bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective
      in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).
    

Detailed description: 
      Patients with chronic refractory ITP are eligible for a 6- to 12-week therapeutic trial.
      After 24 months of treatment, patients who continue to demonstrate a sustained response, in
      the investigator's judgment, will be offered the opportunity to receive ongoing therapy.
    

Intervention name(s): Fostamatinib Disodium / R935788
Intervention type(s): Drug
Intervention description(s): R935788 tablets
Other intervention name(s): R788
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult Refractory Immune Thrombocytopenic Purpura (ITP)
The Specific Elastance in ARDS Patients: a Pediatric Study
Condition: Pediatric ARDS
Study type: Observational

Summary: 
      Aim of this study is to assess lung specific elastance in a population of pediatric patients
      with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a
      pediatric population of ICU patients with healthy lung which are treated with mechanical
      ventilation for other clinical purposes.
    


Intervention name(s): Lung specific elastance
Intervention type(s): Other
Intervention description(s): Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ARDS pediatric patients in mechanical ventilation or patients with healthy lung treated
        with mechanical ventilation for clinical purposes
      
Keywords: ARDS; Lung; Specific Elastance; Pediatric patients
Music and Local Anesthesia During Dermatologic Procedures
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The goal of the study is to determine the effect of classical music on participants pain and
      anxiety associated with lidocaine administration during routine standard of care dermatologic
      procedures.
    

Detailed description: 
      The study is a randomized, unblinded, prospective, single center clinical trial. The purpose
      of the study is to determine the effect of a music intervention in reducing anxiety and pain
      from local anesthesia administration in subjects undergoing a routine, standard of care
      dermatologic procedure. The study population will consist of 100 adult subjects undergoing a
      dermatologic procedure on the head and neck. Subjects will be randomized 1:1 into either the
      placebo or music intervention group.

      Individuals randomized into the placebo (P) group will undergo a set of standardized steps
      prior to local anesthesia injection. Other factors such as skin preparation technique, needle
      size, anesthesia temperature, use of unbuffered solution, needle angle and approximate depth
      of injection will remain standardized. Individuals randomized into the music intervention
      (MI) group will undergo the same set of standardized steps and then be played Frederic
      Chopin's piano sonatas through a headphone device prior to injection. After local anesthesia
      administration, subjects in both treatment arms will be asked to fill out a demographics,
      pain and anxiety questionnaire.
    

Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia during their routine standard of care dermatologic procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pain; Anxiety; Lidocaine; Local anesthesia; Dermatologic procedures; Dermatology
Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of alendronate
      sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a
      single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates
      Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA
      are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp & Dohme, USA.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Alendronate Sodium Tablets 70mg; Fosamax® Tablets 70mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 70mg, single dose fasting; 1 x 70 mg, single dose fasting
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will
      be studied in clinical trial in White and Asian healthy volunteers.
    


Intervention name(s): Rosuvastatin; Rosuvastatin plus rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 20mg po x1; Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1
Other intervention name(s): Crestor; Crestor; Rifadin; Rifampicin
Intervention MeSH terms: Rifampin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: rosuvastatin; rifampin; pharmacokinetics; drug interaction; healthy volunteer; drug transporter; Asian; White
Pilot Study on Mixed Nuts and Food Intake
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objectives of this study are 1) to determine if consumption of mixed nuts influences food
      intake and choice, and 2) to determine how personality traits affect food choice, including
      mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food
      intake control.
    

Detailed description: 
      The condition of being overweight or obese has skyrocketed in recent decades, bringing with
      it many secondary health problems. Therefore, it is important to seek strategies to promote
      weight loss and to assist in weight maintenance after weight loss. Different diet
      compositions may have different effects on satiety and thus affect food choice. A pilot study
      will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires
      will also be administered to determine if personality characteristics are also influencing
      food choice.
    

Intervention name(s): Nut Free Diet; Added Mixed Nuts Diet
Intervention type(s): Other; Other
Intervention description(s): Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.; Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).
Other intervention name(s): Control Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluating the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of an HIV-1 nef/tat/vif,
      env pDNA vaccine delivered with electroporation (EP), followed by a recombinant vesicular
      stomatitis virus (rVSV) HIV envC vaccine boost, in healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety and tolerability of an HIV-1 nef/tat/vif, env pDNA
      vaccine delivered with EP, followed by a rVSV HIV envC vaccine boost, in healthy,
      HIV-uninfected adults.

      Participants will be randomly assigned to one of two groups. Participants in Group 1 will
      receive the HIV-1 nef/tat/vif, env pDNA vaccine at Day 0 and Months 1 and 3, followed by the
      rVSV HIV envC vaccine boost at Months 6 and 9. Participants in Group 2 will receive placebo
      vaccine at Day 0 and Months 1, 3, 6, and 9. Study visits will occur at Day 0, Week 2, and
      Months 1, 1.5, 3, 3.25, 3.5, 6, 6.25, 6.5, 9, 9.25, 9.5, 12, and 15. Visits may include
      physical examinations, urine collection, blood collection, HIV testing, risk reduction
      counseling, assessments, and questionnaires. Participants will be contacted by study staff
      for follow-up monitoring annually for 3 years following the initial study injection.
    

Intervention name(s): HIV-1 nef/tat/vif, env pDNA vaccine; rVSV HIV envC vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1500 mcg to be administered as 0.5 mL intramuscular (IM) in the deltoid of the non-dominant arm (unless medically contraindicated) using the Ichor Medical Systems TDS EP device; 1 × 10^7 PFU to be administered as 1 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated); Sodium Chloride for Injection, USP 0.9%;
At Months 0, 1, and 3: administered as 0.5 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated) using the Ichor Medical Systems TDS EP device.
At Months 6 and 9: administered as 1 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated).
Other intervention name(s): ProfectusVax DNA Plasmid HIV-1 nef/tat/vif, env; ProfectusVaxVSV IN HIV envC
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects Of Prednisolone On Rheumatoid Arthritis Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of
      Prednisolone on Rheumatoid Arthritis (RA) patients.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene
        Expression in Rheumatoid Arthritis Patients and pharmacodynamic effects on whole blood gene
        and protein expression.
      
Keywords: Rheumatoid Arthritis
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU in Older Adults
Condition: Influenza
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase I/II, randomised, multicentre, partially double-blind (group 1, 2, 4 and 5),
      parallel-group study designed to primarily evaluate the safety, tolerability and immune
      response in older adults (age 50 to 75 years) following Immunose™ FLU vaccination at 5 sites
      in Sweden. A total of 300 subjects will be randomised to 1 of 7 treatment groups. The
      hypothesis is that Immunose™ FLU is safe and tolerable and will increase the
      influenza-specific mucosal immune response in older adults.
    


Intervention name(s): Immunose™ FLU 1%; Immunose™ FLU 2%, 200 μl; Immunose™ FLU 2%, 300 μl; Influenza antigen; Placebo; i.m comparator
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Biological
Intervention description(s): Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2; Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2; Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2; Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2; NaCl dosing volume 200 μl, intranasal administration x 2; Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
Other intervention name(s): Saline (NaCl)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Mindfulness Training for Seniors
Condition: Well Aging
Study type: Interventional

Summary: 
      The purpose of this research study is to learn more about how mindfulness training may
      influence thinking and feeling.
    


Intervention name(s): Mindfulness training (MT) Connect
Intervention type(s): Behavioral
Intervention description(s): MT Connect will involve instructor-led weekly sessions and mindfulness exercises over a 4-week interval for a total of 8 to 10 hours. There will be one instructor-led session per week that will last between 2 and 2.5 hours. Participants will also be asked to complete three categories of mindfulness exercises (formal and informal mindfulness exercises, and reflective practices) as part of their daily 'out-of-class' homework. The daily homework will require between 10 to 30 minutes to complete.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The wait-list control group will receive the training program at a later point.
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
Condition: Atherosclerosis Cerebral Infarction
MeSH terms: Cerebral Infarction; Intracranial Arteriosclerosis; Atherosclerosis; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, control, open label, multicentre clinical study. The patient who are in
      accordance with subject inclusion and exclusion criteria will be randomized to A group:
      Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment +
      Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
    

Detailed description: 
      Efficacy index:

      After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker
      between 4 modality groups.

      Pharmacokinetics:

      After 12 weeks of treatment, the study medication plasma concentration including of Probucol
      ,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured.

      Safety evaluation:

      Analysis the abnormality of Adverse Event, Vital Sign, Physical Examination, 12-lead ECG, and
      Laboratory Tests (including blood routine examination, routine urine analysis, blood
      biochemistry examination, glycosylated hemoglobin) in 4 modality groups.
    

Intervention name(s): Cilostazol group; Probucol group; Cilostazol + Probucol group; control group
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid.; Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner; Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid.
Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner; routine treatment
Other intervention name(s): Pletaal; Changtai; Pletaal and Changtai; Routine Treatment
Intervention MeSH terms: Cilostazol; Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modulation of Reinforcement Learning
Condition: Impact of Oxytocin on Social Learning
Study type: Interventional

Summary: 
      This study aims to examine the modulation of neuronal and behavioural parameters of social
      reinforcement learning.
    


Intervention name(s): Oxytocin vs. Placebo
Intervention type(s): Drug
Intervention description(s): FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to measure the PK, safety, and tolerability of S-217622 in
      participants with mild, moderate, or severe renal impairment and in those with normal renal
      function.
    


Intervention name(s): S-217622
Intervention type(s): Drug
Intervention description(s): Tablet for oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
Condition: Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effect of atorvastatin, a weak
      cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2
      primary metabolites, M1 and M3.
    

Detailed description: 
      This study will be a single center, randomized, open-label, 2-arm study to evaluate the
      effects of atorvastatin, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy male and
      female subjects when atorvastatin is administered simultaneously with lomitapide and when it
      is administered 12 hours after lomitapide.
    

Intervention name(s): lomitapide; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg dose; 80 mg
Other intervention name(s): Juxtapid; Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I Healthy volunteer study with the primary objective to evaluate the safety
      and pharmacokinetics profile of AX-158. The first part will evaluate single ascending dose
      administrations. A substudy will be performed as well to evaluate possible impact of food on
      drug exposure if administered under fasted or fed state. The second part will evaluate
      multiple ascending dose over 10 days of dosing in fed or fast state depending on the results
      of the substudy food effect on AX-158.
    

Detailed description: 
      This is a phase I, randomised, double-blind , placebo controlled study to investigate the
      safety, tolerability, and PK of AX-158 in healthy male participants following single (Part A)
      and multiple (Part C) ascending doses including food effect (Part B).The study will be
      conducted in three parts (Part A, Part B and Part C). Part A will enrol 8 participants per
      cohort randomised (3 :1) to receive AX-158 (6 participants) or placebo (2 participants). Part
      A will follow a single ascending dose (SAD) design with all participants receiving one dose
      of AX-158 (or placebo) in the fasted state. Part B (Food Effect) will be conducted in 8
      participants in a cross-over manner; each participant will receive AX-158 in the fed and
      fasted state. Part C will enrol 8 participants per cohort randomised to (3 :1) to receive
      AX-158 (6 participants) or placebo (2 participants). Part C will follow a multiple ascending
      dose (MAD) design with participants receiving AX-158 (or placebo) once daily for 10
      consecutive days, in a fed or fasted state (depending on the outcome of the Part B (Food
      Effect).
    

Intervention name(s): AX-158
Intervention type(s): Drug
Intervention description(s): Oral administrations of AX-158
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether etrasimod is a safe and effective treatment
      for ulcerative colitis.
    


Intervention name(s): Etrasimod; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from
      peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen
      receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB
      and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to
      treatment and with a prognosis of less than 2 years.
    


Intervention name(s): Adult differentiated autologous T-cells
Intervention type(s): Biological
Intervention description(s): After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CART19