cyrilzakka/clinical-trials huggingface dataset:
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study

There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.

Keratoconus is a progressive ectatic disease of the cornea, leading to worsening of astigmatism and vision over time. With FDA approval of corneal collagen cross-linking (CXL), we now have the ability to halt the progression of keratoconus and prevent further vision loss in these patients. Although CXL has now become standard of care, the immediate post-operative period can be quite painful despite use of anti-inflammatory medications/eye drops. The goal of this study is to evaluate the efficacy of an intracanalicular dexamethasone insert in reduction of post-CXL pain as compared to routine steroid eye drop therapy.

To date, no studies have been performed evaluating the success of an intracanalicular dexamethasone insert for the treatment of postoperative inflammation and pain in corneal cross-linking patients. Oftentimes, patients experience a great deal of discomfort post-CXL, which may also make it difficult to apply eye drops in the correct fashion. Use of a dexamethasone insert alleviates the need for postoperative steroid eye drops and may provide increased pain relief post-CXL as compared to topical therapy. This will be a head-to-head study where steroid therapy (topical or insert) will begin in a standard fashion on the date of CXL. This will allow for accurate comparison of a 4-week taper of topical steroids, versus a dexamethasone insert designed to release steroid for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Progressive keratoconus with planned corneal cross-linking in one or both eyes
* Age 18 years and older
* Ability to provide informed consent for procedures
* Ability to attend scheduled follow up visits

Exclusion Criteria:

* Age less than 18
* Pregnancy/currently breast-feeding
* Inability to provide informed consent
* Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
* Punctal stenosis
* Previous corneal transplant surgery
* Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)
* Concurrent use of topical steroid eye drops
* Systemic, topical or intravitreal steroid use within 1 month of baseline
* Active history of chronic or recurrent inflammatory eye disease in either eye
* History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
* History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
Efficacy of IVMED-85 on Pediatric Myopia

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on the change and/or progression of myopia.

The main question\[s\] it aims to answer are:

* Does IVMED 85 improve visual acuity
* Does IVMED 85 slow or otherwise change the progression of myopia

Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* To be considered for enrollment in the study, the patient must meet all of the following criteria:

  1. Age 5 to 16 years and 6 months, three age groups cohorts (5-8), (9-12), and (13-16) (Phase 1 patients will be exclusively age 13-16).
  2. Refractive error by cycloplegic refraction in both eyes: myopia -0.75 D to -9.75 D spherical equivalent; astigmatism ≤ 4.00D; anisometropia \<3.00 D
  3. Best corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyes
  4. Kmax \>40 D and \<50 D in both eyes
  5. Minimum corneal thickness \> 350 microns in both eyes
  6. Absence of ocular comorbidities (glaucoma, cataract, anterior segment dysgenesis, corneal scarring, juvenile rheumatoid arthritis, lens subluxation, uveitis, collagen disorders (Ehlers-Danlos, Marfan's syndrome, osteogenesis imperfecta, retinal diseases) in both eyes
  7. Written informed consent from a parent or legal guardian and assent from participant
  8. Willing and able to comply with clinic visits and study-related procedures.

     Exclusion Criteria:

A patient who meets any of the following criteria, in either eye, will be excluded from the study:

1. Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinic
2. Significant central corneal scarring or hydrops
3. Known copper allergy
4. Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screening
5. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia) or intraocular surgeries
6. Prior history of ocular disorder (e.g., current or prior history of strabismus (exotropia or esotropia), amblyopia, glaucoma, cataract, retinal detachment or nystagmus, or abnormality of the cornea, lens, iris, ciliary body, or central retina)
7. Myopic degeneration with potential visual acuity worse than Snellen 20/40 (logMAR equivalent 0.3)
8. Intraocular pressure \>26 mmHg
9. Medical conditions pre-disposing patient to degenerative myopia or abnormal ocular refractive anatomy (e.g., Stickler Syndrome, Down Syndrome, osteogenesis imperfecta, Ehler's-Danlos Syndrome, Retinopathy of Prematurity)
10. Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1
11. Employees of the study site or their immediate families
12. Pregnancy
13. Hypothyroidism or hyperthyroidism
14. Patient less than 17 Kg weight
15. Planned ophthalmic surgery during the study
Violence Against Women and Consequences During Climacteric´s Phase

Objective- Analysis of the health status of women who were or are victims of domestic and sexual violence seeking attention at the outpatient clinic for Endocrines Gynecology and Climactery - University of Sao Paulo General Hospital.

