bioihbjkbjnl/mcl2 huggingface dataset:
APPSPIRE App in Preventing Students From Smoking
Condition: Cigarette Smoker; Current Every Day Smoker; Student
Study type: Interventional

Summary: 
      This trial studies how well APPSPIRE, a smartphone app, works in preventing students from
      smoking. Technology-driven intervention programs, such as the APPSPIRE app, have the
      potential to increase access to health behavior treatments and therapies, such as tobacco
      cessation support, and provide effective prevention messaging.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Develop a prototype of the APPSPIRE (phone application [app] of a smoking prevention
      interactive experience).

      II. At post assessment, students enrolled in the study will qualitatively provide information
      about the usability and usefulness for the prevention and cessation sites.

      III. Investigate frequency of use of and exposure to APPSPIRE modules via an objective
      measure of general use.

      IV. Investigate how feasible the program will be. V. Obtain a maintained use of APPSPIRE with
      high completeness and extent of completion.

      VI. Evaluate change in stage of change from baseline to about 1 and 4-month follow-ups among
      participants.

      OUTLINE:

      Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app.
      After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour
      to discuss how they liked the app and its usefulness.
    

Intervention name(s): APPSPIRE; Focus Group; Survey Administration
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Given APPSPIRE app; Attend focus group; Complete survey
Other intervention name(s): APPSPIRE Smartphone Application; APPSPIRE Smartphone App; APPSPIRE App; APPSPIRE Application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study
Condition: Abdominal Pain; Zoster With Other Complications
MeSH terms: Herpes Zoster; Abdominal Pain
Study type: Interventional

Summary: 
      The aim of this study is to identify the frequency of enteric zoster using salivary varicella
      zoster virus (VZV) DNA PCR in patients who visit the emergency room due to acute abdominal
      pain.
    

Detailed description: 
      Varicella zoster virus (VZV) infects and establishes latency in neurons in the ganglia of the
      cranial nerve, dorsal root, and enteric ganglia. VZV reactivation in enteric neurons (enteric
      zoster) can cause nonspecific abdominal pain and/or serious gastrointestinal dysfunction
      without cutaneous manifestations. Detection of VZV DNA in saliva may be useful for
      identifying enteric zoster. We evaluated the frequency of putative enteric zoster based on
      the presence of salivary VZV DNA in patients with acute abdominal pain.

      Adult patients who visited the emergency room due to moderate to severe acute abdominal pain
      were prospectively enrolled at a tertiary hospital between May 2019 and November 2019.
      Abdominopelvic computed tomography (APCT) was performed in all patients. Saliva samples were
      collected from all studied patients. Enteric zoster was suspected based on the presence of
      salivary VZV DNA, detected using real-time polymerase chain reaction (PCR).
    

Intervention name(s): Salivary VZV-DNA PCR
Intervention type(s): Diagnostic Test
Intervention description(s): VZV-DNA PCR of saliva samples
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: varicella zoster virus; enteric zoster; saliva
Brief Web-Based Alcohol Reduction Intervention for Undergraduates
Condition: Alcohol Use; Heavy Drinking; Negative Consequences of Alcohol Use
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally
      utilized with Australian students, is unique in that it contains efficacious components
      derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral
      therapy (protective behavioral strategies), yet is very brief and has established efficacy.
      This study aims to test versions of THRIVE tailored to American college students. In addition
      to replicating original results with THRIVE, we will also test versions containing unique
      subsets of protective behavioral strategies to reduce alcohol consumption. The primary
      hypothesis is that versions of THRIVE will be associated with lower overall alcohol
      consumption than an assessment and brief brochure control condition.
    


Intervention name(s): THRIVE; Brief brochure and assessment control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): THRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
Other intervention name(s): Tertiary Health Research Intervention Via Email
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: brief intervention; web-based interventions; computer-based interventions; harm reduction; young adult; college student
A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee (With 7-Day Follow-up)
Condition: Pain
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the analgesic efficacy and safety of Tramadol Once
      a Day 100, 200, 300 mg and Placebo
    


Intervention name(s): Tramadol Once A Day; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One Tramadol Once A Day tablet at randomized dose daily.; One Placebo tablet daily.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain due to Osteoarthritis of the Knee
Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder
Condition: Major Depressive Disorder; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study evaluates the addition of light therapy with LUMINETTE device to usual treatment
      (antidepressant drug and psychotherapy) in the treatment of Major Depressive Disorder (MDD).
      Half of the participants will receive active light therapy with LUMINETTE device while the
      other half will receive placebo light therapy with LUMINETTE placebo device.
    

Detailed description: 
      Major depressive disorder (MDD) is a world wide spread disorder. According to the World
      health organization, MDD affects more than 300 million people of all ages in the world.
      Treatments of MDD include pharmacological treatment and psychotherapy. Pharmacological
      treatments, mostly serotonin selective reuptake inhibitors, have a delayed onset of action,
      require long-term treatment and have partial efficacy. In fact, only one third of patients
      respond to the first antidepressant treatment and two-third after multiple trials. So, there
      is a need for new treatment strategy.

