bioihbjkbjnl/mcl2 huggingface dataset:
Fentanyl Sublingual Spray in Opioid Naive Participants
Condition: Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic
      relationship of multiple dose administration of fentanyl sublingual spray in opioid naive
      participants. The secondary objective is to determine the safety and tolerability of multiple
      dose administration of fentanyl sublingual spray in opioid naive subjects.
    

Detailed description: 
      For all cycles, blood will be drawn according to the following schedule:

      The 0 time (pre-dose) blood sample will be collected within 60 minutes prior to first study
      drug administration.

      Cohort l: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2, 4 (prior to
      second-dose), 4.083, 4.25, 4.5, 5, 6, 8 (prior to third-dose), 8.083, 8.25, 8.5, 9, 10, 12,
      16 and 24 hours after the first dose.

      Cohort 2: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2 (prior to
      second-dose), 2.083, 2.25, 2.5, 3, 4 (prior to third-dose), 4.083, 4.25, 4.5, 5, 6, 8, 10,
      12, 16 and 24 hours after the first dose.

      Cohort 3: 0 (pre-dose), 5, 15, 30 and 45 minutes after the first dose and at 1 (prior to
      second-dose), 1.083, 1.25, l.5, 1.75, 2 (prior to third-dose), 2.083, 2.25, 2.5, 2.75, 3, 4,
      8, 12, 16 and 24 hours after the first dose.

      Cohort 4: 0 (pre-dose), 5, 15, 30 (prior to the second-dose), 35, and 45 minutes after the
      first dose and at I (prior to the third-dose), 1.083, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3,
      4, 8, 12, 16 and 24 hours after the first dose.
    

Intervention name(s): Fentanyl Sublingual Spray; Fentanyl Citrate IV
Intervention type(s): Drug; Drug
Intervention description(s): Fentanyl delivered at low, medium and high doses by sublingual spray (FSS); Fentanyl Citrate 50 mcg, delivered intravenously
Other intervention name(s): SUBSYS®
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Retrospective Analysis: Whether Five Factors Affect PFS in Patients With Locally Advanced Cervical Cancer
Condition: Locally Advanced Cervical Cancer; Radiotherapy
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      In previous studies, the investigators found that five factors were effective in predicting
      the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.A
      retrospective study was conducted to explore the influence of 5 factors on PFS in patients
      with locally advanced cervical cancer receiving radiotherapy and chemotherapy.
    

Detailed description: 
      In previous studies, the investigators found that five factors were effective in predicting
      the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.5
      factors included positive iliac lymph nodes, histological type, tumor size, positive pelvic
      lymph nodes on both sides, and maximum lymph node diameter greater than 1cm. Different
      factors give different scores.If the score is higher than 3, the probability of
      retroperitoneal lymph node metastasis in patients with locally advanced cervical cancer is
      significantly increased, and the prognosis of patients is affected. Patients with locally
      advanced cervix receiving radical radiotherapy were scored based on 5 factors.Patients with
      scores greater than or equal to 3 points were compared with patients with scores less than 3
      points.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From May 2016 to July 2021, 183 patients with locally advanced cervical cancer received
        radiotherapy in our hospital ,with or without chemotherapy.Patients were scored according
        to 5 factors. PFS were compared between patients with scores greater than or equal to 3
        points and those with scores less than 3 points. PFS is defined as the time from the end of
        treatment to disease progression or the time of the last follow-up 2022-10-01.
ERGT for Women Engaging in NSSI - an Effectiveness Study
Condition: Borderline Personality Disorder; Non-suicidal Self-injury (NSSI)
MeSH terms: Personality Disorders; Borderline Personality Disorder; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy
      (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.
    


Intervention name(s): Emotion Regulation Group Therapy (ERGT).
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM)
      who are receiving metformin monotherapy
    


Intervention name(s): JTT-662; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug tablets containing JTT-662; Placebo tablets matching in appearance to the active drug tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: JTT-662; Diabetes; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics
NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective is to improve the cure rate of children with newly diagnosed acute
      myeloid leukemia (AML) who undergo risk-adapted therapy.

      Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and
      response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg)
      will be evaluated.
    

Detailed description: 
      The overall objective is to improve the cure rate of pediatric patients with newly diagnosed
      acute myeloid leukemia (AML). The specific aims are as follows:

      1.1 Therapeutic aims

      To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.

      To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to
      high-risk patients based on cytogenetics and response to induction therapy.

      To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated
      donor (MUD).

      To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post
      consolidation therapy.

      1.2 Biologic aims

      To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time
      points and to study the prognostic impact of MRD.

      To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data
      to background factors and clinical outcome.

      To secure storage of biological material from diagnosis for future biologic studies
    

Intervention name(s): Gemtuzumab ozogamicin
Intervention type(s): Drug
Intervention description(s): Two courses of Gemtuzumab vs. no further therapy
Other intervention name(s): Mylotarg
Intervention MeSH terms: Gemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; Children; Gemtuzumab ozogamicin; Stem cell transplantation
Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ONO-2952
      across ascending multiple doses in healthy adult male and female subjects. The secondary
      objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.
    


Intervention name(s): ONO-2952; ONO-2952 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg to 100 mg QD at a multiple dose, and 21 days duration; 30 mg to 100 mg QD at a multiple dose, and 21 days duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-2952; Healthy adult subjects; Multiple dose; Safety; Tolerability; Pharmacokinetics
Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
Condition: Anaemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary
      bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The
      purpose of this study was to compare the clinical efficacy of intravenous and oral iron in
      anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular
      surgery under extracorporeal circulation.
    

Detailed description: 
      Prospective double dummy triple blind study of 159 patients undergoing CPB; randomised in 3
      groups treated with iron intravenously (iv) (group I), with iron orally (group II) controlled
      with placebo (group III). Patients from group I were treated with iv Iron sucrose , three
      doses of 100 mg of iv iron every 24 hours during postoperative hospitalization and 1 pill/24
      h of oral placebo during the first month after discharge. Group II was programmed to receive
      1 iron pill orally every 24 hours pre and postoperatively and up to one month after discharge
      and a placebo while hospitalized. Group III was programmed to receive an oral and iv placebo
      pre and postoperatively.

      Variables were collected preoperatively, at operation room and at Intensive Care Unit
      admission and discharge, at postoperative floor discharge and at one month after surgical
      discharge.
    

Intervention name(s): IV trivalent saccharose hydroxide ferrous; Oral ferrous fumarate; Oral and intravenous Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Preoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up
1 month 1 oral placebo /24h; 200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®)
Postoperative Period:
200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet; Preoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h
Other intervention name(s): Venofer
Intervention MeSH terms: Ferrous fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac surgery; Extracorporeal circulation; Anaemia; Intravenous iron; Oral Iron
Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus
Condition: Atrophy; Jaw, Edentulous, Partially; Sinus Floor Augmentation; Bone Substitutes; Bone Regeneration
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      Objectives: The aim of the study was to compare histological and histomorphometric results of
      six bone substitute materials used as graft in two-stage maxillary sinus augmentation model,
      after 6-month-healing.
    

Detailed description: 
      Materials and Methods:

      A two-stage sinus augmentation was carried out in six patients using mineralized
      solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA),
      anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic
      calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite
      (HA-β-TCP 30/70), or bioapatite-collagen (BC).
    

Intervention name(s): Sinus floor augmentation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized,controlled, double-blind clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sinus floor augmentation; Bone regeneration; Histology; Biocompatible materials; Bone transplantation
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether the risk of serious asthma-related events
      (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11
      years old taking inhaled fluticasone propionate/salmeterol combination is the same as those
      taking inhaled fluticasone propionate alone.
    

Detailed description: 
      Progress of Enrollment, Updated Annually: This study has been completed and the final
      clinical study report was submitted to the FDA in May of 2016. This is the final update, as
      this study is complete.
    

Intervention name(s): ADVAIR 100/50mcg; ADVAIR 250/50mcg; FLOVENT 100mcg; FLOVENT 250mcg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate (100) twice daily (AM and PM) for 6 months; fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Other intervention name(s): FSC 100/50; FSC 250/50; FP 100; FP 250
Intervention MeSH terms: Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; ADVAIR; FLOVENT; asthma
A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Impulsive Aggression Comorbid With ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Aggression; Impulsive Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and
      safety study in children with impulsive aggression comorbid with
      Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and
      female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120
      subjects will be randomized across approximately 30 US centers to one of four treatment
      groups.
    


