bioihbjkbjnl/mcl2 huggingface dataset:
Matrix on Fruit Constituent Bioavailability
Condition: Healthy Non-smoker
Study type: Interventional

Summary: 
      Primary objective is to evaluate the influence of matrix on the bioavailability of key
      phytochemical constituents in fruits and their subsequent effect on chronic disease risk
      factors.
    

Detailed description: 
      This study is a single-center, randomized, cross-over, 4-arm, single- blinded, 6-hour
      postprandial study to evaluate the effects of strawberry or comparator fruit provided in a
      formulated beverage with milk (as the base) or water or fresh/pureed.

      A planned sample size of 10 men and women will be recruited into the study. Subjects will be
      required to meet several inclusion and exclusion criteria, which will be assessed through
      online and clinic screening mechanisms, including questionnaires, fasting glucose
      concentration, and anthropometric measurements. Eligible subjects will be invited to
      participate in the study. Subjects will begin by completing a 3-day pre-study assessment of
      their usual dietary intake using 3-day food diary. After reviewing baseline food records,
      subjects will be instructed to avoid polyphenolic-containing foods for 2 days prior to the
      study visit, while maintaining their usual diet pattern and physical activity.

      Subjects will participate in 6 h postprandial study days. Subjects will be randomized on the
      first day of starting the first post prandial visit day.

      For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures
      published by our lab previously. This includes: pre-study evaluation for compliance (fasting,
      dinner consumption, limited polyphenol intake) and readiness for study visit, catheter
      placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate
      meal accompanied by 1 of the treatment beverages, subsequent blood sampling from catheter [
      ~1 tablespoon (12ml)] at designated time points for 6 hours.

      Each postprandial study visit day will last approximately 7 hours and subjects will be
      required to remain at the Clinical Nutrition Research Center at the Illinois Institute of
      Technology main campus for the duration of the visit. The visit procedures are repeated four
      times ~ 1 week apart to accommodate subject testing with all four beverages; all procedures
      are identical on each postprandial study test visit with the exception that only an assigned
      test beverage per each visit will be consumed with the breakfast.
    

Intervention name(s): Milk-based Strawberry Beverage without meal; Water-Based Strawberry Beverage without meal; Milk-based strawberry Beverage with meal; Water-Based strawberry Beverage with meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Bioavailability; Strawberry polyphenols; Fruit Beverage Matrix
Evaluation of Glycemic Response in Individuals With Type 2 Diabetes
Condition: Glycemic Control
Study type: Interventional

Summary: 
      This is a randomized, controlled, crossover study to compare the effects to two treatments on
      postprandial glucose in adults with type 2 diabetes.
    


Intervention name(s): Experimental Formula; Test Meal
Intervention type(s): Other; Other
Intervention description(s): Diabetes-specific study formula; Instant oatmeal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
Condition: Haemophilus Influenzae Type b; Tetanus; Hepatitis B; Whole Cell Pertussis; Diphtheria; Poliomyelitis Vaccines
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the immunogenicity and safety of three formulations of
      GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines
      administered concomitantly, when administered as a single booster dose to healthy
      poliovirus-primed toddlers aged 12-24 months.
    

Detailed description: 
      The study will be conducted in a partially double-blinded manner. The study will be
      double-blinded with respect to the three GSK2036874A formulation groups and open-label with
      respect to the Control Group.
    

Intervention name(s): GSK2036874A vaccine; Zilbrix™/Hib vaccine; Poliorix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular, single dose; Intramuscular, single dose; Intramuscular, single dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of this project is to determine whether outreach to HIV-negative patients who are
      overdue for a Pap smear at a New England urban community health center can increase cervical
      cancer screening rates. It additionally seeks to determine which form of outreach - via
      letter, email, phone, or a mixture of those modalities- is most effective among these
      patients.
    

Detailed description: 
      To the investigators' knowledge, this study will be the first to assess the efficacy of email
      in cervical cancer screening outreach in a randomized controlled trial. It will also be one
      of the few randomized controlled trials to directly compare different outreach media
      directly, as opposed to different variations within a single medium (e.g. two different types
      of letters). Lastly, given the unique patient demographic makeup at Fenway, including a
      significant number of lesbian, bisexual and transgender patients, secondary subanalyses have
      the potential to significantly add to the investigators' knowledge of what media work best in
      conducting cervical cancer screening outreach with sexual and gender minorities, who are
      disproportionately underscreened compared to heterosexual cis-gendered women.
    

Intervention name(s): Letter and informational sheet; Email; Phone; Multimodal
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.; The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.; The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.; The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening
Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The scientific objective of the project is to evaluate if the topical administration of
      Fluoresceinisothiocyanate (FITC)-Adalimumab during the endomicroscopic examination of the gut
      in Crohn's disease (CD) patients shows an acceptable safety profile. Another objective is to
      explore whether the use of FITC-Adalimumab as a predictive biomarker might reliably predict
      patient response to Adalimumab therapy and hence enable optimized utilization of this
      treatment option.
    


Intervention name(s): FITC-Adalimumab
Intervention type(s): Drug
Intervention description(s): The study product FITC-Adalimumab will be topically applied via a spray catheter to the intestinal mucosa of Crohn's disease patients during endomicroscopy of the gut. One mL of the diluted study product will be applied each time to overall four selected intestinal areas at a concentration of 20 μg/mL respectively (equivalent to 20 μg of FITC-Adalimumab per area). Total amount applied will be 80 μg FITC-Adalimumab per patient.
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Subjects with active Crohn's disease; Safety and tolerability of FITC-Adalimumab; Intestinal topical application
Effectiveness of Proprioceptive Exercise in Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Introduction: Neck pain is among the most common and costly for industrialized societies. It
      is difficult to know the exact structure causing the pain so most are considered as
      non-specific neck pain. There is a correlation between the alteration of craneocervical
      proprioception and neck pain. The evidence for treatment with proprioceptive exercises is
      very limited.

      Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to
      compare its effects with a cervical mobility program.

      Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are
      included. They will be randomized into two groups of exercises: proprioception or mobility,
      which will be developed over a period of two weeks, every day, with a total of 10 sessions
      per patient.
    


Intervention name(s): Mobility exercises; Proprioception exercises
Intervention type(s): Other; Other
Intervention description(s): Usual treatment and exercises of cervical mobility before a mirror.; proprioceptive exercises for craniocervical sensorimotor control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proprioception
Alternate Dosing Schedules Study for HPV Vaccine
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types
      6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response
      (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd
      dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing
      schedule. This is a prospective observational study of healthy 9-18 year old female patients
      receiving either a second or third dose of HPV vaccine as part of their well child care.
      Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after
      the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV
      vaccine when administered at naturally occurring longer dosing intervals to the immune
      response to HPV vaccine when administered as routinely recommended.

      Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines
      by injection were randomized to receive either the HPV vaccine first or their concomitantly
      administered vaccines first. Pain following vaccination was assessed in each arm using the
      Faces Pain Scale - Revised.

      Please note: This record refers only to the randomized portion of the study where pain
      following vaccination was assessed. Please refer to NCT02280642 for the observational portion
      of the study.
    


Intervention name(s): Received HPV vaccine first; Received concomitant vaccines first
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human papillomavirus; Cervical cancer; Genital warts; Vaccine; Immunogenicity
Continuous Glucose Monitor Use in School
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to find the impact of continuous blood glucose sensors use in
      the classroom/school environment. We will be asking the subject,subject's parent and
      subject's teachers to complete a short survey/questionnaire. The survey will take
      approximately 10-15 minutes.
    

Detailed description: 
      The purpose of this study is to find the impact of continuous blood glucose sensors use in
      the classroom/school environment. Recent technological advancements in diabetes management
      have resulted in increased use of devices during class/school. Although many studies have
      examined the quality of life and the impact on the family and subject of these devices, to
      our knowledge this is the first study that will examine the impact of the continuous glucose
      monitor during class/school. To our knowledge, this is first study to involve the teachers.
      The results of this study is particularly important since the future of diabetes therapy will
      be to use continuous glucose monitors and insulin pumps to develop a closed loop system of
      insulin therapy or "artificial pancreas."
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Anyone with diabetes mellitus who is wearing a continous glucose sensor and is in school.
Complications in Inguinal Hernia Surgery
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable
      complication rates, thousands of patients worldwide suffer from inguinal hernia surgery
      complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives
      reports from surgical complications. In this study, the database of FPIC is used to compare
      the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Finnish patients having had complicated inguinal hernia surgery 2002-2010.
Atorvastatin for HAART Suboptimal Responders
Condition: Acquired Immune Deficiency Syndrome Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      We hypothesise that atorvastatin changes immune activation among HAART-treated adults with
      suboptimal cluster cell differentiation 4 (CD4) recovery by 25%
    

Detailed description: 
      The investigators have previously shown that up to 40% of HAART-treated adults have
      suboptimal CD4 recovery despite viral suppression. The investigators have also shown that
      immune activation and exhaustion are significantly higher among patients that do not exhibit
      satisfactory rise in CD4 counts despite viral suppression (suboptimal responders); when
      compared with their counterparts with viral suppression and satifactory CD4 count recovery
      (optimal responders). Given that atorvastatin changes immune activation in this pilot study,
      then larger studies can be done to understand its effect on CD4 count increase among
      suboptimal responders.
    

Intervention name(s): atorvastatin, Lipitor®; Placebo
Intervention type(s): Other; Drug
Intervention description(s): PBMC collected for immune activation assays using flowcytometry; PBMC collected for immune activation assays using flowcytometry
Other intervention name(s): Lipitor®; atorvastatin placebo
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: immune activation; antiretroviral therapy; atorvastatin; immune exhaustion; adults; Africa
Effect of Statin Use on Aldosterone Secretion
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research protocol is to determine if the same effects are observed in
      vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the
      widely used statin class of medications on the mineralocorticoid pathway would likely have
      significant clinical implications on the future management of hypertension and other
      cardiovascular disease given the known pleiotropy of aldosterone action.
    

Detailed description: 
      In order to provide additional evidence regarding the effect of statin therapy on aldosterone
      levels, the investigators propose the following randomized, double-blinded, placebo
      controlled protocol in relatively healthy volunteers. The investigators will evaluate
      aldosterone and cortisol production in response to an angiotensin II infusion under the
      following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3)
      pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of
      both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.
    

Intervention name(s): Simvastatin; Pravastatin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure; Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure; Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
Other intervention name(s): Zocor; Pravachol
Intervention MeSH terms: Simvastatin; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety and reactogenicity of Poliorix given as primary
      vaccination course to Chinese children at 2, 3 and 4 months of age.
    


Intervention name(s): Poliorix
Intervention type(s): Biological
Intervention description(s): All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IPV
A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection
      combination with cyclophosphamide and sequential treatment of docetaxel for patients with
      locally advanced breast cancer
    


Intervention name(s): Doxorubicin Hydrochloride Liposome Injection; Cyclophosphamide; docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-center, randomized, double-blind, placebo-controlled study will evaluate the
      effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who
      are inadequately controlled on metformin monotherapy. Patients will be randomized to receive
      either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their
      existing dose and regimen of metformin.
    


Intervention name(s): aleglitazar; metformin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mcg orally daily, 16 weeks; patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label); orally daily, 16 weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg
      (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy
      subjects.
    


Intervention name(s): Mucinex® SE; Vicks Cough Syrup for Chesty Coughs
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet; Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup
Other intervention name(s): guaifenesin bi-layer tablet; guaifenesin
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess dose-response characteristics in Japanese
      patients with Type 2 Diabetes taking LY2189265 monotherapy.
    


Intervention name(s): LY2189265; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.; Administered by SC injection, QW for 12 weeks.
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Diseases; Glucose Metabolism Disorders; Diabetes; GLP-1; Lilly
An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and
      100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with
      generalized anxiety disorder
    


Intervention name(s): SSR149415; Placebo; Paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration (capsules of 50 and 100 mg); Oral administration (capsules); Oral administration (capsules)
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-anxiety agents; antidepressive agents; controlled clinical trial