cyrilzakka/clinical-trials huggingface dataset:
Functional Vision in TBI

The objective of this study is to test functional vision outcome measures that reflect the loss in everyday life tasks that require vision and that are sensitive to changes after a course of vision rehabilitation in Veterans/participants with TBI.

Traumatic brain injury (TBI) can cause vision loss because of diffuse or focal neuronal injury. Vision can be compromised because of local injury to one or both optic nerves, diffuse brain injury, and/or limitation in eye movements because of dysfunction of cranial nerves. These typical injuries may compromise any of the neural pathways that subserve afferent or efferent visual function. Self-reports of vision loss include diplopia, visual field loss, light sensitivity, reading problems and contrast sensitivity (color and luminance) loss. This project will pursue the following aims: 1) Identify the relationship between functional vision loss in everyday vision tasks (reading, visual search, way finding) and the characteristics of potential visual impairment (visual acuity, contrast sensitivity, visual fields, stereoacuity, eye movement disorders) associated with TBI; and 2) Determine the ability of the vision rehabilitation interventions (both monotherapy and combination therapy) to improve functional vision outcome measures that reflect everyday visual tasks. The vision rehabilitation interventions incorporated into this study will be Vision Restoration Therapy, NVT Eye Scanning Therapy, and standard Eccentric Viewing Training. These therapies are rehabilitative interventions prescribed for Veterans in Polytrauma Rehabilitation Centers, Blind Rehabilitation Centers, and advocated for VA Medical Center TBI clinics.

Eligibility Criteria:
Inclusion Criteria:

* TBI (any form)
* Hemianopic Visual Field Loss
* Stable fixation
* 1.0 logMAR or better Reading Acuity
* 20 words per minute or better reading rate

Exclusion Criteria:

* Visual Neglect
* medical conditions that prevent sitting for 30 minutes or following instructions
A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion

This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed at least 1 year before inclusion
* Blood glucose criteria must be met
* Microalbuminuria criteria must be met

Exclusion Criteria:

* Pregnant or nursing females or females of childbearing potential not using a medically approved birth control method
* Blood glucose criteria outside the specified range
* Microalbuminuria criteria outside the specified range
* Serious cardiovascular events within the past 6 months
* Other protocol-defined exclusion criteria may apply
Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.

Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Intertrochanteric fractures of the femur need surgery
* Male and female, age more than 75 years old
* Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders
* The patient is still able to tolerate surgery through the anaesthesia and related department assessment
* Signed written informed consent

Exclusion Criteria:

* No complications associated with internal medicine
* Mild fracture displacement and conservative treatment required
* Multiple trauma involving more than one organ system
* Known to have progressive malignant neoplasms
* It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study
Safety Study of BMS-816336 in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* BMI of 18 to 32 kg/m²
* Men only, ages 18-55 years

Exclusion Criteria:

* Sexually active men not using effective birth control if their partners are WOCBP
* Any significant acute or chronic medical illness
* Family history of Gilbert's disease
* History of Pancreatitis
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
* QTc interval \> 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)
* Second- or third-degree A-V block or clinically relevant ECG abnormalities
* History of allergy to 11-β-HSD-1 inhibitors or related compounds
* Prior exposure to BMS-816336
* Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
* Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
* Use of any glucocorticoid topical creams within 4 weeks of study drug administration
* Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
Influenza Vaccine Effectiveness in Among Young Children in Taiwan

This project uses questionnaires to statistically analyze whether influenza vaccination is protective for young children.

This plan is expected to admit 350 children who are admitted to the emergency department or hospitalized due to influenza and are aged from 6 months (inclusive) to under 18 years old. Vaccine status, statistical analysis of whether the flu vaccine is protective.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of influenza by Flu A+B rapid antigen test
* Known vaccination status

Exclusion Criteria:

* Unknown vaccination status
Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT

There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard.

The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early diagnosis of CFRD is important to slow the deterioration of lung function and nutritional status, both of which increase mortality.

The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years should be screened annually.

The World Health Organisation has pointed out that due to the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method for measuring and reporting glucose concentration in blood. However, it has also recognised that there is a widespread use of capillary sampling. Although fasting values for venous and capillary plasma glucose are the same, in the nonfasting state capillary samples will give higher results than venous samples, and glucose values require conversion which can be problematic.

HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory quality test results at the point of care for the diagnosis, screening and monitoring of diabetes mellitus. The analyzer is easy to use and the system can be operated by nonlaboratory personnel, also the results can be presented immediately, leading to significant time and resource saving. The patient also benefits from having the result immediately instead of waiting for several hours. With immediate result, the doctor and health care professionals can provide education, support and reassurance, and implement care plans, if appropriate, at the earliest opportunity.

The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the laboratory standard method in the analysis of blood glucose concentration during oral glucose tolerance test.

All CF patients attending annual review who require an OGTT will have a venous and a capillary blood sample taken simultaneously before (fasting = 0 min) and 2 hours (post glucose load = 120 min) after the administration of 75 grams Glucose solution orally.

The capillary sample will be analysed immediately using HGS 201 RT. The venous sample will be collected in a Fluoride Oxalate tube (WHO guideline) and sent to the Trust's laboratory for analysis as per usual practice.

Eligibility Criteria:
Inclusion Criteria:

The first 70 consecutive suitable consenting adult CF patients, who are 16 years of age and over, attending annual review at the Royal Brompton Hospital from June 2013 to March 2014, are eligible for the study

Exclusion Criteria:

Patients with an existing diagnosis of CFRD are exclude.
Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months

This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated with GA and in healthy controls.

The primary aim of this study is to explore whether treatment with Copaxone may decrease accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a reference population of healthy controls.

The secondary objective of this study is to investigate the effect of GA on total macular volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the 24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by Expanded Disability Status Scale (EDSS).

Eligibility Criteria:
Inclusion Criteria:

* MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
* Starting GA monotherapy (20mg/day sc) at the time of the OCT scan
* Having baseline clinical OCT scan that included RNFLT and TMV assessment at the start of the GA
* Having baseline clinical OCT scan that included RNFLT and TMV assessment (healthy controls)
* MS patients having a RR disease course (Lublin and Reingold, 1996)
* Age 18-65 (healthy controls will be matched to MS patients for age and sex)
* Signed informed consent at the 24-month follow-up
* None of the exclusion criteria

Exclusion Criteria:

* Patients who had a relapse within 30 days prior to OCT scan date
* Patients who received steroid treatment within 30 days prior to OCT scan date
* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
* MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
Interprofessional Collaborative Practice in Primary Care: Potentially Avoidable Hospitalization

The World Health Organization supports collaborative practice in primary care, defining it as "when multiple health professionals from different professional backgrounds work together with patients, families, carers and communities to deliver the highest quality of care across settings" (1). Previous research have shown that collaborative practice in primary care improves care pathways, efficiency of care (2,3), job satisfaction among health professionals (4-6), and economic efficiency (3,7). Riverin et al. found a reduction in post-hospitalization mortality with collaborative practice (8).

In France, the establishment of primary care teams following the American model of Centered Medical Homes is encouraged. In the Pays de la Loire region, two models exist: A national and a regional model.

A major issue for patient care team is the care of seniors (9,10).Hospitalizations can have adverse health effects for this population (11,12). 45% of emergency admissions follow by a hospitalization concern them (13).

The hypothesis of the study is that collaborative practice could reduce the global rate of potential avoidable hospitalizations among seniors.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 75 years old and over 65 years old with chronic disease(s), with a general practitioner in Pays de la Loire, affiliated with the general health insurance system and have had at least one healthcare encounter, and residing in the Pays de la Loire region.

Exclusion Criteria:

* Patients whose general practitioner has ceased their practice or changed their affiliation, as well as patients who have switched to a new general practitioner.
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes


Eligibility Criteria:
Inclusion Criteria:

* Black men or women 18 years or older
* History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
* Documented herpes simplex virus type 2 (HSV-2) seropositivity
* Willingness to discontinue suppressive therapy during study, if applicable
* Willingness and ability to comply with the study protocol

Exclusion Criteria:

* Pregnant or breastfeeding women
* Women of childbearing potential not using accepted methods of contraception
* Hypersensitivity to famciclovir or drugs with similar chemical structures
* Renal dysfunction
* Known or suspected to have decompensated liver disease
* Known to have gastrointestinal malabsorption
* Known to be immunocompromised
* Known to be hypersensitive to ingredients in study medication
* Other protocol-defined inclusion/exclusion criteria may apply
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults

This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

Exclusion Criteria:

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
2. Treatment for drug or alcohol dependence.
Edwards Cardioband European Post-Market Study, MiBAND

To demonstrate reduction of MR with durable performance and im-provements in functional status

MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.

Eligibility Criteria:
Main Inclusion Criteria:

* Age ≥ 18 years;
* MR (≥ 2+ by echocardiography);
* Patient is eligible to receive the Edwards Cardioband Mitral System

Main Exclusion Criteria:

* Active bacterial endocarditis
* Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue
* Heavily calcified annulus or leaflets
* Patients in whom transesophageal echocardiography is contraindicated
* Patients who cannot tolerate an anticoagulation/antiplatelet regimen
* Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated.
* Pre-existing prosthetic heart valve or annuloplasty in the Mitral position
* Life expectancy of less than twelve months
* Patient is pregnant or lactating
Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.

This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to artificial tears in improving the ocular surface interface in patients with dry eye disease over 1 year period.

Patients fulfilling the selection criteria will be enrolled from eye OPD of KTH. A written informed consent will be taken after explaining the purpose of study. Data will be collected on a pre-designed structured proforma. Demographic data including age, gender, educational status, socioeconomic status will be noted. Each participant will undergo a complete history assessment and the OSDI score will be calculated after taking extensive history. Ophthalmologic examination, including visual acuity, refraction, slit-lamp examination, corneal staining, schirmer test and TBUT will be performed in each patient. Both eyes will be selected for each secondary outcome measure (TBUT \& SCHIRMER TEST). However, only one OSDI score could only be obtained per patient for assessing primary outcome. All the previous medications used for dry eye will be stopped Participants' eyes will be randomized by blocked randomization in a 1:1 ratio to be treated with topical artificial tears (group I) and topical insulin 1U/ml (group II). The patients will be masked for the treatment, but not the principle investigator. Another investigator will prepare the topical insulin according to a written protocol. Participants will be given a white, unlabeled eye dropper containing the same volume of artificial tears or topical insulin for groups I and II respectively. Group I will receive artificial tears (control group) four times daily. Group II will receive topical insulin of 1u/ml four times daily. Follow-up assessments will be conducted at 4, 8 and 12 weeks for each participant to measure changes in TBUT, schirmer test, and OSDI score.

Eligibility Criteria:
Inclusion Criteria:

* Patients having Schirmer's test values of less than 10mm after 5 minutes of the procedure recording plus a non-invasive tear breakup time (TBUT) of less than 10 seconds and the Ocular Surface Disease Index (OSDI) of more than 32 (diagnosed as dry eye disease as per the operational definition of this study).
* any gender.
* aged 18 years and above.

Exclusion Criteria:

* Patients with active ocular infection, severe ocular surface disease other than Dry eye disease, and those who have undergone ocular surgery within the past 6 months.
* Under 18 years old
Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.

Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial will compare two interventions designed to help smokers stop using tobacco: (1) External Coaching Program (Standard Care) and (2) Internal Coaching Program, a chronic disease management strategy for treating tobacco use and dependence.


Eligibility Criteria:
Inclusion Criteria:

* Current permanent employee of Partners Healthcare, Inc. or their adult dependent
* Current tobacco smoker (smoked a cigarette, even a puff, in the past 30 days)

Exclusion Criteria:

* Temporary, per diem or former employee of Partners Healthcare, Inc.
* Plan to leave Partners employment in the next 12 months
* Inability to give informed consent or participate in counseling due to serious psychiatric disorder or cognitive disorder
The Prediction Model of Elderly Patients in Taiwan Triage and Acuity Scale

In the year of 2010, the Taiwan Ministry of Health and Welfare had implemented the 5-level Taiwan Triage and Acuity Scale(TTAS) in Taiwan emergency department. TTAS is a triage system that was modified from CTAS. It has a comprehensive chief complaint system and accomplished with an electronic decision support system (eTTAS) to help triage nurse to assign acuity level on emergency patients in emergency departments of Taiwan. TTAS has adult and children modifiers, but no modifier for the elderly. In emergency departments, the geriatric population have been increasing in many countries for the last few years. They often present with atypical symptoms or signs, and multiple comorbidities that complicate diagnosis and treatment and are at risk of under-triage. Although the TTAS has overall validity and reliability, its performance in geriatric patients has not been well studied.

In order to reduce the chance to under-triage the geriatric patients in emergency departments and to improve the discriminatory and predictive power for triaged patients who require admission, the objective of the study is to examine the difference of urgency, admission rate and medical resource consumption of geriatric patients with different age group compared to non-geriatric patients, to develop predictive model for hospitalization and medical resource consumption among geriatric patients and to develop special geriatric modifiers.

Age and frailty have been demonstrated to be associated with clinical outcomes in the elderly presented to emergent departments (EDs). This study aimed to assess the association of age and frailty on admission rate and to find out whether the current Taiwan Triage and Acuity Scale (TTAS) under-triage elderly presented to EDs.

This was a retrospective cohort study that reviewed medical records of adult patients from a single ED from 2016 to 2017. Data collected included patients' demographics, TTAS level, chief complaints, frailty status, and intensive care unit (ICU) admission rate. Adults patients included in the study were divided into three age groups of 18-\<65, 65-85, and \>85 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old who go to the emergency department.
* Those who are willing to participate in the trial and sign a consent form and are willing to be tracked.

Exclusion Criteria:

* Patients under 65 years old who go to the emergency department.
* Patients over 65 years old who go to the emergency department, unwilling to participate in the trial and sign the consent.