bioihbjkbjnl/mcl2 huggingface dataset:
Human Immunome Program
Condition: Healthy
Study type: Observational

Summary: 
      The Human Immunome Program is a large-scale, open-source effort seeking to fill a major gap
      in our knowledge of the immune system. The power of the immune system to fight disease lies
      in its ability recognize and adapt to an astonishing range of threats from viruses, parasites
      and bacteria to cancer cells. Underlying this ability is a vast but specific set of genes and
      molecular structures known as the human immunome, or the "parts list" of the immune system.
      This study aims to decipher the genetic sequences that make up this part list and link it to
      information about a person's microbiome composition and characteristics such as health
      history, race, and demographics over time. This information, made freely available to the
      public for use in research in de-identified form, will allow investigators to answer a wide
      variety of different questions about immune system function. This could transform how we
      diagnose, prevent and treat disease though the identification of new biomarkers while
      enabling highly targeted, computationally designed vaccines and therapies that reduce time
      and risk of product development.
    


Intervention name(s): Biospecimen and survey collection
Intervention type(s): Other
Intervention description(s): Blood, microbiota, surveys/questionnaires, electronic medical records.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers
      
Biospecimen description: 
      -  Peripheral blood mononuclear cell (PBMCs)

        -  Microbiome (stool, tongue, skin swabs)(optional)
    
Keywords: Immune system
Pulmonary Rehabilitation at Home Versus at the Gymnasium
Condition: COPD
Study type: Interventional

Summary: 
      Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality
      of life of chronic obstructive respiratory disease (COPD) patient is well known. However,
      there is an important gap between the scientific knowledge and the clinical use of pulmonary
      rehabilitation since a a very small number of patients benefit from this therapeutic
      intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have
      access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based
      rehabilitation program as a way to facilitate the access to rehabilitation.
    

Detailed description: 
      This article on the main outcome is available. Maltais F, Bourbeau J, Shapiro S, Lacasse Y,
      Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD,
      Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based
      pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized
      trial. Ann Int Med 2008;149:869-878.
    

Intervention name(s): Pulmonary rehabilitation (teaching and exercise)
Intervention type(s): Behavioral
Intervention description(s): After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: COPD; Exercise; Self-management; Rehabilitation; Quality of life; Health economy; Cost effectiveness; Health care utilization
A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the
      purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection
      to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic
      parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.
    


Intervention name(s): Midazolam; Ginkgolides Meglumine Injection; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Ginkgolides Meglumine Injection
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
Condition: Raynaud's Disease; Scleroderma; Autoimmune Diseases
MeSH terms: Raynaud Disease; Autoimmune Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to test the safety, tolerability, and effectiveness of
      Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase
      blood flow to the fingers.
    

Detailed description: 
      The purpose of this clinical study is to determine, in a controlled fashion, the ability of
      Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health
      assessment as indicated by patient and physician assessments, decrease the frequency of
      Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain,
      tingling, numbness) in the fingers of Raynaud's patients. The study will include patients
      with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary
      to autoimmune diseases such as scleroderma.
    

Intervention name(s): Topical AmphiMatrix with nitroglycerin (MQX-503)
Intervention type(s): Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Raynaud's
Theta-Burst Neuromodulation for PTSD
Condition: Chronic Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta
      Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD.
      Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome
      measures focusing on changes in PTSD symptom severity and quality of life and
      social/occupation functioning.
    

Detailed description: 
      The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial
      magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will
      result in development of methods needed to conduct an adequately powered, randomized
      controlled study of TBS for PTSD, which will assess the relationship between change in
      symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation
      studies combining neuromodulation and psychotherapy in the longer term.

      TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation
      (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter
      time period, and a stimulation pattern that may specifically affect key brain regions
      involved in PTSD. The significance of this research is the development of a novel,
      non-invasive brain stimulation approach for PTSD recovery. This project will provide the
      foundation for the development of methods needed to conduct an adequately powered, randomized
      controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can
      be combined with evidence-based psychotherapy, to develop a more powerful, individualized
      rehabilitation option for Veterans with PTSD.
    

Intervention name(s): Theta burst stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Theta burst transcranial magnetic stimulation; Sham Theta burst transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quality of Life; Post-Traumatic Stress Disorder; Transcranial Magnetic Stimulation; Feasibility studies
YouTube-Delivered Physical Activity Intervention
Condition: Healthy
Study type: Interventional

Summary: 
      This study will be an 8-week randomized controlled trial examining the effects of a
      YouTube-delivered aerobic and muscle strengthening physical activity intervention on
      university students' physical activity, fitness, sleep quality, and psychosocial health
      outcomes. Participants will be randomized into 1 of 2 groups: (1) intervention group (receive
      twice-weekly YouTube videos [1 aerobic workout video; 1 muscle-strengthening workout video]
      for 8 weeks); or (2) control group (receive twice-weekly YouTube videos with general health
      information [no physical activity-related information or workouts] for 8 weeks). Baseline (0
      weeks), mid-point (4 weeks), and post-test (8 weeks) testing will take place and the
      following outcome measures will be assessed at these time points: participants' free-living
      (7-day) objectively-measured physical activity and sleep quality data will be collected;
      anthropometric measures (height, weight, percent body fat); cardiorespiratory and muscular
      fitness; and psychosocial assessments (perceived physical activity barriers and social
      support).
    


Intervention name(s): YouTube-delivered aerobic and muscle-strengthening physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention group will receive two YouTube-delivered videos each week, for 8 weeks. In detail, on Monday, participants will receive an aerobic-based physical activity video with information and a workout to complete and on Thursdays, the participants will receive a video with muscle-strengthening physical activity information and a workout to complete.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: youtube; physical activity; fitness
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
Condition: Periodontitis; Periodontal Inflammation
MeSH terms: Periodontitis; Chronic Periodontitis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      For proving the potential of tropical medicaments on clinical parameters of periodontitis, a
      comprehensive assessment is required between therapeutic medicaments. The main aim of the
      study was to clinically evaluate and compare the efficacy of indocyanine green mediated
      photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to
      scaling and root planning (SRP) for treatment of chronic periodontitis.

      One hundred and fifty patients included in this study were randomly distributed in three
      treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical
      parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and
      clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th
      month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and
      TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent
      assay (ELISA) technique.
    


Intervention name(s): Plant extract
Intervention type(s): Combination Product
Intervention description(s): Natural plant extract
Other intervention name(s): Aloe Vera
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients
Condition: Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      Design and Outcomes This research study is designed as open-label, sequential dose-escalating
      clinical trial. There will be two phases of enrollment.

      In the first phase, pediatric dengue patients with body weight greater than 30 kg will be
      recruited. The first six volunteers will be administered with 400 μg/kg every 24 hours for a
      total of three times. The last six volunteers will be administered with 600 μg/kg every 24
      hours for a total of three times.

      In the second phase, pediatric dengue patients with body weight between 15 to 30 kg will be
      recruited. Similar to the first phase, the first six and the last six volunteers will be
      administered with 400 μg/kg and 600 μg/kg every 24 hours for a total of three times,
      respectively.

      A total of 24 volunteers will be recruited from Faculty of Medicine Siriraj hospitals
    

Detailed description: 
      The research team has planned to conduct three interim analyses for safety and one final
      report. The interim analyses will be conducted as follows:

        1. First interim analysis: After the completion of the last volunteer of the group with
           body weight >30 kg receiving ivermectin 400 μg/kg every 24 hours for a total of three
           times (i.e. the sixth volunteer).

        2. Second interim analysis: After the completion of the last volunteer of the group with
           body weight >30 kg receiving ivermectin 600 μg/kg every 24 hours for a total of three
           times (i.e. the twelfth volunteer).

        3. Third interim analysis: After the completion of the last volunteer of the group with
           body weight 15 to 30 kg receiving ivermectin 400 μg/kg every 24 hours for a total of
           three times (i.e. the twelfth volunteer).

      The results of each interim analyses will be submitted to DSMB to determine whether the study
      is safe to be conducted in the next group of volunteers. Additionally, the results of interim
      analyses and the safety assessments from DSMB will be submitted to all ECs
    

Intervention name(s): Ivermectin
Intervention type(s): Drug
Intervention description(s): Ivermectin once every 24 hours for three administrations
Intervention MeSH terms: Ivermectin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is open-labe randomized multicenter comparative Phase III study conducted in 11 medical
      facilities. The objective of the study is to evaluate efficacy and safety of the drug
      JTBC00201, tablets in the setting of pathogenetic and symptomatic therapy as compared to
      standard therapy in outpatients with COVID-19.
    

Detailed description: 
      Upon signing the informed consent form and screening, 264 eligible outpatients with mild or
      moderate COVID-19 were randomized at a 1:1 ratio to receive either nirmatrelvir/ritonavir
      tablets, 300/100 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC
    

Intervention name(s): nirmatrelvir/ritonavir; Standard of care
Intervention type(s): Drug; Drug
Intervention description(s): Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days; The administration of 'Standard of care' drugs was done according to the regimen recommended in the 'COVID-19 TreatmentGuidelines' validated at the time of the study
Other intervention name(s): JTBC00201
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Nirmatrelvir and ritonavir drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nirmatrelvir/ritonavir; Skayvira; SARS-CoV-2
Efficacy of Tinoridine in Treating Pain and Inflammation in Adults
Condition: Pain; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL), three
      times daily (TID), in the treatment of pain and inflammation in patients with acute
      tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.
    

Detailed description: 
      Tonsillitis and pharyngitis are the most common upper respiratory tract infections. The signs
      and symptoms are sore throat, difficulty with swallowing and/or inflamed tonsils and/or
      pharynx. In most cases these infections are viral in origin.

      Tinoridine is a nonsteroid anti-inflammatory drug with a different mechanism of action than
      common nonsteroidal anti-inflammatory drugs (NSAIDs), which act by inhibiting the
      cyclooxygenase enzyme and thereby inhibit the synthesis of prostaglandins.

      The purpose of this study is to confirm the efficacy of tinoridine in the treatment of pain
      and inflammation in patients with acute tonsillitis and/or acute pharyngitis of nonbacterial
      origin versus placebo.
    

Intervention name(s): Tinoridine HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.; Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.
Other intervention name(s): Nonflamin
Intervention MeSH terms: Tinoridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillitis; Pharyngitis; Sore Throat; Drug Therapy
Role of Pancreatic Triglyceride Content in Beta-cell Function
Condition: Obesity; Type 2 Diabetes
Study type: Observational

Summary: 
      The study evaluates if fat accumulates in the pancreas in individuals at risk of developing
      obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict
      the residual functional capacity of the pancreas (insulin secretion).
    


Intervention name(s): No intervention planned.
Intervention type(s): Other
Intervention description(s): This is a cross-sectional observational study, no intervention is planned.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We enroll adult volunteers of all ethnicities who have no contraindications to the study
        procedures or use medications that interfere with our measurements.
Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a blinded observer randomized controlled trial comparing two nebulizer devices. The
      objective of this study is to evaluate the efficacy of two different nebulizers.
    

Detailed description: 
      The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will
      lead to statistically greater improvement in FEV1 when compared to an equivalent dose
      delivered via a standard t-piece nebulizer. The primary aim will be to study changes in
      forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric
      emergency department with a moderate to severe acute asthma exacerbation when utilizing these
      two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency
      department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes,
      medication side effects, and total quantity of albuterol given in the ED. A distal aim of the
      study will be to perform a cost analysis; though the investigators will likely need further
      clinical trials utilizing multiple dose administration in order to accurately analyze cost.
    

Intervention name(s): T-Piece Nebulizer; Breath-Enhanced Nebulizer; Albuterol; Pre-Treatment Spirometry Measurement; Post-Treatment Spirometry Measurement
Intervention type(s): Device; Device; Drug; Procedure; Procedure
Intervention description(s): Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ); Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA); One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.; Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.; Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.
Other intervention name(s): albuterol sulfate
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation
Condition: Speech Disorders
MeSH terms: Speech Disorders
Study type: Interventional

Summary: 
      Speech is a privileged means of communication for humans: its trouble can thus prove being
      extremely handicapping. Standard speech therapy is limited in some cases by the lack of
      sensory feedback available to the patient (hearing, surgery, neural damage, etc.).

      The present study aims at quantify the contribution of the tongue articulatory visual
      feedback offered by ultrasound echography to speech trouble rehabilitation.

      Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and
      10 childrens with important speech troubles due to central nervous system damage.

      The principle is to conduct standard speech therapy sessions, alternating series of sessions
      with the use of visual feedback and sessions without visual feedback.

      The progress will be regularly measured by means of standard batteries of speech articulation
      tests.
    


Intervention name(s): Visual feedback
Intervention type(s): Device
Intervention description(s): Use of ultrasound echography for tongue articulatory visual feedback
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Speech disorders; Speech therapy; Visual feedback; Buccopharyngeal surgery; Central nervous system damage