cyrilzakka/clinical-trials huggingface dataset:
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Age between \>19 and \<61 years
* No known systemic or ocular diseases

Exclusion Criteria:

* Cardio-vascular disease
* Lung disease
* Epilepsy
* Previous ocular disease
* Previous treatment with medications influencing the intraocular pressure or the metabolism of nitric oxide or prostaglandins
* Daily intake of medicine except contraceptive pills
* Pregnancy or breastfeeding
* Known allergy against any of the drugs used in the interventions
Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.

Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.

Eligibility Criteria:
Inclusion Criteria:

1. Male of female age 18 years or older
2. Type 1 or Type 2 diabetes
3. Best corrected visual acuity (BCVA) score of \>24 and \<78 letters
4. History of at least 3 anti-VEGF intravitreal injections over the past 5 months
5. Presence of macular edema defined as central subfield thickness of \>340 microns on Cirrus OCT

Exclusion Criteria:

1. Anti-VEGF intravitreal treatment in the last 4 weeks
2. Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
3. Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
4. Active iris neovascularization
5. Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
6. Uncontrolled systemic disease
7. Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications
8. Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit
9. Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception
10. Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study
11. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
12. Aphakia or pseudophakia with anterior chamber intraocular lens
13. Hypersensitivity to any components of Ozurdex or Avastin
Association Between Haptoglobin Genotype and Brain Swelling

Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. This study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.

Intracerebral hemorrhage is bleeding into the brain parenchyma. It is a major cause of stroke, and is associated with significant morbidity and mortality. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain edema, especially perihematomal edema, develops causing further compression that may lead to brain herniation and death. Several factors are implicated in the development of brain edema, including inflammation resulting from the oxidative stress caused by iron-rich hemoglobin released from lysed erythrocytes in brain tissue. This study investigates the neuroprotective role of an acute phase reactant, haptoglobin, in minimizing the development of perihematomal edema following intracerebral hemorrhage. This protein protects brain tissue from hemoglobin degradation products by forming haptoglobin-hemoglobin complexes that are subsequently cleared by the spleen. Notably, different alleles of haptoglobin exist in humans, with varying affinities for hemoglobin. Investigating the association between the different alleles and the degree of perihematomal edema formation is the primary goal of this study. The investigators will also look at a marker of inflammation, matrix metalloproteinases, and analyze its level of expression in subjects with different alleles of haptoglobin.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous intracranial or intraparenchymal hemorrhage
* 18-85 years of age
* Hemorrhage occurred in a supratentorial location

Exclusion Criteria:

* Inability to obtain consent within 3 days of hemorrhage onset
* Known pregnancy
* Therapeutic anticoagulation with Lovenox, Coumadin or Heparin
* Prior history of therapeutic radiation to any area
* Brain tumor
* Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation
* Central nervous system infection
* Subdural hematoma
* Subarachnoid hemorrhage
* Chronic immunosuppression, including steroids or chemotherapy agents
* Infratentorial location
* Unable to obtain MRI due to mental status or other contraindication (metal, pacemaker, etc.)
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma

This is an open label phase II pilot study assessing the metabolomic and inflammatory effects of oral aspirin (ASA) in human subjects at risk for melanoma.

Primary Objectives

I. Open label trial in 60 patients to assess the capacity of either of one daily dose (81, 325 mg) of sub-chronic ASA administration to increase the plasma and nevus ASA metabolites such as: salicylate, salicylurate, gentisic acid, and salicyl acyl glucuronide.

II. Open label trial in 60 patients to assess the capacity of sub-chronic daily ASA (81, 325 mg) administration to reduce levels of prostaglandin E2 (PGE2) in plasma and nevi.

Secondary Objectives

I. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi.

II. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma.

III. Determine whether ASA affects inflammatory cytokines in plasma.

Eligibility Criteria:
Inclusion Criteria:

* Must have at least 2 nevi (each \>5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
* Must be older than age 18.
* Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* The patient is a minor, under age 18.
* The patient cannot speak / understand English or Spanish.
* The patient is pregnant or breastfeeding.
* The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
* The patient has history of allergic reaction to ASA.
* The patient has history of severe asthma.
* The patient has been taking ASA or any NSAID in the past 2 weeks.
* The patient has been taking a blood thinner in the past 2 weeks.
* The patient has history of bleeding disorder.
* The patient has history of peptic ulcer disease.
* The patient has had recent intense UV exposure in the past month.
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,

This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women between the ages of 55-80
* Body Mass Index between 27-35
* Non Diabetic
* Normal liver, kidney and heart functions within 10% of clinical normalcy
* Not currently following a weight loss or other special /non balanced diets
* weight stable

Exclusion Criteria:

* fasting glucose \> 110 mg/dl
* blood pressure \> 160/110 mm Hg
* plasma total cholesterol \> 260 mg/dl
* LDL-cholesterol \>160mg/dl
* triacylglycerol\>400 mg/dl
* \>than 1 hour/week of habitual aerobic and /or resistance exercise
* Currently taking prescribed blood thinners
Conventional vs Digital CAD/CAM Splints for Bruxism

This is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. Participants will be randomized to receive either a conventional stabilization splint or a CAD/CAM splint. Each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. The study aims to compare the quality, precision, and comfort of the two types of occlusal splints. Outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged between 20 and 55 years.
* Probable or confirmed diagnosis of sleep bruxism.
* No previous treatment with occlusal splints.
* Absence of periodontal diseases and/or dental fractures.
* Patients must have a minimum of 28 teeth.

Exclusion Criteria:

* Patients with systemic diseases affecting the temporomandibular joint, such as rheumatoid arthritis, osteoarthritis, and osteoporosis.
* Chronic users of medications that may interfere with the study results, including analgesics, anti-inflammatory drugs, anxiolytics, antidepressants, and anticonvulsants.
* Patients with a history of temporomandibular joint surgery.
* Pregnant or breastfeeding women.
* Patients with severe dental misalignment or malocclusion that would affect splint fitting and evaluation.
Diaphragmatic Myofascial Release Techinque on Chest Expansion and Heart Rate in Patients Having Thoracic Kyphosis

The air of this RCT is to evaluate the effects Diaphragmatic Myofascial Release technique on chest expansion and heart rate in patients with thoracic kyphosis

This study focus on diaphragmatic release technique along with conventional therapy is more effective in improving chest expansion and with im-proved chest expansion, heart rate and blood pressure is also improved because tho-racic kyphosis impacts the way of heart and lung function creating stress response and increasing heart rate and blood pressure. Lung capacity is also reduced in indi-viduals with thoracic kyphosis. Postural alterations of thoracic spine result in im-paired chest expansion and length tension curve of diaphragm.

Eligibility Criteria:
Inclusion Criteria:

* Both male and females
* age 18-40 years
* patients who consented to the purposes of this study and participated voluntarily.
* patients with thoracic kyphosis ≥40

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.
* Vertebrobasilar insufficiency, rib fracture, rib dislocation and/or signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
* History of cervical spine surgery in previous 12 months
* Signs of cervical radiculopathy or myelopathy; and vascular syndromes such as basilar insufficiency.
* Patients with diagnosed any respiratory condition.
* Patient diagnosed with hypertension or taking any medication
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial

Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be randomized to either methylprednisolone or saline preoperatively, to examine the effects of methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia repair.

Preoperative high-dose glucocorticoid has been shown to attenuate the postoperative inflammatory response leading to decreased morbidity and length of stay (LOS) after colorectal and aortic surgery, as well as decreased pain and subjective recovery after orthopedic surgery. Methylprednisolone (MP, "Solu-Medrol") is one such glucocorticoid, which has been shown to be safe for usage in surgery. Giant ventral hernia repair is associated with a high risk of postoperative morbidity and prolonged LOS compared with other hernia repair procedures requiring laparotomy. Further, the total costs of these procedures remain high. Systemic administration of high-dose preoperative MP in ventral hernia repair has only been described anecdotally in the literature, and never with the aim to improve the treatment of this patient group specifically. It is however unknown to what extent benefits weigh out downsides from usage of high-dose MP in giant ventral hernia repair, patients often at increased risk of postoperative wound infection. On this background we hypothesize that a preoperative high-dose MP results in improved recovery after giant ventral hernia repair compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Ventral incisional hernia with horizontal fascial defect \> 10 cm described at either computed tomography scan or clinical assessment
* Planned elective open hernia repair
* Ability to speak and understand Danish
* Ability to give written and oral informed consent

Exclusion Criteria:

* Daily use of systemic glucocorticoid
* New York Heart Association class 3-4 heart disease
* Chronic renal failure (eGFR \< 60 ml/min per 1.73 m2)
* Insulin-dependent diabetes
* Excessive abuse of alcohol
* Known allergy to methylprednisolone or any substance in study medicine
* Planned pregnancy within three months postoperatively
* Pregnancy, evaluated by pregnancy test preoperatively
* Breastfeeding
* Actively treated ulcer disease up to one month preoperatively
An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects

This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts:

Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an elected dose. A screening will be used to determine patients' suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose escalation. During this part, patients will undergo rectal manometry to determine anal pressure at baseline. Afterwards coated suppositories at various drug concentrations will be inserted and follow up manometries will be performed to determine response.

Patients that presented with an increase in rectal resting pressure without adverse events will enter the second part of the study. In this part, patients will be administered with a coated suppository, at a dose found at part 1 of the study to cause significant anal contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and 5 hours after insertion.

Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after administration.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female subjects 18 to 55 years of age;

Exclusion Criteria:

* Known allergy to the active drug or excipients.
* Pregnancy or lactation.
* Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
* Type 1 diabetes mellitus;
* Insulin treated type 2 diabetes mellitus;
* Renal insufficiency.
* Liver insufficiency.
* Malignant disease within 5 years of screening;
* History of rectal surgery.
* History of HIV, hepatitis B, hepatitis C.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
* Chronic use of medications with the exception of birth control pills.
A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)

This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile of MabThera after treatment and retreatment will also be investigated. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-80 years of age;
* RA for \>=3 months;
* receiving outpatient treatment;
* failed treatment with \>=1 DMARD (but not anti TNF or other biologic therapy);
* inadequate response to methotrexate, having taken and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks.

Exclusion Criteria:

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
* history of, or current, inflammatory joint disease other than RA, or other systemic autoimmune disorder;
* diagnosis of RA before the age of 16;
* bone/joint surgery within 12 weeks of study;
* prior use of anti-TNF or other biologic therapy, an anti-alpha 4 integrin, or any cell-depleting therapies.
Daily Aspirin Vs Split Dosing in High-risk Pregnancies (DASH)

Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.

This is an unblinded randomized controlled Phase I/II trial comparing high risk singleton pregnancies randomized to 162mg daily (daily dose) vs 81mg q12hours (split dose). Participants will be enrolled prior to 16 weeks gestation. The primary outcome is platelet inhibition as assessed by PFA-100 epinephrine closure time, assessed 2-4 weeks after initiation and again at 28-32 weeks gestation. A subset of participants will be enrolled in a pharmacokinetic study to evaluate pharmacokinetics of aspirin in pregnancy at the two dosing intervals. Secondary outcomes include urine thromboxane at each visit, platelet associated microRNAs. Individual factors associated with aspirin pharmacokinetics and pharmacodynamics in pregnancy will be assessed. Finally, the relationship between these pharmacodynamic markers and pregnancy outcome will be evaluated.

Eligibility Criteria:
Inclusion Criteria

* Singleton gestation gestational age \<16 0/7 weeks, dating confirmed with ultrasound
* ≥1 high risk factor for preeclampsia or ≥2 moderate risk factors as per United States Preventative Services Task Force (2021)
* Recommendation for 162mg aspirin daily in pregnancy
* Age 16-55 years old

Exclusion criteria

* Contraindication to aspirin
* Current or planned use of any other anticoagulation
* Thrombocytopenia, other known platelet or bleeding disorder
* Abnormally elevated baseline PFA-100 epinephrine closure time prior to aspirin initiation
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects

This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent.
* MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
* MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio.
* Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks.
* Male or Eligible Female Subjects. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.

Exclusion Criteria:

* Hypersensitivity related to mepolizumab.
* Clinically significant change in health status since completing participation in the MEA112997 trial.
* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
* For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator.
* Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
* Screening ECG which has a clinically significant abnormality.
* Received Xolair (omalizumab) within the past 130 days.
* Participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of Screen Visit, whichever is longer.
* Current smokers.
To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines.

To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.

Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 19 and 65 at screening visit.
* Patients who voluntarily sign the informed consent.
* Patients who can comply with the study procedures and visit schedule.

Exclusion Criteria:

* Patients with infection, skin disorders, or scars at the glabellar region.
* Patients with facial palsy or the symptoms of blepharoptosis.
* Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
* Subjects who are not eligible for this study based on investigator's judgement.