bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative
      oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted
      conditions.
    


Intervention name(s): Seltorexant 40 mg; Seltorexant 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.; Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine
Condition: Guillain-Barre Syndrome
MeSH terms: Guillain-Barre Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      In developed countries, Guillain-Barre Syndrome (GBS) is the most common cause of acute
      neuromuscular paralysis, afflicting about 5,000 persons annually in the United States. Over
      20% of GBS patients have permanent residual motor deficits that affect their activities of
      daily living.

      The goal of this study is to assess the potential usefulness and safety of 4-aminopyridine
      (4-AP) in those patients who suffer chronic functional deficits from GBS.This medication is a
      potassium channel blocker that has the potential to improve nerve conduction, particularly
      across partially demyelinated axons. It is felt that by increasing nerve conduction there
      will be improved motor performance for walking and activities of daily living, as well as
      decreased fatiguability. This medication has demonstrated potential usefulness in central
      demyelinating diseases such as multiple sclerosis.Because the peripheral nervous system is
      much more accessible to systemic medication delivery it is felt that this medication may
      improve the functional status of those patients who are suffering from the residual side
      effects of this medication.
    

Detailed description: 
      Objective.- To determine the safety and efficacy of orally delivered 4-aminopyridine for
      motor weakness due to Guillain-Barre Syndrome (GBS) under a FDA approved protocol (IND No:
      58,029).

      Setting.- Tertiary care outpatient rehabilitation center directly attached to a university
      hospital.

      Subjects.- Subjects who are unable to ambulate more than 200 feet without assistive devices
      and have residual nonprogressive motor weakness due to GBS more than one year out from the
      initial episode.

      Design.- Subjects will be randomized to a double-blind, placebo-controlled, cross-over
      design, which had two eight-week treatment arms with a three-week washout. The average dosage
      at 4 weeks will be 30 milligrams (mg) per day.

      Patients who demonstrate improvement will be continued on the medication for an additional
      three months. Assessments will be performed every two weeks during the randomized trial and
      every month for those continued for up to three months on the medication.
    

Intervention name(s): 4-aminopyridine (4-AP)
Intervention type(s): Drug
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: Guillain Barre Syndrome; 4-aminopyridine
Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers
Condition: Deficiency of Vitamin D3
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day
      for 12 weeks can be used to normalize vitamin d-Status
    

Detailed description: 
      It is the objective of this study to investigate whether a supplementation with Vitamin D3
      can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk
      factors such as hypertension, inflammation and hyperlipidemia. The research question is
      whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an
      effect on blood lipids.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): daily dosage of 20 µg Vitamin D3 for 12 weeks
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
Condition: Fat Burn
Study type: Interventional

Summary: 
      This study will evaluate the clinical safety and the performance of the BTL-899 device during
      the treatment of upper arms.
    

Detailed description: 
      The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy
      (reduction of excess adipose tissue) will be assessed via correct identification of
      pre-treatment and 3-months follow-up images by at least two out of three independent blinded
      evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and
      satisfaction will be assessed via standard questionnaires.

      Safety measures will include documentation of adverse events (AE) during and after the
      procedures.
    

Intervention name(s): BTL-899
Intervention type(s): Device
Intervention description(s): Treatment with study device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that
      is not treated properly can reduce quality of life. Programs to help AYA learn to live with
      and manage pain are very important. Our team is developing a smartphone application (app) and
      website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood,
      activities, and exercise and help AYA set and achieve goals. The website will give
      information about pain and how to manage it independently. We will build the program and make
      sure it is easy to use and understand. We will also test if the program can be put into
      practice as planned and if AYA using the program feel less pain, have less limitations, and a
      better quality of life.
    


Intervention name(s): iCanCope app and website; Attention control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to standard medical care, adolescents and young adults in the experimental group will receive access to the "iCanCope with Pain" smartphone app and website for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component. The website provides chronic pain-specific education, self-management strategies, and resources.; The control group is designed to control for the potential effects on outcomes of time, attention, smartphone and computer use during the intervention. In addition to standard medical care, adolescents and young adults in the attention control group will receive access to the "iCanCope with Pain" smartphone app (control version, with limited functionality), and a pain resource website without access to self-management strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI
      (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus
      glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine
      beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993
      200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of
      lung functions parameters and rate of exacerbations, as well as to assess its safety and some
      health economics outcomes.
    


Intervention name(s): CHF 5993 200/6/12.5 µg; CHF 1535 200/6 µg; CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, Anticholinergics, Triple combination
Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to investigate the effects of a 12 week course of intravenous QAX576
      6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients
      by 75% or greater when compared with baseline.
    


Intervention name(s): QAX576 placebo; QAX576
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Esophagitis; Digestive System Diseases; Esophageal disorder; Eosinophilic esophagitis
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
Condition: Alcohol Use Disorder (AUD); Substance Use Disorders
MeSH terms: Substance-Related Disorders; Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to validate W-SUDs as a digitally-delivered substance use disorder program
      through a fully-powered randomized control trial that will test the comparative efficacy of
      the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative
      to a psychoeducation control condition, which has no cognitive behavioral therapy and the
      content is not delivered through a conversational user interface.
    

Detailed description: 
      Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a
      psychoeducation control condition. Primary outcomes will be measures of the quantity and
      frequency of substance use including number of substance use occasions, heavy drinking days
      (if applicable) and percent of days abstinent. Additionally, Phase II will evaluate whether
      W-SUDs results in a greater reduction in substance-related problems compared to a
      psychoeducation control group and explore if engagement with W-SUDs, relative to
      psychoeducation control,

        1. improves symptoms of depression and anxiety;

        2. improves work productivity (i.e. reduce presenteeism/absenteeism);

        3. reduces cravings;

        4. improves situational confidence to resist substance use.
    

Intervention name(s): W-SUDs; Digitally-delivered Psychoeducation
Intervention type(s): Device; Other
Intervention description(s): Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.; A form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alcohol Use Disorder; Substance Use Disorder; AUD; SUD; AUD Treatment; SUD Treatment; Smartphone Application; Digital Therapeutic; Alcohol Use Disorder Treatment; Substance Use Disorder Treatment
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label extension study for patients who participated in the BPS-MR-PAH-201
      study.
    

Detailed description: 
      This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and
      have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return
      to the clinic following enrollment in the study at 3, 6, and 12 months, and annually
      thereafter for assessment.

      Currently enrolled patients may be invited to participate in an optional four times daily
      (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the
      main study. Patients will return to the clinic for baseline visit, week 12, and then will
      follow the visit schedule provided to them in BPS-MR-PAH-202 main study.
    

Intervention name(s): Beraprost Sodium Modified Release
Intervention type(s): Drug
Other intervention name(s): BPS-MR Tablets, 60 mcg; Beraprost Sodium Modified Release Tablet, 60 mcg
Intervention MeSH terms: Epoprostenol; Beraprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis
Condition: Secondary-progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess the efficacy of Mayzent on microglia pathology in patients with active SPMS, as
      compared to the active control group of MS patients treated with the Ocrevus, as measured by
      changes in microglial activation in the lesional and non-lesional NAWM and NAGM and in the
      peri-plaque area of chronic lesions in the brain.
    

Detailed description: 
      Multiple sclerosis (MS) is primarily a demyelinating disease of the central nervous system
      (CNS), but many patients also undergo progressive atrophy, especially in the gray matter
      (GM). GM atrophy plays a particularly prominent role in development of cognitive and physical
      disability in MS. Evidence is mounting that there is a profound infiltration of activated
      microglia and blood-borne macrophages throughout the lesions, whereas in slowly expanding
      (smoldering) or chronic active expanding lesions, the microglia and macrophages are
      concentrated as a dense rim around the lesions. Microglia is also activated, in a more
      diffuse way, in the white matter (WM) and GM with concomitant axonal degeneration and
      meningeal inflammation. Thus, chronic activation of microglia has been linked to
      neurodegeneration in the progressive phase of the disease and development of brain atrophy.

      No longitudinal studies in MS examined the association between development of
      microglia-related pathology in patients treated with siponimod (Mayzent®). This will be the
      first study to examine the treatment effect of Mayzent on microglia in MS.
    

Intervention name(s): Mayzent; Ocrevus
Intervention type(s): Drug; Drug
Intervention description(s): PET imaging to evaluate the effects of Mayzent on the microglia of the brain.; PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.
Intervention MeSH terms: Ocrelizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease is a respiratory disease that results in progressive
      airflow limitation and respiratory distress.

      The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation
      programme is uncertain. The investigators aimed to demonstrate that, in patients with
      obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement
      of dyspnoea and exercise tolerance.
    

Detailed description: 
      The purpose of this study is to evaluate the effect of the inspiratory muscle training (with
      incremental load every two weeks in two months) performed during pulmonary rehabilitation on
      dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory
      questionnaire (SGRQ) in COPD patients.
    

Intervention name(s): Pulmonary rehabilitation+IMT; Pulmonary rehabilitation
Intervention type(s): Other; Other
Intervention description(s): The experimental group receives inspiratory muscle training and aerobic exercise.; The Active Comparator group received only aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: COPD; IMT; 6MWT; Dyspoea; SGRQ
Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels
Condition: Perioperative/Postoperative Complications; Fluid Overload; Hemoglobin H
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      The objective of the study is to evaluate influence of perioperative fluid therapy on
      Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be
      related to metabolic signs of oxidative stress (changes in blood lactate). Patients
      undergoing major abdominal surgery will be included into the study.
    

Detailed description: 
      Increasing plasma volume by intravenous administration of crystalloid and/or colloid
      solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that
      is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in
      oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large
      amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as
      is frequently done as part of perioperative goal-directed therapy; this may lead to an actual
      decrease in the DO2 due to a decrease in Hb concentration.

      Another potential parameter that may reflect the development of dilutional anemia is
      methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental
      studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide
      synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and
      oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress'
      associated with reduced tissue perfusion during acute hemodilution.
    

Intervention name(s): GDT
Intervention type(s): Other
Intervention description(s): individualized fluid therapy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing major abdominal surgery
      
Keywords: fluid therapy; perioperative; hemodilution
A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions
Condition: Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to determine the relative bioavailability of two candidate formulations of
      mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg)
      from Dainippon Pharmaceutical Company in healthy adult subjects. This will be an open-label,
      randomised, single dose, three-way crossover, six sequence study. Subjects will receive a
      single oral dose separated by at least 7 days and no greater than 14 days washout period.
      This study is required to select a candidate mosapride citrate (GR107719B) formulation for
      further development and provide data to allow the design of a future pivotal bioequivalence
      study. The candidate formulations will be compared with the innovator GASMOTIN. GASMOTIN is a
      trademark of Dainippon Sumitomo Pharmaceutical Company.
    


Intervention name(s): Reference mosapride citrate (GASMOTIN); GR107719B (Formulation 1); GR107719B (Formulation 2)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Reference mosapride citrate (GASMOTIN) 5mg will be supplied as caplet shaped tablet embossed with P218 and film-coated; administer orally with approximately 240 mL of water.; GR107719B (Formulation 1) 5 mg will be supplied as L-HPC disintegrant caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water.; GR107719B (Formulation 2) 5 mg will be supplied as caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water.
Intervention MeSH terms: Mosapride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy adult human subjects; Mosapride citrate anhydrous; Bioequivalence; Dyspepsia
Live Your Life Without Diabetes
Condition: Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      Aim: To examine the effect of a brief theory-based health promotion intervention delivered in
      the community on health behaviour and diabetes-related risk factors among Danish adults at
      high risk of diabetes.

      Methods: A randomised trial was conducted among 127 individuals aged 28 to 70 with fasting
      plasma glucose: 6.1-6.9 mmol/l and/or HbA1c : 6.0-<6.5% (42- < 48 mmol/mol) recruited from
      general practice in Holstebro, Denmark. Participants were randomised to a control group or to
      receive the intervention delivered over four 2 h group sessions during five weeks, and two
      further sessions after one and six months. Questionnaire data and clinical measures were
      collected at baseline, three months and one year after intervention.
    


Intervention name(s): Brief theory-based health promotion intervention (group-based)
Intervention type(s): Behavioral
Intervention description(s): The intervention is depicted using a PaT Plot in the published paper: Juul, L et al. Effectiveness of a brief theory-based health promotion intervention among adults at high risk of type 2 diabetes: One-year results from a randomised trial in a community setting. Primary Care Diabetes 1 0 ( 2 0 1 6 ) 111-120.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention