bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years
Condition: Gastric Neoplasm; Gastric Cancer; Gastric Adenoma; Gastric Atrophy; Intestinal Metaplasia
MeSH terms: Stomach Neoplasms; Adenoma; Gastritis; Gastritis, Atrophic; Atrophy; Metaplasia
Study type: Observational [Patient Registry]

Summary: 
      Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic
      gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination
      of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for
      detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis.
      The investigators aimed to uncover whether this combination method could predict the risk of
      gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the
      participants will be followed for an expected average of 3 years.
    

Detailed description: 
      According to the Correa's hypothesis, the combination method using serum pepsinogen levels
      and serum Helicobacter pylori antibody would predict the risk and cell type of gastric
      neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries
      (Korea, Japan, and China), most of the aged population are have current or had past H. pylori
      infection. Therefore, in this study, we are going to uncover whether the risk of gastric
      neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by
      atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In
      addition, we are going to investigate whether those slow-growing gastric neoplasms such as
      differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more
      commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing
      gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with
      Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a
      whole, our study result will provide an evidence whether this biomarker strategy are useful
      for the detection of individuals at increased risk of gastric neoplasm.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic Korean adults who underwent serum PG tests, H. pylori serology, and upper
        gastrointestinal endoscopy on the same day at our center.
      
Biospecimen description: 
      Serum for Helicobacter pylori antibody and pepsinogen levels Gastric biopsy for the diagnosis
      of intestinal metaplasia, atrophy, inflammatory cells, Helicobacter pylori, and the presence
      of gastric neoplasm if any.
    
Keywords: Gastric atrophy; Helicobacter pylori; Pepsinogen; Gastric cancer; Gastric adenoma
Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the
      opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in
      both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by
      tDCS will be assessed using both laser stimuli and cold pressor test. In patients the
      assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep
      and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage
      and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular
      cortex). In patients, three separate conditions (two active and one sham) will be tested in
      randomised order. In healthy subjects, two other conditions are added to control for
      attention and distraction confounders.
    


Intervention name(s): transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session; transcranial direct current stimulation of opercular-insular cortex - active control session; transcranial direct current stimulation of opercular-insular cortex - sham control session.
Intervention type(s): Device; Device; Device
Intervention description(s): transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.; transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.; transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Resistance; Neuropathic Pain; opercular-insular cortex; Transcranial Direct Current Stimulation
Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The
      study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory
      effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.
    


Intervention name(s): QAX028; Placebo; Tiotropium bromide; QAX028; QAX028
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD/TIOTROPIUM/QAX028
Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19
Condition: Covid19; SARS-CoV Infection
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in
      participants with clinical symptoms of COVID-19 that have begun within the past 72 hours
      prior to testing.
    

Detailed description: 
      This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in
      participants with clinical symptoms of COVID-19 that have begun within the past 72 hours
      prior to testing. A confirmatory diagnosis of COVID-19 via nasopharyngeal swab, with a
      positive PCR result within 48 hours of testing.

      Consented participants who complete screening and meet study eligibility criteria will be
      randomized in a 1:1 ratio to receive DuACT or Placebo for 5 days.

      Study drugs will be administered BID for 5 days with a loading dose on Day 1. Following
      randomization, participants will complete a symptom questionnaire, record temperature and
      record oxygen saturation daily for 10 days and at day 28. A thermometer and pulse oximeter
      will be provided to each patient at the baseline visit (Day 1).

      On study days 3, 6 and 10 participants will have a clinic or home visit by a home healthcare
      provider. At these visits, a mid-turbinate nasal swab will be obtained, confirmation of the
      patient's clinical symptoms questionnaire will be completed and any adverse events will be
      assessed.
    

Intervention name(s): Placebo; DuACT
Intervention type(s): Drug; Drug
Intervention description(s): Placebo administered on Days 1-5; Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Ribavirin; Nitazoxanide; SARS-CoV-2
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Condition: Metastatic Cancer
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      RSR13 may make tumor cells more sensitive to radiation therapy.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the
      brain with or without RSR13 in treating patients who have brain metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the median survival time in patients with brain metastases after receiving
           treatment with whole brain radiotherapy with or without RSR13.

        -  Compare the response rate to these treatment regimens in these patients.

        -  Compare the time to progression after receiving these treatment regimens in these
           patients.

        -  Compare quality of life in these patients receiving these treatment regimens.

        -  Compare cause of death (neurologic vs nonneurologic death) in these patients after
           receiving these treatment regimens.

        -  Determine the safety of RSR13 in these patients.

        -  Assess the pharmacokinetics of RSR13 in these patients.

      OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are
      stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients
      are further stratified within the RPA class II stratum according to site of primary cancer
      (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two
      treatment arms.

        -  Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in
           conjunction with supplemental oxygen breathing.

        -  Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy
           and supplemental oxygen breathing as in arm I.

      Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months,
      and then every 3 months until disease progression.

      Patients are followed at 1 month, 3 months, every 3 months until disease progression, and
      then for survival.

      PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for this
      study.
    

Intervention name(s): efaproxiral; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Efaproxiral
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tumors metastatic to brain
A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study will investigate in humans the enzyme inhibition effects of SB-649868 on
      CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single
      doses: alone, and on two different occasions after repeat doses of SB-649868, at the same
      time as SB-649868 and 2h before SB-649868.
    


Intervention name(s): Atorvastatin; Simvastatin; SB649868
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period.; 10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period.; 20mg daily given for 14 days.
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: repeat dose; statins; safety and tolerability; drug interaction; sb649868; healthy male subjects; pharmacokinetics
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to assess the effectiveness of epidural patient-controlled analgesia
      compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic
      gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain
      control than IV PCA even for laparoscopic gastrectomy.
    


Intervention name(s): Epidural PCA Ropivacaine; IV PCA Fentanyl+nefopam+Ramosetron
Intervention type(s): Drug; Drug
Intervention description(s): Epidural catheter insertion at T10 level before surgery, the tip of catheter location at T8-9 level.
Total volume: 500ml, 16.7mcg/kg+0.75% Ropivacaine 80ml+N/S; Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.
Other intervention name(s): Epidural patient-controlled analgesia Ropivacaine; intravenous patient-controlled analgesia
Intervention MeSH terms: Fentanyl; Nefopam; Ramosetron; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gastric cancer; epidural; PCA; laparoscopy
Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
Condition: Kidney Cancer; Melanoma (Skin); Metastatic Cancer
MeSH terms: Melanoma; Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      brain metastases caused by kidney cancer or melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of sunitinib malate, in terms of objective radiographic response
           of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or
           melanoma.

      Secondary

        -  Determine overall and progression-free survival.

      OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every
      6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed periodically.
    

Intervention name(s): sunitinib malate
Intervention type(s): Drug
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV melanoma; tumors metastatic to brain; stage IV renal cell cancer; recurrent melanoma; recurrent renal cell cancer
Treatment-Resistant Depression Cohort in Europe
Condition: Depressive Disorder, Treatment-Resistant
MeSH terms: Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Observational

Summary: 
      The purpose of this study is to assess the participants socio-demographics and
      disease-related characteristics, long-term naturalistic treatment patterns and the clinical,
      social and economic outcomes of routine clinical practice in the treatment of participants
      with treatment-resistant depression (TRD) in a variety of European countries.
    

Detailed description: 
      This TRD cohort study will collect critically important data from routine clinical practice
      in Europe which will further substantiate the understanding of TRD in European clinical
      practice, with the aim of improving guidance and informing the development of better
      treatment strategies for this medically important condition. All data recorded in the case
      report form (CRF) should be documented in participants' medical records, that will be the
      primary data source of each participant. Participants who meet the diagnostic criteria for
      Major Depressive Disorder (MDD) and the diagnostic criteria for TRD, and are initiating or
      planned to initiate a new antidepressive treatment regimen will participate in the study. The
      end of the entire study will be 6 months after enrollment of the last participant in the
      study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with Major Depressive Disorder (MDD) who fulfill the most commonly adopted
        criteria for treatment-resistant depression (TRD) with outcomes in routine clinical
        practice across the European region will be part of the study.
Comparing the Effect of Video-cases and Text-cases on Medical Students' Learning in Tutorial
Condition: Education, Medical; Education, Medical, Undergraduate; Problem-based Learning; Problem Solving; Interactive Tutorial
Study type: Interventional

Summary: 
      This study is designed to examine how the type of learning case affects the thinking of
      medical students in tutorial
    

Detailed description: 
      Tutorials at Harvard Medical School use problem-based learning with written cases. Students
      work in groups under the supervision of a tutor who guides their exploration of the material.
      As students progress through the curriculum there is an opportunity to advance the complexity
      of the material they are presented with. Video-based patient case studies have been shown to
      improve critical thinking ratios in paediatric medical student problem-based learning
      exercises, and time spent on data exploration, theory building and theory evaluation in
      postgraduate residency programs. We hypothesize that video provides a stimulus that improves
      cognitive processing and critical thinking among medical students, as compared to working
      from the text-based transcript of the same case.
    

Intervention name(s): video case modality; Text case modality
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients whose case histories are pathophysiologically illustrative will be recruited, and interviewed on video. Their stories will be edited and divided into sections, and combined with the patient's laboratory, imaging, and pathological reports when appropriate; Patients whose case histories are pathophysiologically illustrative will be recruited, and interviewed on video. Their stories will be edited and divided into sections, and combined with the patient's laboratory, imaging, and pathological reports when appropriate. The transcript of these video-recordings will form the basis of the text-based case presentation modality.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: medical education; problem-based learning; interactive tutorial
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
      Vehicle Lotion.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle
      Lotion. To be eligible for the study subjects must be at least 9 years of age and have a
      clinical diagnosis of moderate to severe acne.
    

Intervention name(s): IDP-123 Lotion; IDP-123 Vehicle Lotion
Intervention type(s): Drug; Drug
Intervention description(s): Tazarotene 0.045% Lotion; Vehicle Lotion
Other intervention name(s): IDP-123; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
    

Detailed description: 
      This study (TOPAZ-II; M14-222), was a Phase 3b, open-label, multicenter study conducted in
      the United States which, together with its companion study TOPAZ-I (M14-423; NCT02219490)
      conducted outside of the United States, was designed with the primary objective of assessing
      the effect of treatment response on long-term clinical outcomes in adults with chronic HCV
      GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or
      interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were
      treated with the 3-DAA regimen with or without RBV. This study consisted of a screening
      period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects
      without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated
      cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a
      260-week post-treatment period.
    

Intervention name(s): ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet for oral use; Tablet for oral use; Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Other intervention name(s): ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; Paritaprevir/ritonavir/ombitasvir also known as Viekirax; ABT-333 also known as dasabuvir; ABT-333 also known as Exviera
Intervention MeSH terms: Ritonavir; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naïve; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder