bioihbjkbjnl/mcl2 huggingface dataset:
Preemptive Therapy With CMV-specific T Cells Infusion to Prevent Refractory CMV Infection Post Transplantation
Condition: CMV Infection
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cytomegalovirus (CMV) infections remain an important cause of morbidity and mortality in
      allogeneic hematopoietic cell transplant (HSCT) recipients, especially in patients received
      haploidentical transplantation. During the past decades, prophylactic or preemptive treatment
      with antiviral drugs has significantly reduce the incidence of early-onset CMV infection.
      Unfortunately, prolonged antiviral treatment is associated with substantial toxicity and may
      delay recovery of virus specific immune responses, resulting in an increasing of late-onset
      CMV disease.

      To date, adoptive immunotherapies have been developed as treatment alternatives to antiviral
      agents for CMV infection after HSCT. Studies have demonstrated that prophylactic or
      preemptive therapy with donor CMV-specific T cells can restore antiviral immunity and clear
      CMV viremia after transplantation. In this prospective clinical phase I/II trial, we propose
      to reconstitute antiviral immunity against CMV by preemptive transfer of CMV-specific T cells
      at an early time point after allogeneic stem cell transplantation. We also propose to
      demonstrate whether protect against CMV is associated with recovery of CMV-specific T cells.
    

Detailed description: 
      Acute lymphoblastic leukemia (ALL) patients enrolled into this clinical trial are standard
      risk patients diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and received
      haploidentical blood and marrow transplantation. When patients develop acute graft versus
      host disease (aGVHD), CMVpp65-specific T cells will be generated and transferred to the aGVHD
      controlled patients(patients who do not develop aGVHD are at low risk of refractory CMV
      infection, and are not include in treated group). Physical exams and blood tests will be
      performed -2w, -0d before and +1d, +2w, +4w, +8w, +12w, +24w after adoptive CMV-CTL
      transfusion. The end points were safety and clinical and immunologic response. Following time
      is 12 months.
    

Intervention name(s): Donor-derived CMVpp65-specific T cells
Intervention type(s): Biological
Intervention description(s): About 1 million per kg CMVpp65-specific T cells will be infused once acute GVHD ocurred post haploidentical transplantation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CMV-specific T cell; haploidentical stem cell transplantation; immunologic response; acute GVHD
Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
Condition: Recurrent Pregnancy Loss; Fetal Demise; Abortion, Habitual; Antiphospholipid Antibodies; Inherited Thrombophilia
MeSH terms: Abortion, Habitual; Fetal Death; Thrombophilia
Study type: Observational

Summary: 
      To determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a
      low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who
      have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited
      thrombophilia.
    

Detailed description: 
      This study's specific objectives include:

        1. Evaluating pharmacokinetic (concentration-time) and pharmacodynamic (concentration-
           effect) parameters for dalteparin and UFH prior to pregnancy, during the 1st, 2nd and
           3rd trimesters and postpartum, using revised dosing protocols based on previous study.

        2. Determining therapeutic response to the heparins, i.e. live birth rate and lack of
           maternal or fetal complications, in relation to drug exposure, based on AUC.

        3. Documenting maternal and fetal complications during pregnancy for dalteparin and UFH,
           using the revised dosing protocols.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 15 subjects prescribed dalteparin and 15 subjects
        prescribed unfractionated heparin, who are identified through the University of Chicago
        Recurrent Pregnancy Loss Program.
      
Biospecimen description: 
      Plasma from subjects to obtain concentrations of heparin will be retained
    
Keywords: Recurrent Pregnancy Loss; Habitual abortion; Fetal demise; Antiphospholipid antibodies; Inherited thrombophilia
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination
      with Metformin in pediatric patients with type 2 diabetes
    

Detailed description: 
      A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy
      and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in
      Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin
      Alone or in Combination with Baseline Insulin Therapy
    

Intervention name(s): Placebo matching with Saxagliptin; Metformin IR; Metformin XR; Saxagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52; Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52; Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52; Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
Other intervention name(s): BMS-477118
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Smartphone Addiction on Myoelectrical Activity of Sternocleidomastoid Muscle in Adult
Condition: Heavy Smart Phone Users
MeSH terms: Internet Addiction Disorder
Study type: Observational

Summary: 
      This study will be conducted to identify the effect of smartphone addiction myoelectrical
      activity on sternocleidomastoid in adults by measuring The amplitude of EMG signals of the
      sternocleidomastoid muscle in adults and Root mean square of EMG signals of the
      sternocleidomastoid muscle in adults
    


Intervention name(s): EMG
Intervention type(s): Device
Intervention description(s): Neuro-EMG-Micro, Neurosoft, Ivanovo, Russia, will be used for the assessment of muscle activity for muscles.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        smart phone users
Safety and Tolerability of NTRX-07 in Healthy Volunteers
Condition: Pain, Neuropathic
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult
      healthy volunteers (HVs).
    

Detailed description: 
      Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel
      subjects and a staggered-dosing-days approach.

      Up to 6 cohorts, A-F, are planned for a total of 48 completing subjects. Each dose cohort
      will be randomized with 6 subjects receiving active drug and 2 placebo.
    

Intervention name(s): NTRX-07-SDD
Intervention type(s): Drug
Intervention description(s): NTRX-07-SDD for oral administration
Other intervention name(s): MDA7
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Preoperative Use of Montelukast Sodium
Condition: Airway Reactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Supraglottic airway equipment used during anaesthesia application can lead to airway
      reactivity or even larynx spasm in sensitive children.

      Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist
      which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of
      Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and
      corticosteroids.
    

Detailed description: 
      The study will comprise 30 american society of anesthesiology (ASA) I-III patients, aged 4-8
      years, undergoing inguinal hernia surgery. Patients will exclude if receiving asthma
      treatment, if they had upper respiratory tract infection in the last week and if the
      laryngeal mask airway (LMA) could not be placed at a single attempt.

      Patients will be separated into 3 groups as Group E (n=10) with high immunoglobulin E (IgE),
      Group C (n=10) with normal IgE and Group M (n=10) who were administered with 4mg peroral
      Montelukast Sodium, 10 days before surgery because of high IgE.

      With spontaneous breathing after anaesthesia induction, a classic LMA will be placed.
      Anaesthesia will be maintained with a mixture of 1.3 minimum alveolar concentration (MAC)
      sevoflurane 500%2 - N2O. At 5-minute intervals, oxygen saturation (sPO2), End-Tidal carbon
      dioxide, Heart Rate, tidal volume (VT), respiratory rate (f) and peak airway pressure (PAP)
      will be monitored and coughing, apnea, laryngospasm , bronchospasm, desaturation and need for
      steroids will be noted.
    

Intervention name(s): montelukast sodium
Intervention type(s): Drug
Intervention description(s): 4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Airway Resistance; montelukast sodium; laryngeal mask airway
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
Condition: Incomplete Abortion
MeSH terms: Abortion, Incomplete
Study type: Interventional

Summary: 
      This study will investigate the use of misoprostol for first-line treatment of incomplete
      abortion at tertiary hospitals in Myanmar.
    

Detailed description: 
      This open-label feasibility study seeks to examine the potential of 400μg sublingual
      misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): 400 mcg sublingual misoprostol
Other intervention name(s): cytotec
Intervention MeSH terms: Misoprostol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury
Condition: Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study examines the possible microstructural changes in the brain during recovery after
      mTBI using diffusion MRI.
    

Detailed description: 
      This study is embedded in a larger randomized controlled trial (RCT) (ClinicalTrials.gov ID:
      NCT02337101) from which the subjects are recruited and will separately examine the possible
      microstructural changes in the brain during recovery after mild traumatic brain injury (mTBI)
      in subjects with ongoing symptoms more than 2 month after mTBI in both groups from the RCT.

      Several biomarkers and brain areas has been investigated as possible sites of injury after
      mTBI. The nature of the diffuse chronic post-concussion symptoms (PCS) makes corpus callosum
      (CC), thalamus (THA) and hippocampus (HIP) interesting because of their central position and
      connection to widespread motor, sensory and cognitive processes and other brain areas. In
      most prior studies conventional magnetic resonance imaging (MRI) has failed to detect
      pathology especially in the chronic phase after mTBI. Diffusional Kurtosis Imaging (DKI) and
      Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might
      serve as biomarkers in the brain after mTBI.

      We hypothesized that a change in symptoms (as measured by cognitive performance and self
      reported symptoms) will correlate with a change in microstructural changes (as measured with
      DKI) in thalamus, corpus callosum and hippocampus from baseline 2-6 month after mTBI to
      follow up 6 month after.

      Separate correlations will also be made for both treatment and control group within the
      cohort.
    

Intervention name(s): Graded and behavevial theraphy
Intervention type(s): Behavioral
Intervention description(s): Graded and behavevial theraphy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mild traumatic brain injury subjects with ongoing symptoms 2-6 months after trauma
A Study of VBP-245 in Pediatric Patients With Molluscum Contagiosum
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the
      Efficacy, Tolerability, and Safety of Topical VBP-245 in Pediatric Subjects for the Treatment
      of Molluscum Contagiosum (VBP-245-MCV).
    


Intervention name(s): VBP-245 Topical Gel; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Topical application BID; Vehicle Control With No Active Pharmaceutical Ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: viral skin disease
Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Giving hydroxychloroquine together with temsirolimus may kill more
      tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine
      when given together with temsirolimus in treating patients with metastatic solid tumors that
      have not responded to treatment.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of hydroxychloroquine (HCQ) in combination with
           temsirolimus (TEM) in patients with metastatic refractory solid tumors.

