bioihbjkbjnl/mcl2 huggingface dataset:
Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection
Condition: Goal-directed Fluid Therapy
Study type: Interventional

Summary: 
      Perioperative fluid management is a key component of anesthetic management during thoracic
      surgery. On one hand, fluid restriction could compromise perfusion of vital organs and
      surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary
      complications, notably pulmonary edema, which carries a high mortality rate. Perioperative
      fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed.
      Therefore, to achieve the balance between preventing fluid overload and optimising organ
      perfusion, the practical index to guide fluid management, which can predict whether fluid
      loading will improve haemodynamic conditions in an individual patient, would be very valuable
      during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of
      tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory
      variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure
      variation] can predict fluid responsiveness in mechanically ventilated patients under various
      conditions. Therefore, pressure variations are increasingly being advocated for fluid
      management.This study will discuss the effects of pulse pressure variation(PPV) in different
      level during anesthesia on patients with oxygenation index and short-term prognosis
      undergoing video-assisted thoracoscopic surgery for pneumoresection.
    


Intervention name(s): Fluid therapy
Intervention type(s): Device
Intervention description(s): Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: goal-directed fluid therapy; thoracic surgery, video-assisted; acute lung injury
Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercise With Knee Osteoarthritis
Condition: Exercise
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is a chronic disease process characterized by degeneration and
      inflammation in the joint cartilage and subchondral bone, synovial fluid and joint capsule.
      One of the most affected joints in OA is the knee joint, and the incidence of OA increases
      with age.

      Different treatment approaches are used in the treatment of osteoarthritis. The aim of the
      study is to examine the effectiveness of Mulligan technique and core exercises applied to
      female patients with knee osteoarthritis. In addition, the investigators did not find any
      study examining the effect of Mulligan technique on static balance in the treatment of OA.
      This is the secondary aim of the study.
    


Intervention name(s): Mulligan mobilization; Core stabilization; Conventional therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Mulligan mobilization technique will be apply.; Core stabilization technique will be apply.; Conventional therapy exercise will be apply.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pain, Joint; Mulligan; Core stabilization
The Effect of Food on the Pharmacokinetic Characteristics of CKD-501
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food on the pharmacokinetic
      characteristics of CKD-501 in healthy subject.

      And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.
    

Detailed description: 
      Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs.
      fasting), two-period, two sequence crossover.

      Every time before and after each medication, PK parameters and safety of CKD-501 1mg is
      performed using a blood sample and conducting some tests respectively.
    

Intervention name(s): CKD-501 1mg
Intervention type(s): Drug
Intervention description(s): This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
Condition: Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study with two sequential cohorts, each with three treatment periods. Single doses
      of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose
      projected to be under the current limits for drug concentration. Each cohort will aim to
      achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary
      endpoint is MDS-UPDRS part III.
    


Intervention name(s): PF-06649751; Trimethobenzamide Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg.; 300mg TID, Capsules. Optional in both Cohorts.; Subjects completing all three treatment periods will be receiving placebo once.
Intervention MeSH terms: Trimethobenzamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pakinson's Disease, Movement Disorders
A Study of LY3316531 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess study drug activity by giving LY3316531 or placebo
      into a vein in the arm and then measuring blood flow to the skin, after capsaicin is applied
      to skin's surface. The study will last about 16 weeks inclusive of the screening period.
    


Intervention name(s): LY3316531; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Headache
MeSH terms: Arthritis; Arthritis, Rheumatoid; Headache
Study type: Interventional

Summary: 
      Rheumatoid arthritis is a common type of autoimmune arthritis that is characterized by
      inflammation of the synovial membranes. Even though any joint can be affected by the disease,
      cervical spine is often affected, and cervical pain is reported by 40-88% of RA patients,
      Cervical spine involvement is a feature of long-lasting disease, where atlantoaxial impaction
      with odontoid process vertical subluxation through the foramen magnum being one of the
      greatest and dangerous complications
    

Detailed description: 
      To our knowledge the effectiveness of 3rd occipital nerve blocks in managing chronic upper
      neck pain, headache in RA patients is not measured yet, so we aimed at assessing the the
      effectiveness of 3rd occipital nerve blocks in headache management in RA patients who used
      other medical agents and to compare the results with those of the patients who used only 3rd
      occipital nerve pulsed radiofrequancy on clinical and radiographic bases.
    

Intervention name(s): Radiofrequency; Steroids
Intervention type(s): Drug; Drug
Intervention description(s): ), received bilateral 3rd occipital nerve RF under fluoroscopic guidance. Levobupivacaine (0.3 mL; 0.75%) and triamcilonone (1 mg) were injected at each level; received systemic steroids oral prednisolone tablet, 10 mg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To our knowledge the effectiveness of 3rd occipital nerve blocks in managing chronic upper neck pain, headache in RA patients is not measured yet, so we aimed at assessing the the effectiveness of 3rd occipital nerve blocks in headache management in RA patients who used other medical agents and to compare the results with those of the patients who used only 3rd occipital nerve pulsed radiofrequancy on clinical and radiographic bases.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this research study is to implement and evaluate a lifestyle program designed
      to help women who have high glucose levels during pregnancy make healthful diet and physical
      activity changes to lose weight. Eligible women will be randomly assigned to life-style
      intervention or usual medical care.
    


Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gestational Diabetes; Weight Loss; Physical Activity; Pregnancy; Postpartum; Intervention
Remifentanil for Preventing Propofol Injection Pain in Elderly Patients
Condition: Drug Usage
Study type: Interventional
Phase: Phase 4

Summary: 
      Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually
      need smaller doses of anesthetic drugs than younger patients. The purpose of this study was
      to investigate the optimal effect-site concentration of remifentanil for preventing injection
      pain during propofol induction in elderly patients by the Dixon's up-and-down method.
    


Intervention name(s): Remifentanil; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years); Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years)
Other intervention name(s): Ultiva; Ultiva
Intervention MeSH terms: Remifentanil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pain; propofol; remifentanil
The Role of Mechanical Stress and Muscle Fatigue in Strength Gains
Condition: Strength Training; Muscle Strength, Muscle Mass, Inflammatory Processes
Study type: Interventional

Summary: 
      The purpose of this study is to compare the impact of different levels of mechanical stress
      and muscle fatigue in strength training conditions on muscle strength, muscle mass and
      inflammatory processes.
    


Intervention name(s): Strength training
Intervention type(s): Other
Intervention description(s): Leg extension exercise:
Experimental: 60 repetitions at 20-25% of 1RM, 10-12 repetitions at 40% of 1RM Active Comparator: 10-12 repetitions at 80% of 1RM Placebo Comparator: 10-12 repetitions at 40% of 1RM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
School-based Approaches to Help Pre-teens Manage Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This random trial will deploy 2 interventions and a control group with eleven and twelve year
      old, low income, African American students in middle schools in Detroit, MI. The goals are to
      determine if 1) a self-management program focused on pre-teen capabilities designed for
      middle schools produces desired outcomes, and 2) if the program, enhanced by a peer
      component, improves upon outcomes. Outcomes of interest are symptom experience, quality of
      life, self-management, and school grades.
    

Detailed description: 
      BACKGROUND:

      To date, no data provide information on the effects of middle school based interventions for
      pre-teens with asthma or the advantages of an approach that recognizes the importance of peer
      influence on pre-teen's asthma behavior. Interventions to reach low income minority
      populations are particularly needed.

      DESIGN NARRATIVE:

      If only one primary outcome is to be specified, it would be asthma morbidity, as evident in
      asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months
      post program through parent interviews and student surveys.

      Additional primary outcomes listed in the protocol include: Asthma related quality of life,
      disease management behavior and academic performance.

      Secondary outcomes include: peer support, school attendance, physical activity, health care
      use, and smoking behavior.
    

Intervention name(s): Open Airways Educational Intervention; Peer Asthma Action Educational Intervention
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): A 6 week asthma educational self management program for middle school students.; Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial is a study on all-trans retinoic acid in combination with induction and
      consolidation therapy as well as pegfilgrastim after consolidation therapy in younger
      patients with newly diagnosed acute myeloid leukemia (AML).
    

Detailed description: 
      First Induction Therapy:

        -  Cytarabine 100 mg/m² cont. i.v. days 1-7

        -  Idarubicin 12 mg/m² i.v. days 1,3,5

        -  Etoposide 100 mg/m² i.v. days 1-3

        -  ± ATRA 45 mg/m² p.o. days 6-8

        -  ATRA 15 mg/m² p.o. days 9-21

      Second Induction Therapy:

        -  Cytarabine 100 mg/m² cont. i.v. days 1-7

        -  Idarubicin 12 mg/m² i.v. days 1 and 3

        -  Etoposide 100 mg/m² i.v. days 1-3

        -  ± ATRA 45 mg/m² p.o. days 6-8

        -  ATRA 15 mg/m² p.o. days 9-21

      Consolidation Therapy:

      cohort 1 (<= ID 336)

        -  Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5

        -  ± ATRA 15 mg/m² p.o. Tag 6-21

        -  Pegfilgrastim 6 mg s.c day 10

      cohort 2 (> ID 336)

        -  Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3

        -  ± ATRA 15 mg/m² p.o. Tag 4-21

        -  Pegfilgrastim 6 mg s.c day 8
    

Intervention name(s): Cytarabine; Idarubicin; Etoposide; All-trans retinoic acid; Pegfilgrastim
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3; 12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle); 100mg/m² i.v. day 1-3 (induction therapy); 45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy); 6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Other intervention name(s): Neulasta
Intervention MeSH terms: Cytarabine; Etoposide; Idarubicin; Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338
      (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with
      or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral
      antidiabetic therapy
    


Intervention name(s): insulin 338 (GIPET I); insulin glargine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administered once daily in combination with metformin with or without DPP-4 inhibitor; Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor; Administered once daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
S90652 in Paediatric Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects
      on blood pressure of a paediatric formulation of perindopril given in hypertensive children
    


Intervention name(s): Perindopril
Intervention type(s): Drug
Intervention MeSH terms: Perindopril
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of Selpercatinib (LY3527723) on the
      heart rate-corrected QT (QTc) interval. The study will last up to 41 days.
    


Intervention name(s): Selpercatinib; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus; Active Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in
      reducing disease activity in participants with systemic lupus erythematosus (SLE) with active
      cutaneous manifestations and joint involvement (Part A), and in participants with active
      cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic
      CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations
      (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in
      reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of
      BIIB059 (Parts A and B).
    


Intervention name(s): BIIB059 (litifilimab); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Other intervention name(s): litifilimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus
Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, open-label, single-sequence, drug-drug Interaction study is conducted to
      evaluate the effect of diltiazem extended release (ER) (a moderate CYP3A inhibitor and P
      glycoprotein [Pgp] inhibitor) on the pharmacokinetics (PK) of a single oral dose of E2027 in
      healthy participants.
    


Intervention name(s): E2027; Diltiazem ER
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 50 mg capsules, once daily on Day 1 and Day 12; 1 x 300 mg capsule, once daily on Days 7 through 24
Intervention MeSH terms: Diltiazem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: E2027; Healthy participants; Pharmacokinetics
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Condition: Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
MeSH terms: Lymphoma; Leukemia; Lymphoma, Follicular; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of
      ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia
      (CLL) patients. subject will receive ofatumumab 8 weekly infusions.
    


Intervention name(s): ofatumumab
Intervention type(s): Drug
Intervention description(s): Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.
Intervention MeSH terms: Ofatumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD20 positive; Chronic lymphocytic leukemia; Follicular lymphoma; GSK1841157; Japanese patient; Ofatumumab