bioihbjkbjnl/mcl2 huggingface dataset:
CBT vs. ABM vs. for Social Anxiety
Condition: Social Phobia
MeSH terms: Phobia, Social
Study type: Interventional

Summary: 
      Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual
      cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).

      Outcome measures will be social anxiety symptoms and severity as measured by gold standard
      questionnaires as well as diagnosis of social anxiety disorder derived from structured
      clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.

      The investigators expect to find significant reduction in social anxiety symptoms in all of
      the groups, with the cognitive behavior therapy group showing greater reduction in symptoms
      than the other groups. Mechanisms of change in all of the groups will be examined via
      measures of cognitive biases, affect, and other common and specific factors.
    

Detailed description: 
      120 Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an
      individual cognitive behavior therapy (CBT), attention bias modification treatment (ABM)).

      Outcome measures will be social anxiety symptoms and severity as measured by gold standard
      questionnaires as well as diagnosis of social anxiety disorder derived from structured
      clinical interviews based on DSM-IV criteria.

      The investigators expect to find significant reduction in social anxiety symptoms in all of
      the groups, with the cognitive behavior therapy group showing greater reduction in symptoms
      than the other groups. Mechanisms of change in all of the groups will be examined via
      measures of cognitive biases, affect, and other common and specific factors.
    

Intervention name(s): Attention Bias Modification (ABM); Cognitive Behavior Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.; CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Very Low Nicotine Cigarettes in Smokers With Schizophrenia
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Smokers with serious mental illness including those with schizophrenia and bipolar disorder
      infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter
      lifespan due to smoking-related illness. This study will examine whether reducing the
      nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking
      in smokers with serious mental illness. Smokers will be randomized to one of two experimental
      conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content
      (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of
      exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms),
      psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
    


Intervention name(s): Very low nicotine content cigarettes; standard nicotine content cigarettes
Intervention type(s): Other; Other
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Gemcitabine in Treating Children With Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I trial to study the effectiveness of gemcitabine in treating children who have
      refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells
      from dividing so they stop growing or die.
    

Detailed description: 
      OBJECTIVES:

      I. Estimate the maximum tolerated dose of gemcitabine in children and adolescents with
      refractory solid tumors.

      II. Assess the toxicity of gemcitabine in this patient population. III. Determine the
      pharmacokinetic profile of gemcitabine in male and female children and adolescents.

      IV. Assess the antitumor activity of gemcitabine within a phase I study.

      OUTLINE: This is a dose escalation study.

      Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving
      objective response or stable disease after 3 weeks may receive additional courses of therapy
      every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
      patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is
      determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients
      experience dose limiting toxicity. Patients are followed at week 4 and then every 6 months
      until death.
    

Intervention name(s): gemcitabine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
Effects of Ground-based Walking Training in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined
      as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms
      such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise
      capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It
      is recommended that patients with PH should be included in cardiopulmonary rehabilitation
      programs in addition to medical treatment. Ground-based walking training is a safe and
      effective method for COPD patients. In the literature, there are no studies evaluating the
      effects of ground-based walking training in PH patients.
    

Detailed description: 
      The aim of this project is to determine the effect of ground-based walking training on
      physical activity, exercise capacity, balance, peripheral muscle strength and quality of life
      in patients with PH.
    

Intervention name(s): Ground-based walking training
Intervention type(s): Other
Intervention description(s): Patients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pulmonary Hypertension; Walking Training; Exercise; Balance; Quality of Life
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
Condition: Aspergillosis, Aspergilloma
MeSH terms: Infections; Mycoses; Aspergillosis
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study we will measure the concentration of the drug called voriconazole which is used
      to fight infections caused by fungus in children who usually are cancer patients and have
      their immune system down. Since we know the dose in adults, and we think we know the matching
      doses in the young patients ages 2 to less than 15 years old, we will compare the amount of
      drug that goes into the system with what we know works in adults. We give the drug by a
      needle directly into the blood, then few days later we stop that and give the drug by mouth.
      Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.
    


Intervention name(s): Voriconazole; Voriconazole
Intervention type(s): Drug; Drug
Intervention description(s): Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.
Notes:
If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
(IV = Intravenous; POS = Powder for oral suspension); Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.
Notes:
If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
(IV = Intravenous; POS = Powder for oral suspension)
Other intervention name(s): UK-109,496; Vfend; Voriconazole; UK-109,496; Vfend; Voriconazole
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Open-Label; Pharmacokinetics; Intravenous to oral switch; Safety; Voriconazole; Immunocompromise; Children; High Risk For Systemic Fungal Infection
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This proposal will evaluate a potential mechanism of increased risk of lung function
      impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this
      pathway. This study will improve the understanding of factors which can lead to chronic lung
      disease. If effective, this application would also provide the justification to study vitamin
      D as a therapy to improve lung health.
    

Detailed description: 
      Understanding mechanisms leading to decrements in lung function, the physiologic hallmark of
      obstructive lung diseases including chronic obstructive pulmonary disease (COPD), are
      necessary to inform interventions to improve lung health. The antimicrobial peptide
      cathelicidin, and its primary regulator vitamin D, has been implicated in development and
      progression of chronic lung disease. In this study, the investigators will evaluate the
      effect of oral vitamin D supplementation on lung cathelicidin levels in humans. Cathelicidin
      has bactericidal and inflammatory activities in the lung and is regulated by vitamin D
      levels. The investigators hypothesize that oral vitamin D supplementation will raise
      cathelicidin levels in the pulmonary compartment, thereby restoring lung cathelicidin
      deficiency. To test this hypothesis, the investigators will recruit from two ongoing cohort
      studies: 1) At Johns Hopkins, the Subpopulations and Intermediate Outcome Measures in COPD
      Study study and 2)at University of North Carolina at Chapel Hill pulmonary and general
      medicine clinic. The investigators will measure blood and lung lavage cathelicidin levels in
      40 vitamin D insufficient individuals (20 from each cohort) before and after eight weeks of
      oral vitamin D supplementation to determine the effect of vitamin D supplementation on
      cathelicidin levels.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cathelicidin; Vitamin D
An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients

        2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
    

Detailed description: 
      The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese
      hypertriglyceridemia patients.
    

Intervention name(s): Omacor®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in 4 g and 2 g Omacor® will take this drug; Subjects in placebo group will take this drug
Other intervention name(s): Omega-3-acid ethyl ester 90; Olive oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertriglyceridemia, omega-3-acid ethyl ester
Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention
      for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on
      improving management of bipolar disorder, reducing involvement in high-risk behaviors, and
      enhancing psychosocial functioning. The intervention also focuses on issues specific to
      transition-age youth. The study includes two phases: In phase 1, the intervention will be
      developed, refined, and openly piloted with several participants. In phase 2,the
      investigators will conduct a randomized clinical trial, in which 40 participants will be
      randomized either to receive the intervention right away, or to a 14-week waitlist condition.
      Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period,
      as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors,
      drug and alcohol use, and psychosocial functioning.
    


Intervention name(s): cognitive-behavior therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): 14 sessions of individual cognitive-behavior therapy. Sessions last 50-60 minutes and are held weekly. 2 optional monthly booster sessions may also be held after the end of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; cognitive behavior therapy; alcohol abuse; drug abuse; high risk behaviors; medication adherence; psychosocial functioning
The Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization on Patients With Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      In this study, it was aimed to examine the effects of two different treatments applied to the
      neck region, which have been popular in recent years, on migraine.The study included 45
      female patients aged 20-50 years with migraine complaints. The patients were divided into 3
      randomized groups: control group (n=15), Instrument-Assisted Soft tissue Mobilization (EDYDM)
      group (n=15) and on Occipital nerve TENS (OTES) group(n=15).Each group was given home
      exercise to their treatment. Home exercises applied 1 time per day for 5 weeks. Each exercise
      in the exercise program was performed with 10 repetitions
    


Intervention name(s): IASTM; home exercise; Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
Intervention type(s): Other; Other; Device
Intervention description(s): instrument-assisted soft tissue mobilization; home exercise; OTES (Occipital Transcutenous Electric Stimulation)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Diode Laser 940 nm in Management of Loss of Taste Sensation
Condition: SARS-CoV Infection
MeSH terms: Infections; Severe Acute Respiratory Syndrome; Ageusia
Study type: Interventional

Summary: 
      The global pandemic has recently emerged by transmission of SARS-CoV2 virus. The virus has
      had a massive impact on health, wealth and social aspects worldwide. Since the identification
      of this virus in Wuhan, China, millions of cases has been diagnosed worldwide with mortality
      rates ranging from 3% to 12 %
    

Detailed description: 
      'Long COVID' is emerging as a phenomenon where patients have long-term unresolved symptoms
      (8,9). These could be prolonged symptoms of SARS-CoV2 or a posteSARS-CoV2 syndrome for which
      dysfunction of smell and taste sensation has been proposed.

      The proposal presents the diode laser 940 as possible treatment for the loss of taste
      sensation in patients with long SARS-CoV2. The effect of low levels of laser energy was first
      discovered by Dr Endre Mester in 1967.5 Since then it has been used for various applications
      in the field of medicine and dentistry and is broadly termed 'low level laser therapy'(LLLT)
      or 'biostimulation' or 'phototherapy'. It is defined as a 'non-thermal' laser light
      application using photons (light energy) from the visible and infrared spectrum for tissue
      healing and pain reduction (North American Association of Laser Therapy-NAALT). Several in
      vitro studies have demonstrated that the effects of laser light on wound healing are much
      greater than obtained with light from other sources, such as light-emitting diodes
      (LEDs).(10-13)
    

Intervention name(s): a 940-nm diode laser
Intervention type(s): Device
Intervention description(s): a 940-nm diode laser (EPIC™, BIOLASE, www.biolase.com) with an adjustable pain therapy handpiece capable of creating diffuse laser energy patterns ranging from 15 mm to 30 mm in size.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with SARS-CoV2 infection confirmed with PCR with loss of taste sensation
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV; , loss of taste; , Diode laser
Efficacy, Immunogenicity and Safety of Inactivated ERUCOV-VAC Compared With Placebo in COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective is to determine the efficacy, immunogenicity and safety of two different
      strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to
      demonstrate the efficacy and safety in prophylaxis of COVID-19. A 3rd application will be
      performed to approximately the half of the volunteers who were administered 3 μg/0.5 ml and
      who accept to be vaccinated for a 3rd time, on their month 4 visit.
    


Intervention name(s): ERUCOV-VAC 3 µg/0.5 ml Vaccine; ERUCOV-VAC 6 µg/0.5 ml Vaccine; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Two IM applications on Days 1 and 28; Two IM applications on Days 1 and 28; Two IM applications on Days 1 and 28
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; Vaccine; Inactive; Phase 2
Water Consumption, Hydration and Resting Energy Expenditure
Condition: Hydration and Resting Metabolism
Study type: Interventional

Summary: 
      A randomized, cross over study will assess the effects of ingestion of high and low volumes
      of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water
      250ml. Participants will be computer randomized to determine which volume of water to receive
      first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and
      7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any
      food or drink after 10pm the night before the assessment. Participants will also be asked to
      abstain from alcohol and caffeine for 3 days before the assessment. After verification of
      eligibility, baseline REE will be measured for 30 minutes followed by administration of first
      assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and
      heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period,
      participants will return for their second test day where the second dose of water will be
      administered. A 7-10 day washout period was selected to allow participants time to resume
      normal diet and hydration between visits.
    


Intervention name(s): water intake
Intervention type(s): Other
Intervention description(s): After an overnight fast participants' RMR will be measured by indirect calorimetry for 30 minutes after which either a low (250ml) or high (500ml) dose of water will be consumed followed by an additional 90 minutes of indirect calorimetry. The test day will be repeated after 7-10 days with the second dose of water. The order in which the dose of water will be consumed will be randomized
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: RMR; hydration; substrate oxidation