cyrilzakka/clinical-trials huggingface dataset:
Effect of Ectoine After Photorefractive Keratectomy (PRK).

This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.

Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.

Exclusion Criteria:

* patient spherical equivalent more myopic than -4 diopters
* Patients with astigmatism more than 2.5 diopter
* Patients with anisometropia ( difference \> 2 diopters)
* Patient with previous ocular surgery
* Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)
* Pregnant and lactating females
Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine

A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes;
* Aged between 18 and 65 years old;
* Capable and willing to give free and informed informed consent in writing;
* Migraine patients with or without aura, according to the International Headache Society (IHS).

Exclusion Criteria:

* Chronic migraine;
* Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion

The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness, and there is no scale for evaluating lumbar stiffness in China.Based on the Delphi method and the analytic hierarchy process, this study will improve and optimize the quality of life evaluation system for patients with severe degenerative lumbar disease, so as to obtain a concise, practical, and effective patient-reported outcome instrument.

Although lumbar fusion can improve function by correcting deformity,restoring spinal stability,and reducing pain, it also by intention leads to spinal stiffness which can impair function of daily activities.The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness.Lumbar Stiffness Disability Index (LSDI) has not been used widely, and there is no scale for evaluating lumbar stiffness in China.In addition, even if LSDI is modified, there is still an evaluation dilemma: after lumbar long-segment fixation, the pain and neurological function-related scale scores show that the quality of life is improved, while the lumbar stiffness-related scale scores show that the quality of life is reduced . So overall, is the patient's quality of life improved or decreased? Simply combining these two types of scales cannot explain clearly.

This study can be roughly divided into the following 5 main steps:

Step 1:Collect and sort out the dimensions and exhaustive items that affect the patients' quality of life by systematically reviewing the related literature and a qualitative interview study.

Step 2: Through a cross-sectional survey and experts' meetings, the items is initially optimized, and 35-45 items will be retained.

Step 3: Screen 20-25 excellent items by 2-3 rounds of Delphi method, then use the analytic hierarchy process to determine the weight of each item, so as to establish a initial PRO instrument.

Step 4: Verify the reliability and validity of the initial PRO instrument, and further optimize the initial PRO instrument in order to be used in clinical practice and research.

Step 5: Verify the responsiveness of the initial PRO instrument, calculate the ES, SRM, AUC and MICD values of the initial PRO instrument.

Finally, a novel, concise, practical, and effective PRO instrument for use in degenerative lumbar disease patients will be established.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Lumbar Spine Degeneration
* Plan for or have undergone lumbar fusion
* Be willing to participate in this research

Exclusion Criteria:

* Combined with neurological disease such as Motor neuron disease, Progressive muscular dystrophy, Peripheral neuropathy, Spinal cord disease, et al.
* Combined with severe cervical/thoracic spine disease or other diseases that seriously affect the quality of life
* Suffer lumbar spine trauma after lumbar fusion
* Preoperative cases exclude patients who plan for revision surgery
* Be unwilling to participate in this research
The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain

The purpose of this research is to determine if mind and body counseling and training improves quality of life in women undergoing treatment for chronic pelvic pain.

Patients with chronic illnesses are expected to self-manage much of their treatment. Barriers include limited time during appointments, consultations with multiple different providers, technical communication style, health literacy issues, and a sense of feeling overwhelmed. Patients with chronic pain syndromes experience symptoms which can negatively impact their quality of life by interfering with ability to sleep, work, and function in their social roles. One proposed mechanism in chronic pain management is mindfulness. Mindfulness is the intentional and non-judgmental conscious awareness of the present moment, or "paying attention on purpose" with the goal of physical and psychological health improvement. Participants are taught autonomy, increasing self-regulation, and focusing awareness on a particular goal or activity.

The investigators hypothesize that a mind-body counselor will improve patient engagement and promote adherence to pain coping treatments. If the initial findings from this project support the use of Integrative Medicine services in women with chronic pelvic pain, the investigators hope to expand this study to a larger, randomized controlled trial that is adequately powered to determine significant difference among participants in the control and study groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic pelvic pain.
* Must speak English.
* Must be ages 18 through 89.
* Must be willing and able to provide informed consent for participation.
* Must have access to the Patient Online Services portal to complete the questionnaires.

Exclusion Criteria:

- Diagnoses of primarily non-gynecologic pain, acute pelvic pain, and active abdominal or pelvic malignancy.
Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. The ideal sedative agent for use in critically ill children has to be effective and short-acting, of rapid onset of action, lacks active metabolites, does not accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or respiratory adverse effects, and has few drug interactions.

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically ventilated adults for less than 24h. However, the literature is full of many research studies that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both adult and pediatric population and proved its safety and effectiveness.

The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in two different doses in sedation for critically ill mechanically ventilated infants with respiratory failure for 72h duration.

Eligibility Criteria:
Inclusion Criteria:

* Infants (1-12 months).
* Respiratory failure/
* Requiring PICU admission and mechanical ventilation up to 72h.

