bioihbjkbjnl/mcl2 huggingface dataset:
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Condition: Ventricular Tachycardia; Ventricular Fibrillation; Atrial Fibrillation; Supraventricular Tachycardia
MeSH terms: Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation; Tachycardia, Supraventricular
Study type: Interventional
Phase: Phase 4

Summary: 
      The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention
      and termination therapies, minimized ventricular pacing, and remote monitoring will reduce
      the rate of inappropriate shocks and improve quality of life compared to optimally programmed
      back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac
      death
    

Detailed description: 
      While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for
      sudden death prevention in high risk individuals, reduction of device associated morbidity
      remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately
      detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks
      in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown
      modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular
      (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and
      treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now
      made available in our current devices. The choice of dual chamber versus single chamber ICD
      for primary prevention warrants re-assessment of atrial prevention and termination therapies,
      without the potentially adverse effects of RV pacing.

      This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50
      to dual chamber ICDs. Patients will be followed for one year.
    

Intervention name(s): Dual Chamber ICD; Single Chamber ICD
Intervention type(s): Device; Device
Intervention description(s): Dual Chamber ICD: Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation Dual Chamber ICD Atrial prevention and termination therapies, Managed Ventricular Pacing (MVP)along with VT/VF detection and therapies for dual chamber device.; Single Chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
VT/VF detection and therapies with discrimination criteria for single chamber device.
Other intervention name(s): Virtuoso DR D154AWG; Virtuoso VR D154VWC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shock prevention; Single vs. Dual Chamber; Reduce ventricular pacing; Atrial Fibrillation; Remote Monitoring; ICD; Implantable Cardioverter Defibrillator
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in
      patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for
      patients in the core trial, to obtain safety and tolerability information. The study will
      address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over
      a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in
      psoriatic arthritis a decision will be made as to whether or not to continue dosing for
      another 6 month period (Part 2).
    


Intervention name(s): AIN457A; Other
Intervention type(s): Biological; Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriatic arthritis; IgG1K monoclonal antibody; Interleukin -17A neutralizing
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)
      affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin.
      The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.
    

Detailed description: 
      This study will be an open label (all volunteers and study staff know the identity of the
      assigned treatment), randomized (the treatment is assigned by chance), multiple dose,
      cross-over study (all volunteers will switch from one treatment to another) to determine how
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes
      mellitus) affects the pharmacokinetics of digoxin (a drug used to treat various heart
      conditions). Volunteers will be randomly assigned to 1 of 2 treatment sequence groups: Group
      AB or Group BA. Volunteers assigned to Group AB will be given Treatment A: digoxin once a day
      for 7 days. Volunteers assigned to Group BA will be given Treatment B: digoxin and
      canagliflozin once a day for 7 days. A washout period (when no medication is given) of at
      least 14 days will follow the first 7-day treatment period. Following the washout period,
      volunteers will be assigned to the treatment that they did not receive during the first
      treatment period. This second treatment period will last for 7 days. Each volunteer will
      participate in the study for approximately 60 days.
    

Intervention name(s): Digoxin 0.5 mg; Digoxin 0.25 mg; Canagliflozin (JNJ-28431754)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.; One 0.25 mg tablet taken orally on Days 2 through 7.; One 300 mg tablet taken orally on Days 1 through 7.
Other intervention name(s): Lanoxin; Lanoxin; JNJ-28431754
Intervention MeSH terms: Canagliflozin; Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Digoxin (LANOXIN)
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
Condition: Post Polio Syndrome, PPS
MeSH terms: Poliomyelitis; Postpoliomyelitis Syndrome; Syndrome
Study type: Interventional

Summary: 
      The primary objective was to assess the effect of Xepol compared to placebo on physical
      health and on muscle strength in subjects with post-polio syndrome.The secondary objective
      was to assess the effect of Xepol compared to placebo on functional balance, activity
      patterns, pain, fatigue, sleep, vitality, muscular strength, pulmonary capacity, walking
      ability, balance and safety.
    

Detailed description: 
      Study Rationale:

      In an earlier open and non-controlled study in 10 patients with PPS, Xepol was given during
      three days. The patients showed improvements in muscular strength and co-ordination and a
      decrease in pain. The aim of this study was to investigate if these findings can be confirmed
      in a larger, double-blind, randomised and placebo controlled study.

      There are no simple clinical findings and specific laboratory changes that can be used to
      indicate the severity and progress of PPS. Different self-reporting questionnaires and
      objective measures of disability have often been used in clinical studies including SF-36
      questionnaire, muscle strength measurement and walking test. The primary and secondary
      variables in this study were based on the clinical experience and literature reviewed.
    

Intervention name(s): Xepol
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Post Polio Syndrome; PPS; Poliomyelitis; Paralylic Polio; Late effects of polio; Late onset polio sequele; Xepol; IvIg; Intravenous Immunoglobuline
The PACO RCT Study
Condition: Physical Activity; Sedentary Lifestyle; Behavior
Study type: Interventional

Summary: 
      The aim of this school-based cycling intervention called "Cycling and Walk to School" (PACO,
      for its Spanish acronym) will be to examine their effects on adolescent's cycling to and from
      school and physical activity (PA). This study will also examine the effects of this
      intervention in several active commuting to and from school (ACS)-related variables belonging
      to Self-Determination Theory (SDT) and Social-Ecological Model (SEM).
    

Detailed description: 
      This study will also examine the effects of this intervention in several active commuting to
      and from school (ACS)-related variables belonging to SDT and SEM. In this randomized
      controlled trial will participate 360 adolescents, belonging to six secondary schools (three
      experimental and three control) from three Spanish cities. The intervention will be conducted
      by both the research staff and the physical education (PE) teacher through four cycling
      sessions (one per week). PA levels will be measured by accelerometers, and the other study
      variables by using self-reported scales, before and after the intervention programme. The
      primary outcomes will be: cycling to school, ACS, and PA levels. The secondary outcomes will
      be: SDT (Self-Determination Theory) -related variables in ACS and individual, interpersonal,
      communittal and environmental variables related to ACS belonging to SEM (Social-Ecological
      Model). The findings of this study will provide a comprehensive understanding of the effects
      of this short-term school-based intervention on cycling to school and PA levels of Spanish
      adolescents.
    

Intervention name(s): Bike Intervention Group
Intervention type(s): Behavioral
Intervention description(s): A 1-month biking-based program. The biking program consists of 4 sessions/month of 120 min at physical education lessons in school, and will focus on promote biking through theory and practice lessons about cycle training skills including on-road training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trials
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Active Commuting; Health behaviour; Design; School-based intervention; Children; Youth; Self-Determination Theory; Walking
Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
Condition: Enteral Nutrition (Food for Special Medical Purposes)
Study type: Interventional

Summary: 
      The purpose of this pilot study is to investigate the effect of an oral nutritional
      supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing
      elective pancreaticoduodenectomy.
    


Intervention name(s): preOP booster (oral nutritional supplement, food for special medical purposes)
Intervention type(s): Dietary Supplement
Intervention description(s): 3x1 dosage pre-operatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the
      efficacy and safety of asenapine compared with placebo in participants with an acute
      exacerbation of schizophrenia.
    


Intervention name(s): Asenapine 5 mg; Asenapine 10 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.; Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.; A matching placebo of asenapine sublingual tablet not containing asenapine
Other intervention name(s): SCH 900274; SCH 900274
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Immunopharmacology of EDP1815 and EDP2939
Condition: KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers
MeSH terms: Dermatitis; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.
    

Detailed description: 
      This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939
      on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal
      challenges in healthy volunteers.

      EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human
      commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular
      vesicles.

      Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule
      formulations and doses, administered for 60 days. Volunteers will be immunised with
      intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on
      Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using
      dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as
      well as dermal and systemic immunological biomarkers.
    

Intervention name(s): EDP1815; EDP2939; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): EDP1815 is an essentially non-viable, non-replicating pharmaceutical preparation of a single strain of Prevotella histicola, a naturally occurring human commensal microbe.; EDP2939 is a pharmaceutical preparation of extracellular vesicles.; Placebo.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a single-center, randomized, double-blind, placebo-controlled, platform trial to evaluate the effects of EDP1815 and EDP2939 on the systemic immune system, using intradermal KLH and topical IMQ skin challenges. A total of at least 72 healthy volunteers will be divided into 4 cohorts.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Modelling of the Upper Airway in Children With Controlled Asthma
Condition: Controlled Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Asthma in children is recognized as a disease area with a high medical need. As the
      investigators move into this field it is necessary to improve the investigators knowledge of
      upper airway anatomical structure in paediatric patients. This study will provide
      airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can
      be used in order to build models to study the delivery of medication through a device that
      requires for example a facemask. In this study the anatomical structure of the upper airway
      and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan.
      The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.
    


Intervention name(s): Cone Beam Computed Tomography
Intervention type(s): Radiation
Intervention description(s): CBCT scan of upper airway at visit 1
Other intervention name(s): CBCT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: asthma; controlled; Cone Beam Computed Tomography; upper airway; paediatric
Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS
Condition: Coenzyme q10
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in
      women with polycystic ovarian syndrome. Half of the participants will receive coq10 and
      ovulation induction with clomiphene and other half would receive a placebo with clomiphene.
    


Intervention name(s): Coenzyme Q10; clomiphene citrate
Intervention type(s): Drug; Drug
Intervention description(s): antioxidant used to decrease oxidative stress and improve fertility prospects; ovulation induction drug
Other intervention name(s): celeron sr; clomid
Intervention MeSH terms: Ubiquinone; Coenzyme Q10; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ovulation induction; coenzyme q10; pregnancy rate
Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical
      hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent
      chemo-radiotherapy is necessary if the patients have high-risk factors, including positive
      surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that
      combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of
      post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.
    

Detailed description: 
      In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either
      neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and
      pelvic+/- para-aortic lymph node dissection. According to the surgical findings,
      post-operative chemo-radiotherapy will be performed.
    

Intervention name(s): combination group; chemotherapy group
Intervention type(s): Radiation; Drug
Intervention description(s): chemotherapy (paclitaxel/cisplatinum) and brachytherapy; chemotherapy: (paclitaxel/cisplatinum)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoadjuvant chemotherapy; brachytherapy; radiotherapy
Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth
Condition: Pulp Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This randomized, controlled, blinded clinical trial evaluated the effectiveness of different
      desensitizing protocols in preventing pulp inflammation after bleaching treatment with 35%
      hydrogen peroxide (PH) (Whiteness PH 35%).
    

Detailed description: 
      Thirty healthy third human molars extracted by orthodontic indication were randomized and
      allocated into five groups (n = 6): CN (negative control): without intervention; CP (Positive
      control): PH; PMB: PH + photobiomodulation with low power laser; CPP: PH + casein
      phosphopeptide phosphopeptide amorphous calcium phosphate (CPP-ACPF); NANO: PH +
      nanohydroxyapatite. The office whitening was performed in two sessions with a single
      application of 45 min and an interval of 48 hours between them. Pulp tissues were removed for
      immunohistochemical analysis. Immunostaining was performed for Caspase 3 using an Axio
      Scope.A1 microscope.
    

Intervention name(s): Whiteness HP 35%; Whiteness HP 35% + LASER; Whiteness HP 35% + CPP; Whiteness HP 35% + NANO
Intervention type(s): Other; Device; Other; Other
Intervention description(s): Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm; A dose of LASER (60 J / cm2, for 16 seconds) was applied at two points, one point in the cervical region and another in the center of the buccal surface of the third molars, using visible infrared LASER therapy (Photon III / DMC, São Carlos, SP, Brazil), with a wavelength of 808 nm, and AsGaAl, as an active medium.; Topical application of casein phosphopeptide amorphous calcium phosphate fluoride CPP-ACPF (My Paste Plus, Recaldent, GC, USA) with the aid of a microbrush (KG Sorensen, SP, Brazil) in a passive way for 5 minutes.; A topical application of nanohydroxyapatite (Nano P FGM, SC, Brazil) was performed with the aid of a microbrush (KG Sorensen, SP, Brazil) in a passive way for 5 minutes after teeth whitening.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapies; Caspase 3; Immunohistochemistry
Pain Coping Skills for Colorectal Cancer Survivors
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer survivors experience long-term negative physical and psychosocial
      consequences of their disease. There is a critical need to develop novel behavioral
      interventions for improving colorectal cancer survivor outcomes. The investigators have
      developed a pain management intervention for colorectal cancer survivors that focuses on
      addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain
      and comorbid psychological distress as a concern during a clinic-based survivorship care
      consult will be recruited. Participants will be randomized into either: Telephone-Based
      Coping Skills Training (CST) for pain and comorbid psychological distress or standard care.
      The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that
      teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring)
      relevant to managing pain and psychological distress. The standard care control condition
      will receive resources and referrals related to managing survivorship health.
    


Intervention name(s): Telephone-Based Coping Skills Training (CST)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer survivor; cancer pain; psychological distress; coping skills training; symptom management; cancer survivorship