cyrilzakka/clinical-trials huggingface dataset:
Managing Dry Eye in Patients Using Glaucoma Drops

A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Able and willing to comply with the treatment/follow-up schedule
* Bilateral signs and symptoms of dry eye disease

Exclusion Criteria:

* Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
* Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
* Previous ocular surgery or trauma
* 1-month history of blepharal and periorbital skin disease or allergies
* Severe dry eyes with corneal epithelial defect
* Limbic keratitis
* Pterygium
* Corneal neovascularization
* Breastfeeding
* Rheumatic immune systemic diseases
* Herpes zoster infection
* Pregnant women
* Allergic to fluorescein
* Contact lens wearers
Spherical Aberration and Contrast Sensitivity Function in Eyes Implanted With Spherical and Aspheric Intraocular Lenses: A Clinical Trial

Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve contrast sensitivity function after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Senile cataract

Exclusion Criteria:

* Glaucoma, corneal opacity, retinal abnormality, previous history
Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.

Mosquito-bite symptoms include wheals and pruritic bite papules. Oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials.

Subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.

Eligibility Criteria:
Inclusion Criteria:

* Recent history of suffering from mosquito-bite reactions.
* At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes

Exclusion Criteria:

* Pregnancy or lactating females
* Oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (NSAID) use within two weeks before the study.
* Severe or moderate systemic illness
* Allergy to rupatadine or other antihistamines
* Anaphylaxis from mosquito bites
Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers

The purpose of this study is to learn more about how asthma develops in early childhood. This will help doctors understand how to prevent and treat asthma better.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 months to 36 months at first research encounter
* For enrollment in Emergency Department (ED)/Inpatient Visit: Presentation to the ED/Inpatient with an acute wheezing episode AND either evidence of at least one prior wheezing episode documented in the electronic medical record (i.e., wheezing, pneumonitis, bronchiolitis, reactive airways disease, or asthma) that occurred ≥ 14 days from current episode, or caregiver report of one of the following:

  * Child has had wheezing or whistling in the chest at any time in the past lasting at least 24 hours and occurring at least 14 days prior to the current ED visit
  * Child has been treated with albuterol or used an inhaler or a nebulizer at least 14 days prior to the current ED visit
  * Caregiver has been told that their child has bronchiolitis, asthma, or reactive airways disease at least 14 days prior to the current ED visit
* For enrollment in Visit 1: At least three separate wheezing episodes, separated by at least 14 consecutive days without a wheezing episode (wheezing lasting ≥ 24 hours), as reported by parent/caregiver or patient's care provider and/or documented in the patient's medical record

  * Third episode may be at time of presentation to ED or admission as inpatient (IP) to hospital when recruitment would occur (Visit ED/IP)
  * Bronchiolitis and wheezing/asthma exacerbations are considered wheezing episodes
  * The wheezing episode does not require treatment with bronchodilators
* Live within a US Office of Management and Budget-defined Metropolitan Statistical Area (MSA) and meet at least one of these criteria:

  1. Have publicly funded health insurance AND/OR
  2. Live in a census tract within an MSA where ≥10% of families have income below the poverty level

Exclusion Criteria:

* Wheeze attributed to alternative diagnoses other than bronchiolitis or asthma, including congenital anatomical abnormalities, foreign body aspiration, chronic lung disease of prematurity, other chronic lung disorders such as cystic fibrosis, and cardiac, immune, and gastrointestinal disorders.
* Gestational age \< 32 weeks.
Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment

The purpose of this is that the researcher can use low power Near Infrared laser treatment non-painful and non-damaging dose to changes the skin properties.The researcher can prove that signaling and a significant increase in the number of skin cells in skin tissue exposed to the laser can improve the human skin immune system to help improve human body response to vaccines.

The researcher can use low power laser light one-minute exposures delivered to the skin at non-painful and non-damaging dose. The resulted in significant immunologic changes in the skin that included up-regulation of specific skin tissue and skin genes and the activation and mobilization of specific skin cells.

In the first part of the study, the researcher will make a determination of the laser irradiance that will be tolerated. The highest irradiance the subject tolerates for 1 minute will be identified as that subject's maximum tolerable irradiance. After all subjects are tested, researcher will select the highest irradiance that was tolerated and use this in the second phase of the study.

Approximately 24 hours after the first test exposures, each subject will receive a one minute laser treatment at the maximum tolerable irradiance. Four hours later, two skin biopsies will be collected from laser treated site a untreated.

One tissue sample will be test at UC Irvine Dept. of Dermatopathology to evaluate microscopic skin changes, one skin sample will be delivered to Massachusetts General Hospital to evaluate RNA and protein expression.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women with skin type 1 and 2
* Not pregnant

Exclusion Criteria:

* Use of systemic steroids, topical steroids, tanning solutions and anticoagulant
* History of HIV, mentally incompetent, prisoner, alcohol or drug impairment
* Abnormal photosensitivity
Detection of Fabry Disease in Chronic Renal Failure Patients in Area Provence - Alpes - Côte d'Azur

Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function properly. As a result, the lipid accumulates in the body, this leads to multisystem impairment, including progressive renal failure.

Several studies have focused on the detection of this disease in end-stage renal failure patients, transplant or hemodialysis.

This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine level greater than 0,5 g/l.

This screening will be conducted by a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper. If this assay was positive, confirmation of diagnosis of Fabry disease will done the standard method: macrodosage of leukocytic alpha-galactosidase A activity.

This multicenter prospective study, openly contacted in medical practice, with patient follow-up corresponding to the management of renal insufficiency, will be offered to all departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.

The objective of this study is to assess the prevalence of Fabry disease in the target population and to identify previously undiagnosed patients, enabling them to benefit from appropriate management of their disease, including whether need enzyme replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 60 years
* Glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1,73m2 in association with proteinuria greater than 0.3 g/g creatinine or 0.5 g/l
* Patient able to understand the benefits and risks of the study
* Written Consent, informed, signed
* Patients insured under Social Security,

Exclusion Criteria:

* Patients with a confirmed diagnosis of Fabry disease
* Patients belonging to a family in which a diagnosis of Fabry disease was confirmed
* Patients protected by law (under guardianship).
Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Age \> 45 years
* Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee

Exclusion Criteria:

* Skin lesions or dermatological diseases in the treatment area
* Directly or indirectly involved in the conduct and administration of this study
* Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
* Pregnancy or lactation
* Residents of psychiatric wards, prisons or other state institutions
* Malignancy within the past 2 years
* Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
* Epilepsy
* Schizophrenia
* Neuropathic pain and any other pain condition requiring chronic use of pain medication
* Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose
* Peripheral arterial disease and/or cerebrovascular disease
* History of stroke or myocardial infarction
* Congestive Heart failure NYHA Class II-IV
* History of pancreatitis or peptic ulcers;
* Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
* Serum creatinine levels \> 2.5 milligrams/deciliter (mg/dL)
* ALT or AST levels ≥ 5 times the ULN
* Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer

The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long.


Eligibility Criteria:
Inclusion Criteria:

* Female participants with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be estrogen response (ER) and/or parathyroid hormone receptor (PtR) positive.

Note: Hormone receptor positivity is defined as ER or PtR greater than 10 fmol/mg by biochemical assay or 10% positive cells by immunohistochemistry

* Participants are resistant to aromatase inhibitors (AI) therapy
* Females with postmenopausal status
* Previous radiation therapy is allowed, but should have been limited
* Measurable or non-measurable disease
* Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have adequate organ function
* Have an estimated life expectancy of at least 24 weeks
* Must sign an informed consent document

Exclusion Criteria:

* Have had prior treatment with fulvestrant or enzastaurin
* Are receiving concurrent administration of any other antitumor therapy, with the exception of gonadotropin-releasing hormone (GnRH) antagonists.
* Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry
* Have received supplemental estrogen or progesterone within 4 weeks prior to study entry
* Are hormone estrogen receptor (HER2)-positive
* Are unable to discontinue use of anticoagulants
* Have hypercalcemia
* Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Have documented central nervous system (CNS) metastases, symptomatic pulmonary lymphangitis, or involvement of more than 1/3 of the liver
* Have a serious concomitant systemic disorder
* Have a serious cardiac condition
* Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy
* Are unable to swallow tablets.
Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury

Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Admitted in Brest hospital between 2015 and 2018 for moderate TBI, defined by Glasgow coma scale (GCS) score 9-13

Exclusion Criteria:

* Non consenting patients
A Trial of an Online Problem-solving Intervention for Aggression

Aggressive behaviour among adolescents is a social problem that can be reduced by social problem-solving interventions. However, these interventions usually include more than one technique, and the specific techniques that are effective in reducing and preventing aggression remain to be identified. Therefore, the main aim of this study is to test whether the instruction and practice of problem-solving on their own are effective in changing aggressive behaviour among adolescents.

As the intervention in this trial is aimed at the general population, it will be delivered online. The rapid growth in the use of the Internet among young people provides an opportunity to deliver interventions universally in a cheap and efficient way.

Problem-solving skills are fundamental to effective behaviour change. Therefore, problem-solving skills will be measured to assess whether they mediate the effect of the intervention on aggressive behaviour.

Finally, young people with callous-unemotional traits are less likely to change their problematic behaviour such as aggression after an intervention. Therefore, Callous-Unemotional traits will be measured to assess if they act as a moderator of effectiveness.

It is expected that participants randomised to the intervention improve their problem-solving skills and consequentially, reduce their aggressive behaviours. In addition, participants with lower callous-unemotional traits are expected to have a greater change.


Eligibility Criteria:
Inclusion Criteria:

* Living in the UK
* Fluent in English
TXI for the Recognition of Adenomas in Colonoscopy

This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.


Eligibility Criteria:
Inclusion criteria:

- All \>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance

Exclusion criteria:

* patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
* Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.
SURVEY ABOUT STRESS-COVID IN HEALTH CARE WORKERS IN NORTH AFRICA COUNTRY

This study aimed to investigate the psychological impact of the COVID-19 outbreak on healthcare workers (HCWs) and to identify ways of coping with this unprecedented stressful situation.

This was a cross-sectional study based on an online questionnaire that included 62 questions (scores, 0 - 3). The chi-square (χ²) test was used to compare the responses between professional groups, age groups, and genders.

Eligibility Criteria:
Inclusion Criteria:

* HEALTH CARE WORKERS

Exclusion Criteria:

* no one
A Comparative Study of Robotic Thyroidectomy Using Transaxillary Approach Versus Conventional Open Thyroidectomy

Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction.

Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. In this study, we designed a prospective study comparing the cosmetic satisfaction and the postoperative body image change which associated with patient self-esteem between robotic thyroidectomy and conventional open thyroidectomy group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with papillary thyroid carcinoma who underwent thyroidectomy
* Age was over 20 years old

Exclusion Criteria:

* Keloid
* Previous neck or anterior chest operation history
* The patients who underwent combined radical neck dissection
* The patient with postoperative wound problem
* The patient with underlying systemic disease which can make influences on the wound healing process
* The patient who can not read and understand the questionnaire
The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)

This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT study. Site investigators will conduct a chart review and complete a data collection form. The purpose of this study is to describe the treatment used and clinical outcomes of these subjects following completion of the ATTRACT trial up until their most recent assessment by the treating physicians.

Subjects were selected for this study using a non-probability sampling method.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been enrolled in the two year follow-up phase of ATTRACT and have continued treatment with the site investigator
* Signature of informed consent.

Exclusion Criteria:

* Not specified in the protocol.
Umbilical Cord Serum Eye Drops

In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.


Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent corneal erosions

Exclusion Criteria:

* none
Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* - Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
* Individuals who are able to comply with all study procedures and requirements;
* Healthy volunteers and volunteers specifically with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment may be eligible;
* Please contact the site for additional eligibility criteria.

Exclusion Criteria:

* Individuals who are not able to follow all the required study procedures for the whole period of the study;
* Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
* Please contact the site for additional eligibility criteria.
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children

It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.

Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.

2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.


Eligibility Criteria:
Inclusion Criteria:

* age 3-12 years
* minor surgeries / diagnostic procedures such as endoscopy, biopsy

Exclusion Criteria:

* children that do not speak Hebrew
* American Society of Anesthesiologists (ASA) status above II
* a need for regional anesthesia only
* a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.