      Light therapy is a well established non pharmacological treatment of seasonal affective
      disorder, a clinical subtype of affective disorder characterized by recurrent episodes of
      depression occurring with a seasonal pattern. Patients are exposed to artificial light for a
      variable duration and intensity. Although the precise mechanism of bright light therapy
      remains unknown, it is thought to act through the eyes by activating the suprachiasmatic
      nucleus, the principal circadian pacemaker.
    

Intervention name(s): active light therapy (LUMINETTE®); placebo light therapy
Intervention type(s): Device; Device
Intervention description(s): light therapy on a portable light visor device; placebo portable light visor device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: light therapy
Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone
      in depression.
    


Intervention name(s): Vilazodone
Intervention type(s): Drug
Intervention MeSH terms: Vilazodone Hydrochloride
Primary purpose: Treatment
Quality of Life and Surgical Late Effects of Melanoma Treatment
Condition: Melanoma; Quality of Life; Lymphedema; Depression; Anxiety; Pain; Cicatrix
MeSH terms: Melanoma; Lymphedema; Cicatrix
Study type: Observational

Summary: 
      Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.
    

Detailed description: 
      The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients:

        1. Health-related quality of life assessing psychological, physical and social well-being

        2. Physical long term side effects (lymphoedema, scarring and neuropathic pain)

        3. Lymphoedema assessed by clinical examination and DXA scans
    

Intervention name(s): DXA scan; Clinical examination
Intervention type(s): Radiation; Procedure
Intervention description(s): DXA scan; Clinical examination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients treated for cutaneous melanoma (AJCC stage IB-III) with wide local excision (WLE)
        and sentinel lymph node biopsy (SNB) and/ or complete lymph node dissection in the axilla
        and/or groin will be included in the study.
Anesthesia-induced Hypotension and Fluid Responsiveness
Condition: Hypotension on Induction
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The purpose of this study is to find out which of the variables related to fluid
      responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry
      plethysmographic variance [ΔPOP]) can best predict hypotension during induction of
      anesthesia.
    

Detailed description: 
      Propofol is a widely used intravenous agent for induction of anesthesia in children aged 3
      years and more. A well-known adverse effect of propofol is hypotension, which can be properly
      dealt with hydration and/or administration of inotropics and vasopressors. However, severe
      hypotension during anesthetic induction may not be immediately cured if anesthesiologist
      should concentrate on ventilation of the patient. Since pediatric patients have smaller
      reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of
      severe hypotension may result in irreversible damage to the vital organs.

      Hypotension during anesthesia is caused, though not entirely, by dehydration. There are a
      variety of non-invasive variables that are related to the severity of dehydration, but which
      of the variables can best predict anesthesia-induced hypotension in pediatric patients. In
      this study, we will measure the preoperative values of non-invasive variables related to
      fluid status, and find out which of them are most closely related to the occurrence of
      hypotension during anesthesia induction.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 3-6 years
      
Keywords: Dehydration
A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases
Condition: Atopic Healthy Subjects; Adult Subjects With Mild Allergic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, PK, and PD following
      subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild
      allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo
      group, or the omalizumab group.
    

Detailed description: 
      YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated
      allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum
      IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine
      release caused by degranulation when exposed to allergens Based on its non-clinical study
      results, this study aims to evaluate the safety, tolerability, PK, and PD following
      subcutaneous injections of YH35324 in atopic healthy subjects or subjects with mild allergic
      diseases.
    

Intervention name(s): YH35324; Placebo; Omalizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection of YH35324; Subcutaneous injection of None of active ingredient; Subcutaneous injection of Omalizumab
Other intervention name(s): Xolair® for injection
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: YH35324; GI-301; Allergic disease
Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of
      psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to
      check blood glucose levels can help improve blood glucose levels in teens with type 1
      diabetes.
    

Detailed description: 
      Glycemic control deteriorates during adolescence as parents become less involved in teens'
      diabetes management and adherence declines. Thus, there is a need to improve adherence and
      glycemic control in mid to older teens with type 1 diabetes by strengthening the teens'
      self-efficacy for daily diabetes self-management to help prepare them for the transition
      between pediatric and adult care. This 18-month, multi-center RCT is designed to increase
      frequency of blood glucose monitoring and improve glycemic control in teens with type 1
      diabetes through a behavioral intervention called Teenwork with or without text message
      reminders to check blood glucose levels.

      We will implement and evaluate the Teenwork intervention and text message reminders to check
      blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites,
      will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual
      Care.

      Participants in the Teenwork Group will meet with a research assistant during each study
      visit to review strategies for improving self-care, including self-management and
      self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration.
      Participants in the Text Message Group will be instructed in the use of the text messaging
      system. They will receive 2-way text message reminders to check blood glucose levels at
      self-selected times and to reply by text message with blood glucose results. Participants in
      the Teenwork/Text Message Group will receive both the Teenwork intervention and the text
      message reminders (as described above). Participants in the Usual Care Group will receive the
      same intervention as the Teenwork/Text Message Group, but not until after 1 year.
    

Intervention name(s): Teenwork intervention; Text message reminders
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration; Text message reminders to check blood glucose levels at self-selected times
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
Condition: Patients With Closed Neer Type 4 Proximal Humerus Fractures
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      The investigators tried to evaluate the results of our patients who underwent plate
      osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal
      humerus fractures.
    

Detailed description: 
      The risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is
      the most serious form of proximal humerus fracture.Bone impaction grafts are an important
      treatment option when osteosynthesis with LCP plate is desired especially for osteoporotic
      patients. Fibular strut grafts (FSGs) and autologous iliac bone impaction grafts (AIBIGs),
      which are frequently used to provide mechanical support, may have the risk of nonunion in
      osteoporotic bone whose vascular support is weakened due to fracture. Bone pedicled
      pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.
    

Intervention name(s): Pectoralis Major Pedicle Bone Graft
Intervention type(s): Procedure
Intervention description(s): It is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures. Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method. The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: proximal humerus; closed; fracture; bone pedicled graft
EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
Condition: Malignant Distal Biliary Obstruction
Study type: Interventional

Summary: 
      This research is being done to study the safety and feasibility of recruiting patients
      eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety
      and effectiveness of this procedure.
    

Detailed description: 
      Our central hypothesis is that EGBD is equally effective and safe to percutaneous
      transhepatic biliary drainage (PTBD) but is associated with better quality of life than PTBD
      in patients with inoperable malignant distal biliary obstruction who have failed prior ERCP.
      Furthermore, EGBD may be associated with decreased procedure-related costs. Patients who
      undergo PTBD usually require multiple procedures for stent exchange/upsize. Our initial study
      will be a prospective multicenter feasibility study that will include patients with
      inoperable distal biliary obstruction who have failed ERCP. If feasibility is demonstrated,
      our goal will be to compare EGBD and PTBD in a randomized multicenter international trial
      with a crossover design.
    

Intervention name(s): EUS-guided biliary drainage
Intervention type(s): Other
Intervention description(s): Based on the patient's condition, the will receive:
Rendezvous technique
Direct transluminal access transesophageal technique
Direct transluminal access transduodenal technique
or direct transluminal access using transgastric approach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EUS-Guided Biliary Drainage; Endoscopic retrograde cholangiopancreatography; Malignant Biliary Obstruction
The Effect of Video Training o Symptom Management With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this clinical study is to compare the effect of video-assisted training on the
      quality of life and symptom management of patients over the age of 65. The main questions it
      aims to answer are:

      -Is there a difference between symptom management and quality of life between the first and
      last follow-up periods of patients in the application and control groups?
    

Detailed description: 
      Heart failure is the primary disease of old age. 20% of the reasons for hospital admission
      for patients aged 65 and over are due to heart failure.The most common symptoms in patients
      with heart failure are; fatigue, weakness, dyspnea, orthopnea, paroxysmal nocturnal dyspnea,
      edema and changes in mental status.Due to these physical symptoms; there is a decrease in the
      functional capacity of patients, difficulty in performing daily life activities, inability to
      perform self-care, and the incidence of depression and anxiety increases.

      In symptom management of patients with heart failure; these include knowing the clinical
      course of the disease, adapting to the disease and treatment, monitoring symptoms, educating
      the patient on self-care, and regular follow-up after discharge.It is stated that with
      patient education given to individuals in a planned and regular manner, the frequency and
      severity of the symptoms experienced decreases, the management and control of the disease is
      ensured, and thus the patient's quality of life is increased by creating the necessary
      behavioral changes.Due to the increase in the number of internet users in patient education,
      web-based education becomes more prominent.Thanks to video training, patients will be able to
      experience a permanent learning process by accessing the training content wherever they want,
      as often as they want.
    

Intervention name(s): Training videos
Intervention type(s): Behavioral
Intervention description(s): After determining the application and control groups in the research, the purpose of the research was explained to both groups. The mobile phone usage skills of the individuals who will be included in the application group were evaluated with the Digital Literacy Scale. Training videos for 15 people each (30 minutes in total) regarding symptom management were shared on the phones of the patients/relatives in the application groups, and the patients and their relatives were informed and watched the training video. Data collection forms would be filled out before the application (Z0), on the 30th day of the application (Z1), and on the 90th day of the application (Z2).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It consists of two groups, application and control, and three follow-ups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Quality of Life; Geriatrics; Nursing