cyrilzakka/clinical-trials huggingface dataset:
Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes

The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Specific diets with high polyphenol content are associated with lower incidence of cardiovascular disease and can improve macrovascular function when consumed acutely and chronically. Which role the smallest blood vessels (microcirculation) play in this and if the microcirculation responds to therapies is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation.

The current randomised controlled cross-over proof-of-concept study will test the acute effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of hands and feet together with macrovascular function of upper and lower extremities in healthy and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as compared to placebo can acutely increase microvascular vasodilation and macrovascular endothelial function in arms and legs together with arterial stiffness in both healthy and type 2 diabetes participants.


Eligibility Criteria:
Healthy:

Inclusion Criteria:

* Healthy, 20-70 years
* BMI 20-30 kg/m\^2

Exclusion Criteria:

* Diabetes mellitus
* Symptoms of acute infection
* Cardiac rhythm other than sinus
* Active malignancy
* Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
* Active vasoactive medication.

Type 2 Diabetes:

Inclusion Criteria:

* Type 2 diabetes mellitus
* 20-70 years
* BMI 20-30 kg/m\^2

Exclusion Criteria:

* Symptoms of acute infection
* Cardiac rhythm other than sinus
* Active malignancy
* Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
* Active vasoactive medication.
Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension

The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.

It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension.

Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure in OSAS patients. But level of blood pressure (BP), drug treatment were not equal between groups and it's difficult to single out independent role of cPAP.

Our study has the objective to compare the effects of cPAP on hypertension in OSAS patients. After 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who reached target level of BP will be randomized either in the group "treatment by cPAP" or in the group "treatment by cham-cPAP" for 3 weeks and then we'll perform cross-over.

Eligibility Criteria:
Inclusion Criteria:

* male/female over than 18 years old
* patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15)
* patient with weak or moderate hypertension (140 \<= SBP \< 180 mmHg and 90 \<= DBP \< 110 mmHg)
* negative pregnancy test
* ambulatory patient
* patient who have signed the informed consent form

Exclusion Criteria:

* pregnant or nursing woman
* woman who refuses to use contraceptive method
* acute hepatic failure, biliary cirrhosis, cholestasis
* clearance of Cockcroft \< 30 ml/min/1.73m2
* kaliemia \>= 5.5 mmol/l
* acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
* acute daytime sleepiness (Epworth rating scale \> 15)
* patient with a profession that is inconsistent with the continuous positive airway pressure (CPAP) treatment
* known cardiovascular pathologies
* contraindication to CPAP
* allergy to valsartan and/or amlodipine
* patient treated with lithium
* patient on tutelle or curatelle
* patient kept in detention, major protected by the law, hospitalized person patient currently participating in another clinical trial
The Sunnybrook Dementia Study

The prospect of disease-modifying therapies in the pipeline for Alzheimer's Disease (AD) has intensified efforts to use brain imaging more effectively for diagnosis and monitoring of dementing illnesses. There is also emerging awareness of the destructive interplay between AD and Cerebrovascular Disease (CVD) in our aging population; both disorders share common vascular risk factors and may respond to similar prevention treatments. Brain mapping techniques capitalize on the fact that different neurodegenerative diseases target particular brain areas. Brain shrinkage and stroke disease can be quantified on Magnetic Resonance Imaging (MRI) using computerized analysis.

This ongoing study applies advanced MR imaging analysis, genetic testing and standardized cognitive and functional assessments done at yearly intervals to measure and monitor longitudinal change in patients with AD, vascular and other neurodegenerative diseases and potentially to measure modifying effects of emerging therapies. Over 1700 patients (Mild Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and 140 normal elderly have already been enrolled, with 180 autopsies.

This study utilizes specialized imaging analysis software packages to reliably quantify brain tissue volumes and small vessel disease, the most common type of CVD.

The SDS also investigates other potential biomarkers of dementia such as eye-tracking, optical coherence tomography, gait and balance, and the gut microbiome to explore their clinical utility.

Results from this study will help to improve diagnosis, to customize treatment, and to better monitor disease-modifying therapies currently under investigation should they become applicable to everyday practice.


Eligibility Criteria:
Patient Inclusion Criteria (General):

* Age between 40 and 90 (inclusive)
* Fluent in English
* Completed 8 years of education or higher
* Visual and auditory acuity adequate for neuropsychological testing
* Mini-Mental State Exam (MMSE) score ≥ 16

Patient Exclusion Criteria (General):

* Possible secondary causes of dementia, concomitant or history of neurological or psychiatric illness (other than stroke or Parkinsonism)
* History of alcohol or substance abuse or dependence within the past 2 years

Normal Control Inclusion Criteria:

* Age between 40-90
* Fluent in English
* Completed 8 years of education or higher
* No significant memory complaints

Normal Control Exclusion Criteria:

* Being treated or history of being treated for psychiatric or neurological illness
* History of alcohol or substance abuse or dependence within the past 2 years
* Current use of psychoactive medications (e.g. antidepressant, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.)
* Medical contraindications to MRI
The Central Venous Catheter Related Complications in Critically Ill Patients

In this prospective clinical study, the researchers investigate the incidence of catheter-related thrombosis and catheter-related infection during indwelling central venous catheterization in critically ill patients, and analyzed the risk factors for catheter-related complications and the relationship between catheter-related thrombi and catheter-related infections. The sample size is about 500.

A prospective clinical trial is conducted. Five hundred participants who need to place central venous catheters admit to the Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University from February 2019. Ultrasound is used for screening catheter-related thrombosis, and catheter-related infections are diagnosed according to the Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infections. The primary outcome is the incidence of catheter-related thrombosis and catheter-related infections. The primary exposure factors are age, gender, APACHE II, RBC, Hct, PLT, FIB, D-dimer, PCT, blood glucose, anticoagulants, and vasoactive drugs, catheter type, tube placement, indwelling time, etc. Descriptive analysis is used for the incidence of various complications. T-test or non-parametric statistical test is used for single factor analysis of risk factors, chi-square test or Fisher's exact probability test is used for counting data. Multivariate analysis of risk factors and the relationship between complications are analyzed by logistic regression. Statistical analysis is performed with SPSS Statistics version 20.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old and \<80 years old;
* Central venous catheter is required to be placed through the internal jugular vein, subclavian vein or femoral vein;
* Catheter placement is estimated to be ≥ 72 hours.

Exclusion Criteria:

* The central venous catheter has been placed before entering the department;
* There is obvious trauma or infection at the site of implantation;
* There is already a blood vessel thrombus in the site before implantation;
* Recently, deep vein thrombosis or catheter-related thrombosis has occurred.
PKP2-ACM Natural History Study

The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.

This is an observational study with both retrospective and prospective data collection. The study is designed to describe the natural history of PKP2-ACM including the signs and symptoms, key clinical events, and impact of the disease on quality of life. A hybrid (retrospective and prospective data collection) approach is being taken with the aim of achieving robust and longitudinal data generation.

Eligibility Criteria:
Inclusion Criteria

Patients must meet all the following criteria (and none of the exclusion criteria) to be eligible for study participation:

1. Male or female age 12 years or older at the time of providing informed consent (i.e., ICF provision).
2. Capable and willing to provide signed informed consent and/or assent, which includes compliance with the requirements and restrictions listed in the ICF and protocol.
3. Clinical diagnosis of arrhythmogenic cardio myopathy (ACM) as defined by the 2010 revised Task Force Criteria (TFC)
4. Documentation of a pathogenic or likely pathogenic variant in PKP2 by a CLIA-certified genetic testing laboratory
5. History of ICD implantation ≥6 months prior to ICF provision
6. Left ventricular ejection fraction by echocardiogram or cardiac magnetic resonance (CMR) ≥50% at ≤12 months prior to ICF provision

Exclusion Criteria

Patients meeting any of the following criteria are excluded from study participation:

1. Gene testing indicates that the subject's arrhythmia or cardiomyopathy may be related to a genetic etiology other than PKP2 truncating variant.
2. Concurrent participation in any other clinical investigation involving use of an investigational agent that could confound results of this study.
3. Previous participation in a study of gene transfer or gene editing.
4. NYHA Class IV heart failure.
5. Presence or requirement for mechanical circulatory support (MCS) or predicted need for MCS or heart transplantation within 6 months of enrollment.
6. Prior cardiac or other organ (lung, liver, other) transplantation.
7. Pacemaker dependent rhythm documented, as assessed by the principal investigator ≤12 months prior to enrollment.
8. Positive human immunodeficiency virus (HIV) antibody test.
9. Unwillingness to comply with study procedures, including follow-up as specified by this protocol, or unwillingness to fully cooperate with the investigator.
Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder

Background: Postoperative Frozen-Shoulder (FS) or adhesive capsulitis is a relatively frequent complication (5-20%), even after simple arthroscopic shoulder surgeries. The pathophysiology is still unclear, but psychological factors may play a pivotal role. From clinical experience, the investigators hypothesized that participants, who are reluctant to take medications, particularly "pain-killers", have an increased incidence of postoperative FS. The investigators retrospectively compared participants with and without postoperative FS by their attitude towards medication and by depression scale questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder arthroscopy

Exclusion Criteria:

* Active frozen shoulder
Whole-body Vibration as a Treatment for Parkinson's Disease

This study will evaluate whether whole-body vibration applied over a 12-week period is effective in treating motor symptoms of Parkinson's disease.

Parkinson's disease (PD) is a progressive neurodegenerative disease resulting in the loss of dopaminergic neurons projecting from the substantia nigra pars compacta to the striatum.

Whole-body vibration (WBV) is potentially beneficial in treating Parkinson's disease because it has been shown to elicit effects specific to both the brain and muscular system. Animal models of PD indicate that whole-body vibration can increase striatal dopamine levels, as well as the number of dopaminergic neurons in the substantia nigra. These findings were correlated with increased levels of brain-derived neurotrophic factor.

In addition to the potentially neuroplastic effects, \>20 Hz WBV has been shown to improve muscular performance. Improved muscular performance is believed to be attributed to WBV induced neuromuscular effects rather than muscle hypertrophy, with the specific mechanism defined as the tonic vibration reflex.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's Disease by a Neurologist
* Currently taking anti-Parkinsonian medication
* Able to stand for 2 minutes without assistance
* Able to walk 10 meters without assistance
* Ability to understand English instructions
* Normal or corrected vision

Exclusion Criteria:

* A neurological disease other than PD
* recent stroke
* cardiovascular disease
* previous major hemorrhage
* artificial pacemaker
* currently pregnant
* Current participation in any physical therapy or experimental treatments
* Peripheral neuropathy, severe osteoporosis
* Visual impairments that cannot be corrected
* Clinically diagnosed with dementia
* Greater than mild dementia (screened using Montreal Cognitive Assessment (MOCA) \<24 being excluded)
Psychoeducation Group Intervention for FND

This study aims to assess the feasibility of running a brief psychoeducation group intervention in an outpatient setting to assess the practicalities and benefits of offering this type of intervention for both clinicians and patients

A Functional Neurological Disorder (FND) is when the brain has difficulties sending and receiving signals . As a result people can experience problems in how their body and senses work, but there is no physical problem to treat.

Currently there is little treatment to offer after diagnosis, this study will investigate the feasibility and potential benefit to offering a group intervention to people with FND. This group intervention will offer chance to access information and the opportunity to meet others with the similar difficulties. Eligible participants will be those currently attending neurology clinics within NHS Grampian. Participants will complete prior to, during and at 3 months after the group is completed. These measures include health care use of participants, reported physical symptoms, subjective quality of ife and mood we will also take a brief measure of attention and concentration. Reported physical symptoms, subjective quality of life and mood will also be collected before the first group and at the last group.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18-64 years with a diagnosis of FND

Exclusion Criteria:

* Anyone the clinical neuropsychologist/neurologist feels, as a result of their clinical judgement, lacks capacity to consent.
* People who are unable to understand the information sheet due to English not being their first language.
* Severe sensory impairment.
* Anyone experiencing active severe psychiatric symptoms
* A dependency on alcohol or recreational drugs
* Learning disability as classified by ICD 10.
* Those unable to travel independently to attend group sessions due to the severity of their symptoms
Farming and Movement Evaluation Study (FAME)

The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with a focus on environmental determinants. We propose to investigate the relationship between Parkinson's disease and exposure to pesticides and other factors by conducting a nested case-control study in the Agricultural Health Study.

The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with a focus on environmental determinants. We propose to investigate the relationship between Parkinson's disease and exposure to pesticides and other factors by conducting a nested case-control study in the Agricultural Health Study.

The Agricultural Health Study is a cohort study of 52,000 licensed pesticide applicators and 32,000 of their spouses, conducted in North Carolina and Iowa. It is a joint effort of the National Cancer Institute, the National Institute of Environmental Health Sciences, and the US Environmental Protection Agency.

The studies proposed here take full advantage of the Agricultural Health Study. We believe that this work could provide a critical and dramatic next step in furthering our knowledge of environmental determinants of PD, and thereby take us closer to our goal of finding its cause(s)

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be recruited from members of the Agricultural Health Study cohort.
Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.

A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.

Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic steroids can be given to control this inflammatory process but their widespread use is limited by their systemic side effects and concerns for long neurodevelopmental adverse sequelae. Delivering steroids by inhalation which has been proven to be effective in young infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may be due to the fact that current delivery devices do not meet the requirements of the specific anatomical and physiologic characteristics of the airways and breathing patterns in this special group of patients. A novel approach to facilitate delivery directly to the lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as a vehicle.

Eligibility Criteria:
Inclusion Criteria:

1. Birth weight 501-1000 g and ≤ 28 weeks gestational age
2. Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
3. Still ventilated on day 5-9 of life.
4. An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.

Exclusion Criteria:

1. Congenital or chromosomal anomalies
2. Occurrence of perinatal sepsis
3. Use of intravenous steroids \> 7 days
Families Moving Forward (FMF) Connect Pro for Mental Health Providers

The goal of this clinical trial is to test a new provider-assisted version of the caregiver Families Moving Forward (FMF) Connect app ("FMF Connect Pro") with mental health providers in the United States. In FMF Connect Pro, mental health providers learn to do routine screening for prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support families in using the FMF Connect caregiver app.

Two different training methods will be compared with a waitlist group in this study. The first training method involves 13-sessions of tele-mentoring using an Extension of Community Healthcare Outcomes (ECHO) approach. The second training method involves a self-directed approach in which providers will access similar content in any asynchronous format on a website.

The main questions this study aims to answer are:

* What is the proportion of agencies and providers who accept and participate in the clinical trial (Reach)?
* Do study groups differ on provider outcome measures of Effectiveness (clients screened/diagnosed), Adoption (provider change in knowledge, self-efficacy), Implementation (practice change, FMF Connect Pro Dashboard usage), and Maintenance of FASD-informed care practice change?

All mental health providers in the study will complete online assessments at study entry, 6 months, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Licensed mental health provider or supervised trainee
* Employed by a community mental agency or in private practice
* provides mental health services to children ages 3 to 12 or their families
* provides services in the United States
* Fluency in English
* Access to the internet

Exclusion Criteria:

* Provides services outside of the United States
* Does not provide mental health services to children ages 3 to 12