cyrilzakka/clinical-trials huggingface dataset:
Ablation of Inappropriate Sinus Tachycardia

Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation at the junction of the superior vena cava and the right atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation.

Inappropriate sinus tachycardia syndrome describes a condition in which a patient's heart rate is intermittently (or persistently) higher than expected for the physiological circumstances, with ECG appearance indistinguishable from normal sinus rhythm, after the exclusion of medical conditions causing sinus tachycardia.

Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation at the junction of the superior vena cava and the right atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18 and 80 years old, who are scheduled for an ablation procedure for suspected inappropriate sinus tachycardia, with symptomatic palpitations during periods where documented electrogram recordings suggest sinus tachycardia (holter, event recorder, or 12 lead ECG).
2. Sinus rate greater than 100 bpm with minimal physiologic challenge, or mean sinus rate during 24 hour holter more than 95bpm, or daytime resting heart rate more than 95bpm.
3. Symptoms (or sinus rate) not explained by an alternative medical or electrophysiological diagnosis.
4. Symptoms refractory to treatment with beta-blocker medication, or beta-blockers contra-indicated or not tolerated

Exclusion Criteria:

1. Children under 18 years of age (due to greater risk from exposure to X rays).
2. Any medical condition significantly increasing the risk of extending the ablation procedure or of X ray exposure, including pregnancy.
3. Significant orthostatic hypotension (due to need for rapid chronotropic response to fall in blood pressure)
4. An alternative cause for sinus tachycardia identified (e.g. hyperthyroidism or pheochromocytoma).
5. Inability or unwillingness to provide informed consent.
Analgesic Effect of the QLB-3 for Patients Undergoing a Total Hip Surgery

Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.


Eligibility Criteria:
Inclusion Criteria:

• All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of inclusion criteria.

* Obligation for all patients to be affiliated with social security
* Patient Informed Consent Signature

Exclusion Criteria:

* chronic opiod consumption
* pregnancy
* mental disorder that prevents the usage of the numeric analog scale
* Contra indications of the realization of QLB

  * Local infection
  * Allergic to the local anesthesia
  * Hemostasis disorder
  * Incapacity of giving the consent : individuals under guardianship by court order, or under judicial protection
Decreasing Delirium Through Music

DDM is a study designed to Test the efficacy of personalized music therapy in reducing delirium incidence and severity among patients admitted to the Intensive Care Unit.

Over 1 million adults are admitted to the intensive care unit and placed on mechanical ventilation on an annual basis. Intravenous sedatives and analgesics are commonly administered to these patients to reduce pain and anxiety. While the recent reduction in benzodiazepine usage has helped reduced ICU-related acute brain dysfunction (delirium), up to 80% of ventilated patients still develop acute brain failure. This is characterized by disturbance of consciousness with reduced ability to focus, sustain or shift attention, occurring over a short period of time and fluctuating over the course of a day.

Acute brain dysfunction has both short-term and long-term health impacts. It is associated with increased hospital length of stay, increased in-hospital mortality and post-discharge mortality as well increased health-care costs. Patients who experience delirium are at greater risk for post-discharge institutionalization and newly acquired cognitive impairment similar to dementia.

Despite the prevalence and morbidity associated with delirium, there is a scarcity of effective pharmacological and non-pharmacological interventions to prevent and treat this condition. While music therapy has shown to reduce anxiety and stress in cancer and dementia patients, these studies were performed outside the intensive care unit. It is hypothesized that music lowers inflammatory mediators such as cytokines and cortisol. Delirium pathophysiology similar to anxiety has a strong inflammatory component with excess of pro-inflammatory cytokines such as interleukins 1, 6, and 8. Given the beneficial effects of music in reducing inflammatory mediators, it stands to reason that such intervention will have a beneficial impact on reducing delirium.

The investigators propose a randomized, three-group (personalized music intervention versus generic music intervention versus attention control) trial to test the feasibility and efficacy of music therapy in reducing delirium incidence, duration, and severity among critically ill patients in the ICU.

Our study focuses on the effect of music therapy on the incidence and severity of delirium in the intensive care unit at a large urban academic health center.

The investigators hypothesize that music therapy will lead to reduced levels of anxiety, delirium and need for sedating medications, leading to shorter hospital stays.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* English speaking
* admitted to the intensive care unit (medical or surgical)
* receiving mechanical ventilation

Exclusion Criteria:

* history of dementia
* psychiatric illness which is not well controlled
* alcohol withdrawal symptoms/concern for withdrawal
* suspected or confirmed drug intoxication/overdose
* traumatic brain injury
* hearing or vision impairment including legal blindness
* aphasic stroke
* coma after cardiac arrest/hypothermia protocol
* pregnant or nursing
* prisoners
* patients enrolled in another clinical trial.
High Intensity Interval Training in Geriatrics

This is a pilot study for evaluating the feasibility of using High Intensity Interval Training in geriatric hospitalized patients compared to the standard current rehabilitation practice.

High Intensity Interval Training (HIIT) has shown a superior effectiveness and efficiency when compared to Moderate Intensity Continuous Training (MICT) in several types of patients and in healthy subjects. There are no data on HIIT in a general geriatric population. This study is a pilot study evaluating the feasibility of using HIIT in geriatric hospitalized patients compared to the standard current rehabilitation practice without HIIT. It is our desire to perform a larger randomized comparative trial between HIIT and MICT if the pilot study proves its feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years and older hospitalized for rehabilitation after an acute medical condition
* Expected duration of the rehabilitation ≥ 2 weeks
* Ability to follow instructions to perform a Timed up and Go Test
* Ability to perform exercises
* Willing to participate in 4 sessions of HIIT per week for 2 weeks

Exclusion Criteria:

* Any acute condition with tachycardia, hypotension or fever.
* Abnormal cycle ergometer stress test with
* significant ECG modification
* decrease of more than 20 mmHg of the blood pressure with exercise
* angina
* ST depression at a workload \<6 METs
* Inability to reach an intensity of 15/20 in the Borg's scale of perceived exertion
* Any unresolved acute medical or surgical condition of the following kind:
* acute heart failure
* acute coronary syndrome \< 1 month
* strole \< 1 month
* active pericarditis / myocarditis / endocarditis
* thromboembolic disease with \< 2 weeks of anticoagulation
* acute infection requiring intravenous treatment
* ongoing intravenous perfusion
* surgery \< 2 months
* recent bone fracture
* Previous episode of primary cardiac arrest (ie, cardiac arrest that did not occur in the presence of an acute myocardial infarction or during a cardiac procedure).
* Severe heart failure (NYHA III and IV)
* Severe stenotic or regurgitant valvular disease
* Uncontrolled hypertension at rest (SBP≥160mmHg, DBP≥100mmHg)
* Uncontrolled dysrhythmia
* Non-sustained ventricular tachycardia with exercise
* Implanted defibrillator
* Obstructive cardiomyopathy
* Resting HR \> 100/min
* Severe peripheral artery disease
* Severe COPD (VEMS \< 50%)
* Exercise-induced asthma
* Oxygen dependency
* Muscular-skeletal anomaly that may limit exercise participation
* Delirium
* Inability to follow instructions
* Inability to consent
The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes

The purpose of this study is to determine if Flash glucose monitoring system improves glycemic control in adults with new-onset type 2 diabetes

People with new-onset type 2 diabetes who achieve and sustain glycemic targets is important for reducing the risk of complications and all-cause mortality.Glucose monitoring is the key point of diabetes management.Continuous glucose monitoring(CGM)can identify day-to-day glucose profiles to guide management decisions.Flash glucose monitoring is a variant of CGM and is factory calibrated,requiring no finger pricks.The purpose of this study is to determine if Flash glucose monitoring improves glycemic control in adults with new-onset type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* peolpe with type 2 diabetes in accordance with the dignosed criteria of CDS2017
* type 2 diabetes duration of \<6months
* with certain read-write ability
* willing to use FSL or follow study protocol

Exclusion Criteria:

* acute complication of diabetes condition(DKA,HHH)
* pregnancy,lactating or planning pregnancy
* allergy to adhesive tape
* skin with large area of rubefaction and wounds
Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease

This is a multi-center, prospective study. This study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria Tablets on patients with chronic obstructive pulmonary disease (COPD). In addition, this study investigates the improvement of hospitalization, improvement of pulmonary function, improvement of symptoms, and the use of anti-Infective drugs among COPD patients.

A total of 750 eligible COPD patients were enrolled, and were randomly divided into experimental group and control group with a ratio of 2:1. Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Drug administration is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months. Control group will receive standard care without interventions.

All participants have to sign informed consent. After baseline (V0/V1), participants will be followed up for 12 months with four follow-up visits at 4 weeks ± 14d (V2), 13 weeks ± 14d (V3), 26 weeks ± 14d (V4), and 52 weeks ± 14d (V5). Among them, V2 can be phone interview.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years, males and females.
* Clinical diagnosis of COPD, defined as FEV1/FVC\<70% after inhaling bronchodilators.
* At least 1 moderate to severe acute exacerbation of COPD in the past year.
* Patient or their legal agent sign informed consent with a date after understanding the purpose and procedures of the research, and be willing to participate in the study.

Exclusion Criteria:

* Patients with active pulmonary tuberculosis, asthma, or uncontrolled advanced malignant tumors; or after partial, lobar, or total pneumonectomy.
* Patients with acute cardio cerebral vascular disease such as acute myocardial infarction, acute stroke and acute heart failure.
* Patients with liver failure or renal failure and need blood purification treatment.
* Patients with rheumatic diseases and autoimmune diseases.
* Have participated or currently in interventional clinical trials within 30 days.
* Patients with previous (within 3 months before signing the informed consent) or current use of immunomodulatory drugs (including thymosin, thymosin, interferon, transfer factor, BCG vaccine polysaccharide, and any kind of bacterial extract such as Biostim, pneumonia vaccine, and influenza vaccine).
* Currently pregnant or breast-feeding women, or those who have fertility but cannot take contraceptive measures during the study period.
* Other conditions that are not suitable for the trials according to investigator's judgement.
Posterior Capsule Opacification Development With Two Different Intraocular Lenses

Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 3 years.


Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* intraocular complication like posterior capsular tear
* glaucoma
* uveitis
* corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
Five, Plus Nuts and Beans for Kidneys

This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.

This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD.

150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American race
* Age 21 years or older
* Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59 ml/min/1.73m2.
* Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months).
* Must have a systolic blood pressure of \<=160 mmHg and a diastolic blood pressure of \<=100 mmHg (average of two visits)
* Be on stable doses of antihypertensive medications for a minimum of two months prior to randomization.

Exclusion Criteria:

* Cardiovascular (CV) event within 6 months
* Chronic disease that might interfere with trial participation (e.g. stage 4 or 5 Chronic Kidney Disease, Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2)
* Unwillingness or inability to adopt a DASH-like diet
* Consumes over 14 alcoholic drinks per week
* Poorly controlled diabetes (Hemoglobin A1c \>9%).
* Patients with a serum potassium \>4.6 milliequivalent (mEq) /L45
* Urine ACR ≥ 1,000 mg/g
Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds

To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry dressing in the treatment of open wounds after incision and drainage.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients with soft tissue abscess that will result in an open surgical wounds greater than or equal to 4 cms in any dimension
* Wound will require serial dressing changes
* Greater than or equal to 18 years of age
* Ability to obtain informed consent

Exclusion Criteria:

* Inability to obtain informed consent
* Pregnancy
* Prisoner
Multi-Center Study of Iron Overload: Survey Study (MCSIO)

The purpose of this study is to demonstrate that a sufficient number of iron-overloaded thalassemia (THAL), Sickle Cell Disease (SCD)and Diamond Blackfan Anemia (DBA) populations with similar duration of chronic transfusion, and age at start of transfusions would be available for a confirmatory study. The study will examine the hypothesis that a chronic inflammatory state in SCD leads to hepcidin- and cytokine-mediated iron withholding within the RES (reticuloendothelial system), lower plasma NTBI (non-transferrin bound iron) levels, less distribution of iron to the heart in SCD.

A detailed iron burden, transfusion and chelation history will be obtained from chart review or from participant recall.

Iron burden data will include: 1) documentation of liver iron, and 2) average annual ferritin values.

Transfusion data will include: (1) age at onset of regular transfusions, (2) years of chronic transfusion therapy, and (3) pre-transfusion Hb calculated as average of all assessments for each year.

Eligibility Criteria:
Inclusion Criteria:

* 10-20 years of transfusion (defined as 0.2-0.6mg Fe/kg/day exposure with annual ferritin levels greater than 2500 in at least 60% of years of chronic transfusion);
* 0 to 9 years old at the initiation of chronic transfusions; no exchange transfusions in the previous 6 months
* iron overload documented by either liver biopsy, MRI or SQUID with estimated LIC of greater than 7 mg/g dry wt in the previous 6 months or ferritin level greater than 1500mg/dl.

Exclusion Criteria:

* Patients with HbSC, HbS/β thalassemia
* Pacemaker (active or inactive) or other implanted magnetic devices, severe claustrophobia, or other contraindications to MRI; Unable to remove ferro-magnetic objects from the body in regions to be imaged (e.g., jewelry or piercing)
* Presence of any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment;
* Any chronic inflammatory illness other than the SCD, THAL or DBA;
* Any acute illness within a 14 day period prior to blood sampling;
* Patients receiving intensive chelation in the 6 months prior to enrollment including deferoxamine 24 hours per day, 7 days per week or combination treatment with 2 chelators
* Pregnancy