bioihbjkbjnl/mcl2 huggingface dataset:
Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education
      and Relationships) program was to examine the effectiveness of one of the first
      linguistically and culturally tailored intervention programs to increase quality of life
      among Korean American breast cancer survivors.
    

Detailed description: 
      This study employed a randomized trial design, consisting of a standard and enhanced
      intervention group. Participants attended seven weekly sessions and one follow-up session
      that lasted for about 2 hours each. All sessions were conducted by two Korean female
      bilingual licensed clinical psychologists.

      The specific aims of this study were to: (1) Implement and evaluate the effects of tailored
      intervention on perceived stress, coping and quality of life among Korean American breast
      cancer survivors; and (2) Conduct a process evaluation to assess the feasibility and fidelity
      of the intervention, which will provide data that can inform the development of future
      interventions.
    

Intervention name(s): Linguistically and Culturally Tailored Information; Cognitive-Behavioral Stress Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received linguistically and culturally tailored information on diet and nutrition, physical activity, managing treatment side effects, follow-up care plans, complementary and alternative medicine, reducing environmental exposure to estrogen, navigating cancer-related financial issues, family history, body image, sexuality, and advances in breast cancer research.; Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Breast Cancer; Korean Americans; Survivorship; Quality of Life; Coping Skills; Perceived Stress
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a 52-week, open-label extension trial to investigate safety and to explore
      efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706)
      (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol
      P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate
      in Protocol 176004 (P05708) after signing informed consent.
    


Intervention name(s): Org 50081
Intervention type(s): Drug
Intervention description(s): One tablet daily
Intervention MeSH terms: Mirtazapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fifty two weeks; Open label; extension
Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia
Condition: Vitreoretinal Surgery Under Sub-Tenon's Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigator evaluated the motor and sensory block durations and the postoperative
      analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in
      patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered
      as a primary endpoint.
    

Detailed description: 
      Background: The investigator evaluated the motor and sensory block durations and the
      postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's
      anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations
      were considered as a primary endpoint.

      Methods: The investigator investigated 60 patients subjected to vitreoretinal surgery under
      sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups
      conferring to the local anesthesia (LA) solution used to receive either 4 mL of
      levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4
      mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with
      1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block
      (akinesia) and sensory block durations were evaluated until the return of normal motor and
      sensory function. The sedation level was assessed during the surgery period and 24 hours
      postoperatively together with the degree of postoperative pain and the efficiency of
      postoperative analgesia. The sleep quality of the first postoperative night was assessed
      using the Consensus Sleep Diary (CSD).
    

Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): adding dexmedetomidine to the local anesthetic
Other intervention name(s): Precedex, 200 μg per 2 mL; Hospira, USA
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Dexmedetomidine
Nano-Hybrid vs Bulk-Fill Resin Composites
Condition: Composite Resin; Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study is to compare the 2-year clinical performance of bulk-fill composites,
      which can be applied as a single layer, and the nano-hybrid filled composite resins, which
      are frequently used in clinical routine, in children in a split-mouth design.

      This study was conducted on 89 patients aged 6-12 years who had caries on bilateral
      mandibular first molars. Our study has a randomized, cross-controlled, and double-blind
      design. In split-mouth design, restorations of mandibular permanent molars completed with
      nano-hybrid ORMOCER based bulk-fill filling material Admira Fusion x-tra (Voco GmbH,
      Cuxhaven, Germany) and nano-hybrid composite Grandio (Voco , Cuxhaven, Germany). Futurabond U
      single dose (Voco, Cuxhaven, Germany) universal adhesive was used for all restorations, in
      the selective enamel etching mode. The clinical success of the restorations will be evaluated
      at 6, 12 and 24-month controls. Evaluations has been made by two physicians other than the
      one who did the restoration, who do not know which restorative material was applied to which
      tooth.
    


Intervention name(s): Bulk-fill composite resin; Nano-fill composite resin
Intervention type(s): Device; Device
Intervention description(s): Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation; Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation
Other intervention name(s): Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany); Grandio (Voco , Cuxhaven, Germany)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In a split-mouth design, 89 patients' 2 mandibular first molars were divided into 2 groups. Per patient, one mandibular first molar had bulk-fill ormocer-based composite resin restoration and 1 mandibular first molar had nanofill composite resin restoration via incremental technic.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia
Condition: Major Depressive Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to examine the effectiveness of brief behavioral therapy for
      insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for
      refractory insomnia among patients with major depression in partial remission.
    


Intervention name(s): brief behavioral therapy for insomnia (bBT-I); Treatment as usual (TAU)
Intervention type(s): Behavioral; Other
Intervention description(s): 4 50-minute individual sessions every week for 4 weeks; The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive disorder; Sleep initiation and maintenance disorder; Behavior therapy
Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase Ib/IIa to evaluate the safety and tolerability of oral treatment with OST-122 in
      patients with moderate to severe ulcerative colitis over 28 days. This trial will also
      explore pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with
      OST-122 through biomarker analysis and clinical, endoscopic and histologic assessments.
    

Detailed description: 
      OST-122 is an oral, gut-restricted and subtype-selective Jak3/Tyk2/Ark5 inhibitor for the
      local treatment of inflammatory bowel disease (IBD) including ulcerative colitis, Crohn's
      disease and, potentially, fibrotic lesions in Crohn's patients. The compound was well
      tolerated in a Phase 1 study in healthy volunteers and has been shown to be stable during the
      GI transit, while no significant plasma levels were detected. The gut-restricted PK profile
      of OST-122 lowers the risk of systemic toxicities inherent to other JAK inhibitors. In the
      current proof of concept study, the compound's safety, PK profile and trends of efficacy will
      be investigated in patients with moderate to severe ulcerative colitis.
    

Intervention name(s): OST-122; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active dose; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
Condition: Breast Cancer; Ovarian Cancer; Colon Cancer; Lung Cancer; Gastric Cancer; Solid Tumors
MeSH terms: Ovarian Neoplasms; Stomach Neoplasms; Colonic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac
      repolarization in patients with solid tumors who's cancer has recurred or is no longer
      responding to current treatment.
    


Intervention name(s): Veliparib (ABT-888); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Veliparib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Solid Tumors; Ovarian Cancer; Colon Cancer; Lung Cancer; Breast Cancer; Gastric Cancer
Influence of Polishing After Bleaching on Color Change and Enamel Morphology
Condition: Tooth Discoloration; Morphologic Change; Tooth Sensitivity
MeSH terms: Dentin Sensitivity; Tooth Discoloration
Study type: Interventional

Summary: 
      This trial evaluated the influence of polishing on enamel color change after in-office
      bleaching treatment. It also evaluated the influence of polishing on tooth morphology and
      sensitivity.
    


Intervention name(s): Hydrogen Peroxide 35%; Hydrogen Peroxide 35% + Polishing whitened teeth
Intervention type(s): Other; Other
Intervention description(s): Group that received only bleaching treatment. Soft tissue protection was performed with a Top Dam light-curing gingival barrier (FGM, Santa Catarina, SC, Brazil). Application of whitening gel (Whitness HP 35%/FGM) on the buccal surface from premolar to premolar in the upper and lower arches. Three 45-minute sessions were held with an interval of seven days between them.; Group that received only bleaching treatment followed by polishing. Soft tissue protection was performed with a Top Dam light-curing gingival barrier (FGM, Santa Catarina, SC, Brazil). Application of whitening gel (Whitness HP 35%/FGM) on the buccal surface from premolar to premolar in the upper and lower arches. Three 45-minute sessions were held with an interval of seven days between them. After bleaching, the vestibular surfaces were polished for 20s on each bleached tooth, with polishing paste and felt disc (Diamond Flex, FGM, Santa Catarina, SC, Brazil) in low rotation.
Intervention MeSH terms: Hydrogen Peroxide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
Condition: Bone Tumor
MeSH terms: Bone Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety
      and pharmacodynamic of MW032 and Xgeva® in healthy adults.
    

Detailed description: 
      This is a phase I, single center, randomized, double-blind and parallel group clinical trial.

      The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous
      injections of MW032 and Xgeva® in healthy volunteers.

      The secondary objective are to assess the Clinical safety and immunogenicity similarity of
      single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.

      At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and
      Xgeva®.

      Subjects would receive a single 120mg（1.7mL）of MW032 or Xgeva® through subcutaneous
      injection.
    

Intervention name(s): MW032; Xgeva®
Intervention type(s): Drug; Drug
Intervention description(s): Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment.; Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Denosumab; Biosimilar
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body
      build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery
      may be a more effective treatment for malignant glioma.

      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in
      treating young patients who are undergoing surgery for malignant glioma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor
           lysate-pulsed dendritic cells after surgical resection in pediatric patients with
           malignant glioma.

        -  Determine the maximum tolerated dose of this vaccine in these patients.

      Secondary

        -  Determine, preliminarily, the survival of patients treated with this vaccine.

        -  Determine, preliminarily, the time to tumor progression in patients treated with this
           vaccine.

        -  Determine cellular immune response in patients treated with this vaccine.

        -  Determine age-dependent differences in response to this vaccine, in terms of
           immunocompetence, in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate.
      Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for
      generation of dendritic cells (DC). DC are pulsed with tumor lysate to produce an autologous
      dendritic cell vaccine. Approximately 10-30 days after leukapheresis, patients receive
      vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0, 14,
      and 28 in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of vaccine until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity.

      After completion of study treatment, patients are followed at 2 weeks and then every 2 months
      for 1 year.

      PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2-4.5
      years.
    

Intervention name(s): therapeutic autologous dendritic cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood high-grade cerebral astrocytoma; recurrent childhood cerebral astrocytoma; childhood oligodendroglioma
Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride
      (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada
      and the US.
    

Detailed description: 
      The SPD503-315 clinical program has studied the efficacy, safety, and tolerability of this
      product in treating symptoms of ADHD in children and adolescents aged 6-17 through
      short-term, placebo-controlled studies and long-termn, open-label studies. This study will
      more rigorously assess the long-term maintenance of efficacy using a placebo-controlled,
      randomised-withdrawal design. To date, all of the completed studies conducted as part of the
      SPD503 proigram have enrolled subjects from the US. This study is designed to evaluate the
      long-term maintenance of efficacy of SPD503 for the treatment of ADHD in children aged 6-17
      years in Europe, Australia, Canada and US.
    

Intervention name(s): Extended-release Guanfacine Hydrochloride (SPD503); Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): dosing in all subjects will initiate with 1mg/day, and may be increased by 1 mg increments after a minimum of 1 week on the current dose to the maximum doses based on age and weight.
Other intervention name(s): Extended-release Guanfacine Hydrochloride; SPD503
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Dexmedetomidine and Remifentanil Infusion During CABG
Condition: Coronary Artery Bypass Graft; Hypokalemia; Cardiac Arrhythmia; Dexmedetomidine; Remifentanil
MeSH terms: Arrhythmias, Cardiac; Hypokalemia; Potassium Deficiency
Study type: Interventional

Summary: 
      We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease
      the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients
      undergoing off-pump coronary artery bypass graft, and trying compare these effects with those
      of remifentanil infusion.
    

Detailed description: 
      Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or
      adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the
      central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood
      pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine
      stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase
      the incidence of arrythmia, especially in cardiac patients. We postulated that
      dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia
      during cardiac surgery. Furthermore, dexmedetomidine have been reported to have
      cardioprotective effect with previous animal studies.

      Therefore, the aim of the present study is to investigate whether the intraoperative
      dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and
      myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also
      trying to compare these effects with those of remifentanil infusion.
    

Intervention name(s): Dexmedetomidine infusion; Remifentanil infusion
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery; Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Other intervention name(s): Dexmedetomidine; Remifentanil
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: coronary artery bypass graft; hypokalemia; cardiac arrhythmia; dexmedetomidine; remifentanil