cyrilzakka/clinical-trials huggingface dataset:
ERAS in Video-assisted Mediastinal Surgery

This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.

Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients elective mediastinal surgery;
* BMI 18-30 kg/m2.

Exclusion Criteria:

* Patient refuse;
* ASA≥3;
* Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions

A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:

  1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is \>0.5 cm and \< 2 cm in size and has had or will have additional workup with focused ultrasound.
  2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size.
  3. Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound.

Exclusion Criteria:

1. Are unable to understand and sign the consent form
2. Are pregnant or lactating
3. Are physically unable to sit upright and still for 40 minutes
4. Have undergone bilateral mastectomy
5. Are not scheduled to undergo conventional ultrasound
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.


Eligibility Criteria:
Inclusion Criteria:

* signed consent
* patient age under 12
* PIV with continuous fluids

Exclusion Criteria:

* no consent
* patient age over 12
* PIV fluids not continuous
Urine Methylation Markers in UTUC

This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Zymo/Pangea Research Corporation for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years
* Primary UTUC

Exclusion Criteria:

* Patients who do not understand and/or are unwilling to sign a written informed consent
Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

The assessment of digestive inflammation and disease activity in paediatrics Crohn's disease (CD) is currently based on anamnestic, clinical and paraclinical elements such as the paediatric CD activity index (wPCDAI) , faecal calprotectin measuring or digestive endoscopy. Infrared thermal imaging is based on capturing electromagnetic waves, on a specific Wavelength, emitted by the human body surface and representing local thermic-metabolic activity. It concern metabolic activity in digestive inflammations. Infrared imaging is a non-invasive, contactless, stressless technique that assess the variations in skin surface temperature of the patient's entire abdomen or more targeted areas in a single photography. This technique would be useful for determination of Crohn's disease activity, inflammation's degree and partial mapping of inflammatory lesions.

In a specific room with a patient lying, the investigators will determine the abdominal infrared radiation with a FLIR® thermal camera. This will be correlated with the measurement of the faecal calprotectin concentration and the composite CD activity index wPCDAI.

All measurements will be performed during the standard follow-up of Crohn disease. No additional follow will be necessary.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CD according to the Porto criteria \[6\]
* Aged from 4 years to 17 years-old
* Follow-up at the Amiens Picardie University Hospital (CHU Amiens Picardie)
* Child's affirmative agreement and assent and permission of their parents to participate in research

Exclusion Criteria:

* Recent abdominal surgery
* Other Inflammatory bowel disease
Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants

This research project seeks to learn more about how lifestyle interventions can help liver and kidney transplant recipients achieve weight loss goals. The investigators want to evaluate if an intervention using weight and activity wrist monitors, as well as nutritional coaching group sessions is acceptable and useful for post-transplant patients aiming for weight loss. All participants will be given a wrist activity monitor, and a scale. Half of participants will be invited to participate in the nutritional coaching group sessions. The research team will look at weight loss, devices' usage, and satisfaction, and see if there are any difference among the two groups.

This project aims to understand feasibility, acceptability, and appropriateness of using connected health services (use of Fitbit and Scale), and nutritional coaching group sessions as a lifestyle intervention for post-transplant patients seeking weight loss. Secondarily, the investigators aim to assess effectiveness of the intervention to generate weight loss. Enrolled patients will receive a wrist activity tracker (Fitbit Charge 4) and a scale, of which information synchronizes to the electronic health record. Steps, usage, and weight values will be recorded and analyzed from the devices. All patients will be followed with monthly calls to assess issues with devices, and address case-specific questions. Simultaneously, half of the patients will be randomized to receive every other month nutritional coaching group sessions on topics related to nutrition and physical activity. Patients will have an in-person follow-up appointment where laboratory values, body measurements, and physical and mental readiness for weight loss surveys and scales will be applied at 6 and 12-months. Patients that don't accomplish weight loss goal at 6 months will be invited to cross over to the nutritional coaching group sessions intervention arm.

Eligibility Criteria:
Inclusion Criteria:

* Prior liver or kidney transplant recipient
* BMI \>=30
* 6 months to 10 years post-transplant
* Stable immunosuppression as defined by no treatment for rejection in the past 3 months
* Access to Smartphone or computer
* Able to provide informed consent

Exclusion Criteria:

* Dual and/or simultaneous organ kidney and liver transplant
* Any type of other prior transplant
* Age \<= 18 years old
* Treatment for rejection within the last 3 months
* Major infection requiring hospitalization within the last 3 months
* Relisting for liver transplant or returned to dialysis for kidney transplant
* Physical inability to participate in lifestyle intervention activity recommendations
* Patients that are actively enrolled in a weight center program
The Connection Between Personality, Burnout, and Hypertension in Nigerian Bank Employees

This is a longitudinal study which we plan to examine the link between personality traits, burnout, and hypertension in bank employees in South-eastern Nigeria

This proposed longitudinal study aims to examine the relationship between personality traits, burnout, and hypertension in bank employees in South-eastern Nigeria, where hypertension is a significant public health issue. The study will involve bankers as participants, who will be asked to complete self-report questionnaires and measure their blood pressure over four weeks. The research seeks to determine if personality differences and burnout levels contribute to hypertension risk in this population. By understanding the role of psychosocial factors in hypertension risk, the study hopes to provide recommendations for workplace adjustments that could improve employee well-being and reduce hypertension risk among Nigerian bank employees.

Eligibility Criteria:
Inclusion Criteria:

* Any staff of the Bank

Exclusion Criteria:

* Non Staff
Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.

For 8 weeks, our study will search effect of acupuncture on tinnitus (chronic subjective type), lipids and weight reduction in obese persons.

Eligibility Criteria:
Inclusion Criteria:

* obese patients
* tinnitus complaints (chronic subjective form)

Exclusion Criteria:

* diabetics
* cardiovascular and neurogenic manifestations
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy

Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit.

Background: Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking.

Methods: Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit. Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). 193 patients with AGC from January 2010 to December 2018 in two different China university hospitals were included in this study. The before neoadjuvant chemotherapy imaging scoring system (BNCISS), imaging change scoring system before and after neoadjuvant chemotherapy (ICSS), which were constructed based on computed tomography images before after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection

Exclusion Criteria:

* Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.
Endoscopic Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer

This study aims to evaluate the EUS-RFA in terms of efficacy for pain management and improvement in quality-of-life parameters for patients with advanced inoperable pancreatic cancer. The primary objectives of this study are to 1) evaluate the utility of EUS-RFA for pain control and improvement in quality-of-life parameters for patients with advanced pancreatic cancer; 2) to measure the reduction of analgesic medications' requirements in patients affected by inoperable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatic cancer based on clinical, radiological, or pathological assessment;
* Referred for abdominal and/or back pain due to pancreatic cancer;
* No prior history of RFA;
* Cancer pain unresponsive to the WHO 3-step analgesic ladder;
* Willingness to consent to participate in the study.

Exclusion Criteria:

* Patients who are not willing to give informed consent or agree to participate in the study
* Surgically resectable pancreatic cancer;
* Abdominal pain with etiology other than pancreatic malignancy;
* Evidence of concurrent infection;
* Patients with irreversible coagulopathy international normalized ratio \>1.5 or platelet count \<50,000/mm3),
* Patients with a preliminary diagnosis of adenocarcinoma are not possible established with intraprocedural at EUS-guided FNA.
Olanzapine for Acute Headaches

This trial is a prospective, randomized, feasibility trial with the primary aim of comparing how well oral rapidly dissolving olanzapine controls primary headache pain when compared to the current treatment strategies used in emergency departments which often require intravenous or intramuscular medications.

Primary Question:

Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute headache of non-organic origin (primary headache) who come to the ED for abortive therapy when compared to current standard of care?

Secondary Aim:

Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1) duration of ED length of stay and 2) need for IV access when compared to the current standard of care.

This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient between 18-65 years of age presenting to the emergency department with acute primary headache
2. Patient approved for inclusion by primary attending physician in the emergency department

Exclusion Criteria:

1. Age \< 18 or \> 65
2. Pregnancy
3. Known allergy to olanzapine
4. Known QT prolongation or underlying condition that places patient at risk for QT prolongation
5. Inability to give written consent (intoxication, altered mental status)
6. Headache of organic origin (trauma, infection, previous recent head or neck surgery)
7. Patient already prescribed daily olanzapine on an outpatient basis
8. Patient has been administered olanzapine within the past 24 hours
9. Language barrier
A New Technique to Measure the Heart's Microvascular Function in Patients Experiencing Heart Attack

The goal of this observational study to measure the heart's microvascular function in the setting of a myocardial infarction (MI), or heart attack, using a method called continuous saline thermodilution (CST). The participants will include people who are experiencing MI from sudden and complete blockage of a coronary artery requiring immediate balloon and/or stent therapy. After getting the balloon and/or stent therapy, participants will have their heart's microvascular system tested using CST. The main questions it aims to answer are:

* What measurements using CST can we expect from the heart's microvascular system during a treated MI?
* Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers?

For this study, participants will undergo measurement of their heart's microvascular function after balloon and/or stent therapy for the MI. They will then receive an MRI scan of the heart several days after the MI.

Sampling: Consecutive presenting patients with STEMI who meet the inclusion criteria will be eligible for participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Adults (persons \>18 years old) presenting to Cleveland Clinic cardiac catheterization lab within 24 hours of symptom onset, with clinical and EKG findings concerning for STEMI, with intent to undergo emergent primary PCI, who have culprit artery identified on diagnostic angiography
* Adults (persons \>18 years old) presenting to Cleveland Clinic cardiac catheterization lab for pharmaco-invasive management of failed fibrinolysis, with intent to undergo emergent PCI, who have culprit artery identified on diagnostic angiography
* On-call treating interventional cardiologist is trained in the method of continuous saline thermodilution for coronary microvascular assessment

Exclusion Criteria:

* No evidence of coronary obstruction on diagnostic angiography (e.g., Takotsubo, myocarditis leading to STEMI activation).
* Patients in hemodynamic shock
* Culprit artery \<3.0 mm in diameter.
* Culprit artery being a bypass graft
* Patients physically unable to tolerate additional time required to conduct coronary microvascular testing after primary PCI.
* Patients with eGFR \<30 mL/min/1.73m2 are excluded from contributing cardiac MRI data
* Patients with standard contraindications to CMR (e.g., pacemakers, cochlear implants, certain prosthetic heart valves, certain surgical implants) are excluded from contributing cardiac MRI data
* Unable to provide verbal and written consent
* Pregnancy
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)

This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years
* Presence of GAD65 antibodies
* Detectable C-peptide level
* Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)
* Written informed Consent

Key Exclusion Criteria:

* Treatment with insulin
* Intolerance to OHA
* Secondary diabetes mellitus
* History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis)
* Treatment with any vaccine within one month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* Pregnancy (or planned pregnancy within one year after 2nd administration)
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
* Significant illness other than diabetes within 2 weeks prior to first dosing
* Unwillingness to comply with the provisions of the protocol
* Clinically significant history of acute reaction to drugs in the past
* Treatment with immunosuppressants
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis

The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a 6-week nutrition, movement, and mindfulness program for youth with recent diagnosis of psychosis.

The purpose of this study is to determine the feasibility of a 6-week nutrition, movement, and mindfulness program (M³ Program) for youth with a recent diagnosis of psychosis. Program effects on metabolic and mental health outcomes compared to wait-list control will also be assessed. Participants will be 15-25 years of age, and have a recent diagnosis of psychosis. Twenty participants and their study partners (20 study partners) will be equally divided into two cohorts. Participants will sign up for one of the two series on a rolling enrollment basis until both of the program date frames are filled. Participants that signed up for the second series will serve as a wait-list control; outcomes from the participants in the first series will be compared to this group. M³ will be a combination of didactic and experiential training. The course will meet once-a-week for six weeks. Participants will learn how to prepare healthy snacks and meals, make healthy choices when eating out, and interpret food packaging and labels. They will also learn about different forms of mindfulness exercises and movement, such as yoga, martial arts, and a Japanese style of drumming. Feasibility will be assessed throughout the program.

Eligibility Criteria:
Inclusion Criteria:

* First diagnosis of psychosis occurs within 3 years of enrollment into the study or are a graduate of the Early Assessment and Support Alliance Program (EASA).
* Established mental health provider and primary care physician.
* Age 15 to 25 years (inclusive)
* Able to enroll with a study partner (study partner can be a healthy volunteer)
* Able to read and write in English

Exclusion Criteria:

* Active suicidal or homicidal thoughts
* Mental status exam which suggests high risk for disruptiveness to group process or danger to self and others.
* If a graduate of EASA, the participant must have a primary care or mental health provider.
Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures

Introduction:

Opioids, such as morphine, act at receptors in the central nervous system, but many studies have suggested direct action peripherally on opioid receptors in sensory neurons terminals, melanocytes, keratinocytes and fibroblasts. These receptors are stimulated when occurs inflammatory processes.

Hypothesis:

Treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure, decreases pain in children.

Method:

A randomised double-blind parallel study to evaluate the effect of topical application of a 0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be included. Randomly assigned to either the morphine gel or a placebo hydrogel, it will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with "Face, Legs, Activity, Cry, Consolability scale" (FLACC scale).

The use of an opioid such as morphine topical gel 30 minutes before a procedure would be effective in reducing pain in children. It has proven effective analgesic with minimal adverse effects, especially in children older than 6 months, and even its use is authorized in young children.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized children aged 1 month to 10 years, who needs a medical procedure over previously injured skin, associated with moderate-severe pain.

Exclusion Criteria:

* Refusal to participate