cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of Acyclovir for Viral Uveitis

This project is designed to test the hypothesis that acyclovir is clinically useful for patients with refractory viral uveitis.

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the study design, aims, benefits and potential risks. This is a prospective non-comparative interventional study.

Aqueous humor samples were collected from participants to virus detection. Participants will take oral acyclovir 100 mg three times a day and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 12 months to determine efficacy, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and above.
* Chronic, vision threatening viral uveitis.
* Patients can't tolerate hormone therapy bacause of drug side effects.
* Consent to undergo anterior chamber tap and give aqueous for the study.
* Able to undergo relevant tests.
* Able to come for subsequent follow-up visits.
* Ability to provide informed consent.

Exclusion Criteria:

* Patients who are allergic to ayclovir.
* Immunocompromised patients
* Positive for HIV, Hep B and Hep C
* Not keen on participating in the study
* Patients who are incapable, either by law or mental state, of giving consents in their own right.
* Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol.
* Patients who are pregnant or breastfeeding.
* Any other specified reason as determined by the clinical investigator.
Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.


Eligibility Criteria:
Inclusion Criteria:

ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.

Exclusion Criteria:

* chronic pain
* high preoperative opioid requirement
* age \< 18 years old
* non-English speaking
* contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
* need for postoperative nerve function monitoring
* patient refusal
* dementia
* pulmonary disease or low baseline oxygen saturation
Pathway to Diagnosis of Ovarian Cancer

The purpose of this study is to describe the prediagnostic symptoms and the events along the pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of ovarian cancer
* Indication for chemotherapy
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy
* Unable or unwilling to participate in interview
3 Month Outcome of Ziv-aflibercept for DME

The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.

Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which is FDA approved for colon rectus cancer treatment and it is cost effective.

Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.

Eligibility Criteria:
Inclusion Criteria:

* Patients with central diabetic macular edema
* Best corrected visual acuity is 20/25 or less
* Central macular thickness more than 250 microns
* Patients who are able to come for all follow-up

Exclusion Criteria:

* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
* Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
* Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
* History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
* Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.

This study tests whether chronic caloric restriction improves risk factors of longevity in humans as it is known to do in animals, by measuring a variety of factors dealing with metabolism and oxidative stress, through physical evaluations and laboratory tests.

Participants will receive dietary counseling and free medical evaluations. In addition, each volunteer will be asked to do one of the following:

1. Follow a reduced calorie diet
2. Follow a reduced calorie diet using a liquid diet
3. Increase physical activity while on a reduced calorie diet
4. Follow a standard diet.

Three separate five-day inpatient stays are required.

Eligibility Criteria:
Inclusion Criteria:

* Resident of greater Baton Rouge area for 1 year or longer
* Men between ages 25-50
* Women between ages 25-45
* Body Mass Index (BMI) between 25-30 (never having had BMI greater than 32)
* Healthy, non-smokers with no history of cardiovascular disease, high blood pressure, diabetes, eating disorder, or major psychiatric disorder

Exclusion Criteria:

* Pregnant or breastfeeding
* Personal history of cardiovascular disease or elevated high blood pressure (higher than 160/90 mmHg)
* Abnormal electrocardiogram (EKG)
* Personal history of diabetes
* Personal history of major psychiatric disorders
* Personal history of eating disorder
* Smoking
* Exercising regularly (more than twice a week)
* Individuals with alcoholism or other substance abuse
* Post obese (never have had a BMI greater than 32)
* Regular use of medications, except oral contraceptives
* Individuals who were ever injured by a metallic foreign body which was not removed
* Individuals who wear braces on their teeth, have non-removable false teeth, or non-removable bridgework
* Individuals in occupations requiring full alertness and motor skills (airline pilots, etc.) where even a small chance of postural dizziness would be unacceptable.
Investigation of Plasma Proteins in Patients With Hereditary Haemorrhagic Telangiectasia and PAVMs

Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an disease that leads to the development of dilated and fragile blood vessels, including arteriovenous malformations in the lungs (PAVMs). We hypothesize that the genetically-determined abnormality in the blood vessels of HHT patients leads to alteration in the concentrations or activity of several proteins in the blood stream. We propose to take blood samples from patients at defined times in order to study changes in blood protein levels and activity


Eligibility Criteria:
Inclusion Criteria:Patients with hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations -

Exclusion Criteria:Unable to provide informed consent

-
Myosfascial Trigger-Points and Effects on Neuromuscular Response

The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response.


Eligibility Criteria:
Inclusion Criteria:

* Subjets with both active or latent Myosfascial Trigger Points

Exclusion Criteria:

* Pregnant women
* Musculoskeletal problems in the last month
* Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
* Psychological or nervous alterations
* Uncomprehension of the study protocol
Comparison of Physiological Variables During Blood Donation

The investigators have developed a system based on a pulse oximeter, a tablet, and an algorithm running on the tablet that analyzes the pulse oximeter waveform.

The algorithm that runs on this system should be able to accurately keep track of blood loss during blood donation. The investigators will compare the algorithm with the blood loss tracked by a device called a flow meter.

The algorithm that runs on this system should be able to accurately keep track of stroke volume changes. The investigators will compare the algorithm with the stroke volume changes tracked by a device called a CCNexfin.

The algorithm that runs on this system should work whether it's in place for the whole blood donation, or if it's placed after the blood donation has started. The investigators will use two pulse oximeters for the system on each hand and compare one that is used for the whole blood donation versus one that is not used for the whole blood donation.

Hypothesis: p-values for testing the hypothesis of no correlation against the alternative that there is a nonzero correlation for each subject will be calculated. The minimum average power correlation, alpha = 0.05, will be used. Correlation will be made (CRI trend during 550ml blood volume removal) using pre and post blood draw data.

Specific Aims: These data will be submitted to the FDA with the following claims: The CRI algorithm

1. Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of intravascular volume changes (hemorrhage)
2. Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of stroke volume changes and
3. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does

Eligibility Criteria:
Inclusion Criteria:

* Subject is planning on donating blood and is approved by Children's Hospital Colorado's Blood Donation Center
* Age 18-89 years
* Previously donated blood (lower likelihood of vasovagal response)

Exclusion Criteria:

* Pregnant
* Incarcerated
* Limited access to or compromised monitoring sites for non-invasive finger sensors
Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

The optimal consensus concerning treatment of incidental small paraclinoid unruptured intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to reveal the natural history of small paraclinoid UIAs with the goal of informing the treatment plan.

A prospective observational study will be conducted in 13 Korean centers enrolling a consecutive series of 645 patients with small paraclinoid unruptured intracranial aneurysms (UIAs) from 2015 to 2017.

The investigators defined the cohort population as adults(20 years old or more) with small (less than 5mm) unruptured paraclinoid aneurysm. To determine the growth rate and risk factors, the angiographic features based on MRA or CTA(ex) size, arterial relationship, multiplicity)and the clinical characteristics (ex) age, hypertension (HTN), diabetes mellitus(DM), Hyperlipidemia, smoking) are recorded at initial visit, 1 year, 2years, 3years, and 5years.

The cumulative risk and the risk factors of aneurysmal rupture and growth will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed small unruptured paraclinoid aneurysms who agreed to participate.
* 20years old or more
* less than 5mm in maximum diameter
* neurological status of patients should be satisfied with less than modified Rankin score 2 or more than 70 in Karnofsky performance score

Exclusion Criteria:

* patients had previous subarachnoid hemorrhage that could be related to the rupture of paraclinoid aneurysm.
* traumatic, infectious or dissecting aneurysms
* fusiform aneurysms
* aneurysms that related to other vascular disease or brain tumor
* aneurysm that associated with the atherosclerotic change of a parent artery
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)

This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.
* Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
* If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study

Exclusion Criteria:

* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
* Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
* Subject has used any systemic methotrexate, retinoids, systemic corticosteroids \[including intralesional, intra-articular, and intramuscular corticosteroids\], cyclosporine or analogous products within 90 days prior to study start.
* Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start.
* Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
* Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids, vitamin D analogs) within 14 days prior to study start.
* Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start.
* Subject is currently using lithium or Plaquenil (hydroxychloroquine).
* Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized.
* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.
* Subject has been previously enrolled in this study and treated with a test article.
Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke

This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).

Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. first-ever cerebral cortical region involved chronic stroke, onset over a month,
2. able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and
3. at stable medical condition for intervention

Exclusion Criteria:

1. history of other neurological disorders,
2. cognitive impairment (Mini-Mental State Examination score \<24, MMSE),26
3. unable to follow orders,
4. contraindications of ES, and
5. under 20 years old
Evaluation of Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX)

The objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. Subjects will be randomized to either start with the low calorie diet with PGX or the low calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour placebo control.


Eligibility Criteria:
Inclusion Criteria:

- BMI 25-35 Kg/m2

Exclusion Criteria:

* Known diabetes
* Medications or natural health products that affect appetite
* Contraindications to LCD
* Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact

Suicide is a leading cause of death among adolescents in the United States and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. Integrating such interventions into routinely accessed settings, such as pediatric primary care, holds promise; however, many clinicians in these settings fail to adequately screen or intervene in youth suicidal thoughts and behaviors, representing a key barrier to reducing suicide. The proposed study is a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of an adaptation of the SAFETY-Acute suicide prevention intervention implemented in 3 pediatric primary care clinics.

This project aims to take an innovative, user-centered design approach to adapt and optimize a brief, evidence-based suicide intervention, SAFETY-Acute (SAFETY-A; formerly known as Family Intervention for Suicide Prevention -aka FISP), for use in primary care settings to support primary care management of adolescents with low to moderate risk suicidal thoughts and behaviors (STB). In this trial, the investigators will conduct a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of an adapted STB model of care based of the SAFETY-Acute intervention, compared to treatment as usual, with 3 primary care clinics. The trial will include 48 10-18-year-old patients with STB and their parents/caregivers (16 dyads per clinic). The investigators will assess acceptability and feasibility of the STB model of care, preliminary intervention impacts, and need for further adaptation.

Eligibility Criteria:
Inclusion Criteria:

* adolescent between the ages of 10 and 18 years old
* speaks fluent English
* current or past low to moderate suicide risk (denies current plan or intent to kill self)

Exclusion Criteria:

* high suicide risk (endorses current plan or intent or ASQ score =5, or prior attempt within last 3 months)
* does not speak fluent English

Note: Caregivers of 10-18 yr olds will also be included so age limits for participating samples include:

1. Adolescents: ages 10-18 years old
2. Parents/Caregivers: ages 18 years and older
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, and is \>=18 years old
* Stable hemodialysis or peritoneal dialysis
* Subjects have stable phosphate control
* Subjects on stabilized phosphorus diet
* Subjects undergoing regular dialysis treatment
* Females and of child-bearing potential have a negative serum pregnancy test
* Male subjects must agree to use appropriate contraception

Exclusion Criteria:

* Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study
* serum albumin level \< 3.0g/L
* PTH level \> 1000pg/mL
* Hemoglobin level \< 8mg/dL
* A History of significant gastrointestinal motility problems
* Biliary obstruction or proven liver dysfunction
* A positive test for HIV 1 and 2 antibodies
* A history of substance or alcohol abuse within the last year
* Seizure disorders
* A history of drug or other allergy
* using cholestyramine, colestipol or colesevelam
* Schedule to receive a kidney transplant within the next 6 months
* Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent