bioihbjkbjnl/mcl2 huggingface dataset:
Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.
Condition: Anxiety; Depression, Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This is a randomized-controlled interventional treatment study with three arms of comparable
      demographics to evaluate the safety and efficacy of OVR Health's VR experience to improve
      control over the focus of attention and reduce worry and rumination in individuals who have
      reported problems with these issues.
    


Intervention name(s): OVR Health's VR experience
Intervention type(s): Device
Intervention description(s): Virtual reality experience
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Virtual reality
Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid
      (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly,
      nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting
      data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to
      determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization
      at high temperature in comparison to tobacco cigarette smoking on several advanced
      cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers.
      Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be
      quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative
      stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the
      first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco
      cigarette smoking on the cardiovascular system in relation to vaporization temperature,
      nicotine delivery and oxidative stress.

      Aims of the study: This study tests the following hypotheses: 1) acute high temperature
      vaporization of propylene glycol and vegetable glycerin has no deleterious effects on
      cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma
      and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping
      don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases
      superoxide anion production.
    


Intervention name(s): e-cigarette (PG+VG without nicotine; low temperature); e-cigarette (PG+VG with nicotine; low temperature); e-cigarette (PG+VG without nicotine; high temperature); e-cigarette (PG+VG with nicotine; high temperature); tobacco cigarette
Intervention type(s): Device; Device; Device; Device; Other
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: electronic cigarette; e-cigarette; oxidative stress; tobacco smoking
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
Condition: Grass Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to asses efficacy and safety of a sublingual extract of a six grass
      pollen mixture
    


Intervention name(s): Grass pollen formulation; Comparator
Intervention type(s): Biological; Other
Intervention description(s): Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.; Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Other intervention name(s): specific immunotherapy; Specific Immunotherapy
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Rhinoconjunctivitis; Rhinitis; Asthma
ACP-104 in Acutely Psychotic Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study,
      evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia
      who are experiencing an acute psychotic episode.
    


Intervention name(s): ACP-104; ACP-104; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg, tablet, BID, 6 weeks; 100 mg, tablet, BID, 6 weeks; placebo, tablet BID, 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia, psychotic disorders
Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory
      response and alter the diversity of periodontal disease. In recent years, various
      host-response modulation therapies have been developed to block the pathways responsible for
      periodontal tissue breakdown.

      There have been significant changes with respect to the effectiveness of, and attitudes
      towards conventional antimicrobial therapy to combat disease. With the threat of widespread
      antibiotic resistance rendering many antibiotics useless against important diseases, there is
      an increased necessity not only to minimise antibiotic use and develop novel
      non-antibiotic-based treatments, but also to raise the profile of disease prevention. One
      approach that has gained interest over recent years is the use of probiotic bacteria for oral
      applications. The rationale for their use in oral health care stems from the increase in
      evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an
      important role in the maintenance of health by stimulating the natural immunity as well as by
      contributing to the balance of the microflora, by interacting with the other members of the
      flora. The application of health promoting bacteria for therapeutic purposes, is one of the
      strongest emerging fields. Time has come to shift the paradigm of the treatment from specific
      bacteria elimination to alteration of the bacterial ecology by using probiotics.

      So the purpose of this study is to discover a more promising approach for the treatment of
      chronic periodontitis .
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2; Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Other intervention name(s): L. brevis CD2 Lozenges
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Condition: Primary Progressive Aphasia
MeSH terms: Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the feasibility of a program of remotely supervised
      transcranial direct current stimulation (RS-tDCS) paired with language skills practice for
      people living with the semantic or logopenic variants of primary progressive aphasia (PPA).
      There are currently no established standard-of-care treatments for PPA. This study will
      evaluate whether RS-tDCS combined with language skills practice is a feasible study design
      for individuals with PPA.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS); Word-Naming Activity
Intervention type(s): Device; Behavioral
Intervention description(s): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through scalp sponge electrodes. The device is preprogrammed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout session (29 minutes), and then ramp down (for 30 seconds) at the end.; During each tDCS session, the tDCS clinician will guide the participant in a word-naming exercise. Participants will be presented with photos of target items and prompted to verbally produce the names of the pictures.
Other intervention name(s): Soterix Medical mini-CT Model 1601-LTE Stimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation (tDCS)
A Study of Anti-HIV Monoclonal Antibody KD-247
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247
      over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters
      of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma
      HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.
    

Detailed description: 
      A minimum of 6 active subjects and 3 placebo subjects for each dose cohort will complete 2
      weeks of infusions. A maximum of 27 total subjects will be dosed with KD-247 and up to 9
      total will receive placebo. Per cohort subjects randomized to active treatment will receive
      iv infusions of KD 247 over 2 hours at each dosing visit. Subjects randomized to placebo will
      receive 2-hour iv infusions of saline solution at each dosing visit. Following the first
      infusion of KD-247 (or placebo) for each subject in the study, there will be a 24-hour
      in-patient observation period before the next subject can be randomized within the study.
      Dose escalation will proceed only after safety data through Day 18 for all subjects in the
      lower-dose cohort is reviewed.
    

Intervention name(s): KD-247; Physiological saline
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1 - 4 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 2 - 8 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 3 - 16 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 1 - Physiological saline IV on Days 1, 8, and 15; Cohort 2 - Physiological saline IV on Days 1, 8, and 15; Cohort 3 - Physiological saline IV on Days 1, 8, and 15
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; monoclonal antibody; KD-247; treatment naive
Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there
      is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the
      airways
    

Detailed description: 
      Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.

      1a) Determine the effects of systemic corticosteroids on breath pH in children with severe
      and mild to moderate asthma.

      1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict
      clinical outcomes in children with severe and mild to moderate asthma.

      1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway
      glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH
      disturbance in children with severe asthma.

      1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more
      frequent in children with severe asthma than in children with mild to moderate asthma.

      1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in
      children with severe asthma and mild to moderate asthma.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of children with physician-diagnosed asthma in the Atlanta,
        Georgia area across a wide range of asthma severities (mild, moderate, severe)
      
Keywords: severe asthma; poorly controlled asthma
EMA-Defined Tinnitus Subgroups
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this research study is to test a new way of measuring the severity of tinnitus
      using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the
      relationship with this tool with another widely used questionnaire. Previous studies we have
      done suggest there are different patterns of tinnitus bother; we plan to explore how often
      these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want
      to test how reliable this type of testing is for measuring the amount of bother people
      experience from their tinnitus.

      Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.

      Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of
      bother individuals have from tinnitus.
    

Detailed description: 
      You to need to complete this brief survey to determine if you meet the criteria for
      participation in the study. You are free to skip any questions that you prefer not to answer.
      We will only use the information you provide in this survey to determine if you qualify for
      the EMA-Defined Tinnitus Subgroups study.

      To be in this study, you will be required to have a smart phone that can receive text
      messages, is connected to the internet, and will allow you to connect via the internet to a
      Washington University secure server. It is necessary to connect to the Washington University
      server in order to complete a short survey four times a day for two separate two-week
      periods.

      The study involves us sending you text messages at 4 random times during the day, between the
      hours of 8: 00 am - 9: 00 pm. The texts prompt you to click on a link and respond to a short
      EMA survey regarding what you are doing, what your environment is, and how your tinnitus is
      at that moment. These text messages will be sent daily for two weeks. Then you will have two
      weeks off. Finally you will again receive the text messages asking for you to respond to the
      survey for two more weeks. You will receive a total of 112 text messages over four weeks. In
      addition we will send you four emails or texts asking you to complete a survey at the
      following times: before you complete your first set of EMA surveys, at the end of the first
      set EMA surveys, prior to starting the second set of EMA surveys, and a final time after you
      have completed the final EMA survey. This study requires no visits to Washington University.

      In order to participate you must complete this short prescreening survey to see if you
      qualify.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from Otolaryngology Clinics and from Tinnitus Support Groups
      
Keywords: Tinnitus; EMA; Bothersome
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction
Condition: Musculoskeletal Cancer; Sarcoma,Soft Tissue
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study intends to determine if any correlation exists between administration of TXA or
      not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood
      loss and blood transfusion rates.
    

Detailed description: 
      Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a
      significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is
      an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most
      often arthroplasty. The aim of this study is to determine in a randomized controlled fashion
      if there is any difference in perioperative blood loss and blood transfusion rates when TXA
      is used compared to when it is not used in patients undergoing radical resection of bone and
      soft tissue sarcomas with endoprosthetic reconstruction.
    

Intervention name(s): Tranexamic Acid (TXA)
Intervention type(s): Drug
Intervention description(s): Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to one of four groups. One group is the bony tumor treated with TXA, second group is the bony tumor treated without TXA, third group is the soft tissue sarcoma treated with TXA, and the fourth group is soft tissue sarcoma treated without TXA.
Masking: Single (Participant)
Primary purpose: Treatment
NeuroQore rTMS (Monophasic vs. Biphasic) for Major Depressive Disorder: A Randomized Controlled Pilot Trial
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Major depressive disorder (MDD) is a debilitating illness that affects millions of
      individuals in North America and can result in clinical symptoms including loss of pleasure
      and feelings of worthlessness, in addition to significant cognitive impairments (e.g.,
      memory, attention) that affect daily functioning. Major depression bears a heavy burden for
      the individuals and family members afflicted, as well as an enormous health care and economic
      cost. Approximately half of major depressive patients seek out treatment for their illness
      and only 20% of those individuals report their treatment as satisfactory. Many MDD patients
      do not respond to pharmacological therapy following the first course of treatment, resulting
      in the need for alternative measures to alleviate the clinical and cognitive symptoms of
      treatment-resistant depression and the targeting of these therapies to better suit each
      individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted,
      non-invasive technique that utilizes currents to induce electrical fields that excite
      specific brain regions. The current recommended practice of rTMS involves the administration
      of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove
      more effective for the treatment of depression. The present study aims to determine the
      effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients
      through electrophysiological recordings of the brain taken before and after 6 weeks of
      stimulation. Additionally, the study aims to investigate various biological markers linked to
      clinical rTMS response; these brain markers will help in personalizing treatment for
      individuals suffering from MDD.
    


Intervention name(s): NeuroQore rTMS Device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic
      potential of quetiapine fumarate (SEROQUEL) compared with that of a putative
      non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being
      conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic
      potential.
    


Intervention name(s): quetiapine fumarate; risperidone
Intervention type(s): Drug; Drug
Intervention description(s): flexible dose oral; flexible dose oral
Other intervention name(s): Seroquel; ICI 204,636
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy
      subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's
      disease.
    


Intervention name(s): AMG 181; Placebo for AMG 181
Intervention type(s): Drug; Other
Intervention description(s): Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.; Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment