cyrilzakka/clinical-trials huggingface dataset:
Clinical Utility of the Spyglass System in Primary Sclerosing Cholangitis (PSC)

This study aim to prospectively evaluate the clinical utility of Spyglass in sclerosing cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ERCP). Fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP from September 2008 and onwards will be investigated with peroral cholangioscopy using Spyglass direct visualization system. Clinical data on all patients will be collected at time of the ERCP including information on the Primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD), serum liver function tests and indication for ERCP.

A structured data collection form including information on Majoie Score, macroscopic features of the bile ducts at cholangioscopy, quality of the investigation, technical difficulties, and an overall judgment of whether any abnormalities observed were benign or malignant was completed by the endoscopist in conjunction with the procedure.


Eligibility Criteria:
Inclusion Criteria:

* sclerosing cholangitis with indication for ERCP
* Over 18 year
* informed consent

Exclusion Criteria:

* Not able to sign informed consent
Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity

The prevalence of sarcopenic obesity (SO) is increasing worldwide, posing important challenges to public health and national health care system, especially during the COVID pandemic. In subjects with SO, it is essential to reduce body weight preserving lean mass, in order to avoid a worsening of muscle function. Lifestyle modification with adequate nutrition and proper physical activity is essential to counteract SO progression. In accordance with the Position Statement of the Italian Society of Endocrinology, Very Low Calorie Ketogenic Diet (VLCKD), a well established nutritional intervention in the context of obesity, has been promoted also for the treatment of SO. Moreover, the source of protein, timing of intake, and specific amino-acid constitution also represent critical factors in increasing muscle mass and strength. Recent studies have shown how protein supplementation, especially with high leucine content, can be effective in degenerative and end-stage diseases.

To date, the effects of physical training during VLCKD have not been studied. The aim is to determine the efficacy of VLCKD combined with interval training, compared to a VLCKD or a LCD alone, on weight-loss, body composition and physical performance in patient with SO.


Eligibility Criteria:
Inclusion Criteria:

* obesity (BMI 30-40)
* FAT MASS % ( \> 41% for W, \>29% for M)
* HOMA-IR \> 2,5

Exclusion Criteria:

* known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac or cerebrovascular diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery
This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.

This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.
* Adult patients of both sexes.
* Peripheral neuropathy patients.
* Patients without wounds or ulcers at the examination time.
* Patients with a foot ulcers history.
* Patients with or without minor amputation prior to the inclusion time in the present study.
* Patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait.

Exclusion Criteria:

* Patients with mayor amputation.
* Patients with rheumatic disease that affect the feet.
* Patients with peripheral neuropathy of different etiology to Diabetes mellitus.
* Patients with several critical ischemia criteria, defined by TACS II guideline.
A Comparison of Physical Activity Levels With and Without Feedback Via Fitbit® Flex™ in Hemodialysis Patients

This is a pilot study intended to gather data in order to inform future studies about the role of feedback as an incentive for increasing levels of physical activity which could improve health in hemodialysis patients.

In prior studies that have analyzed physical activity in dialysis patients, three-dimensional accelerometers, physical performance tasks or self-reporting physical activity questionnaires have been used to measure levels of activity. This proposed study differs in that it will determine the effectiveness of providing "feedback" to dialysis patients using a fitness tracking bracelet. For the purpose of this study, the word 'feedback' is used to refer to the information provided to the subject that demonstrates the number of steps taken since the previous dialysis session as displayed by the Fitbit® application. This 'feedback' will allow subjects to be more aware of their overall physical activity on a quantitative level.

The study will seek to explore an association between feedback and physical activity. Improved physical activity could improve indicators of subjects' health status such as blood pressure, inflammatory markers, and pre-albumin levels, which will also be monitored and recorded.

While informing subjects quantitatively about their levels of physical activity could be a promising method to encourage them to be more active, it is unclear at this point if that strategy actually works. This is an important practical question though, because actually informing subjects on a regular basis about their activity level may pose substantial operative challenges and result in additional costs.

