cyrilzakka/clinical-trials huggingface dataset:
Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)

In the study the investigators aim to test whether transcranial direct current stimulation (tDCS)-induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel diseases (IBD).

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via MRI.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease
* Chronic pain (more than 3 months)
* Pain (VAS \> 3/10)

Exclusion Criteria:

* Contraindication to transcranial direct current stimulation
* Contraindications to magnetic resonance imaging (MRI)
* Pregnancy
* Sever internal or psychiatric condition
Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer

The purpose of this study is to determine if PEM scan can improve axillary lymph node staging by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM stands for positron emission mammography, a relatively new and advanced application of positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose and treat disease.

Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).

Exclusion Criteria:

* Children (\<18 years old)
* Pregnant or Lactating women
* Diabetic patients (Type I or II)
* Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
* Patients who have NOT undergone a standard of care bilateral breast MRI at UC.
EFS of the CardioMech MVRS

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen (18) years of age or greater
* Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
* Intermediate or high surgical risk for mitral valve repair

Exclusion Criteria:

* History of rheumatic heart disease
* History of prior endocarditis
* History of prior repair or replacement of the mitral valve, or annuloplasty
* Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
* Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency

In the treatment of heart failure (HF), SGLT-2 inhibitor (SGLT-2i) can significantly improve the clinical outcome and quality of life related to HF. The current data show that SGLT-2i is effective and safe in improving HF outcomes in patients with chronic kidney disease (CKD) stage 4, but there is little clinical evidence in patients with eGFR\<20 ml/min/1.73 m2. Therefore, our research is designed to confirm that SGLT-2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and severe chronic renal insufficiency (eGFR\<20ml/min/1.73m2).


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years
* Patients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, New York Heart Association (NYHA) grade II-IV
* Left ventricular ejection fraction (LVEF) ≤ 40% in the past 1 year
* Clinically confirmed chronic renal insufficiency, eGFR\<20ml/min/1.73m2 or maintenance hemodialysis

Exclusion Criteria:

* Allergy to SGLT-2i
* ALT or AST \>3 times the upper limit of normal value; Or total bilirubin\>2 times the upper limit of normal value
* Urinary or reproductive system infection in the last month
* Blood potassium is greater than or equal to the upper limit of normal value
* Patients with acute heart failure
* Patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics
* Patients who need intravenous vasodilators, including nitrates, before randomization
* Systolic blood pressure\<100mmHg measured during screening or at randomization
* Hemoglobin\<90g/L
* Uncontrolled serious arrhythmia
* Myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization
* Proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization
* Patients with malignant tumors
* Drug or alcohol addicts
* Patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period
* Pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period
* Patients with uncontrolled abnormal thyroid function
* Type 1 diabetes
* Not suitable evaluated by the investigator
Herpes Zoster: Risk Factors, Complications and Special Situations

This retrospective analysis is to investigate patients' history and clinical presentation in Herpes Zoster (HZ), Zoster-related complications, post-Zoster neuralgia and Herpes Zoster management in order to improve the management of HZ patients, to refine HZ-vaccination strategies and elucidate cost factors of HZ in in the setting of a university hospital in Switzerland generally and in a dermatology department specifically.


Eligibility Criteria:
Inclusion Criteria:

* Reports of patients with HZ at University Hospital Basel between 2004-2018

Exclusion Criteria:

* rejection to use patient data
The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps

This prospective cohort study is designed to investigate and to compare the diagnostic performance of contrast-enhanced ultrasonography (CEUS) and multidetector computed tomography (CT) for gallbladder cholesterol polyps, adenoma and gallbladder cancer.

In this study, investigators aimed to investigate the diagnostic performance of CEUS and high resolution CT (HRCT) for the preoperative differential diagnostic accuracies of gallbladder polypoid lesions.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US.

Exclusion Criteria:

* Gallbladder polyp with a diameter less than 10 mm.
* Lesions highly suspected to be cancer due to visible metastasis.
* Allergy to contrast agents and cannot received CT or CEUS examination.
* Women in pregnancy or lactation.
Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia.

Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy. Hypothesis is that performing short myotomy will result in similar efficacy in achalasia cardia while reducing the total time taken for the procedure and ultimately will result in less complications.

The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cm in stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. It is hypothesized that If shorter proximal myotomy that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one, there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum. Additionally, there is chance that many patients regain some esophageal peristalsis after both LHM and POEM. Patients undergoing POEM for type 1 and type 2 Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 and 2 achalasia with eckerd score \>3 (0-12 scale achalasia) -.
2. Age 18-75 years.
3. Treatment naïve or history of pneumatic balloon dilatation.
4. Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.

Exclusion Criteria:

1. Type 3 achalasia cardia or any other esophageal motility disorder
2. Previous surgery of the esophagus or stomach
3. Active severe esophagitis
4. Large lower esophageal diverticula
5. Large \> 3cm hiatal hernia
6. Sigmoid esophagus
7. Known gastroesophageal malignancy
8. Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
9. Cirrhosis with portal hypertension, varices, and/or ascites
Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).

Stroke was the second leading cause of death worldwide and the leading cause of death in China in 2017. ICAS accounted for 10% to 15% of ischemic stroke in Western countries, and as much as 46.6%in Asia in 2009.

For patients with ICAS, the risk of stroke is highly related to the histopathology of atheromatous plaques. Therefore, characterizing the morphology and composition of plaques in ICAS may help to predict the risk of stroke occurrence and allow the adoption of preventive or therapeutic management to prevent such life-threatening events. OCT, with a resolution of 10μm, may provide more reliable information in characterizing atheromatous plagues.

This study aims to get a better insight into the value of OCT in evaluating the vessel wall structure and therefore guiding the interventional therapy of ICAS. In addition, the clinical and biological information will be included to achieve correlation analysis so as to get biomarkers subject to various plaque characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic ICAS. Participants with ICAS with a transient ischaemic attack (TIA) or stroke attributable to the territory of the stenotic artery were defined as symptomatic. A TIA was defined as a transient episode of neurological dysfunction (focal weakness or language disturbance, transient monocular blindness, or required assistance in walking) caused by focal brain or retinal ischaemia that lasted for at least 10 minutes but resolved within 24 hours
* Stenotic degree ≥ 50%, measured by digital subtraction angiography
* The stenosis must located in at least one major intracranial artery (internal carotid artery, vertebral artery, middle cerebral artery, or basilar artery)

Exclusion Criteria:

* Arteriovenous Malformation
* Aneurysm
Correlation Research of Thioredoxin Reductase in Lung Cancer

In pre-clinical study the investigators found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.

This is a cooperative research project in Thoracic Surgery Department and Medical Oncology Department of Affiliated Cancer Hospital of xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early staged(Ⅰ\~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. The secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven staged(Ⅰ\~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass
* Receive surgery in Thoracic Oncology department Hunan Tumor Hospital without contraindication of surgery
* Malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
* Signed informed consent about providing blood and tissue for study

Exclusion Criteria:

* Patients have received antitumor treatment
* Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
* Pregnant or breast feeding women
Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17

The purpose of this study is to see if substances contained in ginger or aloe plants, called exosomes, will treat and improve the condition polycystic ovary syndrome


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 year
* Patients must have a confirmed diagnosis of PCOS according to the Rotterdam Criteria. At least 2 of the following 3 characteristics must be present: 1. Oligo-anovulation 2. Clinical and/or biochemical signs of androgen excess and 3. Polycystic ovarian morphology (PCOM) (defined by an increased number of small antral follicles \[≥12 follicles that were \<10 mm in diameter\] or an increased individual ovarian volume \[\>10 cm3\] in 1 or both ovaries. Disorders mimicking PCOS must also be excluded, including thyroid dysfunction, hyperprolactinemia, late-onset congenital adrenal hyperplasia, and ovarian or adrenal androgen-producing tumors.
* Of all subjects screened patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
* Ability to understand and willingness to sign a written informed consent document.
* Absence of life limiting medical conditions

Exclusion Criteria:

* • Pregnancy

  * Known HIV
  * Patients receiving immunosuppressive drugs
  * Patients taking confounding medications such as sex steroids, infertility medications or insulin sensitizers or any medication deemed to alter glucose and/or insulin levels
  * Active malignancy in the last 5 years
  * Patients receiving any other investigational agent(s)
  * Ginger and/or aloe allergy
A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy

In addition to bowel cleansing agents, the current practice of bowel preparation for colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day before the procedure. This study aims to test whether patients who consume a low residue breakfast the day prior to colonoscopy have a difference in the quality of their bowel preparation. Patients requiring outpatient colonoscopies will be asked to participate. They will be randomized to either breakfast or no breakfast the day before the procedure. Colon cleanliness, patient hunger, and tolerance will be assessed.

The investigators hypothesize that there will be no difference in bowel preparation scores and will be better tolerated

Colon cleansing prior to colonoscopy is essential for an adequate examination. Research has shown that preparation prior to colonoscopy remains one of the biggest deterrents for patients considering colon screening (1).

In addition to the bowel cleansing agents another important aspect of the preparation is the diet consumed prior to the procedure. Currently 48 hours prior to colonoscopy patients are asked to consume a low residue diet. The day before the procedure they are switched to a clear fluid only diet which many patients find difficult to follow due to hunger and can lead to non-compliance with the preparation.

There have been no trials to date which have answered the question whether the consumption of breakfast alters colon cleansing with the cleansing agents currently used in Canada. Investigators found that in patients receiving sodium phosphate preparations, a full breakfast or low residue lunch had no effect on colon cleansing scores and improved hunger and energy levels (2). Several studies have looked at the result of low residue diet kits taken the day prior to the procedure and showed no difference in colon cleansing or tolerability compared to the traditional clear fluid regime (3,4).

This study aims to test whether patients who consume a low residue breakfast the day prior to colonoscopy have a difference in the quality of their colon cleansing or tolerability of the preparation compared to those who consume a clear fluid diet. The investigators hypothesize that there will be no difference in bowel preparation scores and will be better tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom a GI physician has ordered a colonoscopy will be approached for inclusion in the trial

Exclusion Criteria:

* ileus or bowel obstruction -significant constipation (\<3 spontaneous bowel movements/day)- previous colorectal surgery
* ascites
* active inflammatory bowel disease
* pregnancy
* recent (\<6 months) myocardial infarction or unstable angina
External Ankle Supports - 3D Motion Analysis

Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means of different tests. The dynamic postural control is quantified. The hypothesis was that the devices would stabilize differently the foot segments.


Eligibility Criteria:
Inclusion Criteria:

* chronic ankle instability
* "giving way"
* repeated ankle sprains

Exclusion Criteria:

* other injuries of the lower extremities
* surgery on the lower extremities
Leap Motion Controller for Pain During Venipuncture in Pediatrics

Venipuncture is the most frequent invasive procedure in hospitals and clinics. In the pediatric population this is very often associated with fear, anxiety, distress and enhanced perception of pain. Local anesthetic creams (like EMLA) are used to reduce pain and distress but they need 30-60 minutes of waiting between the application and the puncture, which is too much time for most of everyday life clinical contests. Many distraction techniques have been studied, both active (ie video games, virtual reality) and passive (ie listening to music, visual stimulation).

Active production of music is one of the most complex activities for our central nervous system. It requires a precise timing of a lot of well-coordinated actions, like recognition and conservation of a rhythmic structure, precise execution of quick and complex fine movements, and with an important involvement of intense emotional experience. It stimulates bilaterally primary and secondary auditory cerebral areas, but also motor and premotor areas, language areas and their contralateral, cognitive areas. At the same time, it activates reward and gratification circuits with stimulation of the limbic system and endorphin release and also neurovegetative system. Music is probably the most immediate and spontaneous communication tool that can also act at subcortical level without the person being aware of what they are receiving and transmitting. Music activates the dopaminergic mesolimbic system, which regulates memory, attention, executive functions, motivation and also mood and pleasure through the nucleus accumbens. It also produces measurable cardiovascular and endocrine responses indicated by reduced serum cortisol levels and inhibition of cardiovascular stress reactions.

The Leap Motion Controller is an infrared device that digitalizes the movements of the hand above it in real-time: this is connected with a software that converts this signal into a musical tone specifically set. The melody is created very easily just by moving the hand above it. With this device, children will be able to produce music without anything interposing between them and the sound production. This will allow the patient to focus only on the melodies, without technical difficulties that could derive for instance from a visual interface or an instrument you have to hold.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-17 years undergoing venipuncture

Exclusion Criteria:

* Patients with cognitive impairment
* Patients who do not understand the Italian language or with parents who are unable to provide a written informed consent in Italian language
* Patients medicated with local anaesthetic cream