cyrilzakka/clinical-trials huggingface dataset:
Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE

The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor.

Basic (Level 1) Critical care echocardiography (CCE) involves using an ultrasound device to qualitatively assess the heart at the bedside. It is increasingly being used at the bedside for diagnostics and screening of key differential diagnoses. Increasingly, CCE is being taught to more medical staff from many fields in medicine, including emergency medicine, anaesthesiology, intensive care medicine and even family medicine. There is a wealth of learning resources online but access to direct supervision by trainers and in-person courses is can be limited and costly. At the time of the study, one local medical school incorporated a lecture there is no credentialling pathway within local medical schools or institution. There has been increasing use of machine learning in medical imaging and deep learning algorithms are now able to guide image acquisition and allow novices with minimal training in echocardiography to obtain diagnostic-quality images. Artificial intelligence (AI) in echocardiography may improve image by novices. Ultrasound hardware that implement machine learning software in real-time can help with structure detection and identification, but more studies are needed to determine the extent that AI impacts learning.

Eligibility Criteria:
Inclusion Criteria:

* Medical students will have limited clinical exposure to critical care echocardiography
* above the age of 21 years

Exclusion Criteria:

* prior attendance of a critical care echocardiography courses or
* refusal to participate in the study or complete both hands on sessions
A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy

The present pilot study is designed to assess the extent to which rasagiline may improve cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to assess changes in the SCOPA-COG, FAB, and UPDRS II \& III at the end of week 14.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40 or older with idiopathic Parkinson's disease on stable dopaminergic therapy for at least 1 month. The UK Brain Bank Criteria will be used to establish the diagnosis of Parkinson's disease. Women must be post menopausal or agree to avoid pregnancy. Modified Hoehn \& Yahr staging \< 3 and MoCA score must be greater than 21 but less than 28. Geriatric Depression Scale (GDS) is a sensitive and specific screen for depression in the Parkinson's disease population. GDS scores of \< 5 will be included in the study.

Exclusion Criteria:

* Patients with secondary dementia, severe depression and atypical Parkinson's syndromes or Parkinson's plus will be excluded from the study. Patients on acetylcholine esterase or NMDA inhibitor medication will be excluded from the study. Patients with history of brain surgery for Parkinson's disease, stroke or significant head injury, active epilepsy will be excluded. Patients on Amantidine, neuroleptics, metoclopramide, alphamethyldopa within the last 6 months will be excluded. Individuals using meperidine, and tramadol will be excluded. Patients with congestive heart failure or myocardial infarction will also be excluded to avoid vascular dementia.
Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia

The goal of this retrospective, international, multi-center chart abstraction is to learn about the long-term impact of product-specific immunogenicity-related factors in different botulinum neurotoxin type A formulations in patients suffering from cervical dystonia. The main question it aims to answer is:

Do complex-containing (CC) botulinum toxin formulations impact the long-term clinical outcome in cervical dystonia patients compared to a complex-free (CF) formulation?

Researchers will compare differences observed in years 2 and 7 between two toxin groups, i.e., botulinum neurotoxins type A containing complexing proteins (CC) and without complexing proteins (CF).

Botulinum neurotoxin type A (BoNT/A) is first-line treatment in patients suffering from cervical dystonia. Effect of BoNT/A is temporary and must be repeated to maintain clinical effect. As for all biologics, repeated treatment bears the risk of activating an immune response due to the immunogenic nature of foreign proteins. Clinical signs of a potential immune response are reduced, or loss of efficacy, decreased duration of effect, and the need of a dose increase to maintain effect. Due to the different degree of purity and protein content, it is reasonable to assume that commercial BoNT/A formulations differ in immunogenic properties.

Pivotal clinical trials and monocentric real-world studies demonstrated an increased incidence of neutralizing antibodies (NAbs) and NAb-associated partial or complete secondary non-response. However, the clinical relevance of potential immunogenicity-related mechanisms has not been demonstrated in a larger multicentric cohort in a real-world setting. This chart abstraction is designed to address this gap.

Eligibility Criteria:
* Clinical diagnosis of cervical dystonia
* Adults (m/f) 18-64 years of age at start of BoNT/A treatment
* Patient's written informed consent if required by local and/or national law.
An Interactive Web-Based Program to Improve Food and Activity Choices of Teens

This study will test a website for teens designed to help them improve both diet and physical activity. The website will have several components: educational messages, role model stories, goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet and physical activity (PA) assessment questionnaires.

Increasing numbers of youth are at risk for becoming overweight because of poor diets and low physical activity levels. Prevention is key to reducing the obesity problem. Intervention programs must be easily accessible, and include intervention materials in a format that draws attention and interest. This study evaluates an 8-week web-based intervention for teens to promote healthy food and physical activity choices. The web program includes role model stories, nutrition and activity information pieces, goal setting and problem solving, and self-monitoring. Students will complete assessments at baseline, 8-weeks post, and then 6 and 12-months post intervention.

Eligibility Criteria:
Inclusion Criteria:

* ability to speak English
* 12-17 years old

Exclusion Criteria:

* no special diets
Contribution of a High-resolution Diffusion Sequence at 3T for the Detection of Acute Punctate Ischemic Brain Lesions

Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke, its contribution being diagnostic, etiological and prognostic.

Among the MRI sequences used in stroke emergencies, the diffusion sequence plays a key role in highlighting ischemic lesions as early as the hyperacute phase, even though the other sequences in the protocol do not reveal any anomaly. This sequence alone conditions the management of patients, particularly in the context of "thrombolysis emergencies".

It has been shown that the sensitivity of the diffusion sequence for the detection of ischemic lesions can directly depend on acquisition parameters such as b value, slice thickness or spatial resolution.

Recent advances in MRI now allow us to perform diffusion sequences with higher spatial resolution. The matrix is an important acquisition parameter of MRI sequences defining the ability of the sequence to distinguish 2 pixels in the acquisition plane. The higher the matrix, the higher the spatial resolution of the sequence in the acquisition plane.

At the Saint-Joseph Hospital, we have a new 3T MRI since September 2020 allowing the acquisition in clinical routine of a more resolved diffusion sequence: 160x200 matrix ("high resolution" diffusion, HR), against 128x140 ("standard" diffusion usually). These two sequences are acquired in particularly short acquisition times (1 minute 37 seconds). This HR diffusion sequence is performed as part of routine care since September 2020 for specific situations: absence of lesion highlighted on the standard diffusion sequence while the patient has a suggestive symptomatology (especially for lesions of the brainstem), search for lesion in other vascular territories (thus in favor of an embolic origin) in a patient who presents an isolated ischemic lesion or ischemic lesions in a single territory.

It has been reported in the literature that increasing the spatial resolution can reveal small lesions that were not visible on more conventional sequences. There is a clear rationale for seeking to improve the detection of small lesions (\<5 mm) because their detection may have important therapeutic implications for many patients (particularly in the context of thrombolysis emergencies, transient ischemic attacks, or amnesic strokes).


Eligibility Criteria:
Inclusion Criteria:

* Patients with age ≥ 18 years
* Patients who underwent a 3T brain MRI for suspected stroke/TIA (MRI performed within 7 days of clinical symptomatology) and for whom the "HR" diffusion sequence was considered useful for diagnosis
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis

Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Eligibility Criteria:
Inclusion Criteria:

* Refractory forms of acute leukemia, but in complete remission (CR)
* Second and third remission of acute leukemia
* 2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL)
* relapsed multiple myeloma
* advanced leukemia

Exclusion Criteria:

* ICU
* Mechanical ventilation
Ex Vivo Drug Sensitivity Testing and Mutation Profiling

This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput drug sensitivity testing (DST). In addition, genetic information will be obtained from cancer and normal (germline) tissue and correlated with drug response. This study will provide the platform for informing treating physician about individualized treatment options. The main outcome of this study will be the proportions of the patients whose treatment was guided by the personalized medicine approach.

PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on ex vivo drug sensitivity testing (DST) and genomic profiling.

SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with DST-guided therapy as compared to non-DST guided (conventional) therapy.

EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies and ex vivo drug response.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.

  * Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
  * Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers)
  * Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing
  * Subjects or their parents or legal guardians willing to sign informed consent
  * Subjects aged 7 to 17 willing to sign assent

Exclusion Criteria:

* Subjects who do not have malignant tissue available and accessible
* The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
* Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA) to assess safety and tolerability

A phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial of the safety and tolerability of GD2-SADA:177Lu-DOTA complex in GD2 expressing solid tumors.

The trial is planned as a Phase 1 trial with three parts, A, B and C. Escalation in this trial will be based on a classical 3+3 trial design.

Part A is a GD2-SADA dose escalation phase, in which patients will receive one treatment cycle.

Part B is a 177Lu-DOTA dose escalation phase, in which patients will receive up to 2 treatment cycles .

Part C is a repeated dosing phase where the doses determined in Part A and B will be administered. Patients will receive repeated treatment cycles with a maximum of 5 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from patient, legal guardian(s) and/or adolescents obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations.
* Age ≥18 years at the time of informed consent, for High Risk Neuroblastoma \&amp; sarcoma age ≥16 years of age at time of informed consent/assent
* Measurable disease according to RECIST 1.1
* ECOG performance status 0-1
* Expected survival \&gt;3 months
* Platelet counts ≥100,000 cells/mm3
* Hemoglobin ≥9 g/dL
* Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60mL/min as calculated using the Cockcroft-Gault equation
* Patient willing and able to comply with the trial protocol

Exclusion Criteria:

* Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the IMP per protocol
* Patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the IMP per protocol
* Ongoing radiation toxicities from prior RT therapy
* Patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (active)
* Prior treatment with anti-GD2 antibody
Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy

Exclusion Criteria:

1. Age \< 18 years
2. Intrauterine pregnancy
3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
4. Unable to obtain consent for the procedure from either the patient or LAR
5. Altered anatomy due to prior gastroduodenal surgery
6. Presence of other adhesions or synchronous obstructive lesions in the small bowel
7. Prior treatment for gastric outlet obstruction
8. Presence of large volume malignant ascites
Evaluation of Changes of Venous Return After Spinal and Epidural Analgesia and Anesthesia by Ultrasound Guided Vena Cava Diameter Measurement

The investigators propose this study to test the hypotheses that inferior vena cava (IVC) diameter can predict hypotension after labor analgesia (epidural, combined spinal-epidural) and neuraxial anesthesia for cesarean section (epidural, combined spinal-epidural and spinal block) in full-term pregnant patients.

After approval by the Institutional Review Board and patient consent, term pregnant patients (\>37 week gestation) admitted to the obstetric service of Augusta University Medical Center, who require administration of neuraxial analgesia for labor or regional anesthesia for cesarean section, will be included in the study. The consent will be obtained by the attending, resident or medical student in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. Demographic variables (age, BMI, Gravity, parity and gestation weeks) and hemodynamic variables (MAP and HR) will be recorded. All patients will be lying in supine position, breathing spontaneously. The ultrasound examination will be performed before commencement of the neuraxial procedure and will be repeated two minutes after administration of the neuraxial anesthetic. Ultrasound measurements will be made with a Sonosite Edge (Sonosite Inc. USA) machine and a C60X curved linear phased array transducer (Sonosite Inc.) set to abdominal mode. All measurements will be made by two attending anesthesiologists (ERP and AR) who have experience in transthoracic echocardiography, and a resident who receives the basic instruction to measure IVC diameter. The medical student will be present during the procedure and will ensure that the study echocardiographic views are taken.

The IVC will be visualized using a paramedian long-axis view via a subcostal approach according to guidelines of the American Society of Echocardiography. A two-dimensional image of the IVC will be obtained and pulsed wave Doppler will be used to differentiate from the aorta. Variations in IVC diameters will be assessed with M-mode applied 2 cm. distal to the right atrium. To ensure consistent measurements, each operator will take three images. The best quality images are chosen. Maximum and minimum IVC diameters during a single respiratory cycle will be measured.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant patients \>37 weeks of gestation
2. Indication for neuraxial labor analgesia or regional anesthesia for cesarean section
3. Age older than 18 years
4. Pregnancy without diagnosed comorbidities

Exclusion criteria:

1. Unwillingness to participate in the study
2. Diagnosis of Hypertensive disorders of pregnancy
3. Diagnosis of cardiopulmonary disease
4. Allergy to US gel
Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis

The study is aimed to investigate the different rates of pyloric/ pseudopyloric metaplasia or spasmolytic polypeptide-expressing metaplasia (SPEM) of corpus between autoimmune gastritis and H. pylori-infected non-ulcer dyspepsia.

Autoimmune gastritis is not an uncommon disease among northern European ancestry, but its prevalence rates are unclear in other populations, including Taiwanese. A study showed that near 2% of persons more than 60 years old have undiagnosed pernicious anemia, one of the complications of autoimmune gastritis. Believed to be undiagnosed, patients are at risk of gastric malignancy and vitamin B12 deficiency-related complications until the end stage. Therefore, use of available diagnostic tools to diagnose patients with autoimmune gastritis has been important. However, autoimmune gastritis has a silent course and is not easy to be early recognized. Early recognition is important because in the late stage, vitamin B12 replacement treatment may correct pernicious anemia only but not neurologic disorders. Fundus and corpus atrophy with parietal cells loss presented 2 to 3 decades before anemia develops in autoimmune gastritis. It is no doubt that autoimmune gastritis could be diagnosed if vitamin B12 deficiency with megaloblastosis and anemia developed; however, it could be diagnosed earlier if the gastric pathological finding was noticed to be a diagnostic clue. Nevertheless, fundus and corpus atrophy is presented not only in autoimmune gastritis but also in H. pylori-related gastropathy. Therefore, we need a pathologic feature which could help physicians differentiate autoimmune gastritis from H. pylori-infected gastropathy. Here, we propose that pyloric or pseudopyloric metaplasia of corpus is distinct from H. pylori-infected gastropathy. We believe that this specific pathologic feature will be helpful to diagnose patients with autoimmune gastritis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present with relevant symptoms or signs of upper gastrointestinal diseases, including, but not limited to the following: impaired gastric emptying, epigastric discomfort, postprandial bloating, early satiety, epigastric pain, acid regurgitation, dyspepsia, anemia, or vitamin B12 deficiency, or iron deficiency, are candidates to be enrolled to receive gastroscopy.

Exclusion Criteria:

* The exclusion criteria are as follows including use of aspirin, non-steroidal anti-inflammatory drugs, or cyclooxygenase-2 selective inhibitors for more than 3 months, or diagnosis with upper gastrointestinal cancer including esophagus, stomach, duodenum, mucosa-associated lymphoid tissue lymphoma, other gastric lymphoma, or pancreas.
Phase III Study of 5LGr to Treat Tic Disorder

The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.

5LGr is a kind of traditional Chinese medicine(TCM) which under the direction of TCM theory.The aim of this study is prove the effective and safety of 5LGr in children and adolescence of Tic syndrome sub-population with specific TCM syndrome differentiation, when compared with tiapride and placebo.

Eligibility Criteria:
Inclusion Criteria:

* \>1 year history of diagnosed tic disorder;
* age:5-18 yrs;
* YGTSS score\>=30 at baseline.

Exclusion Criteria:

* Diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,Wilson's disease.
* Any indefinite tic disorder or tic disorders caused by medication.
* Participation to other studies.
* Patients with loose stool.