bioihbjkbjnl/mcl2 huggingface dataset:
Journey for Control of Diabetes Study (0431-111)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar
      goals, but most care systems do not provide effective support to assist patients in
      successful ongoing self-management. After initial education, many programs are limited by
      allowable Medicare reimbursement for diabetes education which currently requires physician
      referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of
      nutritional services. These services are usually provided either on an individual basis or
      occasionally through a traditional group class approach. For patients with established type 2
      diabetes who are not achieving optimal glycemic control, we propose to develop and formally
      evaluate in a randomized trial a novel group experience to educate and motivate patients with
      established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This
      multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood
      sugar control levels to one of 3 study groups: (1) IDEA - patients receive group sessions
      totaling 8 hours, with an average of 10 patients per group, using conversation maps as a
      conduit to facilitate dialogue between providers and patients (2) Individual Education (IE) -
      patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual
      care (UC)- patients receive no research intervention. The primary analyses will involve mixed
      model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar
      level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and
      behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12
      months. Depending on 12 month results, a longitudinal four year post intervention analysis is
      planned to assess sustainability of treatment effects and cost-effectiveness.
    


Intervention name(s): Interactive Dialogue to Educate and Activate (IDEA); Individual Education (IE)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients.; IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine
      hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known
      whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given
      together with epirubicin hydrochloride or docetaxel in treating patients with advanced or
      metastatic pancreatic cancer.

      PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin,
      capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared
      with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel
      and to see how well it works in treating patients with stage III or stage IV pancreatic
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Assess 6-months progression-free survival of patients with stage III or IV
           adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine
           hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.

        -  Evaluate the activity and toxicity of these regimens in these patients.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

        -  Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on
           days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to
           6 courses in the absence of disease progression or unacceptable toxicity.

        -  Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin
           hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28
           days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Patients may then undergo surgery if the tumor becomes resectable.
    

Intervention name(s): capecitabine; cisplatin; docetaxel; epirubicin hydrochloride; gemcitabine hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Given systemically; Given systemically; Given systemically; Given systemically; Given systemically
Other intervention name(s): XELODA; Cisplatino-TEVA; TAXOTERE; FARMARUBICINA; GEMZAR
Intervention MeSH terms: Gemcitabine; Docetaxel; Capecitabine; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage III pancreatic cancer; stage IV pancreatic cancer
Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, pilot study designed to explore whether daratumumab may have a
      clinically meaningful effect in patients with mild to moderate Alzheimer's disease.
    

Detailed description: 
      Daratumumab is a human antibody that targets CD38. It is FDA-approved for the treatment of
      multiple myeloma, has broad-ranging immunomodulatory effects on nonplasma cells that express
      CD38, and is able to cross the blood-brain barrier. CD38 expression on CD8+ T-cells is
      significantly increased in the blood of early AD patients as compared with age-matched
      controls, and activated T-cells are capable of trafficking into the central nervous system
      and exerting toxic effects. This study is designed to explore whether treatment with
      Daratumumab may have a clinically meaningful effect on patients with mild to moderate
      Alzheimer's disease.
    

Intervention name(s): Daratumumab Injection
Intervention type(s): Drug
Intervention description(s): Daratumumab SC 1800 mg (daratumumab 1800 mg with rHuPH20 30,000 units) subcutaneous infusion
Intervention MeSH terms: Daratumumab
Intervention model: Single Group Assignment
Intervention model description: Open-label treatment group.
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors of the Duodenum or Pancreas That Cannot Be Removed By Surgery
Condition: Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neoplastic Syndrome
MeSH terms: Neoplasms; Carcinoid Tumor; Malignant Carcinoid Syndrome; Gastrointestinal Neoplasms; Adenoma, Islet Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
      more tumor cells.

      PURPOSE: This phase II trial is studying how well combination chemotherapy works as
      first-line therapy in treating patients with locally advanced or metastatic neuroendocrine
      tumors of the duodenum or pancreas that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the 6-month progression-free survival rate in patients with unresectable
           locally advanced or metastatic neuroendocrine tumors of the duodenum/pancreas treated
           with fluorouracil, leucovorin calcium, and irinotecan hydrochloride as first-line
           chemotherapy.

      Secondary

        -  Determine tumor and biologic response at 6, 12, 18, and 24 months in patients treated
           with this regimen.

        -  Determine the duration of response of the primary tumor in patients treated with this
           regimen.

        -  Determine the tolerability of this regimen in these patients.

        -  Determine the progression-free survival of patients treated with this regimen.

        -  Determine the overall survival of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2
      hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Courses repeat every 14
      days in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed every 3 months for 1 year and then
      every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): fluorouracil; irinotecan hydrochloride; leucovorin calcium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; gastrinoma; insulinoma; WDHA syndrome; glucagonoma; pancreatic polypeptide tumor; somatostatinoma; recurrent islet cell carcinoma
Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional

Summary: 
      Study objectives:

      Primary:

      Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups
      compared to placebo, measured by the incremental area under curve (iAUC) analysis

      Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to
      lactase group, measured by the incremental area under curve (iAUC) analysis

      Secondary:

      Breath test

        -  Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo

        -  Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo

      Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert
      scale) in lactase and probiotic groups compared to placebo

        -  Abdominal pain

        -  Flatulence

        -  Bloating

        -  Nausea and vomiting

        -  Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol
           stool scale and number of bowel movements to be recorded)

      Ancillary:

        -  Baseline fasting BHC (ppm)

        -  Breath methane CH4 (ppm)

        -  Breath carbon dioxide CO2 (ppm)

        -  Probiotic identification in feces before each lactose challenge by molecular methods

        -  Gene test to determine lactase deficiency status at screening (following SNP variants to
           be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T
           (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))
    


Intervention name(s): Probiotic; Lactase; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Intake of probiotic; Intake of lactase; Intake of placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients
Condition: Gingivitis; Inflammation
MeSH terms: Gingivitis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the efficacy of a proprietary probiotic formulation comprising 6
      strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11
      and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a
      prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this
      study will be randomly assigned to receive either the probiotic treatment or a placebo, both
      in the form of a dissolving lozenge; for which the placebo is exactly the same shape,
      texture, taste, and composition as the probiotic treatment, but does not contain the active
      probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen
      for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque
      scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days.
      They will also be assessed for the same measures at day 56, following a 28-day wash-out
      phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of
      changes in microbial pathogens and/or inflammatory cytokines.
    


Intervention name(s): Probiotic formulation
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingivitis; inflammation; plaque; orthodontics
User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Condition: Gestational Diabetes Mellitus; Preeclampsia; Gestational Hypertension; Pre-term Delivery; Delivery of Small for Gestational Age (SGA) Baby
MeSH terms: Diabetes, Gestational; Pre-Eclampsia; Hypertension, Pregnancy-Induced
Study type: Observational

Summary: 
      Refine content and delivery of the mHealth delivered lifestyle intervention program through
      iterative testing with small groups of users who provide feedback through on-line
      asynchronous focus groups.
    

Detailed description: 
      Participants are asked to:

        -  Use mobile app for 4 weeks

        -  Receive support from the lifestyle coach

        -  Provide weekly and ongoing feedback via an online asynchronous user group platform on
           usability, navigability, acceptability, and satisfaction.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Potential participants will be identified via the Perinatal Clinical & Translational
        Research Center (CTRC) at the University of Colorado at Anschutz Medical Campus.
      
Keywords: mobile application; postpartum; weight loss
Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this study is to validate a diagnostic test that combines different blood
      markers to identify and correctly classify patients with Alzheimer's disease (AD) compared to
      individuals with behavioural variant frontotemporal dementia (bvFTD, patient control) versus
      cognitively healthy individuals (healthy control).
    

Detailed description: 
      The purpose of this study is to validate a new multi-parameter diagnostic test, on a
      well-characterised population based on new AD diagnostic criteria, that combines different
      types of markers, selected based on prior exploratory studies carried out by Raman Health
      Technologies.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        It is estimated that a sample of 500 patients (250 with AD and 250 with FTD) and 200
        controls (700 individuals in total) will be sufficient to corroborate the hypothesis that
        permits validation of the new diagnostic test. The sample size estimate is based on a
        hypothesis of non inferiority between the new test and the test used in normal clinical
        practice, expecting a 10% delta of the 75% validity, sensitivity and specificity indices
        with an alpha error of 0.05 and a beta error of 0.20.
      
Biospecimen description: 
      3 tubes of blood ( 30 mL of blood in total) for further analysis of their products (plasma,
      cells and DNA) in Alzheimer's research unit project CIEN Foundation would be extracted .
Resistance Training in People Living With HIV/AIDS
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The aim of this study will be to verify effects of resistance training in people living with
      HIV/AIDS.
    

Detailed description: 
      The aim of this study was verify effects of resistance training in cognitive function, body
      composition and biochemical parameters of inflammation and oxidative stress in people living
      with HIV/AIDS. The sample was composed by patients with HIV/AIDS of both sexes. The patients
      were randomized in two groups, a exercise group (EG), which was receive intervention with
      eight weeks of resistance training, and a control group (CG), that was not to do exercise.
      The cognitive function was analyzed with Stroop Test and Trail Test; body composition was
      evaluated by bioimpedance; blood tests was use to analyze biochemical parameters of
      inflammation and oxidative stress. For statistical analysis was used ANOVA of two factors for
      repeated measurements, having the (EG and PG) group and the time (pre and post exercise).
      Level of significance adopted was P < 0,05.
    

Intervention name(s): Exercise group
Intervention type(s): Other
Intervention description(s): Resistance training 3 times per week (45-60 minutes of resistance training)
Other intervention name(s): Training group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Cognition; Body composition; Inflammatory biomarkers; CD4
Yoga Exercises Applied With Two Different Technological Access
Condition: Work Related Stress; Pain; Fatigue
MeSH terms: Occupational Stress
Study type: Interventional

Summary: 
      Yoga, a form of exercise designed to bring balance and health to the physical, mental,
      emotional and spiritual dimensions of the individual, will benefit many white-collar workers
      by using popular technological environments to increase overall physical activity and
      well-being. The aim of this study is to examine the effects of yoga exercises applied with
      two different technological access in white-collar employees on musculoskeletal pain,
      fatigue, sleep quality, stress level, quality of life and work efficiency.
    

Detailed description: 
      Considering the importance of the workforce and possible health problems in white-collar
      workers, it seems rational to implement health promotion practices in accordance with the
      digital age. There is no study in the literature examining the effectiveness of
      technology-based yoga on selected health outcomes in white-collar workers. Based on this
      shortcoming, the aim of this study is to examine the effects of yoga exercises applied with
      two different technological access in white-collar employees on musculoskeletal pain,
      fatigue, sleep quality, stress level, quality of life and work efficiency.
    

Intervention name(s): Yoga exercises
Intervention type(s): Other
Intervention description(s): Yoga-based exercise training includes a warm-up and cool-down period for beginners
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: white collar workers; yoga; remote exercise
LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade
      of molecular events that control cell growth and have been linked with the development of
      many human cancers, including pancreatic cancer. Information from research studies suggests
      that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In
      this research study, the investigators are looking to determine the maximum dose of LDE225 in
      combination that can be given safely to patients with locally advanced or metastatic
      pancreatic cancer.
    

Detailed description: 
      Study medication will be given in cycles of 14 days. Subjects will keep a study drug diary
      for each treatment cycle. LDE225 capsules will be taken by mouth in the morning every day of
      each cycle.

      On days 1-2 of each cycle, subjects will take LDE225 at the clinic followed by FOLFIRINOX
      intravenous infusion (through a vein).

      Subjects will come to the clinic weekly for the first 5 weeks, then every other week (Week 7,
      9, 11, etc.) and receive the following procedures:

      Review of current medications and any side effects Physical exam Performance Status Blood
      tests (2 teaspoons of blood) Assessment of tumor (repeated every 8 weeks) ECG at week 3 and 5

      Subjects will also have pharmacokinetic (PK) blood samples taken. PK samples are used to find
      out the amount of study medication in the blood. Each PK sample is about 1/2 teaspoon of
      blood. Subjects will have PK samples taken on:

      Day 1 of Cycles 1, 2, 3, 4, 6, and 7 before the dose of LDE225 Day 1 of Cycle 5 - drawn
      before the first dose of LDE225 and at 1, 2, 3, 4, 5, and 6 hours Day 2 of Cycle 5: One PK
      blood sample
    

Intervention name(s): LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan
Intervention type(s): Drug
Intervention description(s): LDE225 200-800 mg daily orally. Fluorouracil 2400 mg IV every other week. Irinotecan 180 mg/m2 IV every other week. Oxaliplatin 85 mg/m2 IV every other week. Leucovorin 400 mg/m2 IV every other week.
Other intervention name(s): FOLFIRINOX; 5-FU; CPT-11
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Folfirinox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic; untreated; advanced