bioihbjkbjnl/mcl2 huggingface dataset:
Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
Condition: Polycystic Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      The aim of this study is to determine the effect of Lanreotide on polycystic liver and
      kidneys in patients with autosomal dominant polycystic kidney disease.
    

Detailed description: 
      The aim of this single center observational study is to assess the effect of lanreotide on
      polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and
      several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR,
      blood pressure, and urinary tubular damage markers and serum biomarker FGF23.

      The investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The
      duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first
      screening visit will take place four weeks before start of treatment. Eligible patients will
      be invited to participate.
    

Intervention name(s): Lanreotide
Intervention type(s): Drug
Intervention description(s): 120 mg every 28 days intramuscular
Other intervention name(s): Somatuline
Intervention MeSH terms: Lanreotide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ADPKD patients in Radboud University Hospital
      
Biospecimen description: 
      Blood samples
Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea
Condition: Chemotherapy-induced Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced
      diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients
      with colorectal cancer.
    

Detailed description: 
      Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to
      adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen
      containing fluorouracil, capecitabine and/or irinotecan. Eligible chemotherapy regimens
      include Irinotecan, Leucovorin (folinic acid), and Fluorouracil(IFL), Leucovorin,
      Fluorouracil, and Irinotecan (FOLFIRI), combinations of Irinotecan and Capecitabine, the
      Roswell Park regimen and the Mayo Clinic regimen, all of them without or with Oxaliplatin,
      Bevacizumab or Cetuximab. Patients receiving Erlotinib, or other Tyrosine-kinase, Epidermal
      Growth Factor Receptor (EGFR)-inhibitors, will not be eligible.

      The acute treatment for diarrhea will be left to physician's discretion in both groups.
      Patients in the control arm will be treated without Octreotide LAR. Patients in the
      experimental arm will receive the first dose of Octreotide LAR (30 mg) at chemotherapy
      initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR
      (with an interval of 28 days between them), until chemotherapy is discontinued or for a
      maximum of six doses of Octreotide LAR, whichever occurs first. Patient evaluation will be
      done at each cycle for efficacy and toxicity.
    

Intervention name(s): Octreotide Long Acting Release; Standard Treatment
Intervention type(s): Drug; Other
Intervention description(s): Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first.; Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
Other intervention name(s): Octreotide LAR; Sandostatin LAR
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colorectal cancer; diarrhea; drug therapy; octreotide; fluorouracil; irinotecan; capecitabine; prevention
Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks
Condition: Diet Habit
Study type: Observational

Summary: 
      This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks
      using pooled NHANES data.
    

Detailed description: 
      This study uses the Alternative Healthy Eating Index-2010 (AHEI-2010) and Dietary Approach to
      Stop Hypertension (DASH) scores to compare diet quality between U.S.-born (n=3,837) and
      foreign-born (n=406) non-Hispanic Black adults aged 22-79y, based on pooled nationally
      representative data (NHANES 2003-2012); as well as by length of U.S. residency. Association
      between nativity and diet quality was done using multivariable-adjusted linear regression for
      the continuous total diet quality scores and their components, or multinomial (polytomous)
      logistic regression for categorical tertiles (low, medium, or high) of the total scores and
      their components. The study found that foreign-born Blacks had significantly higher AHEI-2010
      and DASH scores compared to U.S-born Blacks, and more favorable intakes for many of the score
      components. Among foreign-born Blacks, diet quality did not significantly differ by length of
      residency. Foreign-born Blacks were more likely to be in the high than low tertile for fruit
      (including and excluding fruit juice), vegetables (excluding starchy vegetables), percent
      whole grains, and omega-3 fatty acids. Overall, the study suggests that foreign-born Blacks
      have better diet quality compared to their U.S.-born counterparts. Considering nativity among
      U.S. Blacks in nutrition research and public health efforts may therefore improve accuracy of
      characterizing dietary intakes and facilitate development of targeted nutrition interventions
      to reduce diet-related diseases in the diverse Black population in the U.S.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population comprised 4,243 non-Hispanic Blacks, including 3,837 U.S.-born (90.4%)
        and 406 foreign-born (9.6%). Compared to U.S.-born Blacks, a higher proportion of
        foreign-born Blacks were male, had attained a higher level of education, were classified as
        normal or overweight, had never been a smoker, engaged in physical activity, and had lower
        energy intake. In comparison to those who were in the U.S. for <10 years, more foreign-born
        Blacks who were in the U.S. for ≥30 years were current smokers (14.8% vs. 5.0%,
        respectively), had higher income (IPR of ≥4.00: 43.5% vs 7.9%, respectively), and a higher
        percent with a college degree or higher (39.4% vs. 18.3%, respectively). Foreign-born
        Blacks residing in the U.S. for ≥30 years reported higher BMI in comparison to those
        residing in the U.S. for <10 years (28.8 vs. 26.7 kg/m2).
      
Keywords: diet quality; health disparities; immigrants; foreign-born; Blacks/African Americans; place of birth/nativity; length of residency; NHANES; acculturation
A Study to Assess the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 Micrograms (mcg) Combination When Administered in Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a randomized, double-blind, placebo controlled cross-over study in 32 adult
      subjects with moderately severe asthma. In this study the bronchodilator effect of a single
      morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry. After the
      screening the subject will be randomized and will be assigned to one of two treatment
      sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the two treatment
      periods there will be a washout period of 7-14 days. A serial forced expiratory volume in one
      second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and
      72 hours post dose. Safety assessments will include vital signs, electrocardiograms (ECGs),
      adverse event (AE) monitoring and laboratory safety tests however, these will not constitute
      study endpoints. The results of the study will provide supporting information to prescribers
      on the bronchodilator effect of FF/VI over 72 hours.
    


Intervention name(s): FF/VI 100/25 mcg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): First strip: Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister; First strip: Inhalation powder of lactose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacodynamics; FF/VI; asthma; duration of action
Mechanisms and Treatment of Intradialytic Hypertension
Condition: Intradialytic Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis
           patients if blood pressure elevations with hemodialysis are associated with decreased
           endothelial cell function (measured by brachial artery flow mediated dilation and
           endothelial progenitor cell number), both of which are novel mechanistic markers in the
           causal pathway for detrimental cardiovascular outcomes; and

        2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood
           pressure elevations with hemodialysis can improve endothelial cell dysfunction as a
           surrogate mechanistic marker for improving cardiovascular outcomes.
    


Intervention name(s): Carvedilol
Intervention type(s): Drug
Intervention description(s): Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
Intervention MeSH terms: Carvedilol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Hemodialysis
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126
      immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI
      (ST-segment Elevation Myocardial Infarction)
    


Intervention name(s): Placebo; LC28-0126 Dose A; LC28-0126 Dose B; LC28-0126 Dose C
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo; LC28-0126 Dose A; LC28-0126 Dose B; LC28-0126 Dose C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of
      24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.
    

Detailed description: 
      The study included a maximum 2-week screening period, a 4-week single-blind introduction
      period, a 24-week double-blind treatment period, a 28-week open extension treatment period,
      and a 4-week safety follow-up period.

      At the end of the single-blind entry period, eligible subjects were randomly assigned to two
      different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.

      All subjects who completed the double-blind treatment entered the open extension treatment
      phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28
      weeks.

      Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit
      visit in the open extension period.
    

Intervention name(s): GLP-1 receptor agonist; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).; PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
Other intervention name(s): PB-119 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Cervical Length and Thickness of Cesarean Section Scar With Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional

Summary: 
      Although the Cesarean section is one of the most common obstetric operations around the
      world, the World Health Organization recognizes that where cesarean rates are higher than
      10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted
      that in countries where cesarean rates are above 15%, populations experience higher maternal,
      infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to
      require neonatal intensive care unit and have greater respiratory complications, and higher
      odds for childhood asthma, and obesity.

      Preterm is defined as babies born alive before completing 37 weeks of pregnancy.

      Preventing Preterm birth is a global priority due to increased risk for neonatal morbidity
      and mortality.
    


Intervention name(s): Ultrasound
Intervention type(s): Radiation
Intervention description(s): ultrasound assessment of pregnant women
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of RO4995819 to Assess Bioavailability and Safety in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label, cross-over study will assess the bioavailability and safety of
      RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet
      and capsule) of the study drug under fed and fasting conditions.
    


Intervention name(s): RO4995819; RO4995819
Intervention type(s): Drug; Drug
Intervention description(s): Oral doses of RO4995819 (tablet); Oral doses of RO4995819 (capsule)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Comparison of the Effects of TFPB and Anterior QLB on Postoperative Analgesia in Cesarean Section Surgery
Condition: Analgesia; Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional

Summary: 
      This study evaluates the postoperative analgesic effects of transversalis fascia plane block
      and anterior quadratus lumborum block in patients having cesarean section under general
      anesthesia. General anesthesia will be performed to all patients for the surgery.
    

Detailed description: 
      In this study, patients are divided into two groups. After the general anesthesia is
      performed and cesarean section surgery is over; TFPB block will be performed to patients in
      Group A ; while anterior QLB block will be performed to patients in Group B. In addition,
      patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Group
      A - Patients in group A will have TFPB block after the surgery. In addition, patient
      controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Group B -
      Patients in group B will have anterior QLB block after the surgery. In addition, patient
      controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
    

Intervention name(s): Regional anesthesia TFPB; Regional anesthesia QLB
Intervention type(s): Other; Other
Intervention description(s): Transversalis Fascia Plane Block will be performed with 25 mL of 0.25% bupivacaine,after the end of cesarean surgery before extubation.; Anterior Quadratus Lumborum Block will be performed with 25 mL of 0.25% bupivacaine, after the end of cesarean surgery before extubation.
Other intervention name(s): Transversalis Fascia Plane Block; Anterior Quadratus Lumborum Block
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer-generated randomization codes.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Regional Anesthesia; Acute and chronical pain; Transversalis Fascia Plane Block; Quadratus Lumborum Blocks; Cesarean Section
The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer
Condition: Minor Recurrent Aphthous Stomatitis Lesions
MeSH terms: Stomatitis; Stomatitis, Aphthous; Recurrence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to
      evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous
      stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of
      less than 48 hours duration. It was randomly determined which powder was used first; all
      subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder
      twice daily and maintained a daily log recording the size of the ulcer, its erythema score,
      and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer
      was resolved.
    


Intervention name(s): 2-DeNT powder; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum
Other intervention name(s): placebo powder containing zinc oxide, karaya gum, and yellow dye, which was added to imitate the color of the original powder
Intervention MeSH terms: Zinc Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Unicirc Adolescent 12-15 Year Old Boys
Condition: Circumcision, Male
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged
      12 to 15 years.
    

Detailed description: 
      Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with
      moderate phimosis and tight frenulum were included. Informed assent was obtained.
    

Intervention name(s): Unicirc circumcision
Intervention type(s): Device
Intervention description(s): Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Urinary Incontinence: Reproductive/Hormonal Risk Factors
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      This study is a continuation or follow-up of two previous studies (RRISK and RRISK2)
      conducted at the Kaiser Division of Research. This study will invite previous study
      participants, as well as a randomly selected group of Northern California Kaiser Permanente
      Members, to participate in an interview, mailed survey and lab visit. The purpose of this
      study is to examine the risk factors for bladder and pelvic problems.
    

Detailed description: 
      Using a cohort established during two previous studies (RRISK, CN-97Svand-01-H and RRISK2
      CN-02Svand-07-H), this study will follow a well characterized cohort of middle-aged and older
      women who have been members of Kaiser Permanente Medical Care Plan (KPMCP) of Northern
      California continuously since age 18. The cohort is composed of over 2000 women for whom we
      have data from abstracted medical records, in-person interview, voiding diaries, physical
      assessments, laboratory data, and banked sera. Our cohort is unique in including a
      substantial number of women from the 4 major ethnic/race groups (white non-Hispanic, Black,
      Asian and Hispanic.) For this study, we will re-interview as many study participants from
      RRISK and RRISK2 as are willing. This study will also expand to further increase its
      diversity by adding a total of 450 Black, Asian and Hispanic women to the cohort. The overall
      goal of the study is to advance our understanding of mechanisms of Urinary Incontinence and
      facilitate the translational development of novel approaches to treatment and prevention.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A previously identified cohort of approximately 2000 women who are members of Kaiser
        Permanente Northern California (KPNC) health plan, having seen a Provider for
        bladder/incontinence related issues and have previously participated in the RRISK and
        RRISK2 studies. We will also randomly identify an additional cohort of women who are
        current members KPNC which report race/ethnicity as Asian, Hispanic or Black/African
        American (to total an additional 450 women across all groups.)
      
Biospecimen description: 
      Sera will be banked for this cohort.
    
Keywords: Urinary Incontinence; Incontinence; bladder problems; bladder dysfunction
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the
      investigational GSK Biologicals' GSK3277511A vaccine in adults
    


Intervention name(s): Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A; Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A; Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule; 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule; 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule; 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Reactogenicity