cyrilzakka/clinical-trials huggingface dataset:
A Drug Interaction Study of Mosapride and Rebamipide

The investigators investigate the potential pharmacokinetic drug-drug interaction between Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.

To evaluate the safety, drug-tolerance, pharmacokinetics of Mosapride citrate 5 mg or Rebamipide 100 mg monotherapy or Mosapride citrate 5 mg and Rebamipide 100 mg combination in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers, age 20 to 45 years
2. Body weight ≥ 55kg (male), ≥ 50kg (female)
3. Body weight index (BMI) 18.5 \~ 25
4. Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
5. Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.

Exclusion Criteria:

1. Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
2. Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
3. Subject has hypersensitivity reaction to drug (aspirin, antibiotics, including study durgs, etc.) or history of clinically significant hypersensitivity reaction.
4. Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg(Sitting blood pressure) during the screening procedure
5. Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test.
6. For women, pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test
7. Subject takes caffeine-containing food 5 cups per day
8. Subject continually drinks (in excess of 210g/week)
9. Subject smokes 10 cigarettes or more in one day
10. Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug within 1 week prior to the first medication (however, the subject can be included if other criteria are met according to the discretion of the investigator).
11. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 30 days prior to the first dosing
12. Subject participated in another study and received medication within 2 months prior to the first medication day.
13. Subject received whole blood transfusion (500 mL) within 2 months prior to the first medication or blood transfusion within 1 month prior to the first medication.
14. Subject was judged not to be eligible according to the discretion of the investigator for other reasons.
Comparative Effectiveness Research of Electroacupuncture and TENS in Patients With Rheumatoid Arthritis

The aim of this pilot study is to compare the effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation in reducing the tenderness in the patients with rheumatoid arthritis. The study adopted a pragmatic, randomized, patient-centered approach to investigate the effectiveness of clinical symptoms and quality of life.

A total of 80 volunteers of patients with rheumatoid arthritis will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital and Dalin Tzu-Chi Hospital. These patients will be randomized to receive electroacupuncture (40 participants) or transcutaneous electrical nerve stimulation (40 participants) treatment two sessions per week and for 10 treatments in total.

The investigators expect that electroacupuncture or transcutaneous electrical nerve stimulation can reduce the severity of pain in the patients with rheumatoid arthritis. The effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation can be detected by visual analogue scale, simplified disease activity index, and disease activity score and be used to improve the clinical symptoms and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 20-70 years old
* Met the American College of Rheumatology criteria (2010) for RA
* Classification of X-ray : Stage I\~III
* The participants' RA medication regimen (DMARD, NSAID, steroid)were eligible if they were on a stable dose for at least 3 months before entry into and throughout the study.
* All patients were instructed not to make any changes in their background therapies during the study.
* Intra-articular or pulse steroid were not permitted during the study

Exclusion Criteria:

* Be treated with biological agents, such as antagonist of TNF-alpha, IL-6, Jak, and CD20 mono antibody in the last 3 months
* Having history of serious drug allergy
* Pregnancy or breastfeeding
* Bleeding or coagulation disorders
* Localized skin infections
* Uncontrolled or ill-controlled blood pressure with diastolic pressure≥110 mmHg
* Any other acupuncture treatment or herbal medication for RA within 2 weeks before screening
* needle phobia
* Intra-articular corticosteroid or pulse steroid within 4 weeks preceding the study
* Any severe chronic or uncontrolled comorbid disease
Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas

This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.

PRIMARY OBJECTIVE:

I. Characterize how the metabolic aMRI parameter kᵢₒ\*V differs in tumor versus (vs) normal brain. Researchers will assess the validity of aMRI as a metabolic imaging approach via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET.

SECONDARY OBJECTIVES:

I. Post-gadolinium (Gd) T1 MRI will be used to distinguish the contrast-enhancing "ring" region indicating the metabolically active tumor periphery from the less viable and/or necrotic tumor core. The utility of aMRI to differentially assess the metabolically active tumor periphery and necrotic core regions will be determined and compared to that of ¹⁸FDG PET (SUVmax).

II. Characterize how the metabolic aMRI parameter kᵢₒ\*V differs in the various normal appearing brain sub-regions unaffected by tumor, in comparison to ¹⁸FDG PET.

EXPLORATORY OBJECTIVE:

I. To compare how the aMRI metabolic parameter kᵢₒ\*V within disease lesions change with different disease types, their disease stage, and their treatment status.

OUTLINE:

Patients receive ¹⁸FDG IV, then 60 minutes later undergo simultaneous MRI and PET scanning. During this scanning period, patients will receive gadoterate meglumine IV to obtain post-contrast MRI. Total scanning time will take 45-60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging.
Sanger Human Cell Atlasing Project

"Cell Atlasing" refers to a novel strategy to characterise cells in tissues at the molecular level in a quantitative manner. The international Human Cell Atlas consortium brings together a community of biologists, clinicians, technologists, physicists, computational scientists, software engineers, and mathematicians to capitalise on drawing together leaders with various biological, technical and computational expertise. The project is based on the aim to define all human cell types in terms of their distinctive patterns of gene expression, physiological states, developmental trajectories, and location. This will pave the way to create a reference map of all human cells as a basis for understanding human health and diagnosing, monitoring, and treating disease.

Previous methods for quantifying molecular states of cells included microarray and standard RNA-seq analysis on a tissue section (RNA-seq is a technique to look at the activity of all the genes in a cell). These methods estimate the activity of any given gene by averaging the signal from millions of cells. Given the heterogeneity of cell populations (i.e.how uniform they are), measurement of the mean values of signals overlooks the internal interactions and differences within a cell population that may be crucial for maintaining normal tissue function and facilitating disease progression.

The Sanger Human Cell Atlasing project will adopt various genomic approaches that will provide genome-wide information in a single experiment. This project aims to scale up the single cell genomics and high-throughput highly multiplex spatial gene expression profiling approaches. Coupled with powerful computational methods, this strategy will produce a comprehensive and systematic reference map of human cells, providing a fundamental blueprint of cell states for both basic biological research and clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Samples are from the living and the deceased age 0 to 99+ from healthy and diseased individuals.
* All samples will have fully informed consent for use in research.

Exclusion Criteria:

* Samples taken without consent for use in future research
* Samples taken from individuals without the capacity to consent to use in research
Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease

The primary objective of the study is to evaluate the safety and tolerability of a range of single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy participants and participants with early Parkinson's disease (PD). Secondary objectives of the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose administration and to evaluate the immunogenicity of BIIB054 after single-dose administration.

Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with early PD will be enrolled in Cohort 7

Eligibility Criteria:
Key Inclusion Criteria:

1. All women of childbearing potential and all men must practice effective contraception during the study and for 6 months after their last dose of study treatment.
2. Must have a body mass index from 19 to 32 kg/m2, inclusive.
3. Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.

   For cohort 7 only:
4. Diagnosis of idiopathic PD

Key Exclusion Criteria:

1. History of cardiovascular disease.
2. Subject smokes more than 5 cigarettes or the equivalent in tobacco daily.
3. Surgery within 3 months prior to Day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the Investigator).
4. History or positive test result for hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
5. Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of Lumbar Traction in Lumbar Disk Herniation

The purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.

This is a prospective and randomized study. Medical treatment = anti-inflammatory therapy and epidural Medical treatment associated with lumbar traction medical treatment = + 5 lumbar traction sessions.

Eligibility Criteria:
Inclusion :

* patient with lumbar disc herniation with radiculopathy, over 18 years and consenting

Exclusion :

* sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction
* previous lumbar surgery
* sciatica without disc herniation
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.

Patients separated into four groups using the sealed envelope method.

Eligibility Criteria:
Inclusion Criteria:

* VLBW infants admitted to NICU at the first 7 days of life

Exclusion Criteria:

* expected life lower than 7 days,
* babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
* severe asphyxia,
* severe congenital anomaly
Prehospital Kcentra for Hemorrhagic Shock

This is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field.

Prospective randomized trials have shown that 4-factor prothrombin complex concentrate (4FPCCs) result in more rapid correction of coagulopathy and greater likelihood of achieving hemostasis in patients receiving vitamin K antagonists who require emergent operations or who are bleeding. 4FPCCs have not been studied in the pre-hospital setting as a primary resuscitative adjunct. The investigators believe the effects of Kcentra to prevent or treat coagulopathy early after injury combined with its ability to treat the endotheliopathy of trauma and prevent organ failure will results in improved outcomes in severely injured trauma patients with hemorrhagic shock. The investigators have chosen to study a population of trauma patients in severe hemorrhagic shock (SBP \< 70mmHg) because this population is at greatest risk for developing acute coagulopathy of trauma and has the greatest potential to benefit from the proposed therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Trauma patients age 18 years or greater, or weight \> 50 kg if age unknown
2. Systolic blood pressure \< 70 mmHg
3. Suspicion of hemorrhagic shock based on mechanism of injury
4. EMS transport to a participating trauma center

Exclusion Criteria:

1. Age less than 18
2. Unknown time of injury
3. Out-of-hospital cardiopulmonary resuscitation
4. Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke
5. Known oral anti-coagulant use to include warfarin and novel anti-coagulants
6. Severe hypothermia (\<28°C)
7. Drowning or asphyxia due to hanging
8. Burns more than 20% total body surface area
9. Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter
10. Isolated blunt or penetrating head injury
11. Isolated spinal cord injury
12. Ground level (same level) falls
13. Inability to obtain intravenous access
14. Inability to administer randomized therapy within 4 hours of ambulance notification
15. Known transfers and inter-facility transfers
16. Known Do Not Resuscitate (DNR) prior to randomization
17. Known or suspected pregnancy
18. Known prisoners
19. Patients who have activated the "opt-out" process
Intrapartum Epidural Catheter Displacement: Dressing Methods

Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. It has been argued that prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed epidurals in obstetrics.

Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.

Primary aim: The investigators will evaluate the efficacy of three different epidural catheter dressing systems in laboring patients.

Secondary aims: To compare the effect of different degrees of obesity measured by BMI, on epidural catheter migration and quality and failure of epidural labor analgesia. To evaluate the effect of time an indwelling catheter remains in place, level of insertion and patient's height on epidural catheter migration.

Hypothesis: The use of dressing with transparent TegadermTM plus catheter support pad dressing is superior to the dressing with TegadermTM plus Steri-StripTM bands, and to a dressing with TegadermTM only, for epidural catheter fixation in laboring obese and morbidly obese patients, in terms of catheter migration. epidural quality and failure and epidural catheter replacement in the labor analgesia setting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia.
2. BMI \>30 kg/m2.
3. Age older than 18 years old.

Exclusion Criteria:

1. Allergy to adhesive tape or to the components of the dressings used in the study.
2. Preexisting sensory neurologic deficits affecting lower extremities.
3. Patients taken to the operating room for cesarean section during the study period.
4. Chronic pain conditions.
5. Patients with intrathecal catheters.
Dichotic Listening as a Predictor of Medication Response in Depression

This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.

Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning , and do not show an advantage of drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18-65
2. Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified

Exclusion Criteria:

1. Known Hearing impairment
2. Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis).
3. Hamilton Rating Scale for Depression (HAMD), 21-item total score \>20
4. Current (past 6 months)alcohol and/or drug abuse or dependence
5. Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine)
6. Bipolar I
7. Psychosis
8. Non-response to adequate trial of study medication (i.e., \> or = 4 weeks on \> or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d)
9. Premenopausal women not using known effective birth control
10. Not currently depressed (whether considered due to current treatment or not)
11. History of seizure, seizure disorder, anorexia nervosa, or bulimia
12. Left-handed -
Hematopoetic Stem Cell Transplant and Physical Function

This study will determine if a structured walking intervention will help maintain or improve physical activity levels, physical function and quality of life in hematopoietic stem cell transplant patients.

The researchers will quantify the decline in physical function of HSCT patients using valid and reliable tests aimed to mimic activities of daily living, quantify cardiovascular health, and quantify muscle power declines. Also, patients will undergo a walking program during their hospitalization, which is designed to increase physical activity levels and maintain and improve physical function and quality of life. Additionally, using valid and reliable questionnaires, the researchers will gauge perception of exercise, quantify current exercise levels, determine preference of exercise programs and counseling, and measure differences in quality of life before and after HSCT treatment.

Eligibility Criteria:
Inclusion Criteria:

* Be between 40 and 80 years of age
* Willing and able to provide written informed consent in English
* Ability to comprehend the purpose of the study
* Be scheduled to receive an autologous or allogeneic hematopoietic stem cell transplant at Sylvester Comprehensive Cancer Center
* Have an expected hospital stay of at least 2 weeks
* Not currently be participating in an exercise training program

Exclusion Criteria:

* Dementia, altered mental status, or psychiatric condition
* Received erythropoiesis-stimulating proteins within 4 weeks prior to enrollment
* Comorbid conditions that would contraindicate exercise testing
* Undergoing concurrent non-transplant-related chemotherapy or radiation