cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients

Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device.

Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.

The patients will attend 4 visits.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* Patients with dry eye syndrome in allergic conjunctivitis

Exclusion Criteria:

* Severe dry eye syndrome
* Severe ocular pathology
Feasibility and Acceptability of a Web-based Multidomain Intervention to Maintain Cognitive Function in Older Adults

The primary purpose of the protocol is to evaluate the feasibility and acceptability of a home-based (using information and communication technologies) intervention composed of nutritional counselling, exercise and cognitive training in older adults and its potential effect on various health outcomes.

Nutritional interventions, physical exercise and cognitive training have been used to delay cognitive decline during aging, with mixed results being obtained. However, few studies have investigated the health benefits of combining two or more of those interventions (ie, the so-called multidomain approach) in older adults. Intensive in-person multidomain intervention may difficultly be translated into the "real world" of healthcare systems because currently unpractical.

Therefore, (cost-)effective interventions provided at distance and without the physical presence of healthcare professionals have the potential to be better translatable from research to real life. Information and Communications Technologies (ICT) have a crucial role to play in this context. However, to the best of our knowledge, no studies have investigated the effects of an ICT multidomain intervention on cognition in the elderly yet.

Thus, the main objective of eMIND is to test the feasibility and acceptability of a 6-month, home-based multidomain intervention composed of nutritional counselling, exercise, and cognitive training provided using ICT solutions in people aged 65 or over.

Secondary objectives include to obtaining preliminary data on the effects of the intervention on clinical outcomes in order to inform the design and sample size calculations of a future trial.

eMIND has a mixed design, being composed of a randomized controlled trial (RCT, with two groups: the ICT multidomain intervention group vs Control Group) and a qualitative study (semi-structured interview to assess the easiness-of-use of the website).

Eligibility Criteria:
Inclusion Criteria:

* Mini-mental State Examination ≥ 24
* Presenting subjective memory complaints
* Have easy access to internet (defined as Internet access at home or elsewhere at least twice a week)

Exclusion Criteria:

* Terminal illness with life expectancy less than 6 months;
* Diagnosis of dementia of any subtype according with DSM-V
* diagnosis of neurodegenerative diseases, particularly Parkinson's disease;
* Major depression
* unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;
* Dependency in ≥ 1 activity of daily living (basic ADL) already participating in structured sessions of physical exercise or cognitive stimulation ≥ 2 times/week in the last 2 months prior to the date of baseline assessments
EKOS in Patients With Pulmonary Embolism (PE)

A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital.

A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital. Patients aged at least 18 years with a diagnosis of submassive or massive acute PE were included. Patients were excluded if they either did not receive EKOS intervention or were presented with stable PE. The primary outcome was the change in RV/LV diameter ratio from baseline to first outpatient follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years diagnosed with massive or submassive acute PE.

Exclusion Criteria:

1. Patients presented with stable PE
2. Patients did not receive EKOS intervention.
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.


Eligibility Criteria:
Inclusion Criteria:

* Surgery for Upper GI cancer
* Age over 18
* Informed consent

Exclusion Criteria:

* Major swallowing disorders
* Dementia or other psychological state precluding compliance and understanding of research protocol
* Pre-existing enteral or parenteral nutrition
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.


Eligibility Criteria:
Inclusion criteria:

* Healthy 1 month old infants
* Available for the duration of the study and reachable by telephone
* Able to complete two blood drawing procedures during the study

Exclusion criteria:

* Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
* Bleeding disorder, immune deficiency or significant chronic or congenital disease
* Previous receipt of blood products or immune globulin
Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)

NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID).

The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU).

