cyrilzakka/clinical-trials huggingface dataset:
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.

the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.

Eligibility Criteria:
Key Inclusion Criteria:

* Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.
* Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD.
* Age 18 years or older.

Key Exclusion Criteria:

* Previous surgical or catheter ablation for atrial fibrillation.
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days.
* Valve repair or replacement or presence of a prosthetic valve.
* CABG surgery within the past 6 months (180 days).
* Any carotid stenting or endarterectomy within the past 6 months.
* Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
* Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
* Documented LA size \> 50 mm.
* Documented LVEF \< 40%.
* Contraindication to anticoagulation (e.g., heparin).
* MI/PCI within the past 2 months.
* Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
* Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
* Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
* Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
Investigating the Effect of Caffeine Consumption on Speech Understanding in Noise in Young Adults

Caffeine is a widely consumed substance worldwide and is often used to increase alertness and improve cognitive functions. Caffeine stimulates brain activity by binding to adenosine receptors, which increases alertness instead of sleepiness. Studies on the effects of caffeine on cognitive functions have shown that it improves basic cognitive functions such as attention, reaction time, and alertness, while a less pronounced effect is seen on sensory functions such as vision and hearing. However, no study has been found investigating the effect of caffeine consumption on understanding speech in noise. Understanding speech in noise is a skill that includes not only auditory functions but also cognitive functions. This skill is affected by cognitive elements such as selective attention and executive functions. In this context, it is thought that this study, which aims to examine the relationship between caffeine and understanding speech in noise, will contribute to the literature. 60 participants between the ages of 18-30 will be included in this study. Participants will consist of individuals without hearing loss (SSO\<25 dB nHL), no history of neurological or psychological disorders, non-smokers, and those who do not use ototoxic drugs. Participants will be randomly divided into a placebo group that consumes decaffeinated coffee and a study group that consumes coffee containing 300 mg caffeine. The Turkish Matrix Test will be administered 30 minutes after coffee consumption. In addition, participants will be asked to keep a caffeine diary for one week to determine their daily caffeine consumption and will be asked to fill out the Caffeine Use Disorder Scale. Thus, they will be divided into low and high caffeine consumption groups and their speech understanding skills in noise will be compared.


Eligibility Criteria:
Inclusion Criteria:

* For both groups, it was planned to include individuals who had no hearing loss (SSO\<25 dB nHL), no history of neurological or psychological disorders, were non-smokers, and did not use ototoxic drugs.

Exclusion Criteria:
MRI Assessment of Cartilage Damage in Tibial Nailing

Fractures of the tibia (shin bone) are frequently treated with a metal nail that is passed down the inside of the bone (an intra-medullary nail). This nail is inserted through the top of the tibia at the level of the knee joint. There are two ways for the nail to be inserted - either through an incision below the patella (kneecap) or above the patella.

The benefit of the incision above the patella is that it can make it technically easier to insert the nail into the correct position. However, the perceived risk of damage to the knee cartilage has prevented this technique from being widely adopted.

The investigators will use MRI scanning to assess the cartilage for damage using both techniques. The results will enable the investigators to determine if the theoretical risk of cartilage damage is found in real-world scenarios and to generate data for further, larger studies.

Intra-medullary nailing is a common form of treatment for a variety of tibial shaft fractures. Traditionally this has been done via an infra-patella approach. More recently the use of a supra-patella approach has become more popular. However, there are concerns that the supra-patella approach may cause unacceptable damage to the cartilage of the patello-femoral joint (PFJ).

This study will use a novel MRI technique developed at the University of Cambridge to compare the amount of damage caused to the knee joint by both infra- and supra-patella nailing techniques. Specific cartilage assessment sequences will enable a fuller assessment of cartilage damage than can be achieved with normal structural sequences. Participants will also be asked to complete Patient Reported Outcome Measures (PROMs) regarding their injury to assess their clinical outcome.

Infra-patella and supra-patella nailing techniques are now both routine methods of carrying out intra-medullary nailing of the tibia. Further evidence is required, however, in order to fully assess whether one method is superior to the other.

Eligibility Criteria:
Inclusion Criteria:

* Closed tibial shaft fracture suitable for intramedullary nailing
* Able to consent
* Able to undergo MRI scanning
* Able to attend follow up for 6 months post operatively
* Suitable for surgery

Exclusion Criteria:

* Polytrauma
* Ipsilateral acute ligamentous knee injury
* A contra-indication to MRI scanning
Optical Tomography in Prostate Cancer

This study is looking to see if a new device, diffuse optical tomography (DOT), can detect prostate cancer. The investigators will also see if DOT can tell the difference between high risk and low risk prostate cancers.

While some of these tools have helped to guide therapy in patients with prostate cancer, they are imperfect and as a result many men undergo unnecessary treatment for a disease that would not have caused their deaths. An improved method to risk stratify men with prostate cancer prior to definitive therapy may reduce the over-treatment rate, while maintaining or improving mortality.

Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. DOT analyzes the light being reflected and transmitted through tissue to generate three-dimensional images of chromophores and light scattering. As such, DOT serves as a functional imaging modality, measuring both tissue vascularity and architecture. The investigators believe that DOT will be able to detect prostate cancer in men suspected of the disease and will also be able to risk-stratify patients found to have prostate cancer to help guide treatment options. DOT may be able to directly measure two factors important in the prognosis of patients with prostate cancer: the Gleason score and microvessel density (MVD).

Eligibility Criteria:
Inclusion Criteria:

* Men 18 years of age or older scheduled for transrectal prostate biopsy or radical prostatectomy at Columbia University Medical Center
* Signing consent for study imaging procedure and analysis of prostate biopsy

Exclusion criteria:

* Patients failing to meet the inclusion criteria
* Contraindication for magnetic resonance imaging
Bond Failure of Two Types of Molar Buccal Tubes

This study looks at two new types of orthodontic brackets (metal squares of the brace) that have recently been released. Both types have been developed to allow the brackets to stick better to the tooth surface. The difference between the two groups is the adhesive ('glue') that is used. One uses a more conventional type of pre-coated adhesive (APC-II). The other type uses a new flash-free adhesive that does not require the excess to be removed once placed. It is claimed by the manufacturer that this new adhesive has a far lower failure rate than other types. However, there are very few studies that have looked into the bond failures of these adhesives comparatively, with most being lab-based studies outside of the mouth.

The purpose of this study is to investigate which of the two bracket types lasts longest when glued to teeth for brace treatment and if there are any particular reasons why they may fail. This in turn will provide good evidence and research for future use of different bracket types, with an aim to prevent brackets from coming loose as little as possible during treatment. This could potentially result in smoother treatment for the participants and fewer visits.

A total of 56 participants within the Orthodontic Department at Guy's Hospital London, shall be recruited to the trial and randomly placed into one of the two groups. The participants invited to take part in the trial will require fixed braces ('train-tracks') and meet the specific criteria that the investigators are looking for. Once the braces are fitted, regular appointments are made and participants are asked to return for emergency appointments if any of the brace comes loose. The total time for follow-up after the brace is fitted is a maximum of 3 months. The results shall then be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring fixed appliances.
* Patients aged \>8 years old

Exclusion Criteria:

* Orthognathic patients requiring bands on first permanent molar teeth.
* Patients with cleft lip/palate or any other craniofacial anomalies.
* Patients already in fixed appliances.
* Patients who have first permanent molars missing.
* Patients with hypoplastic first permanent molars/fluorotic first permanent molars.
* Patients with first permanent molars in crossbite with displacement.
* Patients requiring sectional fixed appliances (not including the molars).
* Patients requiring bands on first permanent molars for TPA, Quadhelix etc.
* Patients who have buccal restorations/crowned first permanent molars.
* Patients who do not speak English fluently or understand written English easily.
Effect of Myofascial Release Technique on Reducing Symptoms in Patients With Chronic Disc Protrusion

The purpose of this study is to determine whether myofascial release technique are effective in the treatment of low back pain due to lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* lumbar disc herniation
* Muscular trriger points
* independent ambulated patients

Exclusion Criteria:

* Neoplasm
* Lumbar surgery history
* fracture
* inflammatory disease
Use of a Brief Phone Call After ED Discharge

The purpose of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the Emergency Department (ED) decreases return visits to the ED/ hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary outcomes, time to follow up appointment with physician and economic impact of this intervention will be assessed.

Patients 65 years of age and older will be randomized following discharge from the ED into one of two groups. Group 1(Intervention) will receive a phone call collecting information about understanding of ED discharge instructions and guiding patient through the discharge instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction survey.

We hypothesize return visits to the ED and readmission to the hospital will decrease as a result of the nurse phone call intervention.

Procedures: All patients age 65 and above will be randomized to one of two groups within 1-3 days after discharge from the UNC ED: 1) Interventional follow-up phone call; or 2) Placebo phone call, implementing only a satisfaction survey.

The intervention phone call will ask whether patients have obtained the newly prescribed medicines, ask if the patient understands the instructions for taking the medicines and inquire if a patient has made an appointment with his/her personal physician. The caller will attempt to answer questions about the medicines, and encourage patients to take the medicines as directed. The caller will also encourage the patients to follow-up with their own physician in a timely manner and offer to help with setting up follow up appointments if needed.

Subsequently, 30-35 days after ED discharge, all patients will receive a phone call to evaluate rates of compliance with medicines and scheduling follow-up appointments. All calls will be made by trained nurses.

Using an α 0.05 and β 0.80 we will need to enroll 2235 patients to detect a decrease in ED return visits/re-admission/ death of 6%. There will be one interim analysis 1 year into the two year planned study.

Eligibility Criteria:
Inclusion Criteria:

* All patients age 65 and above discharged from the ED
* English speaking

Exclusion Criteria:

* Younger than 65 years of age
* Unable to pass 6-item memory screener
* Lives in skilled nursing facility
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias

The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the German guidelines. Medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.


Eligibility Criteria:
Inclusion Criteria:

* Indication for cardiac pacing according to the German guidelines
* Documented (electrocardiogram; ECG) atrial arrhythmia during the last three months before enrollment
* Willingness to terminate antiarrhythmic drugs until the first recurrence of an atrial arrhythmia
* Sinus rhythm during 24 hours before implant of the device

Exclusion Criteria:

* Ejection fraction below 40%
* Mechanic prosthesis of the tricuspid valve
* Indication to implantable cardioverter defibrillator (ICD)-implantation
* Pregnancy
Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
* Multiple sclerosis (MS) onset within one year before enrolment
* ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
* No previous disease modifying and/or immunosuppressive treatments for MS.
* Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

* Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
* Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
* Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
* History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
* History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
* History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
* History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
* An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
AutoMatic disPERsion Tagging Function Preliminary Evaluation

Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3D-map in real-time.

Ablation of Atrial Fibrillation (AF) and Atrial Tachycardia (AT) is typically performed in predetermined anatomic regions of the left atrium (pulmonary veins isolation) and may be supplemented by a tailored ablation approach in order to identify areas of interest specific to the patient. The VX1+ medical device is intended to assist operators in the manual or automatic real-time annotation of 3D electroanatomical maps of the heart for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatio-temporal dispersion during ablation procedures.

This study will specifically allow to evaluate the peroperative performance of VX1+ automatic tagging function in bi-directional configuration with a compatible 3D mapping system.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older.
* Patient candidate for catheter ablation of atrial tachycardia, or paroxysmal or persistent atrial fibrillation, de novo or after one or several previous ablation procedures.
* Continuous anticoagulation for more than 4 weeks before ablation.
* Patient giving his signed consent form to participate in the clinical study.
* Patient affiliated to the French social security

Exclusion Criteria:

* Contraindication to AF/AT catheter ablation.
* Major bleeding disorder.
* Contraindication to anticoagulation (Heparin, Warfarin or novel oral anticoagulants (NOAC)) or lack of anticoagulation for 4 weeks prior to the procedure.
* Presence of a left atrium (LA) thrombus on transesophageal echocardiography (TEE) prior to the procedure.
* Patient who is or could potentially be pregnant.
* Person deprived of liberty or under guardianship.
* Patient's refusal to participate in the study.
The Pathophysiology of Functional Neurological Disorders

Functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense.

Functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. Intriguingly, they typically manifest when patients pay attention to them and disappear with distraction.

The investigators aim to further the understanding of the pathophysiological mechanisms underlying functional neurological disorders in order to improve treatment. In particular they aim to understand the effect of attention on movement in general, on functional neurological mechanisms and on the sense of agency (of subjective control) over a movement.

Patients with a functional neurological disorder, patients with an organic neurological disorder and healthy participants will perform simple tasks, such as reaching to a target, while additional tasks will manipulate their attention. The effects of these attentional manipulations will be analysed on several levels: movement performance, analysed by the kinematics and electromyography (EMG),and psychophysical measures, such as the sense of agency.

If the hypothesis turns out to be true, then changing the attentional focus could be used as a treatment in functional neurological disorders.


Eligibility Criteria:
Inclusion Criteria:

* We will recruit three groups of participants:

  1. functional neurological disorders, e.g. functional tremor: diagnosed by a neurologist.
  2. organic counterpart of the functional neurological disorders, e.g. in the case of functional tremor, the organic counterpart would be organic tremor: presence of an organic tremor according to internationally recognised guidelines and diagnosed by a neurologist.
  3. healthy age-matched controls.

Exclusion Criteria

* Healthy Participants: Major neurological disorder.

All groups:

1. Age under 18 or over 80
2. Significant impairment in ability to give informed consent for study procedures due to significant cognitive impairment and/or inability to understand study literature,
3. very severe tremor
4. moderate or severe cognitive impairment