bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewing's Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Biological therapies use different ways to stimulate the immune
      system and stop cancer cells from growing. Combining chemotherapy with biological therapy may
      kill more tumor cells.

      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy
      with or without biological therapy in treating patients who have newly diagnosed high-risk
      Ewing's sarcoma.
    

Detailed description: 
      OBJECTIVES: I. Compare the effects of dose intensive regimens of vincristine, doxorubicin,
      cyclophosphamide, and dexrazoxane with or without ImmTher (a muramyl dipeptide liposome) on
      the 2 year disease-free survival of patients with newly diagnosed high risk Ewing's sarcoma.
      II. Evaluate the feasibility and determine the toxicity of administering weekly ImmTher for 1
      year to these patients. III. Determine which therapy is worthy of further evaluation.

      OUTLINE: This is a randomized study. Patients are stratified according to the presence of
      bony metastases at diagnosis. Patients are randomized to one of two treatment arms. All
      patients receive dexrazoxane IV followed 30 minutes later by doxorubicin IV over 30 minutes
      on day 1, vincristine IV on day 1, and cyclophosphamide IV over 6 hours on days 1 and 2.
      Treatment is repeated every 3 weeks for 3-6 courses in the absence of disease progression or
      unacceptable toxicity. Patients are evaluated after course 3 and undergo surgery and/or
      radiation therapy. The next 3 courses of chemotherapy are administered after recovery from
      surgery/radiation therapy. Within 1 month after completion of all chemotherapy courses,
      patients randomized to arm I receive ImmTher IV over 60 minutes weekly for 1 year. Patients
      randomized to arm II receive no further therapy. Patients are followed every 6 weeks for 2
      years.

      PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within
      approximately 5 years.
    

Intervention name(s): cyclophosphamide; dexrazoxane hydrochloride; disaccharide tripeptide glycerol dipalmitoyl; doxorubicin hydrochloride; vincristine sulfate; surgical procedure; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vincristine; Dexrazoxane; Razoxane; Glycerol
Allocation: Randomized
Primary purpose: Treatment
Keywords: nonmetastatic childhood soft tissue sarcoma; metastatic childhood soft tissue sarcoma; extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor; localized Ewing sarcoma/peripheral primitive neuroectodermal tumor; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
Skeletal Muscle and Adipose Tissue Study
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare the current standard of care for
      prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of
      Cefazolin during pediatric spinal surgery.
    

Detailed description: 
      Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using
      microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing
      posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion
      or intermittent bolus.
    

Intervention name(s): Bolus dose of Cefazolin; Continuous Cefazolin drip; Paraspinal muscle microdialysis catheters; Subcutaneous microdialysis catheters
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): Mode of Cefazolin administration will be a intermittent bolus; Mode of Cefazolin administration will be a continuous drip; Two dialysis probes will be inserted into a paraspinal muscle; Two dialysis probes will be inserted into a paraspinal subcutaneous region
Other intervention name(s): Standard mode of prophylactic cefazolin administration; Continuous infusion of prophylactic cefazolin; Paraspinal muscle dialysate sample; Subcutaneous dialysate sample
Intervention MeSH terms: Cefazolin; Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tissue microdialysis; spinal fusion; surgical site infection
Subclinical Delirium and Clinical Outcome
Condition: Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      Delirium has been associated with clinical outcomes in critical care setting. However, its
      subclinical form has not been investigated. The investigators aimed to establish the
      association of subclinical delirium with outcome.
    

Detailed description: 
      Delirium has been associated with clinical outcome in critical care setting. This syndrome
      has been associated with longer length of stay in ICU and hospital, longer duration of
      mechanical ventilation and higher mortality rate. however, its subclinical form has not been
      investigated. The subclinical syndrome is defined by CAM-ICU, in which several features of
      delirium are fulfilled but the diagnostic criteria are not fulfilled. The investigators aimed
      to establish the association of subclinical delirium with outcome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients enter ICU GCS > 10 RASS > -2 No dementia
      
Keywords: delirium; outcome
A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and
      pharmacodynamic effects of Aes-103 (active ingredient 5-hydroxymethyl-2-furfural [5-HMF])
      compared with placebo in subjects with stable sickle cell disease (SCD). Safety will be
      measured by monitoring adverse events (AEs), electrocardiograms (ECGs), vital signs, and
      laboratory values. Pharmacokinetics of Aes-103 will be measured over time in plasma, red
      blood cell hemolysate and binding of Aes-103 to hemoglobin. Pharmacodynamic effects will be
      assessed by measuring partial pressure of oxygen at which 50% of hemoglobin is saturated with
      oxygen (p50) while breathing normal air, blood oxygen levels (SpO2), ex-vivo antisickling
      effects in a hypoxic environment, and by imaging related changes in tissue blood flow and
      oxygen levels.
    


Intervention name(s): Aes-103; Aes-103; Aes-103; Aes-103; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.; 1000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.; 2000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.; 4000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.; Orange juice vehicle, a solution that is highly similar in appearance to the Aes-103 orange juice solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antisickling Agents
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
Condition: Novel 2009 Influenza H1N1
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
      S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
    


Intervention name(s): MF59-eH1N1_f; eH1N1_f
Intervention type(s): Biological; Biological
Intervention description(s): MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal; Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Swine Flu; Flu; Vaccine; Adjuvant
Impact Evaluation of Family Expectations: A Program to Strengthen the Relationships of Disadvantaged Expectant Couples
Condition: Committed Couple Expecting a Child; Parenting; Family Relations
Study type: Interventional

Summary: 
      This study investigates the effectiveness of a program to strengthen the relationships of
      disadvantaged expectant couples, and to increase co-parenting, father involvement, and
      economic stability. Couples are randomly assigned to Family Expectations or a control group,
      and assessed at baseline and one year.
    

Detailed description: 
      The birth of a child can trigger relationship distress and dissolution. Family Expectations
      (FE) targets the transition to parenthood as a critical time to help couples focus on family
      success. Regardless of whether couples are married or unmarried, the goal of FE is to
      strengthen relationships and advance the well-being of economically disadvantaged couples who
      are expecting a baby or who are new parents, and to improve the lives of their children. The
      FE program, including the Becoming Parents (BP) curriculum and supplemental services, is
      designed to address specific risk factors that affect individual family members and the
      relationships among them, and to build protective factors that help families avoid, minimize,
      or manage risks (e.g., individual maladaptation [mother, father, child], couple relationship
      difficulties, parenting difficulties, and economic insufficiency).

      A total of 1,355 couples will be randomly assigned to either Family Expectations (n = 813;
      60%) or an untreated control group (n = 542; 40%). Once assigned, participants in the study
      will complete baseline questions by survey. Those assigned to the FE track will be scheduled
      for services with the FE intervention team and the control group will not receive the FE
      intervention. Members of the intervention and control groups will be surveyed both before
      they are randomly assigned and 12 months later. The study will examine if the Family
      Expectations program is associated with improved outcomes on relationship quality, stability,
      parenting quality, father involvement, child wellbeing, and hopefulness about employment.
    

Intervention name(s): Family Expectations
Intervention type(s): Behavioral
Intervention description(s): Relationship education and referral services for expectant couples.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Expectant parents; Relationship education
Intensity of Physical Activity Measured by Activity Monitors in Elderly Persons
Condition: Healthy
Study type: Observational

Summary: 
      Aim of this study is to identify intensity cut off points for physical activity in a
      population over the age of 70.
    

Detailed description: 
      Activity monitors measure activity in counts. The higher the counts, the higher the intensity
      of the measured activity. In this study the count cut off points for low, moderate and high
      intensity activity will be investigated in a population of elderly people over the age of 70.
      This information will subsequently (in future studies) be used to investigate the physical
      activity patterns in a population of elderly over the age of 70 who have worn an activity
      monitor for a duration of 7 days.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Persons in the age of 70-76 living in Trondheim, Norway
      
Keywords: oxygen consumption; activity monitors; METs; intensity
Thoraco-Lumbar Fascia Mobility
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to
      measure the movement of connective tissue in the low back area of individuals with chronic
      low back pain (lasting more than 1 year). This study will compare baseline measurements,
      measurements after a single high velocity low amplitude spinal manipulation (HVLA-SM) and
      after a course of up to 16 HVLA-SM.
    

Detailed description: 
      The investigators will conduct a single arm pilot (proof-of-concept) clinical trial.
      Approximately 30 participants with self-reported chronic low-back pain (LBP), defined as pain
      for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be
      enrolled.

      This trial will consist of two separate enrollment phases. Phase 1 consists of enrollment at
      baseline followed by 3 separate ultrasound measurements. Phase 1 ends after a 4-week no
      treatment run-in phase.

      Phase 2 begins twice-weekly HVLA-SM treatments to the thoracolumbar region for 8-weeks. Two
      ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). Pre-treatment
      ultrasound evaluations will be obtained at 4-weeks and 8-weeks.

      The primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound)
      at the level of the lumbar L2-L3 vertebrae bilaterally. Ultrasound measures will be obtained
      with a Terason t3000 system using a 12L5 linear array probe with 10 MHz setting. Because
      shear strain may differ between sexes, we will attempt to recruit equal numbers of male and
      female participants.
    

Intervention name(s): High Velocity Low amplitude spinal manipulation (HVLA-SM)
Intervention type(s): Other
Intervention description(s): HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.
Intervention model: Single Group Assignment
Intervention model description: Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Back Pain; Ultrasound; Fascia
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability
      in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose
      of Vadadustat.
    


Intervention name(s): Vadadustat
Intervention type(s): Drug
Intervention description(s): oral capsules
Other intervention name(s): AKB-6548
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD; CKD, Stage 3; CKD, Stage 4; Vadadustat; pharmacokinetics
MRS Probe Study of Alcohol
Condition: Heavy Dose Drinkers
Study type: Interventional

Summary: 
      This protocol will investigate the neurobiological underpinnings of alcohol craving in
      recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This
      clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and
      other brain metabolites correlate to measures of alcohol craving severity
    


Intervention name(s): Magnetic Resonance Spectroscopy
Intervention type(s): Procedure
Other intervention name(s): MRS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: MRS; Heavy dose drinkers; Alcohol; NIAAA
Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
Condition: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Indeterminate Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Ulcer
Study type: Interventional

Summary: 
      A series of N-of-1 trials will be used to determine the effectiveness of a specific
      carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and
      inflammatory burden at both the individual and population level. This is a four-year study.
      The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18
      with mild to moderate disease activity.
    


Intervention name(s): Specific Carbohydrate Diet (SCD); Modified Specific Carbohydrate Diet (MSCD)
Intervention type(s): Other; Other
Intervention description(s): Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.; Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: We are using a series of N-of-1 trials where patients alternate (cross) between the two study interventions at set intervals. N-of-1 trial results will be examined at the individual and population level (through meta-analysis of individual N-of-1 trials)
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Two Different Formulations of Pirtobrutinib (LOXO-305) In Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare two different formulations (mixtures) of
      pirtobrutinib (LOXO-305) in healthy participants. This study will compare how much of each
      formulation gets into the blood stream and how long it takes the body to remove it.
      Information about any side effects that may occur will be collected. The study will last up
      to 65 days.
    


Intervention name(s): Pirtobrutinib
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Pirtobrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different
      ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose
      cytarabine works in treating patients with acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the complete remission rate (CR).

        -  Determine the proportion of patients who are bone marrow-positive at day 7
           post-induction chemotherapy.

        -  Further evaluate the toxicity of this regimen.

      OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and
      idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy
      7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or >
      10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
    

Intervention name(s): cytarabine; idarubicin
Intervention type(s): Drug; Drug
Other intervention name(s): Cytosine Arabinoside; Cytosar-U; Depocyt; 4-demethoxydaunorubicin; Idamycin; Zavedos
Intervention MeSH terms: Cytarabine; Idarubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); secondary acute myeloid leukemia; untreated adult acute myeloid leukemia
Evaluation of Procedural Analgesia for Liposonix Treatment
Condition: Body Contouring
Study type: Interventional

Summary: 
      The objectives of this study are to evaluate the safety and effectiveness of procedural
      analgesia for improvements in tolerability of treatment with the Liposonix System.
    


Intervention name(s): Liposonix System (Model 2); Pre-treatment analgesia
Intervention type(s): Device; Drug
Intervention description(s): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).; Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effects of the investigational drug, SB-509 on
      progression of the disease in subjects with ALS
    

Detailed description: 
      SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a study
      doctor injects SB-509 into the muscles of your neck, arms and/or legs, the drug enters the
      muscle and nerve cells around the injection sites and causes these cells to make a protein.
      This protein causes your cells to increase production of one of your own protein called
      vascular endothelial growth factor(VEGF-A), which may improve the structure and function of
      nerves and muscles. In addition, there are changes in the levels of 28 additional proteins in
      your cells. These proteins function to promote the growth of cells, are structures in cells,
      help synthesize products, and affect immune cells, and some have unknown functions. This
      increase in your own VEGF proteins may protect and repair the damaged nerves and muscles
      caused by ALS.
    

Intervention name(s): SB-509
Intervention type(s): Drug
Intervention description(s): Intramuscular injection of 60 mg of SB-509. Two doses on Day 0 and Day 90.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis,; ALS,; Lou Gehrig's Disease