bioihbjkbjnl/mcl2 huggingface dataset:
Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving cetuximab
      together with combination chemotherapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination
      chemotherapy works in treating patients with advanced or metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan
           hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced
           or metastatic colorectal cancer.

      Secondary

        -  Increase the effectiveness of this regimen by intensifying the treatment.

        -  Specify the constitutional genetic and genomic tumor parameters that could interfere
           with and predict the toxicity and/or antitumor efficacy of this regimen.

        -  Assess the time to progression.

      OUTLINE: This is a multicenter study.

      Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2
      hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV
      continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of
      disease progression or unacceptable toxicity.

      Pharmacokinetic and pharmacogenetic studies are also conducted.
    

Intervention name(s): cetuximab; fluorouracil; irinotecan hydrochloride; leucovorin calcium; pharmacological study
Intervention type(s): Biological; Drug; Drug; Drug; Other
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan; Cetuximab; Calcium; Levoleucovorin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; recurrent colon cancer; stage IV rectal cancer; recurrent rectal cancer
The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and
      vascular endothelial function with respect to gut microbiota and metabolome in women with
      established insulin resistance and its tolerance after 12 weeks of probiotic therapy.

      The hypothesis is probiotic therapy in women with established insulin resistance undergoing
      metformin treatment increases the drug's efficacy to improve insulin sensitivity and
      intestinal endothelial function, and reduces gastrointestinal side effects.

      Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a
      placebo (GP). The randomization scheme will be computer-generated using permuted blocks of
      block size 4.
    


Intervention name(s): the group GS (probiotic); the group GP (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The probiotic-supplemented group will receive 2 capsules of freeze-dried powder of a probiotic mixture containing the following bacterial strains twice a day, 3-month: Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24; The placebo group will receive 2 capsules consisting of the probiotic product carrier, which is corn starch and maltodextrin, twice a day, 3-month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insulin Resistance; Multistrain Probiotic; Gut Microbiota
Tonsillar Retractor-induced Subacute Submassive Tongue Edema
Condition: Side Effects; Tonsil Hypertrophy; Children, Only
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      This study aimed to detect tongue edema induced by the pressure exerted by tonsillar
      retractor; edema detection was made through tongue area measurement using ultrasonography
      (USG) in pediatric patients who underwent tonsillectomy surgeries.
    

Detailed description: 
      The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect
      the occurrence of tongue edema through USG examination and to educate clinicians about the
      association between subacute tongue edema and tonsillar retractor in pediatric patients.
    

Intervention name(s): Ultrasonography imaging
Intervention type(s): Diagnostic Test
Intervention description(s): This study aimed to measure the tongue areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue areas.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 16 years or younger who were to undergo tonsillectomy surgery were eligible
        for inclusion in this group. Informed consent was obtained from the parents of all the
        patients with a clinical diagnosis of chronic tonsillitis and tonsillar hypertrophy (except
        adenoidectomy surgeries) and were to undergo tonsillectomy surgery.
      
Keywords: ultrasonography; children; tonsil; diagnostic imaging
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      The traditional model of localizing a nerve for blockade is using a peripheral nerve
      stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide
      nerve blockade. However despite excellent visualization nerve block success has not
      significantly improved. I aim to show that this is because the PNS stimulation of a nerve is
      more than a proximity response as thought but a correct fascial plane response and hence the
      high success rate of this blind approach.
    


Intervention name(s): Stimuplex HNS 12
Intervention type(s): Device
Other intervention name(s): Peripheral nerve stimulator for nerve location
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient Satisfaction for Digital Versus Conventional Maxillary Obturator
Condition: Maxillofacial Prosthesis User
Study type: Interventional

Summary: 
      Evidence regarding the performance of digital obturators totally fabricated using 3D printing
      is insufficient. This prospective randomized crossover study aimed to evaluate patient
      satisfaction with conventional maxillary obturator and totally full digitally fabricated
      obturator. Patient satisfaction was evaluated using two scales: The Obturator Functioning
      Scale" and "The Patient and operator-centered outcomes were assessed through two visual
      analog scale (VAS) questionnaires.
    

