bioihbjkbjnl/mcl2 huggingface dataset:
Text Messages in Preventing Tobacco Use in Young Adults
Condition: Healthy Subject
Study type: Interventional

Summary: 
      This trial studies how well text messages work in preventing tobacco use in young adults.
      Text messaging may help to teach young adults about the risks of tobacco products.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess baseline knowledge and risk perceptions about the use of conventional and new
      and emerging tobacco products among a subset of community college students from the two
      participating Houston Community College (HCC) campuses (Central and Coleman campuses). (Phase
      1.1) II. Test the text messages with university students enrolled in the health
      communications academic programs. (Phase 1.2) III. Assess the awareness, attitudes,
      receptivity, and comprehension of the harmful effects of conventional and new and emerging
      tobacco products among young adults. (Phase 2) IV. Identify the most effective combinations
      of text message framing for communicating information about the potential harmful effects of
      tobacco products to young adults. (Phase 2) V. To obtain an objective measure of the
      psychological (i.e., emotional and cognitive) effect of the messages on young adults. (Phase
      3)

      EXPLORATORY OBJECTIVES:

      I. Define and analyze key moderators of young adult awareness, attitudes, receptivity, and
      understanding of the harmful risks and constituents of conventional, new and emerging tobacco
      products. (Phase 2)

      OUTLINE:

      PHASE I: Participants attend focus group over 2 hours.

      PHASE II: Participants receive 2 text messages per day for 30 days at baseline and after 3
      months.

      PHASE III: Participants read 64 computer messages with or without images over 30 minutes and
      have their facial expressions assessed.
    

Intervention name(s): Computer-Assisted Intervention; Focus Group; Informational Intervention; Survey Administration
Intervention type(s): Other; Behavioral; Other; Other
Intervention description(s): Read computer messages; Attend focus group; Receive text messages; Complete surveys about experience
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Fast & Fed Pharmacokinetic (PK) Study
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to provide information on how well an extended release
      formulation (a medication that is released and absorbed over a longer period of time than a
      regular release formulation of the medication) of naproxen sodium is absorbed into the
      bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14
      hours).
    


Intervention name(s): Naproxen sodium; Naproxen sodium
Intervention type(s): Drug; Drug
Intervention description(s): Administered under fasting condition; Administered under fed condition
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Naproxen Sodium
Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release
      of the neurotransmitter dopamine in the brain. The purpose of this study is to further
      examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.
    

Detailed description: 
      This randomized, double-blind dose study will compare the effectiveness of three active
      medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine
      dependence. Participants will be randomly assigned to one of the four following dosages of
      dextro-amphetamine sulfate: 0 mg, 40 mg, 60 mg, or 80 mg. Participants will undergo a 2-week
      stabilization period followed by a 25-week study period. The study period will include
      administration of the stable medication dose for 21 weeks, followed by 1 week of dose
      reduction, and then 3 weeks without medication. All participants will receive weekly
      cognitive behavioral therapy and electrocardiograms. Participants will be given the option to
      participate in a voluntary plasma blood draw during Weeks 4, 8, and 20 and will be scheduled
      for follow-up assessments at Months 1 and 3 post-treatment.
    

Intervention name(s): Dextro-Amphetamine Sulfate
Intervention type(s): Drug
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cocaine Abuse; Dextro-Amphetamine Sulfate
Pharmacokinetic Study of ASP1517 With Kremezin®
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of
      single dose of ASP1517 in healthy non-elderly adult male subjects when administered
      concomitantly or in a time separated manner.
    


Intervention name(s): ASP1517; Kremezin®
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction; Kremezin; Pharmacokinetics; ASP1517
Oxytocin and Social Cognition in Frontotemporal Dementia
Condition: Frontotemporal Dementia; Pick's Disease
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional

Summary: 
      Investigations into the components of cognition damaged in frontotemporal dementia (FTD)
      demonstrate that patients with FTD show deficits in facial and verbal expression recognition,
      lack insight into what others think or might do (theory of mind skills), and in decision
      making tasks requiring processing of positive versus negative feedback. These cognitive
      functions are thought to be critical for appropriate social behavioural regulation (Blair,
      2003). Recent studies in animal models and humans suggest that the neuropeptide oxytocin is
      an important mediator of social behavior and that oxytocin may facilitate emotion
      recognition, theory of mind processing, and prosocial behaviors (Donaldson and Young, 2008).
      Together, these findings suggest that upregulation of oxytocin dependent mechanisms of social
      and emotional cognition may be a valuable treatment approach in patients with FTD. The aim of
      this study is to determine how administration of intranasal oxytocin to patients with
      frontotemporal dementia affects behavior and processing of specific types of social and
      emotional information.The investigators' hypothesis is that oxytocin administration will
      improve emotional and social cognitive deficits in patients with FTD, resulting in improved
      decision making and behaviour.
    


Intervention name(s): intranasal oxytocin
Intervention type(s): Drug
Intervention description(s): Participants will receive 24 IU of oxytocin or placebo (Salinex saline nasal spray) intranasally 30 minutes prior to completing the experimental tasks. Two weeks later participants will return for a second visit and receive the alternate drug (either intranasal oxytocin or Salinex) prior to completing the experimental tasks.
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Cognition; Oxytocin
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are:

        -  To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and
           cilofexor (CILO), administered alone or in combination, in participants with bridging
           fibrosis or compensated cirrhosis due to NASH

        -  To evaluate changes in liver fibrosis, without worsening of NASH
    


Intervention name(s): SEL; FIR; CILO; Placebo to match FIR; Placebo to match CILO; Placebo to match SEL
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 18 mg tablet administered orally once daily without regard to food; 20 mg tablet administered orally once daily without regard to food; 30 mg tablet administered orally once daily without regard to food; Tablet administered orally once daily without regard to food; Tablet administered orally once daily without regard to food; Tablet administered orally once daily without regard to food
Other intervention name(s): GS-0976; GS-9674
Intervention MeSH terms: Firsocostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Radiological Images for Nasotracheal Tube Size Estimation
Condition: Nasotracheal Tube Passage Through Nasal Cavity
Study type: Observational [Patient Registry]

Summary: 
      This trial is planned to estimate the size of nasotracheal tube (NTT) by calculating the
      diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below
      the inferior turbinate and floor of nose in coronal planes. Smallest diameter will be
      considered to calculate the outer diameter of NTT, hence the size .
    

Detailed description: 
      The planned trial will estimate the size of nasotracheal tube (NTT) by calculating the
      diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below
      the inferior turbinate and floor of nose at different levels in coronal planes. Smallest
      diameter will be considered to calculate the outer diameter of NTT, hence the size. The side
      of nasotracheal intubation will be decided after view the radiological images and the
      estimated size of NTT will be used. Finally the ease of intubation and complications will be
      recorded.
    

Intervention name(s): Nasotracheal Intubation
Intervention type(s): Other
Intervention description(s): side of nostril and size of endotracheal tube estimation for nasotracheal intubation will be done based on radiological imaging ( CT/MRI head)
Other intervention name(s): Malinckrodt flexometallic tube
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        oncosurgical patients with oral malignancies who required nasotracheal intubation for
        COMMANDO surgeries.
      
Keywords: Nasotracheal tube size based on radiological images of nose.
The Effect of Plant Sterols on the Blood Lipid Profile of Subjects With and at High Risk of Type 2 Diabetes Mellitus
Condition: Vascular Diseases; Hypercholesterolemia; Diabetes Mellitus
MeSH terms: Vascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional

Summary: 
      Double-blind, randomised, placebo-controlled, parallel group study with two intervention
      arms. The study will be conducted in 150 subjects and the primary objective is to show a
      fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with
      established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.
    

Detailed description: 
      The main aim of the study is to investigate the effect of plant sterols on fasting
      triglycerides and LDL-cholesterol concentrations.

      This study also aims to study the effect of plant sterols on fasting total cholesterol,
      HDL-cholesterol concentrations and Lipoprotein (a). Furthermore the effects of plant sterols
      on fasting blood glucose and insulin will be explored. At last, in a sub-group, at end of
      intervention the acute, chronic and acute upon chronic effect of plant sterols on
      postprandial blood lipids, glucose and insulin responses during a mixed meal challenge rich
      in fat and carbohydrates will be explored.
    

Intervention name(s): Plant sterols; Placebo product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Plant sterols; Placebo product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: plant sterols; blood lipids
Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy
Condition: Adenocarcinoma of Pancreas
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      A pilot randomized feasibility trial with a blinded evaluator.
    

Detailed description: 
      Chemotherapy-induced peripheral neuropathy (CIPN) has a dose limiting effect which can
      greatly affect quality of life and often limits the amount of treatment patients can receive
      in treating their cancer. In the discipline of hand therapy, there is a science-based body of
      knowledge with effective protocols to treat neuropathies associated with injury and disease.
      These interventions have not been explored on patients with CIPN.
    

Intervention name(s): Hand Therapy Until CIPN
Intervention type(s): Other
Intervention description(s): Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an opene-label, single center, randomized prospective pilot study to compare the
      efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and
      emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).
    

Detailed description: 
      Scheme:

      Eligible fosaprepitant sensitive (complete response [defined as no emesis and no use of
      rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of
      cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1
      ratio.

        -  Weekly Arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during
           concurrent chemoradiotherapy.

        -  Triweekly Arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during
           concurrent chemoradiotherapy.
    

Intervention name(s): fosaprepitant
Intervention type(s): Drug
Intervention description(s): fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy
Intervention MeSH terms: Fosaprepitant; Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
High Dose Radiotherapy for the Treatment of Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      While surgery remains the standard treatment for rectal cancer, some patients still firmly
      refuse surgery for various reasons. Here, we conducted this retrospective observation study
      to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating
      rectal cancer We retrospectively collect data of rectal cancer patients who were treated with
      high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April
      1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have
      received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor
      residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have
      received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy
      regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.

      After treatment, patients were followed every 3 months for the first two years, at least
      every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.

      Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local
      recurrence and distant metastasis rate, progression free survival, and overall survival were
      calculated using the Kaplan Meier Method and were compared by log-rank test.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This retrospective study included subjects identified from the database of the Sun Yat-sen
        University Cancer Center in the period of April 2006 to July 2017.
      
Keywords: high dose radiotherapy; rectal cancer
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of this study is to assess the sensitivity and specificity of a
      MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow
      up visit.
    

Detailed description: 
      This monocentric, prospective, non-randomized study assesses the amount of the main
      metalloproteinases (MMP1, MMP9, MMP13) and their inhibitor TIMP-1 in wound fluid from
      diabetic foot ulcers.

      It aims at demonstrating whether a MMP-1/TIMP-1 ratio equal to 0.24 at study entry can
      predict wound healing 12 weeks later. All patients will receive the same treatment according
      to our local protocol. The difference with standard care will be a sample of wound fluid at
      week 0 and week 4 and a numeric photograph for wound area measurement at week 0, week 4 and
      week 12.

      The main outcome measurement is the percent change of wound area between week 0 and week 12
      Secondary objectives include the evaluation of a MMP-1/TIMP-1 ratio equal to 0.4 and the
      search for confounding factors. A correlation between MMP-9, MMP-13 and wound healing will
      also be investigated.
    

Intervention name(s): Picture + MMPs and TIMP1 at week 0 and week 4
Intervention type(s): Other
Intervention description(s): Sample of wound fluid will be collected using a non traumatic procedure at week 0 and week 4. This will allow to assess the level of MMP9, MMP13, MMP1 and TIMP1. A numeric photograph of the wound will be taken at week 0, week 4 and week 12 in order to assess wound area.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: type 1 diabetes; type 2 diabetes; Diabetic foot ulcer
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this trial is to evaluate if the use of a newly developed lipid formulation
      versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of
      supplementation.
    


Intervention name(s): modified lipid formulation; Fish oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.; Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Genetic Study of Young Patients With Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan
      effective treatment for patients who develop colorectal cancer at an early age.

      PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the
      outcome of treatment in patients who develop stage I, stage II, or stage III colorectal
      cancer at an early age.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the prognostic significance (e.g., overall survival) of microsatellite
           instability (MSI) status in patients with early age-of-onset stage I-III colorectal
           cancer, assuming the presence of a quantitative interaction between MSI status and
           family history of cancer.

        -  Evaluate the development of metachronous neoplasms in this patient population.

        -  Evaluate the histologic features and genetic changes associated with hereditary
           nonpolyposis colorectal cancer in this patient population.

      OUTLINE: This is a multicenter study. Patients are stratified according to family history
      using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs
      negative).

      Patients undergo baseline colonoscopy before or within 6 months of initial curative resection
      and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The
      number, size, location, histology, and method of removal of polyps are documented at the time
      of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and
      complete family history questionnaires at baseline.

      The prognostic significance of family history and MSI status is evaluated. The individual
      histologic features of the tumors are compared with the MSI status to determine their
      predictive value. The histologic features are also correlated with outcome to determine their
      prognostic significance.

      Patients may be referred for genetic counseling.

      A certificate of confidentiality protecting the identity of research participants in this
      project has been issued by the National Cancer Institute.
    

Intervention name(s): microsatellite instability analysis
Intervention type(s): Genetic
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with adenocarcinoma of the colon or rectum.
      
Keywords: stage I colon cancer; stage II colon cancer; stage III colon cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum