cyrilzakka/clinical-trials huggingface dataset:
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥18 years of age;
2. History of serum TG concentration ≥500 mg/dL within the past 5 years;
3. Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
4. Have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of physical examination, ECG, medical history, and routine laboratory test results;
5. Willing to maintain his/her current activity level and to follow either the NCEP TLC diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through 12);
6. Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during Visits 4b and 6b (Weeks 4 and 12);
7. Willing to abstain from alcohol consumption and avoid vigorous physical activity for 48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and
8. Subject understands the study procedures and is willing and able to sign the informed consent form to participate in the study and the Health Insurance Portability and Accountability Act authorization for release of relevant protected health information to the Investigators and study personnel.

Exclusion Criteria:

1. An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff)
2. Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 \[Week 0\])
3. A history of cancer (other than basal cell carcinoma) in the last 2 years
4. A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to Visit 1
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients

Problem Formulation

1. Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
2. Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District?
3. Is there an effect of brisk walking exercise and combined administration of jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
4. Is there a difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise and the combination on blood pressure in obese people in Jekan Raya District?

Research Objectives

General Objective:

This study aims to determine the difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise on blood pressure in obese people in Jekan Raya District.

Specific Objectives:

This study specifically aims to:

1. Knowing the effect on blood pressure of obese people in Jekan Raya District before and after giving Jamu Sambiloto (Andrographis paniculata).
2. Knowing the effect on blood pressure of obese people in Jekan Raya District before and after doing Brisk Walking Exercise.
3. Knowing the effect before and after giving Jamu Sambiloto (Andrographis paniculata) and Brisk Walking Exercise on Blood Pressure in obese people in Jekan Raya District.

This type of research uses the Quasi Experimental method type Non-equivalent control group design, with a research design in the form of two group pre test and post test design, in this study there are two groups that will be measured pretest before intervention and post test after intervention and 1 control group without being given intervention. The intervention group is divided into two groups, namely the group given the sambiloto herbal medicine, and the group given the Brisk Walking Exercise treatment. Quasi-experimental research design with research design in the form of two group pre test and post test design.

Eligibility Criteria:
Inclusion criteria in this study are:

Body Mass Index (BMI) ≥ 25 kg/m2 (Obesity 1) Blood pressure does not exceed 139/89 mmHg (High Normal) Adult age (19-39 years) Willing to be a respondent with informed consent Have health insurance coverage

Exclusion Criteria

Exclusion criteria in this study are:

Not in place or out of town during the study Experiencing illness that cannot carry out research interventions and data collection Resign during the study Routine exercise (Exercise every day less than 6000 steps). Taking anti-hypertensive drugs regularly Pregnant and breastfeeding mothers Routinely consume jamu sambiloto History of bone and joint disease that prevents physical activity History of cardiovascular or kidney disease
Valproate Versus Ketorolac Versus Metoclopramide

This randomized study is testing 3 different intravenous medications to see which one is best for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.

One million patients present to US emergency departments (ED) annually for treatment of acute migraine headache. A variety of parenteral medications are used to treat acute migraine, but none offer rapid and complete headache relief without side effects. Preliminary studies have suggested that intravenous valproate, an anti-epileptic medication with established efficacy as a migraine preventive, may be useful for the treatment of acute migraine. We propose a randomized, comparative efficacy trial in which intravenous valproate is compared to two standard parenteral therapies for acute migraine. There will not be a placebo control. Included subjects will be adults 64 years and younger who meet International Headache Society criteria for acute migraine, who do not have clinical evidence of secondary (organic) headache, and who do not have allergy or contra-indication to the investigational medications. The investigational medications are 1gm of valproate, 10mg of metoclopramide, and 30mg of ketorolac. Patients will be approached for participation and randomized at the time of presentation to the ED. Pain will be assessed on an 11 point (0 to 10) verbal pain scale, validated for use in acute pain trials. Medication will be infused as a slow intravenous drip. The primary outcome will be an improvement in headache intensity one hour after initiation of the intravenous drip. Secondary outcomes include assessments of pain, functional disability, adverse events, and satisfaction with the investigational medication one, two and 24 hours after initiation of the intravenous drip. The primary analysis will use a Student's t-test for independent samples and involve three pair-wise comparisons. Using an alpha of .017 (to account for the three pairwise comparisons), a standard beta, and a validated minimum clinically significant difference on the verbal pain scale, we calculated the need for 330 subjects. An interim analysis will be conducted to determine lack of efficacy of valproate.

Eligibility Criteria:
Inclusion Criteria:

* IHS migraine without aura
* IHS probable migraine (all migraine without arua criteria must be met except duration may be \>72 hours or \<4 hours)

Exclusion Criteria:

* Allergy or contra-indication to investigational medication
Nausea and Vomiting After Gynecologic Surgery

In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Epidemiological, surgical, anaesthetic characteristics and post-operative treatment are considered as predictors for the post-operative nausea and vomiting. The primary objective is the incidence of nausea and vomiting. The secondary objective is the possible predictors of nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Elective surgeries for gynecologic disease
* Good performance status
* Signed an approved informed consents
* Post-operative stay 72 hours or longer

Exclusion Criteria:

* Emergency surgeries
* Not meeting all of the inclusion criteria
iHSCs With the Gene Correction of HBB Intervent Subjests With β-thalassemia Mutations

This is a single centre、single arm、open-label study，to investigate the safety and efficacy of the gene correction of HBB in patient-specific iHSCs using CRISPR/Cas9.

The purpose of this study is to evaluate the efficacy and safety of transplantation iHSCs intervent subjests with β-thalassemia mutations.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 2 and ≤ 60 years of age
2. Subjects was confirmed the transfusion-dependent β-thalassemia
3. Adequate organ function, as defined by:

   Serum creatinine ≤ 1.5 mg/dl ； Serum ALT/AST）≤2.5×ULN；ALB≥25g/L； Serum total bilirubin \< 1.5x ULN Left ventricular ejection fraction≥50%
4. Chest X-ray and ecg test results were normal, no serious cardiopulmonary diseases
5. Subjects survival was expected≥6 months
6. Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge
7. Subjects and the guardians able to undergo post-physical therapy/rehabilitation

Exclusion Criteria:

1. Subjects allergic to macromolecular biological agents such as antibodies or cytokines
2. Subjects receipt of any investigational clinical trials within 3 months.
3. Subjects previous treatment with any hematopoietic stem cell transplantation or other organ transplantation
4. Uncontrolled bleeding symptoms
5. Severe cardiovascular disease is known, including any of the following:

   Myocardial infarction or thrombosis has occurred in the past six months Subjects with unstable angina pectoris Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
6. Subjects have one kinds of tumors within 5 years
7. Active hepatitis B (HBV DNA\>1000copy/mL), hepatitis C or HIV infection.
8. Subjects have an infectious diseases that cannot be controlled within 4 weeks
9. subjects have severe central nervous system disease or epilepsy
10. Subjects are Suffering from mental illness; Patients with alcohol dependence, drug abuse, drug addiction, and medical, psychological or social conditions that may interfere with research or have an impact on the evaluation of research results
11. Women in pregnancy (positive urine/blood pregnancy test) or lactation
12. Subjects who have other conditions that were not appropriate for the group determined by the researchers.
Use of Static Ultrasound Guidance for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients

Cannulation of the internal jugular vein (IJV) for central venous access is a standard practice in cardiac surgery. In this study, the authors tested the hypothesis that using an ultrasound (US) scanner would increase the success of IJV cannulation and decrease the incidence of complications in adult cardiac surgical patients.

The study will include adult cardiac surgical patients, randomized into two groups (control vs. US). In the control group, IJV cannulation will be performed by the conventional landmark technique using Seldinger method. In the US group, the course of the IJV will be marked before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate, number of attempts, cannulation time and complication rate will be compared for the two groups.

Use of real time ultrasound has recently been recommended as the standard of care for insertion of central venous catheters. However, its usage is limited by various factors which include availability, space constraints and perceived lack of need according to surveys including cardiovascular anesthesiologists. We will conduct a prospective randomized controlled trial to compare the conventional landmark technique with the static ultrasound (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which is supplied along with the transesophageal echocardiography machines for internal jugular vein cannulation in adult cardiac surgical patients.

After ethical committee approval and patient consent, adult patients scheduled for elective cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of the two methods: standard landmark technique (group A: control group), static US technique using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total cannulation time and complication rate in the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

* patients undergoing bidirectional Glenn shunt, Fontan surgery or emergency surgery
* local site infection
* presence of coagulopathy
* anatomical deformity of neck(burns, neck swelling, surgical scar)
MK0524 Seasonal Allergic Rhinitis Study (0524-005)(COMPLETED)

To assess the efficacy of MK0524 on seasonal allergies.


Eligibility Criteria:
Inclusion Criteria:

* Person has had at least 2 years of seasonal allergies
* Person has had a positive skin test to at least 1 of the allergens of the season
* Person is a non-smoker

Exclusion Criteria:

* Person has been hospitalized within the last 4 weeks
* Person is a female who has had a baby within the last 8 weeks or is still breast-feeding
Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis

This randomized controlled trial attempts to determine whether the measurement of pleural pressures during therapeutic thoracentesis affects the development of chest discomfort after the procedure. During thoracentesis, pleural fluid is drained from the pleural space, resulting in lung expansion. In some cases, the lung is not completely re-expandable, in which case continued drainage results in the development of negative pleural pressures and chest discomfort. Negative pleural pressures may also result in other complications such as re-expansion pulmonary edema and pneumothorax. The identification of negative pleural pressures via manometry during the procedure may lead to a reduction in the complication rate.

PRIMARY OBJECTIVES:

I. To study the impact of pleural manometry on the development of chest discomfort during therapeutic thoracentesis compared to conventional symptom-guided thoracentesis.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo manometry-guided therapeutic thoracentesis.

ARM II: Patients undergo symptom-guided thoracentesis.

Eligibility Criteria:
Inclusion Criteria:

* Referral to pulmonary or interventional radiology services for large-volume thoracentesis
* Presence of a symptomatic moderate or large free-flowing pleural effusion on the basis of:

  * Chest radiograph: effusion filling \>= 1/3 the hemithorax, OR
  * Computed tomography (CT)-scan: maximum anteroposterior (AP) depth of the effusion \>= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR
  * Ultrasound: effusion spanning at least three rib spaces with depth of \>= 3 cm

Exclusion Criteria:

* Inability to provide informed consent
* Study subject has any disease or condition that interferes with safe completion of the study including:

  * Coagulopathy, with criteria left at the discretion of the operator
  * Hemodynamic instability with systolic blood pressure \< 90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians
* Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
* Referral is for diagnostic thoracentesis only
* Manometry felt to be clinically indicated
* Inability to assume or maintain a seated position for the procedure
* Presence of multiple loculations on bedside pre-procedure ultrasound
Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis

Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.

This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
2. Age ≥6 to \<18 years old.
3. Established diagnosis of active moderate-to-severe plaque psoriasis defined as a PASI score ≥ 10, body surface area (BSA) involvement of ≥10% and PGA score ≥ 3 only or with concomitant psoriatic arthritis.
4. Failure or intolerance of prior psoriasis treatment.
5. Patient was prescribed with secukinumab within 4-16 weeks before inclusion.
6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.

Exclusion Criteria:

1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
2. History of chronic recurrent infection.
3. Clinically significant infection exacerbation, including active tuberculosis.
4. Age \<6 years or ≥18 years.
5. Pregnancy and breastfeeding.
6. Patients participating in parallel in an interventional clinical trial.
7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.
8. Patients within the safety follow-up phase of interventional study.
9. Active inflammatory bowel disease at inclusion.
10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation.
Young Adult Naturalistic Alcohol Study (YANAS) Using Smartphone Technology in a Simulated Laboratory Environment

It is important to explore use of technology to reduce drinking. The purpose of this research study is to compare different types of mobile technology for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in four phases: a web-based screening assessment; brief appointment on the day of the alcohol drinking session; alcohol drinking session; and a follow-up appointment. Participation in this study will last approximately two months.


Eligibility Criteria:
Inclusion Criteria:

* Be able to read English and complete assessments
* Drink alcohol regularly

Exclusion Criteria:

* Test positive on a urine test for use of certain illegal drugs
* Undergraduate student enrolled in the University of Florida
* Graduate students from the College of Health and Human Performance at the University of Florida
* Pregnant, or breast feeding
UAB AIM Virtual Magic Camp

The magic camp for children with disabilities at UAB has been conducted yearly since 2018. This year, because of the Covid-19, the magic camp will be conducted online. The virtual magic camp will start in the beginning of June . It will run for 4 weeks. After one cohort, there will be another cohort starts in the beginning of July . Each cohort will have about 30 children with disabilities. Two occupational therapy graduate students will teach each child via Zoom to learn magic hand trick 3 times a week, one hour each. No studies evaluate the psychological benefits of learning magic tricks via online in children with disabilities. Therefore, this study is to evaluate the psychological being of the children participants after completing a virtual magic camp.


Eligibility Criteria:
Inclusion Criteria:

* Have some form of ASD
Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix

This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.

Keloid, scleroderma, acne keloidalis nuchae, and burn scars are all characterized by collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis. Treatments for these disabling conditions are inadequate at present. Recently, in non-controlled studies, UVA1 was shown to induce improvement in patients with scleroderma, granuloma annulare and urticaria pigmentosa.

However, UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix metalloproteinases (MMPs). The investigators' preliminary data show that high dose UVB (160 mJ/cm2) will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs. They postulate, therefore, that in pigmented skin, higher than usual UVB doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen via activation of MMP pathways.

The purpose of this research project is to study the effectiveness of high dose UVB (290-320nm at up to 320mJ/cm2) irradiation for the treatment of skin conditions with altered dermal matrix in patients with increased skin pigmentation. These disorders include but are not limited to keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, and granuloma annulare. Up to fifty patients with one of these diagnoses or related conditions will receive UVB irradiation up to 5 times per week, for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* In good general health and between 10-80 years of age.
* Willing and able to receive UVB, as directed in the protocol; make evaluation visits; follow protocol restrictions; and sign a written, witnessed, informed consent form.
* Have a clinical diagnosis of keloid, scleroderma, old burn scars, granuloma annulare, or acne keloidalis nuchae.
* No disease states or physical conditions that would impair evaluation of the test site
* Must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

* Have a history of photosensitivity (development of hives or bumps with exposure to light) or experience hypersensitivity in a UVB photo-provocation test.
* Have participated in another investigational study in the past 4 weeks, taken oral therapy for skin condition, or on photosensitizing medications.
* Pregnant, nursing, or planning to become pregnant during the study.