bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The DreaMed Advisor Pro is a software which automatically analyses treatment information,
      learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed
      Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary
      blood glucose measurements), insulin dosing and meal data during daily routine home care.
      Following a 5-minute data collection and analysis, the algorithm learns and suggests
      pump-setting changes for optimization of glucose control

      The algorithm is designed as an advisory tool and has three main components:

        1. A statistical analysis of the insulin pump and sensor data: insulin delivery,
           bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia
           patterns.

        2. Practical recommendations, alert messages based on aforementioned data

        3. Recommendation for new insulin pump settings: including basal intervals and rate,
           different carbohydrate ratio according to time of day, correction factor and insulin
           sensitivity time.

      The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with
      Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump
      users.

      The main objective of the proposed study is to evaluate the safety and efficacy of using the
      DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin
      dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.
    


Intervention name(s): DreaMed Advisor Pro; Medical guided recommendation
Intervention type(s): Device; Other
Intervention description(s): Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro; Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin pump treatment; Type 1 diabetes; Pump setting advisor
Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of an investigational Vero
      cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza
      virus that is antigenically similar to one of the three strains in the vaccine. Subjects will
      be randomized in a double-blind fashion to receive a single intramuscular injection of either
      the investigational vaccine or placebo. Blood will be drawn from all subjects for a
      determination of hemagglutination inhibition antibody titers on Days 0 and 21, body
      temperature and injection site reactions will be monitored daily for 7 days. In addition,
      subjects must return to the clinic promptly to have swab samples of their nose and throat
      taken whenever they feel flu symptoms and all subjects will be monitored for adverse events
      until Day 180.
    


Intervention name(s): Vero cell-derived, trivalent, seasonal influenza vaccine; Placebo: Phosphate-buffered saline
Intervention type(s): Biological; Biological
Intervention description(s): Single intramuscular injection; Single intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Gardasil Immunogenicity With Needle-Free Injection
Condition: HPV Seroconversion
Study type: Observational

Summary: 
      Using biospecimens collected in a trial by the Thai Red Cross AIDS Research Center that
      studied two new human papillomavirus (HPV) vaccine delivery regimens, the investigators at
      UCSF will be testing the serum for antibodies to measure the strength of their response to
      the vaccine.
    

Detailed description: 
      Primary Objectives

        1. Compared rates of seroconversion and geometric mean titers (GMTs) generated following a
           3-dose series of vaccine in women given low doses of vaccine by the intradermal (ID)
           route with the needle-free injector (NFI) (Group III) to those women given standard
           doses by the intramuscular (IM) route with a needle and syringe (Group I) at 1 month, 6
           months and 12 months following completion of the vaccination series.

        2. Compared rates of seroconversion and GMTs generated following a 3-dose series of vaccine
           in women given standard doses of vaccine by the IM route with the NFI (Group II) to
           those women given standard doses by the IM route with a needle and syringe (Group I) at
           1 month, 6 months and 12 months following completion of the vaccination series.

      Serum samples were collected on 4 successive occasions: (1) day zero, prior to the first
      immunization, (2) at visit 4, one month following the third and final immunization, (3) at
      visit 5 (12 months) and (4) and at visit 6 (24 months after enrollment). Samples were split,
      stored and transferred in batch for analysis.

      Merck received samples for processing and determined the geometric mean titer of antibodies
      specific to HPV (types 6, 11, 16, and 18) and results were transferred to the principal
      investigator. The University of California, San Francisco (UCSF) used a portion of the
      collected blood samples for pseudovirion-based neutralisation assay (PBNA) analysis conducted
      at UCSF.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study was for women and focused on the safety and immunogenicity of the HPV vaccine.
        Separate studies will be done in men if the dosing regimens in Groups II or III are shown
        to be non-inferior to the standard regimen
      
Keywords: HPV; Gardasil; seroconversion
A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics
      (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.
    

Detailed description: 
      This is an open-label (physician and participant will know the name of the assigned drug),
      multi-center, non-randomized, drug/drug interaction study of JNJ-38518168 in participants
      with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The
      treatment phase will last 16 days. Participants will be housed in the clinic for dosing and
      study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. Participants
      completing treatment will have a follow-up visit between Days 22 and 25. Participants who
      discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the
      time of discontinuation or as soon as possible thereafter. The duration of participation in
      the study for an individual participant will be up to 7 weeks (including screening).
      Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly
      methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of
      JNJ-38518168, administered daily.
    

Intervention name(s): JNJ-38518168 / MTX
Intervention type(s): Drug
Intervention description(s): Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; JNJ-38518168; Methotrexate
Tailored PCA Based on Preoperative Pain Sensitivity
Condition: Analgesia, Patient-Controlled
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for
      postoperative pain control. However, effective pain control with minimized side effects of
      analgesic agents is still challenging. Several studies reported that preoperative pain
      sensitivity measured by quantitative sensory test could predict postoperative pain.
      Therefore, the investigators planned this trial to evaluate the effectiveness of tailored
      patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain
      threshold in patients undergoing gynecological surgery.
    


Intervention name(s): Tailored regimen of IV PCA according to pain sensitivity; Regimen of IV PCA without considering pain sensitivity
Intervention type(s): Other; Other
Intervention description(s): In tailored group, fentanyl dosage in IV PCA will be determined according to preoperative pain sensitivity. In control, group, fentanyl dosage in IV PCA will be determined without consideration of patient's pain sensitivity.; In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fentanyl; Pain Threshold; predicted
Safety and Immunogenicity Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)
Condition: AIDS
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by
      recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk
      of HIV infection. In addition, the effect of different intervals of the prime-boost will be
      studied.
    


Intervention name(s): DNA vaccine; DNA vaccine prime with the addition of electroporation; rTV boost; rTV boost; rTV boost
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4mg/dose, three doses at week 0,4,8; 4mg/dose, three doses at week 0,4,8; at week 16; at week 24; at week 32
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prophylactic; vaccine
Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
Condition: Hematopoietic Syndrome Due to Acute Radiation Syndrome
MeSH terms: Radiation Injuries; Acute Radiation Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of
      HemaMax in healthy male and female volunteers.
    

Detailed description: 
      A randomized, placebo-controlled, double-blind study of HemaMax to evaluate the safety,
      tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single 12 μg
      subcutaneous dose of HemaMax on 60 healthy subjects for 28 days after HemaMax administration.
    

Intervention name(s): HemaMax; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): single subcutaneous 12 microgram dose of HemaMax; single subcutaneous dose
Other intervention name(s): rHuIL-12, NM-IL-12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HemaMax, NM-IL-12, HSARS, Safety
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
Condition: Hepatitis C; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir
      400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200
      mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral
      response rate at 12 weeks.
    

Detailed description: 
      Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot
      tolerate interferon, the previous standard of treatment. The new direct acting antivirals
      have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg
      and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for
      12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but
      that recommendation is based on the lack of data for shorter periods. In order to evaluate
      the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100
      HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3
      patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease
      (MELD) > 20 are excluded. The investigators will calculate the sustained viral response rate
      at 12 weeks (SVR12).
    

Intervention name(s): Sofosbuvir; Daclatasvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir; 60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir; 1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses
Other intervention name(s): Sovodak; Sovodak; RBV
Intervention MeSH terms: Ribavirin; Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Cirrhosis; Sofosbuvir; Daclatasvir; Ribavirin
Increasing Water Access and Appeal in Community Recreation Centers
Condition: Health Behavior
Study type: Interventional

Summary: 
      This study is a cluster randomized controlled trial with n=28 City of Philadelphia recreation
      centers (14 matched pairs) designed to determine the effectiveness of a comprehensive
      multi-level intervention to increase water access and appeal in community recreation centers
      on 1) center-level water intake as measured by water meters, and 2) purchase of outside
      beverages as measured by observations of recreation center youth.
    


Intervention name(s): Hydrate Philly
Intervention type(s): Behavioral
Intervention description(s): Hydrate Philly is a multi-component intervention that includes water safety testing, provision of 1-2 hydration stations per recreation center, distribution of reusable water bottles for youth, a campaign to promote the acceptability of tap water, and the reduction of access to competing unhealthy beverages through vending machine standards and discouraging "black bags" (characteristic small, black, plastic bags provided to customers with their corner store purchases, typically including a sugar sweetened beverage and/or unhealthy snack foods).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This cluster RCT involves 14 matched pairs; study recruitment and randomization occurs at the recreation center-level. Participating sites are matched based on center size, summer program enrollment, presence of indoor gym, neighborhood income & race/ethnicity. Then, an intervention site and control site are randomly determined by a coin flip within each pair.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hydration; water intake; sugar sweetened beverages; youth; children
Mirabegron For Erectile Dysfunction
Condition: Erectile Dysfunction; Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Erectile Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The only class of oral erectile dysfunction (ED) medication on the market are the
      phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the
      effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder
      (OAB) symptoms and mild to moderate ED.
    

Detailed description: 
      ED affects up to 30 million men in the United States. The only class of oral medication
      approved for ED is PDE5i. These include sildenafil, tadalafil, vardenafil and avanafil. Other
      pharmacologic options in the treatment of ED are delivered as an intraurethral suppository
      (alprostadil) or intracavernosal injection (alprostadil, papaverine, phentolamine, atropine).
      These are more invasive routes of administration. Men who fail to obtain benefit from a PDE5i
      or those who have a contraindication to this class of medication may ultimately avoid further
      pharmacologic treatment options. An alternative class of oral medication to treat ED may
      prove to be of benefit to a large population of underserved men.

      There is in vitro evidence that beta-3 adrenergic receptors exist in human corpus cavernosum
      tissue. Activation of these receptors results in vasorelaxation, suggesting a potential
      pro-erectogenic effect is possible in vivo. Additionally, nebivolol, a beta-blocker, has
      pro-erectogenic effects noted in several studies. There is evidence that nebivolol exerts
      beta-3 adrenergic agonism, which may explain the mechanism by which these effects occur.

      Mirabegron is the only available beta-3 adrenergic agonist in the United States. Its
      favorable safety profile and the potential for therapeutic efficacy in ED make it suitable
      for further investigation.

      It is hypothesized that beta-3 adrenergic activation offers a pharmacologic target for the
      treatment of ED. Men with mild, mild to moderate, or moderate ED and symptoms of OAB can be
      recruited with pre- and post- Mirabegron administration assessment of their ED to determine
      the validity of this hypothesis. Men with severe ED will be excluded as historical data shows
      they are less likely to benefit from oral pharmacologic therapy alone. Mirabegron is approved
      by the U.S. Food and Drug Administration (FDA) for the treatment of adults with OAB.
    

Intervention name(s): Mirabegron
Intervention type(s): Drug
Intervention description(s): FDA-approved, beta 3 agonist for over active bladder
Other intervention name(s): Myrbetriq
Intervention MeSH terms: Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mirabegron; Overactive Bladder; Erectile Dysfunction; Beta 3 agonist
Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia
Condition: Early Gastric Cancer; Gastric Dysplasia
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification
      imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous
      studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal
      polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are
      limited data exploring the application of pCLE to gastric lesions, and this is the first
      study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the
      final specimens obtained from endoscopic resection as a reference standard. The aims of this
      study were (1) the accuracy of pCLE compared to conventional forceps biopsy using
      histopathology results following endoscopic resection as a reference, and (2) comparison of
      "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and
      off-line interobserver agreement.
    


Intervention name(s): Endoscopic submucosal dissection
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients referred to a tertiary medical center for endoscopic resection of
        gastric superficial lesions.
      
Biospecimen description: 
      Endscopic resection specimens of gastric neoplasia. Speciments were obtained either by
      endoscopic mucosal resection or endoscopic submucosal dissection.
Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study is designed to determine whether symptom burden differs by time to infusion.
    


Intervention name(s): Ocrelizumab
Intervention type(s): Drug
Intervention description(s): Administer Ocrelizumab under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions.
Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion.
Subsequent doses: single 600 mg intravenous infusion every 6 months.
Observe the patient for at least one hour after the completion of the infusion
Other intervention name(s): OCREVUS
Intervention MeSH terms: Ocrelizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving Multiple Sclerosis care at the NYU Comprehensive MS Care Center or the
        Elliot Lewis MS Center will be recruited. A clinical list of patients currently receiving
        ocrelizumab, or potentially starting ocrelizumab will be screened for study
        inclusion/exclusion criteria.
      
Biospecimen description: 
      Study-specific biospecimens (peripheral venous blood) will be collected.