To widen the comprehension of the binomial relationship violence-pathologies by professionals/staff who work in health services, offering women in such situation humane, comprehensive and qualified attention. Specific Objectives: decreasing the rates of domestic and sexual violence against women employing: prevention, health education and treatment - within the context of health services and public policies.

Methodology - Project Type: Research in Action A- Attention to women in a situation of domestic and sexual violence during climactery; B- Information/Education/Communication (IEC) C- Behavioral Intervention (IC) D- Institutional Development (DI). Target Populations: 1. Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence; 2. Professional/staff who work in services attending women in sexual and domestic violent situations (health professionals, policemen, civil society) in areas located within the South Regional Health Coordination - SRC. To collect information, a semi structured questionnaire will be employed during seven months in 2009.

Trained professionals will work in the regions of: Campo Limpo, M'Boi Mirim, Santo Amaro and neighboring regions, neighborhood in which the Social Vulnerability Index of São Paulo (IPVS) shows high records.

Eligibility Criteria:
Inclusion Criteria:

* Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence

Exclusion Criteria:

* Women who were not victims of domestic and/or sexual violence.
* Women that were not 40 to 65 years.
Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.

Background: Vertigo as acute symptom seem to be one of most common presentation in ED, can be treated in ED with multiple medication . Objective: This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED . Methods: A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo in three medical centers : AlNahdha hospital Oman , Sohar Hospital Oman and AFH hospital Oman. Oman From February 2022 to August 2024.

* Background Vertigo is one of most ED visit symptoms, It can be due to central or peripheral cause. The most frequent three reasons for vertigo are acute peripheral vestibulopathy (vestibular neuritis, labyrinthitis), Meniere's disease, and benign paroxysmal positional vertigo (BPPV). Usually ED doctors started with Epley maneuver for relief of symptoms and then started with medication.
* Objective:

This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED .

• Research methods: This will be done by assessing the Best medication can be used to treat peripheral vertigo with least side effect through Randomized triple blinded analysis will use 3 medications. All medications will be saved in similar syringe with white paper cover and labeled as A,B, C .The treating EM Doctor will prescribe medication as anti-vertigo then one of covered medication will be randomly taken among 3 medication groups. Target population will be all patient in age group (18-60) years visiting the emergency department at Al Nahdha hospital, AFH and Sohar hospital who complain of peripheral vertigo after assessment and excluding central cause. Ethical approval will be applied for through the OMSB (Ministry of health ethical committee)

Eligibility Criteria:
Inclusion Criteria:

* □ Acute peripheral vertigo with nausea or vomiting (vas, visual analog scale \>5) during their emergency department episode of care for which the attending physician recommending antiemetic, onset with in 3 days .

  * Age( 18- 60).

Exclusion Criteria:

* • Age \>60.

  * Any organic brain disease (Clear central cause; "malignancy with brain metastasis".)
  * History of epilepsy
  * Pregnancy.
  * Dementia, Parkinson's disease
  * Abnormal vital signs
  * Any known drug allergy to the study drugs
  * Undergoing chemotherapy or radiotherapy
  * Mechanical bowel obstruction or perforation, gastrointestinal bleeding
  * Inability to understand study explanation or outcome measures (any reason)
  * Patients who refused to participate study.
Bacteriophage Therapy in Tonsillitis

The patients received bacteriophage therapy with a liquid piobacteriophage complex (liquid pyobacteriophage complex - PCL). PСL was administered via nebulizer inhalation to irrigate the tonsil mucosa. A total of 5 ml of PCL was inhaled for 10 minutes every 5 days. The drug causes the lysis of certain bacteria, including staphylococcus, enterococcus, streptococcus, enteropathogenic E. coli, Proteus vulgaris, Proteus mirabilis, Pseudomonas aeruginosa, Klebsiella pneumoniae and Klebsiella oxytoca. The choice of this drug was based on bacteriological studies.

Comprehensive outpatient treatment was based on standard clinical guidelines, and symptomatic treatment was performed. On the first day of diagnosis, patients were prescribed complex antibacterial therapy on the basis of possible causative agents. Subsequently, antibiotic therapy was adjusted based on the results of the bacteriological examinations. A total of 67 patients received bacteriophage therapy using a liquid complex of pyobacteriophages (pyobacteriophage complex liquid - PСL). PСL was administered via nebulizer inhalation to irrigate the mucous membranes of the tonsils. In total, 5 ml of PCL was inhaled for up to 10 minutes once every 5 days.

The drug causes lysis of specific bacteria including Staphylococcus, Enterococcus, Streptococcus, enteropathogenic Escherichia coli, Proteus vulgaris, Proteus mirabilis, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Klebsiella oxytoca. The drug is recommended for use for diseases of the ear, throat, nose, respiratory tract and lungs; inflammation of the sinuses and middle ear; tonsillitis; pharyngitis; laryngitis; tracheitis; bronchitis; pneumonia, pleurisy; and other inflammatory diseases. The choice of this drug was based on bacteriological studies.

Eligibility Criteria:
Inclusion Criteria:

* children from 3 to 14 years old.
* children with sore throat.
* children diagnosed with acute tonsillitis.
* children diagnosed with acute respiratory infection (rhinitis, sinusitis, nasopharyngitis).
* children with the opportunity to visit the outpatient clinic.
* children with the ability to receive inhalation therapy.
* children from parents (or guardians) who have given written permission to conduct clinical and laboratory research.

Exclusion Criteria:

* children under 3 years old and over 14 years old.
* children receiving hospital treatment.
* children with acute respiratory tract diseases (bronchitis, pneumonia, pleurisy).
* children with сhronic respiratory tract diseases (bronchitis, pneumonia).
* children who are allergic to antibiotics.
* children with cancer, immunological and hematological diseases.
* children with severe psychological illnesses (schizophrenia, mental retardation, etc.)
* children with cancer, immunological and hematological diseases.
* children with tuberculosis.
Taiwan Associated Genetic and Nongenetic Small Vessel Disease

The TAG-SVD enrolled patients with clinical and neuroimaging features of cerebral small vessel disease (CSVD). All enrolled patients will receive next-generation sequence (NGS) with probes designed to target five candidate CSVD genes, and patients will be divided into genetic or non-genetic groups accordingly. Their clinical features and outcome will be followed for at least 2 years.


Eligibility Criteria:
Inclusion Criteria:

Participants must have at least one of the following symptoms/signs or history

* stroke (especially small vessel occlusion type of ischaemic stroke, spontaneous ICH or young stroke)
* cognitive impairment or dementia
* gait disturbance
* parkinsonism (especially vascular parkinsonism features)
* headache (especially migraine)
* positive family history of hereditary CSVD
* MRI evidence of CSVD (MRI may be done for other reasons), including mild to moderate white matter hyper intensity, any lacune, or any cerebral microbleed

Exclusion Criteria:

* MRI evidence of CSVD due to other inflammatory, malignancy, or structural lesions
* patients or family members not willing to sign informed consent
Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases

The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis
* Decision to initiate Humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label
* Prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research.

Exclusion Criteria:

* Inadequate response to previous standard treatment with anti-tumor necrosis factor (TNF) biological agent according to the physician's clinical judgment.
* Participant has been treated with adalimumab within 70 days (five half-lives) prior to the Baseline Visit.
* Participants discontinued due to adverse drug reaction of previous adalimumab treatment.
* Participants who fulfill any of the contraindications as per adalimumab label in China.
* Participants, who in the clinician's view, may not be able to comply with the study requirements.
RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

The investigators are studying motivational interviewing (MI). MI is a counseling method to help people adopt healthy behaviors. The investigators will test whether MI improves patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All patients will receive their usual eye care. Based on chance, some patients will also be supported by a glaucoma educator. The groups will be compared on medication adherence using micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a medication bottle is opened. Patients will be aware that their medication use is tracked. The groups will also be compared on treatment value, outcomes, and cost. The investigators will also collect data on variables that may predict medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* community-dwelling adults with primary or secondary open-angle glaucoma, and
* a current prescription for monotherapy topical glaucoma medication.

Exclusion Criteria:

* patient-reported inability to administer eye drops that cannot be addressed successfully through in-person instruction at the clinic,
* cognitive impairment at a level that would in the judgment of the referring physician interfere with study participation,
* referring physician's determination that glaucoma surgery is likely within the next 6 months,
* any active medical, psychological, or substance use disorder that would in the referring physician's judgment significantly interfere with study participation (e.g., comorbid congestive heart failure (CHF) resulting in a recent hospitalization; active psychosis due to uncontrolled bipolar disorder; etc.), or
* no visual field test within the past 6 months (data required for the randomization approach described below).
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)

The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.

Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in France, has never been evaluated.

The investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress.

Comparison(s): The investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 15 days to 24 months
* First acute bronchiolitis
* Indication of hospitalisation
* One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate \> 60/min; pulse oxymetry \< 95%; alimentary intake \< 2/3 of the needs.

Exclusion Criteria:

* Prematurity (gestational age \< 32 weeks)
* Brondysplasia
* Chronic lung disease or congenital heart disease
* Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)
* 3 or more chest physiotherapy procedures since hospitalisation
* Parental refusal
* Any chest physiotherapy contra-indication
Surgery and ART For Endometrioma

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of endometrial-like tissue, glands and stroma outside the uterine cavity. Although endometriosis is classified in four stage (minimal, mild, moderate, severe), from the clinical point of view it is possible to subdivide among peritoneal superficial lesions, ovarian endometriomas and Deep Infiltrating Endometriosis (DIE).

According to the European Society for Human Reproduction and Embryology (ESHRE) Guideline on the management of women with endometriosis, it is recommended to clinicians that in infertile women with endometrioma larger than 3 cm, cystectomy should be considered prior to Assisted Reproduction Technology (ART) to improve endometriosis-associated pain or the accessibility of follicles. They further recommend that clinicians counsel women with endometrioma regarding the risks of reduced ovarian function after surgery, the possible loss of the ovary, and consider that the decision to proceed with surgery should be taken carefully if the woman has had previous ovarian surgery.

In addition, this Guideline suggests that clinicians can prescribe prolonged (3-6 months) pituitary downregulation with Gonadotropin Releasing Hormone-agonists (GnRH-a) prior to ART, in order to increase live birth rate by four-fold.

Despite these recommendations, to date there is not robust evidence to choose between the two strategies prior to ART in order to improve reproductive outcomes.

For this reason, the aim of the current study will be to compare reproductive outcomes in infertile women affected by ovarian endometrioma, undergoing laparoscopic enucleation or prolonged pituitary downregulation with GnRH-a, prior to ART.


Eligibility Criteria:
Inclusion Criteria:

* Indication for ART: compromised tubal function, male factor infertility, other treatments have failed and/or prolonged infertility of more than 4 years.
* Age between 18 and 35 years.
* Ultrasound diagnosis of one ovarian endometriotic cyst with a diameter of 30 mm or more, according to the International Ovarian Tumor Analysis (IOTA)-criteria for reliable diagnosis of endometriomas in premenopausal women.

Exclusion Criteria:

* Any comorbidity other than ovarian endometrioma.
* Deep Infiltrating Endometriosis.
* Previous ovarian surgery.
* Bilateral endometriomas.
* The use of donor oocytes/sperm.
* ART with preimplantation genetic testing, as the number of embryos suitable. for transfer or cryopreservation is significantly lower compared to normal ART.
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation

* Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation.
* Secondary objective was to obtain safety data regarding adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) \> = 120% as measured by body plethysmography
* Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study.

Exclusion Criteria:

* Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing Information