cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety and Efficacy of Three Flavors of Supportan® Drink in Cancer Patients in Taiwan

The goal of this clinical trial is to demonstrate safety and efficacy of Supportan® Drink (three flavors:Tropical Fruits, Cappuccino, and Pineapple-Coconut), administered as oral nutritional supplement, that will be taken in addition to the patient's normal dietary intake to meet the daily nutritional targets. in cancer patients. The main questions it aims to answer are:

Primary Efficacy Endpoint 1. Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline) Secondary Efficacy Endpoints

1. Change in CRP from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 -Baseline)

Participants will be enrolled in one of three flavor group by his/her recruiting time. Each subject needs visit hospital at baseline, week 2 and week 4 for checkups and test. And he/she needs take two bottles of Supportan Drink per day. During the study periods, subjects need write down his/her dietary records every day for evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving chemotherapy and/or radiotherapy, or immunotherapy, or targeted therapy;
2. Patient with diagnosed cancer of any type (e.g., head and neck cancer, lung cancer, digestive tract cancer, breast cancer);
3. Patient with or at risk of malnutrition defined as meeting Malnutrition Universal Screening Tool (MUST) with score ≥2;
4. Capable of using oral nutritional supplementation;
5. Written informed consent from patient.

Exclusion Criteria:

1. Patient with documented diagnosis of liver, kidney or heart disease in the hospital's electronic medical record (EMR); severity of disease evaluated by Investigator as not being suitable to participate in this study;
2. Current alcohol or substance abuse as assessed by Investigator;
3. Patient had a stroke in the past year and is after Investigator assessment judged as not yet clinically stable at the time of screening;
4. Patients who are diagnosed with mental illness or depression assessed by the Investigator as too severe for being suitable to participate in this study;
5. Pregnant or breastfeeding woman;
6. Allergic to any ingredient of the investigational products;
7. Patients receiving or having received standard (not disease specific) oral nutritional supplements (ONS), standard enteral formula/tube feeding or standard parenteral cancerspecific nutrition supplements in the last 3 days;
8. Patients receiving or having received ONS, enteral formula/tube feeding or parenteral nutrition with high fish oil or high EPA/DHA content (above 1 g/day) in the last 28 days;
9. Current use of medication, food supplements or ONS containing more than 500 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)/day or fish oil capsules/supplements containing more than 500 mg EPA and DHA/day at screening;
10. Transfusion of blood products within 1 week before screening;
11. Surgery scheduled during the trial;
12. Participation in other clinical trials using investigational drugs within 14 days before the start of the trial or during the trial.
Real-World Evaluation of Eko Algorithms in a Point of Care Setting

The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.

Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation.

In November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late.

Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021.

This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.

Eligibility Criteria:
Inclusion Criteria:

* Patient consents to participation
* Willing to have heart sounds recorded with an electronic stethoscope
* Willing to undergo echocardiography
* Willing to undergo a 12-lead electrocardiogram
* Adults aged 65 years and older
* History of at least one of the following: hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
* No prior diagnosis of valve disease or heart murmur

Exclusion Criteria:

* Patient is unwilling or unable to give written informed consent
* Patients experiencing a known or suspected acute cardiac event
* Under the age of 65 years old
* Prior diagnosis of valve disease or heart murmurs
Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease

The principal means of measuring motor impairment in Huntington disease (HD) is the Unified Huntington's Disease Rating Scale (UHDRS) total motor score, which is subjective, categorical, requires significant training to administer correctly, and only captures impairments in clinic. In this Direct to Phase II SBIR we will develop a wearable sensor system for objective, sensitive, and continuous assessment of Huntington's chorea during activities of daily living. The developed technology could be used clinically to detect changes in motor function in response to medications, or could be used scientifically to expedite and reduce the cost of early stage pharmaceutical clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* CAG expansion ≥ 36

Exclusion Criteria:

* N/A
Bilateral vs. Unilateral Erector Spinae Plane Block

The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Pateints undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)

End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.


Eligibility Criteria:
Inclusion Criteria: All patients presenting with end-stage heart failure defined as:

* A left ventricular ejection fraction ≤25%
* Or an oxygen consumption peak \< 14 mL/kg/min
* Or severe symptoms (NYHA class III or IV) despite optimal medical treatment
* Or a cardiogenic shock

Exclusion Criteria:

* Age over 70 years
* Active neoplasia
* Suspected or active systemic infection
* Body mass index ≥40 kg/m2
* Severe chronic obstruction pulmonary disease
* Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal within 4 days before the randomisation, or biopsy proven liver cirrhosis
* Significant chronic renal impairment with persistent creatinine \>2.5 or clearance \< 25ml/min
* Pregnant or lactating female
* Patient under consideration for conventional revascularization procedures, therapeutic valvular repair, left ventricular procedure or cardiomyoplasty
* Presence of implanted mechanical aortic valve that will not be converted to bioprothesis at the time of ventricular assist device implantation
* Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal, or biopsy proven liver cirrhosis
* Occurrence of stroke within 90 days or history of cerebrovascular disease with major (≥ 80%) extracranial or carotid stenosis documented by Doppler study
* Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer's disease or any other form of irreversible dementia or both
* Major peripheral vascular disease accompanied by pain on rest or leg ulceration
* Recent history of psychiatric disease that is likely to impair compliance
* Drug or alcohol dependence
* Difficult social surroundings
COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?

Purpose of the study:

To assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.

Null Hypothesis:

There will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Type II diabetes mellitus diagnosed by a physician as having HbA 1c of \&gt; 6.5%.
2. An established diagnosis of T2DM for at least 1year and less than 5 years.
3. Women patients.
4. Age between 35 to 45 years old.
5. Systolic Blood pressure less than or equal 130 mmHg.
6. Obese patients (BMI is between 30 and 39.9 kg/m 2 )
7. Patients with HbA 1c of 7-9%.
8. A self-reported sedentary lifestyle.
9. Patients receiving oral hypoglycemic medications described by the physician
10. Patients with hyperlipidemia.

Exclusion Criteria:

1. Patients with Cardiac diseases.
2. Patients with glaucoma.
3. Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
4. Musculoskeletal or neurological limitations to physical exercise.
5. Pregnancy
6. Patients under insulin therapy
7. Patients with poorly controlled DM (HbA1c \&gt; 9%)
8. Bronchial asthma and chronic obstructive pulmonary disease.
9. Smokers.
10. Morbidly obese BMI ≥ 40 kg/m 2
11. Males.

11. Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin \&lt; 12 g/dL) 13. Osteopenia.
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages

Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion

This clinical study is a regulatory Post Market Clinical Follow-Up (PMCF) measure and is aiming to collect clinical data on the performance and safety of the TSPACE® 3D implants. It is designed as a prospective, randomized, single-blind, non-interventional study in order to gain clinical data within the routine clinical application of the investigational device.

The study shall answer the question if there are detectable differences between the established titanium coated Polyether Ether Ketone (PEEK) cages of the manufacturer and the new 3D printed cages. Differences shall be observed in terms of clinical outcome, quality of life, patient satisfaction, radiological outcome and occurrence of Adverse Events / Serious Adverse Events.

Eligibility Criteria:
Inclusion Criteria:

* Indication for one, two or three-segment lumbar interbody fusion according to Instructions for use
* Written informed consent for the documentation of clinical and radiological results
* Willingness and mental ability to participate at the follow-up examinations

Exclusion Criteria:

* Patient is not willing or able to participate at the follow-up examination
* Patient age \< 18 years and \>80 years
* Patient is pregnant
* Previous instrumented lumbar spine surgery
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol

Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction treatment.

Eligibility Criteria:
Inclusion Criteria:

* Range of Fitzpatrick skin color scores I to III
* Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).
* Tattoo age between 1 and 20 years.
* Professionally applied.

Exclusion Criteria:

* Subject is pregnant or planning to become pregnant during the duration of the study.
* Prior tattoo removal procedures on target tattoo.
* Self-applied or amateur tattoo.
* Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.
* Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).
Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) postoperatively were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* 75 patients aged between 18 and 50 years old
* Both sex of ASA physical status I and II
* 70-90 kg body weight
* Height 160-180 cm
* Undergoing elective single level lumber laminectomy under general anesthesia.

Exclusion Criteria:

* Patients with impaired kidney or liver functions
* History of cardiac or central nervous system disease
* History of drug or alcohol abuse
* History of chronic pain or daily intake of analgesics
* Uncontrolled medical disease (diabetes mellitus and hypertension)
* History of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery or allergy to the used medications
* Coagulation defect
* Local infection at the site of application of transdermal patch
* Patient refusal or duration of surgery more than 120 minutes were excluded from the study.
Performance and Team Pre-critical Staff Before Critical Event in High Fidelity Simulation for Anesthesiology Residents

Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and plannification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare team performance during the scenario with or without a liberal preparation team staff of 4 min, suggested after the briefing of the scenario but before the scenario starts.

High fidelity simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur, plannification of team resources, priority in the treatment strategy and effective communication within the team, may help to improve team performance during the scenario. The investigators' goal is to compare team performance during the scenario with or without a preparation team staff of 4 min. This staff will be suggested after the briefing of the scenario but before the scenario starts. The investigators are going to compare groups of anesthesiology residents going through same scenarios of simulated critical events in high fidelity simulation session. Scenarios will be recorded to be analyzed by 2 reviewers independantly. A checklist of appropriate treatment and a non technical skill checklist will be use to cote team performance. Stress of the participants will be assessed by visual analogic scale of participants anxiety and stress. the two groups (preparation staff or no preparation staff) will be compare to see if improvement in team performance is associated with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology resident in the education simulation curriculum

Exclusion Criteria:

* no verbal consent
Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women

The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown.

Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women

Exclusion Criteria:

* diabetes mellitus or impaired glucose tolerance
* clinical signs of hyperandrogenism
* polycystic ovary
* hormonal therapy
* BMI \> 30 kg/m2
* dysmenorrhoea
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.

Eligible participants will be randomized in a 1:1 ratio to receive either GME751, or European Union (EU)-authorized pembrolizumab (Keytruda-EU) in combination with chemotherapy. The maximum study duration for a participant will be approximately 56 weeks including screening.

Treatment duration is 52 weeks (17 treatment cycles of study treatment GME751 or Keytruda-EU in combination with chemotherapy, each cycle with a duration of 3 weeks).

Participants will discontinue study participation in case of disease progression, unacceptable toxicity or other reasons.

Participants who are benefiting from treatment with pembrolizumab without signs of progression or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Untreated metastatic NSCLC
* Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements
* Measurable disease according to RECIST 1.1
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Squamous cell or mixed histology in NSCLC
* Known history of hypersensitivity (grade ≥3) to pembrolizumab, chemotherapy or their excipients
* Active autoimmune disease that has required chronic systemic treatment in the past 2 years.
* Received live vaccine ≤30 days before the first study treatment
* Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer.

Other protocol-defined inclusion/exclusion criteria apply.
Registry of CytoSorb Therapy in COVID-19 ICU Patients

The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed COVID-19
2. Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.

Exclusion Criteria:

1. CytoSorb therapy for diseases other than COVID-19
2. Survival unlikely within 24 hours (for prospectively enrolled patients)