Intervention name(s): SPN-810; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): administered orally; administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impulsive Aggression; Attention Deficit Hyperactivity Disorder; ADHD
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will build upon a previous finding that showed a triglyceride lowering effect of
      prescription omega-3 in combined therapy with statins. The proposed study will use a simple
      change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin
      therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 -
      screening (blood draw for qualification and safety); day 7 - before taking prescription
      omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking
      prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study
      will include up to 15 subjects and will utilize several different measures of lipoprotein
      structure and function. The investigators will measure functional parameters such as the
      binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The
      investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma,
      very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density
      lipoprotein (HDL).
    

Detailed description: 
      This study will build upon a previous finding that showed a triglyceride lowering effect of
      prescription omega-3 in combined therapy with statins. The proposed study will use a simple
      change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin
      therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 -
      screening (blood draw for qualification and safety); day 7 - before taking prescription
      omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking
      prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study
      will include up to 15 subjects and will utilize several different measures of lipoprotein
      structure and function. The investigators will measure functional parameters such as the
      binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The
      investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma,
      very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density
      lipoprotein (HDL).
    

Intervention name(s): Lovaza
Intervention type(s): Drug
Intervention description(s): 1 gram gel capsule 4 capsules per day for 8 weeks
Other intervention name(s): Omega-3 Fatty Acid; fish oil; Omacor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertriglyceridemia; Omega-3 Fatty Acids; Lipoprotein; Statin; Lovaza
CoolCap Followup Study-Coordination of Participating Centers
Condition: Neonatal Encephalopathy
MeSH terms: Brain Diseases
Study type: Observational

Summary: 
      This observational study will assess long-term functional outcome of survivors from neonatal
      encephalopathy who were previously treated with either head cooling or with conventional care
      in a randomized clinical trial. Children's parents will be interviewed by phone by trained
      staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a
      set of skills basic to daily life. This instrument is able to assess a very wide range of
      abilities, from independently functioning to needing total assistance. The ratings will be
      used to examine the relationship between the outcome previously measured at 18 months age and
      functional outcome at school age and to triage the children into those who clearly could not
      be tested on standardized exams of cognitive functioning, those who potentially could, even
      if at a low level of cognitive ability, and those who appear to be functioning at an
      age-appropriate level.
    

Detailed description: 
      Previous studies have demonstrated that hypothermia for hypoxic-ischemic encephalopathy in
      the neonatal period is generally safe and feasible, and can improve intermediate term
      survival without handicap. There is, however, no information on whether cooling improves
      longer term (school-age) outcomes in non-handicapped survivors. The current observational
      trial is designed to help obtain additional followup information on children who participated
      in the initial randomized clinical trial of head-cooling for neonatal encephalopathy. A first
      step is to collect information on the current status (at 7-8 years of age) of participants in
      the original study using a standardized telephone questionnaire. This will allow the
      investigators to more appropriately target children for whom further, more detailed,
      in-person neurodevelopmental testing would be appropriate. Given limited resources,
      identification of children for whom such testing would be helpful and instructive is a
      necessary goal.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible children will be those who participated in the original randomized clinical trial,
        "Brain Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy". Infants
        enrolled in that study were randomized to cooling or standard care. Survivors to 7-8 years
        of age are eligible for this observational followup study.
      
Keywords: neonatal encephalopathy; therapeutic hypothermia; head cooling; neonatal asphyxia
A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of
      Ensartinib Capsules.
    

Detailed description: 
      The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of
      Ensartinib Capsules in Chinese Healthy Volunteers. In addition, the safety of Ensartinib
      Capsules in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be
      evaluated.
    

Intervention name(s): Ensartinib with fed or fasting
Intervention type(s): Drug
Intervention description(s): The two groups of subjects were given an equal dose of Ensartinib capsules (225 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of Ensartinib.
Intervention MeSH terms: Ensartinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment