bioihbjkbjnl/mcl2 huggingface dataset:
G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Condition: Myelodysplastic Syndrome; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning
MeSH terms: Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient
      tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess
      blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome
      (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS
      undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study,
      the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning
      regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are
      evaluated.
    

Detailed description: 
      Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS.
      At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing
      allo-HSCT remains in discussion. BUCY conditioning regimen is the standard myeloablative
      regimen for MDS and AML secondary to MDS undergoing allo-HSCT. However, it appears to have
      higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning
      regimen. In this prospective randomized controlled study, the safety and efficacy of G-CSF +
      Decitabine + BUCY and BUCY myeloablative conditioning regimens in RAEB-1, REAB-2 and AML
      secondary to MDS undergoing allo-HSCT are evaluated.
    

Intervention name(s): Decitabine; Busulfan (BU); Cyclophosphamide (CY); Granulocyte Colony-Stimulating Factor(G-CSF)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Decitabine was administered at 20mg/m2/day on days -14 and -10.; Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.; G-CSF was administered at 5-10 ug/kg/day on days -17 and -10. When white blood cell is more than 20G/L, stop using G-CSF.
Intervention MeSH terms: Cyclophosphamide; Busulfan; Decitabine; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Pulse oximetry monitoring is considered a standard physiological measurement and is used by
      clinicians in everyday situations to estimate arterial oxygen saturation. There are two
      devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart
      SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry
      accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with
      infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and
      Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the
      range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
    

Detailed description: 
      Pulse oximetry monitoring is considered a standard physiological measurement and is used by
      clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is
      a device that measures the oxygen saturation of arterial blood non-invasively.

      The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat
      v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the
      range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2
      validation.

      The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational
      device Owlet Baby Care, Inc. Smart SockTM V. 2.

      It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required
      specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2
      thereby demonstrating an acceptable SpO2 accuracy performance specification.

      No risks or adverse device effects were expected. There were no contraindications for use in
      the proposed study population.

      The study was conducted in accordance to the code of federal regulations for non-significant
      risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable
      sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket
      Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration
      Staff (issued: March 4, 2013)
    

Intervention name(s): Pulse oximetry with Owlet BabySat v1.0 sensor
Intervention type(s): Diagnostic Test
Intervention description(s): A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare glucose lowering with CS-917 compared to placebo after 3 months of
      treatment
    


Intervention name(s): CS-917; metformin hydrochloride; pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes mellitus, Type 2; High blood sugar; Hyperglycemia; Antihyperglycemic agents; CS-917
Endothelial Dysfunction and Coronary Artery Spasm
Condition: Coronary Vasospasm
MeSH terms: Coronary Vasospasm
Study type: Observational

Summary: 
      Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia
      in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA).
      CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG).
      Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive
      evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip
      RH-PAT could predict the presence of CSA in women.
    

Detailed description: 
      Outline of methods:

      RH-PAT was measured in women with chest pain prior to CAG. Coronary spasm was diagnosed by
      intra-coronary acetylcholine (ACh) provocation test. Using Flow-Wire, we assessed coronary
      endothelial function by coronary blood flow increase in response to ACh (ACh-CBF) and
      coronary flow reserve was assessed by adenosine (Ad-CFR).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Kumamoto University Hospital
      
Keywords: Coronary Vasospasm; Endothelium, Vascular; Vasodilation; Hyperemia
Direct Comparison of Spinal Cord Stimulator Parameter Settings
Condition: Spinal Cord Stimulation; High-frequency Stimulation; High-density Stimulation
Study type: Interventional

Summary: 
      (Primary)

        1. To compare the clinical effects and side effects of two different stimulation strategies
           that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for
           electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for
           back and leg pain, the Brief Pain Inventory, the SF-36, and the Pain Vigilance and
           Awareness Questionnaire.

           (Secondary)

        2. To compare the clinical effects of the subthreshold (paresthesia-free) stimulation
           patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the
           necessity of paresthesias and current amplitudes on clinical benefit for pain.

        3. To identify the ability of subthreshold high-frequency to improve axial pain or the
           affective component of pain.
    

Detailed description: 
      This is a prospective, randomized, double-blind study of different stimulation patterns in
      patients undergoing implantation of neurostimulator systems for chronic medically intractable
      neuropathic pain. Research participants will be individuals who have undergone implantation
      of neurostimulator electrodes into the spinal column or peripheral nervous system for
      clinical treatment of neuropathic pain. All patients will already have undergone empiric
      programming of the stimulator using conventional settings (typically 40-60 Hz, 350-450 usec
      pulse width). However, other stimulation parameters, including high-frequency stimulation,
      are also feasible and FDA-approved using the implanted device, and it is possible to do this
      without producing a sensory percept, which makes it possible to test efficacy in a double
      blind manner. For this study, two different stimulation parameters will be tested during four
      two-week periods: 1000 Hz and placebo. Clinical response and side effect profile for each
      setting will be measured.
    

Intervention name(s): High-frequency stimulation; Sham Stimulation; Conventional spinal cord stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.; Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.; Patients will receive conventional spinal cord stimulation (aka 60Hz, aka tonic stimulation, aka paresthesia-based stimulation) for 2 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks
Condition: Spinal Anesthesia
Study type: Interventional

Summary: 
      Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty
      at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance
      of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of
      the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many
      of the patients presenting for total joint arthroplasty. This is because of obesity, previous
      spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in
      a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an
      appropriate site for needle insertion in spinal anesthesia, and that this results in a high
      success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The
      investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia
      is extremely useful, especially in patients with poor-quality surface landmarks. However
      there are no published randomized controlled trials to date that compare the efficacy of the
      ultrasound-assisted technique with the traditional surface landmark-guided technique of
      spinal anesthesia.
    


Intervention name(s): Ultrasound guidance; Manual palpation
Intervention type(s): Procedure; Procedure
Intervention description(s): ultrasound imaging; Manual Palpation of vertebra
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal anesthesia; ultrasound; palpation; knee; hip; surgery; intervertebral space
Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this explorative clinical trial is to study parasite population dynamics,
      diversity and clearance kinetics of Plasmodium falciparum as well as determination of the
      molecular mechanisms associated with drug resistance during the early phase of
      artemether-lumefantrine treatment when the drug intake is either accompanied with or without
      intake of fatty food. The hypothesis is that intake of fatty food together with
      artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of
      early selection of genetic markers related to drug resistance. The study population is
      children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled
      children will be randomly allocated to either intake of a fatty meal or not together with the
      study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses
      according to bodyweight. Study participants will be admitted during the study period (3
      days)to allow close supervision and detailed blood sampling.
    


Intervention name(s): artemether-lumefantrine
Intervention type(s): Drug
Intervention description(s): All treatment doses given either accompanied or not-accompanied with intake of fatty food.
Other intervention name(s): All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Pentoxifylline on Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      To study whether pentoxifylline has additive renoprotective effect in patients taking ARB
    

Detailed description: 
      In patients with CKD and serum creatinine 1.3~6.0 md/gl, having taken losartan 100 mg/day for
      at least 3 months, with stable renal function, will be recruited to a randomized open-label
      trial. Patients taking pentoxifylline or not will be compared for their spot urinary
      proteinuria, estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine
      ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone
      concentration between groups in a 2-year study. Add-on pentoxifylline in control group in the
      same dose as in treat group will be performed to observe the renoprotective effect if any
      protective potential is demonstrated in the end of maintenance 12 months.
    

Intervention name(s): pentoxifylline (drug)
Intervention type(s): Drug
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD, pentoxifylline
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
Condition: Leiomyoma
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and
      tolerability of BAY1002670 (vilaprisan)
    


Intervention name(s): Vilaprisan (BAY1002670)
Intervention type(s): Drug
Intervention description(s): 2 mg tablet, single dose, oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics
Pilates in Women With Chronic Low Back Pain
Condition: Back Pain, Low
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a Pilates exercise program (PEP) on
      the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal
      trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal is to
      investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and
      functional capacity and analyse their relationship with the FRR.
    

Detailed description: 
      Purpose: To evaluate the effect of a Pilates exercise program (PEP) on the flexo-relaxation
      ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension
      in women with chronic low-back pain (LBP). A secondary goal was to investigate the effect of
      PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse
      their relationship with the FRR. Material and methods: Thirty women with chronic LPB were
      randomly assigned to either PEP (EG, n=15) or control group (CG=15). EG followed an 8-week
      PEP while no specific intervention was carried out on the controls. Before and after this
      period all variables were recorded.
    

Intervention name(s): Pilates exercise program
Intervention type(s): Other
Intervention description(s): The Pilates Exercise Program (PEP) (1 h x 2 sessions per week x 2 months) was delivered by one Pilates professional (with a mean of 6.5 years of experience in Pilates). The PEP carried out by Pilates instructor has been published in a previous study [31]. The exercises focused on core stability, posture, breathing, flexibility, strength, and muscle control, being the active awareness of the use of trunk muscles to stabilize the pelvic-lumbar region the main approach. The exercises performed were: the hundred, the rolled up, single leg circles with bent leg, spine stretch, rolling like a ball and single leg stretch. Each exercise was performed as follows: 4 repetitions of 30 seconds with 2 minutes of recovery between repetitions. In order to complete the 60 minutes session two exercises: the "superman" and the double leg bridge were added to the mentioned PEP.
Other intervention name(s): Core strength exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the acceptability of product user guides for
      untrained subjects and to evaluate the performance of the system with lay users and
      healthcare providers (HCPs).
    

Detailed description: 
      The study evaluated the acceptability of product labeling for performing blood glucose
      testing with the new blood glucose meter system (BGMS) and for using meter features. Sections
      of the User Guide and Quick Reference Guide that gave instruction on performing a blood
      glucose test and operating system features were evaluated, including instructions on
      connectivity of the system with a computer, meter setup, glucose trends display, and other
      system features. The study also evaluated the performance of the blood glucose meter system
      (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects
      and healthcare professionals provided feedback about the BGMS and its features. Some subjects
      took the system home to evaluate the robustness of the BGMS.
    

Intervention name(s): Apollo Blood Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.
Other intervention name(s): Commercial name is CONTOUR® USB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Impact of Non-Commercialism Policy in Seattle Schools
Condition: Obesity
Study type: Interventional

Summary: 
      This is a 3-year pilot study funded by National Institute of Health will assess and evaluate
      obesity-related health outcomes of a real-life policy decision, recently voted on and adopted
      by the Seattle School Board.
    


Intervention name(s): Water, Cafeteria and Staff Health Promotion
Intervention type(s): Behavioral
Study of Acamprosate in Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused
      on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability
      that commonly occur in persons with ASD. Despite over two decades of significant
      pharmacotherapy research, to date no medication has been shown in controlled trials to
      enhance the core social deficits of ASD. Based upon findings describing the neurobiology of
      ASD combined with our preliminary results, we believe the novel drug acamprosate will show
      evidence of reducing social skills deficits associated with ASD.
    

Detailed description: 
      Each subject with ASD will receive 10 weeks of blinded treatment with acamprosate or matching
      placebo. After completion of the double-blind phase, all subjects will have an opportunity to
      receive acamprosate as part of the study procedures for 16 weeks.
    

Intervention name(s): Acamprosate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 50kg and 1332 mg per day for those less weighing less than 50kg.; Subjects receiving placebo will be dosed similarly to the acamprosate group.
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Laparoscopy for Endometriosis in Obese Patients
Condition: Endometriosis; Obesity
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.
    

Detailed description: 
      Obesity may influence surgical variables such as operative time, laparotomic conversion rate
      and intraoperative and postoperative complication rate. Moreover, it might influence the
      hospital length of stay. For that reason, the study aims to compare a group of obese patients
      with a non-obese group of patients about these topics.
    

Intervention name(s): Laparoscopy
Intervention type(s): Procedure
Intervention description(s): Laparoscopy for endometriosis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis
        removal.
      
Keywords: Endometriosis; Obesity; Laparoscopy