cyrilzakka/clinical-trials huggingface dataset:
SharkCore Versus Acquire FNB

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%.

Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.

Subjects will come to a pre-procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time-out to make sure current patient and procedure are performed. A time-out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation.

All EUS-FNB will be performed in the standard manner using linear echoendoscopes. All EUS-FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL-Abiad).

The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients schedule for EUS guided biopsy

Exclusion Criteria:

* Patients who had EUS-FNA for cystic fluid aspiration
* Pregnant females
* International normalized ratio \>1.5 and platelet count \< 50,000
* Medically unstable
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme

Patients attending the smoking cessation programme at the Virgen del Rocío University Hospital under the SoLoMo clinical trial of the SmokeFreeBrain project and provided with the SoLoMo mobile app will be observed for one year. This mobile app which sends the patients tailored health motivational messages selected by a health recommender system, and based on their user profile retrieved from an electronic health record. Patients' messages feedback and interactions with the app will be analyzed and evaluated following an observational prospective methodology to see whether patients like the messages, and measure the patient engagement with the health recommender system.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be taken from the the smoking cessation unit of the Virgen del Rocio University Hospital (Seville, Spain)
* Patients must be willing to start the treatment to quit smoking
* Patients must own an Android smartphone and be able to interact with it
* Patients must be willing to and install the "Libre de Humos" smoking cessation app recommended by the doctor in the SmokeFreeBrain study.
* Patients must sign an informed consent

Exclusion Criteria:

* Patients have known previous adverse effects on the pharmacological treatment included in the study (Bupropion \& Varenicline)
Genes, Exercise, Memory and Neurodegeneration

The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.

This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years
* Ability to exercise vigorously without harm
* Mild AD
* Study partner
* In good general health
* Willing to exercise for 6 months
* Body Mass Index (BMI) less than 37
* Women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study

Exclusion Criteria:

* MMSE score below 20
* TG (Triglyceride) greater than 400 mg/dl
* LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms
SGM-101 in Colorectal Brain Metastases.

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

1. History of any anaphylactic reaction;
2. Previous use of SGM-101;
3. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
4. Laboratory abnormalities defined as:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
5. Patients pregnant or breastfeeding;
6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program

An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.

In this International multi-center prospective observational study, 250 patients with severe symptomatic aortic stenosis (AS) and eligibility for transfemoral TAVI with ACURATE Neo Bioprosthesis, will be pre-procedurally selected for participation in an early discharge protocol in which patients are discharged within 48 hours after uncomplicated TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for ACURATE Neo valve implantation
* Patient agrees to follow-up duration
* Patient is able to understand and sign written informed consent

Exclusion Criteria:

* BMI \> 35
* Pregnancy

Cardiac

* Moderate to severely impaired left ventricular ejection fraction (LVEF \<35%)
* Mitral regurgitation \> moderate
* Pulmonary hypertension (sPAP \> 60mmHg)
* No complex coronary artery disease
* Untreated high degree AV-block or RBBB

Pulmonary

* COPD Gold \> 2

Kidney function

* GFR \< 35ml/min

Frailty

* Inappropriate social support and/or (familial) care
* Patient is walking aid dependent

TAVI strategy

* Presence of severe peripheral artery disease
* Transfemoral approach not possible

Follow up

* Inability to adhere to follow-up
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
* Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
* An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
* Demonstration of reversible airway obstruction

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Acute illness other than asthma at the start of the study
* Patients with clinically significant laboratory abnormalities at screening
* Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
* Use of other investigational drugs at the time of enrollment
ALPPS Combined With Tislelizumab in Liver Malignancy

Study design: Prospective, single-center, phase IIa clinical trial; Primary endpoint: Recurrence free survival; Secondary endpoints: Safety, overall survival; Main characteristics of patients: Liver malignancy, required (extended) hemihepatectomy, insufficient liver reserve; Study approaches: The experimental group is treated with ALPPS combined with Tislelizumab, and the control group was treated with ALPPS; Sample size: 20 (10:10); Study process: In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W 6-12 months after stage II surgery; In control group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks after stage I surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤70 years;
2. ECOG physical condition score: 0\~1;
3. Clinical/pathological diagnosis of primary liver cancer or intrahepatic metastatic colorectal cancer;
4. Clinical evaluation requires (extended) hemihepatectomy;
5. Liver function Child A level
6. sFLR \< 30%
7. The main organs function well, and the examination indicators meet the following requirements:

   Routine blood tests:

   Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×10\^9/L; Platelet count ≥80×10\^9/L;

   Biochemical examination:

   Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula);
8. Sign the informed consent voluntarily;
9. Good compliance, and family members willing to cooperate with follow-up.

Exclusion Criteria:

1. Presence of extrahepatic organ/distant lymph node metastasis;
2. Hilar lymph node metastasis cannot be radically resected;
3. Patients with intrahepatic metastatic colorectal cancer had received second-line or above systemic therapy;
4. Other uncured malignant tumors;
5. Pregnant or lactating women who are pregnant during the study period need to withdraw from the clinical trial;
6. Concurrent use of any other antitumor therapy in patients with primary liver cancer;
7. Patients with intrahepatic metastatic colorectal cancer have been treated with antitumor therapy in addition to primary surgery and standard first-line/second-line therapy;
8. Patients with a known history of other systemic serious diseases before screening;
9. Long-term unhealed wounds or incomplete healing fractures;
10. Previous organ transplantation history;
11. Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
12. A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
13. Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose blood levels in patients with Type 2 Diabetes Mellitus.

This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin in patients with Type 2 Diabetes Mellitus (T2DM) who are currently taking metformin at a stable dose of \>=1500 mg/day. Patients will participate in the study for up to approximately 16 weeks. During the study, patients will receive 4 treatments (A, B, C, and D); each treatment will be administered during a 3-day treatment period. Patients will receive 1 dose of study medication in the morning of Day 1 and Day 2 of each treatment period and treatment periods will be separated by approximately 2 weeks. Treatments will consist of placebo (A), canagliflozin 300 mg and placebo (B), canagliflozin 300mg (C), and canagliflozin 300mg and canagliflozin 150mg (D).

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements \>=130 mg/dL and \<=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea \[SU\] or a meglitinide or a dipeptidyl peptidase-4 \[DPP-4\] inhibitor) are eligible for enrollment in the study.

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* history of a severe hypoglycemic episode within 6 months before screening
* Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements \>=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
* History of or current illness considered to be clinically significant by the investigator
Selective Bronchial Intubation (SBI)

Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. However, existing indices are not adapted to selective bronchial intubations.

The aim of the study is to determine the incidence of unexpected difficult SBI using conventional screening tests. It is a prospective descriptive epidemiological monocentric study comparing two groups of patients (selective vs. non selective intubations).


Eligibility Criteria:
Inclusion Criteria:

* For adult patients : age greater than or equal to 18 years
* Patients with thoracic, cardiac, vascular or plastic surgery

Exclusion Criteria:

* Intubations performed before admission to the operating room or catheterization room;
* Patient whose age is less than 18 years
* Traditional re-intubation at the end of the procedure after a selective lung IOT;
* Selective re-intubation in a patient previously intubated on arrival at the operating theater;
* IOT in other departments of the HML (intensive care, Pulmonary Postoperative Unit (UPOP), bronchoscopy, hospitalization services, Intensive Care Unit (ICU), etc.).
Effect of High-intensity Laser Acupuncture on Muscle Performance, Pain and Quality of Life in Low Back Pain

To investigate the effect of high-intensity laser acupuncture on muscle performance, pain, and quality of life in patients with chronic nonspecific low back pain (CNLBP).

Chronic non-specific low back pain (CNSLBP) is a persistent back pain that affects people of all ages and significantly impacts individuals' daily activities and quality of life. While various treatment modalities exist, there is ongoing interest in exploring novel approaches to manage this condition effectively. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause analgesic effects. In recent years, high-intensity laser has been used for managing musculoskeletal pain and dysfunction that allows for more energy deposition in deep tissues, resulting in both biological effects and thermal effects. High-intensity laser acupuncture (HILA) has emerged as a promising intervention that combines the therapeutic effects of high-intensity laser therapy and the principles of acupuncture point stimulation on the body (acupoints) to induce physiological effect. However, there is limited evidence supporting HILA efficacy in the management ofCNSLBP, with only a few studies available. For that, this study aims to investigate the effect of HILA on muscle performance, back pain, and quality of life in patients with CNSLBP. Through this current randomized controlled trial, we seek to provide evidence-based insights into the potential effects of this combined approach on measurements of muscle performance, back pain, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. The patients had CNSLBP with age from 20 to 40 years from both genders.
2. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.
3. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.
4. Patients with normal BMI ranges between 18.5:24.9 kg/m2.
5. The study populations must be willing to participate in the study

Exclusion Criteria:

1. Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.
2. Psychiatric/mental deficit.
3. Patients who had a previous surgical history (within 6 months) will also excluded.
4. participation in other treatment within the previous 3 month.
5. Pregnancy.
6. History of spinal fracture, tumor, osteoporosis
7. use of medication, such as corticosteroids, anticonvulsants, and antiinflammatory drugs that may affect the outcome of the study.
8. prior history of adverse effects to physical stimulation therapy.
9. significant physical or mental deficiencies preventing a clear understanding of the study procedure.
10. spinal stenosis, thyroid dysfunctions, obesity, pace-maker.
The Influence of Regular Beef Consumption and Protein Density of the Diet on Training-induced Gains in Muscle Strength and Performance in Healthy Adults

Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in cognitive function. It is not quite clear why this happens; however, it is known that the loss of muscle and strength can increase risk for physical and mental health risks and impair the ability of older people to remain physically independent. Weight lifting and proper nutrition, particularly eating high quality protein at the proper time and quantity, may help prevent these losses when a person gets older. To determine if regular beef consumption as part of a higher protein diet aids the muscle adaptive response to resistance training and improvements in cognition, seventy healthy individuals will be recruited to lift weights 3 times a week for 10 weeks. One group (n=36) will consume the Recommended Dietary Allowance (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume an amount twice the RDA (1.6g/kg/day), which is in agreement with recommendations from the American College of Sports Medicine. Participants will have their muscle strength tested and samples of blood and muscles will be collected before and after training to determine how the muscle adaptive response to resistance exercise is affected by higher protein intake. In addition, participants will undergo cognitive assessments at baseline and follow-up to determine the influence of improving muscle strength on attention and memory. Overall, the investigators proposed study will use sensitive methodology to determine if providing protein above the RDA and at optimal times during the day in combination with a weight lifting program can help make someone stronger and build larger muscles than someone consuming the RDA, as well as what processes may be responsible for helping the muscles to get bigger and stronger.


Eligibility Criteria:
Inclusion Criteria:

* Non-obese adults: BMI \<30 kg/m2
* Aged between 40-64 years
* Sedentary
* Weight-stable for 6 months prior

Exclusion Criteria:

* Allergies to beef consumption
* Phenylketonuria (PKU)
* BMI \>30 kg/m2
* history of active cardiovascular disease, diabetes mellitus, GI disorders, musculoskeletal/orthopedic disorders (e.g. osteoarthritis, rheumatoid arthritis, tendinitis, gout, fibromyalgia, patellar tendinopathy, or chronic low back pain)
* hypersensitivity or allergy to antibiotics
* Kidney, urinary, or liver conditions
* Epilepsy
* Diagnosed mental illness
* have bleeding or clotting disorders (or take related medications e.g.. Coumadin/ low dose Aspirin)
* High alcohol consumption
* use tobacco
* uncontrolled hypertension
* vegan/vegetarian diets
* on medications known to affect protein metabolism (i.e. corticosteroids, androgen/estrogen containing compounds, non-steroidal anti-inflammatories)
* habitual consumption of high (\>1.8 g protein/kg/d) or low (\<0.66 g protein/kg/day)
* pregnancy
* supplements that influence protein metabolism (e.g. omega 3 fish oils)