bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a controlled study designed to compare relapse-free survival and overall survival in
      patients receiving UFT with those in patients receiving surgery alone. Patients will be
      randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative
      resection. To assess treatment efficacy, data on recurrence and survival will be collected
      for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events
      will be collected for 12 months after the start of treatment.Evaluations will be separately
      done for colon cancer and rectal cancer.
    


Intervention name(s): UFT (uracil, tegafur); Surgery alone
Intervention type(s): Drug; Procedure
Intervention description(s): to receive oral uracil-tegafur 400 mg square meter for one year; Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
Intervention MeSH terms: Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Cancer
Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the
      pediatric emergency department.
    

Detailed description: 
      A randomized double blinded placebo controlled trial comparing one dose of dexamethasone
      administered in the Emergency Department with two doses, the first given in the emergency
      department and the second 24 hours after the index ED visit.
    

Intervention name(s): Dexamethasone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
Other intervention name(s): decadron
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Pediatric; Emergency Department; Dexamethasone; Steroid
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      There is no definite conclusive work about the benefit of OCT-guided PCI, which should be
      determined in complex PCI, assuming better stent optimization by OCT. In the study, we will
      explore the clinical implication of OCT-guided PCI of complex lesions.
    

Detailed description: 
      Eligible patients will be randomly assigned to either OCT-guided PCI arm and
      angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio. Within
      OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and
      postprocedural OCT only arm. and comparison of stent implantation with and without
      preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization
      will be assessed). In angiography-guided PCI arm, PCI for complex lesion will be performed
      without guidance of intravascular imaging, and routine use of high pressure postdilation with
      NC balloon will be also recommended. Primary endpoint will be evaluated during 12 months
      after PCI.
    

Intervention name(s): OCT-guided PCI; Angiography-guided PCI
Intervention type(s): Device; Device
Intervention description(s): Patients will receive PCI under OCT-guidance. Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.; Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary artery disease; Optical coherence tomography; antiplatelet therapy
A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction
Condition: Healthy Subjects(Only Men)
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Korea red ginseng has been used in maintaining vitality throughout the globally and
      metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied.
      KRG has been used in various ailment, and to prove its efficacy for erectile dysfunction an
      international study on contries other than Korean was performed. In the present study,
      subjects with borderline organic and psychogenic erectile dysfunction will be included. KRG
      will be give daily, and placebo will be give as control. Outcomes including libido, erection,
      sexual activity, and sexual satisfaction will be measured.
    

Detailed description: 
      Among the three main lines of therapy for erectile dysfunction (ED), that is, oral therapy,
      self-injection therapy and penile prosthesis implantation, the first line therapy is always
      the first option. Despite the successful advent of sildenafil, the first effective oral agent
      for ED, further development of new drugs and phytochemical studies of widely known herbal
      plants are desirable. Furthermore, there seems to be a large population that prefers to use
      phytotherapies rather than pharmaceutical drugs for their health. Korean red ginseng, a
      phytotherapy plants, used frequently for ED. Ginseng is one of the most popular herbs in both
      Eastern and Western countries. It is known as a traditional Asian medicine for stimulation of
      sexual function and studies have shown the effects of ginseng on relaxation of penile corpus
      cavernous smooth muscle in many studies. In the present study, the investigators will be
      determined the real role of Korean red ginseng in the treatment of ED.
    

Intervention name(s): EFLA400; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): EFLA400(960mg/day)for 12 weeks; Placebo(960mg/day) for 12 weeks
Other intervention name(s): EFLA400 Korean red ginseng
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Erectile dysfunction; Korean Red Ginseng; IIEF(International Index of Erectile Function); MSHQ(Male Sexual Health Questionnaire,)
Journey of Hope in Appalachia: Supporting Resilience in the Region's Youth
Condition: Adverse Childhood Experiences
Study type: Observational

