bioihbjkbjnl/mcl2 huggingface dataset:
Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per
      night for 4 weeks) on nighttime blood pressure in African Americans with a history of
      elevated nighttime blood pressure.
    

Detailed description: 
      The main outcome of interest is the mean nighttime blood pressure. The investigator is also
      trying to see the mechanism of action of melatonin on blood pressure by analyzing data from
      sleep studies to see if melatonin lowers blood pressure by providing a better quality of
      sleep or is that independent of the quality of sleep.

      The investigator is also looking into the effect of melatonin on sympathetic nervous system
      by measuring urinary catecholamines.

      Finally, the investigator is looking into changes in vascular biology markers (P-selectin and
      e-selectin) on melatonin.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 8 mg time-release melatonin pills, orally, once per night for 4 weeks.; Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Melatonin; Hypertension; Blood Pressure; Cardiovascular; Sleep; Nighttime; Nocturnal; Catecholamines; Sympathetic Nervous System; Endothelial function; African American
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
Condition: Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical investigation is to evaluate the safety and effects of
      CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung
      carcinoma(NSCLC).
    


Intervention name(s): CCCR-NK92 cells
Intervention type(s): Biological
Intervention description(s): CCCR-NK92 cells will be administered intravenously over 1h. The starting dose of CCCR-NK92 cells will be 1×10e7-1×10e8,twice a week. The first evaluation of the efficacy after 3 weeks of treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Condition: Septic Shock; Sepsis
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out whether stress doses of hydrocortisone attenuate
      coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by
      which little doses of hydrocortisone influence coagulation system in sepsis.
    

Detailed description: 
      Patients were randomized to receive either low-dose hydrocortisone or matching
      placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the
      complications and mortality in two groups, and analyzed the relationship between
      hydrocortisone and coagulopathy.
    

Intervention name(s): Hydrocortisone
Intervention type(s): Drug
Intervention description(s): Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coagulopathy; hydrocortisone; organ failure; hemodynamic improvement induced by hydrocortisone
Testing of an Electronic Patch During Mild Dehydration
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to
      detect mild dehydration in healthy volunteers following the administration of Furosemide. In
      addition, the study will investigate changes in bioimpedance related to normal variation in
      tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The
      study will also provide information on the durability of the sensor.
    

Detailed description: 
      The subjects will use the patches for ten days. During the ten-day period, subjects are
      exposed to an intervention on day 2 or 3 while being monitored by health personnel:

        -  Subjects are given a diuretic (Furosemide) and monitored for two hours without any
           intake.

        -  The intervention is followed by intake of a rehydration solution (up to 1500 ml),
           containing glucose and electrolytes (Resorb Sport, Nestle S.A.).
    

Intervention name(s): Dehydration; Rehydration
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): The subject is brought to mild dehydration (loss of approximately 1.5% of body weight) through intravenous injection of up to 40 ug Furosemide. The subject shall not ingest any fluid for the next 120 minutes.; The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.
Other intervention name(s): Dehydration from Furosemide; Rehydration by Resorb Sport
Intervention MeSH terms: Furosemide
Intervention model: Single Group Assignment
Intervention model description: Open-labeled
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dehydration; Rehydration
Consumption of 4D Dietary Supplement on Perceptual-Cognitive and Visual-Motor Performance
Condition: Dietary Supplementation
Study type: Interventional

Summary: 
      The purpose of this investigation is to determine if supplementation with the 4D dietary
      supplement impacts perceptual-cognitive and visual-motor skills in healthy individuals.
    

Detailed description: 
      Multi-ingredient supplements (MIS) have been reported to positively impact various aspects of
      performance. While caffeine alone has been shown to improve aerobic performance, resistance
      training (such as bench press), reaction time and sprint performance, it has also been
      suggested that it lacks the ability to improve cognition. Therefore, the purpose of this
      investigation is to examine the effects of a caffeine containing MIS on measures of cognition
      and reaction time, with the intent of providing additional benefits to athletic performance.

      This study will utilize a randomized, double-blind, placebo-controlled design. Following two
      familiarization trials, participants will complete two testing visits. During these visits,
      they will complete baseline assessments, consume either the 4D dietary supplement or a taste
      matched placebo, and rest for 45 minutes. Reaction time, cognition assessments (visual
      tracking speed), and reactive agility performance will be assessed following the rest period.
    

Intervention name(s): 4D; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): multi-ingredient supplement mixed with 24 ounces of water; taste-matched placebo mixed with 24 ounces of water
Other intervention name(s): Crystal Light®
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will consume the 4D dietary supplement and the placebo in a randomized order on different testing days. Both the supplement and the placebo will be mixed with 24 fluid ounces of water. All drinks will have a similar appearance and taste. Researchers and participants will be blinded to the contents.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: multi-ingredient supplement; reaction time; reactive agility; cognition
Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      Menopause represents a critical period in a woman's life as the hormonal changes and the
      failing ovarian function not only determine relevant modifications in the reproductive
      function but also in many other conditions and organs that apparently are scarcely linked
      with hormones. The PI's centre has among its main goals the treatment of chronic liver
      disease; in the last years, a increasing interest in gender-related issues has grown.

      Goal of this study is to verify the impact of menopause on response to antiviral therapy for
      CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve
      this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the
      University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic,
      clinical and biochemical data as well data regarding the reproductive history, time, type,
      length of estrogen deprivation and of hormone-replacement therapy will be collected.
    

Detailed description: 
      The study is designed retrospective epidemiological cohort study. Overall, a group of 442
      women (168 still in fertile age; 274 menopausal) with HCV-positive CAH who underwent PEG IFN
      treatment in the last 5 years will be evaluated. For comparison, a group of 548 HCV-positive
      males with CAH will be evaluated. Liver biopsies before undergoing standard antiviral therapy
      will be scored for fibrosis, inflammation and steatosis. In women the presence, type and
      timing of menopause, associated hormonal/metabolic features and serum interleukin-6 (IL-6)
      and hepatic tumor necrosis factor-α (TNF-α) levels will be evaluated.

      The primary endpoint will be evaluation of SVR in females (in fertile and menopausal age) and
      in males.
    

Intervention name(s): PEG IFN/Ribavirin
Intervention type(s): Drug
Intervention description(s): PEG IFN/Ribavirin
Other intervention name(s): Pegylated IFN 2a Pegasys; Pegylated IFN 2b PegIntron; Copegus; Rebetol
Intervention MeSH terms: Ribavirin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A group of 442 women (168 still in fertile age; 274 menopausal) with HCV-positive CAH who
        underwent PEG IFN treatment in the last 5 years will be evaluated. For comparison, a group
        of 548 HCV-positive males with CAH will be evaluated.
      
Keywords: Hepatitis C; Gender; Menopause; Sustained viral response; Cytokines
Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition
Condition: Barrett's Esophagus; Gastroesophageal Reflux Disease
MeSH terms: Barrett Esophagus; Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by
      acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell
      cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF
      (vascular endothelial growth factor) signaling that triggers the EMT
      (epithelial-mesenchymal-transition) program in Barrett's esophagus.
    

Detailed description: 
      Gastroesophageal reflux disease (GERD) and its complication, Barrett's esophagus (BE), are
      risk factors for esophageal adenocarcinoma. In BE, GERD causes inflammation with oxidative
      DNA damage and genomic instability that contributes to carcinogenesis. In BE, one response to
      oxidative stress is p38 pathway activation, which might protect against cancer development by
      initiating G1 arrest and enabling repair of DNA damage. Inflammation and oxidative stress
      also might induce epithelial-mesenchymal transition (EMT), the process in which epithelial
      cells acquire mesenchymal characteristics including the ability to migrate. This study will
      elucidate mechanisms whereby the oxidative stress of acute reflux esophagitis in BE activates
      p38 to regulate proteins controlling the G1/S cell cycle checkpoint, and activates HIFs to
      cause autocrine vascular endothelial growth factor (VEGF) signaling that triggers the EMT
      program.
    

Intervention name(s): Cessation of Acid Suppressing Medications
Intervention type(s): Other
Intervention description(s): Acid suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations are performed while the participant is not on acid-suppressing medications. Endoscopy with biopsies will be performed in all patients on day 0, 7, and 14.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Barrett's esophagus; Gastroesophageal Reflux Disease
An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423
Condition: Hepatocellular Carcinoma; Liver Disease
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Diseases
Study type: Observational

Summary: 
      Specific urine proteases or groups of these enzymes can be reliable biomarkers and an
      effective gauge of response to therapy in patients with hepatocellular carcinoma.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from Vanderbilt internal medicine, hepatology, hepatobiliary
        surgery, and general surgery clinics.
      
Keywords: HCC; Liver Disease without HCC
Pediatric Metabolism and Microbiome Repository
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The aim of this project is to establish a bio-repository of diverse specimen types to provide
      investigators access to specimens in order to further research related to metabolism and the
      microbiome in the pediatric population.
    

Detailed description: 
      Human microbial cell lines, stool and/or DNA and RNA will be collected from participants
      10-18 years with a BMI greater than 95th percentile and their healthy siblings.

      Specimens will be collected at 3 time points over a seven month period. Healthy siblings will
      provide just one blood and stool sample. Samples will be maintained at the Duke Medical
      Science Research Laboratory.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Samples will be collected upon consent from the patient poplation of the Healthy Lifestyles
        Program at Duke for the care of children with obesity, a sibling of a patient in the
        Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.
      
Biospecimen description: 
      Human microbial cell lines, stool and/or DNA and RNA will be collected from participants
      10-18 years with a BMI greater than 95th percentile and their healthy siblings.

      Specimens will be collected at 3 time points over a seven month period. Healthy siblings will
      provide just one blood and stool sample. Samples will be maintained at the Duke Medical
      Science Research Laboratory.
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute
      Treatment of Migraine When Administered During the Prodrome
    


Intervention name(s): Ubrogepant 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours; For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine
Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris
Condition: Pemphigus Vulgaris
MeSH terms: Pemphigus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to find out about the effectiveness and the safety of an
      investigational drug called etanercept (Enbrel) to treat pemphigus vulgaris. Pemphigus
      vulgaris is a potentially life threatening blistering condition that currently has no cure.

      An investigational drug is one that has not been approved by the United States (US) Food and
      Drug Administration (FDA) to treat a particular condition or disease. Etanercept has been
      approved by the FDA to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and
      psoriasis, but not pemphigus vulgaris.
    

Detailed description: 
      People with pemphigus vulgaris have been found to have an increased amount of a substance
      called tumor-necrosis factor-alpha (TNF-alpha) in their blood. Etanercept may control
      pemphigus vulgaris by blocking the effect of TNF-alpha. Patients diagnosed with pemphigus
      vulgaris have been asked to participate in this research study.

      Enrolled subjects will be given either etanercept or placebo. A placebo looks just like the
      study drug but contains no active medication. Placebos help study doctors find out if the
      effects of the study drug are due to the drug itself or just because of being in the study.
      This type of study design helps measure the true effectiveness of a treatment. Patients have
      2 chances in 3 of receiving etanercept and 1 chance in 3 of receiving placebo.

      The researchers expect to enroll 24 subjects in this study. Up to 16 subjects will be
      enrolled at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH).

      This study is sponsored by Amgen, Inc., the manufacturer of etanercept.

      If taking part in another research study or have taken part in a research study in the last
      28 days, patients will not be able to take part in this study. Patients cannot be on multiple
      studies simultaneously; however, exceptions are made for non-invasive, non-interventional,
      and observational studies.

      This study will last about 16 weeks with a total of 6 study visits: screening, week 0
      (baseline), weeks 2, 4, 8 and 16. The participants will be able to continue on your current
      medications for pemphigus throughout the study.

      All participants must be at least 18 years of age with a clinical diagnosis of pemphigus
      vulgaris and at least 6 active blisters or erosions. Neither pregnant nor nursing women will
      be included in the study.
    

Intervention name(s): Enbrel (Etanercept)
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pemphigus Vulgaris; Chronic Pemphigus; Etanercept; Enbrel; anti-TNF-alpha; TNF-alpha antagonist; biologic; immunomodulator; subcutaneous medication
Effect of Vestibular Rehabilitation on Trunk Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis
Condition: Vestibular Rehabilitation in MS
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The Cawthorne Cooksey exercises and conventional program of physical therapy were
      administered.
    

Detailed description: 
      • The Cawthorne Cooksey exercises and conventional program of physical therapy were
      administered.
    

Intervention name(s): Cawthorne Cooksey exercise protocol; conventional vestibular rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Cawthorne Cooksey exercise protocol; conventional vestibular rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Trunk kinetic and kinematic parameters, Vestibular rehabilitation, Multiple Sclerosis.
Anfibatide Phase 1 Clinical Trial in Healthy Volunteers
Condition: Coronary Heart Disease; Coagulation Disorder
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of
      Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical
      evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and
      low bleeding potential in healthy human subjects.
    


Intervention name(s): Anfibatide
Intervention type(s): Drug
Intervention description(s): To investigate the safety and tolerability of single intravenous dose of Antiplatelet Thrombolysin for Injection of 0.33,0.66,1.0,1.5,2.0,3.0,4.0,5.0μg (body weight 60kg) in healthy volunteers.
To investigate the safety and tolerability of continuous administration of three dose regimen: ① give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours. ② give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. ③ give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment