bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To reduce the number of donors treated with IV AMD3100 who require a second collection to
      obtain the minimum cells necessary for allogeneic stem cell transplant.
    

Detailed description: 
      -  To reduce the number of donors treated with intravenous (IV) AMD3100 who require a
           second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem
           cell transplantation when compared to our historic group who received 240ug SC AMD3100
           from 33% (8 in 24) to 11% (3 in 27).

        -  To estimate with 95% confidence intervals the proportion of human leukocyte antigen
           (HLA)-identical sibling donors who experience grade 3-4 infusional toxicity and the
           proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized
           following one or two intravenous infusions.

        -  To determine the kinetics of stem cell and lymphocyte mobilization using IV AMD3100 and
           to determine if peripheral blood stem cell products collected after mobilization with IV
           AMD3100 can be used safely for hematopoietic cell transplantation in HLA-matched
           recipients as measured by neutrophil engraftment by day +21.

        -  To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and
           T-cell phenotyping and on immune reconstitution after transplantation.

        -  To determine the rate of acute graft-versus-host disease (GVHD) and chronic GVHD in
           patients who receive IV AMD3100 mobilized peripheral blood stem cells.
    

Intervention name(s): AMD3100; Leukopheresis; Stem cell transplant
Intervention type(s): Drug; Procedure; Procedure
Other intervention name(s): Mozobil; Plerixafor
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Age on Dexmedetomidine Pharmacodynamic
Condition: Spinal Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its
      selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent
      sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects
      .At earlier time It was approved by the FDA only for short-time sedation during mechanical
      ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory
      , currently it was more and more widely used to sedate patients undergoing regional
      anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age
      and gender,such as the drug sensitivity of propofol and remifentanil is increased with
      age,while the current study also demonstrated that gender may influence the sedate efficacy
      of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to
      the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim
      to explore the right DEX dose of different Age of patients to produce suitable
      sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for
      sedation,which is monitored by the BIS,during the operation.The relation between BIS values
      and the depth of sedation for patients is also investigated.
    

Detailed description: 
      120 patients scheduled to undergo lower extremity surgery were included in one of three
      groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood
      up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in
      the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose
      adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an
      OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.
    

Intervention name(s): Dexmedetomidine 01; Dexmedetomidine 02
Intervention type(s): Drug; Drug
Intervention description(s): Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg.; Initial doses was 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Age; Pharmacodynamics; dexmedetomidine
Health-related Quality of Life in a Cohort of Spanish Schoolchildren.
Condition: Quality of Life; Physical Inactivity
Study type: Observational

Summary: 
      Background: Health-related quality of life (HRQoL) allows knowing the subject&#39;s feelings
      in terms of distress and well-being, as well as her perception of her current and future
      health.

      Objective: Evaluate the associations between health-related quality of life, physical state,
      and adherence to the Mediterranean diet in a cohort of Spanish children and adolescents.
      Methods: A cross-sectional study was carried out in a cohort of 305 (47.2% women) children
      and adolescents aged between 8 and 16 years, in the Primary and Secondary Schools of the
      province of Ávila (Spain). For the analysis of the different variables, the subjects were
      classified according to their quality of life in three groups from highest to lowest (Group 1
      &gt; Group 2 &gt; Group 3).
    


Intervention name(s): The short questionnaire of healthy habits
Intervention type(s): Behavioral
Intervention description(s): collects sociodemographic data, weight, height, and physical activity, self-reported.
Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        school children aged 8 to 16.
      
Keywords: Health-related quality of life; physical state; adherence to the Mediterranean diet; schoolchildren
A Walking Intervention Through Text Messaging
Condition: Physical Activity; Behavior; Overweight; Motor Activity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate adaptive goal setting and feedback
      interventions (Adaptive Interventions) to promote physical activity behaviors and compare it
      to static physical activity interventions (Static Interventions) using two levels of goal
      setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures
      (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All
      four groups will receive the intervention via a semi-automated text message system developed
      by the investigators study team.

      The primary aim of this study will be to:

        1. Evaluate whether the adaptive interventions result in greater change in physical
           activity (pedometer-measured steps/day) compared to the static Intervention groups.
           HYPOTHESES: Participants in the adaptive interventions will increase their steps/day
           more than participants in the Static Intervention groups. The Adaptive Goals and
           Reinforcement Group will outperform the other 3 groups.

           The secondary aims of this study will be to:

        2. Evaluate the effectiveness of the adaptive and static goal interventions in improving
           anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES:
           Participants in the adaptive interventions will show greater improvements in fitness,
           lean and fat body mass, and serum biomarkers than participants in the Static
           Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the
           other 3 groups.

        3. to assess participants' satisfaction with the overall program.
    


Intervention name(s): Adaptive Goals; Reinforcement; Static Goals
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
Condition: Ovarian Carcinoma; Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with
      recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers
      to identify objective response rate and to assess for early markers of activity and to assess
      correlative markers that may provide helpful information for subsequent clinical trials.
      Approximately 110 patients from 7 centers in Canada will be enrolled into this study
    


Intervention name(s): AZD2281
Intervention type(s): Drug
Intervention description(s): PARP inhibitor Olaparib tablets, oral
Other intervention name(s): Olaparib
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 parallel arms for the 2 tumour types and the BRCA mutation groups:
Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally
High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally
Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Ovarian cancer; BRCA; Triple negative; Poly(ADP ribose) polymerases; Known BRCA or Recurrent High Grade Serious/ Undifferentiated Tubo- Ovarian Carcinoma; Known BRCA or Triple Negative Breast Cancer
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
Condition: Primary Erythromelalgia; Inherited Erythromelalgia
MeSH terms: Erythromelalgia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether XPF-001 is safe and effective in the
      treatment of pain caused by Inherited Erythromelalgia (IEM).
    


Intervention name(s): XPF-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety Study of Nebulized RNS60 to Treat Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in
      healthy human subjects and in subjects with mild asthma, in a single-dose administration.
      Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate
      asthma over a 4-week period.
    


Intervention name(s): RNS60; RNS60 - single dose
Intervention type(s): Drug; Drug
Intervention description(s): RNS60, 4ml nebulized twice daily for 15 minutes.; RNS60, single 4 ml dose nebulized for 15 minutes
Intervention MeSH terms: RNS60
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perioperative Dexamethasone on Postoperative Outcome in IBD
Condition: Inflammatory Bowel Diseases; Dexamethasone; Postoperative Ileus; Postoperative Complications
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Postoperative Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this RCT is to determine the efficacy of a single preoperative dose of
      Dexamethasone for accelerating the recovery and reducing the incidence of postoperative
      complications in adult patients undergoing intestinal resection for inflammatory bowel
      disease.
    

Detailed description: 
      Patients undergoing surgery for IBD is associated with increased inflammatory response and
      incidence of prolonged ileus after surgery compared to other colorectal disease such as CRC.
      Previous studies have revealed that preoperative administration of glucocorticosteroids(GCs)
      decreased complications and length of postoperative length of hospital after major abdominal
      surgery as a likely consequence of attenuating the postsurgical inflammatory response. Also,
      a single dose of GCs did not increase complications in colorectal surgery. The aim of the
      study is to examine whether a single dose of dexamethasone prior to induction of anesthesia
      could promote the recovery of patients and reduce the incidence of prolonged ileus after
      surgery for IBD
    

Intervention name(s): Dexamethasone; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 8mg intravenously prior to induction of anesthesia; Normal saline 1.6ml intravenously prior to induction of anesthesia
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Diseases; Glucocorticosteroids; Postoperative Outcome
Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, randomized, double-blinded study is designed to evaluate the postoperative
      analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in
      patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the
      intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce
      postoperative opioid consumption and pain severity in patients with VATS.
    

Detailed description: 
      Adult patients undergoing elective unilateral VATS wedge resection, segmentectomy, or
      lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen
      (300 mg) fixed-dose combination (n=48) or not (n=48). At the end of induction, the
      intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15
      min, every 6 hours, a total of 4 times. The control group will receive intravenous normal
      saline with the same volume and same time points as the intervention group receives.
    

Intervention name(s): acetaminophen/ibuprofen fixed-dose combination; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml); 100 ml of normal saline
Other intervention name(s): Maxigesic; Placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized double-blinded study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Pain
Tailored Messaging for CRC Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a randomized controlled trial to to determine whether direct, tailored messaging to
      patients prior to scheduling colonoscopy will increase patient adherence to provider
      recommendation for screening colonoscopy.
    

Detailed description: 
      The proposed study is a prospective, randomized trial. All eligible subjects (patients
      identified to be contacted to schedule screening colonoscopy) will be randomized to one of
      three study arms: usual scheduling process (control), a generic message arm, or a tailored
      message arm. Patients in the "tailored message" arm will receive a telephone call and be
      asked a series of questions that will be used to assign patients to one of four messaging
      cohorts. After these questions have been answered, the patient will then receive a tailored
      message corresponding to his or her respective messaging cohort, encouraging them to schedule
      a colonoscopy with a directed script. In the "generic message" arm, patients will receive a
      telephone call and be asked to answer the same series of questions as the "tailored message"
      group, then receive a single, standard script encouraging them to schedule a colonoscopy.
    

Intervention name(s): Generic message; Tailored message
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Generic message; Tailored message
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal cancer screening
Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Stimulation of the left and right auditory cortex with daily transcranial random noise
      stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
    

Detailed description: 
      Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a
      result of functional reorganization of auditory neural pathways and the central auditory
      system. These changes are represented by hyper-activity and hyper-synchronicity in the
      auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has
      shown to be effective in the treatment of chronic tinnitus with moderate effect size.
      Preliminary data presented on international conferences suggest the use of transcranial
      random noise stimulation (tRNS) over both auditory cortices as new and highly effective
      treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling
      hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to
      feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an
      one-arm pilot trial.
    

Intervention name(s): Transcranial random noise stimulation (tRNS)
Intervention type(s): Device
Intervention description(s): High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tinnitus; transcranial random noise stimulation; tRNS; auditory cortex; non-invasive brain stimulation
Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem 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: 
      This phase I trial is studying the side effects and best dose of vandetanib when given
      together with radiation therapy in treating young patients with newly diagnosed diffuse brain
      stem glioma.
    

Detailed description: 
      Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Specialized radiation therapy that delivers a high dose of radiation directly to the
      tumor may kill more tumor cells and cause less damage to normal tissue. Giving vandetanib
      together with radiation therapy may kill more tumor cells.

      Patients undergo conformal radiotherapy once daily, 5 days a week, for 6 weeks. Patients also
      receive oral vandetanib once daily beginning on the same day as radiotherapy and continuing
      for up to 2 years in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of vandetanib until the maximum tolerated
      dose (MTD) is determined.

      Blood samples are collected periodically for pharmacokinetic studies, polymorphism analysis
      (e.g., CYP3A4/5), and immunological laboratory methods (e.g., western blot assay). Imaging
      studies are also conducted periodically.
    

Intervention name(s): vandetanib
Intervention type(s): Drug
Intervention description(s): Oral vandetanib administration will start on the same day as RT. Treatment with vandetanib will extend for the entire duration of RT, and then will be continued after completion of RT for a maximum duration of 2 years.
Other intervention name(s): ZD6474; Zactima
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated childhood brain stem glioma