cyrilzakka/clinical-trials huggingface dataset:
Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with severe systolic heart failure (HF) and ventricular desynchronization. Despite the consistently observed structural and functional improvements as well as reductions in HF events and mortality in large multicenter randomized trials, 30% patients remain classified as nonresponders. Present evidences showed that QRS duration was the most effective parameter to predict responsivity of CRT in patients with severe HF. But some studies showed that QRS duration could be influenced by obesity and gender. Accordingly, the simple QRS interval width of body surface electrocardiograph should not be the most satisfactory parameter for screening patients suitable for CRT. Recent study showed that left ventricular electrical delay, as measured by the time from the onset of QRS to the LV electrogram peak (QLV), predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO) can increase the likelihood of structural response to CRT. However, it is unclear whether it is suitable for Chinese patients. The investigators would like to validate this relation in a Chinese population and explore if a corrected QLV might do better to predict the responsivity of CRT.


Eligibility Criteria:
Inclusion Criteria:

* •More than 18 Years

  * Informed consent signed
  * NYHA class ≥ II, an ejection fraction of ≤ 0.35, QRS duration of ≥ 150 milliseconds with Non-LBBB) or ≥ 120 milliseconds with LBBB, who treated with CRT
  * The Estimated survival time was more than one year
  * sinus rhythm, pacemaker independent

Exclusion Criteria:

* •NYHA class I symptoms

  * Severe liver or kidney dysfunction
  * Valvular heart disease
  * Pregnancy or lactation women
  * percutaneous coronary intervention (PCI) or cardiac artery bypass graft (CABG) within 3 month
  * Have malignant tumors and the Estimated survival time was less than one year
  * an enzyme-positive myocardial infarction within 3 months before enrollment, or atrial fibrillation
  * any reasons cannot complete follow-up; Or researchers think that don't suit to be included in the research of other conditions
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)

This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin

The PK of rosuvastatin will be monitored following single-dose administration of rosuvastatin with and without multiple-dose administration of 4 g Epanova™ for 13 consecutive days in order to detect a possible interaction between rosuvastatin and Epanova™. The PK of total EPA, total DHA and total EPA+DHA will also be monitored following multiple-dose administration of Epanova™ with and without single-dose administration of 40 mg rosuvastatin. A single dose administration for rosuvastatin has been judged sufficient to yield plasma concentrations that will be detectable with an adequate validated analytical method and characterize adequately the PK of rosuvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Male or female (non-childbearing potential)
* Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
* Non-smoker
* Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs

Exclusion Criteria:

* mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
* History or presence of myopathy and/or hypothyroidism.
* History or presence of transaminase elevations
* History or presence of hypersensitivity or idiosyncratic reaction to rosuvastatin, to other HMG-CoA reductase inhibitors, to Epanova™, to Vascepa®, or to related compounds
* Known sensitivity or allergy to soybeans, fish, and/or shellfish.
* Has consumed fish within 7 days prior to check-in.
* Female subjects who are pregnant or lactating.
* Positive urine drug and alcohol results at screening or check-in.
* Positive urine cotinine at screening and check-in
* Use of any drugs known to be inducers of CYP enzymes and/or P-gp
* Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
* Plasma donation within 7 days prior to the first dose of study medication.
* Participation in another clinical trial within 28 days prior to the first dose of study medication.
Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children

Children often experience pain and anxiety during minor medical procedures. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during minor painful procedure in the Plastic Surgery clinic. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Children age 6 to \< 17 years
* Patients scheduled for minor elective plastic surgery procedure
* Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

* Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
* Facial features or injury prohibiting wearing the VR goggles
* Procedure in the face, where the VR system may interfere with Plastic Surgeon work
Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers

This study will test new techniques to image the heart, blood vessels, and legs using magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments using minimally invasive methods.

Healthy normal volunteers 18 years of age and older may be eligible for this study.

For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal cyclinder. Special antennas, covered in pads, are placed against the subject s body. The scan time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes. The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a belt or finger pad for monitoring breathing. During the test, a contrast agent called gadolinium may be injected. This substance brightens the heart and arteries during the scan, providing a better picture of blood flow.

During the procedure, subjects may be asked to exercise their legs on a machine to evaluate the effects of motion and exercise on the MRI exam.

Large blood pressures cuffs may be placed on either or both thighs or calves to try to measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least 50 mmHg higher than thesubject s systolic blood pressure (up to 250 mmHg) for up to 10 minutes.

Subjects may be asked to return for repeated scans.

We will evaluate new developments in fast magnetic resonance imaging (MRI) of the heart and blood vessels on healthy volunteers. These studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media, supine exercise or the inflation of blood pressure cuffs on the lower extremities during the MRI imaging. The results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.

Eligibility Criteria:
* 1. GENERAL INCLUSION CRITERIA:
* Healthy adult volunteers, age is greater than 18 years of age, who consent to participate in writing

  2. EXCLUSION CRITERIA: MRI risk
* Cardiac pacemaker or implantable defibrillator
* Cerebral aneurysm clip
* Implanted neural stimulator (e.g. TENS-Unit)
* Any type of ear or cochlear implant
* Intra-ocular foreign body (e.g. metal shavings)
* Any implanted device (e.g. insulin pump, drug infusion device)
* Metal shrapnel or bullet
* Morbid obesity
* Claustrophobia

  3. EXCLUSION CRITERIA: Contrast media risk:
* Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
* Known hemoglobinopathy
* Known kidney disease
* Exposure to gadolinium MRI contrast agents in the past 18 hours, if the study requires gadolinium MRI contrast agent.
* Diabetes
* Children are not included.
Bariatric Surgery and Pharmacokinetics of Apixaban

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on apixaban.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Pertussis (Tdap) Vaccination in Pregnancy

Despite good vaccination coverage, included in national immunization programs in developed countries, the number of reported pertussis cases is rising, also in very young infants. Current immunization strategies fail to protect infants too young to be immunized with the licensed vaccine. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants. Early humoral immunity will be assessed and the influence on vaccine response of the infant measured. The present study offers the opportunity to have new insights in neonatal immunological mechanisms against pertussis and a better understanding in strategies to protect infants against pertussis.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-35 years
* Willing to be immunized during pregnancy OR
* Received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner.
* Age matched controls will be identified in the same time period in the recruiting hospital.
* Availability for follow-up visits and phone call access through 16 months following delivery
* Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal Belgian schedule) with pediatrician, the general practitioner or at the Centre for the Evaluation of Vaccination.
* In the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician

Exclusion Criteria:Women:

* Serious underlying medical condition
* History of a febrile illness (\>= 38° Celsius) within the past 72 hours before injection
* Previous severe reaction to any vaccine
* Receipt of tetanus-diphtheria toxoid immunization within the past 1 month
* Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization in the last 10 years
* Receipt of a vaccine, blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection
* Receipt of or plans to receive influenza vaccine within the 4weeks prior to or following injection. One month interval should be respected in order to evaluate eventual Adverse events following one of both vaccines (fever, local symptoms).
* High risk for serious obstetrical complication
* Anything in the opinion of the investigator that would put the participant at risk.

Exclusion criteria for the offspring:

* Serious underlying medical condition
* No signed informed consent by both parents
* Severe reactions to any vaccine
* Anything in the opinion of the investigator that would put the participant at risk.
Adherence in Global Airways

There is a strong case for treating diseases of both the upper and lower airways (global airways) simultaneously because they share the same inflammatory mechanisms. About 9% have chronic sinusitis (CRS) and 4% of the Danish population are diagnosed with CRS with nasal polyps (CRSwNP)) and 7-10% have asthma. CRS has a multifactorial background, with CRSwNP characterized by Type 2 inflammation, and approximately 50% with Type 2 CRSwNP also have co-morbid asthma. Well-treated CRS has an impact on asthma control, and well-treated asthma has an impact on CRS.

Several studies show that patients with asthma have low adherence, but only a few if any of studies are available on adherence in CRS.

Aim:

To investigate the effect of systematic and structured nursing supervision in patients with CRSwNP and asthma primarily on adherence.

Hypothesis and research questions: Patients with respiratory diseases can improve their adherence to their non-medical and medical treatment for CRSwNP/CRS and asthma by systematic and structured nursing supervision compared to patients who receive usual care.

In a randomized clinical trial, we will investigate whether the level of adherence measured by the questionnaire MARS-5-N and MARS-5- L in patients with CRSwNP and asthma can be improved by 7 points after systematic and structured nursing guidance at baseline visit and controlled after four months - compared with those patients who have not received the above guidance.

Primary outcome: is change in adherence rate measured by the MARS-5-N/L questionnaire in patients with CRSwNP and asthma can be improved by 4 points after systematic and structured nursing guidance at the initial visit and controlled after four months - compared with patients who have not received the above guidance.

Inclusion Criteria:

Adherence to MARS- 5 L/N ≤35 at first visit, diagnosed with asthma (with/without allergic rhinitis) at initial visit, diagnosed with CRSwNP, able to use smartphone, ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma), \>18 years of age, SNOT-22 score ≥35

Exclusion Criteria:

* Adherence to MARS-5- L/N \>35 points at first visit,do not have smartphone, does not read/speak English, other illness requiring regular medication, pregnancy/pregnancy that started during the study, server psychological comorbidities

Questionnaires: Patients must answer the following questionnaires at baseline and at 4 months follow up ESS, SNOT-22, ACQ-7, ACT, MiniAqLq, HADS, STARR-15


Eligibility Criteria:
Inclusion Criteria:

* Adherence to MARS- 5 L/N ≤35 at first visit
* Diagnosed with asthma (with and without allergic rhinitis) at initial visit
* Able to use smartphone
* ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma)
* Be over 18 years of age
* SNOT-22 score ≥35
* Diagnosed with CRSwNP

Exclusion Criteria:

* Adherence to MARS-5- L/N \>35 points at first visit
* Do not have smartphone
* Does not read or speak English
* Other illness requiring regular medication
* Pregnancy and pregnancy that started during the study time period
* Servere psychological comorbidities
Genes, Omega-3 Fatty Acids and Cardiovascular Disease Risk Factors

The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors.

The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors. To do so, the metabolic risk factor response to an n-e PUFA supplementation will be compared in carriers and non-carriers of polymorphism within genes acting as fatty acids sensors.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women aged between 18 to 50 years;
* having a BMI between 25 and 40kg/m2;
* plasma triglycerides levels \<4.0 mmol/L;
* non-smokers;
* free of any thyroid or metabolic disorders requiring treatment such as diabetes, hypertension, severe dyslipidemia, and coronary heart disease.

Exclusion Criteria:

* subjects taking medication for hyperlipidemia, hypertension, diabetes or taking anticoagulant or n-3 PUFA supplementation;
* having a taste aversion for fish, fish allergy or regular alcohol drinker;
* body mass index \> 40kg/m2;
* pregnant or nursing women.
Cutaneous Microcirculation After Remote Ischemic Preconditioning

In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on second-degree burns, superficial and chronic wounds in a human in-vivo setting for the first time.


Eligibility Criteria:
Inclusion Criteria:

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.

Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.

Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.

Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident.

Exclusion Criteria:

General exclusion criteria

* below 18 years of age
* wounds requiring artificial respiration, since consent for the study participation is unobtainable

Exclusion Criteria Groups A, B, D:

* peripheral arterial occlusive disease
* vasculitis
* diabetes mellitus
* chronic kidney or liver disease
* cardiac dysfunction
* arterial hypo- or hypertension

Anamnestic exclusion criteria

* ongoing immunosuppressive or chemotherapy treatment
* drug abuse
* systemic skin diseases
* systemic and local cortisone therapy
Myofascial Release and Mobilization With Impulse Technique Torsion in Low Back Pain

The purpose of the current randomized clinical trial was to compare the effectiveness of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability, and kinesiophobia in individuals with chronic non-specific low back pain.

Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability and kinesiophobia in individuals with chronic non-specific low back pain.

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Intervention: For 12-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will receive a mobilization with impulse technique torsion (anterior) (1/week).

Main Outcome Measures: Intensity of pain, disability, fear of movement, isometric endurance of trunk flexor muscles and lumbar mobility in flexion data will be collected at baseline, and 24hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Score ≥4 on the Roland Morris Disability Questionnaire
* Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
* Low back pain for ≥3 months
* Not undergoing another physical therapy treatment

Exclusion Criteria:

* Disease of the central or peripheral nervous system
* Having previously undergone spinal manipulative therapy
* Contraindication to low back thrust manipulation
* A history of spinal surgery
* Treatment with corticosteroid in the past two weeks
* Clinical signs of radiculopathy
* Presence of lumbar stenosis
* Diagnosis of spondylolisthesis
Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy

The proposed study will be a pilot randomized controlled trial comparing treatment as usual (TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention (TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing persistent post-operative pain. The ACT intervention is a single individual therapy session scheduled two weeks following surgery. Potential participants will be recruited from the University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the study is 72 participants. Study measures will consist of self-report questionnaires and medical record data. Data will be collected prior to surgery, one-week after surgery, and 3 months after surgery.

Psychological interventions addressing depression, anxiety, and psychological approaches to pain management in pre-surgical patients may serve to prevent the development of persistent post-surgical pain, depression, and anxiety in at-risk individuals. Acceptance and Commitment Therapy (ACT) is a psychological therapy that has been shown to be effective in minimizing the impairing impact of chronic pain and in treating depression and anxiety. ACT is a behavior therapy incorporating mindfulness, which aims to increase psychological flexibility via facilitating psychological acceptance and committed action in the direction of one's personally identified values. ACT has also shown promise in brief interventions, including a one day ACT workshop with patients with comorbid migraine and depression. The current study proposes to identify pre-operative breast cancer patients who are at increased risk for developing persistent post-surgical pain and to offer a brief ACT intervention with the aim of reducing the incidence of persistence post-surgical pain and psychological sequela.

Eligibility Criteria:
Inclusion criteria: 1) ≥18 years of age, 2) scheduled for mastectomy or lumpectomy for breast cancer or DCIS, 3) identified to be "at risk" (per guidelines below).

At risk criteria: Psychological distress (elevated anxiety, depression, or pain catastrophizing), under the age of 50, or with a pre-existing chronic pain condition. Scores of 10 or above on the Generalized Anxiety Disorders 7-item scale or the Personal Health Questionnaire Depression 8 item Scale will indicate elevated anxiety or depression. A score of 30 or above on the Pain Catastrophizing Scale will indicate elevated catastrophizing.

Exclusion Criteria:

1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Prospective Randomized Study of Glucocorticoids in the Impact of the Liver Function and the Prognosis After Hepatectomy of HCC

The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function. Perioperative steroid administration has been advocated to reduce liver damage. The aim of this prospective, randomized study was to determine whether steroid administration can reduce liver injury and impact the prognosis


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* diametre of the mass\>3cm.
* hcc