bioihbjkbjnl/mcl2 huggingface dataset:
Analyzing IBS to Identify Biomarkers and Microbiome Signatures
Condition: Diarrhoea Predominant Irritable Bowel Syndrome; IBS
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      Microbiota from fecal samples from IBS-D patients, in combination with vitamin D
      supplementation added to our 3-D immunocompetent intestinal models will establish a high
      fidelity disease model to achieve our long-term goal to understand the relationship between
      gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could
      ultimately be used as a testing platform for treatment and prevention.
    

Detailed description: 
      The pathophysiology of IBS is not well understood. Preliminary studies support IBS-D patients
      with varied microbiome fingerprints, vitamin D levels, and blood serotonin levels compared to
      non-IBS patients. The investigators have novel 3-D immunocompetent intestinal models to
      establish a new model of high fidelity disease to examine the relationship of IBS-D patients
      gut microbiome, with supplemental vitamin D levels, and the relationship of blood serotonin
      and vitamin D levels. IBS-D patients and healthy controls will be asked to provide a fecal
      sample, a biopsy sample of colonic tissue obtained during a clinically appropriate flexible
      sigmoidoscopy or colonoscopy, and a blood sample. There will be 1-2 office visits. One visit
      will last 30 minutes, the second visit no longer than 3 hours. This study is funded by a
      combined MAYO-Arizona State University seed grant. The samples will be analyzed at ASU. Our
      long-term goal is to understand the relationship between gut microbiome, vitamin D levels,
      host gene expression, serotonin levels, and IBS-D symptoms that could ultimately be used as a
      testing platform for treatment and prevention of this highly prevalent disorder.
    

Intervention name(s): endoscopy for tissue biopsy; Blood Sample; Stool Sample
Intervention type(s): Procedure; Other; Other
Intervention description(s): endoscopy to obtain tissue biopsy for analysis of biomarker status; Blood draw to evaluate serotonin and Vit D level.; Stool sample to evaluate microbiome fingerprint.
Other intervention name(s): Sigmoidoscopy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: microbiome; biomarkers; Vitamin D; Serotonin
Pith Moromo 2: Cohort to Study Health Consequences of Food and Nutrition Insecurity During Pregnancy and Lactation
Condition: Food Insecurity; Nutrition; Maternal and Child Health; HIV
Study type: Observational

Summary: 
      In this study, the investigators conducted research among HIV-infected and -uninfected
      pregnant and lactating women to understand the potential role and importance of food
      insecurity on participant physical and psychosocial health and nutrition.
    

Detailed description: 
      The central hypothesis of this study was that food and nutrition insecurity are detrimental
      to the health of HIV+ pregnant women and their infants via nutritional, disease, and
      psychosocial pathways.

      In the first phase, the investigators collected descriptive data to describe and assess food
      and nutrition insecurity and the associated modifiable determinants among HIV+ pregnant and
      lactating women in Kenya.

      In the second phase, the investigators collected longitudinal cohort data from women who were
      recruited during pregnancy and have been followed throughout the infant's first year of life.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of 371 pregnant HIV-infected and -uninfected women (ratio 1:1) were recruited from
        7 rural and urban clinics in Nyanza, Kenya. Participants were followed from ≤30 weeks
        pregnancy until 9 months postpartum.
Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy
      before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with
      carboplatin may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin
      works in treating women who are undergoing surgery for newly diagnosed, locally advanced
      breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the clinical and pathological response in women with newly diagnosed, locally
           advanced operable breast cancer treated with neoadjuvant chemotherapy comprising
           paclitaxel and carboplatin.

        -  Evaluate specific biomarkers for prognostic value and as markers for response/resistance
           in patients treated with this regimen.

        -  Determine the tolerability and toxicity of this regimen in these patients.

      OUTLINE: This is an open-label study.

      Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks
      before beginning neoadjuvant chemotherapy.

      All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on
      day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease
      progression or unacceptable toxicity.

      Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel
      lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All
      patients undergoing lumpectomy or mastectomy with high-risk disease also undergo
      radiotherapy.

      Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core
      needle biopsy.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.
    

Intervention name(s): carboplatin; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: invasive ductal breast carcinoma; invasive lobular breast carcinoma; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer
A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study is to assess the safety, tolerability and efficacy of
      multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with
      moderately active Rheumatoid Arthritis (RA).
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, multiple ascending dose
      study to evaluate the efficacy and safety of multiple doses of the mavrilimumab (CAM-3001)
      (10 milligram [mg], 30 mg, 50 mg, and 100 mg) administered subcutaneously in adult subjects
      with moderately active RA.
    

Intervention name(s): Mavrilimumab 10 mg; Mavrilimumab 30 mg; Mavrilimumab 50 mg; Mavrilimumab 100 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.; Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.; Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.; Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.; Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.
Other intervention name(s): CAM-3001; CAM-3001; CAM-3001; CAM-3001
Intervention MeSH terms: Mavrilimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Mavrilimumab; CAM-3001
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and
      the safety of fimasartan in renal impairment patients and healthy volunteers.
    


Intervention name(s): fimasartan
Intervention type(s): Drug
Intervention description(s): single administration of fimasartan 120mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: fimasartan; renal impairment; hypertension
Early Surgery Versus Conventional Treatment in Infective Endocarditis
Condition: Endocarditis
MeSH terms: Endocarditis, Bacterial; Endocarditis
Study type: Interventional
Phase: Phase 4

Summary: 
      There have been no prospective clinical studies in infective endocarditis comparing early
      surgery with the conventional treatment strategy based on current guidelines. The purpose of
      this prospective randomized trial is to compare clinical outcomes of early surgery versus
      conventional treatment strategy in patients with high embolic risk of infective endocarditis.
    

Detailed description: 
      Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of
      embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of
      surgery was particularly high in patients with abscess formation, periannular complications,
      and moderate to severe heart failure related to acute mitral or aortic regurgitation.
      Retrospective studies reported that valve surgery was associated with improved survival, but
      the benefit of early surgery has not been adequately studied due to inherent treatment biases
      and significant differences in baseline characteristics. Embolic indications for surgery are
      more controversial, and surgery is usually performed in cases of recurrent emboli and persist
      vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and
      valve prosthesis needs to be balanced against the potential benefit of preventing embolism
      and improving survival. Risk-benefit balance changes recently to favor early surgery in
      patients with high embolic risk of endocarditis for the following reasons. Identification of
      patients with high risk of embolism becomes possible with the use of transesophageal
      echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography
      have a significantly higher risk of embolization. With advances in surgical technique, urgent
      surgery is feasible with low operative mortality, and the success rate of valve repair has
      been increased.

      To the best of our knowledge, there have been no prospective outcome studies comparing early
      surgery with the conventional treatment strategy based on current guidelines. The purpose of
      this multi-center, prospective, randomized trial is to compare clinical outcomes of early
      surgery versus conventional treatment strategy in patients with high embolic risks of
      infective endocarditis.
    

Intervention name(s): Valve surgery with removal of vegetations
Intervention type(s): Procedure
Intervention description(s): Early valve repair or replacement with removal of vegetations within 48 hours of randomization
Other intervention name(s): early surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endocarditis
The Liver in the World Trade Center Health Program General Responder Cohort and Controls
Condition: Steatosis of Liver; NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      This project investigates whether exposure to the World Trade Center Attack is a risk factor
      for liver injury.
    

Detailed description: 
      This is a prospective cross-sectional study of liver disease in individuals who meet the
      United States Preventive Services Task Forces guidelines for lung cancer screening because
      they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are
      either current smokers or who quit during the past 15 years. Liver disease will be compared
      between individuals who are members of the World Trade Center General Responder Cohort and
      individuals who are not members of this cohort. The basic objective is to determine whether
      exposure to the WTC attack increased liver disease.

      Data will be obtained from the World Trade Center Data Center, from Mount Sinai Medical
      records, EPIC, the data warehouse, and from data collected by the Lung Cancer Screening
      Program of Dr. Henschke. Results of genetic tests that relate to liver disease will be
      collected from the medical record.
    

Intervention name(s): Fibroscan of Liver; Low-dose non-contrast CT
Intervention type(s): Device; Procedure
Intervention description(s): A non-invasive diagnostic device used to measure liver scarring; CT scan as part of routine research care
Other intervention name(s): FibroScan Test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Members of the World Trade Center General Responder Cohort and individuals who are not
        members of this cohort.
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance
      treatment in patients with schizophrenia.
    

Detailed description: 
      This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of
      Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies
      246/247. The treatment history of subjects prior to enrollment in the open-label study will
      vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or
      31-07-247).

      This open-label study will be comprised of phases similar to the pivotal double-blind studies
      (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if
      applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance
      phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.

      During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be
      allowed for subjects who do not meet stability criteria or meet the criteria for impending
      relapse/exacerbation of psychotic symptoms.
    

Intervention name(s): Aripiprazole IM Depot
Intervention type(s): Drug
Intervention description(s): 300mg or 400mg
Other intervention name(s): Oral Aripiprazole
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole; IM Depot; Schizophrenia; Intramuscular
An Open-label, Randomized, Single Period, Parallel-Cohort Study To Evaluate Serum and Pulmonary Pharmacokinetics Following Single and Multiple Dose Administration of Intravenous GSK2251052 in Healthy Adult Subjects
Condition: Community-acquired Infection
MeSH terms: Community-Acquired Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that
      inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with
      tRNA and is currently in development for the treatment of hospital acquired Gram-negative
      infections (including E. coli, K. pneumoniae, and Enterobacter spp.).

      This is an open-label, randomized, single period, parallel-cohort pharmacokinetic study to
      evaluate serum and pulmonary pharmacokinetics following single dose and multiple dose
      administration of intravenous GSK2251052. In Cohort 1, approximately 15 healthy adult
      subjects will be randomized to receive a single IV dose of GSK2251052 1500 mg in the fasted
      state. Following the dose, bronchoalveolar lavage (BAL) fluid and serial plasma samples will
      be collected for determination of GSK2251052 parent and metabolite concentrations. In Cohort
      2, approximately 15 healthy adult subjects will receive GSK2251052 1500 mg IV BID x 5 doses
      (Cohort 2). Following the last dose in the fasted state, bronchoalveolar lavage (BAL) fluid
      and serial plasma samples will be collected for determination of GSK2251052 parent and
      metabolite concentrations. Vital signs, ECGs, and adverse events will be monitored throughout
      the study. A follow up visit will occur 10 to 14 days after the last dose of study drug.
    


Intervention name(s): GSK2251052
Intervention type(s): Drug
Intervention description(s): 1500 mg (dosing detailed in Arm description)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; bronchoalveolar lavage; GSK2251052; pulmonary; healthy volunteer; antimicrobial
Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to increase survival of patients with locally advanced
      triple-negative breast cancer using two consequent induction preoperative chemotherapy
      regimens.
    

Detailed description: 
      Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a
      lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's
      why new approaches to treatment of this aggressive breast cancer subtype are extremely
      anticipated.

      One of the ways to improve the results of treatment of locally advanced triple-negative
      breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation
      of the rate of pathological complete responses after completion of intensification induction
      preoperative chemotherapy enables to decrease the stage and increase survival of this
      aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment
      responses than with standard chemotherapy regimens and therefore to improve treatment
      outcomes of this extremely adverse group of patients.
    

Intervention name(s): Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine
Intervention type(s): Drug
Intervention description(s): Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks
Intervention MeSH terms: Paclitaxel; Doxorubicin; Capecitabine; Cyclophosphamide; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate the effects of a clinically approved and commercially available iron oxide
      formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel
      demineralization. This study will be testing topical application of Ferumoxytol extra-orally
      using a standard in situ biofilm demineralization model.
    

Detailed description: 
      This will be a randomized, crossover, single blind in situ study with three test periods
      utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have
      already had a study partial denture made for them as a part of a partial denture panel under
      14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was
      previously approved as part of the panel. The study partial dentures or personal partial
      dentures can house the specimen holders in two hollowed out areas of the buccal surface of
      two posterior denture teeth. The subjects will wear the lower partial dentures with enamel
      specimens in place for three consecutive 14-day study periods.
    

Intervention name(s): Ferumoxytol/Hydrogen peroxide; Hydrogen Peroxide; Water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.; Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.; Sham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.
Other intervention name(s): Feraheme
Intervention MeSH terms: Hydrogen Peroxide; Ferrosoferric Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a randomized, crossover, single blind in situ study with three test periods utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have already had a study partial denture made for them as a part of a partial denture panel under 14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was previously approved as part of the panel. The study partial dentures or personal partial dentures can house the specimen holders in two hollowed out areas of the buccal surface of two posterior denture teeth. The subjects will wear the lower partial dentures with enamel specimens in place for three consecutive 14-day study periods.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention