cyrilzakka/clinical-trials huggingface dataset:
Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated.

Aims: To compare the rate of free resection margin (R0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery.

Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (R0) or infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy

Exclusion Criteria:

* Patients with hepatic or peritoneal metastasis
* Patients with irresectable tumor
* Patients with R2 resection
* Patients Grade IV of the American Society of Anesthesiology Score
* Patients with neoadjuvant treatment
The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level

The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, normal BMI

Exclusion Criteria:

* Metabolic disorders
* Smokers
* Drinkers
* Taking nutritional supplement
TAES Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure

To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a non-invasive modality in improvement of the function of respiration and circulation on elder patient during colonoscopy.

To assess the function of respiratory and circulation before precondition, during colonoscopy and end of the procedure, blood cortisol and catecholamine levels were measured also.The incidence of airway support, application of vasoactive drug or atropine during procedure were recorded in the meantime.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged 65 or older
2. American Society of Anesthesiologists (ASA) grade I\~II
3. consent and voluntary participation in this experiment
4. patients under colonoscopy
5. none allergic to propofol and fentanyl
6. airway assessment for none difficult airway

Exclusion Criteria:

1. Allergic to propofol, fentanyl.
2. ASA is greater than or equal to grade 3
3. Abnormal respiratory tract may cause severe respiratory obstruction
4. unsatisfactory control of hypertension, systolic pressure over 160 millimeter of mercury (mmHg) or diastolic pressure over 100 mmHg
5. Hypotension, systolic pressure below 90 mmHg, heart rate (HR) \<50bpm or \>100bpm
Vonoprazan for Helicobacter Pylori Eradication in Adolescents

The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determine if it offers superior eradication rates (VONTAPE trial).

The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy.

The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent.

Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance.

In the VOTSAPE trial, we will test this efficacy in the \< 18 years adolescents.

Eligibility Criteria:
Inclusion Criteria:

1. Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.
2. Who is positive for H. Pylori infection by a standardized diagnostic test.
3. Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication according to the Maastricht V consensus report.

Exclusion Criteria:

1. allergy to any of the drugs used in the study
2. previous attempts to eradicate H.P.
3. Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.
4. Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.
5. Liver or kidney failure.
6. symptoms suggestive of functional disorders.
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)

This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood
* Body mass index (BMI) of 18 to 37 kg/m\^2
* No clinically significant abnormality on electrocardiogram (ECG)
* Stable health
* Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug

Exclusion criteria:

* Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease (exceptions of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or other malignancies which have been successfully treated ≥10 years prior and unlikely to recur
* Positive Hepatitis B surface antigen
* Documented human immunodeficiency virus (HIV) infection
* Consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 mL/10 ounces\],wine \[125 mL/4 ounces\], or distilled spirits \[25 mL/1 ounce\]) per day
* Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day
* Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment
* History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment
* Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug induced hepatitis, autoimmune hepatitis
* Previous treatment with other HCV NS3/4A protease inhibitors
* Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment
* Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3)
* Participation in another investigational study within 4 weeks prior to enrollment
Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients

The use of ultrasound in clinical practice is feasible for monitoring muscle mass in critically ill patients. Assessment of muscle mass by ultrasound is clinically relevant and adds value for guiding therapeutic interventions, such as nutritional and physical therapy interventions to maintain muscle mass and promote recovery in critically ill patients.

Critical illness is characterized by substantial hormone- and cytokine-mediated protein metabolism changes in various organs, leading to increased breakdown and decreased synthesis rates. Consequently, a considerable and life-threatening loss of muscle mass occurs. Medical therapeutic measures such as long-term sedation and mechanical ventilation during ICU stay can further enhance this muscle degradation (up to 2 % muscle mass per day leading to clinically relevant symptoms known as ICU-acquired weakness. Nutritional modulation, particularly of dietary amino acids, may have benefits to prevent or attenuate disease-induced muscle wasting. while there are several accurate muscle mass measurement methods and techniques \[including computed tomography (CT) scan, bio-impedance analysis and ultrasound\], not all are routinely feasible in clinical ICU practice. The use of ultrasound in assessing muscle mass in critically ill patients has gained much attention recently as it is non-invasive and can easily be utilized at the bedside. There are two main goals for the assessment of muscle mass: first, to assess the current muscle mass for the patient as part of (nutritional) diagnosis, and thereby risk stratification and second, to monitor the progression of muscle loss and/or recovery of muscle mass, and create opportunity to examine the effectiveness of therapeutic interventions to reduce muscle loss and/or promote muscle recovery.

Eligibility Criteria:
Inclusion Criteria:

* all critically ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II (8) (APACHE II score ) ≥ 25 and could be enterally or parenterally fed in the critical care unit of Assiut University Hospitals.

Exclusion Criteria:

* patients with malabsorption syndrome, previously diagnosed myopathies, traumatic brain injuries, intracerebral hemorrhages and cerebral ischemia.
Modern Hybrid Imaging in Patients With OSCC

Prospective diagnostic study to determine the diagnostic accuracy of preoperative 18F--fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.


Eligibility Criteria:
Inclusion Criteria:

* Histopathological proven head and neck carcinoma
* Written inform consent
* 18 years of age

Exclusion Criteria:

* Cancer of unknown primary
* En-bloc resection of lymph node levels
* Uncertainties regarding the removed lymph node levels
Effects of Shrinker Use on Healing and Volume

We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".

Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.

Eligibility Criteria:
Inclusion Criteria:

* Recently undergone primary transtibial amputation
* Patients between ages of 18 and 100 years of age

Exclusion Criteria:

* Undergone previous amputations above the Symes level
The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery

This study aimed to predict different physical activity (PA) levels in patients undergoing thoracoscopic lung resection surgery (LRS) using the International Physical Activity Questionnaire (IPAQ) and investigate the association between the PA levels and the incidence of postoperative pulmonary complications (PPCs). The patients were classified into the high-level and low-level PA groups based on the IPAQ scores. The incidence of PPCs within postoperative 5 days, number of PPCs, the incidence of postoperative adverse events (PAEs) within postoperative 5 days, extubation time, length of hospital stay (LOS), unplanned admission to the intensive care unit (ICU), and the mortality 1-month postoperatively were recorded. Arterial blood samples were collected before induction of anesthesia and 1 hour postoperatively, and the supernatants were centrifuged for cytokine analysis. Binomial logistic analysis was performed to determine the relationship between predefined variables and PPCs. Receiver operating characteristic (ROC) curve analysis was performed to identify independent risk factors, and the area under the curve (AUC) was calculated.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years and younger than 80 years;
2. Patients scheduled to accept elective thoracic surgery under general anesthesia;
3. Patients of American Society of Anesthesiologists (ASA) Ⅱ～Ⅲ level grade;
4. Patients signed the informed consent form for the clinical study.

Exclusion Criteria:

1. Patients with moderate or severe chronic obstructive pulmonary disease (GOLD Grade III or IV level grade)；
2. Patients with severe or uncontrolled bronchial asthma；
3. Patients with severe neuromuscular disease or thoracic malformation；
4. Patients with severe heart disease (New York Heart Association Class III or IV level grade or acute coronary syndrome or persistent ventricular arrhythmia)；
5. Patients with cognitive dysfunction；
6. Patients who have participated in other clinical trials within the previous 30 days；
7. Patients with coagulation dysfunction；
8. Patients who received radiotherapy or chemotherapy within 2 months before surgery.
Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

The aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally.

Of those affected by lateral epicondylalgia will 90% be free of symptoms within 8 months to 2 years with conservative treatment. In this study surgical radiofrequency microtenotomy and eccentric exercise for chronic (more than two year) lateral epicondylalgia that is unilaterally will be used as treatment. Patients is randomized to a group with eccentric exercise or a group with surgical radiofrequency microtenotomy and postoperatively eccentric exercise. Home based eccentric exercise program is instructed by a physical therapist and is performed for three months. Women start with 0.5 kg and men 1.0 kg weight, they perform 3 sets with 5 reps once a day and register pain and exercise in a diary. Function, pain and quality of life will be followed and are carried out after 6 weeks and after 3, 6 and 12 months. The surgery and eccentric exercise is instructed and followed at the investigators clinic.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18 and under the age of 70 year
* lateral epicondylalgia at least two year
* tried conservative treatment

Exclusion Criteria:

* complicated systemic diseases (such as diabetes)
* understand spoken and or/written instructions in Swedish
Control Systems Engineering for Weight Loss Maintenance

