cyrilzakka/clinical-trials huggingface dataset:
CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)

The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy.

This study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.

Eligibility Criteria:
Inclusion Criteria:

* Sign written informed consent form;
* Geographic atrophy in both eyes;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or lactating women and women of child-bearing potential;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study;
* Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution;
* Any contraindications to IVT injections;
* Ocular surgery in either eye within 90 days of screening;
* Uncontrolled ocular hypertension or glaucoma in the study eye;
* Other protocol-specified exclusion criteria may apply.
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component
* Previous treatment with at least one anti-angiogenic agent
* Progressed within 6 months of study enrollment
* Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
* Must have available tumor tissue for submission
* Subjects must also meet various laboratory parameters for inclusion

Exclusion Criteria:

* Subjects with any active autoimmune disease or a history of known autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply
Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab

The study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (QoL) and work productivity in patients with rheumatoid arthritis (RA) in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
* Male or female subject ≥ 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
* Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) (ESR) or DAS28 (CRP) \> 3.2
* Biologically treatment naïve and initiated adalimumab at baseline visit
* Availability of clinical data of the previous 12 weeks prior to baseline
* Ability to self-complete patient questionnaires
* Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

* Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
* Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline
* Patients who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization
* Patients who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.
The Use of Tissue Oxygen Monitoring in Critically Injured Patients

It is anticipated that the use of tissue oxygen monitoring to measure brain tissue oxygen and deltoid muscle oxygen will provide more precise information about focal brain ischemia and systemic hypoperfusion than current techniques and measures such as blood pressure, heart rate and intracranial pressure. Understanding the relationship between tissue oxygen tension collected from the brain and deltoid muscle in critically injured patients could lead to a broader understanding of the important metabolic and cellular events that occur following severe injury and the changes induced by therapeutic interventions. Furthermore, the use of interventions designed to improve tissue hypoxia, as measured by low brain or muscle tissue oxygen, may improve mortality or neurological recovery after systemic trauma or head trauma compared to current approaches that do not involve tissue metabolic monitoring.

This is a prospective, observational, cohort study designed to investigate metabolic changes in the brain and deltoid muscle of injured patients. Study objectives are as follows:

* To establish critical, abnormal levels of tissue oxygen in the brain (PbrO2) and muscle (PmO2) of injured patients.
* To correlate PbrO2 with other currently available diagnostic measures used in head-injured patients, including ICP, mean arterial blood pressure (MAP), CPP, SjO2, CT findings, neurological examinations, and clinical outcomes from traumatic brain injury.
* To correlate PmO2 with base deficit measurements, standard physiologic variables, near infra-red oxygen levels, infectious complications, and outcomes in critically injured patients.

Investigators will enroll patients with multisystem trauma including brain injury. In addition to the results obtained from oxygen monitoring, other data collected prospectively will include:

1. Baseline Characteristics- mechanism of injury, arrival blood pressure and GCS, results of imaging procedures, age, gender, blood gas analysis, injuries and injury severity, and all operative procedures,
2. ICU Care - MAP, ICP, CPP, base deficit, oxygen saturation, CVP, cardiac output, GCS scores, short-term outcome data, infectious complications and organ dysfunction.

All physiological data will be downloaded automatically and continuously from the bedside monitor, ventilator, and oxygen monitors via a study-dedicated computer and customized software (Aristein Bioinformatics, Palo Alto, CA).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Intubated and assisted mechanical ventilation
* Traumatic brain injury requiring advanced neuromonitoring
* Abbreviated injury scale 3 or more in torso. abdomen, or extremities

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

The purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.

This is a investigator-initiated, multi-center, prospective, registered cohort study. The study is intended to enroll 4000 patients with intracerebral hemorrhage from 50 hospital in China. Clinical and imaging data, as well as the results of laboratory examination will be collected to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)
2. Age ≥18;
3. Admission within 24 hours of symptom onset
4. CT available at 24 hours
5. Informed consent obtained

Exclusion Criteria:

1. Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc.
2. Deep coma at admission (GCS≤8)
3. Intended to have a surgery within 24 hours
4. Congenital coagulation dysfunction
5. Previous intracerebral hematoma have not been absorbed
The STEPS - Totalis™ Trial

The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis

Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a radiographically-confirmed diagnosis of central canal stenosis, with or without mild or moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all inclusion/exclusion criteria, including ≥6 months of non-operative management.

Patients included in the clinical investigation will return for follow-up visits at 1 week for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment to collect data for evaluation of safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects greater than or equal to 55 years of age
* Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion
* VAS leg symptom severity \>50 (in either leg) during episodes of neurogenic claudication
* Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms
* Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence
* Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy

Exclusion Criteria:

* Significant back, buttock or leg pain from causes other than lumbar central canal stenosis
* Axial back pain only
* Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level
* Severe lateral recess stenosis
* Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
* Prior decompressive surgery at index level (s) or fusion at any lumbar level
* Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments
* Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1
* Spondylolysis (pars fracture)
* Significant degenerative lumbar scoliosis at index level(s)
* Morbid obesity
* Significant peripheral vascular disease
* Active significant co-morbidity
* Undergoing immunosuppressive therapy or long-term steroid use
* Current spinal cord stimulator or implanted pain pump
* Life expectancy less than 2 years
* Evidence of substance abuse within the year
* Involvement or potential involvement in litigation related to the spine or worker's compensation related to a back and/or leg issue
Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Oedema (ACPE) patients in the Emergency Department (ED) delivered by Helmet CPAP (hCPAP) and HFNC.Patients will be randomized to receive either hCPAP or HFNC.

Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. The appropriate interface is necessary to provide comfort and lead to the success of NIV.

Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.

HFNC which delivers heated humidified high flow oxygen provides a good alternative to the conventional NIV in terms of comfort

Eligibility Criteria:
Inclusion Criteria:

All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.

Exclusion Criteria:

1. Age less than 18 years old
2. Low GCS (less than 8), altered mental status
3. Hemodynamic instability, impending cardiopulmonary arrest
4. Use of vasopressors, inotropes
5. Exacerbation of asthma or chronic respiratory failure
6. Urgent need for endotracheal intubation
7. Absence of airway protective gag reflex
8. Elevated intracranial pressure
9. Tracheostomy
10. Pregnant
11. Upper airway obstruction
12. Injuries or surgery to head and neck less than 6 months upon presentation
13. Claustrophobia
14. Blind or poor vision
15. Medico-legal related cases
Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).

The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck vessels injury.

The main questions it aims to answer are:

* If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower than and Aspirin 325 mg.
* If rate of hemorrhagic complications in patients with head and neck vessels injury taking Aspirin 81 mg is not higher than patients that take Aspirin 325 mg.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission

Exclusion Criteria:

* Age \<18
* Pregnant women
* No enteral route access for Aspirin administration
* Patients who are on Heparin drip or other full dose anticoagulation when BCVI diagnosed
* Patients who are on other Anti-Platelets aside from Aspirin when BCVI diagnosed
* Patients with BCVI grade 5 injury based on Biffl classification
* Presence of any contraindication or history of allergy to Aspirin
* Patient with the diagnosis of acute stroke at the time of BCVI diagnosis matching the injured vessel territory on imaging
* Patients with acute spinal trauma that needs surgical intervention
Long-term Evaluation of Single-piece ACrysof IOL Implantation on Development of Posterior Capsule Opacification

Although contemporary cataract surgery has made tremendous strides in technological advancement, posterior capsular opacification (PCO) is still the most frequent long-term complication leading to decreased visual functions and thereby dissatisfying results. A great deal of effort has been made to develop new ways to prevent the formation of PCO. A key factor, widely discussed in literature, is the material and design of the intraocular lense (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL produces less PCO because of its optic geometry alone or whether the biomaterial contributes to the inhibition of PCO. With the clinical introduction of the single-piece acrylic hydrophobic IOLs with some optic and haptic design differences compared with three-piece acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material and design on PCO prevention. It is well established that the development of PCO is a dynamic process and that a longer follow-up time is correlated with a higher degree of PCO. So far, there have been prospective clinical studies on the clinical results of single and three-piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the PCO further increases or becomes stable or regresses on a long-term basis has not yet been answered. Since there is paucity of available literature that prospectively evaluates the development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL on a long-term basis, the investigators decided to observe the degree of development of PCO at 5 years after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients with uncomplicated age-related cataract who were otherwise healthy

Exclusion Criteria:

* a history of diabetes mellitus (DM),
* patients with glaucoma,
* high myopia (axial length \> 27.0 mm),
* pseudoexfoliation,
* traumatic cataract,
* subluxated cataract,
* previous ocular surgeries, and
* allergy to dilating drops.
Clinical Evaluation of the Treatment of Spider Angioma

To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.

