cyrilzakka/clinical-trials huggingface dataset:
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention

The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.

Whereas CTO PCI techniques and success rates have significantly improved during the last decade, CTOs still pose a significant technical challenge for accurate stent sizing (primarily due to negative remodelling and subsequent distal vessel dilatation post-PCI) resulting in a potentially increased risk of stent failure. Hence, the concept of DCB as a definitive treatment for native CTO is appealing and warrants further investigation. The IMAGINATION trial has been designed as a prospective research to: 1) investigate both the immediate and intermediate-term angiographic, IVUS and physiologic efficacy outcomes as well as safety profile of DCB for native vessel coronary CTO, and 2) to provide a basis for future randomized clinical trial comparing DCB to drug-eluting stents.

All patients with CTO will be screened for potential inclusion in the study. After obtaining written informed consent, patients with successful intraplaque guidewire crossing through CTO lesion (excluding the use of dissection and re-entry techniques) will undergo IVUS-guided PCI with a scoring balloon (balloon-to-artery ratio of 1:1) followed by the use of a paclitaxel-coated balloon. Following satisfactory angiographic result, IVUS and physiological measurements (FFR and non-hyperemic pressure ratios) in the target vessel will be performed. At 6-months follow-up, invasive angiography with IVUS and FFR/non-hyperemic pressure ratios in the target vessel will be repeated. In addition, patients with pre-procedural CCTA will undergo follow-up CCTA after 12 months (CCTA substudy).

Eligibility Criteria:
Inclusion Criteria:

* clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
* native CTO lesion as defined by invasive coronary angiography
* informed consent for participation in the study

Exclusion Criteria:

* \<18 years of age
* myocardial infarction
* cardiogenic shock
* severe valvular disease
* estimated life expectancy \<1 year
* contraindication to PCI
* positive pregnancy test or breast-feeding
* in-stent CTO
* CTO recanalization using antegrade or retrograde dissection and re-entry techniques
Pilot Study Using a Wireless Motility Capsule

Research suggests dietary fiber may decrease transit time through the gastrointestinal tract. Research studies traditionally use radio-opaque markers to determine gastric emptying, colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be used to determine gastric emptying, colonic transit, and whole gut transit time without requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and the SmartPill detect the similar transit times.

The purpose of this pilot study is to determine if the SmartPill can detect a change in transit time using a significant dose of dietary fiber.

The ability of a device to track gastrointestinal transit time, including gastric emptying time, was measured in healthy people consuming low and high fiber diets.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18 - 65
* Non-smoking
* Not taking medication
* Non-dieting
* BMI 18-30
* English literacy
* Ability to swallow the SmartPill

Exclusion Criteria:

* Do not regularly consume breakfast
* Food allergies to ingredients fond in study products
* Dislike of hot cereal
* BMI \<18 or \>30
* Are not weight stable
* Diagnosed with diabetes, cardiovascular, renal, or hepatic disease
* Cancer in previous 5 years (except basal cell carinoma of the skin)
* Any gastrointestinal disease or condition
* Any gastrointestinal surgeries that alter motility
* Recent antibiotic usage (\< 6 months)
* recent or concurrent participation in an intervention research study
* History of drug or alcohol abuse in prior 6 months
* Use of laxatives, anti-diarrheal, antacids, or medications which alter motility
* Vegetarians
* People who eat more than approximately 15 grams of fiber per day
* Currently consume fiber supplements
* Women who are pregnant or lactating
* Women with irregular menstrual cycles
Characterization of Disease Related Changes in Inflammatory Bowel Disease Using Fecal Metabolite Profiling

The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel Disease(IBD) patients versus healthy controls (HC).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of IBD
* Age \>18 years

Exclusion Criteria:

* Use of antibiotics in the preceding month
* Intake of pre- or probiotics
The Role of m6A RNA Modification in Moyamoya Disease

The purpose of this study is to detect the change of m6A RNA modification from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.

Moyamoya disease (MMD) is a rare cerebrovascular disorder characterized by occlusion of bilateral internal carotid and intracerebral arteries with the compensatory growth of fragile small vessels. The etiology of disease is still unclear. The pathology is associated with blood vessels, characterizing the molecular changes of blood in patients with MMD may yield insights into the disease. N6-methyladenosine (m6A) is identified to be the most common and abundant RNA molecular modification in eukaryotes, and involves in a variety of metabolic processes of RNA, such as RNA transcription, shearing, nuclear transport, and translation ability. The propose of this study is to investigate the change of m6A RNA modification in patients blood with moyamoya disease and its influence on clinical indicators, aiming to provide potential pathogenesis of moyamoya disease.

Eligibility Criteria:
Health volunteers' inclusion criteria:

Age between 4-60; Male or female;

Exclusion criteria:

Exclude the volunteers with history of cerebrovascular disease.
Efficacy and Ventilatory Responses to VHI in Atelectasis Patients

The purpose of this study include (1) To investigate the efficacy of ventilator hyperinflation technique to re-expand lung atelectasis on patients with critical trauma who intubated and mechanical ventilation in the intensive care unit, (2) To investigate the effectiveness of ventilator hyperinflation technique to improve airway clearance on patients with critical trauma in the intensive care unit, and (3) To explore the acute responses of ventilatory functions to ventilator hyperinflation technique on patients with critical trauma who intubated and mechanical ventilation in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Critical trauma patients with pulmonary complications who were intubated and mechanical ventilation and have a diagnosis of lobar atelectasis and/or plate-like atelectasis (atelectasis demonstrated on chest X-ray) will be considered for inclusion. For the sign of plate-like atelectasis will be persist on chest X-ray for 2 day
* The injuries may occur alone or combination of these injuries: 1) head injury, 2) chest injuries, including broken ribs, with or without hemothorax, pneumothorax and hemopneumothorax with intercostal chest drainage (ICD), 3) blunt abdominal, and 4) fracture of the limbs and/or spine.

Exclusion Criteria:

* acute respiratory distress syndrome (ARDS)
* acute lung injury (ALI)
* pulmonary contusion
* undrained pneumothorax, hemothorax, and hemopneumothorax
* bronchospasm
* pulmonary bullae/blebs
* lung tumors
* lung abscess
* haemoptysis
* mean arterial pressure (MAP) \<70 mmHg
* positive end expiratory pressure (PEEP) \>6 cmH2O
* heart rate (HR) \>140 beats/min
* blood pressure (BP) \<90/60 or \>180/100 mmHg
* restlessness
* oxygen saturation (SpO2) \<90%
* spontaneous respiratory rate (RR) \>35 beats/min
Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).

This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-70 years with fasting glucose 100\~126 mg/dL

Exclusion Criteria:

* Abnormal lipid profile values
* Acute/chronic inflammation
* Treated with corticosteroid within past 4 weeks
* Cardiovascular disease
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Participation in any other clinical trials within past 2 months
* Renal disease
* Abnormal hepatic function
* Under hypolipidemic drugs therapy within past 3 months
* Under antipsychotic drugs therapy within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* History of alcohol or substance abuse
* Pregnancy or breast feeding
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine

To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.

This protocol posting deals with objectives \& outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female who had received complete primary vaccination course of hepatitis B vaccine in the primary study
* Written informed consent obtained from the subject and/or parent/guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis B challenge dose.

Exclusion Criteria:

* Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.
* Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
* Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month).
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041's activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC.


Eligibility Criteria:
Inclusion Criteria:

* Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for \> 9 months or seeking medical treatment for a previous documented diagnosis of IC
* Subjects who are not surgically sterile or postmenopausal (amenorrheic \> 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test

Exclusion Criteria:

* Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
* History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state
* Vaginitis or vaginal infection within 1 month before randomization
Follow-up of Coronary Artery Bypass Graft Patency by Multislice Computed Tomography

Coronary artery disease is a major cause of morbidity and mortality across the world and coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment. Patients with recurrent ischemic symptoms after CABG are most likely to have occluded or significantly stenosis in grafts or native coronary arteries. Therefore, there is a need to evaluate the patency of these vessel conduits after CABG. Until now, selective coronary angiography is the traditional gold standard for the assessment of both native coronary arteries and bypass grafts. But it is an invasive procedure that requires x-ray exposure, hospitalization, and includes a risk for complication. However, there is an alternative noninvasive method, multislice computed tomography (MSCT), with high specificity and excellent sensitivity for the detection of the coronary artery disease. It is even cheaper and takes shorter time to perform. Accordingly, the purpose of this study is to use MSCT to evaluate the patency and the quality of all grafts and native coronary arteries after CABG for more than two years. In addition, we will elucidate the relationship of these data and CABG procedures to review our experience.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent CABG and performed MSCT after the surgeries

Exclusion Criteria:

* Nil
Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

The study is designed to assess the safety and tolerability of a novel food ingredient produced from rape seeds supplied as a snack-bar in a 4-week controlled intervention.

An 4-week randomized, double-blind, controlled, parallel-group intervention for assessment of safety and tolerability of a novel rape seed ingredient (RI) followed by a 2-week follow-up period. Baseline measures for digestive symptom frequency questionnaire (DSFQ), blood safety tests and body mass index (BMI) will be collected at screening visit. At the randomization visit, participants' eligibility will be confirmed, and they will be randomly allocated into 2 parallel groups consuming either 20 g (test group) or 0 g (control group) of RI within 2 daily snack bars. During the intervention and follow-up periods participants will bi-weekly respond to a GI symptom questionnaire including DSFQ, stool frequency and stool consistency, and palatability items. At the end of the intervention period (week 4) a clinic visit including BMI and AE recording and blood safety tests will be held.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Age 18-75 years (inclusive)
* Body mass index (BMI) 18.5 - 30 (inclusive)
* Good general health according to medical history and current health status

Exclusion Criteria:

* Allergy or sensitivity to any ingredient of the study products
* Nut or mustard allergy
* Any major diseases or malfunctions including i. Inflammatory bowel disease or functional bowel disorder or any major gastrointestinal medical condition ii. type 1 or 2 diabetes requiring medication iii. active hepatic, kidney or thyroid disease or disorder except if subject on thyroid replacement therapy iv. myocardial infarction, unstable symptomatic angina pectoris, or transient ischemic attack or stroke within 3 months prior to screening v. cancer or cancer treatment within 5 years prior to screening (not including basal cell carcinoma)
* Medication used for treatment of elevated blood glucose levels
* Pregnancy, lactation or planned pregnancy during the trial
* Clinically significant abnormalities in safety laboratory values according to the investigator
* Strict low-carbohydrate or low-fat diet
* Participation in another clinical trial in the preceding 1 month
* Likelihood of any health or safety risk according to the Investigator
* Likelihood of non-compliance according to the Investigator
Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)

This is a prospective randomized study intended to assess the efficacy of erector spinae plane analgesia on acute and chronic postoperative pain for VATS procedures. It will include 72 patients presenting to Severance hospital for a VATS procedure. Patients will be randomized 1:1 to receive either ESP block and intravenous patient-controlled analgesia (IV PCA) or IV PCA only. Ropivacaine will be used in nerve block, and injected at the end of surgery. The primary outcome will be to compare analgesic efficacy between the two groups as defined by immediate postoperative pain scores on the numeric pain rating scale. Secondary outcomes include total opioid consumption, painDETECT score, and chronic pain scores.

Postoperative pain control for thoracic surgery is key to allow faster recovery and diminish postoperative complications. Poorly controlled acute pain may contribute to the impairment of respiratory function and the development of chronic post-thoracotomy pain.

Recently, an increasing number of erector spinae plane (ESP) nerve blocks are being performed as it has been demonstrated, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block and epidural analgesia. Moreover, there is an advantage for novice because ESP block is simpler and safer to proceed than conventional nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female participants providing written informed consent,
2. ASA grade 1-3,
3. aged over 20 and under 80,
4. primary lung cancer participants scheduled segmentectomy or lobectomy c MLND,
5. undergoing a VATS procedure under General Anaesthesia

Exclusion Criteria:

1. Absence of informed written consent,
2. chemotherapy before or after surgery,
3. pre existing infection at block site,
4. severe coagulopathy,
5. pre existing neurological deficit,
6. previous history of opiate abuse,
7. pregnancy,
8. pre existing chronic pain condition,
Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis

This study aims to evaluate the effects of auricular acupressure on salivary flow rate and fluid restriction adherence among children undergoing Hemodialysis .

Hypothesis Children undergoing Hemodialysis who receive both auricular acupressure and fluid restriction program exhibit better salivary flow rate and fluid control adherence than those who receive fluid restriction program only.

A non-randomized control trial was conducted at the Hemodialysis Unit in the Alexandria University Children's Hospital. A convenient sample of 60 children undergoing Hemodialysis was randomly assigned to two parallel groups. Both groups received the fluid restriction program in three types of sessions: general small-group discussion, individualized consultations, and follow-up. The study group also received auricular acupressure on four acupoints: Shenmen, Kidney Concha, Point Zero, and Upper Tragus.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 6 to 18 years
* Receiving hemodialysis for at least one month

Exclusion Criteria:

* Diabetes Mellitus
* Heart Diseases
* Autoimmune Disorders Such as Sjogren's Syndrome
Lymphocyte Sub-populations and Auto Immune Diseases

To determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

The goal of this study is to determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

All patients who had an evaluation of their lymphocyte subpopulations between january 2010 and december 2016 will be included in a retrospective analysis.

Eligibility Criteria:
Inclusion Criteria:

* autoimmune or infectious disease

Exclusion Criteria:

* No