cyrilzakka/clinical-trials huggingface dataset:
Dysregulation of Lipid Metabolism and Right Ventricular Function in PAH

Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial hypertension (PAH). No RV-specific therapies are available, in part because the underlying mechanisms of RV dysfunction are poorly understood. Given the heart's preference for fatty acids (FA) as an energy source, a deeper understanding of FA metabolism may shed light on RV adaptation to elevated afterload in PAH. The purpose of this study is to test the hypothesis that defects in fatty acid metabolism are common in PAH and contribute to RV failure. The investigators will measure peripheral and transcardiac lipid and glucose metabolites in PAH patients in comparison with patients with pulmonary venous hypertension and no evidence of pulmonary hypertension. The investigators will also correlate metabolites with concurrent measurement of right ventricular function.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Scheduled to undergo cardiac catheterization (right ± left heart catheterization) and/or electrophysiology study in the VHVI cardiac catheterization laboratory (CCL)/electrophysiology laboratory (EP lab)
* Hemoglobin value ≥ 10 g/dL or hematocrit of ≥ 30% (measured on clinically-indicated blood draw within 30 days or a point-of-care measurement in CCL/EP Laboratory if clinically-indicated value is not available)

Exclusion Criteria:

* Any individual that is anemic and has a hemoglobin value \< 10 g/dL and hematocrit of \< 30% will be excluded from the study.
* If a physician performing the procedure believes that performing the extra steps and /or acquiring the additional blood samples will delay or otherwise compromise participants' care, he/she can abandon acquisition of those data at his/her discretion.
* Contraindication to cardiac MRI (applies only to patients undergoing CMR as part of this protocol).

  * Implanted ferromagnetic material
  * Glomerular filtration rate \< 60mL/min (measured on clinically-indicated blood draw within 30 days of CMR or a point-of-care measurement in the CMR Laboratory if clinically-indicated GFR is not available)
Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.

Three centers randomized simple blind clinical trial whose objective is to assess the efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized MG who have been stabilized since at least 6 months.

During the 3 months pre-inclusion phase, the characteristics of MG will be collected. Physical activity and performance will be assessed monthly.

MGQOL15 will be assessed at inclusion.

Patients will be randomized in either intervention arm or control arm.

The intervention arm will consist of three sessions exercise per week during three months. The daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability.

Physical activity will be measured with the help of an actimeter.

Once a month, MG evolution and tolerance to exercise will be assessed and MG treatment dose will be collected.

Exercise will be interrupted in case of MG exacerbation.

Quality of life and psychological status will be assessed at 3, 6 and 9 months.

Plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in order to assess the effects of exercise on immune response.

Patients enrolled in the control arm will benefit from the same follow-up but will not have exercise.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with generalized MG of stage II or III according to the MGFA classification, stabilized for at least 6 months. Criteria for MG are either

   * positive dosage of ant-RACh or MuSK auto-antibodies;
   * If absent, myasthenic symptoms decrement\> 10% in EMNG and test the positive prostigmine
2. Patient ≥ 18 and ≤ 70 years old
3. Patient having an health insurance
4. Informed written consent

Exclusion Criteria:

1. Patients under particular protection
2. Enrolment in another biomedical research in the last 3 months;
3. Patients for whom physical practice is contra-indicated because of :

   * Unstable coronary Syndrome or myocardial infarction within the past 3 months
   * Heart failure with systolic ejection fraction \< 50 %
   * Respiratory failure defined by a vital capacity (CV) \< 70 %
   * Stroke
   * Other neuromuscular pathology
   * Disabling Rheumatologic disease (\> 80 % disability according to the Barthel scale)
   * Chronic Pain or disabling orthopaedic conditions
   * Hospitalization in the last 3 months for a serious medical or surgical condition
   * Anemia (hematocrit \< 30%)
4. MGFA grade I, grade IV or V
5. Severe cognitive impairment
6. MGQOL-15 below 15/60
SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion

Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine, a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during posterior spinal fusion surgery before and after Dexmedetomidine administration.

Patients 18-75 years old, ASA (physical status classification system) I-III, scheduled for elective posterior spinal fusion surgery were enrolled in this prospective study. After induction in anesthesia, it was applied SSEP monitoring and a baseline test was performed after 15min (in order to wash out the propofol used for induction). Infusion of Dexmedetomidine was started at a bolus dose of 1mcg/Kg following by 0.7mcg/Kg. Bispectral Index (BIS) monitored the depth of anesthesia and an adequate level (40-50) of anesthesia was maintained by sevoflurane. SSEP were recorded intraoperatively from the tibial nerve (P37) and data were analyzed over that period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA physical status 1-3

Exclusion Criteria:

* Patients with ASA physical status \>3,
* Body Mass Index (BMI) over 30,
* indication for rapid sequence induction,
* any contraindication for receiving b-blocker,
* Glasgow Coma Scale (GCS) \<13,
* history of drug abuse,
* neurologic deficit or preoperatively foreseen delayed extubation,
* preoperative heart rate\<45.
Characterizing Sleep Among Long-term Survivors of Childhood Cancer

The patients are being asked to take part in this clinical trial because they received cancer treatment as a child at St. Jude. The study comprehensively examines sleep among three distinct diagnostic groups of survivors in the SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors.

Primary Objective

The primary aim of this protocol is to estimate the prevalence of various sleep disorders among long-term survivors of childhood ALL, CNS tumors, and non- CNS solid tumors.

Exploratory Objective

The exploratory objective of the study is to explore associations between the prevalence of sleep disorders and clinical outcomes collected in SJLIFE.

A cross-sectional pilot study that will enroll participants for on-campus or remote study activities. The investigators anticipate a targeted evaluable accrual of 120, 40 within each of the three groups identified above. The plan is to employ remote polysomnography and surveys to assess patterns of sleep disorders. These assessments could be done in the homes of survivors or during campus visits.

Eligibility Criteria:
Inclusion Criteria:

* Participant in SJLIFE and \> 5 years from diagnosis.
* \>18 years of age at time of enrollment.
* Diagnosed with ALL (treated with CRT or chemotherapy only) or CNS tumors (posterior fossa tumors or supratentorial tumors) or non-CNS solid tumors (with abdominal or chest radiation or bilateral retinoblastoma survivors).
* Participant was less than 21 years of age at time of diagnosis.
* Speaks and understands English (polysomnography device speaks to patients only in English).
* Remote participant must have Wi-Fi access

Exclusion Criteria:

* Estimated intelligence score \<80.
* Currently prescribed an intervention for a sleep disorder.
* Survivor of craniopharyngioma.
* Survivor of Hodgkin Lymphoma.
* Relapsed or treated with hematopoietic stem cell therapy.
* Brain injury unrelated to cancer diagnosis or therapy.
* Pulmonary injury unrelated to cancer diagnosis or therapy.
Analysis of the Impact of the Fragility of the Over 70 Years of TIAprognosis

Fragility, geriatric concept recent identification is defined by simple physical indicators. The literature suggests that it is related to the risk of hospitalization, falls, institutionalization and death. Some studies have shown a link with heart disease, including heart failure. The link with the TIA (transient ischemic attack) has however never been studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is unknown.

Several questions need to be asked: Among older patients hospitalized for TIA, what proportion of those completing the criteria of frailty? In this same population, is there a correlation between fragility and scores ABCD2 score itself predictive of the risk of subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher risk of ischemic stroke (which could cause a strengthening of prevention measures)?

Hypotheses :

* Frailty is common among the elderly patient population who have a TIA. Compared to control groups of literature.
* Patients with high fragility score ABCD2 also have a high score.
* Patients with a high score of fragility also have a significant number of vascular risk factors (including atrial fibrillation)
* Patients with a high score of fragility also have an average length of stay (ALOS) higher than the others. So underlying the question is: can we learn to better identify patients who are going to need a bigger structure their output at home.

objectives:

* Assess the feasibility of placing a fragile test in acute phase of AIT in USINV.
* To evaluate the frequency of frailty among the population of elderly patients who have a TIA.
* Compare in AIT over 70 years those with fragile high score to those with low scores, especially for ABCD2 score, vascular risk factors and the DMS.
* Statements parameters:

  o The fragility score:
* Choice of fragility score: among the fragility of scores, the most used in international literature is the score of Linda Fried. Moreover, the stress of the study is related to the environment of the USINV (shortly, short DMS, often tired patients). It is therefore important to use this study for a test only, but quick handover. The score Fried also has the advantage (J Gerontol A Biol Sci Med Sci 2001, 56 (3): M146-56) The first 4 items are simple clinical evaluation. The 5th (grip test) will be performed with a device (single gauge measuring the fingers bending strength) loan from the geriatric ward.

Eligibility Criteria:
Inclusion Criteria:

* The TIA is defined pragmatically: any sudden deficit with blood systematization ≤ 1 hour. Among these "TIA", we know that a subgroup may possibly have an MRI with diffusion lesion, indicating a recent ischemic stroke. This subgroup of transient accident is recognized as being at higher risk of recurrence. This criterion will be taken into account in the data analysis.

Exclusion Criteria:

* history of stroke with Rankin score of ≥ 2.
* Dementia
* Severe depression
* evolutionary Cancer
* Heart Failure
Educators' Digital Occupational Well-being Intervention During Working Hours

This controlled quasi experimental intervention study follows the MRC framework for complex interventions (Bleijenberg et al. 2018) aiming to promote educators' individual aspect of occupational well-being. The purpose of this study is: 1) to evaluate the effectiveness of 8-workweek SHINE (= Self-Help INtervention for Educators) on educator's individual aspect of occupational well-being comparing intervention and control groups and 2) to describe the possible associating factors for the effectiveness of the intervention (if any) and 3) to evaluate SHINE's acceptability (utility and usability) within intervention group.

Overall Occupation Well-being (OW) is seen through four aspects of working life: 1) workers's resources and work (individual aspect), 2) work community, 3) working conditions and 4) professional competence (Saaranen et. al 2007). This study focuses in the individual aspect of OW, worker's resources and work and associating factors. This evidence base digital SHINE intervention is conducted in Finland within five different social and health care educational organizations randomly allocated either in intervention group (n=2) or in control group (n=3). Participants are working as qualified full-time educators in these organizations; intervention group (n=39) and control group (n=41). The intervention consists of four components: 1) physical activity, 2) recovery, 3) self-regulation and 4) workplace support designed to promote worker's resources at work. First three of these components are in digital program called, Smart Break SHINE. Educators' does short 3 minute exercises twice/workday (movement and breathing mind/body exercises) and additionally completes weekly reflective wellness actions during working hours. Last component, workplace support, comes from educators' organizations enabling time support and encouraging educators' to conduct these exercises during working hours taking approximately 10-15 min/workday. Control group continues their normal daily routines without this program.

Aim of this intervention is to promote educators' individual aspect of occupational well-being, the balance between individual resources and workload factors, during working hours. Main outcome is resource-workload-balance (RSW) and heart rate variability (HRV) and secondary outcomes are general well-being (GW) and overall occupational well-being (OW). Other outcomes are SHINE-components being associating factors in individual aspect of OW, physical activity, recovery, self-regulation and workplace support (condition outcomes). Also the usability and utility of the intervention is studied from the intervention group after using the program 8 workweeks.

Eligibility Criteria:
Inclusion Criteria:

* Working as qualified educator (at least qualification of EQF 7) in secondary health and social care education
* Full-time work contract
* Having at least one-year employment in the organization

Exclusion Criteria:

* having pacemaker or being pregnant (cause of the HRV measures)
Fluid Kinetics in Patients With Diabetic Ketoacidosis

The purpose with the study is to follow the fluid shifts that occur during fluid resuscitation of patients with diabetic ketoacidosis.

In the study measurements of changes in blood and urine concentrations of Sodium and Chloride as well as blood hemoglobin are used to mathematically calculate changes in distribution volumes of these different endogenous markers.

Patients treated for diabetic ketoacidosis receive 1000 ml of Sodium Chloride during the first 30 minutes of treatment.

Before, during and after this infusion regular blood samples(and urine) are collected (0, 10, 20, 30, 35, 40, 45, 50, 60, 120, 180 and 300 minutes after infusion start).

B-Hemoglobin, P-Albumine, B-Glucose, P-Sodium, P-Potassium. P-Chlorides, U-Sodium, U-Chloride and U-Glucose. Hourly volume of urine is measured.

The 30 minute infusion can be used to calculate the urine extracellular volume. Thereafter during infusion of Ringers acetate changes in electrolytes in blood as well as urine volume and in the urine excreted electrolytes can be used to calculate the fluid shifts between the different fluid compartments.

Eventually 8 to 12 hours later a second infusion of SodiumChloride is as a control performed.

Eligibility Criteria:
Inclusion Criteria:

* diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.

Exclusion Criteria:

* unconscious patient
Patient Education in Pregnant Women With Asthma

Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant women with asthma

Exclusion Criteria:

* women not able to speak and/or read French language
* women protected by the law
Can Video Assisted Therapy Replace In-Person Occupational Therapy After Hand Surgery: a Noninferiority Study

This study will investigate a video assisted, home therapy program where participants complete hand therapy on their own following thumb arthroplasty. In this program, participants will receive prerecorded informational videos. Half of the participants in this study will do standard of care, in-person therapy. The other half will be enrolled in the home therapy program. Participants will fill out an assessment of their physical ability before surgery and again three months after surgery. These assessments will be compared between groups. The study team hypothesizes that the video-assisted, home therapy program will be noninferior to traditional in-person therapy.

Current postoperative hand therapy regimens can be burdensome to patients and non-compliance rates are high. Our service area has a lack of hand therapists in the rural areas and the most common barrier to receiving care is access and transportation. In-person therapy requires patients to have significant flexibility in transportation, work schedule and childcare. Travel time and distances put patients who are already disadvantaged at an increased risk of failed treatment. Furthermore, our hand therapy clinics have high utilization after first CMC arthroplasty (thumb joint replacement) procedures, for which therapy is protocol-driven and results are predictable-two aspects that lend this procedure to amenable results from a virtual, unsupervised program.

This study's central hypothesis is that video assisted therapy can be used in postoperative hand therapy without a change in subject outcomes. In this study, the investigators choose to study therapy for one of the most common postoperative diagnoses seen in Carilion Clinic's hand therapy clinics: thumb arthroplasty (replacement of a thumb joint).

Specific Aim 1 is to determine if a video-assisted, home therapy program (pre-recorded instructional videos) can effectively replace in-person occupational therapy for thumb arthroplasty.

Hypothesis: Outcomes of a therapy program consisting of pre-recorded instructional videos will be noninferior to the standard of care regimen for thumb arthroplasty.

The significance of this study is that it investigates a home therapy solution that the investigators expect to increase access to healthcare in rural populations. This study is novel because it will be the first prospective, randomized control trial to investigate the utility of video-assisted home therapy following hand surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective carpometacarpal (CMC) arthroplasty (CPT code 25447)
* Access to a cellphone, tablet or home computer that is connected to internet and has a 5.5" or larger screen

Exclusion Criteria:

* Bilateral procedures
* Revision procedures
* All concomitant procedures, except MCP fusion, CTS release, and thumb trigger finger release
* Artificial CMC joint replacement
* Inability to provide informed consent for the study
* Non-native English speakers
Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

The clinical trial portion of this study tests the hypothesis that contingency management-based incentives for primary care patients with substance use disorders to attend treatment services will increase treatment initiation and engagement. The investigators are investigating whether this approach that has been found effective in specialty treatment settings will work in the primary care context, in conjunction with screening.


Eligibility Criteria:
Inclusion Criteria:

* Positive self-report alcohol or drug use screen in primary care
* Diagnosis of substance use disorder
* age 18 or older

Exclusion Criteria:

* SUD treatment in past 60 days
* cognitive impairment
Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study

This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.

The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.

The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.

Finally, the investigator is looking into changes in vascular biology markers (P-selectin and e-selectin) on melatonin.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 18 to 64
* Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) \>115 mmHg))
* Taking no more than 2 antihypertensive medications
* African-American race (self-defined by the participant)

Exclusion Criteria:

* Secondary forms of hypertension
* Presence of other diseases requiring treatment with BP lowering medications
* Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and transient ischemic attacks)
* Diabetes mellitus (type 1 or 2)
* Cancer/Malignancy other than nonmelanoma skin cancer
* Primary renal disease
* Serum creatinine \> 1.5 mg/dL in men or \> 1.4mg/dL in women
* Severe anemia
* Liver enzymes \> 2.5 times upper limits of normal
* Hepatitis B, Hepatitis C, or HIV positive as assessed by questionnaire
* Current treatment with or regular use of calcium channel blocking agents, cyclooxygenase-2 or COX2-inhibitors, oral contraceptives, estrogen, sildenafil, vardenafil, tadalafil, antidepressants, corticosteroids, or warfarin
* Current use of melatonin or any sleep aids containing melatonin.
* Regular consumption (1 or more times per week) of any of the following of Vitamin methyl B12, St. Johns Wort, Feverfew, black and white mustard seeds, wolf berry seed
* Severe Sleep apnea
* Night work
* Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.