cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma

Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss.

Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control.

Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above
2. Able to provide informed consent
3. Diagnosed as having unilateral or bilateral, mild to moderate POAG
4. The POAG treated with only two antiglaucoma

Exclusion Criteria:

1. Advanced POAG
2. Patient with contraindication for topical use of a-blocker and prostaglandin analogue
3. Patient with contraindication for systemic use of a-blocker
4. Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol
5. History of orbital or ocular trauma.
6. History of cataract surgery less than 6 months.
7. History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery
8. Any active eye infections or corneal ulceration.
9. Patient with ocular surface disease
10. Other ocular disease that might interfere with IOP measurements or result
11. Precious eye i.e patient with only one good eye
12. Contact lens is not allowed within 1 week before the start of study and during the study
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily

To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.


Eligibility Criteria:
Inclusion Criteria:

* Type of Subject: Outpatient
* Age: ≥12 years of age
* Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
* Asthma Diagnosis: As defined by NIH
* Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio \>0.70
* Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
* Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
* Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
* QTC: QTc(F)\<450msec or QTc(F)\<480 for subjects with Bundle Branch Block
* Liver function: Normal liver function
* Informed Consent

Exclusion Criteria:

* History of Life-threatening asthma: Within previous 5 years
* Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
* Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
* Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
* OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
* Immunosuppressive medications: Either using or required during the study
* Liver disease: Current or chronic history
* Concurrent disease/abnormalities: Clinically significant uncontrolled disease
* Investigational medications: Participation in a study or used investigational drug within 30 days
* Drug allergy: β-agonists, corticosteroids, constituents of inhalers
* Milk Protein Allergy: History of severe milk protein allergy
* Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
* Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
* History of alcohol or drug abuse: Likely to interfere with the study
* Affiliation with Investigator's Site: Relative or employee
Efficacy of TAP Block in Cesarean Section Patients

TAP Block done with 2 different concentrations of bupivacaine and placebo

TAP Block was done using 2 different concentrations of bupivacaine (0.5% and 0.25%) and placebo and the post operative sedation was measured in each arm and compared together.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women

Exclusion Criteria:

* Allergy to local anesthetics
Role of Transposable Elements in Septic Immune Aging

The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:

1. Do transposable elements prematurely age the immune systems of patients with sepsis?
2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?
3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?

Participants will have blood drawn from them but will not be subjected to additional interventions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Admitted to ICU with sepsis (Sepsis 3 Criteria)
* SOFA score of at least 2 at time of enrollment

Exclusion Criteria:

* Patients on organ transplantation immunosuppression
* Patients with preexisting leukopenia
* Cancer patients receiving CAR-T therapy
* Patients who are under 18 years of age or otherwise deemed pediatric
* Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)
* Patients with a chronic hemoglobin below 7.0
* Patients who, prior to their ICU admission, are blood transfusion dependent
Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes

Study is a 12-week Double blind,controlled experiments designed to examine the possible effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.

In a 12-week randomized controlled trial ( double-blind study), based on data on serum 25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week intervention period, the sample size was calculated 40 individuals per treatment group. Considering 3 polymorphic variant groups and one control group which receives plain yogurt drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a total of 180 subjects are required. In treatment groups, all patients receive 500 ml per day of low-fat (1%) Yogurt Drink fortified with approximately 500IU of vitamin D3 . Control group receives 500 ml per day of plain (unfortified) Yogurt Drink. Metabolic, inflammatory and oxidative stress markers are evaluated at the beginning and in the end of the interventional period.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Informed consent
* BMI between 25 to 35 kg/m2
* Age: 30-45 years old
* Willingness to maintain current body weight for the duration of the study
* Willingness to maintain baseline lifestyle activities and routines for the duration of the study
* Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study

Exclusion Criteria:

* History of cardiovascular , Gastrointestinal , Renal disease and any other endocrinological disorders
* Subjects receiving vitamin D or omega-3 supplement
* Pregnancy , or lactation within the study period
* Treatment with insulin
* Treatment for weight reduction
* Treatment for reducing serum lipids
Diurnal Intraocular Pressure and Peripapillary Retinal Blood Flow in Medically Controlled Open-Angle Glaucoma

Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow may have distinctive patterns in medically well-controlled open-angle glaucoma patients. In the results, we found a unique pattern, 'Latent asymmetric IOP', defined as the IOP which differs between the eyes only when placed in the supine position. Unique effects of this latent asymmetric IOP on Visual field and diurnal IOP fluctuations were studied.

Diurnal fluctuations of intraocular pressure (IOP) and peripapillary retinal blood flow have been implicated to be one of the important factors to affect visual field progression. However, there was no study to investigate them in medically well-controlled open-angle glaucoma patients. So we want to find the unique patterns.

Study 1. Subjects : Patients with medically well controlled open angle glaucoma Method : IOP and peripapillary retinal blood flow were measured for 24 hours. The relationship between the two were studied.

Study 2. Of the patients enrolled in study 1 , those on the same medical regimen for both eyes were analyzed for the presence of a latent asymmetric IOP and it's influence and association with visual field and diurnal IOP fluctuation.

Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma
* Topical anti-glaucoma medications

Exclusion Criteria:

* Ocular surgery history
* Other ocular disease history
* Oral glaucoma medications
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome

Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.

Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.

Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.

Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.

This comparison includes preoperative parameters (hemoglobin, creatinine, mini-mental test) and intraoperative parameters (such as type of anesthesia).

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014

Exclusion Criteria:

* None
Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions


Eligibility Criteria:
Inclusion Criteria:

* Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®

Exclusion Criteria:

* Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed for at least 6 months
* Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
* Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
* Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
* Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
* Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
* Body Mass Index (BMI) between 18.5 - 35.0 kg/m\^2
* Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Any contraindication of metformin
* Receipt of investigational drug within the last 3 months prior to this trial
* Any history of chronic insulin therapy (more than 1 week of daily use)
* Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
* Pregnancy, nursing mother, or unwillingness to use adequate contraception
Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic device that is not utilized in any clinical decision-making processes. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via described inclusion and exclusion criteria.

High-resolution pharyngeal manometry (HRM) is a diagnostic technique that has the potential to objectively measure pharyngeal collapse patterns in obstructive sleep apnea (OSA) during sedation as well as natural sleep. The purpose of this study is to assess the utility of HRM in objectively mapping patterns of pharyngeal collapse observed during drug-induced sleep endoscopy (DISE). Quantifying pharyngeal collapse patterns that occur during sedation and in natural sleep may significantly impact the selection and success of surgical treatments, as well as surgical outcome assessment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr
* Intolerant of continuous positive airway pressure (CPAP) therapy due to physical or psychosocial limitations as determined by PI
* Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy

Exclusion Criteria:

* Patient is unable to consent for research due to a pre-existing neurologic condition as determined by PI
* Patient is unable to consent for research due to language barriers
* Patient has a history of egg allergy as determined by history or self- report
* Patient is pregnant as determined by patient report or preoperative anesthesia evaluation
* Cardiopulmonary or other medical conditions precluding safe sedation as determined by clinical history and exam
* History of palatal or pharyngeal airway surgery except tonsillectomy as determined by clinical history and exam
* History of radiation treatment to the head or neck as determined by clinical history and/or exam
* Severe nasal airway obstruction preventing simultaneous flexible nasopharyngoscopy and manometry probe insertion as determined by physical exam
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography

This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
* Able to provide informed consent.

Exclusion Criteria:

* Subjects judged unsuitable for diagnostic intervention or FFR;
* Myocardial infarction within 6 days;
* LVEF ≤50%;
* eGFR \<60ml/min（1.73m²）
* Severe coagulation dysfunction or bleeding disorders;
* Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
* Participated in other clinical trials within 1 months;
* Other situations that were not suitable for inclusion, as judged by investigators.
Men of Color Fatherhood Education and Violence Prevention Project

A 16 session curriculum, developed for noncustodial African American and Latino fathers to improve knowledge, attitudes and skills and enable participants to remain non-violent towards their partners will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Noncustodial fathers
* African American or Latino
* At high risk for violence (prior perpetration, un/underemployment)

Exclusion Criteria:

* Substance abusers
CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.

Eligibility Criteria:
Inclusion Criteria:

* The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
* The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.
* Exclusion Criteria:
* The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
* The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
* The Subject has any acne cyst on the face at Screening and at Baseline visits.
Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease

Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.

ProLowCKD is a single-centre, double-blind, placebo-controlled, randomised study. At enrolment (T0) participants were prescribed a LPD in addition to their ongoing pharmacological therapy and according to their comorbidities; after 2 months (T2) they were randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months (T5) in addition to the continuation of LPD. Enrolled subjects are invited to assume two doses of probiotic/placebo for 1 month and 1 dose for 2 months.

Randomization is 1:1 to receive odd- or even envelopes, according to the odd- or even registration number at enrolment.

Neither the clinician nor the patient knows the content of the odd- and even envelopes.

The evaluations will be performed according to the following schedule: at T0 nephrological evaluation and biochemical analysis, dietary counselling, illustration of protocol and signing of the informed consent, administration of the SF36 questionnaire, body composition evaluation by bioimpedentiometry. At T0, T2, T5: blood biochemical parameters: haemoglobin, urea, creatinine, mean urea and creatinine clearance, CKD and MDRD calculation, sodium, potassium, uric acid, calcium, phosphate, PTH, acid-base balance, CRP, albumin, PC, IS, Lp-PLA2, LPS; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial stools analysis; clinical nephrological and dietitian evaluation.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* GFR \< 20 ml/min/sqm
* afferent to the outpatient clinic in the Nephrology and Dialysis Unit (Azienda Ospedaliero Universitaria Maggiore della Carità)

Drop out or Exclusion Criteria:

* subject refusing to sign the informed consent
* administration of prolonged antibacterial therapy
* dialysis initiation
* death
Study of VYNT-0126 in the Treatment of Rett Syndrome in Adult Patients

This is an exploratory, Phase 2, multicenter, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, and efficacy of oral treatment with VYNT-0126 in female subjects 18-45 years of age with Rett syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Females age 18-45 (inclusive)
* Diagnosis of classic/typical Rett syndrome with a documented mutation of the MeCP2 gene
* Severity rating of between 10 and 36 (Rett Syndrome Natural History/Clinical Severity Scale)
* Concomitant medications (including approved medications for treatment of Rett syndrome) must be stable for \>4 weeks prior to enrollment
* Able to receive liquid study drug orally or via gastrostomy tube (G-tube)

Exclusion Criteria:

* Actively undergoing neurological regression;
* Abnormal QT interval, prolongation or significant cardiovascular history
* Excluded concomitant medications
* Current clinically significant (as determined by the investigator). cardiovascular, endocrine, hepatic, renal, or respiratory disease
* Gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication
* History of, or current cerebrovascular disease or brain trauma
* History of, or current, malignancy
* Clinically significant abnormalities in safety laboratory tests, vital signs, or ECG, as measured at screening or baseline
* Any condition which in the investigator's opinion would affect the ability of the subject to participate in the study
* Allergy to VYNT-0126 or any ingredients of the liquid formulation
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
3. Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.

Exclusion Criteria:

1. Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
2. Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
3. Imaging indicates the presence of thrombus in the left atrium or LAA;
4. Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
5. LAA depth \< 15 mm, or LAA anchor zone diameter \< 10 mm or \> 33 mm;
6. Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
7. Currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up;
8. Other conditions that the investigator deems make the participant unsuitable for this study.