cyrilzakka/clinical-trials huggingface dataset:
Excessive Supraventricular Activity and Atrial Fibrillation

The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.

Excessive supraventricular ectopic activities (ESVEA) are a common finding on long-term ECG recordings and have a connection to atrial cardiomyopathy, incident AF, stroke and mortality.

Holter recording from 2022 preformed at Danderyd hospital will be screened in order to identify 125 recordings with ESVEA, defined as at least 30 atrial ectopic beats/hour or a supraventricular run of at least 20 consecutive beats. Participants fulfilling eligibility criteria will be offered prolonged AF screening with continuous holter recording during 14 days. A matched control group (125 participants) without ESVEA will also be screened using same method.

Cardiovascular data from medical records will be collected in order to obtain information regarding co-morbidities and being able to assess CHA2DS2-VASC score. Participants will be asked to fill in a questionnaire.

Samples of blood will be collected at index time, after 21± 3 months for further analysis with the aim of identifying biomarkers for atrial fibrillation. During these two time periods echocardiography, 24 hour ambulatory blood pressure monitoring and assessment af artery stiffness with Arteriograph will also be preformed.

The study population will after 21± 3 months be subjected to renewed screening with Holter in order to examine the persistence of excessive supraventricular activity.

Four years after the completion of screening visits, data from patient records and information thorough telephone interview and/or data from Swedish Patient Register, Swedish Dispensed Drug Register will be collected

Eligibility Criteria:
Inclusion Criteria:

Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.

Exclusion Criteria:

Age \< 70 years, \>89 years Atrial fibrillation / flutter Lifelong treatment with oral anticoagulant Patients with implantable cardiac device Congestive heart failure (CHF) with Ejection fraction (EF) ≤ 30% Severe valvular heart disease
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.

Eligibility Criteria:
* Inclusion Criteria:

  * Eighteen (18) years of age or older
  * Moderate or greater functional Tricuspid Regurgitation (TR)
  * Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.
* Exclusion Criteria:

  * Patients deemed anatomically unsuitable for the device by echocardiography
  * Patients in whom transesophageal echocardiography (TEE) is contraindicated
  * Previous tricuspid valve repair or replacement
  * Severe aortic, mitral and / or pulmonic valve stenosis
  * Severe aortic, mitral and / or pulmonic valve regurgitation
  * Renal Insufficiency requiring dialysis or severe kidney renal disease
  * Life expectancy of less than twelve months
  * Patient is pregnant or lactating
Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease

This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA) in patients with chronic kidney disease (CKD) improves kidney function. Half of the participants will receive continuous positive airway pressure (CPAP) treatment for their OSA in addition to their regular CKD treatment, while the other half will only receive their regular CKD treatment.

Obstructive sleep apnea (OSA) and associated hypoxemia during sleep have been associated with a decline in kidney function. The abnormalities in kidney function associated with OSA have been improved by treatment of OSA with continuous positive airway pressure (CPAP), which is a common and effective therapy for OSA. Up to now, clinical research on the impact of OSA on kidney function has been performed on patients without CKD. This study will examine the impact of CPAP therapy on kidney function in patients with CKD.

CKD patients with OSA and nocturnal hypoxemia will be randomized into one of two groups where half will receive treatment of their OSA with CPAP and the other half will not. All participants will have kidney function monitored every 3 months for a year by measurement of serum creatinine and proteinuria. The change in estimated glomerular filtration rate (eGFR) and proteinuria between the two groups will be assessed to determine whether treatment of OSA improves kidney function in patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3 or 4
* OSA (RDI\>5) and nocturnal hypoxemia (SaO2 \<90% for \>12% of night)

Exclusion Criteria:

* Failure to meet inclusion criteria
* Current therapy with CPAP or supplemental oxygen
* Severe daytime sleepiness reflected by an Epworth Sleepiness Score \>15
* Any driver who holds a commercial drivers' license or who reports a recent history (past 6 months) of a road traffic accident
* Severe nocturnal hypoxemia reflected by mean SaO2 \<80% during level 3 sleep testing
* Daytime hypoxemia reflected by partial pressure of oxygen in arterial blood (PaO2) less than 60 millimetres of mercury (mmHg) during wakefulness
* Hypoventilation reflected by partial pressure of carbon dioxide in arterial blood (PaCO2) greater than 45 millimetres of mercury (mmHg) during wakefulness
* Central sleep apnea that accounts for \>50% of the estimated RDI
* Unable to provide informed consent
Outcome of Children Born After Pregnancy Denial

The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).

The hypothesis is the denial of pregnancy may have repercussions on children's outcome.


Eligibility Criteria:
Inclusion Criteria:

* Child born after denial of pregnancy
* Child born at term ( \> 37 weeks of gestation)
* Born between the 1st january 2009 and the 30th june 2015 at Maternité Regionale de Nancy

Exclusion Criteria:

* Mother's opposition
* Child doesn't' living in France
State-wide Health Approach to Increase Reach and Effectiveness: Study 1

Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.

Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). Primary outcome is weight loss at 12-weeks.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-70 years
2. Body Mass Index \>25 kg/m2
3. Both genders will be recruited; it is estimated that 70% of participants will be women.
4. All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
5. No health problems that make weight loss or unsupervised exercise unsafe
6. English speaking

Exclusion criteria:

1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
2. are currently pregnant or intend to become pregnant in the next 12 months
3. are planning to move outside of the state within the next 12 months
4. have previously participated in the Shape Up Rhode Island 2008 pilot study
Stepped Care AiTBS 2 Depression Study (Ghent)

Antidepressant-free unipolar melancholic depressed patients (at least stage 2 treatment-resistant) will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed.

STEP 1: Patients will be treated with in total 20 accelerated intermittent Theta Burst Stimulation (aiTBS) sessions (3000 pulses/session) over the left dorsolateral prefrontal cortex, which will be spread over 4 days. On each stimulation day, a given patient will receive 5 sessions with a between-session delay of 15 minutes. Patients will be randomized to receive either the real aiTBS or sham treatment (first week). However, the sham group will receive real aiTBS treatment with 10 days' time interval. The investigators expect that real aiTBS treatment and not sham will result in a significant and clinical meaningful response.

STEP 2: To optimize treatment and reduce relapse following the iTBS treatment, in a stepped care approach, all patients then continue with cognitive control training (CCT) ten days later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to receive either real CCT or a control training. During this follow-up treatment, all patients will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are known to decline over time, the investigators expect that combining aiTBS with a follow-up CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS treatment alone.

For baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.


Eligibility Criteria:
Inclusion Criteria:

* Antidepressant-free unipolar major depression with melancholic features
* Not responding to at least two trials with an antidepressant
* Aged between 18-65 years old

Exclusion Criteria:

* Depression with bipolar/psychotic features
* Dysthymia
* Severe personality disorders
* Active substance abuse/dependence within a year prior to inclusion
* Pregnancy or without effective anticonception for the duration of the trial
* ECT non-responder
* No response to more than 9 antidepressants
* Any neurological condition
* Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
* Any implanted metal device in the head region
* Current or past history of epilepsy
* Neurosurgical interventions
* Known allergic reaction to radiotracers or associated compounds

Healthy volunteers may be accepted as control subjects.
A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.

The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.

Eligibility Criteria:
Inclusion Criteria:

1. Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
2. Participants of nonchildbearing potential may be enrolled in the study.
3. Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy.
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
5. Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2).

Exclusion Criteria:

1. Reported diagnosis or condition that is associated with increased risk of severe influenza disease or complications, including individuals with chronic medical conditions.
2. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
3. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
4. Received corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
5. Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., infliximab), within 180 days prior to Day 1 or plans to do so during the study.
6. Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
7. Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
8. Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1.
9. Received any investigational influenza vaccine, investigational coronavirus disease 2019 (COVID-19) vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. Participants from mRNA-1083-P201 Part 1 will also be excluded from Part 2.

Other protocol-defined inclusion/exclusion criteria may apply.
Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19

The purpose of this study is to adapt and pilot test the feasibility of implementing a corner-based risk reduction program that aims to assist Latino day laborers (LDL) in their efforts to adhere to COVID-19 mitigation practices, including receiving the COVID-19 vaccine, using personal protective equipment (PPE), and practicing social distancing.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic or Latino
* Be present at the corner for the purposes of looking for work

Exclusion Criteria:

* Have not been previously hired to work at a corner
* Symptoms of COVID-19 in the previous 48 hours
Study of LC23-1306 in Healthy Male Subjects

This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 20 and 50 years at screening
2. Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI (kg/m2) = body weight (kg)/ {height (m)}2.
3. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
4. Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
Fast Track Diagnosis of Skin Cancer by Advanced Imaging Technologies and Tumour Tapestripping

In this clinical feasibility study the investigators will test and compare two advanced optical imaging technologies, lipid and RNA tape stripping with regards to diagnostic accuracies for fast bedside diagnosis of pigmented skin tumours.

This original clinical research project utilizes cutting-edge medical imaging technologies for diagnosis of pigmented skin tumours, combined for the first time in Denmark, with molecular RNA and lipid analysis of superficial tumours cells. The scanning technologies are reflectance confocal microscopy (RCM), which is a microscope applied directly to the skin surface, and photoacoustic imaging, also termed multispectral optoacoustic imaging (MSOT), which is an imaging technology actually listening to the skin for immediate bedside diagnosis of pigmented skin tumors. The hypothesis is that treatment guided by diagnostic bedside skin scanning, combined with tumour tape-stripping and RNA and lipid analysis can increase diagnostic accuracy compared to visual inspection of the skin tumour and thus decrease time delay from diagnosis to efficient treatment

Eligibility Criteria:
Inclusion Criteria:

1. 75 patients with histologically verified pigmented skin tumours on areas of the body where scanning is feasible with both imaging systems
2. Patients with clinically suspicious skin tumours, that are not yet biopsied, if the patient is willing to undergo a skin biopsy from the suspicious lesion
3. \> 18 years of age at baseline
4. Legally competent, able to give verbal and written consent
5. Communicate in Danish verbally as well as in writing
6. Subject in good general health, is willing to participate and able to give informed consent and can comply with protocol requirements.

Exclusion Criteria:

1. Individuals with other skin diseases in the skin area of interest
2. Individuals who´s skin tumour is not accessible for imaging e.g. inside the ear, inside nostrils, on eyelids
3. Subjects who will not undergo a skin biopsy after imaging of the suspicious skin tumour and who have not had a skin biopsy taken from the tumour prior to referral
4. Pregnancy
5. Women of child-bearing potential not using a contraceptive agent at the time of inclusion
Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology

The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups: Ⅰ (8-12 years old), Ⅱ (13-16 years old), Ⅲ (over 16 years old). The OK lenses used in the present study are of the same design (Euclid Systems Orthokeratology; Euclid System, Herndon, VA, USA). The base line (Day 0) and different follow-up time point (Day 1, Week 1, Week 2, Month 1, Month 3, and Month 6) of dynamic corneal response (DCR) (including 19 items) of the patients derived by Corvis ST were collected. The difference between before and after wearing OK Lens and the changes of parameters among the three groups were both analyzed. And the correlation between axis length (AL) and the 19 parameters also was analyzed. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Eligibility Criteria:
Inclusion Criteria:

* age from 8 to 40 years old
* spherical equivalent(SE) was range from -1.00D to -5.00D
* conform to the standard of wearing orthokeratology lens

Exclusion Criteria:

* ocular diseases and systemic diseases
* visual acuity was less than 20/20
* unable to follow visitors on time
Non-invasive Pulmonary Artery Prediction (ADOPTS)

A proprietary machine-learning algorithm has been developed to model continuous pulmonary artery pressure (PAP), a physiologic marker of cardiopulmonary function. The algorithm was developed from PAP recordings obtained during invasive right heart catheterization. The study will evaluate whether this algorithm can perform as well when embedded into a non-invasive wearable device that records EKG, heart sounds, and thoracic impedance has yet to be established.

A prototype device will be supplied by Silverleaf Medical Science (Redlands, CA) to record these signals. This study will take place at Loma Linda VA, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. The investigators will screen and enroll 20 Veterans who consent to participate in the study. Veterans who decline to consent and vulnerable populations will be excluded from the study. The investigators will obtain simultaneous recordings from the prototype device (EKG, heart sounds, and thoracic impedance) and from the PAP catheter , both at rest (5 minutes), and in response to physiological maneuvers: hand grip, passive leg raise, and Valsalva (1 minute recordings with 1-minute breaks). De-identified recordings from the prototype device will be shared with the team at Silverleaf Medical Science to derive a computed PAP. The investigators will test the hypothesis that computed PAP is no different than measured PAP. If the algorithm can produce a computed PAP with high accuracy,'\[it would be the first wearable system to non-invasively report PAP.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and authorization to use and disclose health information.
* 20 years of age or older.
* Diagnosis of HF for \>3 months, with preserved or reduced left ventricular ejection fraction (LVEF).
* Female subjects of childbearing age with a negative urine or serum pregnancy test at the time of the right heart cauterization procedure and trial.

Exclusion Criteria:

* Active infection.
* Unable to tolerate a right heart catheterization (RHC), in the investigator's opinion.
* Implantation of cardiac resynchronization therapy (CRT)\<3 months before enrollment.
* Enrolled in concurrent studies that may confound the results of this study.
* Clinical condition that would not allow them to complete the study, in the investigator's opinion.