Detailed description: 
      The use of digital technologies in the fabrication of maxillofacial prostheses has been
      described. Additive manufacturing offers a more convenient and more efficient process with
      reduced material waste compared with traditional subtractive technique. Although Prosthetic
      rehabilitation with Conventional maxillary obturator prosthesis fabricated with a casted
      metal framework using, heat-cured acrylic resin can restore oral function and facial
      esthetics following maxillectomy. But it is time-consuming and labor-intensive. Multiple
      sources of errors can accumulate during the laboratory steps, resulting in a misfit of the
      framework. In this study All patients received a conventional obturator for 6 months, after a
      washout period of one week, they use the digital one. The Obturator Functioning Scale" and
      "The Patient and operator-centered outcomes were assessed through two visual analog scale
      (VAS) questionnaires.
    

Intervention name(s): conventional obturator; 3 d printed obturator
Intervention type(s): Other; Other
Intervention description(s): restoration of midline maxillary defect with obturator made of cast metal , heat cure acrylic resin; restoration of midline maxillary defect with obturator made of SLM metal , 3 d printed resin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: maxillary obturator, selective laser melting
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary Objective:

      - To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles
      of four formulations of SAR161271 in patients with T1DM.

      Secondary Objective:

      - To establish relative potency of SAR161271 compared with insulin glargine in patients with
      T1DM
    

Detailed description: 
      The total per patient is between 31 and 67 days; including post-study visit between 108 and
      172 days. In case of an additional late post-study visit after last dosing, approximately 213
      to 279 days, broken down as follows:

        -  Screening: 3 to 27 days;

        -  Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;

        -  Wash-out between doses: 7 to 10 days;

        -  End of Study visit: 7 to 10 days after last dose.

        -  Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study
           visit 6 to 7 months after last dosing.
    

Intervention name(s): SAR161271; Insulin glargine HOE901
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution for injection
Route of administration: subcutaneous; Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
Condition: AIDS; AIDS Vaccines
Study type: Interventional

Summary: 
      The purpose of this study is to investigate a combined set of parameters deemed to impact the
      quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral
      therapy-naïve HIV-1 infected subjects.
    

Detailed description: 
      This study will address the respective and combined impact of (i) timing between blood
      collection and peripheral blood mononuclear cells (PBMC) processing ["time-to-process"] and
      (ii) timing of PBMC resting before stimulation ["resting -time"].
    

Intervention name(s): Blood sample collection
Intervention type(s): Procedure
Intervention description(s): Blood samples will be collected in all subjects at two time points, at the Screening Visit (Day 0) and at the Sample Collection Visit (Day 15)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CMI; Antiretroviral therapy-naïve; HIV
Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most
      frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all
      visits to physicians for LBP involve individuals over 65. In older adults, LBP has been
      associated with a host of negative consequences, including decreased physical function,
      increased fall risk, increased mood disturbance and increased health care utilization.
      Surprisingly, little research has focused on LBP in people over 65. But, recent evidence
      demonstrates that LBP is associated with increased intramuscular fat infiltration in the
      abdominal and paraspinal muscles and that this altered muscle composition increases the risk
      of mobility-related functional decline in older adults. While trunk muscle training (TMT) has
      been used in younger LBP groups, it is unproven in elders and, alone may not be sufficient to
      substantially improve function and symptoms, given the compromised state of ages muscle. TMT
      augmented with neuromuscular electrical stimulation (NMES) known to improve strength and
      function beyond the capacity of volitional exercise alone, may provide greater improvements.
      Treatment of chronic LBP in older adults using an exercise intervention has been hypothesized
      as a way to prevent functional decline and frailty progression; however this hypothesis has
      yet to be experimentally confirmed. In this exploratory study, the investigators will test
      the hypothesis that TMT plus NMES will result in reduced disability and pain severity
      compared to usual care in elders with chronic LBP.
    


Intervention name(s): Trunk Muscle Training+NMES; Passive control intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals; Passive physical therapy approach to low back pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification
Condition: Coronary Artery Calcification; Coronary Artery Disease; Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Coronary Artery Disease; Arteriosclerosis; Calcinosis
Study type: Interventional

Summary: 
      Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an
      estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with
      atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated
      CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as regulators
      of gene expression, have also emerged as powerful biomarkers in the diagnosis and prognosis
      of cardiovascular disorders and may be used in the detection of CAC. We aim to investigate
      the potential for a "microRNA-signature" in patients with CAC by performing a prospective,
      case-controlled study to identify pathways associated with CAC in humans. Previous research
      has demonstrated an inverse relationship between CAC and bone mineral density (BMD),
      suggesting that these processes may be linked. In a further substudy we plan to define the
      relationship between CAC and BMD as well as a number of markers of bone metabolism.
    

Detailed description: 
      Patients will be prospectively enrolled whilst attending for elective coronary CT (computed
      tomography) angiography including a coronary calcium score, at the Royal Surrey County
      Hospital. Data regarding demographic and clinical characteristics of patients will be
      collected. Peripheral venous blood sampling will take place on this occasion. Coronary artery
      calcification scores will be estimated by a Radiologist using default software. Patients
      eligible for the bone metabolism substudy will be required to attend the University of Surrey
      for peripheral Quantitative Computed Tomography (pQCT) of bone mineral composition of the
      radius. In the intervening period we will ask them to complete a 4-day food diary and wear a
      UV dosimeter, the latter to assess typical UV exposure, for one week.
    

Intervention name(s): Venous blood sampling; 4-day food diary; 1 week UV dosimeter; Peripheral Quantitative Computed Tomography of the radius
Intervention type(s): Other; Other; Other; Radiation
Intervention description(s): 40ml venous blood sampling will be undertaken during participants' attendance for CT coronary angiography (the latter being performed as part of routine clinical investigation).; To be worn on outerwear for one week week prior to attendance for pQCT; To be performed within one month of attendance for CT coronary angiography
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and
      beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol
      concentrations in lactating Bangladeshi women.
    

Detailed description: 
      The specific aim is to compare the effects of orange-fleshed sweet potatoes and tangerines
      compared to white-fleshed sweet potatoes and vitamin A as retinyl palmitate on blood and
      breast milk cryptoxanthin (CX), beta-carotene (BC), and vitamin A (VA) concentrations by
      randomly assigning lactating Bangladeshi women to one of four treatment groups for 6
      days/week for 3 weeks.

      The investigators will also compare the relative vitamin A (VA) value of BC and CX from food
      sources by comparing the mean change in breast milk retinol concentrations of the groups that
      receive tangerines (CX) or orange-fleshed sweet potatoes (BC) with the mean change in breast
      milk retinol of the group that receives retinyl palmitate.
    

Intervention name(s): 0 mg retinol activity equivalents; 12 mg of BC; 6 mg of CX; 1.0 mg RAE
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule; 12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule; 6 mg of CX as tangerines and a corn oil capsule; 1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lactation; cryptoxanthin; beta-carotene; vitamin A
Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Crush Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of Apixaban oral solution
      administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban
      administered as crushed tablet through a nasogastric tube relative to Apixaban solution
      administered orally in healthy subjects.
    


Intervention name(s): Apixaban; Boost Plus
Intervention type(s): Drug; Dietary Supplement
Other intervention name(s): BMS-562247
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
    

Detailed description: 
      A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol
      (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour
      period, followed by a single open-label treatment day with three cumulative doses of
      arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously
      posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo
      Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals
      Inc.
    

Intervention name(s): arformoterol; levalbuterol
Intervention type(s): Drug; Drug
Intervention description(s): Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).; Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Other intervention name(s): Brovana; Xopenex
Intervention MeSH terms: Albuterol; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Respiratory Tract Diseases
Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer
Condition: Lung Cancer, Nonsmall Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of crizotinib as induction therapy in participants with
      surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive
      NSCLC.
    

Detailed description: 
      Participants with stage IA-IIIA, surgically resectable lung adenocarcinoma with an activating
      alteration in ALK, ROS1 or MET will receive neoadjuvant treatment with crizotinib. This
      neoadjuvant treatment will last 6 weeks and on the last day of dosing of crizotinib,
      participants will undergo surgical resection, followed by 5 years of follow-up via chart
      review.
    

Intervention name(s): Crizotinib
Intervention type(s): Drug
Intervention description(s): Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.
Other intervention name(s): Xalkori
Intervention MeSH terms: Crizotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment