bioihbjkbjnl/mcl2 huggingface dataset:
Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation
Condition: Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II trial evaluating the safety & efficacy of Atorvastatin for prophylaxis of Acute
      Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human
      leukocyte antigen (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).
    

Detailed description: 
      The study is a single-arm phase II single institutional trial evaluating the safety and
      efficacy of atorvastatin for the prophylaxis of acute GVHD in patients with hematological
      malignancies undergoing HLA matched related donor HSCT. This study will explore a two-pronged
      acute GVHD prophylaxis strategy, consisting of pre-treating consenting related donors with
      atorvastatin before stem cell mobilization and collection, followed by atorvastatin plus
      methotrexate/tacrolimus-based GVHD prophylaxis in transplant recipient patients.
    

Intervention name(s): atorvastatin; Tacrolimus; methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): donors-will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines.
Patients-will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first.; beginning on Day -2 through approximately Day +180 (that is, approximately 6 months after Day 0); Day +1, +3, and +6 and +11
Other intervention name(s): Lipitor; Prograf; Amethopterin; MTX
Intervention MeSH terms: Methotrexate; Atorvastatin; Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Leukemia; AML; ALL; MDS
Alternate Run Study
Condition: Overuse Injury
MeSH terms: Cumulative Trauma Disorders
Study type: Interventional

Summary: 
      The proposed study will investigate the effect of alternating footwear model and workout-type
      on the occurrence of running-related pain. To achieve this goal participants will be randomly
      assigned into one of four different groups who will perform: 1) the same workout throughout a
      week in the same running shoe model, 2) alternating workout-types throughout the week in the
      same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4)
      alternating workouts in alternating shoes. Participants will be characterized based on body
      alignment, strength, injury and training history. Pain and injury status will be monitored.
    


Intervention name(s): Alternating run training load; Alternating footwear; Constant training; Constant footwear
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period; Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner.; Runners will be assigned identical training sessions over a 7-day period.; Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Running injuries, footwear, alternating load
Effect of Dihydrocapsiate on Energy Expenditure in Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in
      women.
    

Detailed description: 
      Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis.
      Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar
      thermogenic effects without the gastrointestinal side effects. The objective of this project
      is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting
      energy expenditure relative to baseline when compared to a control group consuming products
      without DCT.
    

Intervention name(s): Dihydrocapsiate
Intervention type(s): Dietary Supplement
Intervention description(s): Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.
Other intervention name(s): Natural substances present in sweet chili peppers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Body Weight; Body Composition; Metabolism; Resting Energy Expenditure
Effectiveness of the Use of a Mobile Tool in Improving Lifestyles
Condition: Healthy Subjects Without Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first
      step, and to evaluate the effect of adding this new tool of information and communication
      technologies (ICT), to a standardized intervention to increase adherence to nutritional
      recommendations of the Mediterranean diet and increase physical activity as primary endpoint.
      Analyze adherence and intervention results from a gender perspective. Methodology:
      Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at
      assessing the effects of adding an TIC tool, developed for the Smartphone application
      (intervention), in support of behavioral and educational recommendations (control) in the
      increased physical activity and adaptation to the Mediterranean dietary pattern. Population:
      1215 included subjects younger than 70 years from the project EVIDENT who agree to
      participate. Measurement and interventions: Physical activity will be assessed with the
      accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire
      of adherence and a food frequency survey. It will also assess vascular structure and
      function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media
      thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED)
      and exercise (based on PEPAF project), will be common to both groups. The intervention group
      will be added training and use of an application on a Smartphone designed to promote healthy
      eating and increased physical activity.
    


Intervention name(s): Smartphone with APP; Counseling on lifestyles
Intervention type(s): Device; Behavioral
Intervention description(s): Smartphone with APP (EVIDENT) for 3 months; Counseling on physical activity and mediterranean diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Physical activity; Alimentation; Information and communication Technology; Arterial aging
EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)
Condition: Stroke, Ischemic
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke
      onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from
      4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical
      importance how to extend the time window of intravenous thrombolysis, which can benifit more
      patients. The current trial aims to investigate the effect of intravenous thrombolysis with
      TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be
      neuroprotective.
    


Intervention name(s): TNK-Tissue Plasminogen Activator
Intervention type(s): Drug
Intervention description(s): 0.25 mg TNK thrombolysis
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Serum ANGPTL3, ANGPTL8 and Glypican 4 Concentrations in Relation to the Development of Obesity in Korean Children
Condition: Obesity
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo
      study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit
      lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4
      was identified as a novel adipokine modulating adipocyte differentiation. Thus, the
      investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and glypican
      4 might affect progression of obesity in children. The investigators measure these molecules
      in Korean children, and investigate the association between these molecules and development
      of obesity.
    

Detailed description: 
      Participants in this study were selected from the Korean Metabolic disorders & Obesity Study
      in Elementary School children (KMOSES), the main aim of which was to comprehensively assess
      obesity-related metabolic risk factors and to evaluate clinical outcomes in Korean children
      prospectively. Korean children who were participated in a school-based health examination,
      were reexamined for the 3-year follow-up assessment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants in this study were selected from the Korean Metabolic disorders & Obesity
        Study in Elementary School children (KMOSES).
      
Biospecimen description: 
      Serum was obtained from each subject after the subjects had fasted overnight for more than 8
      hrs.
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the safety and analgesic efficacy of a single
      preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.
    


Intervention name(s): AYX1 Injection 660 mg / 6 mL; AYX1 Injection 1100 mg / 10 mL; Placebo Injection 6 mL; Placebo Injection 10 mL
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 mL solution for intrathecal injection with 660 mg of AYX1; 10 mL solution for intrathecal injection with 1100 mg of AYX1; 6 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug); 10 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Postsurgical pain; Total knee arthroplasty; Total knee replacement
The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      The proposed study will primarily demonstrate the efficacy of kiwifruit as a food
      intervention for the relief of constipation and associated symptoms in functionally
      constipated adults, and those with IBS-C. Secondary measures will show the consumption of
      kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with
      IBS-C.
    

Detailed description: 
      The study is a randomised, single-blinded, cross-over design. Both target study populations
      (those with functional constipation, and the matched healthy control group) will complete the
      16-week trial. Each study group will be randomly selected to either begin the first
      intervention period on the kiwifruit treatment or the psyllium treatment, and following the
      washout period will then receive the opposite treatment. Researchers and analysts will be
      blind as to as to the order of treatment individuals will receive. A dedicated treatment
      administrator will be assigned to provide the treatments to participants and liaise with them
      during the intervention phases.

      All participants will be free living and required to maintain their normal dietary and
      lifestyle habits for the duration of the trial.

      The primary outcome measure will be quantification of CSBM (complete spontaneous bowel
      movement). Secondary outcome measures will include additional stool frequency measures and
      other questionnaires.
    

Intervention name(s): Kiwifruit; Psyllium
Intervention type(s): Other; Dietary Supplement
Intervention description(s): 2 green kiwifruit cultivar 'Hayward'; Pysllium seed husk; ispaghula, isabgol, or psyllium, are portions of the seeds of the plant Plantago ovata, (genus Plantago), a native of India, Bangladesh and Pakistan. They are hygroscopic, which allows them to expand and become mucilaginous. Psyllium is a faecal bulking agent used to treat constipation. It absorbs liquid in the intestines, swells and forms a bulky soft stool that is easy to pass
Other intervention name(s): Ispaghula, isabgol
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Cross Cultural Adaptation of International Physical Activity Questionaire Short Form in Urdu Version
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The IPAQ-SF scale is widely used in our clinical settings. The translated version of IPAQ-SF
      scale in Urdu will help the clinician in collecting data thus, easy to understand for the
      patient and making it more desirable in our region.
    

Detailed description: 
      The purpose of study is to translate IPAQ-SF (International Physical Activity Questionnaire-
      short form) scale in Urdu and to determine the validity & reliability of IPAQ-SF in Urdu
      version. Patients who are at high risk of chronic diseases such as cardiovascular disease,
      diabetes, and hypertension age between 30 to 65 years and can understand Urdu and English
      language are included in my study. 6mint walk test performed to assess aerobic capacity and
      endurance and physical activity over the last seven days is recorded on the translated
      version of IPAQ-SF in Urdu and then back of Urdu into English.
    

Intervention name(s): Validation & reliability
Intervention type(s): Other
Intervention description(s): Translated version of IPAQ(SF) validation & Reliability
Other intervention name(s): Translated Tool
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diseased and Healthy individual group to evaluate the Physical Activity and do validation
        of IPAQ Short form Urdu Version. Test retest reliability in both group for IPQ short form
        urdu version.
      
Keywords: IPAQ-SF; 6MWT; Rate pressure product
Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant
      versus placebo in Type 2 Diabetes Mellitus patients.
    


Intervention name(s): ER niacin/laropiprant; Comparator : placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.; ER niacin/laropiprant Placebo
Other intervention name(s): MK0524A; CORDAPTIVE™; laropiprant (+) niacin
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Human Comedogenicity Test
Condition: Comedogenicity
Study type: Interventional

Summary: 
      Testing comedogenicity potential of a device cream on humans.
    


Intervention name(s): Lotion; Negative Control
Intervention type(s): Device; Other
Intervention description(s): Formulated Lotion F# 13451-131 was applied on an occlusive patch and placed on a test site on each subjects back three times a week for four weeks.; Control. An undosed occlusive patch was placed on a test site on each subjects back three times a week for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The experimental lotion and negative control were both applied to test sites on each subjects back.
Masking: Single (Investigator)
Primary purpose: Other
Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out how an anti-anxiety drug or placebo affects the
      activity of your brain when you are at rest and when you are viewing emotional material, such
      as, emotional faces and pictures.
    

Detailed description: 
      This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to measure the
      response to a known, FDA approved marketed anxiolytic. As such, this is not a study testing
      safety and efficacy of an approved medicine; it is a study to evaluate the usefulness of fMRI
      (a non-significant risk device procedure) to correlate the clinical/behavioral effects of a
      marketed anxiolytic with brain activity assessed by magnetic resonance imaging. fMRI is a
      more direct measure of brain function than behavior, outcomes are quantitative and objective.
      As such, it may be more specific, i.e., may be more sensitive to drug effects or show them
      earlier than clinical endpoints and enable determination of efficacy in smaller or shorter
      studies than those required to show effects on clinical endpoints. Finally, imaging may allow
      differentiation of placebo responders from true drug responders.
    

Intervention name(s): Alprazolam (Xanax); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).; Placebo, bid, p.o. for 28 +/- 2 days.
Other intervention name(s): Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety disorders; Generalized anxiety
Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure
      regimen in healthy children and adolescents aged 2 to 17 years.

      Primary Objectives:

        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of
           subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international
           units (IU)/mL at D42, i.e. 14 days after the last vaccination.

        -  To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a
           lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.

      Secondary Objectives:

        -  To assess the clinical safety of each vaccine after each vaccine injection when
           administered in a pre-exposure schedule.

        -  To describe the immune response induced by each vaccine 14 days after the last
           vaccination, i.e. at D42, and 6 months after the first vaccination

        -  To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e.
           14 days after the last vaccination.
    

Detailed description: 
      Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day
      28, respectively, and will be assessment for immune response to rabies vaccine before the
      first injection (baseline titer), at Day 42, and at Month 6.

      Safety will be assessed in all participants up to 28 days after each injection. Serious
      adverse events and adverse events of special interest (AESIs) will be collected up to 6
      months after the last injection.
    

Intervention name(s): Purified Vero Rabies Vaccine Serum Free (VRVg); Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).; 0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).
Other intervention name(s): Imovax® Rabies
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rabies; Purified Vero Rabies Vaccine - Serum Free (VRVg); Imovax® rabies; Human Diploid Cell Vaccine
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical
      cord blood mononuclear cell transplant, and the combination in the treatment of acute and
      subacute spinal cord injury
    


Intervention name(s): Conventional Treatment; Lithium Carbonate Tablet; Cord Blood Cell; Placebo
Intervention type(s): Procedure; Drug; Biological; Other
Intervention description(s): Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury; 250mg/tablet, administrated orally for 6 weeks.; Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site; Placebo tablet, orally administration of placebo for 6 weeks
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injury; umbilical cord blood cell; cell transplant; lithium carbonate