The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, 5 to 65 years of age (inclusive).
2. Fitzpatrick Skin Types I-IV
3. Subject must be able to read, understand and sign the Informed Consent Form.
4. If subject is a minor (\<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
6. Willing to have limited sun exposure for the duration of the study, including the follow-up period.
7. Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
8. Agree not to undergo any other procedure for the treatment of spider angioma during the study.

Exclusion Criteria:

1. Pregnant.
2. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
3. Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
4. History of seizure disorders due to light.
5. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
6. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
7. Participation in a study of another device or drug within 3 months prior to enrollment or during the study.
8. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
Post Approval Study of the CyPass System

The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).

Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits
* Diagnosis of primary open angle glaucoma (POAG)
* Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg
* An operable age-related cataract eligible for phacoemulsification
* Visual acuity as specified in the protocol
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Inability to complete a visual field test prior to surgery
* Use of ocular hypotensive medication/s, as specified in the protocol
* Diagnosis of glaucoma other than POAG, as specified in the protocol
* Other medical conditions, as specified in the protocol
* Proliferative diabetic retinopathy
* Previous surgery for retinal detachment
* Previous corneal surgery
* Wet age-related macular degeneration
* Poor vision in the non-study eye not due to cataract
* Significant ocular inflammation or infection within 30 days of screening visit
* Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits
* Women who are pregnant or nursing
* Other protocol-specified exclusion criteria may apply.
Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia

Investigators have previously found that sperm quality was not related to obesity indicators, such as body mass index (bmi), waist circumference, waist-hip ratio, girth ratio and serum lipid, but seminal plasma lipids could notably affect the sperm concentration, sperm progressive ratio(PR), sperm DNA fragmentation index (DFI). These results indicates that abnormal lipid metabolism in the male reproductive system may affect male fertility.

It seems that the sperm fatty acid spectrum is associated with n-3 polyunsaturated fatty acids (PUFA) in dietary. Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) are the most common n-3 PUFA. Only plasma DHA/EPA may reflect the quantity of DHA/EPA in adults. Most research indicate that n-3 PUFA is the main polyunsaturated fatty acid in human sperm.

It is well known that diets have great influence on the gut microbiota composition. Many researches have delineated the cause and effect relationship between disturbed gut microbes and diseases, such as irritable bowel syndrome, obesity, diabetes. The disturbed gut microbiota ecosystem may also lead to the intestinal mucosal permeability increasing, which may result in endotoxemia and a series of metabolic syndrome. N-3 polyunsaturated fatty acids may play an important role in regulating metabolism and physiological functions in the body. A clinical research found that both total n-3 PUFA and DHA serum levels were significantly correlated with microbiome alpha diversity. Therefore, investigators may try to figure out the influence of n-3 PUFA supplement on gut microbiota composition and whether the gut microbiota have influence on sperm parameters. So investigators apply for your permission to collected the fecal samples from the participants, which will be a meaningful work.

In the previous work, investigators found high fat diet induced gut microbiota dysbiosis can lead to low sperm motility and sperm count, and also recognised some microbes which may lead to the low sperm motility and sperm count. It is obvious that gut microbiota can influence the sperm quality. And the supplement of n-3 PUFA is significantly correlated with microbiome alpha diversity. So investigators want to collected the fecal samples from the participants, to ascertain whether the supplementation of n-3 PUFA can promote sperm parameters by improve gut microbiota ecosystem.

The potential microbes planing to cultivate: Prevotella spp, bacteroides spp.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Oligoasthenoteratospermia.

Exclusion Criteria:

* Leukocytospermia, prostatitis, genital trauma, testicular torsion, urinary tract infections, cryptorchidism, varicocele, diabetes, inguinal and genital surgery.
* Y chromosome microdeletion and chromosomal karyotype abnormality.
* Extreme oligospermia.
* Hepatobiliary diseases, kidney failure.