bioihbjkbjnl/mcl2 huggingface dataset:
Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify patients with persisting tumor cells after standard
      epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen
      (docetaxel) for these patients, and to explore the analysis of disseminated tumor cells in
      bone marrow as a surrogate marker for clinical outcome.
    

Detailed description: 
      The presence of disseminating (or isolated) tumor cells (DTC/ITC) in bone marrow (BM) after
      completion of adjuvant chemotherapy for breast cancer is associated with poor prognosis.
      Methods for detection of DTC have potential as a tool for monitoring occult residual disease
      during follow up. Also, there exists potent chemotherapy proven to be effective when
      anthracycline-based chemotherapy fails (f.ex. docetaxel). Consequently, a study has been
      started to test DTC detection as a surrogate marker for clinical outcome in localized breast
      cancer patients, selected by the presence of DTC in BM after standard adjuvant chemotherapy,
      receiving secondary treatment with docetaxel. In brief, patients having received
      anthracycline-containing chemotherapy for localized breast cancer are candidates. After
      informed consent and no radiologic signs of distant metastasis, the first BM aspiration is
      performed at the end of radiotherapy or 8-12 weeks after the last chemotherapy cycle. The
      next BM aspiration is performed 6 months later. At that time point the BMs are analyzed for
      the presence of DTC. If DTC are present in the 6 months BM test (the first BM sample is for
      exploratory research purposes), 6 cycles of docetaxel are administered (3qw), followed by a
      third and forth BM analysis 1 month and 13 months after the end of chemotherapy. The patients
      receiving docetaxel with eradication of the DTC will be clinically compared to those with
      persistence of DTC after docetaxel treatment.
    

Intervention name(s): Docetaxel
Intervention type(s): Drug
Intervention description(s): Docetaxel 100 mg/m2 3 qw x 6
Other intervention name(s): Taxotere
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Disseminating tumor cells,breast cancer,docetaxel,adjuvant
Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Ranbaxy and Abbott (TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets under fasting
      conditions.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover , bioequivalence study on clorazepate dipotassium
      comparing clorazepate dipotassium 15mg tablets of Ranbaxy Laboratories with Abbott
      (TranxeneeT-Tab®) 15 mg, in healthy, adult, human, subjects under fasting conditions. A total
      of 32 subjects, 25 males and 7 females, were enrolled in the study, and 31 subjects, 24 males
      and 7 females, completed the study.
    

Intervention name(s): Clorazepate Dipotassium 15mg Tablets
Intervention type(s): Drug
Intervention MeSH terms: Clorazepate Dipotassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence Clorazepate Tablets
A Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Dental Subjects
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in
      multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.
    

Detailed description: 
      A single-blind, randomized, placebo-controlled Phase 2 study to evaluate the safety and oral
      microbiology of C16G2 Varnish application in male and female dental subjects 12-75 years of
      age. This multi-center study will evaluate multiple study drug administrations of C16G2
      Varnish or Placebo Varnish.

      The study will enroll subjects into up to three study arms. Up to 33 subjects will receive
      multiple doses of study drug applied with a small brush typically used in dental varnish
      administration. Subjects will be enrolled in an 8:3 ratio. The Sponsor will perform unblinded
      microbiology review on an ongoing basis to determine whether to enroll additional 11 subjects
      into the next dose cohort or to terminate enrollment based on microbiology data.
    

Intervention name(s): C16G2 Varnish; Placebo Varnish
Intervention type(s): Drug; Drug
Intervention description(s): Antimicrobial Peptide; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus
Condition: Endoscopic Diagnosis in Esophagus
Study type: Interventional

Summary: 
      Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip
      of the colonoscope, was proven to increase the adenoma detection rate during screening
      colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization
      and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is
      still under investigations. The aim of this study is to compare the diagnostic yield of the
      CAE to the standard endoscopy in esophagus.
    


Intervention name(s): cap assisted upper endoscopy; standard upper endoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.; standard examination without using a cap
Other intervention name(s): cap fitted upper endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: upper endoscopy; cap assisted endoscopy; esophagus
A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine
Condition: Rhinitis, Allergic, Perennial and Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomized, 3-way cross-over, and repeat administration study in
      healthy male and female subjects. The purpose of the study is to determine the relative
      bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is
      administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A
      (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18
      subjects will be enrolled). Each part will consist of three treatment periods separated by a
      minimum washout period of 14 days. In each treatment period, subjects will receive seven
      daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray
      according to one of the 6 possible randomization sequences. The study will use an adaptive
      design with an interim review following Part A to confirm whether Part B is required.
    


Intervention name(s): FF/LEV FDC; FF; LEV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intranasal aqueous microsuspension containing 25.0 microgram (µg) of FF and 50 µg of LEV as a fixed dose combination. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state; Intranasal aqueous microsuspension containing 27.5µg of FF. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state; Intranasal aqueous microsuspension containing 50 µg of LEV. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinitis; healthy volunteers; fluticasone furoate; levocabastine; fixed dose combination; pharmacokinetics
Dynamic Changes of Monocytes and NK Cells of CHC Patient Treated by DAAs
Condition: Chronic Hepatitis C (Disorder)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      Recently,surprisingly and unexpectedly increased aggressiveness and high rates of HCC
      recurrence (28%(16/58) and 29%(17/59), respectively) have been reported in patients who
      cleared HCV with DAAs after achieving a complete response to resection or local ablation
      within only 6 months of therapy. The authors hypothesized that the rapid eradication of HCV
      and control of liver inflammation would impact anti-tumoral immune control, which in turn
      might contribute to the neoplastic cells proliferation. Conversely, three independent
      prospective French cohorts failed to reveal an increased risk of HCC recurrence after DAAs
      treatment in CHC patients after receiving curative cancer treatments.Although the impact of
      DAAs treatment on the rate of HCC occurrence or recurrence still remain unclear, it would be
      more important to pay attention to the immunological changes of CHC patients treated with
      DAAs.Up to now, little was known about the immunological changes of chronic hepatitis C (CHC)
      patients treated with direct-acting antiviral agents (DAAs), here we try to explore the
      effect of antiviral treatment of CHC patients with DAAs on the frequency of monocytes, NK
      cells and cytokines that promote their activation.
    

Detailed description: 
      15 treatment-naive CHC patients and 10 healthy controls were recruited. Patients were
      examined before DAAs therapy (0w) and at weeks 4 (4w) and weeks 12 (12w) of the therapy. The
      percentage of monocytes,NK cells of the peripheral blood were analyzed by flow cytometry.
      Serum cytokines IL-12, IL-18, CXCL10, CXCL11, sCD14 and sCD163 were measured by enzyme linked
      immunosorbent assay.
    

Intervention name(s): Ledipasvir-Sofosbuvir; Daclatasvir-Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): 8 CHC patients were treated with Sofosbuvir (400mg, qd)/Ledipasvir (90mg, qd) for 12 weeks; 7 CHC patients were treated with Sofosbuvir (400mg, qd)/Daclatasvir (60mg,qd) for 12 weeks.
Other intervention name(s): Harvoni; Daklinza
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        15 treatment-naive CHC patients and 10 healthy controls were recruited.
      
Biospecimen description: 
      peripheral blood
    
Keywords: Chronic Hepatitis C; Monocytes; Nk cells; direct-acting antiviral agents
Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)
Condition: Urea Cycle Disorders
MeSH terms: Urea Cycle Disorders, Inborn
Study type: Interventional
Phase: Phase 3

Summary: 
      This non-randomized, open-label study was approximately one year in duration and consisted of
      a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a
      12-month long term treatment period involving monthly visits.
    

Detailed description: 
      This was an open-label study consisting of a 10-day switch-over period during which subjects
      were switched from their prescribed dose of sodium phenylbutyrate (BUPHENYLTM or NaPBA) to a
      dose of HPN-100 that delivered the same amount of the active ingredient, PBA, followed by
      long-term treatment with HPN-100 for up to 12 months. The study was designed to capture
      information important for evaluating safety, Pharmacokinetics, and efficacy while recognizing
      sampling limitations in young children and current standard of care. Patients eligible for
      this study included pediatric patients from 29 days to < 6 years of age with either a
      diagnosed or clinically suspected Urea Cycle Disorders (UCD) who are receiving a stable dose
      of the powder formulation of NaPBA. Subjects were clinically stable and had been receiving a
      stable dose NaPBA powder for at least 5 days at the time of enrollment.

      During the switch-over part of the study, subjects switched from NaPBA to HPN-100 in one step
      and had two overnight stays with 24 hour blood sampling, the first of which was on Day 1,
      while still taking NaPBA, and the second of which was on approximately Day 10 while taking
      HPN-100. Subjects then continued in the long-term treatment phase which was 12 months in
      duration.
    

Intervention name(s): HPN-100
Intervention type(s): Drug
Intervention description(s): HPN-100 is a pro-drug of PAA that combines with glutamine to provide an alternative vehicle for waste nitrogen elimination. It is a liquid with minimal taste and odor. Approximately three teaspoons of HPN-100 (~17.4 mL) delivers an equivalent amount as PBA that 40 tablets of NaPBA.
Other intervention name(s): RAVICTI; Glycerol phenylbuterate
Intervention MeSH terms: Glycerol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urea Cycle Disorder; UCD; GT4P; Buphenyl; hyperammonemia; sodium phenylbutyrate
Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the
      treatment of endometriosis.

      There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group
      phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks
      for all subjects who completed the double-blind phase, irrespective of their treatment
      assignment in the first study phase.
    


Intervention name(s): Dienogest (Visanne, BAY86-5258); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg dienogest (DNG) once daily by mouth; Matching placebo once daily by mouth
Intervention MeSH terms: Dienogest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis; Efficacy; Safety; Dienogest
Acute Intestinal Necrosis- the Preoperative Diagnostic Approach
Condition: Acute Mesenteric Ischemia
MeSH terms: Mesenteric Ischemia; Ischemia
Study type: Observational

Summary: 
      To investigate a number of blood based parameters in patients with intestinal ischaemia
      compared to patients with other acute abdominal diseases.
    

Detailed description: 
      Intestinal ischemia is a life-threatening condition defined by interrupted blood supply to
      the intestinal tissue. Primary and secondary ischemia is obstruction of blood-supply due to
      vascular and extra-vascular pathology, respectively.

      Early diagnosis and treatment are critical to save the ischemic bowel. Clinical findings of
      secondary intestinal ischaemia are related to the underlying cause e.g. vomiting and palpable
      hernia. Abdominal computed tomography (CT) can effectively visualize the causes. In contrast,
      the diagnosis of primary intestinal ischemia is often delayed due to the absence of specific
      clinical findings. Primary intestinal ischemia is visualized with CT ateriography, revealing
      mesentery arterial obstruction. However, in the acute setting a non-arterial phase CT is
      often performed but the findings are unspecific in the early stages and the pattern of
      findings which could indicate primary ischemia are not well understood. In primary and
      secondary ischemia, standard blood-based parameters are inconsistently elevated and highly
      unspecific. Newer blood-based parameters such as D-lactate has been proposed as ischaemic
      markers. D-lactate is produced by bacteria in the bowel lumen and translocation through a
      damaged bowel wall makes it a potential marker of intestinal ischemia.

      A case-control-study of all acute admitted patients with abdominal pain in Aalborg, Denmark
      in the mentioned time range. The sensitivity and specificity of potiential biomarkers in a
      blood sample at time of admission as a marker of intestinal ischaemia will be examined.
    

Intervention name(s): Blood sample analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Analysis of proposed biomarkers.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Referred patient from the whole uptake area whic is 590.000 inhabitans for regional
        hospital functions.
      
Biospecimen description: 
      Full blood samples drawn just after inclusion.
A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to see if Glucovance, a medication currently
      approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and
      effectively in children 9 to 16 years of age.
    