Patients will be followed during 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years, fluent in French.
* Planned primary or secondary total hip replacement, regardless of surgical approach or type of prosthesis.
* Receiving paracetamol and ketoprofen postoperatively.
* Under general anesthesia or spinal anesthesia (without intrathecal morphine).
* Participant affiliated to a social security scheme
* Participant's free, informed and written consent

Exclusion Criteria:

* Septic or carcinological surgery
* Allergy to paracetamol, nefopam or NSAIDs
* Angle-closure glaucoma
* Prostate adenoma
* history of convulsion
* Nocturnal pollakiuria in men with more than two risings per night
* Severe hepatic (Child C) or cardiac insufficiency (LVEF \< 30%)
* Renal insufficiency with creatinine clearance \< 50 mL/ min according to Cockroft's formula
* Active peptic ulcer or history of digestive bleeding or peptic perforation
* Patients with opioid treatment for chronic pain other than coxarthrosis (fentanyl, oral morphine \> 50mg/d or equivalent)
* Protected patient: safeguard of justice, guardianship or curatorship
* Incomprehension or inability to use a numerical rating scale or to self-assess/manage pain
* Pregnancy or breast-feeding
Auditory-motor Coupling in Multiple Sclerosis with Cerebellar Lesions

This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Multiple sclerosis \>1 year,
* type of lesions: cerebellar lesions,
* walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted).

Exclusion Criteria:

* relapse 3 months prior to enrollment,
* cognitive impairment impeding understanding of instructions,
* beat amusia,
* deafness,
* pregnancy
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects

This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).

This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).

Eligibility Criteria:
Inclusion Criteria:

* Roux-en-Y gastric bypass surgery performed \> 6 months prior to enrollment
* Diagnosis of PBH

Exclusion Criteria:

* History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
* Current use of insulin or insulin secretagogues.
* History of current dumping syndrome.
* History of current fasting hypoglycemia.
* Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient ≥ 12 years.
* 2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
* 3. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
* 4. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
* 5. Patient affiliated to a social security scheme.

Exclusion Criteria:

* 1. Pregnant and/or breastfeeding woman
* 2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
* 3. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
* 4. Patients with chronic nasal obstruction.
* 5. Patients on local and systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and local antiseptics.
* 6. Concomitant use of other nasal sprays, essential oils for local nasal use, nasal creams or gels.
* 7. Patients under guardianship, curatorship or safeguard of justice.
Gluteus Maximus Versus Gluteus Medius Strength On Back Muscles Performance In Patients With Sacroiliac Dysfunction

This study will be conducted to compare between the effect of glutes maximus and glutes medius muscles strength on back muscle performance in patients with Sacroiliac joint dysfunction.

The purposes of this study are:

1. To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back pain in patient with Sacroiliac joint dysfunction
2. To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back muscle performance in patients with Sacroiliac joint dysfunction
3. To investigate the effects of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on function in patient with Sacroiliac joint Dysfunction

Eligibility Criteria:
Inclusion Criteria:

* Age from 25-40 years.
* Patients with chronic lumbopelvic pain (more than 12 weeks) and clinical test positive for SIJD.
* The pain distribution and tenderness on palpation under the posterior superior iliac spine (PSIS) are reliable signs that the SIJ is the source of pain.
* Complaint of unilateral pain rather than bilateral pain is also considered more likely to be coming from an SIJ.
* Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.

Exclusion Criteria:

* Neurological disorder, psychosomatic disorder
* Tumor.
* Infection condition.
* Recent surgeries.
* Pregnancy.
* Back pain referred from organic cause.
* Osteoporosis and bone disease (induced or idiopathic).
Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine

The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.

Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients that give their informed consent before the procedures of study
* Thrombocytopenia before intervention (\<100 x10\^9 /L)
* Patients of either biological sex older than 15 years old
* Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse
* If the patient is taking steroid based treatment, the dose need to be stable before intervention.

Exclusion Criteria:

* Patients with secondary immune thrombocytopenia
* Pregnant patients
* Patients with hypersensitivity to study treatments
* Patients that are taking anticoagulant medication or any drug that have an effect on platelet count
* Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit.
* Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl
* Any cancer diagnosis
* Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias.
* Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.
Post-exercise Food Intake Regulation in a Hot Environment

The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.


Eligibility Criteria:
Inclusion Criteria:

* healthy and physically active men aged 18-30 years

Exclusion Criteria:

* any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,
* ear troubles
Do Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?

This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated with systemic reactions in these workers.

Randomized controlled trials of split virus vaccines in healthy adults have not been able to detect an increase in systemic adverse events compared to control vaccination. These trials do identify a non-trivial risk of systemic symptoms occurring in the week after both placebo and vaccine. There is a small population of healthcare workers who report consistent systemic symptoms after split virus vaccination which may occur because a small group of healthy adults have true physical reactions to components of the vaccine or excipients. If this is true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray vaccines - might be expected to be better tolerated by these people.

Eligibility Criteria:
Inclusion Criteria:

* Employed or volunteer in a healthcare facility or an ambulatory care setting providing healthcare
* By self report, have had 2 or more doses of trivalent inactivated influenza vaccine (TIIV) in the last 15 years, and after at least the last 2 vaccine doses have had the same systemic adverse event in the 7 days after vaccination, including: fever, chills, myalgia, arthralgia, fatigue, headache, or insomnia;
* Consent to the study, including two injections one month apart, with one being placebo and one a dose of TIIV;

Exclusion Criteria:

* Has a contraindication to TIIV (previous allergic reaction to a dose of vaccine, or Guillain Barre syndrome with onset within 6 weeks of vaccination);
* Has previously received a dose of TIIV for the current influenza season.
* Receipt of another vaccine, or initiation of new medication within 7 days of the study injection (participant may enter the study as long as the gap between other vaccine/initiation of new medication is \>7 days);
* Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day a dose of study medication due (participant may receive injection 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.
Living With Fibromyalgia: Triggers,Subgroups, and a Cognitive-Behavioral and Interactive Technology-Based Intervention

The purpose of this study is to conduct semi-structured qualitative interviews to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.

Fibromyalgia (FM) may currently be the most common rheumatic diagnosis of rheumatologists among their female patients, with 15-20% of all new rheumatology referrals meeting the 1990 American College of Rheumatology (ACR) diagnosis criteria for fibromyalgia. People with fibromyalgia live through widespread musculoskeletal chronic pain, fatigue, psychological distress, and exhibit diminished physical performance due in part to the cycle of pain that adversely affect their activity participation and overall well-being.

The purpose of this prospective mixed methods study is to conduct semi-structured qualitative interviews using ethnographic techniques to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.

Eligibility Criteria:
Inclusion Criteria:

(1)At least 18 years of age; (2) meet the American College of Rheumatology (ACR) criteria for FM as diagnosed by a physician; (3) have been diagnosed with FM at least 1 year prior to admission to the study; (4) have sufficient vision, based on a functional vision test (i.e., read newsprint) to operate a computer program; (5) speak English; and (6) have a private telephone line.

Exclusion Criteria:

(1)Living beyond a 40-mile radius from the Oakland campus of the University of Pittsburgh. (2)Disability in everyday tasks related to a diagnosis other than FM (e.g., stroke, Parkinson disease) will also be grounds for exclusion.
Potential Associated Factors of Uncontrolled Hypertension

The incidence and prevalence of hypertension is increasing while the controlled rate is extremely low in China. A substantial percentage of participants with uncontrolled hypertension are correctable if potential associated factors are identified and corrected. Therefore, it is clinically relevant to investigate and identify these potential associated factors of uncontrolled hypertension so as to increase controlled rate and reduce hypertension-associated health and economic burdens in the future. Investigators plan to conduct a prospective registry study in a single-center to initially investigate the potential associated factors of uncontrolled hypertension in cardiovascular outpatient department. Furthermore, investigators plan to evaluate the effects of potential associated factors correction on hypertension controlled rate and cardiovascular outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).

Exclusion Criteria:

* Known secondary hypertension,
* Pregnant women,
* Chronic kidney disease (CKD) 3 or higher,
* Has a history of connective tissue diseases,
* Has a history of any type of cancer,
* Cognitive disorder which could not finish home blood pressure monitoring,
* Has a history of coronary heart disease,ischemic stroke,transient ischemic attack or heart failure.