This project capitalizes on principles of control systems engineering to build a dynamical model that predicts weight change during weight loss maintenance using behavioral, psychosocial, and environmental indicators evaluated in a system identification experiment. A 6-month behavioral obesity treatment will be administered to produce weight loss. Participants losing at least 3% of initial body weight will be followed for an additional 12 months via daily smartphone surveys that incorporates passive sensing to objectively monitor key behaviors. Survey data pertaining to behavioral, psychosocial, and environmental indicators will be used to develop a controller algorithm that can predict when an individual is entering a heightened period of risk for regain and why risk is elevated. Interventions targeting key risk indicators will be randomly administered during the system ID experiment. Survey and passive sensing data documenting the effects of the interventions will likewise drive development of the controller algorithm, allowing it to determine which interventions are most likely to counter risk of regain.


Eligibility Criteria:
Inclusion Criteria:

* English language fluent and literate at the 6th grade level
* Body mass index (BMI) between 25 and 50 kg/m-squared
* Able to walk 2 city blocks without stopping
* Owns a smartphone

Exclusion Criteria:

* Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling.
* Currently participating in another weight loss program
* Currently taking weight loss medication
* Has lost ≥5% of body weight in the 6 months prior to enrolling
* Has been pregnant within the 6 months prior to enrolling
* Plans to become pregnant within 18 months of enrolling
* Any medical condition that would affect the safety of participating in unsupervised physical activity
* Any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness
A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation

Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives. Direct oral anticoagulants (DOACs) are recommended for patients with NVAF to prevent strokes. Real world data reveal the underuse of anticoagulation in the elderly, especially due to physicians' concern of bleeding, often neglecting the thromboembolic risk. This study is designed to evaluate the safety and effectiveness of edoxaban in Korean elderly patients with atrial fibrillation.

The objective of this study will be to evaluate the safety and effectiveness of edoxaban in patients 80 years of age or older with NVAF. This observational, non-interventional study will prospectively follow Korean patients who have been prescribed edoxaban at the discretion of the physician up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* NVAF participants aged ≥ 80 years old
* Participants who are determined to be prescribed with edoxaban at the discretion of the physician within 8 weeks prior to enrollment according to Package information
* Participants who can return to the site in person for face-to-face visits
* Written informed consent for participation in the study (ICF)

Exclusion Criteria:

* Planning to participate or simultaneously participating in any interventional study
* Life expectancy \< 1 year

No influence on prescribing behavior as participants will only be included in the study after the physicians have made the clinical decision to prescribe edoxaban.
Family Meals on Prescription- a Randomized Controlled Trial

"Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five family meals at a reduced price for three months.

Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.

Children between the age of 5-15 years receiving treatment for obesity at the pediatric clinics in Varberg and Kungsbacka were offered to participate in the trial.

The study population was divided into two arms including 60 patients in each arm:

* In the first arm the patients received care consistent with regional guidelines.
* In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months.

Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 5 to 15
* attending the Paediatric Obesity Clinics in Kungsbacka or Varberg

Exclusion Criteria:

* Younger than 5 or older than 15
Uncuffed Endotracheal Tube vs. no Endotracheal Tube

This is a comparison of uncuffed endotracheal tube (UCETT) vs. no endotracheal tube (ETT) in endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) procedure under moderate sedation in terms of procedure tolerance, duration of the procedure, desaturation, amount of sedation medication usage.


Eligibility Criteria:
Inclusion Criteria:

* Any patient that is scheduled for EBUS-TBNA procedure

Exclusion Criteria:

* Those who are not safe to receive moderate sedation or flexible bronchoscopy
Social Marketing in Prevention Actions

Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation and attendance resulting in Physical Activity (PA) approaches designed to prevent falls actually only benefiting a limited number of elderly subjects. Social marketing has already shown its utility in the construction of prevention programs.

This study uses the social marketing approach to improve a fall prevention program. The intervention territory will receive social marketing campaign while the territory controls will not have a campaign.

The main goal is to improve attendance at our fall prevention program.

Eligibility Criteria:
Inclusion Criteria:

* People living in the one of the territories of the study
* People without medical contraindications to participate in moderate physical activity
* People who has received information about the study and its rights to its data

Exclusion Criteria:

* People unable to attend workshops
* People already registered for adapted physical activity
* People who refused to participate to the study.