      Secondary

        -  Describe the toxicity of this regimen in these patients.

        -  Measure the response rate in patients treated with this regimen.

      Tertiary

        -  Establish a population pharmacokinetic (PK) model for HCQ and its metabolites in
           combination with TEM.

        -  Use the population PK model to estimate the exposure of HCQ in individual patients.

        -  Compare PK parameters for this regimen to data from published single agent studies.

        -  Measure the change in median number of autophagic vesicles/cell in peripheral blood
           mononuclear cells with TEM alone and with TEM and HCQ and correlate these changes with
           HCQ exposure.

      OUTLINE: This is a dose-escalation study of hydroxychloroquine.

      Patients receive temsirolimus IV over 30 minutes once a week beginning in week 1 and oral
      hydroxychloroquine twice daily beginning in week 2. Courses repeat every 8 weeks in the
      absence of disease progression or unacceptable toxicity.

      Blood samples are collected at baseline and periodically during study for pharmacokinetic and
      pharmacodynamic studies and measurement of autophagy inhibition. Samples are analyzed via
      HPLC and tandem mass spectrometry, immunoblotting assays, and electron microscopy.
    

Intervention name(s): hydroxychloroquine; temsirolimus; electron microscopy; high performance liquid chromatography; immunologic technique; laboratory biomarker analysis; mass spectrometry; pharmacological study; autophagy inhibition therapy
Intervention type(s): Drug; Drug; Other; Other; Other; Other; Other; Other; Procedure
Intervention MeSH terms: Hydroxychloroquine; Sirolimus; Temsirolimus; MTOR Inhibitors
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate
Condition: Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      Young patients with rheumatic diseases have challenges different from older patients due to
      their life situation. It has been reported that they do not have the same benefit from age
      non-specific rehabilitation in warm climate. This trial will test the effect of a specially
      adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian
      young adults aged 20-35 years.
    


Intervention name(s): Rehabilitation in warm climate
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Climatotherapy
The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Observational [Patient Registry]

Summary: 
      Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for
      control of Hyperphosphatemia are used. The aim of this study was to assess the effect of
      magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its
      side effects in hemodialysis patients.
    


Intervention name(s): Mg Oxide
Intervention type(s): Drug
Intervention description(s): 250 mg orally for 4 weeks
Other intervention name(s): (Mg®, 21st Century®)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        hemodialysis patients
      
Keywords: mg oxide; hyperphosphatemia; plasma phosphor level
Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
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 of die.

      PURPOSE: Randomized phase II trial to compare the effectiveness of two treatment regimens of
      lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer,
      primary fallopian tube cancer, or peritoneal cancer that has been previously treated with
      chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Compare the anti-tumor efficacy of two treatment schedules of lurtotecan
      liposome, in terms of clinical/radiological response and CA125 tumor marker, in patients with
      previously treated advanced or recurrent ovarian epithelial cancer. II. Compare the safety,
      pharmacokinetics, and possible pharmacokinetic/pharmacodynamic relationships of these
      treatment schedules in these patients. III. Compare the time to progression in patients
      treated with these treatment schedules.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to time
      from last prior chemotherapy (less than 6 months vs 6 months or more) and number of prior
      chemotherapy regimens (1 vs 2). Patients are randomized to one of two treatment arms. Arm I:
      Patients receive lurtotecan liposome IV over 30 minutes on days 1-3. Arm II: Patients receive
      lurtotecan liposome IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the
      absence of disease progression or unacceptable toxicity. Patients achieving complete response
      (CR) receive 2 additional courses after documented CR. Patients achieving partial response
      (PR) receive 4 additional courses after documented PR or until disease progression at
      investigator's discretion. Patients with stable disease continue therapy for a maximum of 6
      courses. Patients are followed at 4 weeks and then every 3 months until disease relapse or
      progression.

      PROJECTED ACCRUAL: A total of 40-74 patients (20-37 per treatment arm) will be accrued for
      this study within 10 months.
    

Intervention name(s): lurtotecan liposome
Intervention type(s): Drug
Intervention MeSH terms: Lurtotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer
Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause
Condition: Menopause; Puncture Site Reaction
Study type: Interventional

Summary: 
      Main objective: to compare the effects of hand-acupuncture and electro-acupuncture
      stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the
      safety and acceptability of hand acupuncture and electroacupuncture stimulation
    


Intervention name(s): Hand-acupuncture; Electrico-acupuncture
Intervention type(s): Behavioral; Device
Intervention description(s): Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.; Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
Other intervention name(s): Use Hua Tuo brand disposable acupuncture needles; SDZ electro-acupuncture device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Acupuncture; Electro acupuncture; Menopause