cyrilzakka/clinical-trials huggingface dataset:
The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study

We aimed to evaluate the usability and efficacy of omalizumab in allergic rhinitis and its potential as an alternative treatment option.

The study was conducted to determine the effectiveness of omalizumab on symptoms in patients diagnosed with allergic rhinitis and to compare it with current medical treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Those who gave informed consent and wanted to participate in the study and did not have any additional systemic or nasal diseases were included.

Exclusion Criteria:

* under 18 years old,
* over 65 years old,
* with systemic comorbidities (diabetes mellitus, hypertension, chronic renal failure, hypothyroidism, etc.)
* patients with rhinosinusitis, nasal polyps, nasal septal deviation, tumors, smoking and nasal surgery, and non-compliant patients were excluded from this study.
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears

To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture for detecting adenoviral conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

Clinical Study Enrollment Criteria

Upon completing the in-vitro studies, a perspective, blinded clinical study was started. Patients who were older than 1 month of age, seen within 7 days of developing a red eye, and who demonstrate at least one criterion from two out of the three categories below were included:

I. History: 1) Spread from one eye to the other several days later, 2) recent or concurrent upper respiratory symptoms within the preceding two weeks, 3) or an exposure to someone with "pink eye" within the preceding three weeks

II. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation

III. Signs: 1) An inferior palpebral conjunctival reaction with \> or = 1+ papillary or follicular reactions, 2) presence of a preauricular node

Exclusion Criteria:

Patients with associated skin vesicles, corneal dendrites, traumatic corneal abrasion, concurrent corneal ulcers, foreign bodies, ocular pemphigoid, trauma, previous history of chemical/thermal injury to eyes or eyelids (anytime in past), or greater than trace intraocular inflammation were excluded from the study. Additionally, patients with allergy to corn starch, talcum powder, or dacron were also be excluded. Patients using any topical ophthalmic medication (i.e. antibiotics) were required to wait at least 30 minutes from their last dose prior to device application and wait at least 2 hours after their last dose of any ointment application
ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPCV
* Patients must have had 3 sequential Eylea injections within the previous 4 months

Exclusion Criteria:

* Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea
* History or evidence of severe cardiac disease
* Any major surgical procedure within one month of trial entry
* Subjects with a clinically significant laboratory value
* Any treatment with an investigational agent in the past 60 days for any condition
* Women who are pregnant or nursing
* Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea
Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease

In this research study, the investigators will use a novel approach to measure what people eat. The goal is to find out whether stable isotopes that can be measured in blood, hair, and fingernails are better at measuring what people eat than the surveys that are currently used. To meet the goal, the investigators will do three things. First, the investigators will feed study participants known amounts of foods and nutrients. Second, after study participants have eaten the food, the investigators will measure stable isotopes in samples of study participants' blood, hair, and fingernails. Third, the investigators will determine how well these samples reflect what was eaten. The investigators will also give surveys to study participants to determine how well the surveys reflect what was eaten. This will allow the investigators to do a relative comparison of the measurements from isotopes and surveys.

This is a controlled feeding study in which the relative validity of stable carbon and nitrogen isotope ratio analysis as a biomarker of dietary intake is compared to controlled feedings and multiple 24-hour recalls. Participants will be randomly assigned to a sequence of diets to be fed on four occasions. Participants will undergo 24 hours of controlled feeding on four non-consecutive days over a month-long period. On the day after feeding, participants will complete 24-hour dietary recalls, and provide blood, hair, and fingernail samples for isotope ratio analyses. The investigators will use a crossover design and the diets will be either high or low in C4 plants (i.e., corn and cane products). A 24-hour urine collection will be done at home during each 24-hour feeding period. Participants will have height and weight measured at the screening visit. Weight will also be measured at each study visit. Additionally, data will be collected via questionnaires administered at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* men and women;
* aged 21 and 74 years;
* no history of chronic disease and in general good health;
* able to provide primary study outcome; and
* willing to tolerate study diets designed for controlled feeding.

Exclusion Criteria:

* recent dietary changes, restrictions, allergies or preferences;
* health conditions that require management beyond the scope of the study (e.g. heart failure, kidney disease, liver disease, gastrointestinal disorder);
* history of drug or alcohol abuse;
* plans to leave the San Diego area before study completion; and
* lack of suitability per investigators' discretion.
Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients

This is a prospective observational single center national study. Lung and heart transplant patients with a definite diagnosis of chronic lung allograft dysfunction (CLAD) or cardiac allograft vasculopathy (CAV) will be assigned for extracorporeal photopheresis (ECP) as per common clinical practice to a 6-month ECP cycle with the aim of limiting progression of organ dysfunction. The exact mechanisms of ECP in chronic rejection after lung and heart transplantation (CLAD and CAV) are elusive but it is thought to induce apoptosis of lymphocytes and to generate regulatory T cells, which modulate transplant immune rejection by a complex effect.

The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.

Eligibility Criteria:
Lung transplanted patients will be enrolled according to current per center protocol at diagnosis of established CLAD grade 1-2 (diagnosis will be made according to published guidelines) . Rate of graft function decline will be classified as rapid (\>/= 100 ml/month) or slow (\< 100ml/month) during the 6 months preceding ECP treatment. All patients will be diagnosed as CLAD after a failure of a 3-month trial with azithromycin. They will be enrolled in ECP treatment at CLAD grade 1-2. ECP response will be assessed after 6 months of treatment and patients experiencing \> 10% decline with respect to baseline value at ECP initiation in graft function will be classified as non-responders.Heart transplanted patients with demonstrated CAV in a recent angiography (\<6 months) in absence of acute cellular or antibodies mediated rejection at myocardial biopsy, will be enrolled The diagnosis of CAV will require the presence of thickening of the arterial intima in any epicardial artery.
The Clinical Application of Artificial Intelligent(AI) Visual Inspection System

In this study, the investigators provide participants from ophthalmic clinic the AI visual inspection system and EDTRS in the purpose of seeking out a better way of visual inspection with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of AI visual inspection system and EDTRS for visual inspection.

Patients ≤90 years old from ophthalmic clinic are enrolled to a prospective, randomized controlled study. Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later. All of the visual inspection methods will be repeated two times. Investigators compare the accuracy and repeatability of the AI visual inspection system, time consuming, costs and the satisfaction level between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients≤90 years old from ophthalmic clinic; Written informed consents provided

Exclusion Criteria:

* Can not cooperate with the visual inspection; Unwilling to participate in this trail
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy

The effect of tonsillectomy therapy on IgA nephropathy is still controversial.Few prospective,randomized investigations have examined how tonsillectomy affects the shortterm and longterm renal outcome of IgA nephropathy.This is A prospective,randomized ,controlled study to explore the longterm effect of tonsillectomy for patients with IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to sign an informed consent
* Age:18\~45 years, regardless of gender
* Clinical evaluation and renal biopsy diagnostic for immunoglobulin A nephropathy (IgAN), excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.
* Any one of three Tonsilar conditions defined by Otorhinolaryngologist : 1,recurrent acute tonsillitis accompanied with gross hematuria or urinary findings abnormality；2,recurrent acute tonsillitis without gross hematuria，but tonsil provocation test was positive；3, No history of acute tonsillitis,body examination found hypertrophy or atrophy tonsils ,crypt pus of tonsils ,or scars on the tonsil surface ,and positive tonsil provocation test.
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

Exclusion Criteria:

* Inability or unwillingness to sign the informed consent
* Inability or unwillingness to meet the scheme demands raised by the investigators
* Rapidly progressive nephritic syndrome and acute renal failure, 24-hour urine protein≥3.5g,including rapidly progressive IgAN (IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.
* Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis
* est GFR \< 30 mL/min/1.73m2
* Malignant hypertension that is difficult to be controlled by oral drugs
* Cirrhosis, chronic active liver disease.
* History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.)
* Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
* Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
* Malignant tumors (except fully cured basal cell carcinoma)
* Current or recent (within 30 days) exposure to any other investigation
* Current exposure to mycophenolic mofetil (MMF),azathioprine or corticosteroids. In case of current treatment with oral steroid ,entry is permitted after corticosteroids dosage below 0.4mg/kg per day.
* Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
* Tonsillectomy had been done when IgAN diagnosis or known contraindication to tonsillectomy(such as neutropenia，bleeding tendency，or anatomic abnormalities）
BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study

Objective:

The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy Mexican volunteers.

Methods: A prospective, longitudinal, open label, non randomized study, was performed. A single oral dose of GLI/METXR (4/850 mg) was administered to 24 health Mexican volunteers 30 min after a high fat meal.

Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma concentration of both drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated. The pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1 / 2 of glimepiride and metformin. The statistical analysis will be descriptive for plasma concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin. Adverse events were determined using clinical and laboratory test results throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Mexican volunteers, considered healthy according to standard screening assessments
* Aged between 18 and 50 years old
* Body mass index (BMI) was 18 to 27.5

Exclusion Criteria:

* Those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality
* Any acute or chronic disease
* Any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding
Physical Conditioning in Management of Chronic Venous Insufficiency

The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). The study will also investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group.

The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). A secondary purpose is to investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group. All subjects will undergo a complete hemodynamic and psychiatric assessment. Key measures will be repeated twice to quantify trend and stability of the baseline measures. Skin biopsies will be obtained in selected patients who demonstrate a response to the physical therapy to evaluate the ultrastructural response therapy. Physical therapy will be conducted 1-3 times per week. Participants will be visited at home and a program will be tailored for each individual to maximize compliance. Validated, standardized questionnaires (FIM, SF-36, OARS, CHART) and functional ratings will be employed at commencement,3,6 and 12 months. Evaluations of hydrodynamics, muscle strength, and ankle motion will be conducted monthly during active physical therapy. Participants in active therapy will be offered to wait listed control group after 6 months.

Eligibility Criteria:
Patients with severe form of chronic venous insufficiency
Discharge Medication Use Post-Operatively in GU Cancer Patients

The main purpose of this research study is to determine the amount of opioids that are taken after discharge following a cystectomy, nephrectomy (partial or total), or prostatectomy surgeries via a 30-day post- discharge opioid use and disposal survey. We will also evaluate the impact of an opioid disposal education pamphlet on proper disposal of unused opioids.

This prospective, non-therapeutic trial aims to evaluate the amount of prescribed opioid medications GU cancer patients are consuming post-discharge following surgical procedure of cystectomies, nephrectomies, and prostatectomies.

Enrolled participants will complete a 30-day post-discharge survey evaluating the usage of prescribed opioids and opioid disposal habits, as well as a patient satisfaction survey. Furthermore, participants will be offered to complete an optional CAHPS® Surgical Care Survey to assess patients' experiences with surgical care during in hospital stay and outpatient office visits.

Education on opioid medication disposal will be provided in the form of a pamphlet to participants that are enrolled beginning in year 2 (approximately month 13) from when the first participant is enrolled or after a minimum of 100 evaluable participants are enrolled in the pre-education cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.
2. Age ≥ 18 years at the time of enrollment
3. Scheduled to undergo surgical cystectomy, partial or total nephrectomy or prostatectomy for a cancer diagnosis.
4. Ability to read and understand the English and/or Spanish language.
5. Enrolling investigator plans to prescribe opioids at the time of discharge for post-operative pain.
6. As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

* None
Positive Peers Intervention Clinical Trial

The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV.

Does use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?

Participants will:

* download the mobile app onto their personal smartphone
* Use the mobile app as they find useful
* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months.

Participants will load the Positive Peers app on their personal device (either immediately or after a 6 month delay) and be encouraged to use the app regularly. Eligible patients who decline participation in the intervention will be asked to participate in an observational arm.

All participants will complete a brief baseline survey. Participants in the immediate or delayed arms will also complete surveys at 3, 6, 9, and 12 months. Medical data will be collected from the medical record and usage data will be collected from the app itself. Medical data will be collected for 12 months prior to enrollment and 18 months after enrollment. At the end of the study, participants are welcome to continue to use the app.

Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Identifies as either a racial, ethnic, sexual or gender minority

One of the following:

* Newly diagnosed within last 12 months
* Out of care (greater than 6 months between any two HIV provider visits in last 24 months)
* Not virally suppressed (any viral load \> 200 copies in last 24 months)
* Has a working smartphone
* Functional English ability

Exclusion Criteria:

* prior use of Positive Peers mobile app
Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers

Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
* Age ≥ 18 and Age ≤ 55 years
* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) and ECG (electrocardiogram)) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with the dietary regimen of trial site
* A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \>450 MS)
* A history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
* Elevated urinary glucose levels at screening (\> 15 mg/dl; \> 0.83 mmol/L)