cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis

Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis

The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma

Eligibility Criteria:
Inclusion Criteria:

* Subjects with h/o CEIOL/OMNI/Hydrus (chosen based on subjects on more than 1 medication pre-operatively) with at least 3 years of follow up data
* have Glaucoma

Exclusion Criteria:

* Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
* Patients with refractory CME or CME persisting 3 months or more post-operatively
* Patients with incomplete IOP, medication logs or VF data within post-operative period
* Prior incisional surgery or MIGS
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor

A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Willing to provide written, informed consent to participate in the study.
3. For subjects with essential tremor (ET):

   1. A clinical diagnosis of ET.
   2. For either upper limb, a tremor severity score of 2 or higher as measured by one of the TETRAS items and a total score of 6 or higher across all TETRAS tasks.
4. For subjects with Parkinson's disease (PD):

   1. A clinical diagnosis of PD (MDS-PD criteria).
   2. A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR
   3. A rest tremor score of 2 or higher on MDS-UPDRS question 3.17 (rest tremor amplitude) in one upper extremity and a score of 2 or higher on MDS-UPDRS question 3.18 (constancy of tremor).
5. Stable dosage of any medication, if applicable, for 30 days prior to study entry.
6. Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.
7. If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.
8. Willing to comply with study protocol requirements including:

   1. Remaining on a stable dosage of current medications, if applicable, during the course of the study.
   2. Remaining on stable caffeine consumption, if applicable, during the course of t the study.
   3. No alcohol consumption on the day before a study visit.

Exclusion Criteria:

1. Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
2. Any current drug or alcohol abuse.
3. Current unstable epileptic conditions with a seizure within 6 months of study entry.
4. Pregnant or nursing subjects and those who plan pregnancy during the course of the study.
5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.
6. Known allergy to adhesives.
7. History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19).
8. Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.
9. Subject is currently participating or has participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor.
10. Subject is unable to communicate with the investigator and staff.
11. Any health condition that in the investigator's opinion should preclude participation in this study.
Overnight Switch From Rasagiline To Safinamide

Rasagiline label report the indication to wait at least 14 days between discontinuation of rasagiline and initiation of another MAO inhibitor. This results in a major inconvenience for Parkinsonian patients (PD) due to their clinical worsening. Safinamide is a reversible MAO-B inhibitor, characterized by a good safety profile. In clinical practice safinamide is often introduced instead of rasagiline following an overnight switch. The aim of this study is to explore the safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) to safinamide, with the expectation that there will be no adverse events or increased risk of hypertensive crisis for patients with PD or signs of serotonin syndrome

Objective: The aim of this study is to verify safety and tolerability of the immediate switch from rasagiline to safinamide trough monitoring of BP by 24-hour Holter recording. The primary objective of the study will be achieved if the mean BP will not increase by \>10 mmHg in the studied population.

Methods: This is an open-label, single-centre study conducted at IRCCS San Raffaele Pisana. Study population included patients with idiopathic PD in the mid-late stage of the disease, suffering from motor fluctuation, on stable treatment with rasagiline and Levodopa (alone or in combination with other anti-parkinsonian medication). The protocol contemplates five visits during six weeks, with two 24-hour Holter recording (first in rasagiline and second in first-day of safinamide therapy), monitoring typical symptoms of the serotonin syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients able to comprehend and provide consent form
* Patients with idiopathic Parkinson's disease diagnosed according to the UK Brain Bank criteria
* Patients in mid-to late stage of the disease (Hoehn \& Yahr: between the stage 2 and 4 in on state).
* Patients suffering from motor fluctuations
* Patients must have a good response to levodopa in the opinion of the investigators (evaluated as improvement ≥ 30% of the UPDRS scores)
* Stable dosage of antiparkinsonian medication for at least 4 weeks prior to study enrollment
* Female patients in post-menopausal state; women of childbearing potential must use an acceptable method of contraception

Exclusion Criteria:

* Atypical Parkinsonism
* Any significant psychiatric, metabolic and systemic concomitant disease
* Patients with clinically significant out of range laboratory values
* Patients participating in a clinical trial in the last 6 weeks
* Patients with moderate-severe cognitive decline not able to provide consent form
* Patients currently lactating or pregnant or planning to become pregnant during the duration of the study
* Patients for whom Xadago is contraindicated according to the current SmPC
Incubation Time and Test of Cure of Chlamydia Trachomatis

Objective was to understand the dynamics of Chlamydia trachomatis (Ct) detection by nucleic acid amplification testing (NAAT) after treatment and consequences for test-of-cure practice.

