cyrilzakka/clinical-trials huggingface dataset:
Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.

This is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Gastrointestinal bleeding as indication for capsule endoscopy.
3. Ability to give informed consent

Exclusion Criteria:

1. Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone;
2. Subjects has gastrointestinal motility disorder;
3. Subjects had stomach or small bowel resection;
4. Pregnancy;
5. Subjects has pheochromocytoma;
6. Subjects has uncontrolled hypertension;
7. Subjects has seizure disorders;
8. Subjects has concurrent MAO inhibitor use;
9. Subject has G6PD deficiency;
10. Subjects has swallowing disorder (including impaired gag reflex);
11. Subjects has hyponatremia with serum sodium less than 130 mm0l/L
Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

The purpose of this study is to gather information to develop a heart failure screening and prevention program.

All participants will undergo phlebotomy for specimen collection (BNP, hs-cTn, BMP and lipid testing, biorepository storage) and baseline echocardiography. All participants will additionally be administered a health and lifestyle questionnaire, undergo measurement of vital signs, and receive uniform education on heart-healthy lifestyle and signs and symptoms of heart failure. Participants who are randomized to the intervention arm will receive a referral to Heart Failure Prevention Clinic, a pharmacist-directed practice in collaboration with an attending cardiologist, where they will be followed for 1 year, with their primary care physician updated after each visit. The information from their BNP, hs-cTn, and echocardiography will be provided to them and their primary care physicians as well as the pharmacist and cardiologist team members. The participants (and their primary care providers) who are randomized to usual care will be blinded to their BNP and hs-cTn values and echocardiography results.

Eligibility Criteria:
Inclusion Criteria:

* 10-year risk of heart failure \>5% based on the PCP-HF equations
* At least one primary care visit in the last 12 months
* At least one additional primary care visit in the last 5 years
* Had cholesterol and glucose checked within the past 5 years

Exclusion Criteria:

* History of cardiovascular disease
* Signs and symptoms of heart failure
* Estimated glomerular filtration rate \<45 mL/min/1.73m\^2
* Stage 3 or 4 cancer
* Pregnancy
The Effectiveness of the Massage and the Hypopressive Abdominal Gymnastics on Low Back Pain (MAS-GAH)

The main goal of this study is to get to know if applying both, massotherapy plus hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low back pain. It actually reduces the inability produced by the pain and improve the patient's quality of life as well as the join range of the lumbar spine, way more than these two therapies applied separately.

Background:

Back pain is one of the most common musculoskeletal disorders in the industrialized society. It is estimated to affect between 70 to 85% of the adult population over their live. The impact of low back pain is widespread in developed countries, and accounts the major spending in economic and health resources, as well as being associated with the leading causes of absenteeism and disability. Diagnosis, in most cases, nonspecific low back pain, the symptoms have no clear cause, so that the source of pain is unknown. In general, a significant percentage progresses to chronic back pain and is accompanied by a limitation of physical activity influenced by improper posture or movement patterns.

Objectives:

To assess the effectiveness of massage therapy and hypopressive abdominal gymnastics, and the combination of both therapeutic modalities, to decrease pain and lumbar disability; and increasing joint mobility and quality of life in patients with chronic nonspecific low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic non-specific low back pain diagnosed and at least 12 weeks of mechanical pain.

Exclusion Criteria:

* Patients:
* With arterial hypertension diagnosed.
* With progressive neurological deficits.
* Pregnant or suspect that they are pregnant.
* With psychological or psychiatric process diagnosed.
* Under analgesic treatment.
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)

This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".

Primary objective:

* To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

The study will be conducted under the real clinical practices in accordance with Korea Food and Drug Administration "Basic standard for reexamination of new drug".

No vaccine will be provided and/or administered as part of this protocol, however only participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics will be part of the surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 16 years and older
* Informed consent signed by the subject and by parent or legal representative for subject aged 16 to 19 years
* Informed consent sign by subject for subject aged of 20 year of age and older
* Receipt of AVAXIM 160U according to Summary of Product Characteristics (SmPC).

Exclusion Criteria:

* Contraindications to vaccination according to AVAXIM 160U Summary of Product Characteristics (SmPC)
* Subject is known to be pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence for at least 4 weeks prior to the vaccination until at least 4 weeks after)
Translating Research Into Practice: Patient Navigation for Breast Cancer

The TRIP Project aims to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women with breast cancer. To accomplish this goal the study team will create (a) regional patient registries; (b) systematic screening for social barriers to care with a personalized referral plan; and (c) patient navigation services that integrate into one model of care to improve the quality and effectiveness of care delivery, for minority and/or low-income women with breast cancer in Boston.

This community-engaged program will demonstrate the feasibility of community-academic partnerships to provide innovations in information sharing and systems implementation targeted to reduce treatment disparities. Patient navigators will be able to utilize the patient database to track their patients throughout their treatment, and receive guidance regarding recommended social resources to patients experiencing hardships via the social determinants platform.

Who: The four Massachusetts Clinical and Translational Science Award (CTSA) hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 5 hospitals that care for women with breast cancer.

Patient population: about 1,300 vulnerable inner city women with risk for delay in breast cancer care. Massachusetts (MA) Cancer Registry data identified the following characteristics of Boston residents with greatest delays in breast cancer treatment: Black, Hispanic, non-English speaking, and public health insurance. Five health care institutions care for \>90% of these women:

1. Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
2. Boston Medical Center (PI: Tracy Battaglia MD, MPH)
3. Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
4. Massachusetts General Hospital (site PI: Beverly Moy, MD)
5. Tufts Medical Center (PI: Karen Freund MD, MPH)

University of Massachusetts Medical Center (PI: Stephenie Lemon, PhD) will play an integral role in the planning and implementation of the TRIP intervention but is not a clinical site.

Eligibility Criteria:
Inclusion Criteria:

1. are an adult female 18 years of age or older;
2. reside within 25 miles of the City of Boston;
3. have any of the following risk factors for delays in care: are Black and/or Hispanic ethnicity, do not speak English as their primary language, and/or have only public insurance or are uninsured at the time of diagnosis.

Exclusion Criteria:

1. cancer diagnosis made \> 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
2. presence of a cognitive impairment such as dementia or delirium from any cause (e.g. metabolic, medication or drug induced), given the unique challenges to their treatment decision making/ adherence and the fact that the intervention would not include the patient directly, but rather the family;
3. home residence is outside of the city of Boston, Massachusetts.
Pulse Wave Velocity and Hemodynamic Response During Anesthesia Induction in Hypertensive Patients

Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. It is a measurement of pulse wave velocity (PWV), a non-invasive indicator of arterial stiffness. It is known that sudden hemodynamic changes that occur during the induction of anesthesia cause undesirable intraoperative and postoperative complications. It is known that arterial stiffness, which is more common in elderly patients, causes orthostatic hypotension in particular. For this reason, more hemodynamic instability may be seen in the general anesthesia procedure in elderly patients with increased arterial stiffness.

In our study, we aimed to investigate whether the hemodynamic changes observed during anesthesia induction in hypertensive elderly patients, whom we think have a high pulse wave velocity, are different from normotensive patients.


Eligibility Criteria:
Inclusion Criteria:

* According to the American Society of Anesthesiologists (ASA), physical condition I-II,
* Elective otolaryngology surgery with endotracheal intubation planned
* Patients aged 50 and over

Exclusion Criteria:

* Hypersensitivity to drugs
* Difficult intubation history
* Diabetes mellitus receiving insulin therapy
* Chronic renal failure or end-stage renal disease
* Heart failure (left ventricular ejection fraction ≤30%)
* Valve disease (moderate to severe)
* Atrial fibrillation
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better.

OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 or older
* Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy
* Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope
* PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.

Exclusion Criteria:

* Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart.
* Patients with history of neuroendocrine tumors (specially insulinomas)
* Patients taking the medication Octreotide
* Patients on total parenteral nutrition (TPN)
* Women who are pregnant or breastfeeding
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).

Eligibility Criteria:
Inclusion Criteria:

1. Female/male ages 30 to 55
2. Bilateral lateral canthal lines rated as moderate or advanced.
3. Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
4. Women of child baring potential must practice and be willing to continue to use an effective method of birth control.

Exclusion Criteria:

1. Muscle weakness or paralysis in the area receiving treatment.
2. Active skin disease or irritation at treatment areas.
3. Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
4. Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
5. Use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through End of Study (Week 6).
6. Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.
Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).

Although these drugs are known to be effective alone, little is known about combining them together in various combinations.

In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.


Eligibility Criteria:
Inclusion Criteria:

* All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP \>25mmHg at rest or \>30mmHg with exercise, by a PCWP\< 15mmHg and by PVR \>3 Wood Units.
* Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
* Willing and able to participate in all study follow-up procedures.
* New York Heart Association (NYHA) Class II-IV.
* Six minute walking distance between 100-450 meters at the baseline assessment.
* Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
* Patients with congenital heart disease are eligible for inclusion.

Exclusion Criteria:

* Functional Class NYHA Class I.
* PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 \< 60% of predicted) or chronic hypoxia.
* Acute intercurrent illness requiring hospital admission in the month proceeding screening.
* Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
* Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
* Concomitant therapy with drugs known to interact adversely with the study drug.
* Chronic renal failure - creatinine clearance \<50ml/min as calculated with the Cockcroft equation.
* Current participation in another clinical trial.
* Pregnancy or planned pregnancy during the study period.
Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

This purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with Type 2 diabetes. A prospective, randomized, double-blind experimental study is designed with 60 diabetic patients randomly assigned to the experimental group receiving continuous blood glucose monitoring and self-regulation mode of health education and the control group receiving self-monitoring of blood glucose and routine health education. Data will be collected three times, including blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.

This purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with Type 2 diabetes. This study is a prospective, randomized, double-blind experimental study. A total of 60 diabetic patients who are willing to participate in the outpatient clinic of the hospital will be recruited. They are randomly assigned to the experimental group and the control group with 30 patients each. The experimental group will adopt continuous blood glucose monitoring for 7 days and self-regulation mode of health education, while the control group is self-monitoring of blood glucose and routine health education. Data will be collected three times: pre-test, eighth day after intervention, and three-month after intervention. The data included blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with diabetes by a doctor, and the patient is over 20 years old
2. Hemoglobin A1C (HbA1C)\> 8 % or more
3. Possessed self-monitoring equipment for blood glucose
4. ability to use a mobile phone
5. before participation, the subject fully understand the purpose and process of the research and obtain their consent.

Exclusion Criteria:

1. Diabetes health literacy lower than 9 points
2. Those who have difficulty in visual, hearing and speech.
3. Use of diuretics and steroids
Phase III Trial of Febuxostat in Korea Gout Patients

This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea

This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.

If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.

Eligibility Criteria:
Inclusion Criteria:

\<Day -14\>

1. age :18-85 years
2. female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
3. female: negative serum pregnancy test
4. subjects who satisfy ARA (American Rheumatism Association)
5. subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL \<Day -1\>

1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria

Exclusion Criteria:

1. women who are breast-feeding or pregnant
2. a history of xanthinuria
3. allopurinol intolerance
4. receiving thiazide diuretic therapy
5. secondary hyperuricemia
6. required \> 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
7. concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day).
8. any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
9. alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
10. concomitant therapy with any urate-lowering therapy
11. active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
12. subject was unable to take colchicine or contradictory to colchicine
13. a serum urate level \< 8.0mg/dL and not taking uric acid lowering therapy
14. rheumatoid arthritis or any active arthritis requiring for the medication treatment
15. a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit
16. participated in another investigational trial within the 30days prior to the screening visit
17. any other significant medical condition as defined by the investigator