bioihbjkbjnl/mcl2 huggingface dataset:
Atherosclerosis in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Endothelial Dysfunction
MeSH terms: Arthritis; Arthritis, Rheumatoid; Atherosclerosis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the link between rheumatoid arthritis and
      cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities,
      and endothelial function.
    

Detailed description: 
      In the general population, individuals with elevated inflammatory markers (e.g. C-reactive
      protein, CRP) have increased cardiovascular disease. Patients with RA have chronic elevations
      in CRP and other inflammatory markers that are usually higher than the levels associated with
      increased cardiovascular risk in the general population. Indeed, RA patients have accelerated
      disease of their blood vessels, and increased cardiovascular death not explained by
      traditional cardiac risk factors but associated with chronic inflammation. However, the
      mechanisms by which inflammation leads to cardiovascular disease are not well characterized
      in RA. Moreover, current treatment strategies of RA largely target joint symptoms rather than
      inflammation, potentially leaving patients at increased risk for cardiovascular disease.
      Studies of markers that increase the risk of heart disease in the full spectrum of RA are
      missing. We hypothesize that inflammatory markers will be more strongly associated with
      abnormalities in blood vessels in RA patients than any clinical measure of disease activity.
      This hypothesis will be tested with a cross-sectional study of patients in the UCSF RA
      cohort. Aim 1 will characterize abnormal blood vessel changes across the spectrum of RA
      disease activity, specifically measuring ultrasound of the upper arm artery, markers of
      oxidative stress, and abnormalities in cholesterol proteins. Aim 2 will identify factors
      associated with these changes across the spectrum of RA disease activity, specifically
      focusing on the association between inflammatory markers, cholesterol, and blood vessel
      abnormalities.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        RA subjects are from the UCSF RA cohort based at San Francisco General Hospital and UCSF
        Medical Center. Controls will be selected from primary care clinics from these hospitals
      
Biospecimen description: 
      serum, plasma
    
Keywords: rheumatoid arthritis; endothelial dysfunction; lipoproteins; inflammation; oxidative stress; arterial stiffness
CG400549 Single Ascending Dose Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy
      Volunteers
    

Detailed description: 
      This was a Phase 1, 2-part study consisting of a randomized, double-blind,
      placebo-controlled,single ascending dose (SAD) part (in 2 alternating panels) and a
      1-sequence food effect (FE) part. In the SAD part, 2 cohorts of 6 healthy male subjects each
      received a single oral dose of CG400549 or placebo in 3 periods, randomized such that each
      subject received active treatment twice and placebo once (in each period, 4 subjects received
      active drug and 2 received placebo). In the FE part, 1 cohort of 6 healthy male subjects
      received a single oral dose of CG400549 in the fasted state in Period 1 and a single oral
      dose of CG400549 in the fed state in Period 2.
    

Intervention name(s): CG400549/placebo; CG400549/placebo; CG400549
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1; Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1; Period 1: a single oral dose of 640 mg CG400549 on Day 1 in the fasted state Period 2: a single oral dose of 640 mg CG400549 on Day 1 in the fed state
Other intervention name(s): Cohort 1; Cohort 2; Cohort 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy male volunteers; fasted and fed state
Phase 1 Study of ELX-02 in Healthy Adults
Condition: Genetic Disease; Nonsense Mutation
MeSH terms: Genetic Diseases, Inborn
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Single Ascending Dose Study in Normal Healthy Volunteers
    

Detailed description: 
      This is a study in humans of ELX-02, an advanced synthetic aminoglycoside optimized as a
      translational read-through drug (TRID) for the treatment of genetic conditions caused by
      nonsense mutations. This is a classical Phase 1a study designed as a randomized,
      double-blinded, placebo-controlled, single dose escalation to evaluate the safety,
      tolerability and pharmacokinetics of ELX-02 in healthy adult volunteers.
    

Intervention name(s): Placebo; ELX-02
Intervention type(s): Drug; Drug
Intervention description(s): Placebo comparator; Synthetic aminoglycoside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Translational read through
Effect of PP-01 on Cannabis Withdrawal Syndrome
Condition: Cannabis Withdrawal
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a randomized, double-blind, placebo-controlled, multicenter trial
      conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with
      discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD).
      The study will enroll approximately 225 participants with moderate to severe CUD and will
      include 5 arms, including a placebo arm, to help assess the incidence and severity of
      withdrawal symptoms in heavy long-term users of cannabis. Participants receive study
      medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).
    