Prospective Cohort Study on Detection of Chlamydial ribosomal ribonucleic acid (rRNA) and deoxyribonucleic acid (DNA) in anorectal and cervicovaginal Chlamydia trachomatis (Ct) infections during 8 weeks after directly observed treatment with Azythromycin. The investigators systematically assessed presence of Ct plasmid DNA and rRNA through multiple time-sequential measurements following treatment with 1000mg Azythromycin. By convenience sampling at our outpatient sexually transmitted diseases (STD) clinic, 46 non-pregnant women and 6 men were included, contributing 45 cervicovaginal and 15 anorectal infections. Over a period of 8 weeks, patients provided a total of 1016 self-taken cervicovaginal and/or anorectal swabs (response: 94%). All patients were negative for Human immunodeficiency virus (HIV), gonorrhea and Lymphogranuloma venereum (LGV), tested in anorectal Ct. Usual care was applied by advising abstinence or safe sex for one week and by providing treatment for steady partners. Participants provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Chlamydia trachomatis diagnosis,
* age \>=18 years

Exclusion Criteria:

* pregnancy,
* doxycycline treated-Ct,
* recent treatment with antibiotics,
* co-infections with other STD
Determination of Lysine Requirement in the Parenterally Fed Neonate

The purpose of this study is to establish the parenteral lysine requirements for neonates.

It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates. Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins. In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies. We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable neonates on TPN
* minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
* Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
* Weight of ≥ 1.5 kg
* NPO or ≤10% of total protein requirement consumed enterally

Exclusion Criteria:

* Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)
Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program

The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was generated to describe their baseline demographic and clinical characteristics.

The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program.

PSS data was obtained from patients with wet AMD who enrolled in the program for the index period 10/10/2019 to 04/30/2020.

* Identification period of the index period: 10/10/2019 to 04/30/2020
* Index date: Date of enrollment in the PSS program
* Study Period: 10/10/2019 to 04/30/2020

Eligibility Criteria:
Inclusion Criteria:

* Patients were enrolled in the brolucizumab PSS program
* ≥19 years old

Exclusion Criteria:

• None
A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)

Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production.

Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 LHON mutation.

Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.

Leber's hereditary optic neuropathy (LHON) is a maternally inherited disease that is characterized by a simultaneous or more common sequential bilateral loss of central vision, which typically occurs during the teenager years or early adulthood. The disease may be progressive and the patients eventually become blind. In contrast to blindness in patients caused by congenital diseases, the patients who develop blindness caused by LHON will have more trouble in their life because they previously had better vision. Although LHON is associated with mitochondrial DNA mutation at a variable nucleotide position but no certain mechanism of optic nerve injury has been found. It has been postulated that a defect in a complex of respiratory chain enzyme which is caused by mitochondrial DNA dysfunction, results in an increase of free radical substances that interfere with optic nerve function in LHON. Some antioxidant substances have been used to decrease the progression of visual impairment. However, there have been few therapeutic trials for LHON.

Curcumin, a component of tumeric, which comes from the root Curcumin longa has antioxidant, anti-inflammatory and anti-carcinogenic activities. There is some evidence which suggests that curcumin contributes to the in vitro removal of free radical gradients in thalassemic serum and to a clinical improvement of thalassemic patients. We propose a randomized controlled trial study of curcumin, which is an antioxidant substance, for LHON. This study will provide not only an insight into the therapeutic efficacy of curcumin, a kind of Thai herb, for LHON but also the development of future therapeutic strategies to prevent blindness.

Eligibility Criteria:
Inclusion Criteria:

* LHON patient with 11778 point mutation

Exclusion Criteria:

* LHON patient with other point mutation
Thrombospondin-1 and Pigmented Epithelium Derived Factor Levels in Patients With Diabetes Mellitus.

You are being asked to be in a research study to determine blood levels and vitreous levels of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF). These compounds exists naturally in your body.

The hypothesis tested here is that diabetic patients that express the higher molecular weight pigment epithelium-derived factor (PEDF) isoform have lower thrombospondin-1 (TSP1) level and, as a result, are at a greater risk for the development of more severe diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Diabetes Mellitus
* Undergoing pars plana vitrectomy for any reason

Exclusion Criteria:

* Use of any anti-VEGF (vascular endothelial growth factor ) medications
Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders

This study intends to conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients, relieve patients' pain, promote patients' postoperative rehabilitation, and provide reference for realizing the rapid rehabilitation of elderly patients with sleep disorders through intravenous administration of research drugs, on the premise of improving patient comfort and ensuring patient safety.