Summary: 
      Rural youth have heightened exposure to adverse childhood experiences (ACES) such as poverty,
      social isolation, chronic hunger, and drug use in the home. These threats can lead to
      downstream problems with emotion regulation, substance abuse, and heightened vulnerability to
      chronic disease. Resilience is the capacity to adapt positively in the face of such
      disadvantage. Youth resilience interventions can buffer the negative effects of ACES.
      Unfortunately, rural schools and other youth-serving agencies often have inadequate capacity
      to provide such interventions. Thus, there is a critical need to develop cost-effective,
      sustainable, and culturally-relevant youth resilience interventions that can be delivered by
      trained personnel with dedicated time and resources. WVU, UK, and Save The Children have a
      long-term goal to establish a sustained community-engaged research partnership to promote
      resilience in Appalachian youth. This is a community-based participatory research
      (CBPR)-guided study being conducted for the purpose of developing a culturally relevant,
      intervention to promote Appalachian youth resilience. The intervention, called Journey of
      Hope in Appalachia (JOHA), has as it's starting point Save The Children's evidence-based
      Journey of Hope (JOH) program that targets youth experiencing acute stress from natural
      disasters and similar events. This program will be culturally adapted to promote resilience
      among Appalachian youth experiencing ACES. JOHA will incorporate positive aspects of
      Appalachian culture (e.g., storytelling, theater, music) and will be designed for
      sustainability and eventual dissemination by Save through the Appalachian Translational
      Research Network (ATRN) and other regional Networks.
    


Intervention name(s): Focus groups
Intervention type(s): Other
Intervention description(s): Focus groups will be conducted with adult stakeholders and with youth in Appalachia. Feedback from the focus groups will guide cultural tailoring of the Journey of Hope in Appalachia intervention for use in a later phase.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Youth of Appalachia Kentucky and West Virginia and adults who are parents of youth or are
        stakeholders in the health and well-being of Appalachian youth.
      
Keywords: Resilience; Appalachian youth; Community-based participatory research
Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus.
      The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and
      glucose lowering capabilities following a single subcutaneous dose.
    


Intervention name(s): Placebo; PF-04603629
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will be given either Placebo or PF-04603629.; Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: GLP-1
A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers
Condition: TB
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the immunogenicity of M. bovis BCG, given intrademally in the standard dose used in
      clinical practice and to measure the development of the immune response in the first six
      months after administration. M. bovis BCG is a fully licensed vaccine that has been in
      routine clinical use for the last 50 years. It is the most widely administered vaccine in the
      world today and has an excellent safety record.
    

Detailed description: 
      Volunteers for the study will be recruited through advertisements. Each volunteer will have
      received an information sheet concerning the study and will have agreed to participate in
      writing.

      Volunteers will be given at least 48 hours between reading the information leaflet and
      agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment.
      Volunteers will give signed consent for their GP's to be notified about their participation
      in the trial. The GP will be faxed a letter on the day of screening and asked to reply if
      they know of a reason why the volunteer should not take part. The signed consent form will
      also be faxed with the letter.
    

Intervention name(s): BCG
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TB; BCG
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study was compare the efficacy of two exercise programs - the first
      consisting of balance training and muscle strength and the second consisting of balance
      training and muscle stretching exercises - to improve postural control in elderly women with
      osteoporosis.
    

Detailed description: 
      The decrease in postural control and muscle strength in lower limbs have been identified as
      major risk factors for falls in older people. Exercises have proven effective in decreasing
      risk factors in healthy elderly, but little is known about the effects of interventions with
      exercise in the elderly with osteoporosis.

      Objective: To compare the efficacy of two exercise programs - the first consisting of balance
      training and muscle strength and the second consisting of balance training and muscle
      stretching exercises - to improve postural control in elderly women with osteoporosis.

      Methods: Fifty elderly aged 65 or older, with a diagnosis of osteoporosis, were randomized
      into 3 groups: Strength Group (n = 17) performed balance training with muscle strengthening;
      Stretching Group (n = 17) performed balance training with stretching; and Control Group (n
      =16) did not do activity. The groups trained for 8 weeks, with sessions of about 60 minutes,
      twice a week. Postural control was evaluated by Modified Clinical Test of Sensory Interaction
      for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate, the
      functional balance by Berg Balance Scale (BBS), muscle strength by dynamometry, the
      shortening of the hamstrings by goniometry and posture by PAS/SAPO (Postural Assessment
      Software).
    

Intervention name(s): Strengthening and balance exercises; Stretching and balance exercises
Intervention type(s): Other; Other
Intervention description(s): The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.; The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Other intervention name(s): Force Platform; Balance Master; Force Platform; Balance Master
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: elderly; postural balance; musculoskeletal equilibrium; posture; muscle strength; muscle stretching exercises
A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size
Condition: Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size
Study type: Observational

Summary: 
      Difficulty in managing the airway is the single most important cause of major
      anesthesia-related morbidity and mortality. The currently used clinical method of predicting
      airway difficulty used by anesthetists is limited and not very highly sensitive or specific.
      Any additional bedside method that increases its specificity and sensitivity would be
      valuable. This project is designed to study and measure the tongue thickness and oral cavity
      height by using an ultrasound scan and comparing them with the same measurements obtained by
      CT scan. These will also be compared to a more complicated measurements used in previous
      studies to investigate any correlation with the currently used clinical methods. This
      information will help us decide if ultrasound may help Anesthesiologists assess difficulties
      in airway management in a more accurate, precise and reliable simpler method.
    


Intervention name(s): Ultrasound scan
Intervention type(s): Other
Intervention description(s): Ultrasound scanning examinations will be performed twice (pre-CT scan and post CT-scan). Each examination will be performed by two observers who are blinded to each other's measured values.Patients will be asked to place a small sip of water (20 mL)in their mouth and keep the mouth open during the imaging. A second ultrasound examination of each patient by the two observers will be performed after the CT-scan.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for high resolution computerized tomography (CT scan) of the head and
        neck as part of their medical investigation of thyroid or laryngeal disorders will be
        recruited for this study.
      
Keywords: Ultrasound; Computed Tomography; Oral cavity size; The Mallampati classification
Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to
      methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This
      study will also compare the safety of CP-690,550 with methotrexate.
    


Intervention name(s): CP-690,550; CP-690,550; Disease-modifying antirheumatic drug
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets administered at a dose of 5 mg BID for 24 months; Oral tablets administered at a dose of 10 mg BID for 24 months; Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Other intervention name(s): DMARD, MTX
Intervention MeSH terms: Antirheumatic Agents; Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oral JAK inhibitor; MTX; DMARD; clinical trial; joint diseases; autoimmune diseases; anti-Inflammatory agents; rheumatic diseases
Real-time fMRI Neurofeedback Training on the Anterior Insula Based on Interoceptive Processing
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the study is to investigate whether subjects can learn self control of
      activity of the anterior insula via real-time functional magnetic resonance imaging (fMRI)
      neurofeedback training based on a regulation strategy of interoceptive processing.
    

Detailed description: 
      A double-blinded, placebo-controled, between-subject design is employed in this study. In a
      randomized order, a total of 90 healthy subjects will be recruited and assigned into the
      experimental group (EG; N=33), which receives real feedback from the left anterior insula, or
      the control group (CG; N=33) which receives sham feedback from a whole slice of top brain, or
      the control group 2 (CG2; N=33) wich receives sham feedback from the middle temporal gyrus.
      Neurofeedback training consists of 4 training sessions with real-time feedback and 1 transfer
      session without feedback. A heartbeat detection task pre- and post-training was used to
      determine interoceptive accuracy changes induced by neurofeedback training. A pre-training
      empathy task before training was used to localise the anterior insula and as a baseline of
      empathic response. A post-training empathy task was used to determine the effects of
      neurofeedback training on empathic response by comparing with the pre-training one.
      Behavioral and fMRI data are collected during the empathy tasks and the neurofeedback task.
      Personality traits of subjects are assessed using validated Chinese version questionnaires,
      including the Toronto Alexithymia Scale (TAS), Multidimensional Assessment of Interoceptive
      Awareness (MAIA), Interoceptive Confusion Questionnaire (ICQ), Beck Depression Inventory
      (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Empathy Quotient
      (EQ). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) twice
      before and after the neurofeedback training task.
    

Intervention name(s): real-time fMRI neurofeedback training procedure; real-time fMRI sham-controlled neurofeedback training procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands); real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: real-time neurofeedback; anterior insula; Interoceptive Processing
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia
Condition: Schizophrenia; Anxiety-comorbidity to Schizophrenia
MeSH terms: Anxiety Disorders; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The PACS study aims to investigate the efficacy and tolerability of pregabalin for
      schizophrenic patients that suffer from comorbid anxiety.

      The study design is an 8 week flexible dosage, randomized placebo controlled.

      The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients
      are recruited from outpatient clinics from entire Denmark.
    


Intervention name(s): Pregabalin; Pregabalin Placebo Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Subjects are randomized 1:1 to either pregabalin treatment or placebo. The intervention period is 8 weeks. The daily pregabalin dose is 75 mg. during the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. Doses above 150 mg. should be divided in two daily dosages.; Parallel to Active Comparator
Other intervention name(s): Brand name: Lyrica(R)
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety-comorbidity to schizophrenia; Double-blinded randomized placebo controlled trial; Pregabalin