cyrilzakka/clinical-trials huggingface dataset:
Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers

The aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT.


Eligibility Criteria:
Inclusion Criteria:

* WHO performance index ≤ 2
* Age \> 18 years
* histologically proven carcinoma: Anal canal cancer locally advanced (\> 4 cm and / or N1 to N3) under irradiation on pelvic and inguinal lymph nodes with concurrent chemotherapy. The boost with brachytherapy are accepted Prostate cancer with pelvic lymph nodes and radiation or hormone therapy Cervical Cancer under a purely medical treatment involving irradiation on pelvic lymph nodes and primary tumor with concurrent chemotherapy without surgery. The Boost by external radiotherapy or brachytherapy are accepted.
* The investigator must ensure that the patient has not expressed its opposition to participate in this study. The signing of a consent form is optional;

Exclusion Criteria:

* History of invasive cancer other than basal cell carcinomas.
* Indication of re-irradiation
* para-aortic radiotherapy associated with pelvic irradiation.
* post-operative radiotherapy.
* geographical distance
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients

The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of transesophageal echocardiography. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as oropharyngeal mucosal injury and hematoma.

Eighty adult patients, who received general anaesthesia for elective open heart surgeries that required transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group C), and videolaryngoscope group (group VL).

Success rate of the selected technique (first attempt and overall), duration of insertion for selected technique, complications such as oropharyngeal mucosal injury and hematoma will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received general anaesthesia for open heart surgeries that required transesophageal echocardiography probe insertion

Exclusion Criteria:

* patients younger than 18 years and older than 70 years
* oropharengeal infection
* esophageal injury and anatomic abnormalities
* known or predicted difficult airway
iTBS in Refractory Pediatric Depression

This work will mark the first step in understanding the neural targets for rTMS in youth with difficult to treat depressive symptoms, creating benchmarks for optimizing the safety and efficacy of rTMS for pediatric populations through precision targeting, and encourage funding applications for larger sham- controlled randomized clinical studies.

Problem Statement: Depression is a global health problem with limited novel and targeted solutions. Currently available interventions (medication and psychotherapy) have failed to provide adequate clinical improvement in 40% of adolescents with depression and only produce remission in 30% of youth. There is a clear need to develop better targeted interventions for this growing population of youth.

Specific Aims Aim 1: To examine the efficacy of a targeting strategy to optimize repetitive transcranial magnetic stimulation (rTMS) delivered to the left dorsolateral prefrontal cortex (DLPFC) to reduce depressive symptoms in adolescents between 12-17 years of age. Hypothesis 1: Six weeks of open-label daily intermittent theta-burst stimulation (iTBS) sessions delivered to the left DLPFC will be effective at reducing depressive symptoms between baseline and 10- week follow-up. Hypothesis 2: iTBS over left DLPFC will decrease functional connectivity between left DLPFC and subcallosal cingulate cortex (SCC) and will reduce depression-related hyperconnectivity between nodes of the default mode network (DMN). Hypothesis 3: Higher anti-correlation between left DLPFC and SCC and lower cingulate glutamate concentrations will predict better clinical outcome following iTBS.

Aim 2: To determine the tolerability of iTBS in adolescents between 12-17 years of age. Hypothesis 1: iTBS will be well tolerated without any more than minimal side effects. Hypothesis 2: iTBS will result in sufficient cortical excitability, as measured by 64-channel-EEG pre, during, and post iTBS, to induce an antidepressant effect but not induce seizures or other adverse events.

Eligibility Criteria:
Inclusion Criteria:

* 10 participants ages 12-21 years of age
* with at least moderate to severe depressive symptoms confirmed by the Children's Depression Rating Scale-Revised (CDRS-R\>40) or Hamilton Rating Scale for Depression (HRSD-17 ≥ 18)
* able to commit to protocol schedule and provide Informed consent by a legal guardian and assent by a youth participant
* have had at least one prior antidepressant treatment failure with adequate dose and duration

Exclusion Criteria:

* prior neurological diagnosis (neurodevelopmental disorders, strokes/traumatic brain injuries, brain tumor, epilepsy)
* contraindications for TMS or MRI e.g. have any implanted metal
* unstable medical conditions
* acute suicide risk, defined as an attempt in past 6 months that required medical treatment, or history of ≥2 suicide attempts in the past 12 months, or has a clear cut plan for suicide
* pregnancy, suspected pregnancy or not on birth control if sexually active; 6) Inability to locate and quantify a motor threshold
* any factor that the PI determines to be reason for exclusion.
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily


Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.

1. Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)
2. Patients who are 50 years or older
3. Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
4. Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)
5. Patients who have at least two of the following risk factors:

   * diabetes
   * hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension
   * smoker (at the time of onset of cerebral infarction)
   * obesity (Body mass index (BMI) is more than 25 kg/m2)
   * previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)
   * end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)
   * hyperlipidaemia

Exclusion Criteria:

1. Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours
2. Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism
3. Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study
4. Patient with hypersensitivity to dipyridamole preparations
5. Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma
6. Patients with a history of peptic ulcer
7. Patients having undergone arterial reconstruction after development of cerebral infarction
8. Patients with very severe impairment (4 or 5 on Modified Rankin Scale)
9. Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)
10. Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)
11. Patients with complications such as serious cardiac, renal and hepatic disorders
12. Patients with a malignant tumour or having had a tumour treatment in the past 5 years
13. Women who are or may be pregnant or lactating women
Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty

Background:

Progressive strength training is a training modality used in rehabilitation after total knee arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be present in the operated leg after TKA, which relates to reduced central nervous system (CNS) activation of the muscle. As increased CNS activation occurs during strength training when muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this also is the case after TKA. The clinical implication is that repetitions performed to contraction failure during strength training, may help reduce CNS activation deficits of the quadriceps muscle after TKA.

Purpose:

The aim of this study is to investigate CNS activation of the quadriceps muscle during strength training performed with repetitions to contraction failure after TKA.

Method:

Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure, etc.) of the set to failure.

Hypothesis:

Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA, the EMG amplitude will increase while the median power frequency will decrease during a strength training set performed to contraction failure after TKA.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary TKA
* Between the age of 18 to 80 years
* Understand and speak Danish
* Informed consent
* 4 to 8 weeks after TKA

Exclusion Criteria:

* Disease/Musculoskeletal disorder, which requires special rehabilitation modality
* Alcohol and drug abuse
* Lack of wish to participate or unwillingness to sign an informed consent
Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality at 30 days in case of subarachnoid hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* subarachnoid hemorrhage by aneurysm rupture
* severe intraventricular hemorraghia

Exclusion Criteria:

* pregnant women
* hemostasis disturbance
Diaphragm Ultrasound in Neuromuscular Disorders

Muscular dystrophies are neurologic disease with higher morbidity and mortality. Cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . Lung function is classically assessed with functionnal pulmonary tests (FPT) . Ultrasound recently emerged as a non-invasive tool to assess diaphragm function.

The aims of the study are:

* to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies
* to assess the correlation between diaphragm ultrasound and FPT
* to assess the correlation between diaphragm ultrasound and cardiac function


Eligibility Criteria:
Inclusion Criteria:

* Duchenne muscular dystrophy,
* Becker muscular dystrophy,
* LGMD,
* myotonic dystrophy type 1 and type 2,
* metabolic myopathy,
* mitochondrial myopathy,
* FSHD1 and 2,
* myasthenia

Exclusion Criteria:

* history of cardiac surgery
* history of thoracic surgery
* brain traumatism
Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients

To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.

Exclusion Criteria:

* Subject not qualifying because of physical or psychological condition that may put them at risk of participating.
Empagliflozin to Prevent Post-Operative Atrial Fibrillation

This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2I), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated CABG. This trial will be conducted in two referral teaching cardiology hospitals in Tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (CABG) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.

Study aim: Evaluating the role of empagliflozin on the rate of postoperative atrial fibrillation in comparison with placebo Design: Two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial on 492 patients Settings and conduct: Recruitment site: Tehran Heart Center and Rajaie Cardiovascular Medical and Research Center For blinding, the drug or placebo will be given to the ward based on the patient's code in the randomization system For monitoring, the blood samples for creatinine, sodium, potassium, and fasting blood sugar along with clinical evaluations will be given on day 0 and daily thereafter (max= 30 days) in specific wards and will be compared at the end of any atrial fibrillation lasting longer than 30 seconds based on 24-hour 12-lead ECG monitoring will be accepted as atrial fibrillation After entering the study, the patients are placed in one of two groups, sample and control; in the sample group, they are treated with the usual treatment regimen plus empagliflozin at a dose of 10 mg during the hospitalization period. Patients in the control arm will receive a matching placebo.

Eligibility Criteria:
Inclusion criteria

* Adult patients (≥18 years) who are candidates for isolated CABG
* Patients who provided written informed consent and are willing to participate in the study

Exclusion criteria

* History of type Ⅰ or Ⅱ diabetes mellitus
* History of ketoacidosis
* History of atrial fibrillation or flutter
* History of recurrent UTI
* SGLT2I or any other oral hypoglycemic medications used due to other indications
* Patients with acute kidney injury (45)
* Severe hepatic disease (Child-Pugh score C)
* Patients with Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m2
* Patients who are candidates for emergent CABG
* Patients with unstable hemodynamic state
* Patients with positive urine culture, urinary symptoms (frequency, dysuria, hesitancy), and asymptomatic bacteriuria
* Patients who are enrolled in other clinical trials
* Patients with a history of drug-sensitive reactions to SGLT2I
* Pregnancy or lactation
Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk of developing mental health issues. Despite this, they experience especially long wait-times for mental health services. To date, there has been minimal research into developmentally appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs) are emerging as a potential treatment to address this need. MBIs are group-based psychological treatments for coping with distress, with the goal of improving mental health. Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and are therefore not sufficiently feasible for the demanding schedules of EA university students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health symptom burden, well-being and reducing acute stress symptoms. The brevity of these interventions make them theoretically better suited for EA university populations. High quality research, including controlled clinical trials are needed to demonstrate whether MBIs can provide efficacious treatment to improve the lives of EA university students. The current study will test the efficacy of a five-week MBI baseline within-subject controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* consenting Emerging Adults
* Ability to communicate, in written and spoken English

Exclusion Criteria:

* Minimal depressive and anxious symptoms (score below 10 and 8 on the PHQ-9/GAD-7
* Current substance abuse or dependence, psychosis or mania
* Current self-injurious behavior of past suicide attempt
* Previously completed \>4 weeks of an MBI, or general Cognitive behavioral Therapy, in the past 3 years
Registry for Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2

Objectives:

To contribute new and prospective data to our existing database library for patients with MEN1 and MEN2 at The University of Texas M.D. Anderson Cancer Center.

Previously followed MEN1 and MEN2 patients at M.D. Anderson Cancer Center will be mailed an introductory letter and a "consent to be contacted" form to determine whether they are interested in participating in the study. New MEN1 and MEN2 patients seen in clinic at M.D. Anderson Cancer Center will be asked if they wish to learn more about this study. Interested patients will also be asked to distribute the introductory letter and consent to be contacted form to their blood relatives. Printed materials regarding this study will only be mailed to non-MDACC individuals with the expressed written or verbal permission from a consenting MDACC patient. All interested individuals will return the signed "consent to be contacted" form to the PI. Consented individuals will be interviewed by phone and/or mail to obtain updated family and medical history specific to their diagnosis of either MEN1 or MEN2. To verify accuracy of medical data collected, all non-MDACC participants will be asked if they consent to have their off-site medical records released to us for review. There will be no treatment or collection of blood or tissue in this study.

Although this study presents minimal risk to participants, participant consent will be obtained due to the need to obtain permission to make contact with patients and their families.

Approximately 1500 patients and their relatives will be included in this study. This will be done on an inpatient and outpatient basis.

Eligibility Criteria:
Inclusion Criteria:

1. Registered MDACC patients diagnosed with MEN1 or MEN2.
2. Close relatives of registered MDACC MEN patients.

Exclusion Criteria:

1. Individuals who are either non-MDACC registered patients or do not have a close relative who is an MEN patient registered at MDACC.
Assessment of Physician Consideration of EPRO's, from Patients with Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus, on the Frequency of Therapeutic Adjustments

Inflammatory rheumatic diseases affect 1% of the population. Treatment of such diseases should be based on disease activity, safety issues and other patient characteristics such as comorbidities (EULAR, 2022), leading to a higher risk of cardiovascular diseases. To this end, the general treat-to-target approach, as recommended in the EULAR guidance, may require several successive treatment lines based on updates to the patients' profile and close monitoring as the keystone of its implementation.

Regular feedback from patients could be used to fuel such strategies. This feedback can be collected using an ePRO (electronic Patient Reported Outcome). The purpose of this study is therefore to assess patient management using the information provided by patients through e-PROs, which will transfer the data provided by the patient to the physician and will notify the investigators via email when a patient has completed a form (no data interpretation or alerts).

The hypothesis is that the more physicians are provided with insights into their patients' health, the more they will function in a treat-to-target approach and the more often they will tend to adjust their patients' treatments.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of at least 18 years of age
* Diagnosed with (at least) one of the following autoimmune diseases:

  * Rheumatoid arthritis (RA) according to the 2010 EULAR/ACR classification criteria,
  * Gout according to the 2015 EULAR/ACR classification criteria,
  * Systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria
  * Sjogren's Syndrome according to the 2016 EULAR/ACR classification criteria
* According to local regulations, patient has expressed his/her non-opposition (for France) or has provided written informed consent (for Switzerland and Germany) to participate in the study
* Patient has access to the internet, a functioning email address and a mobile phone number
* Patient physically and mentally able to use a computer tool connected to the Internet
* Only in Switzerland \& Germany : patient is covered by a health insurance plan

Exclusion Criteria:

* Any neurodegenerative disease that alters cognitive faculties
* Refractory cancer
* Patients who do not have access to the Internet and/or do not master its use in the context of this protocol
* Unwillingness or inability to adhere to study protocol (language barriers, cognitive disorders...) Subject who is compulsorily detained for psychiatric treatment
* Patient who cannot be followed for 2 years by the investigating physician
* Patient over the age of legal majority who is protected, or deprived of liberty by judicial or administrative decision (vulnerable subject)
* Patient with an estimated life expectancy shorter than 1 year