cyrilzakka/clinical-trials huggingface dataset:
Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.

This study will provide an educational intervention through means of a video to educate subjects on the risk of cardiovascular health on Rheumatoid arthritis.

Subjects will be randomized into an interventional group and non-interventional group. Both groups will perform several surveys before an educational intervention may be given. Both Groups will come back 3 months post visit to complete additional surveys.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist

Exclusion Criteria:

* Inability to communicate in English.
Melanoma Perception and Health Literacy in People of Color

This study will examine the effectiveness of a targeted, health literate educational intervention for people of color compared to a standard melanoma education pamphlet for increasing knowledge and promoting early melanoma detection. It is hypothesized that people of color are less aware of their risk for developing melanoma and that a targeted educational intervention will help increase knowledge and promote early melanoma detection especially in individuals with low health literacy.

This targeted educational intervention will compare a standard melanoma education pamphlet with one that has been modified to target people of color. Both pamphlets will include the ABCDEs of melanoma, risk factors, prevention and treatment. In addition, the targeted pamphlet will incorporate the recommendations made by people of color in previous studies. The pamphlets will be randomized to subjects at a study visit along with a health literacy test and a questionnaire aimed at determining subjects' baseline melanoma knowledge and current melanoma prevention practices. 2 months post-intervention, a follow-up phone call will be made to assess subject knowledge retention and behavior change.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic

Exclusion Criteria:

* Not proficient in English
* Unable to give informed consent
* Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants

To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks

To study the weight and the post menstrual age (PMA) at the time of NCPAP wean utilizing the method of sudden wean as compared to gradual wean.

Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age between 26 and 32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared

Eligibility Criteria:
Inclusion Criteria:

* All neonates born 26 to 32 weeks of gestational age

Exclusion Criteria:

* Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically or cytologically diagnosed metastatic triple negative breast cancer (Oestrogen, progesterone and HER2 negative adenocarcinoma of the breast)
* Patients must have normal organ and bone marrow function, ECOG performance status of no more than 2
* Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria:

* Any chemotherapy, radiotherapy (except for palliative reasons) or investigational product, within 2 weeks from the last dose prior to study entry (or longer period, depending on the agent used)
* Major surgery within 4 weeks of starting the study, and must have recovered from any effects of major surgery
* Patients requiring treatment with the following:certain antibiotic drugs, St.John's Wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/ non-nucleoside reverse transcriptase inhibitors used as components of HIV/AIDS treatment,
* Patients with second primary cancer; except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for at least 5 years.
Small Intestinal Function in Patients With Cystic Fibrosis

In patients with Cystic fibrosis (CF) epithelial transport of chloride and sodium is disrupted in several organs such as airways, sweat glands, pancreas and intestines. Gastrointestinal symptoms are frequent but little is known about intestinal motility and function. Earlier studies using lactulose/hydrogen breath tests have found altered intestinal transit time. The method has several sources of errors and results have been questioned. This study is using a new, non invasive method to study intestinal motility patterns and transit times, Magnetic Tracking System - 1 (MTS-1).

The aim is to compare patterns of contractility and transit times in the stomach and small intestine in adult CF- patients with healthy controls.

Methods MTS-1 is performed without radiation and is associated with minimal discomfort for subjects. A small magnetic pill is ingest and detected by a matrix of sensors. Position and orientation of the magnet are defined by five coordinates (position: x, y, z, angle: φ, θ). Frequencies of slow waves as well as number and power of phase III contractions can be identified.

Colorectal transit times are determined with a plain abdominal x-ray. The subjects are asked to ingest a capsule containing 10 radiopaque markers on six consecutive days up to examination. The total number of markers in the entire colorectum is counted. Total transit time, as well as segmental is calculated.

Subjects 15 adult patients (\> 18 years) with CF, homozygote for the mutation ΔF508, are studied. They are all pancreas insufficient (fecal elastase \< 100 µg/g), with no previous intestinal resection or lung transplantation. None of them have diabetes. Patients are all in well-regulated pancreatic enzyme replacement therapy (PERT), thriving and with stabile weight over the last half year. They have had no treatment with antibiotics in the last 14 days up to the examination.

The hypothesis is that patterns of contractility and transit times are the same for CF-patients in well -regulated PERT as for healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis, severe mutations
* Pancreatic insufficiency(Fecal elastase \< 100 µg/g)
* Thriving, stabile weight over the last half year
* No treatment with antibiotics in the last 14 days up to the examination

Exclusion Criteria:

* intestinal resection
* lung transplantation
* diabetes
Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute interval between them, after an 10-h overnight fast in a temperature controlled room. The subjects will be randomized in two groups: one will receive a sensorial stimulus during the interval (stimulus group - SG) and the other will receive no stimulus (control group - CG). The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.

Baseline microvascular parameters will be compared to the results after the interval. The investigators hypothesize that the SG will have greater capillary recruitment due to a possible effect of physiologically secreted insulin provoked by the sensorial stimulation (cephalic phase of insulin secretion).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Aged between 18 and 30 years
* BMI between 18.5 and 24.9 kg/m2

Exclusion Criteria:

* Diabetes mellitus, glucose intolerance or altered fasting glucose;
* Hypertension (Systolic pressure ≥ 130 mmHg and diastolic pressure ≥ 80 mmHg);
* HOMA-index ≥ 2.71
* Dyslipidemia
* Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
* Smoking
* Chronic use of any medication
Adaptive Family Treatment for Adolescent Anorexia Nervosa

Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.


Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for anorexia nervosa
* Lives with at least one English-speaking parent who is willing to participate
* Medically Stable
* Adequate transportation to clinic
* Proficient at speaking, reading, and writing English

Exclusion Criteria:

* Previous FBT for AN
* Medical condition that may affect eating or weight
Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands

The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.


Eligibility Criteria:
Inclusion Criteria:

* has discontinued contact lens wear primarily due to age-related, near vision demands
* requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
* has had an ocular examination in the last 2 years
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* has any ocular disease
* has more than a 2.00D prescription difference between eyes
* cannot be fit successfully with the study contact lenses
* has any systemic disease affecting ocular health
* is using any systemic or topical medications that may affect ocular health
* has undergone corneal refractive surgery
* Other protocol-defined inclusion/exclusion criteria may apply
Autofluorescence in Uveitic and Diabetic Macular Edema

The aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered.

After macular pigment measuring we will perform fundus autofluorescence, fluorescein angiography and optical coherence tomography. any associations of macular pigment distribution and fundus autofluorescence with macular anatomic features are analyzed. primary outcome measure is the macular pigment distribution in patients with altered fundus autofluorescence. Furthermore we will compare the findings between diabetic and inflammatory edema.

Eligibility Criteria:
Inclusion Criteria:

* patients with diabetic or uveitis macular edema

Exclusion Criteria:

* children patients with known allergy to fluorescein
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis

OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total homocysteine concentration in patients with end stage renal disease receiving regular hemodialysis therapy resulting in hyperhomocysteinemia.

II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) daily in these patients.

III. Assess the safety and tolerability of this therapy in these patients.

PROTOCOL OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to prestudy homocysteine levels (above or below average). Patients are randomized to receive placebo or one of two doses of oral folic acid, with or without pyridoxine and cyanocobalamin.

Arm I: Patients receive oral placebo daily. Arm II: Patients receive oral pyridoxine, cyanocobalamin, and oral placebo daily.

Arm III: Patients receive oral pyridoxine, cyanocobalamin, and folic acid daily.

Arm IV: Patients receive oral pyridoxine and cyanocobalamin plus a higher dose of folic acid daily.

Arm V: Patients receive oral placebo and oral folic acid daily. Arm VI: Patients receive oral placebo and higher dose folic acid daily. Treatment continues for 8 weeks.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of end stage renal disease requiring regular hemodialysis treatment 3 times weekly
* Baseline predialysis total homocysteine concentration in plasma greater than 16 micromoles/L
* No prior or concurrent pernicious anemia
* No blood smear examination showing unexplained macrocytosis

--Prior/Concurrent Therapy--

* Chemotherapy: No concurrent chemotherapy for cancer
* Other: No concurrent levodopa or carbidopa No concurrent penicillamine or trimethoprim-sulfonamide combination No concurrent antiviral therapy No concurrent anticonvulsants

--Patient Characteristics--

* Hematopoietic: Hematocrit at least 25%
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No Parkinson's disease No convulsions or epilepsy requiring treatment No lactose intolerance or allergy to milk products No history of allergic sensitization following administration of folic acid, pyridoxine (vitamin B6), or cyanocobalamin (vitamin B12) No vitamin B12 concentration below lower limit of normal (150 picamole/L) No untreated hypothyroidism or psoriasis
Colorado Marijuana Users Health Cohort

In Colorado, marijuana is currently used for both recreational and medicinal purposes.To learn more about the positive and negative long term medical effects of marijuana use. Information obtained during this study may identify new markers that influence the development of lung diseases such as COPD. The Investigators are also interested in learning more about the effects of marijuana use for insomnia and how it may or may not affect sleep.

In Colorado, marijuana is currently used for both recreational and medicinal purposes. The major active drug is tetrahydrocannabinol (THC). The most common route of use is through inhalation of the combustion products of the dried, buds/flowers from the female plant either rolled in paper (joint) or burned through a screen in a dry or water filled pipe (bong). Increasingly THC is consumed.

The side effects of the inhalation of burned leaves are controversial. The purpose of this proposal is to establish a prospective cohort of heavy marijuana users to evaluate positive and negative long term medical effects of marijuana use. As marijuana has also been reported for use to help treat insomnia, a sub-study will focus on how marijuana is used for sleep disorders and disturbances.

This study will enroll individuals that use marijuana to learn more about long-term health effects. The study involves one visit where participants will complete questionnaires, breathing tests, blood and urine collection. There is a sub-study where eligible participants will also complete an at-home sleep monitoring test. Participants will be contacted multiple times a year for long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Colorado-only study
* Age 21-80 years and one of the categories below
* Marijuana use: use of any cannabis (smoked, vaped, edible, etc.) on average more than 3 days per week for at least 1 year
* Combined marijuana use and Tobacco use (current or former): ≥ 30 pack year cigarette smoking history
* Non-marijuana users

Sleep sub-study:

Enrollment in the main cohort building study and a qualifying score on the Insomnia Severity Index questionnaire

Exclusion Criteria:

* Respiratory disorder other than COPD or asthma
* Lung surgery with removal of a lobe or more or lung volume reduction surgery
* Lung cancer or other cancer under active treatment during past 12 months
* ≥ 30 pack year cigarette smoking history for combined marijuana and cigarette users
* Pregnancy
* Use of antibiotics and/or systemic steroids for any lung infection within the last month
* Inability to use albuterol
* Subject enrolled in COPDGene or SPIROMICS

Sleep sub-study:

* Inability to complete home sleep study
A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers

A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.


Eligibility Criteria:
Inclusion Criteria (AD group):

* Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
* History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

* No evidence of significant cognitive impairment by history and psychometric testing
* MMSE of 29 or higher

Exclusion Criteria (both groups):

* Neurodegenerative disorders other than AD
* Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
* Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
* Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
* Clinically significant psychiatric disease
* History of epilepsy or convulsions
* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Current clinically significant cardiovascular disease
* Received investigational medication within the last 30 days
Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects

Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Aged 50 to 85 years, inclusive at time of consent
* Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m\^2) at Screening

Exclusion Criteria:

* Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
* A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
* Any clinically significant findings on neurological examination
* A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
* History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
* A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection)
* A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma

To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients.

Tube shunt implantation is a common type of surgery considered standard of care for treating significant potentially-blinding glaucoma where medical and laser treatment, and previous surgeries, have failed to control intra-ocular pressure (IOP) sufficiently to stop glaucoma progression towards blindness.

Since a larger plate tube (e.g., Baerveldt 350) is more difficult to implant requiring longer surgical time and intraoperative ocular muscle manipulation with possible patient discomfort, a smaller plate tube shunt (e.g., Ahmed ClearPath 250) requiring shorter surgical time and no ocular muscle manipulation may have an advantage if the long term surgical outcomes were the same.

However, the literature is lacking regarding the effect of the tube plate size on the final outcomes of tube shunt implantation. Most published comparisons are between totally different types of tube shunts regardless of plate size, often made of different materials, often comparing valved vs. non-valved tube shunts,combining different plate sizes in the same study groups,5 mixing tubes with or without combined cataract surgery in the same study groups, or comparing surgeries performed by several surgeons utilizing different surgical methods. Further, all these studies utilize tubes implanted into the anterior chamber (AC) thus increasing the risk of corneal failure, with no comparisons at all between tube shunts implanted through the ciliary sulcus of the eye designed to reduce the risk of corneal failure. Our Principle Investigator (AW) is specializing and well-published in this type of tube shunt implantation.

This prospective randomized trial is designed to resolve all these confusing factors in the literature and finally provide the answer of whether tube plate size has an effect on the final outcomes of tube shunt implantation by performing a "clean" study that would isolate the effect of tube plate size on long term outcomes. To achieve this goal our study will utilize two non-valved tube shunts with a different plate size (350 vs. 250 mm2) made of identical materials, in eyes that have already had cataract surgery, and all performed by the same surgeon (AW) through the ciliary sulcus.

Eligibility Criteria:
Inclusion Criteria:

* Significant uncontrolled glaucoma despite medical, laser or previous surgical therapy that requires tube shunt implantation as standard-of-care to stabilize the glaucoma and preserve vision.
* Pseudophakia
* Patients who are willing to participate and are able to understand and sign the study consent form.
* Age ≥18 years.

Exclusion Criteria:

* Phakic eyes (no previous cataract surgery).
* Aphakic eyes (status post previous cataract removal but without a lens implant).
* Age \<18 years.
* Women of child-bearing age.
* Patients unable to comprehend and sign the study consent form.
* Women who are pregnant.