bioihbjkbjnl/mcl2 huggingface dataset:
Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with
      pancreatic cancer that has been removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the ability of cytidine deaminase (CDA) to predict the occurrence of early
           (during the first 2 courses) severe hematological toxicity (grade 3 or 4), induced by
           gemcitabine hydrochloride in patients with resected pancreatic adenocarcinoma.

      Secondary

        -  To determine the ability of CDA to predict the occurrence of severe non-hematological
           toxicity (grade 3 or 4), early (during the first 2 courses), and during the following
           courses, induced by gemcitabine hydrochloride.

        -  To determine the ability of CDA to predict the occurrence of severe hematological
           toxicity (grade 3 or 4) during all courses, induced by gemcitabine hydrochloride.

        -  To determine the impact of CDA status on gemcitabine hydrochloride pharmacokinetics and
           the ratio of gemcitabine hydrochloride/dFdU metabolization.

        -  To study genotype to phenotype of the CDA gene.

        -  To identify new mutations on the CDA gene.

        -  To evaluate the relationship between CDA status and global survival. (Exploratory)

      OUTLINE: This is a multicenter study.

      Within 8 weeks of resection, patients receive adjuvant gemcitabine hydrochloride IV over 30
      minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 6 courses in the absence of
      disease progression or unacceptable toxicity.

      Blood samples are collected periodically for pharmacogenetic and biomarker studies. Some
      patients may undergo blood sample collection for pharmacokinetic studies.

      After completion of study, patients are followed up periodically.
    

Intervention name(s): gemcitabine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage IA pancreatic cancer; stage IB pancreatic cancer; stage IIA pancreatic cancer
Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)
Condition: Small Bowel Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical
      presentation can vary considerably. Patients are frequently assessed by capsule endoscopy
      (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the
      correlations between CE scoring index (CESI), biological markers, and disease activity
      indices remain undefined.

      Methods: A prospective study was conducted between October 2008 and February 2011 on 58
      established SBCD patients and suspected patients who received a definitive SBCD diagnosis
      during study. Patients underwent complete CE, and were scored according to the CESI
      (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and
      Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein
      (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the
      patients underwent CE with scoring for CESI, HBI, and CRP.
    

Detailed description: 
      Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The
      degree of disease involvement in each tertile was determined by assessing three parameters:
      villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of <135.
      Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.

      HBI HBI was used to assess the clinical disease activity. Patients with HBI >4 were
      considered to have clinically active disease.[7]

      Blood analysis At the time of CE, patients provided a blood sample for measurement of
      hemoglobin, serum CRP, and albumin. Hemoglobin (normal ranges: women, 120-160 g/L and men,
      140-180 g/L), albumin (normal range: 35-55 g/L), and CRP (upper limit of normal: <8 mg/L)
      were determined by routine laboratory tests.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients underwent CE examination (described below), and only those patients for whom
        complete CE examination (in which the capsule reached the cecum within the CE test time)
        was achieved were retained for study.
      
Biospecimen description: 
      serum of small bowel Crohn's disease patients
    
Keywords: capsule endoscopy scoring index; Harvey-Bradshaw index; C-reactive protein; serum albumin; hemoglobin
A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relationship between the plasma concentrations
      of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate)
      using exposure-response (ER) analysis.
    


Intervention name(s): Odalasvir 100 mg; Placebo; Odalasvir 500 mg; Odalasvir (Up to maximum 1000 mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive odalasvir 2*50 mg tablet, orally once on Day 1.; Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.; Participants will receive odalasvir 10*50 mg tablet, orally once on Day 1.; Participants will receive odalasvir to be decided up to maximum of 20*50 mg tablet, orally once on Day 1.
Intervention MeSH terms: Odalasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Adherence Monitoring For Substance Abuse Clinical Trials
Condition: Medication Adherence
Study type: Observational

Summary: 
      The purpose of this study is to determine the feasibility and accuracy of an automated
      adherence monitoring system, and to compare the variance between urine and oral fluid
      riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen
      interval.
    


Intervention name(s): Automated Adherence Monitoring System
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Normals
Cervical I/F Cage for Anterior Cervical Fusion
Condition: Cervical Intervertebral Disc Degeneration
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the clinical success of the Cervical I/F Cage in
      treatment of one or two adjacent levels of degenerative disc disease of the cervical spine
      compared with standard of care treatment using either autograft, autograft with a plate or
      allograft with a plate
    

Detailed description: 
      This is a prospective randomized multi-center clinical trial to assess the safety and
      efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent
      levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between
      the investigational and control groups.

      Comparison: The device will be compared to a control group consisting of the 3 accepted
      standard of care treatments (autograft, autograft with an anterior plate, or allograft with
      an anterior plate). For two level fusions, the control group will be limited to autograft
      with a plate or allograft with a plate. Based on the current literature, it is believed that
      there is no difference between the three treatments in terms of clinical success, fusion
      success, or safety issues. However, amongst the investigators there are preferred treatments.
      Each investigator will choose one or more of the control treatments at study initiation.
      Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately
      240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic
      degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical
      treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior
      fusion surgery on the cervical spine.
    

Intervention name(s): Cervical I/F Cage; Autograft or allograft with a plate, or autograft alone.
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fusion; cervical; spine
Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML
Condition: Acute Myeloid Leukemia; Hematopoietic Stem Cell Transplantation
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of
      leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD
      positive acute myeloid leukemia (AML).
    

Detailed description: 
      Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been
      reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML
      patients have an inferior survival, primarily due to lower complete remission (CR) rate and
      higher relapse rate. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT)
      improves the outcomes of some FLT3-ITD-positive AML, a significant number will suffer disease
      recurrence after allo-HSCT. Sorafenib, an inhibitor of multiple kinases including FLT3, has
      shown promising activity in FLT3-ITD-positive AML. Recent studies have shown that sorafenib
      monotherapy or in combination with chemotherapy are effective in attaining CR, but they do
      not have significant improvement in relapse. Currently, prophylactic use of sorafenib after
      allo-HSCT has been rarely reported, and whether it can improve outcomes of FLT3-ITD-positive
      AML remains unclear.
    

Intervention name(s): Sorafenib
Intervention type(s): Drug
Intervention description(s): The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myeloid Leukemia; FLT3-ITD; Hematopoietic Stem Cell Transplantation
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare safety and efficacy of a single dose of
      empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5
      μg/kg/day.
    

Detailed description: 
      BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of
      CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated
      filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of
      filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients
      receiving myelosuppressive chemotherapy.
    

Intervention name(s): empegfilrastim; filgrastim
Intervention type(s): Biological; Biological
Intervention description(s): Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.; Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
Other intervention name(s): Extimia; BCD-017; metpegfilgrastim; pegylated filgrastim; peg-GCSF; empegfilgrastim; GCSF
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: empegfilgrastim; pegylated filgrastim; neutropenia; febrile neutropenia; chemotherapy-associated neutropenia; breast cancer; docetaxel; doxorubicin
"Improves Physiological Based Cord Clamping (PBCC) the Systemic and Cerebral Oxygenation in Term Infants?"
Condition: Near-Infrared Spectroscopy; Umbilical Cord Issue
Study type: Interventional

Summary: 
      The first major intervention a newborn infant is facing following birth is clamping of the
      umbilical cord. This means separation of the infant from the placenta, the newborn becomes an
      independent individual, especially from a cardio-circulatory perspective. There is still a
      lack of understanding of the issues associated with umbilical cord clamping. The aim of the
      present study is to investigate whether cord clamping after onset of sufficient spontenous
      breathing is able to improve systemic and cerebral oxygenation in term infants delivered
      vaginally.
    

Detailed description: 
      Recent literature focused very much on the appropriate timing of the cord clamping (CC),
      distinguishing immediate cord clamping (ICC) from delayed cord clamping (DCC). Although
      potential benefits for DCC have been documented, especially for preterm infants, ICC still is
      the most widely used procedure. Although the reasons for this are unclear, a lack of
      understanding of the issues associated with umbilical cord clamping is thought to be a major
      underlying factor.

      In animal research with fetal lambs it has been shown, that aeration of the lung played a
      crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new
      concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung
      was established, calling this "Physiological-Based Cord Clamping" (PBCC). It was shown, that
      PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral
      oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral
      oxygenation was measured using near infrared spectroscopy (NIRS).

      Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to
      investigate whether PBCC is able to improve systemic and cerebral oxygenation in term infants
      delivered vaginally.
    

Intervention name(s): physiological-based cord clamping
Intervention type(s): Procedure
Intervention description(s): The cord of the newborn infant is clamped after establishing stable breathing efforts. The suspected time ranges from 2-4 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neonatal transition; Umbilical cord clamping; Regional cerebral oxygen saturation; Cerebral blood volume; Near-infrared spectroscopy; Arterial oxygen saturation; Term infants
Head Repositioning Accuracy During Experimental Neck Pain
Condition: Healthy; Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study investigates if/how an experimentally applied neck muscle pain influences head
      repositioning error in healthy participants.
    

Detailed description: 
      Healthy volunteers will participate in a single session study with a crossover design.

      During the study healthy participants will be randomized to either receive a injection of
      hypertonic saline (painful injection) or isotonic saline (control injection) in a neck
      muscle.

      Head repositioning accuracy will be assessed with and without performing a cognitive task.
    

Intervention name(s): Injection of hypertonic saline; Injection of Isotonic saline
Intervention type(s): Drug; Drug
Intervention description(s): Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%); Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)
Other intervention name(s): Hypertonic saline (5.8%); Isotonic saline (0.9%)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to either the painful condition or the control condition first before crossing over to opposite condition.
Masking: Single (Participant)
Primary purpose: Basic Science
Combination of Dental Bleaching Techniques, Randomized Clinical Trial
Condition: Tooth Stain
MeSH terms: Tooth Discoloration
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effectiveness of combining different concentrations of hydrogen peroxide and
      carbamide used during tooth bleaching.
    

Detailed description: 
      120 patiens over 18 years old.

      Design:

      Hydrogen peroxide (HP) Carbamide Peroxide (CP)

      Group 1: CP 10% + HP 40% Group 2: CP 15% + HP 40% Group 3: CP 20% + HP 40% Group 4: HP 10% +
      HP 40%
    

Intervention name(s): Hydrogen Peroxide and Carbamide Peroxide; Hydrogen Peroxide and Hydrogen Peroxide
Intervention type(s): Other; Other
Intervention description(s): Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office; Hydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office
Intervention MeSH terms: Hydrogen Peroxide; Carbamide Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Peroxide
Comparison of Time-Restricted Feeding Versus Grazing
Condition: Prediabetes; Insulin Resistance; Vascular Diseases
MeSH terms: Vascular Diseases; Insulin Resistance; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this pilot study is to find out what eating meals in a short time period early
      in the day (time-restricted feeding) versus eating meals spread out during the day (grazing)
      does to the body's ability to control blood sugar and to the health of its blood vessels.

      The investigators hypothesize that time-restricted feeding will be more effective at
      improving glucose tolerance and vascular condition (inflammation and micro- and
      macro-vascular function) than grazing.
    

Detailed description: 
      Each participant will eat according to one of the two eating schedules (grazing or
      time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to
      the other eating schedule for 5 weeks. Measurements of glucose homeostasis and vascular
      condition will be performed before and after a participant follows each eating schedule.
    

Intervention name(s): Time-Restricted Feeding; Grazing
Intervention type(s): Other; Other
Intervention description(s): Time-restricted feeding is a variant of intermittent fasting that involves eating all of one's calories within a few hours each day (typically 4-9 hours), followed by a daily fast of 15-20 hours.; Grazing involves eating meals spread out over the course of the day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Time-restricted feeding; Intermittent fasting; Prediabetes; Insulin resistance; Glucose tolerance; Insulin sensitivity; Circadian rhythms; Diurnal
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not
      detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or
      tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the
      ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately
      direct prostate needle biopsy using the Gleason score from the histology of the core biopsies
      as standard of truth.
    

Detailed description: 
      In this open label, single center, non-randomized, diagnostic study we plan to include 40 men
      with elevated PSA (ages 30-50 PSA >2.5 ng/mL; ages 50-80 PSA > 4ng/mL), which are assigned to
      a MRI guided biopsy.

      These patients will undergo one additional PET/MRI scan with [68Ga]PSMA within two to three
      weeks before the biopsy (Arm A), or in case of an unclear/negative MRI scan but positive
      biopsy two to three weeks after biopsy (Arm B). In Arm A a radiologist will delineate the
      suspected areas on (A) multiparametric magnetic resonance image (mpMRI) and a nuclear
      medicine physician will delineate and color code the suspicious areas on the PET/MRI: (B)
      [68Ga]PSMA. The images will be loaded into the BiopSee® system. Lesions positive on both
      modalities will be labeled as "AB". Every suspicious lesion will be targeted with 3 cores. A
      maximum of 3 targets will be selected per patient.

      For arm B: PET/MRI results will be correlated with the template biopsy results.

      The data analysis of Arm A and Arm B will be identical. For the analysis the Gleason score
      from the histology of the core biopsies will serve as standard of truth.

      After completion of the PET/MR study part - an amendment for PET/CT was submitted to the
      local ethics commity and acknowledged to include 10 more participants with PSMA PET/CT to
      investigate the use of PET/CT guided biopsy and intraoperative verivication of the target
      with a gamma counter.
    

Intervention name(s): [68Ga]PSMA-11; [18F]PSMA-1007
Intervention type(s): Drug; Drug
Intervention description(s): PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.; 18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.
Other intervention name(s): PSMA PET/MRI; PSMA PET/CT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: In both arms PET/MR is compared to mpMRI for diagnostic accuracy for PCA detection.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PSMA PET/MRI; Guided Biopsy; Prostate Cancer