bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs
Condition: Asthma; COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate
      (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations
      (250 µg FP and 50 µg SAL) from the Advair® Diskus®, Seretide™ Accuhaler™ and CRC749 inhalers.
    

Detailed description: 
      Study drug will be administered through the inhaled route to healthy subjects in single doses
      (three inhalations, i.e. total dose 750 µg FP and 150 µg SAL).

      Each subject will receive the following treatments in a random order:

      A. MGR001 B. Seretide™ Accuhaler™ C. Advair® Diskus® There will be a wash out of 3 7 days
      between treatment periods. Pharmacokinetics will be assessed by the measurement of plasma
      concentrations of FP and SAL over the 48 hours following dosing. Adverse Events will be
      collected throughout the study.
    

Intervention name(s): MGR001; Advair® Diskus®; Seretide™ Accuhaler™
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA); Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA); Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)
Other intervention name(s): FP; SAL; FP; SAL; FP; SAL
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluticasone Propionate; Salmeterol; Pharmacokinetics; Healthy Subjects; MGR001; CRC749; Dry Powder Inhaler; generic; Advair Diskus; Seretide Accuhaler
Infrapopliteal Drug Eluting Angioplasty Versus Stenting
Condition: Arterial Occlusive Disease
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be
      randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm
      will undergo a percutaneous transluminal angioplasty (PTA) with the use of a
      paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES)
      study arm will undergo primary stenting using drug-eluting stent(s). The study's primary
      endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will
      include the immediate technical success,6-month primary patency, target lesion
      revascularization and limb salvage and complication rates.
    

Detailed description: 
      Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial
      disease in our department will be randomized in the above mentioned study arms. The studies
      primary endpoint will be assessed with the use of intra-arterial digital subtracted
      angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up
      is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be
      recorded and analyzed.
    

Intervention name(s): Paclitaxel coated balloon angioplasty.; Infrapopliteal Primary Drug Eluting Stenting
Intervention type(s): Procedure; Procedure
Intervention description(s): Infrapopliteal angioplasty using a paclitaxel coated balloon.; Infrapopliteal primary stenting using drug-eluting stent(s)
Other intervention name(s): DCB; DES
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Drug coated balloons; Drug eluting stents
Pilates Training in Patients With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effects of pilates training on symptoms in
      patients with allergic rhinitis.
    

Detailed description: 
      Twenty allergic rhinitis patients aged 18 - 35 years were randomized into 2 groups: control
      group (CON; n=9) and pilates training group (PTG; n=11). Participants in CON group do their
      daily routine without receiving any training program, while those in PTG group completed
      receiving pilates training program three time a week for ten week-long (60 minutes/time). The
      physiological data, rhinitis symptoms, cytokines, pulmonary function, respiratory muscle
      strength were analyzed during the pre-test and post-tests. The dependent variables between
      pre-test and post-tests were analyzed by paired t-test. The rhinitis symptoms and cytokines
      variables between pre-test and post-test were analyzed by repeated measures ANOVA. In
      addition, an independent t-test was used to compare the variables between groups. Statistical
      significance was defined as p < .05.
    

Intervention name(s): Pilates training
Intervention type(s): Other
Intervention description(s): Subject participating in 60-min sessions for 10 weeks and Each session consisted of a 10-min warm up (Breathing, Imprint & release, Hip release, Spine rotation, Hip rolls, Scapula isolation, Arm circle, Elevation & depression scapulae, Head nod, Cat stretch), Pilates program 40-min (Toe tap, Ad prep, Breast stroke preps, Heel squeeze prone, Side leg lift, Single leg extension, One leg circle, Shoulder bridge prep, Four point, kneeling, Spine twist, Hundred prep, Roll up prep, shoulder bridge prep2, Breast stroke, Swimming, Half roll back) and 10-min cool down (Spine stretch forward, Shell stretch, Side bending, Cat stretch, Roll down)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Pilates; Cytokine; Pulmonary function; Rhinitis symptoms
Dermatologists' Educational Demonstration for Epiduo Application
Condition: Facial Acne; Local Adverse Effects
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and tolerability of this combination
      gel compared with BPO monotherapy in Korean patients, and test clinical practicability of
      dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable
      irritations.
    


