cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device

The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.

Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.

The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.

In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.

The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.

The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.


Eligibility Criteria:
Inclusion Criteria:

* Growth hormone deficiency
* Turner's syndrome

Exclusion Criteria:

* Patients who do not meet the criteria in the treatment Information Sheet
Fast Assessment of STenosis Severity- FASTII Study

The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.

The Multicenter FAST study is a prospective observational multicenter international study in which offline computation of vFFR is compared to conventional invasive, wire based FFR measurements. Pressure wire based FFR will be performed in patients with at least one intermediate coronary lesion at the discretion of the operator (typically defined as a coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3 two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0 (Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D reconstruction of the coronary arteries and one view to ascertain the position of the FFR pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic root pressure. vFFR measurements will be performed online by the different centers. In addition, all angiographic imaging data will be sent to an independent core laboratory (Cardialysis, Rotterdam, The Netherlands) for offline analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years
* indication procedure: stable, unstable angina or non-ST elevation acute coronary syndrome
* Diagnostic coronary angiography or PCI with an indication to perform re-PCI FFR assessment of at least one coronary artery lesion.

Exclusion Criteria:

* ST-elevation myocardial infarction (STEMI)
* Cardiogenic shock
* Severe hemodynamic instability
* Adenosine intolerance
* Lesions containing thrombus, left main lesions, grafts, arteries with collaterals
Creative Writing for Type 2 Diabetes Management

This study is related to the development of a new model of Group Care for patients with Diabetes - the CrewD Program, incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention.

A structured educational model for type 2 diabetic patients using Group Care is currently being used in several institutions for help managing diabetes in these patients. In this study, this model was adjusted by introducing literary texts and using narrative skills. A randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. A total of 49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. Evaluation included anthropometrical measures, A1c and questionnaires for psychological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Only patients with type 2 diabetes of \>1 year known duration, aged \< 85 years were included in the intervention.

Exclusion Criteria:

* Patients that did not complete the four assessments.
A Survivorship Care Plan and Embedded Navigation Tool

This is a parallel group, multisite prospective clinical study. The purpose of this study is to evaluate whether ASCENT enables patients to adhere to the survivorship guidelines and improves coordination of care to address patient needs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of prostate adenocarcinoma
* Age ≥18 years
* Receiving curative intent radiotherapy for prostate cancer (Note: post-operative radiotherapy \[i.e., "adjuvant" or "salvage radiotherapy subsequent to prostatectomy\] is allowed.)
* Subjects will be enrolled within two weeks prior to and two weeks after the final fraction of radiotherapy.
* Receiving androgen deprivation therapy (ADT) for a duration of ≥3 consecutive months as follows:

  * GnRH agonist or antagonist (medical castration), with or without an anti-androgen (i.e., bicalutamide, flutamide, nilutamide, etc.), OR
  * Bilateral orchiectomy (surgical castration)
* Technology requirement: candidates must have access to the internet
* Able to understand and willing to sign a written informed consent document.
* Able to speak and understand English, in the opinion of the treating physician.

Exclusion Criteria:

* Significant concurrent medical or psychiatric condition that would interfere with the patient's ability to abide by the study protocol or cooperate fully with the protocol requirements, including completion of survey and assessment
Thrombolysis With Intra-arterial Urokinase

Patients with acute superior mesenteric artery (SMA) occlusion were included in this study. The clinical presentation and effect of the recanalization of the SMA was analyzed on follow-up angiography.

Thirteen patients with acute SMA occlusion who underwent intra-arterial urokinase thrombolysis between 2008 and 2020 were retrospectively evaluated.

Clinically, the abdominal pain and the effect of the SMA on angiography will be compared in response and non-response groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SMA occlusion

Exclusion Criteria:

* shock in the triage screening
* peritonitis
* 3. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT
Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography

A prospective, observational, case series investigating the feasibility of utilizing OCT scans of the anterior chamber of eyes with uveitis.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to Cole Eye Institute with uveitis.

Exclusion Criteria:

* Inability to provide informed consent, including non-English speaking and cognitively/mentally impaired.
* Severe corneal opacities preventing imaging of anterior chamber
REVEAL AF: Incidence of AF in High Risk Patients

This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients after AF has been detected. This study will also seek to identify what patient characteristics are most predictive of developing AF.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets the approved indications to receive the Reveal ICM
* Patient is suspected, based on symptomatology and/or demographics, of having atrial fibrillation or at high risk of having AF, as determined by the clinical investigator
* Patient has a Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) score ≥ 3 OR has a CHADS2 score = 2 with at least one of the following documented: renal impairment (GFR 30-60 ml/min), sleep apnea, coronary artery disease, or chronic obstructive pulmonary disease. Note: stroke/TIA criterion as part of the CHADS2 score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.
* Patient is 18 years of age or older
* Patient has a life expectancy of 18 months or more
* Patient, or legally authorized representative, is willing to sign and date the consent form
* Patient is willing and able to be remotely monitored (i.e., eligible for enrollment into the Medtronic CareLink Network)

Exclusion Criteria:

* Patient has a documented history of AF or atrial flutter
* Patient had an ischemic stroke or TIA within past year prior to enrollment
* Patient has a history of a hemorrhagic stroke
* Patient is currently implanted with an implantable pulse generator (IPG), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) device
* New York Heart Association (NYHA) Class IV Heart Failure patient
* Patient had heart surgery within previous 90 days prior to enrollment
* Patient had a myocardial infarction (MI) within the previous 90 days prior to enrollment
* Patient is taking chronic immuno-suppressant therapy
* Patient is taking an anti-arrhythmic drug
* Patient is contraindicated for long term anticoagulation medication
* Patient is taking a long-term anticoagulation medication
* Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis)
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
* Patient has a creatinine clearance \<30 ml/min or is on dialysis
Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF

The main purpose of this study is to investigate effect of Medi Yoga on quality of life, biomedical factors and health care consumption, and to study gender differences between individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects their condition.

Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP are positively affected, and that individuals seek less medical care.

Methods / materials The chosen study design is a randomized Three arms controlled trial. The study will be conducted at the Cardiology Clinic at Danderyd Hospital in Stockholm. One hundred and thirty two individuals will be included and randomized to the intervention group (yoga), Music relaxation group or control group (usual follow-up). Inclusion criteria are the diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the last six months. Exclusion criteria are language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also excluded.

The subjects in the intervention group will practice yoga in groups for one hour once a week for 12 weeks in the hospital, with the guidance of a trained yoga instructor. They will receive written instructions on yoga exercises and a CD record to perform the yoga program at home. Added to that, the standard treatment i.e. drugs, cardioversion or ablation. The music relaxation group will listen to Music in half an hour in a group at the hospital.The control group receives usual care.

Participants are followed for three months and the evaluation is done at baseline and after three months. During these visits quality of life will be measured with two surveys, as well as variables such as blood pressure, heart rate, biological markers (CRP , BNP) , and ECG and 24-hour ECG . Primary endpoint: quality of life. In order to obtain a five -point difference in the quality of life, 132 subjects are required to achieve a power of 80 percent (p-value 0.05), including a loss rate of 20 percent. The calculation is based on the results of Substudy I. Analytical methods that will be used are: multivariate analyzes eg logistic regression, MANOVA, etc. and univariate analyzes.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the last six months

Exclusion Criteria:

* language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also excluded.
Resin Infiltration Treatment for MIH

The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.

A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).

Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.

Exclusion Criteria:

* Dental caries and filling on anterior teeth.
* Dental anomaly on anterior teeth.
* Undergoing orthodontic treatment.
* Periodontal diseases.
* Cognitive and behavioural problems.
Implementation of a Cardiometabolic Disease Staging System in Primary Care

The aim of this study is to develop a clinical decision support system (CDSS) that incorporates obesity management guidelines and treatment options for use by physicians and, potentially, patients based on a cardiometabolic disease staging system. This CDSS will be designed using primary care provider input through a qualitative approach to explore physician preferences for the appearance, electronic location, treatment options, referrals, accessibility and other user requirements of the CDSS.

To provide appropriate medical management of obesity and facilitate the diabetes risk assessments of people with excess adiposity, a comprehensive staging system that establishes five stages of cardiometabolic disease risk-the cardiometabolic disease staging system (CMDS) has been developed. This staging is based on Adult Treatment Panel III metabolic syndrome risk factors to guide decision making for selection of treatment modality and intensity in the management of obesity. Hence, the study hypothesis is that providing CMDS to PCPs through a CDSS for medical management of obesity can aid in reducing the barriers of obesity and diabetes treatment at the PCP-level and improve the quality of obesity and diabetes care. In this pilot and feasibility study, investigators will implement an early-phase CDSS in a pragmatic PCP setting to assess the uptake and acceptability of CDSS delivered to PCPs implementing CMDS at the point of care, and collect pilot data to assess change in patient engagement and satisfaction.

Investigators will conduct initial focus groups with PCPs and a series of iterative design steps targeting PCP and patient needs. These qualitative interviews would be used to determine the initial set of requirements and prototypes of the user interfaces and notifications.

Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians employed at the University of Alabama at Birmingham

Exclusion Criteria:

* Physicians ≥19
Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.

* Blood pressure control
* Changing of adiponectin and plasminogen activator inhibitor-1
* Influence metabolizing and cardiac function, etc.

The primary endpoints are:

* blood pressure control
* Adiponectin and plasma type1 plasminogen active inhibitor

The secondary endpoints are

* HOMA-IR
* HbA1c
* TNF-α
* IL-6
* Plasma B-type natriuretic peptide
* LVMI
* E/A ratio
* Tei-index
* Apo-J

Eligibility Criteria:
Inclusion Criteria:

* Out patients with hypertension male and female
* Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
* Waist Surrounding diameter male≧85cm female≧90cm
* Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
* Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol \< 40 mg/dl or fasting blood glucose ≧110 mg/dl
* Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB

Exclusion Criteria:

* Patient who is using ACE-I and ARB
* Serum creatinine ≧ 3 mg/dl
* Liver impairment
* History of allergy to valsartan
* Pregnant women
* Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety
Compassionate Use of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy

The program is to provide access to an experimental drug called pozelimab and to document the long-term safety of pozelimab in patients with Protein-Losing Enteropathy (PLE). CD55-deficient PLE/CHAPLE disease is a rare inherited disease of the immune system. This can be a life-threatening condition that is usually found when patients are children.


Eligibility Criteria:
Key Inclusion Criteria:

1. Clinical diagnosis of CD55-deficient PLE/CHAPLE disease (based on a history of PLE), confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis (frameshift, nonsense mutations) as defined in the protocol
2. Written informed consent from parent/guardian for minor patients
3. Written assent from minor patients as appropriate (eg, above the age of 6 years or the applicable age per local regulatory requirements)

Key Exclusion Criteria:

1. Patients who discontinued the prior pozelimab study due to safety or lack of efficacy
2. Considered by the treating physician as inappropriate for this program for any reason as defined in the protocol

NOTE: Other protocol defined inclusion / exclusion criteria apply
Community Paramedicine at Home

Community Paramedicine @Home (CP@Home) is a novel community paramedicine health assessment program for high users of Emergency Medical Services (EMS). Individuals who have been identified as active callers to EMS, individuals who have called EMS for lift-assists, and direct paramedic referrals are referred into the community paramedicine home visit program. The program will focus on in-home chronic disease management, community health service connections, and EMS usage education. Aside from chronic disease management, aspects of the program include health-related quality of life, social isolation and other social determinants of health. Participants in the program will have up to 3 one-on-one home visits from a community paramedic to ultimately reduce repeat EMS calls and improve their overall health.


Eligibility Criteria:
Inclusion Criteria:

* 3 or more EMS calls in the last 6 months from intervention start date AND active caller in the last 30 days OR
* Any call for a lift assist to EMS in the past 30 days OR
* Paramedic referral into program (identified by paramedic through usual practice)

Exclusion Criteria:

* Individuals living in long term care facilities
* Individuals currently involved in a home visit or social navigator program
Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries

Background:

Augmented Velocity Index (Avi) is a new Doppler index which can potentially be used to assess arterial stiffness. The Avi of common carotid artery is found to be associated with arterial stiffness and have initial correlation with cardiovascular risk factors. Avi can be used in any vessels (superficial or deep vessels) where arterial Doppler waveforms can be obtained.

Aims:

The aims of this study are to investigate the associations of Avi of hepatic artery, renal artery, central retinal artery and internal carotid artery with arterial stiffness and cardiovascular risk factors in a group of apparently normal subjects.

Methods:

Recruit 350 subjects with no known medical illness or drug treatment for ultrasound examinations and blood tests. In ultrasound examination, the Avi of carotid arteries, hepatic arteries, renal arteries and retinal arteries are recorded. The carotid-femoral pulse wave velocity is also calculated for the assessment of central aortic stiffness.

Other important correlates of arterial stiffness including carotid intima-media thickness, fatty liver status, liver stiffness and abdominal fat thickness are assessed in the ultrasound examination.

The clinical and laboratory examinations include anthropometric indexes, plasma glucose level, lipid profile, renal function tests, liver function test, urinary albumin creatinine ratio, blood pressure measurement.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy volunteers

Exclusion Criteria:

* Subjects with known medical illnesses including cancer, stroke, cardiovascular disease, diabetes, hypertension, dyslipidaemia, peripheral vascular disease, gout, systemic lupus erythematosus, psoriasis, rheumatoid arthritis and thyrotoxicosis.
* Subjects with long term drug use