bioihbjkbjnl/mcl2 huggingface dataset:
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional

Summary: 
      The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic
      myelogenous leukemia (CML).

      Its effectiveness in controlling the progression of the disease is such that it is possible
      today to consider stopping treatment in patients with deep molecular response (> RM4.0).

      Only in about 50% of cases, patients relapse. It has been shown in these patients that
      hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These
      cells are probably at the origin of relapse. It is therefore necessary to develop
      complementary therapies to cure the disease and consider discontinuation iTKs The development
      of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric
      antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The
      membrane expression of the IL-1-RAP protein could be an interesting target.
    


Intervention name(s): biological samples
Intervention type(s): Other
Intervention description(s): bone marrow and blood
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Growing evidence over recent years supports a potential role for low grade chronic
      inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we
      will determine whether salsalate, a member of the commonly used Non-Steroidal
      Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2
      diabetes. The study will determine whether salicylates represent a new pharmacological option
      for diabetes management. The study is conducted in two stages. Enrollment in the first stage
      is complete. The primary objective of the first stage was to select a dose of salsalate that
      is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The
      primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood
      sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes
      (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and
      cardiac risk.
    


Intervention name(s): Salsalate; Salsalate Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Salsalate 3.5 g/d orally, divided dosing
Other intervention name(s): disalsid
Intervention MeSH terms: Salicylsalicylic acid; Sodium Salicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus (T2D); Inflammation; Obesity; Metabolic Syndrome; Salicylates
Analysis of the Inner Diameter of the Distal Radial Artery and the Influencing Factors in Chinese Patients
Condition: Distal Radial Artery
Study type: Observational

Summary: 
      Cardiovascular intervention via distal radial artery (DRA) approach has become more and more
      extensive. However, the DRA is smaller than conventional radial artery (CRA). Assessing the
      size of the DRA before vascular intervention is extremely important to select suitable
      patients. There are still few large-sample studies to evaluate the size of DRA and its
      influencing factors in the Chinese population.
    

Detailed description: 
      In recent years, the clinical application of distal radial artery (DRA) approach in
      cardiovascular intervention has become more and more extensive. However, compared with CRA,
      the DRA is smaller, resulting in an increased proportion of patients requiring multiple
      punctures and a lower success rate of implantation. It has been found that the mismatch
      between artery sheath and vessel size is one of the independent risk factors for
      postoperative vascular approach complications. Therefore, assessing the size of the DRA
      before vascular intervention is extremely important to select suitable patients, improve the
      success rate of puncture, and reduce the complications associated with the approach There are
      still few large-sample studies to evaluate the size of DRA and its influencing factors in the
      Chinese population.
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Using ultrasound to measure the diameter of distal radial artery
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who is prepare for coronary angiography
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
Condition: Atherothrombotic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of
      BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)
    


Intervention name(s): BMS 986141; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22); Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study on Cognitive Disorders of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if memantine is effective in the treatment on
      cognitive disorders of Relapsing - Remitting multiple sclerosis. m
    


Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg the first week, then 10 mg the second week, 15 mg the third week and finally 20 mg the fourth week until the end of the study (t0 + 1 year); 5 mg the first week, then 10 mg the second week, 15 mg the third week and finally 20 mg the fourth week until the end of the study (t0 + 1 year)
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Biomarkers of Oat Product Intake: The BiOAT Marker Study
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites
      as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i)
      a single dose through a single meal based on a solid and a liquid oat-based product
      (pharmacokinetic study) ii) week-long consumption at three different intake levels
      (dose-response). The study will be carried out as a two-way cross-over design with two
      different oat products, liquid or solid, where each product is provided 3 times per day
      during 5 days per product. A wash-out period of 8 days where participants consume their
      habitual diet is implemented. The first day of study meal intervention includes postprandial
      measurements during 8 hours.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of transferring the healthy
      intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the
      patient to the pelvic cavity on incontinence problems.
    

Detailed description: 
      66 people with a score of 3 or higher on the Incontinence Severity Index will be included in
      the study. All participants will complete the King Health Questionnaire and Incontinence
      Quality of Life Questionnaires. The control group will consist of 33 people and will apply
      only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will
      consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a
      week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training
      will be given to the experimental group. Practices for using this breathing pattern will be
      done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires
      will be asked to be filled again. The variation between the initial results and the final
      results, as well as the differences between the final changes, will also be compared.
    

Intervention name(s): kegel exercises; 360 degree expanded diaphragmatic breathing training
Intervention type(s): Other; Other
Intervention description(s): Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.; 360-degree expanded diaphragm breathing is the delivery of air taken during inspiration to the postero-lateral wall of the abdomen. Breathing in this way ensures that the pressure in the abdomen is distributed equally in all directions. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 360 degree expanded diaphragm breathing
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: kegel exercises; urinary incontinence; diaphragmatic breathing
Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design

        -  Open, escalating single-dose design.

        -  7 ascending dose cohorts

        -  In each cohorts, subjects will receive a single dose of HM61713.

        -  Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.
    

Detailed description: 
      Primary objectives

      • To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers

      Secondary objectives

        -  To assess the safety and tolerability of HM61713 tablet in healthy male subjects.

        -  To assess the food effect on PK characteristics of HM61713 tablet in healthy male
           subjects.

        -  To assess the ethnic differences of PK characteristics of HM61713 (Korean, Japanese,
           Caucasian)

        -  To investigate genotype of drug metabolism.transport that affect PK characteristics of
           HM61713

        -  To investigate the change of endogenous metabolic markers after administration of
           HM61713
    

Intervention name(s): HM61713
Intervention type(s): Drug
Intervention description(s): Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
Other intervention name(s): Olmutinib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HM61713; pharmacokinetics; Phase I; healthy; olmutinib
MP-AzeFlu Allergen Chamber - Onset of Action Study
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to assess the onset of action of fixed drug combination of azelastine
      hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal
      symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an
      Environmental Exposure Chamber (EEC).
    


Intervention name(s): Azelastine hydrochloride + fluticasone propionate nasal spray; Placebos; fluticasone propionate nasal spray + loratadine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Loratadine; Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Augmentation of Dendritic Cell-Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells in Stage IV Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dendritic cells (DC) are the professional antigen presenting cells of the immune system.
      Multiple distinct DC lineage's exist and it is now well appreciated that the DC subset and
      the maturation stage of the DC determines the type of immune response, ranging from a TH1 or
      TH2 response to immune tolerance. The extremely potent capacity of mature DC to initiate
      immune responses can be exploited to fight infectious diseases and cancer. Others and we are
      currently using tumor antigen loaded mature DC in clinical vaccination studies against
      cancer, and clinical as well as immunological responses have been observed.

      Exciting new insights accompany the revival of suppressor T cells, now referred to as
      regulatory T cells (Treg), and implicate that also Treg play a key role in the control of
      immunity. Treg constitute a sub-population of CD4+ T cells constitutively expressing the
      IL-2R alpha-chain (CD25). Treg show remarkably suppressive activities on different components
      of the immune system, including T lymphocytes and dendritic cells, suggesting they act both
      at the initiation phase (DC) and at the effector phase (activated T cells) of the immune
      response. Interestingly, temporal depletion of Treg has been shown to enhance anti-tumor
      immune responses and in case of prolonged absence of Treg even autoimmunity. Furthermore,
      data in mouse tumor models indicate that temporal depletion of Treg also results in improved
      vaccine efficiency in the therapeutic setting, e.g. in mice with a pre-existing tumor. These
      data imply that in tumor bearing patients depletion of Treg prior to vaccination will improve
      vaccine efficacy.

      In this study we investigate the effect of regulatory T cell (Treg) depletion on the efficacy
      of DC-based anti-tumor vaccines in a clinical study using melanoma associated antigens
      tyrosinase and gp100-loaded DC and a depleting anti-CD25 mononuclear antibody (Daclizumab).
      Our primary objective in this study is the induction of an effective anti-tumor immune
      response. Our secondary objective is the induction of a clinical response.
    


Intervention name(s): Daclizumab; Dendritic cells
Intervention type(s): Drug; Biological
Intervention MeSH terms: Daclizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic Cells; Regulatory T cells; CD25; Melanoma; Immunotherapy; Daclizumab; Stage IV Melanoma
Training Attentional Awareness and Control in ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of different types of cognitive training
      on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile
      software on personal mobile devices.
    

Detailed description: 
      Different types of software-based cognitive training are thought to impact attention via
      different mechanisms. This study examines the nature of the effects on sustained attention of
      two different types of mobile software based training. Because the nature of the training
      method is behavioral, the investigators can not divulge the differences in the training
      methods and their hypothesized differences in their impact on attention.
    

Intervention name(s): Sustained Attention Control (SAC) Method; Scrabble
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.; Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention deficit hyperactivity disorder.; Attention training; Mobile devices; Brain training
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
Condition: Alopecia; Alopecia, Androgenetic; Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability, and pharmacokinetics of new formulation
      of bimatoprost following topical application in patients with alopecia. Two formulations of
      bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be
      investigated in Part 2. Part 2 will begin after Part 1 has completed.
    


Intervention name(s): bimatoprost Formulation A; bimatoprost Formulation B; bimatoprost Formulation C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.; bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.; bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Intervention MeSH terms: Bimatoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if favipiravir is effective in reducing the time to
      resolution of influenza symptoms.
    

Detailed description: 
      The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time
      to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects
      with uncomplicated influenza compared to no treatment (e.g. placebo).
    

Intervention name(s): favipiravir; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered twice daily over 5 consecutive days for a total of 10 doses.
Day 1: 1800 mg twice daily (loading doses)
Days 2 through 5: 800 mg twice daily; Administered twice daily over 5 consecutive days for a total of 10 doses.
Day 1: 1800 mg twice daily (loading doses)
Days 2 through 5: 800 mg twice daily
Other intervention name(s): T-705
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: influenza; flu; fever; cough; body aches; headache; nasal congestion; body pains; sore throat; fatigue; T-705; favipiravir; favor; flu symptoms
Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali
Condition: Malaria,Falciparum
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the gametocytocidal and transmission reducing
      activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with
      and without a single dose of 0.25mg/kg primaquine (PQ). Outcome measures will include
      infectivity to mosquitoes at 2, 7 and 14 days after treatment, gametocyte density throughout
      follow-up, and safety measures including haemoglobin density and the frequency of adverse
      events.
    

Detailed description: 
      Full protocol available on request
    

Intervention name(s): Artesunate-amodiaquine combination; Primaquine Phosphate; Artemether-lumefantrine; Amodiaquine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets containing 50mg/135 mg or 100mg/270 mg of artesunate/amodiaquine will be administered according to weight as per manufacturer guidelines; The single dose of 0.25mg/kg PQ will be administered in an aqueous solution, according to a standard operating procedure (SOP) provided by the manufacturer.; Tablets containing 20 mg artemether and 120 mg lumefantrine will be administered according to weight as per manufacturer guidelines; Tablets containing 153 mg of amodiaquine will be administered according to weight, aiming for a dosage of approximately 10 mg (7.7-15.3mg)/kg/day, given once or twice daily (together with artemether-lumefantrine) for three days.
Other intervention name(s): Camoquin; Primaquine; Coartem
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Primaquine; Artemether, Lumefantrine Drug Combination; Amodiaquine; Amodiaquine, artesunate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Multiple Ascending Doses Study of CG400549
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of 3 multiple and
      escalating dose regimens of CG400549 administered orally in healthy volunteers.
    

Detailed description: 
      This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and
      placebo-controlled design.
    

Intervention name(s): CG400549 640mg; CG400549 320 mg; CG400549 640 mg; CG400549 960 mg; Placebo 640mg; Placebo 320mg; placebo 960 mg; Placebo 640mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state; multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state; multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state; multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state; multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state; multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state; multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state; multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment