cyrilzakka/clinical-trials huggingface dataset:
Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity

This is a randomized prospective study to evaluate the effectiveness of a family-based intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18 years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic multidisciplinary "Be Well" pediatric obesity clinic.


Eligibility Criteria:
Inclusion Criteria:

* Be Well patient
* Age 8\*-18 years
* BMI \> 95%ile
* English speaking

Exclusion Criteria:

* Uncontrolled asthma
* Orthopedic or other medical issue limiting mobility
* Participant has worn an activity-monitor in the past 6 months (ok if parents wear)
Quality of Life Following Radical Prostatectomy

This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn what impact the surgery has upon the participant's sense of health, sexual and urinary quality of life.

To define impact on quality of life issues for patients undergoing radical prostatectomy. This study will distribute a questionnaire to patients who are being scheduled for radical prostatectomy, both before and after surgery, to assess the impact on quality of life issues. This will provide important information regarding the temporal return of issues pertaining to quality of life.

Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled to undergo radical prostatectomy at Stanford

Exclusion Criteria:

- Patients treated with neoadjuvant or adjuvant hormonal therapy or radiation therapy
Tailored Radiofrequency Ablation of Uterine Myomas

To perform the use of radiofrequency myolysis (RFM) for the treatment of intra-uterine fibroids through less invasive access by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy

Given that the RF ablation of solid tumors of the liver and other organs is successfully used as a usual approach, the investigators have decided to transfer this technology to an original treatment of uterine fibroids. The access to each individual fibroid was determined considering passage of the needle towards its centre through only compromised tissue and by the shortest possible route by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy. To optimize radiofrequency myolysis, in fact, the investigators decided to improve the procedure by inserting three innovative elements: application of a virtual needle tracking system to follow the RF electrode during the ablation session, real-time monitoring of RF ablation by contrast-enhanced ultrasound and systematic biopsy of the lesions before electro-coagulation.

Eligibility Criteria:
"Inclusion Criteria":

* women who had symptomatic myomas with diameters ranging between 1.2 and 7.7 cm. - patients who had declined hysterectomy or laparoscopic myomectomy
* submucosal fibroids with intramural extension ≥50%
* intramural fibroids (FIGO G3 / G4 types)
* subserosal fibroids (FIGO G5 / G6 types)

"Exclusion Criteria":

* Women with intracavitary (FIGO G0 / G1 types) or subserosal-pedunculated fibroids / (FIGO G7 types)
* genital malignancy
* cervical dysplasias
* pelvic infection / adhesions
* severe systemic diseases
* pregnancy
* deeply infiltrating endometriosis
* patients who took gonadotropin-releasing hormone therapy or acetate ulipristal within 6 months
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (AVG) in the upper extremity to start or maintain hemodialysis therapy
2. At least 18 years of age at screening
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit
4. The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally provided written informed consent
5. The patient has been informed and agrees to pre- and post- procedure follow-up
6. Life expectancy of at least 12 months

Exclusion Criteria:

1. History or evidence of severe cardiac disease (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (EF) \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
2. Uncontrolled or poorly controlled diabetes
3. Abnormal blood values that could influence patient recovery and or/ conduit hemostasis
4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
5. Any active local or systemic infection
6. Known heparin-induced thrombocytopenia
7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
9. Anticipated renal transplant within 6 months
10. Known or suspected central vein obstruction on the side of planned conduit implantation
11. Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
12. Previous enrolment in this study
13. Subject is participating in another study
14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:

1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
2. How does the quality of life changes after orbital radiotherapy?

Participants have active moderate-to-severe Graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. During the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.

Orbital radiotherapy is a well-established second-line therapy for moderate-to-severe forms of Graves' orbitopathy. However, the question about it efficacy is still controversial. The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:

1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
2. How does the quality of life changes after orbital radiotherapy?

Participants have active moderate-to-severe Graves' orbitopathy untreated or already treated with systemic glucocorticoids and are referred to low dose fractionated orbital radiotherapy, total dose 20 Gy divided into 10 sessions, 2 Gy for each session. A concomitant intake of low-dose glucocorticoids is prescribed to all patient. During the follow-up period they undergo regular ocular examinations (at 1st, 3rd, 6th and 12th month), which includes comprehensive ocular status, hormonal and immunological testing and evaluation of the current therapeutic response. The patients also fill out a disease-specific questionnaire (at 3rd, 6th and 12th months).

Eligibility Criteria:
Inclusion Criteria:

- Active moderate-to-severe Graves' orbitopathy

Exclusion Criteria:

* Contraindications for orbital radiotherapy
Tendon Transfer for Irreversible Radial Nerve Palsy, Does it Help?Retrospective Cohort From Level-1 Trauma Center.

Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. There are three aims in the treatment of radial nerve palsy which comprise the restoration of thumb extension and abduction, finger extension and restoration of wrist extension. In this study we measured the functional outcome after tendon transfer for radial nerve palsy aimed to restore the wrist extension, finger extension and thumb extension/abduction. Investigators' objective was to assess the functional outcome after tendon transfer surgery for radial nerve palsy.

Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. There are three aims in the treatment of radial nerve palsy which comprise the restoration of thumb extension and abduction, finger extension and restoration of wrist extension. In this study we measured the functional outcome after tendon transfer for radial nerve palsy aimed to restore the wrist extension, finger extension and thumb extension/abduction. Investigators' objective was to assess the functional outcome after tendon transfer surgery for radial nerve palsy. So investigators conducted a retrospective study at Aga Khan University Hospital Karachi comprising records of patients operated for irreversible high radial nerve palsy. Investigators concluded that tendon transfer surgery for radial nerve palsy provides excellent results to restore the lost function and therefore must be considered for patients with no signs of recovery after the nerve repair.

Eligibility Criteria:
Inclusion Criteria:

* All participants including paediatric and adult age group with irreversible radial nerve palsy and patients with radial nerve palsy with time interval of more than 9 months were included.

Exclusion Criteria:

* All participants who underwent radial nerve repair or nerve grafting with or without internal splinting, patients with vascular injuries, muscular dystrophies, CVA (Cerebero-Vascular Accident), Dementia and those with limited followup of less than 3 months were excluded.
Evaluation of Mobile Apps for Informal Caregivers of People Living With Dementia

The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.

Informal caregivers of people living with dementia experience stressors that are associated with adverse health outcomes. Mobile applications (i.e., apps) could potentially improve the delivery and increase access to interventions. Although apps for informal caregivers of people living with dementia are available, empirical evidence to support their effectiveness is limited. The evaluation will be conducted by recruiting informal caregivers of people living with dementia. Participants will be randomly assigned to one of the two app-using groups or a wait-list condition. In the rare event that a participant experiences issues downloading an assigned app (and before commencing the 2-week period), participants will be randomly assigned to one of the other two conditions. Participants in the app-using groups will be asked to use their app for a 2-week period, and burden, stress, overall health, and knowledge will be assessed before, after the 2-week period, and at a 3-week follow-up. Subjective app ratings and usability of apps will be collected after the 2-week period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Interviews will be conducted, and textual data will be analyzed thematically to examine caregiver experiences, perceptions of caregivers in using selected apps, and preferences and needs of caregivers in the development of future apps. Findings from the proposed investigation can help guide caregivers in choosing the apps that best address their needs. Moreover, findings from the investigation can inform future developments of apps to address the needs of caregivers of people living with dementia.

Eligibility Criteria:
Inclusion Criteria:

* providing informal care for a person living with dementia (e.g., informal caregivers who are non-professionals; this may include immediate family members such as spouses, children, and other relatives, friends)
* living with or providing primary care for the person living with dementia (i.e., the care recipient is not in a long-term care facility)
* providing unpaid care
* own a smartphone (i.e., an iPhone or Android and/or can access either IOS or Android platforms)

Exclusion Criteria:

- using an app for caregiver stress/burden
Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery

Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.

In cardiac surgical patients, RV dysfunction is associated with organ hypoperfusion and venous congestion leading to increased morbidity and mortality.

Non-invasive methods used to assess RV function are 2D-echocardiographic measurement of tricuspid annular plane systolic excursion (TAPSE), RV ejection fraction (EF), RV fractional area change (FAC), 3D assessment of RV function, tissue Doppler assessment of velocities, and magnetic resonance imaging (MRI). Though MRI is the gold standard method to assess RV function, it cannot be used in the perioperative period.

In the present prospective observational study, The investigators investigated the association between the pattern of portal venous flow and RV function as assessed by echocardiography in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Ability to provide an informed consent
* Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.

Exclusion Criteria:

* Insufficient echogenicity
Diaphragmatic Functional Electrical Stimulation in Heart Failure

Heart failure is an incapacity to provide adequate blood flow to the others organs, such as brain, liver and kidney. The patients presents weakness and fatigue of inspiratory muscles, mainly diaphragm muscle, that contributes to dyspnoea and limited physical capacity in this patients.

Some methods are being studied to decrease the diaphragm weakness. The diaphragm functional eletrical stimulation is a new technique, which has been studied to improve the respiratory muscle strength. Then, the aim of this study is to assess the effects of diaphragm functional electrical stimulation (FES) on respiratory muscle strength and muscle architecture of patients with heart failure.

For this the following assessments will be performed before and after stimulation: manovacuometry to verify the maximum inspiratory pressure and maximum expiratory pressure; and ultrasonography to assess muscle architecture.

The subjects will be selected by the decompensation in heart failure, with the adequate elegibility criteria. This study have no control group, because this technique has been little researched and could be unethical with the patient who won't receive this treatment.

The subjetcs of this research will receive the diaphragm functional electrical stimulation twice of day for consecutive five days or until the hospital discharge.

Expected results at the end of the protocol with Diaphragm Functional Electrical Stimulation are: to improve respiratory muscle strength; to correlate with diaphragm muscle arquiteture.

The research will be developed in the São Francisco Hospital, of Santa Casa de Misericordia de Porto Alegre. After the selection of patients for eligibility criteria they will be evaluated, and subsequently the patients in will be trained twice of day for five days or until hospital discharge. Will be use an electric current called functional electrical stimulation through the stimulator device NEURODYN II, IBRAMED mark, Amparo, São Paulo, Brazil.

Each session will last 30 minutes. The parameters selected in the stimulator will be: 80 Hz frequency, 0.4 ms pulse, rise 1s, 1s time on, decay 2s, 1s time off, intensity as patient tolerance.

The patient will be positioned supine, headboard 30º, knees extended. Furthermore, the electrodes used to perform the electrical stimulation will be adhesive, disposable and hypoallergenic. These will be placed at sixth, seventh and eighth intercostal spaces, axiliar medium line and paraxiphoid both chest sides.

At the end of follow-up, will be compared the data of before and after interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure, being admited at the hospital for decompensation of the disease

Exclusion Criteria:

* Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
* Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change;
* Use pacemaker, cardiac resynchronization and/or implantable cardioverter defibrillator;
* Body mass index \>40Kg/m²
KETOgenic Diet Therapy in Patients With ACROmegaly

Acromegaly is caused by a tumour located at the base of the brain in the pituitary gland that produces too much growth hormone (GH). Symptoms caused by the excess of GH, and consequently increased insulin like growth factor 1 (IGF-1), are disproportionate growth of body parts, fluid retention, snoring and excessive perspiration. The various metabolic changes that occur due to acromegaly increase the risk for insulin resistance, diabetes mellitus, arterial hypertension, sleep apnoea and thus an increased risk of cardiovascular disease if left untreated. The result is signs and symptoms, increased mortality, morbidity, and greatly reduced quality of life (QoL). Normalisation of GH and IGF-1 gives a normalisation of mortality, however morbidity and QoL do not (completely) normalise. After surgery, a somatostatin analogue is the primary medical treatment, however, normalisation occurs in only 40% of patients.

Recently, in a proof-of-principle study, the researchers showed that a 2-week ketogenic diet (low in carbohydrates) in patients with somatostatin analogues could significantly reduce IGF-1 values. Patients felt better and sometimes even needed less somatostatin analogues. This proof of concept led to the new hypothesis that acromegaly patients with somatostatin analogues should possibly be treated with a eucaloric low-carbohydrate ketogenic diet for a longer period of time to improve their biochemistry, symptoms and QoL. Additionally, this diet can make a significant contribution in the treatment of insulin resistance and glucose intolerance that often occur in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older
* Diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor
* IGF-I levels above 80% upper limit of the normal range (xULN)) on a stable medication dose for at least 4 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Pegvisomant treatment
* Has undergone pituitary surgery or radiotherapy within 6 months prior to s study entry;
* It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study;
* History or presence of epilepsy;
* Participation in a trail of an experimental drug or device within 30 days prior to screening;
* Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
* Screening HbA1c \> 6,5%;
* Use of antidiabetic medication other than Metformin
Influence of Students Behaviors on Performance and Quality of Life on the OSCE

The students behave differentially before an exam. This study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their OSCE.

The students behave differentially before an exam. They can be discriminate, on their sleeping, coping, or physical activity behavior. They also show difference in the number of hours they study by weeks or if they use the services offer by their university.

This study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their OSCE (a major exam).

Eligibility Criteria:
Inclusion Criteria:

* all volontary medical students of the third cycle that came for their exam during the sessions of December and May 2023 from the University of Lyon (Medecine ESt)

Exclusion Criteria:

* no exclusion criteria
Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

Recent years, the European Association for the Study of the Liver-chronic liver failure (EASL-CLIF) has defined and graded acute-on-chronic liver failure (ACLF) based on CANONIC study which enrolled cirrhotic patients with acute decompensation. However, the characteristics and definitions of ACLF in non-cirrhotic patients with acute deterioration of liver function and organs injury or failure remain to be clear. As for patients who don't fulfil ACLF criteria, there might be a subgroup with high risk of progression (\>25%) and a moderate 4-week mortality rate (\>7%), which can be defined as "pre-ACLF", while the others are just chronic liver disease with "mere" liver injury or decompensation. This stratification system was primarily verified in a previous retrospective cohort which enrolled Hepatitis B patients only. The stratification criteria for chronic alcoholic liver disease needs to be further defined in detail. Therefore, investigators plan to prospectively recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24 hepatology departments in China, aiming to propose a stratified diagnostic system for chronic alcoholic patients based on organs injury. Meanwhile, risk factors of disease progression and short-term mortality will be analyzed, while characteristics and prognosis will be compared between patients with and without cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. Long-term alcohol consumption (at least one of the followings):

   1. \>40g/d for male and \>20g/d for female, at least for 5 years;
   2. \>50g/d for at least 6 months;
2. Liver injury (at least one of the followings):

   1. AST\>1.0 ULN and AST\>ALT;
   2. TBIL\>2.0mg/dl;
   3. Ascites;
   4. Hepatic encephalopathy;
   5. Esophageal variceal bleeding;
   6. Hypersplenism

Exclusion Criteria:

1. Younger than 18 or older than 80;
2. Other etiologies rather than alcoholic liver disease, including but not limited to the followings:

   1. Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV, etc.
   2. Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease
   3. Inherited metabolic liver diseases: Wilson disease;
   4. Others: Schistosomiasis
3. HIV antibody positive;
4. Malignancies including but not limited to HCC;
5. Pregnancy;
6. Hospital stay less than 24h;
7. Refuse to sigh the informed consent;
8. Combined with other improper situations determined by investigators.