Intervention name(s): PP-01 High Dose; PP-01 Low Dose; Placebo; Nabilone; Gabapentin
Intervention type(s): Combination Product; Combination Product; Drug; Drug; Drug
Intervention description(s): Cannabinoid-1 (CB1) partial agonist / GABAergic modulator; CB1 partial agonist / GABAergic modulator; Placebo comparator; CB1 receptor; GABAergic modulator
Intervention MeSH terms: Gabapentin; Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis Use Disorder; Marijuana Use Disorder
Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces
      starvation, stop of growth and impaired mineralization of bone tissue together with an
      interruption of pubertal development. These consequences are initially reversible following
      food intake return but can lead to a more irreversible status with low height, osteoporosis
      and high fracture risk. The onset of the disease more and more early in life, with the first
      stages of puberty suggest that these consequences will be even more severe as bone resistance
      will be damaged by more profound effects on bone growth as well. It is therefore critical to
      evaluate these bone metabolism alterations in order to better manage these patients.

      At every age and in every clinical circumstance either physiologic or pathologic, high
      resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of
      bone microarchitecture that is more informative than the global quantitative assessment given
      by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical
      fracture risk.

      Here, we propose to measure cortical parameters, such as cortical thickness which plays a key
      role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had
      developed AN as early as the during the first stages of puberty but no longer present,
      compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will
      also be studied. In an exploratory phase, we will evaluate these bone microarchitectural
      parameters together with bone biological turnover markers and markers of sexual maturation in
      adolescents or young adults 20 years-old or less, undernourished and currently managed for
      AN.
    


Intervention name(s): HR-pQCT; DEXA; Blood samples
Intervention type(s): Device; Device; Other
Intervention description(s): The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in human; The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA device that allows short duration measurements (< 15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck
Other intervention name(s): Xtrem CT scanco
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anorexia Nervosa; microarchitecture; prepubertal
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Observational

Summary: 
      The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of
      Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a
      consortium of participating clinical centers (PCCs) and a data coordinating and imaging
      analysis center (DCIAC) to develop and implement studies to test whether imaging techniques
      can provide accurate and reproducible markers of progression of renal disease in patients
      with polycystic kidney disease.

      The awarded participating clinical centers are Emory University, University of Kansas, and
      Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is
      Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington
      University to the University of Pittsburgh, the DCIAC for CRISP II is located at the
      University of Pittsburgh.
    

Detailed description: 
      The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the
      accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD
      defined as a change in both renal and renal cyst volumes and renal function over time.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who are diagnosed with ADPKD between the ages of 15 and 45 with risk factors
        (2/3 of the study population) or without risk factors (1/3 of the study population)for
        progression to ESRD with relatively normal renal function were be eligible for recruitment
        into the CRISP I study. The objective of the recruitment process was to identify ADPKD
        participants with the appropriate level of renal function who are either at high or low
        risk for progression to ESRD, who will be available for the entire follow-up period and who
        are likely to be compliant with the study protocols and visit schedules.
      
Biospecimen description: 
      blood, urine
    
Keywords: Autosomal dominant polycystic kidney disease; ADPKD; kidney; Biomarker; MRI
Study With Candida Antigen for Treatment of Warts
Condition: Warts; HPV
MeSH terms: Warts
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how people respond to the treatment of warts through
      use of the Candida antigen to get an immune response to rid the body of human papillomavirus
      (HPV). The immune system is the part of the body that fights infections like HPV which causes
      warts. This research study will examine the response of your wart when injected with a
      portion of a common yeast (candida) which is the study drug. Your immune system response will
      also be looked at by doing a test called an ELISPOT assay. This test is done on blood
      samples. The results of this test may help us to determine how the Candida antigen affects
      your wart.
    

Detailed description: 
      The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA)
      approved. The primary goal of this work was to assess the safety of Candin as an
      investigational new drug (IND) for the treatment of warts. In addition, clinical resolution
      of treated and untreated warts was evaluated and immunologic responses were examined using an
      ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay in order to elucidate the
      immunologic mechanisms behind the successful regression of warts in patients undergoing
      Candin injection immunotherapy.
    

Intervention name(s): Candida Antigen
Intervention type(s): Drug
Intervention description(s): Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Other intervention name(s): Candin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Warts; Candida; HPV; Injections, Intralesional; Immune System
Dysregulated CNS Inflammation After Acute Brain Injury
Condition: Traumatic Brain Injury; Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Inflammation; Hemorrhage; Wounds and Injuries
Study type: Observational

Summary: 
      By doing this study, the investigator hopes to learn how the levels of important proteins
      involved in inflammation change over time in patients with acute brain injury. The total
      amount of time participants will be asked to volunteer for this study is approximately two
      hours over a five day period.
    

