bioihbjkbjnl/mcl2 huggingface dataset:
Respiratory Muscle Endurance Training in Obese Patients
Condition: Obesity
Study type: Interventional

Summary: 
      Obese patients are known to have increased work of breathing inducing dyspnea, exercise
      intolerance and impaired quality of life. Respiratory muscle training is known to increase
      respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy
      subjects and respiratory patients. The investigators hypothesized that Respiratory muscle
      training would reduce dyspnoea, increase exercise tolerance and quality of life in obese
      patients.
    


Intervention name(s): Respiratory muscle training
Intervention type(s): Other
Intervention description(s): Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Obese patients (BMI > 30 kg / m²)
Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Neuromatrix pain model and new findings on pain chronification process point to a greater
      efficacy of treatments that address central and peripheral rather than only peripheral
      structures. Both cerebral and peripheral electrical stimulations can modulate brain areas
      involved in pain processing. However, their effects on pain modulation systems and clinical
      outcomes are lacking.

      This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS)
      and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure
      pain threshold and conditioned pain modulation in healthy subjects.
    


Intervention name(s): Transcranial direct current stimulation (tDCS); Peripheral electrical stimulation (PES); Sham tDCS
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.; Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.; Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and tolerability of MTS while attempting to establish the
      appropriate starting dose for subjects previously on an existing long-acting methylphenidate
      product.
    

Detailed description: 
      Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3
      main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety
      and tolerability of SPD485 while attempting to establish the appropriate starting dose for
      subjects previously on an existing long-acting methylphenidate product.
    

Intervention name(s): Methylphenidate Transdermal System
Intervention type(s): Drug
Intervention description(s): To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other intervention name(s): MTS
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, fixed-sequence, single-center, 2 period study. The study is
      designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.
    


Intervention name(s): GDC-0980; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Repeating Oral Dose
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well
      it works as first-line therapy in treating patients with prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the progression-free survival at 12 weeks of patients with non-rapidly
           progressive castration-resistant prostate cancer treated with everolimus as first-line
           therapy.

        -  Assess the activity and safety of this regimen in these patients.

      Secondary

        -  Determine the progression-free survival at 24 weeks of patients treated with this
           regimen.

        -  Determine the percentage of PSA response from baseline to 12 weeks in patients treated
           with this regimen.

        -  Determine the changes in PSA-doubling time in patients treated with this regimen.

        -  Determine the overall survival of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in
      the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed up at 28 days and then every 3
      months.
    

Intervention name(s): everolimus
Intervention type(s): Drug
Intervention description(s): Everolimus:
10mg daily
Other intervention name(s): Afinitor®; Votubia®; RAD001
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; hormone-resistant prostate cancer; stage III prostate cancer; stage IV prostate cancer
Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the safety and effectiveness of the combination of Chidamide with Chimeric Antigen
      Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy on HIV patients based on cART.
    

Detailed description: 
      Despite the advent of combined antiretroviral therapy (cART), the persistence of viral
      reservoirs remains a major barrier to cure human immunodeficiency virus type 1 (HIV-1)
      infection. Recently, the shock and kill strategy, by which such reservoirs are eradicated
      following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been
      extensively practiced. It is important to reestablish virus-specific and reliable immune
      surveillance to eradicate the reactivated virus-harboring cells. Some studies have shown that
      Chidamide can highly activate the HIV reservoirs. The VC-CAR-T cells effectively induced the
      cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected
      individuals receiving suppressive cART. Our previous study demonstrated that the special
      features of genetically engineered CAR-T cells make them a particularly suitable candidate
      for therapeutic application in efforts to reach a functional HIV cure. The purpose of this
      study is to evaluate the safety and efficacy of Chidamide together with Chimeric Antigen
      Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy based on cART in HIV-infected adults
      whose plasma HIV has been successfully suppressed after cART.
    

Intervention name(s): Chidamide with CAR-T or TCR-T cell therapy
Intervention type(s): Biological
Intervention description(s): HIV-1 specific therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The control arm includes HIV-infected patients without receiving cellar therapy combined with Chidamide whose HIV-1 has been successfully suppressed after cART.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chidamide,CAR cell therapy,TCR cell therapy
Vitamin D and Periodontitis
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss; Periodontitis
Study type: Observational

Summary: 
      Vitamin D has become important for periodontal disease due to play a role in autoimmunity,
      bone mineral metabolism and inflammation. Our aim was to investigate the relation between
      serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum
      biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and
      periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood
      samples were taken from the subjects to assess each patient's periodontal status and for
      biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor
      activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α
      (TNF-α)).
    


Intervention name(s): fasting venous blood samples
Intervention type(s): Diagnostic Test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Sixty patients (35 girls) who were aged between 25-45 years (30.8 (mean) ± 4.9 (standard
        deviation) and presented to our faculty for periodontal and other dental problems,
        participated in the study.

        Subjects were divided in to 2 groups each containing 30 patients:

          -  Group I - periodontal healthy

          -  Group II - untreated chronic periodontitis (radiographic evidence of bone loss and
             clinical attachment loss in excess of 5 mm in more than six teeth)
      
Keywords: 25-OH vitamin D; RANKL; Osteoprotogerin; TNF-α
Comparison of the Effects of Truview Laryngoscopy and Macintosh Larygonscopy on Intubation Difficulty Score, Intubation Duration and Intubation Quality in Pediatric Patients Between 2-12 Years
Condition: All the Pediatric Patients Needed Intubation for Surgery
Study type: Observational [Patient Registry]

Summary: 
      For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On
      the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having
      a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes.
      The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope
      in terms of intubation difficulty score, time to intubation and intubation quality score.
    


Intervention name(s): Macintosh laryngoscope; Truview EVO2 laryngoscope
Intervention type(s): Procedure; Procedure
Intervention description(s): intubation criterias withMacintosh laryngoscopein pediatric patients; intubation criterias with Truview EVO2 laryngoscope in pediatric patients
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pediatric patients undergoing surgery which needs intubation
Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to determine immunogenicity and safety following administration of 2 doses of novel
      oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or
      the standard 4-week interval in infants
    

Detailed description: 
      This will be a multicenter, randomized, controlled, open-label, parallel-group Phase III
      study in healthy infants aged 6 to 8 weeks who have never been vaccinated against
      poliomyelitis. Approximately 900 infants will be included in the study and randomized with a
      1:1:1 ratio to the following treatment groups:

        -  Group A: approximately 300 subjects to receive 2 doses of nOPV2 administered 1 week
           apart, at Day 0 and Day 7;

        -  Group B: approximately 300 subjects to receive 2 doses of nOPV2 administered 2 weeks
           apart, at Day 0 and Day 14;

        -  Group C (control group): approximately 300 subjects to receive 2 doses of nOPV2
           administered 4 weeks apart, at Day 0 and Day 28. A total of 4 on-site visits are
           planned. Approximately 7 days after each administration of study vaccine, a phone call
           or on-site visit will be performed to monitor subjects' safety and review with the
           subject's parent(s)/guardian(s) any solicited AEs reported in the electronic diary card.
           All subjects will have a safety follow-up phone call 6 months after the last dose of
           study vaccine.
    

Intervention name(s): nOPV2
Intervention type(s): Biological
Intervention description(s): Novel Oral Poliomyelitis Type 2 Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Cognitive Retraining and Brain Stimulation for Alcohol Use
Condition: Binge Drinking
MeSH terms: Binge Drinking
Study type: Interventional

Summary: 
      The overarching goal of this study is to determine whether combined cognitive training and
      Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To
      this end, specific study purposes are: 1) replicate previous findings that cognitive
      retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with
      tDCS, and 3) investigate the neural changes that result from cognitive retraining and tDCS.
      We hypothesize that those participants who receive alcohol avoidance cognitive training will
      have greater reductions in drinking. In turn, those participants who receive a higher level
      of applied tDCS during alcohol avoidance response training will have better avoidance
      learning, as well as, a larger reduction in drinking behavior. Finally, those participants
      receiving a higher level of applied tDCS will have more neuronal response associated with
      alcohol avoidance during the brain imaging session.
    


Intervention name(s): Active Retraining; Sham TDCS; Active TDCS; Sham Retraining
Intervention type(s): Behavioral; Device; Device; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
Condition: Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being
      and quality of life of patients who have cervical cancer. Changes in quality of life may be
      related to changes in immune function and neuroendocrine function.

      PURPOSE: This randomized phase I trial is studying how well telephone counseling works
      compared to standard care in reducing stress in patients who have completed treatment for
      stage I, stage II, or stage III cervical cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare quality of life (QOL) at baseline and changes in QOL, immune response, and
           neuroendocrine parameters over time in patients who have completed treatment for stage
           I-III cervical cancer receiving psychosocial telephone counseling vs usual care.

        -  Correlate psychosocial measures with immunologic stance.

      OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1
      of 2 intervention arms.

        -  Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions
           and a 1-month follow-up session to learn strategies for reducing stress.

        -  Arm II: Patients undergo usual care for approximately 4 months. All patients complete
           questionnaires and Quality of life assessment at baseline and at 4 months. They also
           undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune
           studies.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
    

Intervention name(s): Psychosocial Telephone Counseling (PTC)
Intervention type(s): Behavioral
Intervention description(s): Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: psychosocial effects of cancer and its treatment; stage IA cervical cancer; stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer
Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.
Condition: Pharmacokinetics of Isavuconazole; Healthy Volunteers; Renal Impaired
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the
      pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in
      healthy subjects with normal renal function.
    

Detailed description: 
      In Part 1, eligible subjects will be enrolled into one of 2 groups based on their renal
      function. All subjects will receive a single 1-hour infusion of isavuconazole and will remain
      confined for 4 days. Subjects with normal renal function will return to the clinic for
      several outpatient visits over 15 days after dosing. Subjects with renal disease will
      complete the same outpatient visits which correspond to scheduled dialysis dates and then be
      readmitted to the clinic on study Day 15 to receive a second 1-hour infusion of isavuconazole
      followed by their normal dialysis procedure and then remain confined for 4 days. ECGs, vital
      signs, blood draws will be obtained throughout the study for safety and to assess the amount
      of study drug in the body as well as study drug removed in subjects undergoing dialysis.

      In Part 2, eligible subjects will be enrolled into one of 4 groups based on their renal
      function. All subjects will receive a single 1-hour infusion of isavuconazole and remain
      confined for 4 days. Subjects will return to the clinic for several outpatient visits over 15
      days after dosing. ECGs, vital signs, blood draws will be obtained throughout the study for
      safety and to assess the amount of study drug in the body.
    

Intervention name(s): isavuconazole
Intervention type(s): Drug
Intervention description(s): IV
Other intervention name(s): BAL4815, BAL8557
Intervention MeSH terms: Isavuconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: isavuconazole; BAL4815; BAL8557; BAL8728
Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
Condition: Coenzyme Q Deficiency
Study type: Interventional

Summary: 
      The randomized, open-label, three period crossover single-dose bioavailability study with
      three coenzyme Q10 products
    

Detailed description: 
      The randomized, open-label, three period crossover single-dose bioavailability study with
      three coenzyme Q10 products will include 25 subjects who will test three different coenzyme
      Q10 products. Serum concentration of coenzyme Q10 will be measured.
    

Intervention name(s): Dietary supplement - standard product; Dietary supplement - Investigational product IP1; Dietary supplement - Investigational product IP2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10; Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10; Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: coenzyme Q10; single dose bioavailability
Development of Exercise Promotion Program Using a Mobile Community
Condition: Breast Cancer; Physical Activity
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aims to investigate the effect of a mobile community based on a smart phone
      application to enhance physical activities of breast cancer survivors.
    


Intervention name(s): Mobile community
Intervention type(s): Device
Intervention description(s): A mobile community based on smartphone application (WalkOn) which gives participants to information about their own steps and others'.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two different single-arm study
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to confirm and extend the data from previous studies and to
      demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with
      CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had
      failed at least one DMARD.
    


Intervention name(s): CDP870
Intervention type(s): Drug
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDP870; Certolizumab Pegol