bioihbjkbjnl/mcl2 huggingface dataset:
PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians
Condition: Asthma; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate
      (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium
      Bromide (GB) after inhalation of CHF 5993 in Japanese as well as Caucasian healthy subjects
      under the same setting.
    

Detailed description: 
      The Study is single-centre, randomized, double-blind, single-dose, 4-way cross-over,
      placebo-controlled.

      The safety, tolerability, PD and PK of CHF 5993 will be assessed in Japanese and Caucasian
      healthy volunteers.

      A total of 32 healthy male and female volunteers are planned to be included where they will
      receive four different treatments (study drug or placebo) over four treatment periods.

      Standard safety assessments will be conducted during the study, including safety blood and
      urine laboratory tests, liver function tests, vital signs, physical examinations, ECGs,
      24-hour Holter and observations of any adverse events. Blood samples will also be collected
      for PK analysis. Blood and urine samples will be collected for pharmacodynamics analysis.
    

Intervention name(s): Therapeutic Dose 1; Therapeutic Dose 2; Supra-therapeutic Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CHF 5993 100/6/12.5 µg pMDI, fixed combination of BDP 100 µg + FF 6 µg + GB 12.5 µg.; CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.; CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.; CHF 5993 placebo pMDI
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-way Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Condition: Schizophrenia; Alcohol Use Disorder
MeSH terms: Alcoholism; Schizophrenia; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This double-blind, randomized study will evaluate the efficacy, safety and tolerability of
      ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
    


Intervention name(s): Samidorphan + olanzapine (ALKS 3831); Placebo + olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet, taken once daily; Oral tablet, taken once daily
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; Schizophrenia; Alcohol Use Disorder; ALKS 3831
Does the Order in Which Vaccines Are Administered Affect Pain Response?
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine whether there should be a predetermined sequence
      recommended for administering these two vaccines, with the less painful vaccine being given
      first.
    

Detailed description: 
      Childhood vaccination is one of the most effective public health measures worldwide, with few
      serious adverse effects reported. However, pain on vaccination continues to be a frequent
      occurrence and is the most common cause of childhood iatrogenic pain. In a recent study of
      paediatricians in the USA, more than ninety percent reported at least one parental vaccine
      refusal in the past year. The most common concerns cited by parents were short-term reactions
      and pain from multiple injections.

      One of the factors responsible for vaccination pain is the vaccine material itself. Even the
      same vaccine, when made by different pharmaceutical companies may produce different pain
      responses. Anecdotal reports from doctors and nurses indicate that Pentacel (DPTaP+Hib) is a
      relatively painless vaccine to administer whereas Prevnar (conjugated pneumococcal vaccine)
      causes significant pain on injection and severe distress to the infant being vaccinated. For
      this reason, many vaccinators administer Pentacel [DPT] prior to Prevnar [PCV] when providing
      both vaccines in one visit. However, the difference in infant pain responses has not been
      documented. Although it has been shown that very early pain events affect infants' later
      experience of pain, it has not been demonstrated that the sequence in which vaccines are
      administered affects pain response. This study will assess whether there should be a
      predetermined sequence recommended for administering these two vaccines, with the less
      painful vaccine (Pentacel) being given first.
    

Intervention name(s): Pentacel (DPTaP+Hib); Prevnar (conjugated pneumococcal vaccine)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaccination; Pediatrics; Pain
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed
      to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male
      subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.
    


Intervention name(s): HLX11; CN-Perjeta(Pertuzumab); EU-Perjeta(Pertuzumab); US-Perjeta(Pertuzumab)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): healthy volunteers receive HLX11 (420mg) once; healthy volunteers receive CN-Perjeta (420mg) once; healthy volunteers receive EU-Perjeta (420mg) once; healthy volunteers receive US-Perjeta (420mg) once
Intervention MeSH terms: Pertuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
Condition: Kidney Failure; Renal Insufficiency, Chronic; Dialysis Related Complication
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to
      high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months
      crossovers.
    


Intervention name(s): Medium cut-off; High-Flux
Intervention type(s): Device; Device
Intervention description(s): All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius.
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min; All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp.
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior
      to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or
      operation) for hepatocellular carcinoma in Korea
    

Detailed description: 
      Multicenter, randomized, open-labeled phase 3 clinical trial.
    

Intervention name(s): Immuncell-LC
Intervention type(s): Biological
Intervention description(s): Activated T lymphocyte
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study of AG-348 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose escalation study that will be conducted in healthy volunteers. Multiple
      cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily
      for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the
      pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348
      with specific biomarkers assessed in the blood.
    


Intervention name(s): AG-348; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A range of doses of AG-348 will be tested based on the assessment of safety and tolerability. AG-348 will be administered by mouth (orally) each day for a period of 14 days.; Placebo will be administered by mouth (orally) each day for a period of 14 days.
Intervention MeSH terms: Mitapivat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: safety and tolerability; pharmacokinetic study
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Condition: Agitation Associated With Bipolar Disorder; Agitation,Psychomotor; Bipolar Disorder
MeSH terms: Psychomotor Agitation; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the
      acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to
      characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of
      DEX, HCl) in agitation associated with bipolar disorder.
    

Detailed description: 
      The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg,
      120µg BXCL501, or placebo stratified by age < 65 and age ≥ 65. Male and female adults with
      acute agitation associated with bipolar disorder will be enrolled. Eligible subjects (acutely
      agitated subjects with bipolar disorder, generally hypomanic, manic or mixed episodes) may be
      identified in outpatient clinics, mental health, psychiatric or medical emergency services
      including medical/psychiatric observation units, or as newly admitted to a hospital setting
      for acute agitation or already in hospital for chronic underlying conditions. Subjects will
      be domiciled in a clinical research setting or hospitalized to remain under medical
      supervision while undergoing screening procedures to assess eligibility. Efficacy and safety
      assessments will be conducted periodically before and after dosing.
    

Intervention name(s): Sublingual film containing Dexmedetomidine (BXCL501); Placebo Film
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual film containing Dexmedetomidine (BXCL501); Placebo Film for BXCL501
Other intervention name(s): Dexmedetomidine; Placebo
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: phase III, randomized, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety
      of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes
      inadequately controlled with OAD (oral anti-diabetic drugs).
    


Intervention name(s): repaglinide; metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, effectiveness, and plasma concentration of
      paliperidone (an antipsychotic medication) given once daily in the treatment of patients with
      schizophrenia
    

Detailed description: 
      Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of
      risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter,
      open-label, parallel-group, fixed dose study to evaluate the safety, effectiveness, and
      plasma concentration of paliperidone taken once daily in patients with schizophrenia. The
      patients will receive a fixed dose of paliperidone (3, 9, and 15 mg) for 6 weeks and its
      effectiveness and safety will be observed for an additional 2 weeks.. Efficacy will be
      measured by determining changes throughout the study in the Positive and Negative Syndrome
      Scale (PANSS) score, a scale for the measurement of symptoms of schizophrenia, and the
      Clinical Global Impression (CGI) score. In addition, the study also assesses the relationship
      between dose/plasma drug concentration and dopamine D2 receptor occupancy in patients who
      consent to receive positron emission tomography (PET). Safety evaluations (symptoms, physical
      exams, electrocardiograms, laboratory tests, Drug-Induced Extrapyramidal Symptoms Scale
      [DIESS] results, and adverse event monitoring) will be conducted throughout the study. The
      study hypothesis is that paliperidone will be effective in the treatment of schizophrenia,
      and that it will be well-tolerated. The patients will receive either 3, 9, or 15 mg of
      paliperidone, taken once daily by mouth for 6 weeks.
    

Intervention name(s): paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Positive and Negative Syndrome Scale (PANSS); Clinical Global Impression (CGI); Positron Emission Tomography (PET)
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly
      plus methotrexate with or without other disease modifying antirheumatic drugs therapy with
      that of methotrexate with or without other disease modifying antirheumatic drugs therapy at
      Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved
      low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly
      plus MTX with or without other disease modifying antirheumatic drugs therapy.
    


Intervention name(s): Etanercept; placebo
Intervention type(s): Drug; Drug
Intervention description(s): etanercept 50mg once weekly + methotrexate with or without other DMARDs; etanercept placebo once weekly + methotrexate with or without other DMARDs
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; etanercept; methotrexate; DMARDs
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics
      of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
    

Detailed description: 
      The study includes 2 treatment periods. The open-label run-in period will begin at patient
      enrolment and continue for 3 weeks, during which all patients will receive once daily
      treatment with zicronapine. The double-blind period will begin at patient randomization and
      continue for 5 weeks, during which the patients will be assigned to one group receiving once
      daily treatment with zicronapine and 3 groups receiving once weekly treatment with
      zicronapine.
    

Intervention name(s): Zicronapine open-label lead-in 10 mg daily; Zicronapine 10 mg daily; Zicronapine 20 mg once weekly; Zicronapine 30 mg once weekly; Zicronapine 45 mg once weekly
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Encapsulated tablet ,10 mg, once daily, open-label; Encapsulated tablet, 10 mg, once daily, double-blind; Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind; Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind; Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other intervention name(s): Lu 31-130; Lu 31-130; Lu 31-130; Lu 31-130; Lu 31-130
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic; Zicronapine; Lu 31-310
Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts
Condition: Renal Transplant Rejection
Study type: Interventional

Summary: 
      The goal of this study is to evaluate autologous MSCs as an alternative for antibody
      induction therapy in renal transplantation.
    

Detailed description: 
      Renal transplantation is the most common and successful type of organ transplantation.
      Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly
      improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been
      used successfully to treat graft versus host disease and show immune modulation function both
      in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs
      as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve
      the recovery of early function in transplanted kidney.
    

Intervention name(s): Kidney transplantation with MSCs infusion; kidney transplantation without MSC infusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.; kidney transplantation with standard immunosuppressive treatment regime
Other intervention name(s): MSCs induction plus a standard or a lower dose of CNI; Anti-IL2R induction therapy with standard dose of CNI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplant; Mesenchymal stem cell (MSC)
Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal Iliohypogastric Nerve Block.
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of using TAB and ILIH nerve blocks
      versus ILIH nerve block only for inguinal hernia repair in patients with liver cirrhosis.
    

Detailed description: 
      After obtaining institutional ethical committee approval and written informed consent in
      2019, 60 patients between the age of 40 and 70 year were divided randomly using a computer
      generated randomization table and opaque sealed envelopes into two groups (30 patients in
      each group) according to the type of block they received: Group (T) received ultrasound
      guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal-
      iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal-
      illiohypogastric nerve block only.

      Standard monitoring was used throughout the surgery; heart rate (HR), non-invasive mean
      arterial blood pressure (MAP), respiratory rate (RR) and oxygen saturation (SpO2)documented
      at baseline before the block then at 5-min intervals intraoperative , then during the
      immediate postoperative period at 15 and 30 min, and at discharge from the PACU.

      A nasal prong was applied and supplemental oxygen at 3 l/min of fresh gas flow was given
      throughout the procedure. It was explained clearly to the patients that any pain, discomfort,
      or anxiety would be managed by the administration of local anesthetic (LA) infiltration with
      bupivacaine 0.25% during the operation or by conversion to general anesthesia (GA) if needed.
    

Intervention name(s): Us guided nerve blocks
Intervention type(s): Device
Intervention description(s): The ILIH nerves were identified and located in the fascia compartment between the internal oblique and the transverse abdominis or external oblique muscles, a 20 G needle was advanced between the aponeurosis of the internal oblique and transverses abdominis muscles then 30 ml bupivacaine 0.25% was injected with intermittent aspiration,then 10 ml bupivacaine 0.25% was injected around the nerves.
Other intervention name(s): drug used is bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were divided randomly into two groups (30 patients in each group) according to the type of block they received: Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Transverse aabdominis plane