cyrilzakka/clinical-trials huggingface dataset:
Fenofibrate for Prevention of DR Worsening

This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.

In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.


Eligibility Criteria:
Key Inclusion Criteria

* Age ≥18 years and \< 80 years.
* Type 1 or type 2 diabetes.
* At least one eye with the following:

  * Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.
  * Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study.
* If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)

Key Exclusion Criteria

Eye-level exclusion criteria (the eye is ineligible if any of the following is met):

* Current CI-DME based on clinical exam or OCT central subfield thickness (CST)

  * Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men
  * Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men
* Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
* History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication

Participant-level exclusion criterion (the participant is ineligible if the following criterion is met):

• Decreased renal function, defined as requiring dialysis or central laboratory eGFR value \< 45 mL/min/1.73 m2
Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients

The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

Kidney transplant patients that are cytomegalovirus (CMV) seronegative (IgG negative) at time of transplant and receive a graft from a donor that is CMV seropositive (IgG positive) are at increased risk of developing post-transplant CMV viremia and disease. These patients receive standard CMV prophylaxis with valganciclovir for 6 months post-transplant. However, a considerable proportion of these patients (25 - 42% at our center over the last 5 years) will go on to develop CMV viremia and/or disease after this valganciclovir prophylaxis is discontinued. To date, there is no strong data regarding whether certain patients would benefit from extension of valganciclovir prophylaxis beyond the standard 6-month period.

The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide consent
* Kidney Transplant Recipients
* Classified as CMV high risk at time of transplant (donor CMV IgG positive and recipient CMV IgG negative)

Exclusion Criteria:

* none
Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk of pregnancy complications.

In cases in which metabolic syndrome and non-alcoholic fatty liver are risk factors of obstetric complications, such as gestational diabetes (GDM) or preeclampsia (PE), we are able to offer systematic clinical results from determining the independent risk factor and developing a predictable model. Recently, obstetric complications, especially GDM and PE, have increased due to the growth of elder pregnancy. In addition, as liver dysfunction has been known to be an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction, its clinical importance has risen. Metabolic syndromes, such as obesity, hypertension, type II diabetes and abnormal lipid profile, have been known for its importance in development of non-alcoholic fatty liver disease. Considering abnormal liver function being an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction in normal adult patients, we are able to predict that liver dysfunction might be a high risk factor of obstetric complications in pregnant women. In previous studies, the frequency of liver dysfunction in normal pregnant women was obtained.

The purpose of this current study was to investigate the prevalence of metabolic syndrome, abnormal liver function and non-alcoholic fatty liver in early pregnancy and the related risks of obstetric complications.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient clinic patients of Seoul National University Hospital, Seoul Metropolitan Government Boramae Medical Center, Incheon Seoul Woman Hospital
* Agree with this study
* Do not drink excess amount of alcohol for recent 2 years

Exclusion Criteria:

* Do not agree with this study
* Do not perform blood tests
* Have underlying hepatobiliary diseases
* Take medications which can cause liver abnormalities
Norwegian Capture the Fracture Initiative

The main aim is to assess the effectiveness of introducing a standardized intervention program for treatment of patients with a fragility fracture as measured by changes in the fracture rates and the mortality.

A fracture liaison service model of care is widely recommended but data on its effectiveness regarding reduced risk of recurrent fracture and fracture related mortality are scarce. The investigators therefore aim to assess the risk of subsequent fractures and mortality after a clinical fracture in patients who present to hospitals with a standardized intervention program. Seven Norwegian hospitals will be Stepped Wedge Cluster Randomized to a standardized intervention program with startup date between May 2015 and Jan 2016. The intervention will last throughout 2018 with follow-up throughout 2019. Outcomes before and after the intervention will be compared and each hospital will act as its own control. The effect of the intervention will be measured by using national patient registries on fractures and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Low-energy fracture

Exclusion Criteria:

* finger fracture, toe fracture, face fracture, skull fracture
High-intensity Intermittent Training for Obese Individuals

The most appropriate and effective exercise interventions for weight loss remain a matter of continued discussion and there is a need to identify sustainable exercise programs which successfully promote weight loss and benefit health.

The primary objective of this study is to determine if high-intensity intermittent sprinting (HIIS) produces better results in terms of reducing metabolic and cardiovascular risk factors, with special emphasis to fat mass loss and insulin sensitivity in "healthy" obese volunteers compared with an iso-caloric program of moderate-intensity continuous cycling (MICC) (control condition following the international recommendations). We will also assess the impact of short duration sprints (SDS) in the above factors and to understand the potential mechanisms behind different outcomes among training programs.

The overall hypothesis is that HIIS will lead to a greater reduction in metabolic and cardiovascular risk factors compared with MICC in healthy obese volunteers and that SDS will produce similar improvements in cardiovascular risk factors as the longer duration HIIS

Participants will be randomized to one of three groups: HIIS (8s sprint:12s rest) or MICC (control group) iso-caloric protocols (for the duration needed to induce a 250 kcal energy deficit) or SDS (8s sprint:12s rest) for 10 minutes for 12 weeks. The intervention groups will be matched for age, BMI and male/females ratio and participants will be asked not to change their normal diet throughout the study.

Before and after the exercise intervention (12 weeks), participants will perform the following assessments:

1. Three-day food diaries
2. Anthropometric measurements (weight, height, waist and hips) using standard procedures;
3. Body composition using dual energy x-ray absorptiometry (DEXA)
4. RMR and resting respiratory exchange ratio (RER) using indirect calorimetry;
5. Endothelial function assessed by flow-mediated dilation (FMD) of the brachial artery using vascular ultrasound according to current guidelines;
6. Maximal oxygen uptake (VO2max) and fat oxidation, cardiac output and left ventricular function during exercise using a cycle ergometer;
7. Muscle and fat biopsies
8. Fasting and postprandial release of appetite related hormones (and subjective feelings of hunger/fullness using visual analogue scales - VAS).

Eligibility Criteria:
Inclusion Criteria:

* weight stable on the last three months,
* not currently dieting to lose weight
* inactive lifestyle.

Exclusion Criteria:

* History of endocrine/cardiovascular/pulmonary/kidney disease,
* anaemia,
* gout,
* depression or other psychological disorders,
* eating disorders,
* drug or alcohol abuse within the last two years
* current medication known to affect appetite or induce weight loss.
* planned surgery during the study period
* participation in another research study
* restraint score derived from the TFEQ\>12
* post-menopausal women
A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients

The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
* Diabetes Mellitus diagnosis \<5 years

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
Braining - Evaluation of Acute Effects of Physical Exercise

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period.

The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes.

"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan.

In the present study, the focus is on the acute effects of a booster session of one to three Braining classes on psychiatric symptoms and biomolecular markers as well as impact on motivational factors.

Participants are recruited from the final cohort (N = 51) of the previous retrospective study, (Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety).This final cohort will be contacted to give written consent to partake in the booster session. The Braining classes each have a duration of 30 minutes and are scheduled over the course of a week.

Descriptive data on participating patients will be collected before the booster week. This will include age, gender, diagnoses, employment status. In conjunction with this, basic psychiatric and somatic examinations will be conducted.

During each Braining class, participants' activity level will be measured with a heart rate monitor to ascertain achieveing moderate to vigorous intensity. Directly before and after each class, current anxiety level will be measured on a Visual Analogue Scale 0-100.

Within 30 minutes before and after one Braining class, venous blood samples (50 ml) will be taken for biomolecular markers. Blood samples include 1) inflammation markers such as high-sensitivity C-reactive protein hsCRP, 2) Brain-derived neurotrophic factor BDNF, 3) telomerase activity and 4) epigenetic markers.

Before and after the booster week, self-assessments scales for anxiety and depressive symptoms will be administered. Qualitative data on participants' experience as well as motivational factors will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Included in the retrospective study Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety and has given informed consent to participation in a Braining booster session.

Exclusion Criteria:

* Severe psychiatric disorder such as mania and psychosis
* Medical conditions such as heart- and lung diseases where PE is contraindicated.
* Unable to understand written and spoken Swedish language.
DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.


Eligibility Criteria:
Inclusion Criteria:

* Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;
* Be aged at least 18 years old at the time of enrollment;
* Be able to tolerate a surgical procedure for up to 3 hours;
* Be in a medical condition suitable for cataract surgery;
* Able and willing to participate in study examinations and visit schedule; and
* Understand and freely consent to participate in the study.

Exclusion Criteria:

* In either eye, ocular infection or inflammation within the past 3 months;
* Known allergy to BBG 250;
* Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
* Active treatment for cancer or systemic infection within the past month;
* Active treatment with systemic corticosteroids within the past month;
* Previous participation in this Study for the contralateral eye;
* Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;
* Unwillingness to participate in the study or inability to give informed consent; or
* Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study.
Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric Surgery

Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

To assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment.

The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery.

Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

Eligibility Criteria:
Inclusion Criteria:

Patients with obesity grade 3 \[Body Mass Index (BMI) ≥ 40kg/m2\] or grade 2 (BMI 35-39.9kg/m2) with comorbidities

Exclusion Criteria:

Current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (DPP4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial disease)
Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.

Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Different areas are affected, including upper airway function, trunk motor control and cardiorespiratory performance. The aim of this study was to determinate the relevance of trunk motor control in upper airway function and cardiorespiratory performance in patients with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of MS in any of its forms according to McDonald criteria
* Were aged higher than 18 years
* No pathology in the uppers extremities
* Capacity to understand and response the questionnaires
* Ability to provide informed consent.

Exclusion Criteria:

* Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
* Inability to provide informed consent.
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
* Have normal lid anatomy.

Exclusion Criteria:

* Have an abnormal biomicroscopy or ophthalmoscopy exam.
* Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
* Have used artificial tears in the past thirty days.
* Have a diagnosis of on-going ocular infection or lid margin inflammation.
* Have ever had penetrating ocular surface or intraocular surgery.
* Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
* Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
* Have had corneal or lid abnormalities.
* Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
* Have any ocular pathology with the exception of cataracts.
* Have a serious systemic disease or uncontrolled medical condition.
* Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
* Have a history of liver or kidney disease resulting in persisting dysfunction.
Study of Anti-telomerase T CD4 Immunity in Melanoma

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response might be required for their efficacy and highlight the critical role of antitumor T cell immunity.

Recent progresses on the field of tumor immunology underline the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators team have previously described novel promiscuous peptides (referred as UCP: Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this study in melanoma before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* patient with melanoma, any stade, without history of anti-cancer treatment (surgery, chemotherapy, targeted therapy, immunotherapy...) except for patients with stade IV melanoma for which immunotherapy or targeted therapy is considered. In this case, a first-line chemotherapy treatment is allowed
* written informed consent

Exclusion Criteria:

* patient with immunosuppressive treatment
* active autoimmune diseases, HIV, hepatitis C or B virus
* patients under guardianship, curatorship or under the protection of justice, pregnant women
Home-based Respiratory Training on Swallowing in Stroke

The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.

This study aims to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke
* 18 years of age or more

Exclusion Criteria:

* Cognitive impairment or aphasia that prevents the understanding of instructions.
* Tracheostomy.
* Presence of cancer.
* Patients who present another disease of the central nervous system
* Absence of neuromotor competence to carry out the respiratory function tests.
* Central apnea.
* Hypoventilation-obesity syndrome.
* Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease).
* Patients with recent otorhinolaryngological, abdominal, or thoracic surgery.