The importance of encouraging subjects to be more physically active should not be underestimated. Studying the physical activity of dialysis patients is important because it allows researchers to consider the long-term effects that may influence the subject's well-being. Johansen et al. showed that there was a direct relationship between the inactivity of dialysis patients and susceptibility to hypertension, diabetes, cardiovascular disease and even mortality. Additionally, the study demonstrated the importance of implementing programs to promote physical activity \[1\]. If feedback does indeed increase physical activity, then it will be substantially beneficial for this program to be implemented.

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis three times a week
* On hemodialysis for more than 3 months
* Between the ages of 18 and 75 years
* Able to walk without assistance or assistive devices
* Able to read and understand the English language

Exclusion Criteria:

* Patient already uses an activity tracker
* Unstable health: acute infections, congestive heart failure NYHA class 4 and/or unstable angina
* Hospitalization within the past 3 months for non-access related reasons
* Known allergies to nickel
* Unable to physically grip the handheld dynamometer in order to complete the Hand Grip Strength Test
* Cognitive impairment
Bowel Preparation Before Rectal Cancer Surgery

Traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem.

Cleaning the bowel without complications for the patient is one of the aims for this study.

The other aim is to see if patient nutritional status improves with nutritional drinks as a complement to food intake 4-6 weeks before surgery.

In our institution, patients undergoing surgery for cancer in the rectum are often prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery and less complications. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment.

The actual study's purpose is to find out if rectal cancer surgery can be performed without traditionally bowel preparation. Nutritional drinks are to be used instead of traditional bowel preparation. Patients are randomized into two groups, stratification for stricture, malnutrition and laparoscopic surgery and each group should either bee treated with traditional bowel preparation, Laxabon® (A) or nutritional drinks, Fresubin Energy drink (B) before surgery. Patients in subgroup B take nutritional drinks seven days before surgery instead of ordinary food. Bowel purity degree is measured peroperatively.

The secondary aim is to see if malnutrition can be improved with nutritional drinks as a complement to ordinary food intake before surgery. For four to six weeks before surgery 50 % or more of the caloric need is substituted with nutritional drinks in subgroup B (Fresubin Energy drink 15-30 kcal/kg\*day). Subgroup A only eats ordinary food throughout the same period, before surgery.

Bowel purity degree, physiological functions, and body mass index are measured in all four groups before and after surgery. All patients in the study keep records of physical activity daily, and food diary twice a week. Complications are registered.

Blood samples for hormones and electrolytes are taken before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* rectal cancer
* men
* women
* age 18-90 years

Exclusion Criteria:

* acute ileus
* seriously dementia
* metastatic disease
A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

Previous clinical studies showed there is a potential value of EGFR-TKI in local advanced EGFR-mutant NSCLC, while the risk of radiation pneumonia in combination of EGFR-TKI with thoracic radiotherapy is unknown. This study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in local advanced EGFR-mutant NSCLC patients.

Doublet platinum-based therapy combined with radiotherapy remains the standard treatment for first-line management of unresectable stage III NSCLC patients, regardless of the EGFR mutation status. But the 5-year survival rate is not satisfying. Previous clinical studies showed there is a potential value but also a high risk of radiation pneumonia in treatment regimens of combination TKI with radiotherapy. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in EGFR-sensitive mutated locally advanced NSCLC patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed histologically or pathologically as non-small cell lung cancer;
* According to the eighth edition of the 2015 IASLC international lung cancer staging, imaging staging assessed as inoperable stage III patients (according to the eighth edition of the 2015 IASLC international lung cancer staging);
* Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;
* Have not received systemic anti-tumor therapy;
* FEV1\>0.75L;
* Age ≥ 18 years old;
* ECOG PS score ≤ 2;
* Estimated survival period ≥ 6 months;
* Women must undergo surgical sterilization, post-menopausal, or take contraceptive measures during the treatment period and within 3 months after the end;
* Sign the informed consent form.

Exclusion Criteria:

* Previously received other anti-tumor treatment, including almonertinib or other EGFR-TKI drugs;
* Contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases;
* Other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer);
* Any medical or non-medical reasons prevent the patient from continuing to participate in the research;
* It is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial;
* Currently receiving (or unable to stop using it before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks ago);
* The patient is taking any drugs that prolong the QT interval, and the drug cannot be stopped before the treatment of almonertinib;
* Patients with lung V20 \> 28% even after two-month almonertinib treatment.
* Pregnancy or breastfeeding.
Clinical Study on the Safety of SAFIL® MESH

Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects

The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020

Eligibility Criteria:
Inclusion Criteria:

* Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh

Exclusion Criteria:

* No exclusion criteria have been set.
Mayo Clinic Upper Digestive Disease Survey

The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.

The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes.

Patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Enteral Feeding of Premature Babies and Olive Oil Supplementation

It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding.

Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values.

Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Premature babies born at 32 weeks or less
* Babies who tolerate full enteral feeding at the before end of the second week
* Babies given consent by their parents -

Exclusion Criteria:

* Having a congenital or genetic anomaly
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies

The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.

This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.

Eligibility Criteria:
Key inclusion:

* Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies
* Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies

Key exclusion:

* Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment
* Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk
Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup

This study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the workup of aortic stenosis. Patients will be randomly assigned .23 or .28 sec rotation time CTA. Coronary artery interpretability rates will be determined in both groups.

Coronary artery analysis is an essential component of cardiac CT, but is often challenging without beta-blocker use. CT's technological advances are continuously evolving, paving the way for safer and more accurate diagnoses. Part of these innovations is the development of faster rotation speeds (0.23 sec/rotation), which is expected to allow for heart rate-independent CCTA.

Patients subjected to aortic stenosis workup routinely undergo invasive coronary angiography (ICA) in the catheterization laboratory, voiding the need to control the heart rate at the time of cardiac CT because aortic valve measurements can be performed even at higher heart rate. Still, cardiac CT in this context is performed with ECG-gating, and attempting to evaluate coronary arteries is possible without interfering with clinical decisions. Also, the existing literature advocates the use of gantry rotation speeds of at least 0.5 sec/rotation; consequently, the use of 0.28 versus 0.23 sec/rotation for this study will comply with current guidelines and will have no detrimental impact on patient management. This study aims to evaluate coronary artery interpretability in patients subjected to cardiac CT for the anatomical assessment of aortic valve stenosis prior to endovascular (transcatheter aortic valve implantation \[TAVI\]) or surgical therapy.

Patients will be enrolled after providing written, informed consent, and will be randomly assigned either to the test (0.23 sec rotation time) or control group (0.28 sec rotation).

The participants concerned are not subjected to any additional invasive or stressful procedure compared with those undergoing aortic stenosis workup in clinical routine.

Eligibility Criteria:
Inclusion Criteria:

* Subjected to cardiac CT due to known or suspected aortic valve stenosis

Exclusion Criteria:

* Patients unable to hold their breath, deaf or visually impaired
* Estimated glomerular filtration rate (eGFR) of \<30 mL/min
* Hemodynamic instability or cardiogenic shock, Acute pulmonary edema, Exacerbated chronic obstructive pulmonary disease, Pregnant and breast-feeding women
* Patients with prior coronary artery bypass grafting (CABG)
* Patient incapable of discernment
Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.

There is no gold standard treatment for erythematotelangiectatic rosacea (ETR). In recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A (BoNT-A) treatment in ETR and facial erythema. Studies including objective and quantitative measurements are limited.

This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients.

This randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (ETR). They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side. Clinician's erythema assessment (CEA) score, patient self-assessment (PSA) score, erythema index (EI), melanin index (MI), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Erythematotelangiectatic rosacea subtype
* Willingness to participate in the research and providing informed consent

Exclusion Criteria:

* Patients under 18 years of age, over 60 years of age
* A rosacea subtype other than ETR
* History of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses
* Known history of autoimmune disease
* History of neuromuscular disease
* History of facial botulinum toxin injection within the last six months
* Reporting allergy to the active ingredient
* Pregnant or breastfeeding patients
* Patients who do not accept treatment and follow-up