bioihbjkbjnl/mcl2 huggingface dataset:
Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
Condition: HIV-1-infection
Study type: Interventional

Summary: 
      With this study the investigators propose to evaluate the satisfaction of the patients
      receiving antiretroviral treatment for HIV infection with standard everyday scheme, compared
      to patients receiving the same treatment with short-cycles of 4 days a week.
    

Detailed description: 
      The aim of this study is to evaluate the impact of SCT on the quality of life of HIV infected
      adults by administering HIV Treatment Satisfaction Questionnaires (HIV-TSQs) to patients
      receiving SCT for at least 48 weeks and by comparing their answers to those of patients
      receiving standard 7-days-a-week ART with comparable therapeutic regimens.

      This is an interventional study performed at the HIV outpatients clinics of the Infectious
      and Tropical Diseases department in Azienda Ospedaliera Universitaria Integrata of Verona
      (Italy).

      During standard visits and after collecting their informed consent, the investigators will
      administer HIV-TSQs to 30 patients receiving 4-days-a-week of rilpivirine-containing regimens
      (either rilpivrine/emtricitabine/tenofovir alafenamide or rilpivirine + lamivudine/abacavir)
      and to 30 patients receiving the same regimens but 7-days-a-week.

      For the first group, the investigators will consider patients who have switched to a SCT at
      least 48 weeks before administration of the questionnaire, and data on their
      viro-immunological status (HIV-RNA, CD4+ cells count and CD4+/CD8+ ratio) after the switch to
      SCT will be retrospectively collected as well.
    

Intervention name(s): HIV Treatment Satisfaction Questionnaire status
Intervention type(s): Other
Intervention description(s): Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.
Other intervention name(s): HIV-TSQs
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Short-cycle therapy; SCT; rilpivirine; HIVTSQs; patients' satisfaction
Assessment of Pituitary Adenylate Cyclase Activating Polypeptide-Brain Derived Neurotrophic Factor (PACAP-BDNF) Signaling System Involvement in Etiology and Treatment of Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its receptors
      PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found that PACAP
      treatment of neuronal cell cultures increases expression of Brain Derived Neurotrophic Factor
      (BDNF) that plays an important role in the etiology of psychiatric disorders and action of
      antidepressants. For the first time, the investigators demonstrated that treatment by
      Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and upregulates PACAP mRNA
      expression, whereas Imipramine shows an opposite effect. Moreover, PACAP, PAC1 and VPAC2
      expression is highly correlated with BDNF expression. Their in vivo studies show that
      Imipramine reduces BDNF and increases PAC1 mRNA expression in murine hippocampus, suggesting
      that antidepressants may affect neuronal plasticity through PACAP-BDNF interactions. Based on
      their observations in experimental systems, the investigators hypothesize that PACAP
      signaling system may be involved in the etiology of depression and mechanism of
      antidepressant action. The investigators will evaluate this hypothesis by examining serum
      PACAP levels, effect of antidepressants on PACAP levels, and gene polymorphisms of PACAP and
      its receptors in major depressive disorder patients. This study will enhance the
      investigators' understanding of PACAP's role in the etiology of depression and antidepressant
      treatment and will provide a basis to evaluate PACAP pathway as a potential target for
      diagnostics and novel antidepressants drug discovery.
    


Intervention name(s): SSRI; SNRI; TCA
Intervention type(s): Drug
Intervention description(s): Tablets or Pills, 1 or 2 per day, more than 2 month
Other intervention name(s): paroxetine, fluoxetine, sertraline, escitalopram, citalopram; mirtrazapine, venlafaxine; anafranil
Intervention MeSH terms: Citalopram; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Clomipramine; Escitalopram
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: PACAP (Pituitary Adenylate Cyclase Activating Polypeptide); Major Depression; Receptors; Gene polymorphism; PACAP signaling system; Etiology of major depression; Mechanism of antidepressants action; PACAP receptors gene polymorphism; Pathogenesis of major depression; Responsiveness to the antidepressant drugs
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The overall purpose of this pilot study is to examine effects of Hatha yoga and
      cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our
      preliminary study indicated that a single session of either form of activity intervention
      improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed
      study will extend this preliminary research in several ways.
    

Detailed description: 
      First, the investigators will expand the exercise-based interventions from one to three
      sessions, which will more closely resemble how these interventions may be used in the context
      of smoking cessation. Second, the investigators will recruit smokers who are motivated to
      quit smoking, further increasing the clinical relevance of the research. Finally, the
      investigators will examine the effects of the interventions on actual smoking behavior within
      and outside of the laboratory setting. This may appropriately be considered a "proof of
      concept" study, as the investigators will not be powered to detect treatment outcome (smoking
      cessation) differences, nor are the interventions designed to maximize clinical smoking
      cessation outcomes.

      Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of
      cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to
      occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will
      be assessed before and after each session, and smoking behavior will be assessed following
      each session. Finally, a detailed cue reactivity assessment will be conducted prior to the
      first session and following the last session. Analyses will examine intervention effects on
      craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will
      examine several potential mediators and moderators of intervention effects on smoking
      behavior. Finally, the investigators will continue to examine the feasibility and potential
      acceptability of each active intervention, to assist in developing future clinical
      applications of these techniques in the context of smoking cessation.
    

Intervention name(s): Hatha Yoga (HY); Cardiovascular Exercise (CE); Smoking Cessation Counseling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 3 Sessions of yoga instruction; 3 sessions of cardiovascular exercise; 4 smoking cessation counseling visits.
Other intervention name(s): yoga; exercise; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: craving; mood; cue reactivity; smoking behavior; quit smoking; prevention; Hatha yoga; cardiovascular exercise
Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one
      dose of four different formulations of the MenACWY conjugate vaccine when given to healthy
      subjects aged 15-19 years. The selection of the best formulation will be based on data
      obtained up to one month after the vaccine dose.
    

Detailed description: 
      The study is open. However, the 4 different formulations of GSK's MenACWY conjugate vaccine
      will be administered in a double-blind manner. Mencevax™ ACWY vaccine will serve as active
      control. Subjects will receive one vaccine dose only (GSK's MenACWY conjugate vaccine or
      Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after
      vaccination.
    

Intervention name(s): Meningococcal Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal serogroups A, C, W-135, Y disease
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of single oral therapeutic and
      supratherapeutic doses of AKB-6548 on the QT interval.
    


Intervention name(s): AKB-6548 (therapeutic dose); AKB-6548 (supratherapeutic dose); Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of AKB-6548 at a therapeutic dose level; Single oral dose of AKB-6548 at a supratherapeutic dose level; Single oral dose of placebo; Single oral dose of 400 mg moxifloxacin
Intervention MeSH terms: Moxifloxacin; Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Akebia; QT interval; TQT; pharmacokinetic; anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; safety
Bio Electro Stimulation Therapy for Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction
      and non-motor symptoms. Here, the investigators propose in a pilot device feasibility trial
      to examine whether "Bio Electro Stimulation Therapy" (B.E.S.T.) with a small, non-invasive,
      handheld electronic device designed to apply micro current stimulation to a person's hand can
      ameliorate some of the symptoms of PD.
    

Detailed description: 
      Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction,
      cognitive impairment, and other non-motor symptoms. Here, we propose to use "Bio Electro
      Stimulation Therapy" (B.E.S.T.) using the "e-Tapper TT-R1"owned by Immumax International Co.
      Ltd., a Hong Kong based company. The "e-Tapper" is a non-invasive, handheld electronic device
      designed to apply micro current stimulation to a person's hand at specified points
      representing various body parts, such as the head, leg, or foot. This is one form of Bio
      Electro Stimulation Therapy, known as "11-point Hand Treatment System". The current delivered
      is less than one milliampere. Anecdotal evidence suggests that this micro current stimulation
      may reduce resting tremor, restore facial expressions, and improve ease of movement, mood,
      and sleep quality in patients with PD. Scientific evidence for the effectiveness of the
      B.E.S.T. Hand Therapy appears to be lacking in the English language (Western) literature. The
      goal of this pilot device feasibility study is to examine whether B.E.S.T. can increase
      physical activity and functional fitness, enhance cognition, improve mood and subjective
      sleep quality, and modulate resting tremor and gait parameters in PD patients over a 6-week
      period.
    

Intervention name(s): e-Tapper TT-R1
Intervention type(s): Device
Intervention description(s): The e-Tapper is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hands at specified points representing various body parts, such as the head, leg, or foot. This is one form of "Bio-Electro Stimulation Therapy" known as the "11-point Hand Treatment System". The current delivered is less than one milliampere.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: physical activity; fitness; cognition; mood; depression; anxiety; sleep quality; tremor; gait
Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of itraconazole or
      gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood
      and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021) in
      healthy male participants.
    

Detailed description: 
      This is a single-dose, single-center, open-label (all people know the identity of the
      intervention), 3-treatment, randomized (study medication assigned to participants by chance)
      and parallel-group (a medical research study comparing the response in two or more groups of
      participants receiving different interventions [treatments]) study. The study consists of
      Screening Phase (that is, 21 days before study commences on Day 1); open-label treatment
      Phase and end-of-study or early withdrawal assessment. All participants will be randomly
      assigned to 1 of 3 treatments, that is, Treatment A (single dose of JNJ-56021927 on Day 1),
      Treatment B (200 milligram [mg] itraconazole once daily from Day 1 up to Day 32 along with
      single dose of JNJ-56021927 on Day 4), and Treatment C (600 mg gemfibrozil twice daily from
      Day 1 up to Day 32 along with single dose of JNJ-56021927 on Day 4). Blood samples will be
      collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.
      The maximum duration of participation in the study per participant will be approximately 78
      days (Treatment A) or 81 days (Treatment B and C). Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-56021927; Itraconazole; Gemfibrozil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of JNJ-56021927 240 milligram (mg) capsule will be administered on Day 1 or Day 4 in any of the treatment.; Itraconazole 200 mg (2 capsules of 100 mg) will be administered once daily orally from Day 1 until Day 32.; Gemfibrozil 600 mg oral tablet will be administered twice daily from Day 1 until Day 32.
Intervention MeSH terms: Itraconazole; Gemfibrozil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: JNJ-56021927; Itraconazole; Gemfibrozil
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
Condition: Advanced or Metastatic NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      this is a phase I study comparing PK similarity of sintilimab by different production process
      (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or
      been intolerant to at least one prior line of standard treatment
    


Intervention name(s): Sintilimab (M1b); Sintilimab (approved)
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion; Intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
Condition: Insomnia; Attention Deficit Hyperactivity Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age,
      inclusive) and adolescents (12 17 years of age, inclusive) with attention
      deficit/hyperactivity disorder (ADHD) associated insomnia.
    

Detailed description: 
      This is a multi center, open label, long term safety study in pediatric subjects 6 through 17
      years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete
      Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to
      participate in this long term safety study. Additionally, Treatment naïve subjects will be
      enrolled in this long term safety study in order to meet the overall subject enrollment
      objective of obtaining 100 subjects with 12 months of treatment. This study was previously
      posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo
      Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals
      Inc.
    

Intervention name(s): eszopiclone; eszopiclone
Intervention type(s): Drug; Drug
Intervention description(s): One 2 mg tablet per day for 12 months; one 3mg tablet per day for 12 months
Intervention MeSH terms: Eszopiclone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypnotic; Eszopiclone; Attention Deficit Hyperactivity Disorder; Insomnia; Children; Adolescent
MRI Outcomes of Mindfulness Meditation for Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress
      Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including
      headache frequency and impact and brain activity, will be assessed at baseline, prior to
      intervention, and at 3-, 6-, and 12-months.
    

Detailed description: 
      Subjects in the MBSR group undergo a standardized 8-week MBSR course plus an additional 4
      sessions over another 8 weeks that further emphasize and train subjects on MBSR concepts and
      skills. The SMH group will have 12 sessions spread out in a similar fashion to MBSR. Clinical
      outcomes are compared between groups at 3, 6, and 12 months to assess efficacy of MBSR. MRI
      scans are performed at baseline, 3 months, and 6 months changes in MRI metrics after MBSR and
      changes in MRI metrics associated with long-term MBSR practice. 30 healthy controls will also
      undergo MRI scanning to determine abnormal brain activity and structure in migraineurs
      compared to healthy controls across the 6 month period of observation.
    

Intervention name(s): Mindfulness Based Stress Reduction; Stress Management for Headaches
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness Based Stress Reduction (MBSR) involves focused attention while practicing moment-to-moment nonjudgmental awareness of the self with the goal of achieving emotional balance and clarity of thought. There will be 8 weekly sessions and a half day retreat followed by 4 bi-weekly sessions over a period of 4 months.; Intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills, headache symptoms and their management, sleep hygiene, and healthy eating. There will be 8 weekly sessions followed by 4 bi-weekly sessions over a period of 4 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; headache; meditation; mindfulness based stress reduction; MBSR
Chlorhexidine Drying Time
Condition: Drying Time
Study type: Observational

Summary: 
      Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic
      solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before starting
      the anesthetic procedure. It is not known how much time is needed for the solution to
      completely dry. The investigators aim to determine this.

      As the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be
      using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep
      dries it gives off less and less vapour. The investigators will use this diminishing vapour
      concentration to determine when drying is complete.
    


Intervention name(s): Chlorhexidine gluconate
Intervention type(s): Drug
Intervention description(s): antiseptic
Other intervention name(s): Chloraprep
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Elective cesarean patients at BC Women's Hospital
      
Keywords: obstetric patients; chloraprep; chlorhexidine; drying time
Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis
Condition: Platelet Reactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Clopidogrel administration is commonly prescribed in patients undergoing percutaneous
      coronary intervention, in patients with previous stroke and in patients under chronic
      hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel
      response compared to those with normal renal function. Ticagrelor is a new oral direct-acting
      antagonist, which provides greater platelet inhibition in both clopidogrel responders and
      non-responders. It has also been shown that in patients with chronic kidney disease
      (creatinine clearance <60 mL/min)ticagrelor achieved an absolute risk reduction of
      cardiovascular death, myocardial infarction, and stroke greater than that of patients with
      normal renal function. Clopidogrel resistant patients as assessed by VerifyNow
      P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily
      for 15 days. Platelet reactivity will be determined at the end of the treatment period.
      Bleeding events, major adverse cardiac events and any side effects until Day 15 will be
      reported in a descriptive manner.
    


Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention description(s): Ticagrelor 90mg twice a day for 15 days
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ticagrelor; platelet reactivity; clopidogrel; haemodialysis