Intervention name(s): Glucovance (metformin HCl/glyburide); metformin HCl; glyburide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Glyburide
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type II
Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
Condition: Osteoarthritis; Fibromyalgia
MeSH terms: Osteoarthritis; Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell
      Membrane (NEM) for the treatment of joint and connective tissue discomfort & pain.
    

Detailed description: 
      It is estimated that 140 million adults in the U.S. suffer from some form of joint or
      connective tissue (JCT) disorder (i.e. arthritis, lupus, gout, fibromyalgia, neck or back
      pain, etc.). As the population ages, this estimate is expected to grow rapidly. Traditional
      treatments for most of these disorders attempt to address only the symptoms (pain,
      inflammation, and discomfort) associated with the diseases. This usually involves the use of
      analgesics (i.e. acetaminophen, oxycodone, propoxyphene) or non-steroidal anti-inflammatory
      drugs (NSAIDs) (i.e. ibuprofen, diclofenac, celecoxib), alone or in combination. Most of
      these treatments have shown limited effectiveness in randomized controlled clinical trials
      (RCTs) or are known to have significant and sometimes severe side effects. To avoid the
      cardiac risks, gastrointestinal issues , and dependency issues associated with traditional
      JCT treatments (particularly with long-term use), many patients have turned to complementary
      and alternative medicines (CAMs) such as dietary supplements.

      Glucosamine, chondroitin, and methylsulfonylmethane (MSM) alone and in combination, are
      widely marketed as dietary supplements to treat joint pain due to osteoarthritis (OA). Other
      vitamins, minerals, and botanicals such as kava, pine bark extract, capsicum, boswellia root
      extract, turmeric/curcumin, etc. are also marketed for various JCT pain maladies. We present
      here the use of eggshell membrane as a possible new natural therapeutic for JCT disorders. A
      single center, open label human clinical study was conducted to evaluate the efficacy and
      safety of NEM® as a treatment for pain associated with joint and connective tissue disorders.
      Subjects were to take NEM, 500mg, once daily for 30 days. Subjects were then evaluated for
      pain.
    

Intervention name(s): NEM Formulation X; NEM Formulation Y
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): see Treatment Arms; see Treatment Arms
Other intervention name(s): Natural Eggshell Membrane; Natural Eggshell Membrane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: arthritis; osteoarthritis; fibromyalgia; connective tissue disorder
Pain Reduce Following Refractive Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      applying a material over the exposed stromal bed following refractive surgery to prevent
      local abrasion and significantly reduce pain
    

Detailed description: 
      Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will
      be performed.
    

Intervention name(s): Bandage
Intervention type(s): Other
Intervention description(s): one application for one week
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractive surgery
Open, Single-dose/-Period Study to Assess Mass Balance Recovery, Metabolite Profile/Identification of 14C-Varlitinib
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, single oral dose study in healthy male
      subjects. It is planned to enrol a single cohort of 6 healthy male subjects to ensure data in
      4 evaluable subjects.

      Each subject will receive a single administration of 120 mg [14C] varlitinib oral suspension
      containing not more than (NMT) 2.9 MBq (79 µCi), in the fed state.
    

Detailed description: 
      Subjects will be screened for eligibility to participate in the study up to 28 days before
      dosing. Subjects will be admitted to the clinical unit on the evening prior to IMP
      administration (Day 1) and will fast overnight for a minimum of 8 h. Subjects will be dosed
      on the morning of Day 1 following a light breakfast, and will remain resident in the clinic
      until up to 240 h after dosing (Day 11). It is planned that subjects will be released as a
      group when all subjects have achieved a mass balance cumulative recovery of >90%, or if <1%
      of the dose administered has been collected in urine and faeces within 2 separate,
      consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces)
      will cease and the subjects will undergo discharge assessments. If this criterion has not
      been met by all subjects on Day 11, the residency period may be extended by a further 48 h
      maximum (up to Day 13). If the criterion is still not met by Day 13, or if additional
      residency is not considered appropriate or necessary, then home collections of urine and/or
      faeces may be requested at the discretion of the investigator for individual subjects.
    

Intervention name(s): Varlitinib
Intervention type(s): Drug
Intervention description(s): [14C]-Varlitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science