Detailed description: 
      This pilot project is a prospective, observational study in 20 patients who are admitted to
      University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe,
      non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).

      All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who
      are admitted to the neuroscience or trauma intensive care units will be screened for
      potential inclusion into this study. Once a potential participant is identified, the
      legally-authorized representative will be approached for study consent and HIPAA
      authorization. If the participant regains consent capacity before the end of the
      cerebrospinal fluid (CSF) collection period, assent will be obtained from the research
      participant.

      In this research study, up to 5 small samples of CSF, will be carefully removed from the
      device, already in place, that drains excess CSF from the participant's head. The samples
      will be less than 1 teaspoon (< 5 mL) each. These samples will be frozen and stored until
      samples from approximately 20 participants have been obtained.

      These samples will then be prepared and sent to a research laboratory to analyze the proteins
      in the samples collected from each research participant.

      Because the results of this study will not affect the treatment participants receive in or
      outside of the hospital, the investigator will not share the results of this study with the
      participant, their doctor or their family member(s).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants selected will come from those who have been admitted to the University of
        Kentucky (UK) medical center
      
Biospecimen description: 
      CSF will be collected from an external ventricular drain (EVD) at five time points
      post-injury: 6, 12, 24, 48, 60 hrs
Satiety Response of Four Dietary Fibers
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Studies have found a relationship between dietary fiber consumption and body weight
      regulation. This relationship may stem from enhanced satiety through fermentation of certain
      fibers in the large intestine.

      The objective of this study is to determine and compare satiety ratings, changes in food
      intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble
      corn fiber, and resistant starch.
    


Intervention name(s): Control; Soluble corn fiber; Resistant starch; Fructooligosaccharide; Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.; Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.; Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.; Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.; Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other intervention name(s): Low fiber control; Promitor soluble corn fiber; FiberSym resistant starch; Orafti P95 fructooligosaccharide; Orafti HPX inulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adult; Women; Dietary Fiber; Satiety Response; Food Intake
Online Asthma Self-Management for Children Aged 5-10 and Their Parents
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The potential benefits of this research to public health include improved understanding of
      cultural factors in pediatric asthma self-management, improved self-management skills for
      children, and better asthma management skills for their parents. This could result in eased
      suffering and improved quality of life for millions of children and their families, and also
      reduce the economic burden borne by society in the forms of medical expenditures and lost
      productivity.
    

Detailed description: 
      This proposal will create an interactive multimedia (IMM) program designed to support the
      self-management efforts of asthmatic children aged 5-10 years and their families. This
      behavior change program will be designed to promote self-management by (a) increasing child
      and caregiver knowledge about asthma, (b) encouraging compliance with medication protocols
      and environmental controls, and (c) increasing self-efficacy to create and implement an
      Asthma Action Plan.
    

Intervention name(s): Lungtropolis; Asthma educational booklet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents; Text-based asthma education booklet for parents and children in PDF format
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Self management; Education; Children; Caregivers; Health Care Providers
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma
Condition: Oropharynx Cancer
MeSH terms: Carcinoma; Oropharyngeal Neoplasms; Xerostomia
Study type: Interventional
Phase: Phase 3

Summary: 
      The Phase III study will include 174 patients with locally advanced oropharynx carcinoma,
      receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant
      systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on
      the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on
      a weekly replanning to spare the salivary glands. The main objective is to increase by 25%
      the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing
      local control. The secondary objectives are to increase the salivary flow (scintigraphy),
      reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE),
      while maintaining local control (stopping rule of the trial if difference>15%). 174 patients
      will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human
      Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality
      Assurance) will be performed.
    


Intervention name(s): adaptative radiotherapy
Intervention type(s): Radiation
Intervention description(s): weekly replanning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adaptative radiotherapy; oropharynx carcinoma; xerostomia
A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
Condition: Erythema; Edema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      To evaluate the safety of a new personal lubricant when used at least four times weekly for
      two weeks (including at least twice weekly during sexual intercourse for subjects with
      monogamous male partners), in a population consisting of healthy females.
    


Intervention name(s): Trojan "Chameleon" Personal Lubricant
Intervention type(s): Device
Intervention description(s): silicone base with sensate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other