Intervention name(s): Epiduo once daily with detailed instruction for how to apply it; Epiduo- once daily, simple instruction for application; BPO once daily
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Adapalene, Benzoyl Peroxide Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
Condition: ADME; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-center, open-label, single-sequence, study evaluating the
      absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a
      mixture 14C-radiolabeled and unlabeled material.
    


Intervention name(s): napabucasin
Intervention type(s): Drug
Intervention description(s): Single 240 mg dose containing 100 μCi of 14C-napabucasin will be administered with 240 mL of water following an overnight fast.
Other intervention name(s): BBI-608; BBI608
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV
      (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent
      influenza vaccine in adults 50 to 64 years of age.
    


Intervention name(s): aQIV; Comparator QIV
Intervention type(s): Biological; Biological
Intervention description(s): Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1; Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza, Vaccine, MF59 adjuvant
Reconstitution of HIV-specific Immunity Against HIV
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so
      the viruses could not massively replicate when HAART was discontinued, then make HIV
      functional cure possible.
    

Detailed description: 
      The research aims at establishing a new treatment strategies of HIV. It will significantly
      improve the clinical therapy effects and effectively reduce the morbidity and mortality by
      reconstituting the immune systems of HIV infected patients and combining multiple therapy
      strategies. Therefore, the research could develop an cloning amplification system of
      immunocytes in vitro, and improve the antiviral immune system severely damaged before by
      transfusing the clone cells modified by specific HIV antigen. So HIV infected patients could
      discontinue the traditional anti-viral drug, but not develop opportunistic infections,which
      could obviously increase the life qualities of these patients.
    

Intervention name(s): HIV-specific CD8 cells
Intervention type(s): Biological
Intervention description(s): Based on HAART, receive HIV-specific CD8 cells transfuion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; cellular immunity therapy; functional cure
Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Primary Objective:

           o To assess the efficacy of the probiotics in reducing the duration of diarrhea in
           children suffering from acute gastroenteritis.

        -  Secondary Objectives:

             -  To assess the efficacy of the probiotics in improving the frequency and consistency
                of stools.

             -  To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.

             -  To assess the efficacy of the probiotics on the disease severity.

             -  To assess the safety and tolerability of the studied probiotics.
    


Intervention name(s): Probiotic : Saccharomyces boulardii; Probiotic : Bacillus clausii
Intervention type(s): Biological; Biological
Intervention description(s): Treatment for 5 days; Treatment for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT
      sub-study
    


Intervention name(s): Linagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug 1 tablet PO QD; 1 Tablet PO QD
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Mobile Text Messaging Intervention for Indoor Tanning Addiction
Condition: Indoor Tanning
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of messages communicating the risks (i.e.,
      health harms, addictiveness) of indoor tanning delivered via mobile text messaging among
      young adult women ages 18 to 30 years who meet screening criteria for indoor tanning
      addiction.
    

Detailed description: 
      This is a two arm randomized controlled trial to test the effects of messages communicating
      the risks of indoor tanning delivered via mobile text messaging as a strategy for promoting
      cessation among young adult women who meet screening criteria for indoor tanning addiction.
      Eligible participants are young adult women ages 18 to 30 years who meet screening criteria
      for indoor tanning addiction and have access to the internet and a personal mobile phone to
      complete study procedures. Participants will complete baseline measures and then be
      randomized to the study arms. The text messaging intervention exposure in the intervention
      arm will last for four weeks. The control arm will be given basic indoor tanning education
      information and will not receive any intervention. Follow up assessments capturing study
      outcomes will be administered at 1 month (i.e., immediately post-intervention) and three
      months post-intervention.
    

Intervention name(s): Mobile text messaging intervention
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention arm will receive text messages to their mobile phones designed to communicate the risks of indoor tanning and motivate cessation. The intervention exposure lasts for 4 weeks with messages sent 2 days each week. It is an interactive intervention that engages participants by asking them to respond to prompts, and sending indoor tanning message content in return on message days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized trial with two groups: 1) Indoor tanning education only; 2) Mobile text messaging intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: indoor tanning; skin cancer; mobile health; text messaging
Effects of Urban Afforestation Activity on Mood, Stress, and Anxiety
Condition: Healthy
Study type: Interventional

Summary: 
      This single-group pretest-posttest clinical trial aims to evaluate the effects of a
      single-session afforestation activity on mood, stress, and anxiety in a sample of adults.
    

Detailed description: 
      The participants will perform an afforestation activity for a single session of 90 minutes.
      The therapist will direct the participants' attention to the visual, auditory, olfactory, and
      tactile features of the surrounding environment.
    

Intervention name(s): Urban Afforestation Program
Intervention type(s): Other
Intervention description(s): An afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
Other intervention name(s): Nature-based activity; Afforestation activity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Green spaces; Nature-based activities; Urban afforestation; Horticultural therapy; Mental health; Mood; Stress; Anxiety
A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain
Condition: Depression; Pain
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression
      Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either
      Smilon® or placebo, and will receive the treatment for 8 weeks in this study.
    


Intervention name(s): Smilon®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks; Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mirtazapine; Smilon; Depression; Pain
IVF/ICSI Protocols in Poor Responders With Growth Hormone
Condition: Female Infertility Due to Diminished Ovarian Reserve
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      in this study, we are trying to monitor the effect of the addition of growth hormone on the
      different down regulation protocols ( long, short, antagonist and microflare). The outcome
      will be primarily assessed by the clinical pregnancy rates.
    

Detailed description: 
      Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find
      a proper stimulation protocol is a must. in this study we are trying to detect the best
      stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy
      rates in these patients.
    

Intervention name(s): Growth hormone (Norditropin, Novo nordisk)
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poor Ovarian Response; Poor Responders; IVF/ICSI; Growth Hormone
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
Condition: Congenital Bleeding Disorder; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to assess the safety and
      tolerability of activated recombinant human coagulation factor VII analogue (NN1731,
      vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the
      pharmacokinetics of NN1731 will be examined
    


Intervention name(s): vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); vatreptacog alfa (activated); placebo; placebo; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg; One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg; One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg; One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg; Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dasotraline Pediatric Extension Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open label 26 week extension study for subjects who completed SEP360-202.
    

Detailed description: 
      This is an open-label, flexibly-dosed, 26 week extension study in children and adolescents
      with ADHD who have completed 6 weeks of double-blind treatment in the core study (SEP360
      202). This study will evaluate the long-term safety and tolerability of dasotraline in this
      population.
    

Intervention name(s): Dasotraline
Intervention type(s): Drug
Intervention description(s): Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tinnitus and Acupuncture
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Objective: This study aimed to investigate the effect, onset and duration of action, and
      short-term outcomes of acupuncture therapy in the treatment of patients with severe chronic
      subjective tinnitus.

      Methods: This study is a randomized, controlled trial evaluating patients with chronic,
      idiopathic and severe tinnitus. A total of 105 participants were divided into two groups
      using the randomization method: the study group that received real acupuncture therapy (n =
      53) and the sham acupuncture group. Ten acupuncture sessions were applied over five weeks.
      After treatment, each participant was monitored for up to three months according to the
      changes in the Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Pure-Tone
      Audiometry and Speech Discrimination scores.
    

Detailed description: 
      This was a prospective, randomized, controlled study, approved by the local ethics committee
      and carried out in a single center in accordance with the ethical principles of the Helsinki
      Declaration (E-18-2165).

      The inclusion criteria of the study for patients were determined as; (a) male and female
      patients aged 18 to 60 years, (b) unilateral or bilateral subjective tinnitus, (c) with a
      history of severe subjective tinnitus for at least one year, (d) patients with severe
      tinnitus according to the THI questionnaire result (over 38 points), (e) the patients who
      could not detect etiology of tinnitus in the otolaryngology examination, (f) not having
      received any treatment within the last six months. The patients who applied to the
      otorhinolaryngology clinic of our hospital were included in the study.

      According to the randomization method, the group to which each participant was assigned was
      only known to the researcher who applied acupuncture therapy. The participants and the
      remaining researchers that administered THI to the participants were blinded to the groups.

      The data were obtained from the patients' responses to VAS and THI questionnaires. Each
      participant completed the VAS and THI questionnaires seven times during the course of the
      five-week treatment and the three-month follow-up after treatment.
    

Intervention name(s): acupuncture
Intervention type(s): Biological
Intervention description(s): acupuncture group and control group
Other intervention name(s): sham group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tinnitus; acupuncture; otology; prospective study