visit intervention program in a 6 month trial focused on children identified at well child screening to have BMI \>85%. 200 Families will be randomized to receive either a series of mailed supports over 3 months versus a single generic-content mailing. We will determine the respective impact of these two levels of post-visit support on stage of change, parental action on key obesity risk behaviors, and stabilization of BMI z scores after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Families with children ages 4 to 11 years
* For post visit supports; Children \> 85% for age BMI
Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT)

The hypothesis is that from a cluster defined by a confirmed positive case of COVID-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of COVID-19 infection and to explore the biological profiles related to the observed clinical history. Certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care.

The main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus SARS-CoV-2 (positive COVID-19 cases and contact subjects).

Subjects with a COVID-19 infection and thei contact cases (identification according to health insurance criteria, see "Améli.fr") will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel.

For the main objective: during the D0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine.

For secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative RT-PCR test on D0. A final consultation will be carried out at M3. Nasopharyngeal samples, saliva, blood, stool and urine will be taken on D10 and D21. A blood test will be taken at M3 to carry out a COVID-19 serology.

Eligibility Criteria:
Inclusion Criteria:

* Child or adult, no age limit
* Able to give informed consent to participate in research
* If a minor participant: consent of the legal representatives
* If confirmed case COVID-19 (symptomatic or asymptomatic): laboratory result confirming infection with SARS-CoV-2 by RT-PCR or by serology
* If contact case: people identified as a risk contact according to the criteria of the "Amélie.fr" health insurance

Exclusion Criteria:

* Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
* Refusal of the child
* Refusal of participation