bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of itraconazole on the single dose
      pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.
    

Detailed description: 
      This will be a Phase 1, open-label, 2-period, fixed-sequence, crossover study to investigate
      the effect of the strong CYP3A inhibitor itraconazole on PF-06463922 PK in approximately 16
      healthy volunteers. The study will consist of potentially up to 6 treatments: single dose of
      PF-06463922 50, 75 or 100 mg and PF-06463922 50, 75 or 100 mg in combination with multiple
      dose itraconazole.
    

Intervention name(s): PF-06463922; PF-06463922; PF-06463922; PF-06463922; Itraconazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2; Single oral dose of PF-06463922 75 mg on Day 1 of Period 1 and Day 5 of Period 2; Single oral dose of PF-06463922 100 mg on Day 1 of Period 1 and Day 5 of Period 2; Highest safe single oral dose (mg) of PF-06463922 identified in the previous cohorts will be administered on Day 1 of Period 1 and Day 5 of Period 2; 200 mg oral dose of itraconazole on Days 1 to 11 during Period 2
Other intervention name(s): Lorlatinib; Lorlatinib; Lorlatinib; Lorlatinib; Sporanox
Intervention MeSH terms: Itraconazole
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and
      healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy
      adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a
      single dose of 50 mg in healthy elderly volunteers.
    

Detailed description: 
      The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up
      to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in
      healthy elderly volunteers.
    

Intervention name(s): Drug: E2609; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2609 orally at varying ascending doses; Matching Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) profile
      following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with
      Osteogenesis Imperfecta (OI).
    


Intervention name(s): Romosozumab; Calcium; Vitamin D
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will receive 3 doses of romosozumab via a subcutaneous (SC) injection.; All participants will receive daily supplements of elemental calcium.; All participants will receive daily supplementation with vitamin D.
Intervention MeSH terms: Vitamin D; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc)
      administration of CDP6038 to Japanese subjects.

      To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of
      CDP6038 to Japanese subjects
    


Intervention name(s): CDP6038; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 100 mg/mL solution for injection, single dose; 0.9% sodium chloride for injection Single-dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy volunteers; Japanese
Modeling Bronchial Epithelium Modifications Associated With COPD Using iPS
Condition: Pulmonary Disease, Chronic Obstructive; Smoking
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The primary objective of this study is to to verify the feasibility of obtaining and
      comparing two epithelia in two populations based on the following experiments:

        -  Differentiation of an Induced Pluripotent Stem cell (iPS) clone derived from cutaneous
           biopsy in a population of heavy smokers (plus patients with chronic obstructive
           pulmonary disease) in order to obtain differentiated bronchial epithelia in vitro.

        -  For each of these same patients, generation of bronchial epithelium in vitro from
           bronchial biopsy using human bronchial epithelial cells (HBECs) in air-liquid interface
           (ALI) cultures.
    

Detailed description: 
      Secondary objectives:

        -  Confrontation of the two models of in vitro generation of bronchial epithelium by iPS
           and ALI in order to validate our model of study of the human bronchial epithelium COPD
           generated by the iPS.

        -  Inducing a "COPD-like" epithelial phenotype by exposing the bronchial epithelia
           generated from the iPS to a source of in vitro toxin (tobacco) and studying its effects
           by transcriptomic analysis via high-throughput sequencing (NGS) at key steps during the
           model.

        -  Demonstrate the feasibility of obtaining iPS from peripheral blood sampling.
    

Intervention name(s): Bronchial biopsy; Skin biopsy; Blood sample
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The bronchial biopsy is part of this study's inclusion criteria and is required during routine care for the patient. Bronchial fibroscopy is performed under general or local anesthesia. Biopsies are performed using forceps and according to current recommendations. One biopsy will be fixed immediately in RCL2 medium while the others (between 3 and 6) will be kept in isotonic saline and rapidly prepared for air-liquid-interface (ALI) cell culture.; The skin biopsy will be performed after local anesthesia by hypodermic injection of a 1% Xylocaine solution. A single sample of a skin fragment about 3 mm in diameter will be necessary.; The blood sample will be taken at the end of the cutaneous biospy, approximately 20 ml of blood will be collected.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study includes patients with chronic obstructive pulmonary disease, as well as
        patients without chronic obstructive pulmonary disease, but who are heavy smokers.
      
Biospecimen description: 
      This study will general cell cultures.
Carboplatin and Paclitaxel With or Without ISIS 3521 in Treating Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. ISIS 3521 may help kill more cancer cells by making tumor cells
      more sensitive to chemotherapy. It is not yet known if carboplatin and paclitaxel are more
      effective with or without ISIS 3521.

      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and
      paclitaxel with or without ISIS 3521 in treating patients who have stage IIIB or stage IV
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the overall survival of patients with stage IIIB or IV non-small cell
      lung cancer treated with carboplatin and paclitaxel with vs without ISIS 3521. II. Compare
      the time to tumor progression and time to treatment failure in patients treated with these
      regimens. III. Compare the overall (complete plus partial) response rate in patients with
      measurable disease treated with these regimens. IV. Compare the percentage of patients with
      non-measurable, evaluable disease who have a complete response after treatment with these
      regimens. V. Compare the duration of response in patients with a complete or partial response
      after treatment with these regimens. VI. Compare the safety of these regimens in these
      patients.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to tumor stage (IIIB vs IV) and prior brain metastases (yes vs no). Patients are
      randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours
      and carboplatin IV over 1 hour on day 0. Arm II: Patients receive ISIS 3521 IV continuously
      on days 0-14 and paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 3.
      Treatment repeats every 21 days in the absence of disease progression or unacceptable
      toxicity. Patients with stable or responsive disease receive 6 courses of treatment. Patients
      with responsive disease may receive additional courses of treatment. Patients are followed at
      1, 2, 4, and 6 months and then every 3 months thereafter.

      PROJECTED ACCRUAL: Approximately 600 patients (300 per treatment arm) will be accrued for
      this study within 15 months.
    

Intervention name(s): ISIS 3521; carboplatin; paclitaxel
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) is one of the most common medical complications of
      pregnancy and has serious health implications for both the pregnant woman and her child. In
      particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes
      and metabolic syndrome, perpetuating serious health consequences in subsequent generations.

      Although regular exercise offers numerous benefits for both the mother and her child, its
      effectiveness in preventing GDM remains to be established. It has been recently shown that
      regular supervised home-based exercise may attenuate the decline in glucose tolerance in
      obese pregnant women. This study aims to conduct a single-centred, multi-sited,
      single-blinded randomised controlled trial examining the effect of 14 weeks of supervised
      home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM,
      along with other aspects of maternal and fetal wellbeing.

      Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n =
      100) or a control group (n = 100). The exercise intervention will involve three 60-minute
      home-based, supervised exercise sessions each week. This type of program overcomes many of
      the barriers to exercise in this population including transportation, child care issues and
      embarrassment associated with exercising in a public venue. The investigators have already
      shown this program to be both feasible and warmly accepted by obese pregnant women.
    


Intervention name(s): Supervised home-based exercise
Intervention type(s): Behavioral
Intervention description(s): Each participant randomised to the exercise group will be required to participate in three 60-minute exercise sessions each week, starting at 14 weeks gestation, for a total of 14 weeks (i.e. to be completed by 28 weeks of gestation). All exercise sessions will be home-based and fully supervised by an experienced exercise physiologist. The exercise program will be implemented in accordance with the American College of Sports Medicine and the American College of Obstetrics and Gynecology guidelines. All sessions will be conducted on a stationary cycle ergometer.
Heart rate will be measured continuously during exercise to ensure that the exercise intensity is maintained as prescribed. In addition, blood pressure and rate of perceived exertion will be monitored at 10-min intervals. Perceived exertion will not be allowed to exceed a rating of 14 (i.e. "somewhat hard").
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Association of G9a Protein and the Outcome of Patients With Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      G9a protein was approved to be highly associated with recurrence of breast cancer, gastric
      cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this
      study was to clarify the association and G9a protein and cervical cancer by analyzing the
      immunohistochemical staining of G9a protein to the histopathologic specimen of cervical
      cancer and clinical data.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cervical cancer, and underwent primary treatment (surgery, radiotherapy or
        chemotherapy) in Far Eastern Memorial Hospital
      
Biospecimen description: 
      Residual pathology block after pathological exam
    
Keywords: Outcome of cervical cancer
The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Objective: The main target of this study was to research the early changes in pulmonary
      function and intrarenal hemodynamics, then research the correlation between the pulmonary
      function and the renal hemodynamics in type 2 diabetes (T2DM) patients without diabetic
      kidney disease (DKD).

      Method: 37 T2DM patients (diabetes group) without DKD and 33 healthy people (control group)
      were choosed to research early changes in pulmonary function and intrarenal hemodynamics,
      then research the correlation between the pulmonary function and the renal blood flow in T2DM
      patients, all having normal renal function. The primary endpoints were the pulmonary function
      parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the
      secondary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral
      interlobular renal arteries were evaluated using; the tertiary endpoints were the biochemical
      variables: blood-fat (TC, HDL-C, LDL-C, and TG), renal function parameters (BUN, Cr, and
      GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR)
      were measured.
    

Detailed description: 
      Pulmonary function was measured by spirometer which was provided by Jaska Corporation in
      Japan, model number: HI-101; RI were measured by Logiq 400 MD Pro Series scanner (GE Medical
      Systems, Milwaukee, WI) using a 3.5-4 MHz vector array transducer
    

Intervention name(s): T2DM
Intervention type(s): Other
Intervention description(s): T2DM without DKD
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We selected 42 T2DM patients (24 males, 18 females) without DKD as diabetes group and 38
        healthy people (21 males, 17 females) as control group from the diabetic outpatient clinic
        in Shenyang the Fourth Hospital of People, but only 37 patients (21 males, 16 females) in
        the diabetes group and 33 healthy people (18 males, 15 females) can be researched in our
        study, all the participants were the Chinese Hans.
Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation
Condition: Heart Disease; Heart Failure; Vasodilatation
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The apelin-APJ system is a relatively new discovery. It has generated interest in part due to
      it's apparent ability to counteract the renin-angiotensin system, which is frequently
      overactive in many cardiovascular disease.

      Two of the main actions of apelin are to increase the pumping ability of the heart and cause
      blood vessels to relax. The investigators wish to assess if these actions are altered in the
      setting of normal renin-angiotensin activation and increased renin-angiotensin activity.
    


Intervention name(s): Apelin; Acetylcholine; Sodium nitroprusside; Systemic apelin infusion
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial apelin infusions at 0.3, 1.0 and 3.0 nanomol/ml.; Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 5, 10 and 20 microg/min; Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 1, 2 and 4 microg/min; Following plethysmography patients will receive systemic infusion of (Pry)Apelin-13 (30, 100 and 300 nmol/min) for 5 mins cardiac output, blood pressure, heart rate and systemic vascular resistance will be measured at 5-min intervals.
Intervention MeSH terms: Nitroprusside; Acetylcholine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Renin angiotensin system; Apelin; Cardiac output; Vasodilatation
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study
      conducted at one study center in the United States (US).
    


Intervention name(s): GMI-1271; Filgrastim; Placebo Injection; Placebo Infusion
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block
Condition: Anesthesia, Local; Nerve Block; Brachial Plexus Block
Study type: Interventional

Summary: 
      An ultrasound-guided infraclavicular block performed with the costoclavicular (CC) approach
      and the lateral sagittal (LS) approach will be compared in patients scheduled for forearm and
      hand surgery.
    

Detailed description: 
      The CC approach is a recently introduced infraclavicular approach that targets three cords
      (medial, lateral and posterior) located lateral to the axillary artery in the costoclavicular
      space. Cords in this space are located more superficially than with the classical approach at
      the lateral infraclavicular fossa and are clustered but maintain a consistent anatomical
      relationship with each other.

      Patients will be divided into two groups:

      Group LS: Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5%
      bupivacaine)

      Group CC: Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5%
      bupivacaine)
    

Intervention name(s): Lateral Sagittal Approach; Costoclavicular Approach
Intervention type(s): Procedure; Procedure
Intervention description(s): The US probe will be located medial to the coracoid process in the sagittal plane in the infraclavicular region, and then three cords of the brachial plexus will be viewed. Using the in-plane technique, bupivacaine 0.5% will be administered around the posterior cord (7ml), lateral cord (7ml), and medial cord (6ml).; The US probe will be placed parallel to the clavicle in the midclavicular area and tilted toward the cephalad and the axillary artery, and three cords will be viewed. A needle will be forwarded from lateral to medial with the in-plane technique, and 20 ml of bupivacaine 0.5% will be administered at the center of the three cords.
Other intervention name(s): Infraclavicular Block - Lateral Sagittal Approach; Infraclavicular Block - Costoclavicular Approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia, Conduction; Ultrasound; Brachial Plexus Block/methods; Infraclavicular; Costoclavicular approach; Lateral Sagittal approach; Upper Extremity
A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of BI 730357 under steady state
      conditions on the pharmacokinetics of digoxin, furosemide, metformin and rosuvastatin given
      as a cocktail (Reference, R: cocktail alone; Test T: cocktail given under steady state
      conditions of BI 730357).
    


Intervention name(s): BI 730357; CRESTOR®; Lenoxin®; MetfoLiquid GeriaSan®; Lasix®
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Tablet; Oral solution; Oral solution
Other intervention name(s): Rosuvastatin; Digoxin; Metformin hydrochloride; Furosemide
Intervention MeSH terms: Metformin; Digoxin; Furosemide; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perifollicular Doppler in Natural Cycle In Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Perifollicular Doppler could reflect the quality of the follicle's vascularization and,
      consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the
      analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.

      The goal of this study is to evaluate if there is a link, in natural cycle In Vitro
      Fertilization, between the quality of the vascularization and the one of the oocyte, the
      embryo and the pregnancy.
    


Intervention name(s): Doppler ultrasound
Intervention type(s): Procedure
Intervention description(s): Doppler Ultrasound
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women following In Vitro Fertilization cycle