The purpose of this multicenter, randomized, controlled clinical study was to evaluate the efficacy and safety of propofol compared with normal saline and dexmedetomidine in the effect of postoperative sleep quality in elderly subjects with sleep disorders. Subjects were randomly assigned to propofol group, dexmedetomidine group or normal saline control group. Propofol group: At 21:00 on the night of tracheal extubation, propofol was administered intravenously. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.Dexmedetomidine group: treated with dexmedetomidine at 21 PM on the day of tracheal extubation. During administration, patients were evaluated with MOAA/S every 2min. Normal saline control group: 21 on the night of tracheal extubation: Normal saline was injected intravenously at the rate of 0.5ml/(kg.h) beginning at 00. During the administration, patients were evaluated with MOAA/S every 2min. The effect of drugs on sleep improvement was evaluated by subjective scale and objective electrical monitoring.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years old
* Chronic insomnia
* Pittsburgh Sleep Quality Index\>5 points
* Daytime functional impairment (component Ⅶ ≥2 points in PSQI)
* Patients undergoing elective surgery
* Patients to be admitted to ICU after surgery
* Voluntarily participate in the study and sign the informed consent

Exclusion Criteria:

* Subjects with severe hemodynamic instability
* Subjects with difficult airway
* Patients with other sleep disorders (including sleep apnea syndrome, exercise-related sleep disorders and other types of sleep disorders)
* Subjects requiring sedation, mechanical ventilation, or sleep prior to medication;
* Severe liver dysfunction (Child-Pugh GRADE C)
* Severe renal dysfunction (requiring dialysis before surgery)
* Patients with allergies to study drugs and related ingredients
* Patients with severe dementia, low cognitive function, language impairment, severe hearing or vision impairment, mental disorder, coma and other conditions cannot complete the assessment
A Clinical Trial to Demonstrate the Efficacy of Cangrelor

The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.


Eligibility Criteria:
INCLUSION CRITERIA

To be included in this study, subjects must meet the following criteria:

* Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age \> 65 or diabetes or ST-elevation MI.

EXCLUSION CRITERIA

Subjects will be excluded from the study if they present with any of the following:

1. Not a candidate for PCI
2. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (\<1 month) trauma or major surgery (including by-pass surgery); currently receiving warfarin, active bleeding
3. Impaired hemostasis: known International Normalized Ratio (INR) \>1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/µL), or history of thrombocytopenia or neutropenia associated with clopidogrel
4. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
5. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
6. Receipt of clopidogrel dose exceeding maintenance dose (ie, \>75 mg) at any time in the 5 days preceding randomization
7. Inability to swallow study capsules
8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours \[applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients\]

Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
Metformin Use in Patients Undergoing Total Joint Replacement Surgery

The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.

The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.

Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-99 years
* Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
* Ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use.

Note: Patients with or without type 2 diabetes are considered eligible. (E.g.)

* Type 2 diabetic on metformin
* Type 2 diabetic on metformin and other medication, including insulin
* Type 2 diabetic on medication but not metformin
* Pre-diabetic
* Non-diabetic

Exclusion Criteria:

* Advanced renal insufficiency (glomerular filtration rate (GFR) \< 45, or chronic kidney disease (CKD) stage 3B or higher)
* Advanced liver cirrhosis or failure (Child-Pugh class B or C)
* Congestive heart failure (New York Heart Association (NYHA) class 3 or 4)
* Current alcohol abuse within 30 days of surgery (\>4 standard servings daily for men, \>3 standard servings daily for women)
* Type 1 diabetes
* Received contrast dye within 48 hours of surgery
* Vulnerable populations: Children, pregnant women, neonates, decisionally impaired adults, prisoners
HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102

This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

GC1102 is a new recombinant hepatitis B immunoglobulin (HBIG) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIG derived from blood plasma of human donors. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG and be followed up till 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study
2. Subject aged over 19 years at the time of consent provided
3. Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure
4. Subject with HBsAg(+)

Exclusion Criteria:

1. Subject with planned reoperation following liver transplantation
2. Subject with hemophilia
3. Subject with a history of venous or arterial thrombosis
4. Subject with HAV, HCV or HIV infection
5. Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
6. Subject with hemolytic or blood loss anemia
7. Subject with IgA deficiency
8. Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
9. Subject with moderate to severe kidney disease (serum creatinine \> 20mg/dL or anuria, kidney failure or dialysis)
10. Subject with a history of transient ischemic attack(TIA), myocardial infarction(MI), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(PTA) or coronary artery bypass graft(CABG) within the last 6 months prior to the screening
11. Subject with severe heart failure(NYHA class III\~IV), arrythmia requiring treatment
12. Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
13. Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
14. Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
15. Subject who had received estrogen or hormone alternative medicine
16. Pregnant or breast-feeding women
17. Woman of childbearing potential with positive pregnancy test confirmed by serum beta-human chorionic gonadotropin(B-HCG) test within 28 days prior to dosing by urine pregnancy or Subject who refused to use a reliable method of contraception
18. Alcohol or drug abuse within 6 months
19. Subject who has participated in any other clinical trial within 30 days
20. Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study