cyrilzakka/clinical-trials huggingface dataset:
Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Single vs Double Catheter Procedure

Catheter ablation is recommended as first-line therapy for most patients with typical atrial flutter. The most common approach is to create an ablation line across the cavotricuspid isthmus (CTI). Traditionally, atrial flutter ablation has been performed with a conventional approach using two catheters, an ablation catheter and a duodecapolar catheter that is placed at the level of the tricuspid annulus to confirm the CTI block. Recently, a single catheter approach has been described using the behavior of PR interval change during differential pacing over the ablation line to prove CTI block. This prospective, randomized, multicenter study analyzes the effectivity of a single catheter approach compared with conventional approach in terms of clinical outcomes.

Typical atrial flutter is a reentrant rhythm in the right atrium that is constrained anteriorly by the tricuspid annulus and posteriorly by the crista terminalis and eustachian ridge. Catheter ablation is the first-line therapy for most patients with typical atrial flutter. The most common approach is to create an ablation line across the CTI, from the tricuspid annulus to the inferior vena cava. Traditionally, atrial flutter ablation has been performed with a conventional approach using two catheters, an ablation catheter and a duodecapolar catheter that is placed at the level of the tricuspid annulus that allows to evaluate the right atrial activation sequence to confirm the CTI block. Recently, a single catheter approach has been described using the behavior of PR interval (PRI) change during differential pacing over the ablation line to prove CTI block. The PRIs is measured for three different pacing site, 5 o'clock (medial to CTI line), 7 o'clock (lateral to CTI line), and 9 o'clock position. CTI block was assumed when the PRI at 7 o'clock was \>80ms longer than that at pacing sites of 5 o'clock and the PRI at 9 o'clock was shorter than the PRI at 7 o'clock. However, a direct comparison between this approach and the conventional one was not yet performed. This prospective, randomized, multicenter study analyzes the effectivity of a single catheter approach compared with conventional approach in terms of clinical outcomes. Our research hypothesis is that a single catheter approach has the possible advantages of being a faster, more efficient and cheaper procedure than the conventional approach. Moreover, as it only requires a single venous access, the risk of complications is decreased.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted at any of the centers to perform a CTI ablation.
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy.
* Impossibility to perform CTI ablation.
* Impossibility to measure PRI (complete atrioventricular block).
* Ablation of other cardiac arrhythmias during the same procedure.
* Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow

A randomized prospective controlled study aims to evaluate the effect of neuromuscular electrical stimulation on the renal function and renal blood flow of post partum women with acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or old and hemodynamically stable.
* Post-partum women who developed AKI.

Exclusion Criteria:

* Pregnant women .
* Patients who required any emergency or elective surgery during the study; those who presented acute heart or lung disease, skin rashes, tumors, infections, diabetes mellitus or hypoesthesia in the region that the neuromuscular electrical stimulation would be applied.
* Patients with a Pacemaker.
* Epileptic Patients.
* Patients with recent effects of stroke (less than 3 months).
* Uncontrolled hypertension (systolic blood pressure \> 230 mm Hg and diastolic blood pressure \> 120 mm Hg).
Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.

Chronic Obstructive Pulmonary Disease (COPD) is a condition characterized by a progressive and incompletely reversible limitation of airborne gas flow . The association of co-morbidities with COPD and acute flare-ups of respiratory failure contribute to the overall severity of this disease. The prevalence of COPD is high, affecting up to 10% of people over the age of 40 years and causing high morbidity and mortality rates. While COPD is a disease primarily affecting the lungs, it is associated with many extra-pulmonary conditions including sleep apnea, depression, anemia, chronic kidney failure, wasting, cardiovascular disease, skeletal muscle weakness and osteoporosis (OP).

Osteoporosis, characterized by bone quality disorders and low bone mineral density (BMD) leading to a high risk of fractures, is common in COPD patients. For example, studies have reported OP rates ranging from 9% to 69% in COPD patients. The explanatory factors for this low BMD are clearly multiple, involving to varying degrees of importance, vitamin D deficiency, depression, sedentary lifestyle, smoking, corticosteroids, low lean body mass and body mass index, chronic inflammation, low nutritional status, chronic hypoxia and hypercapnia. This is why patients with COPD have a high prevalence of fractures, particularly vertebral fractures (VF) ranging from 30 to 63% depending on the studies. In these patients the existence of thoracic VF is of crucial importance, as each VF is associated with a 9% decrease in the forced vital capacity of COPD patients.

For these reasons the latest HAS recommendations for COPD management indicate that the risk of osteoporosis should be systematically investigated and treated (HAS, 2014).

However, the relationship between densitometric variations and the presence of thoracic VF and the prognosis and severity of the disease is not yet very clear, as studies of these relationships have produced mixed results.

On the other hand, it is well established that patients with a recent diagnosis of COPD have a high prevalence of densitometric OPs and fractures.

Thoracic kyphosis is one of the determinants of the incidence of vertebral fractures. Increased thoracic kyphosis is associated with decreased physical capacity, increased risk of falls and abnormal respiratory function.

In addition, measurement of thoracic kyphosis was previously carried out either indirectly using point coordinates recorded in a database (patients were assessed in the supine position) or more directly using a ruler applied against the back.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman age \> 40
* FEV1/CVF ratio \< 0.7 as defined by the Global Initiative for Chronic Obstruction Lung Disease (GOLD).
* Moderate to severe COPD as defined by GOLD (grade C and D)

Exclusion Criteria:

* Presence of metal or plastic parts in the field of examination
* Pregnancy
* Patients who are not affiliated with or do not benefit from a social security system
* Person under guardianship or curatorship
General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty.

Primary endpoint: time from end of surgery until the patient is "street ready"

Secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? Is there any difference in post operative "dizziness" between the groups.

Hypothesis: General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total knee arthroplasty (TKA).

Primary endpoint: time from end of surgery until the patient meets the discharge criteria.

Secondary endpoints:

1. Will general anesthesia produce less post operative pain?
2. Is there any difference in post operative orthostatic function (dizziness) between the groups?
3. Time until the patient meets the discharge criteria from PACU
4. How many patients will need at least one urinary bladder catheterization?

Eligibility Criteria:
Inclusion Criteria:

1. patients with osteoarthritis scheduled for surgery
2. patients that will require Total Knee Arthroplasty
3. patients over 45 yrs and under 85 yrs
4. patients that understand the given information and are willing to participate in this study
5. patients who have signed the informed consent document

Exclusion Criteria:

1. prior surgery to the same knee
2. patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain
3. obesity (BMI\> 35)
4. active or suspected infection
5. patients taking opioids or steroids
6. patients suffering from rheumatoid arthritis or have a immunological depression.
7. patients who are allergic to any of the drugs being used in this study
8. patients with other severe medical problems that could affect the perioperative course.
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of GIST.
* Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
* Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease.

Exclusion Criteria:

* Current treatment with another investigational agent.
* Prior sunitinib treatment.
* Prior therapy with known risk for cardiovascular complications.
Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study

The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence.

Among people exposed to the COVID-19 (SARS-COV-2) pandemic, elderly people are considered as particularly vulnerable, especially those living in nursing homes or hospitalized. Furthermore, facilities / accommodations are registered among the main locations of COVID-19 clusters.

These observations have led the French government to establish specific protection measures and survey dependent care facilities for the elderly and long-term care units in the hospital.

With these new standards established, a long-term study of all the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), can provide additional knowledge on COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* residents of the dependant care facility for the elderly
* inpatients of the long-term care unit
* from march, 2020 to december, 2021

Exclusion Criteria:

* opposition to participate in this study
The Effect of Skin Laxity on the PICC

To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).

In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old;
* Patients who need PICC catheterization according to the doctor's advice;
* There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;
* There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before catheterization
* Patients who have not participated in other clinical studies;
* Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up

Exclusion Criteria:

* Known allergy to catheter material;
* The puncture site has a history of infection, injury and radiotherapy;
* The puncture site has a history of venous thrombosis or surgery;
* Severe abnormal bleeding and coagulation function;
* Superior vena cava compression syndrome;
* Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
* The ipsilateral limb of the pacemaker and the arteriovenous fistula;
* patient or her/his family members refuse to sign the informed consent form.
Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension

The study aims to investigate the characteristics of subjects with hypertension at onset among a cohort of apparently healthy subjects, with overweight or obesity (BMI ≥ 25 Kg / m2), and free of any drug treatment at the baseline. The evaluation includes anthropometric (weight, height, BMI, waist circumference), haematochemical (hormones, metabolic and routine) parameters and the screening for hypertension with ABPM. The diagnosis of hypertension is made in accordance with the 2017 guidelines of the American College of Cardiology / American Heart Association ACC / AHA.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias
Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Advances in surgical and clinical management of patients with congenital heart disease has made survival to adulthood an expectation. Today there are more than 1 million adult survivors of congenital heart disease, but increasing age brings additional concerns for this patient population. Although the literature remains scarce, existing evidence suggests that inactivity, obesity, diabetes, cancer, and acquired cardiovascular disease may be at least as prevalent in patients with congenital heart disease, if not more so, than in an age-matched general population. Acquired cardiovascular disease is likely to impact substantially on long-term survival and quality of life in these patients with palliated and already fragile hearts. This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female over 18 years of age
* Moderate or Complex Congenital Heart Disease
* Willingness to Consent

Exclusion Criteria:

* Pregnancy
* Surgery within 6 months
* Unrepaired cyanotic heart disease
* Patients with Eisenmenger Syndrome physiology
Methamphetamine Abuse Treatment in Patients With AIDS - 1

The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.


Eligibility Criteria:
Please contact site for information.
Management of Sepsis in Resource Limited Settings Using a Delphi Method.

Rapid evolution of sepsis syndromes means that timely diagnosis and treatment are critical in improving outcomes but this may be difficult to achieve in many low- and middle- income countries (LMICs) and there is a lack of high quality clinical evidence to guide diagnosis and management in LMIC settings. The wide variability in health systems in LMICs means that additional areas of guidance may be required where staff or facilities are lacking. In the absence of clinical data, to address some of these issues, the investigators aim to use Delphi methodology to obtain experts consensus statements on some specific aspects of sepsis management in LMICs.

The investigators aim to use a Delphi process to generate expert consensus practice statements in the context of diagnosis and management of sepsis in LMICs, including identification of aspects of sepsis diagnosis and management in LMICs not covered by existing guidelines. The questions will undergo several iterative rounds and will be in multiple-choice or Likert scale format. A study steering group will review the results of each round via video conference and design the questionnaire for the next survey. Summary results of each round will be presented to experts, along with the survey questionnaire for the next round. The survey process will be repeated with the modified questionnaire. The Delphi rounds will continue until the desired consensus and stability are achieved.

Eligibility Criteria:
Inclusion Criteria:

* Recognized experts meeting pre-defined criteria (below) from a wide geographical distribution with approximately 70% from LMICs.

  1. Clinical expertise in adult sepsis management, AND
  2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

     Exclusion Criteria:
ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity

This is an observational study to address the important knowledge gap of the metabolic and inflammatory impact of acute overeating and whether timing of acute overeating may modify these effects. The hypothesis is that acute overconsumption of calories will promote inflammation and metabolic dysfunction, with the most detrimental effects observed with evening caloric overconsumption. The expectation is that this study to provide critical insights into the biological consequences of overeating, which will direct novel approaches combating overeating and its detrimental health effects.


Eligibility Criteria:
Inclusion Criteria:

* ages of 18-65 years old
* not pregnant
* no comorbid conditions
* normal BMI (18.5 - 24.9 kg/m2)
* Weight ≥120 lbs self-reported weight

Exclusion Criteria:

* N/A
The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)

A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease


Eligibility Criteria:
Inclusion Criteria:

* Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease
* Inflammatory marker found in your blood, known as hsCRP \> 0.5 mg/L

Exclusion Criteria:

* Age \< 40 or \> 85
* Female
* Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months
* Liver diseased or abnormalities
* HIV infection
* Lupus, rheumatoid arthritis, cancer \<5 years
Effectiveness of Two Exercise Programs on the Neck.

The purpose of this study is to evaluate the clinical results in lower cervical range of motion, size deep muscles, endurance, craniovertebral angle and cervical propioception by a training protocol with the new device for cervical treatment (CDAT) and the conventional training protocol (CT) versus a control group (C) in subjects with cervical deep muscle strength deficit.

Neck pain is one of the major public health problems, which has a great impact on people's lives, with high prevalence and recurrence rate. Cervical vertebral column is heavily dependent on the muscles for its physical support and activities. There are increasing evidences to support that cervical muscles may impair in patients with neck disorders. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with strength deficit of deep cervical muscles, including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

Eligibility Criteria:
Inclusion Criteria:

* Deep flexor strength deficit in craniocervical flexion test.
* Deep extensor strength deficit in neck extensor muscle endurance.
* ≤ 14 score in Neck disability Index

Exclusion Criteria:

* Have received cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
* Have received cervical manual therapy treatment during the last six month.
* A history of cervical trauma or surgery during the last year.
* Chronic neck pain occurring during the last six months (intensity, visual analogue scale \>3/10, frequency \> 2 days/week, duration \>3 hours/day).
Feasibility Study on PoRi Device

This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone. The device's ability to improve spasticity before and after a 20-minute session with the device at Yale New Haven Hospital's outpatient clinic of Physical Medicine \& Rehabilitation, or the Inpatient Rehabilitation Unit.

Each patient will participate in a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and to measure the Modified Ashworth Score (MAS) before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Modified Ashworth Scale (MAS) score of at least 1
* Participants with paralysis or motor function problems of the fingers of one or both hands.

Exclusion Criteria:

* Minors (below age 18)
* Vulnerable populations
* Inability of fingers and wrist to stretch to neutral during passive range of motion