Exclusion Criteria:

* Significant renal, hepatic, endocrine or metabolic disease.
* 2nd or 3rd degree heart block.
* hypotension or bradycardia (defined as any value outside the normal range from the patient's age).
Pathophysiologic Study to Understand and Possibly Treat Nocturia

This study will mainly look at how well compression stockings decrease body weight between morning and night and the number of nocturia events, by preventing blood from pooling in your legs. Also, this research study is being done to collect the thoughts/reactions/opinions on how nocturia affects the life of one who suffers from nocturia.

This study intends to investigate the different causes nocturia. Patients with nocturia will be assigned to wearing knee high then thigh high compression stockings to assess the effect on weight gain during the day and the number of nocturia events. Renin and aldosterone levels will also be assessed. Furthermore, fluorescein dye will be used to to demonstrate vascular leakage of the fluorescent dye.

Eligibility Criteria:
Inclusion Criteria:

* Age above or equal to 18 years at the time of signing informed consent
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

Exclusion Criteria:

* Suspected or proven peripheral arterial disease, including history of peripheral arterial bypass grafting
* Any sensory impairment such as severe peripheral neuropathy as evidenced by patient reported intermittent claudication and/or signs of ischemia such as "blue toes".
* Allergy to stocking textile material.
* Leg edema or pulmonary edema from congestive heart failure.
* Local skin or soft-tissue condition, including recent skin graft, gangrene, oozing dermatitis and severe cellulitis.
* Extreme deformity of the leg, or unusual leg shape or size that would prevent correct fit.
* Treatment with any diuretics such as furosemide or hydrochlorothiazide.
Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric bypass (RYGB) surgery is currently the most effective. It results in long term weight loss maintenance, significant remission of obesity-related comorbidities and decreased overall mortality. It also induces changes in gastrointestinal hormones responses, with an increase of anorexigenic hormones GLP-1, and PYY.

Although successful, the mechanisms for RYGB-induced weight loss are not completely understood. The RYGB does result in increased satiation, decreased calorie intake and decreased preferences for sweet and fatty foods. Previous work from our lab has shown using progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive behaviour after the surgery remain unknown. They may be triggered by changes in gut hormones, conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids levels.

This study aims to assess whether RGYB-induced gut hormone changes contribute to the decrease in appetitive behaviour for sweet and fatty foods observed after the surgery.

This is a double blind controlled study comparing the effect of blocking gut hormones with somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be carried out. Appetitive behaviour will be measured using the progressive ratio task.

The investigators hypothesize that blocking the gut hormones in obese patients with RYGB will increase their appetitive behaviour for sweet-fat candies.


Eligibility Criteria:
Inclusion Criteria:

* Gastric bypass surgery since at least 6 months

Exclusion Criteria:

* serious illness
* pregnancy or breast feeding
* more than three alcoholic drinks per day
* substance abuse
* psychiatric illness
* significant longstanding heart disease or heart intervention (for example, patients who have had heart attacks, have pacemakers or have had heart surgery)
A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas

This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.


Eligibility Criteria:
Inclusion Criteria:

* 1st-line surgically incurable cancer of the pancreas
* ECOG(Eastern Cooperative Oncology Group) performance status 0-1

Exclusion Criteria:

* Previous systemic therapy for pancreas cancer
* History of cancer-associated blood clots
* History of autoimmune disease
Type 1 Together: a Peer Mentorship Program to Increase Equitable Use of Continuous Glucose Monitoring Systems

The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM).

Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM.

The other group will be in our Type 1 Together program for 6 months. This will include:

1. Monthly meetings with a community health worker with expertise in type 1 diabetes self-management,
2. Access to CGM-specific educational resources hosted on a mobile app, and
3. Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently.

The main questions the study aims to answer are:

1. Do families like the Type 1 Together program?
2. Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c?
3. Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?


Eligibility Criteria:
Inclusion Criteria:

* 12 to 17 years old
* Diagnosed with type 1 diabetes for at least 6 months
* Does not use CGM OR uses CGM \< 24 out of the past 30 days
* Use CGM 24 to 30 of the past 30 days but most recent HbA1c was 9% or more
* Able to read and write in English

Exclusion Criteria:

* Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)
* Intellectual disability
* Severe psychiatric comorbidities
The Efficacy of Topical Sesame Oil Versus Topical Triamcinolone on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker [MDA]

use seseme oil and corticosteroid topically for two groups

* The enrolled patients will be divided randomly into two groups.
* Test group will receive topical sesame oil (3 times /day after eating) for a month.
* Control group will receive topical corticosteroid (3 times /day after eating) for a month.
* Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires \& by clinical sign score . MDA will be measured at the baseline \& at the end of four weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be clinically diagnosed as having atrophic \&/or erosive oral lichen planus.

  * Patients with no history of taking topical corticosteroids for the last 2 months and systemic corticosteroid for the last 6 months
  * Patients who agree to take medication and follow up .

Exclusion Criteria:

* Pregnant and lactating ladies.

  * Patients with history of topical steroids during last 2 months \& systemic steroids during last 6 months.
  * Patients with recent dental filling associated with the lesion or associated with recent drug administration.
  * Patient with history of diabetes or hypertension or those with positive HCV ab or HBs Ag.
A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

Minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (MR) imaging and tissues samplings.

Because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem MR imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.

Eligibility Criteria:
Inclusion Criteria:

* stillbirth and fetal deaths over 21 weeks of gestation
* termination of pregnancy over 21 weeks of gestation
* neonatal death
* patient having read the letter of information and signed the consent.

Exclusion Criteria:

* legal incapacity
* limited ability to consent
* lack of parental consent
Observational Study to Assess Genotypes/Phenotypes Correlations in Type-2 Diabetic Retinopathy

The purpose of this study is to characterize type 2 diabetic patients with initial alterations of diabetic retinopathy (DR) based on 3 different phenotypes previously identified and different patterns of progression in order to correlate this data with genetic information.

This study aims to to characterize type 2 diabetic patients with initial alterations of diabetic retinopathy (DR) based on three different phenotypes previously identified and different patterns of progression \[Lobo, 2004\] in order to correlate this data with genetic information (based on a list of candidate genes previously identified as being involved in DR).

The results of this study will be used exclusively for scientific purposes.

Eligibility Criteria:
Inclusion Criteria:

* Type-2 diabetic subjects form the PTDC/SAU-OSM/72635/2006 clinical trial (early stages of non-proliferative retinopathy - level 30 to 35 ETDRS;. females or males; age over 18 years) with a signed Informed Consent for this study.

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations; Vitreous syneresis or posterior vitreous detachment; and Dilatation of the pupil \< 5 mm.
Endurance and Walking Training by Nordic Walking in Multiple Sclerosis

Walking capacity is one of the most valuable body functions among persons with multiple sclerosis (MS) and it is one of the most frequently affected, even in early stages of the disease. Inactivity and deconditioning can accelerate gait impairment and promote other pathologies related with sedentary lifestyle.

Nordic walking (NW) is a fun and effective fitness and rehabilitation activity. The benefits of NW have been extensively described in healthy and elderly population (Tschentscher, 2013; Kappor, 2013) and it is proving to be highly recommended to different neurological conditions, specially to Parkinson Disease (Reuter 2006; van Eijkeren 2008; Fritz 2011; Ebersbach 2014).

There is no evidence on NW and MS, although it's supposed to be an ideal physical activity for many reasons: it tones the upper and lower body at the same time, uses 90% of the skeletal muscles, burns up to 46% more calories than ordinary walking, reduces the pressure on knees and joints, poles propel the walker along easier and faster and it is one of the most effective cross training techniques for people who require improve cardiovascular and endurance conditioning.

A simple blinded randomized controlled trial as designed to assess if an endurance training (20 sessions of 45 minutes x 2 times/week x 10 weeks) using NW improves: walking capacity, balance, fatigue, mood and health-related quality of life of people with MS.

66 people with MS will be randomly allocated in NW group or conventional endurance training group (treadmill and cycloergometer). Assessments will take place before starting the training, after the training and 3 months after.

Eligibility Criteria:
Inclusion Criteria:

* People over 18 diagnosed of MS following the Mc Donald criteria, clinically stable who:
* show mild to moderate balance disorder (BBS\>45). Mild risk of falls.
* refer fatigue during walking and restriction on their usual walking distance during the last 6 months.
* Accept to participate in the study and signed the informed consent.

Exclusion Criteria:

* Other neurological disorders.
* Moderate to severe spasticity (Ashworth\>2)
* Non stable heart diseases, diabetes mellitus, arthritis in lower limbs, acute pain in lower limbs, peripheral neuropathies, severe orthopedics problems, psychiatric problems, pregnancy.
* Incapacity to maintain a minimum walking rhythm at least during 15 minutes.
* Cognitive disability or body schema disorder that limits to fill in the assessment questionaires or understanding and applying the technique.
* To be training in other physical activities that can modify the level of fatigue or walking ability.
A Sedentary Behaviour Reduction Intervention for People With COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of disability. Individuals with COPD are more likely to spend prolonged periods of time in sedentary behaviour (SB) and less in light physical activity compared to their healthy peers. SB is associated with exercise intolerance, reduced motivation to exercise, lower self-efficacy and more frequent acute exacerbations among people with COPD. To date, there is very limited information regarding behavioural approaches to reduce SB in people with COPD. The aim of this study is to examine the feasibility of a new 4-week theory-informed behaviour change intervention to reduce SB in individuals with COPD.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of COPD confirmed by spirometry Forced expired volume to forced vital capacity ration (FEV1/FVC) less than 0.7
* An ability to ambulate.
* An ability to provide informed consent.

Exclusion Criteria:

* Presence of co-existing conditions that may prevent participation in the intervention.