bioihbjkbjnl/mcl2 huggingface dataset:
Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug and giving drugs in different ways may
      kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus
      systemic fluorouracil and leucovorin in treating patients with liver metastases from
      colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the efficacy of hepatic resection followed by portal vein infusion of
           floxuridine plus systemic fluorouracil/leucovorin calcium in patients with metastatic
           colorectal cancer.

        -  Study the toxic effects of adjuvant chemotherapy following hepatic resection.

        -  Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of
           fluoropyrimidines in tumor cells, including thymidylate synthase, ribonucleotide
           reductase, and folylglutamyl synthetase, by polymerase chain reaction and
           immunohistochemistry.

      OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients
      receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists
      of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4
      weeks for a total of 12 weeks.

      If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's
      discretion. Continuation of regional therapy should be considered for extrahepatic failure.
      No concurrent radiotherapy is permitted.

      Patients are followed every 3 months for 3 years, then every 6 months for survival.

      PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5
      years.
    

Intervention name(s): floxuridine; fluorouracil; leucovorin calcium; adjuvant therapy; conventional surgery
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): Starting dose of 0.2 mg/kg/day for 14 consecutive days.; 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.; 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.; Chemotherapy given after hepatic resection; Hepatic resection
Intervention MeSH terms: Leucovorin; Fluorouracil; Floxuridine; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; liver metastases
Staccato Prochlorperazine Single Dose PK Study
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of
      inhaled prochlorperazine
    

Detailed description: 
      The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of
      a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy
      young volunteers.
    

Intervention name(s): Prochlorperazine 0.5 mg IV over 5 sec; Inhaled prochlorperazine 0.625 mg; Inhaled prochlorperazine 1.25 mg; Inhaled prochlorperazine 2.5 mg; Inhaled prochlorperazine 5 mg; Inhaled prochlorperazine 10 mg; Inhaled placebo; Prochlorperazine 10 mg IV over 5 sec
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV Prochlorperazine for bioavailability; Inhaled Staccato Prochlorperazine 0.625 mg; Inhaled Staccato Prochlorperazine 1.25 mg; Inhaled Staccato Prochlorperazine 2.5 mg; InhaledStaccato Prochlorperazine 5 mg; InhaledStaccato Prochlorperazine 10 mg; Inhaled Staccato Placebo (0 mg); Prochlorperazine 10 mg IV over 5 sec for patient qualification
Other intervention name(s): PCZ; PCZ; PCZ; PCZ; PCZ; PCZ; ADASUVE placebo; PCZ
Intervention MeSH terms: Prochlorperazine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine, Prochlorperazine aerosol
A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335
      as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in
      patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47)
      or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without
      Center-involved diabetic macular edema (CI-DME)
    


Intervention name(s): BI 1467335; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily; Once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Omega-3 and Aspirin in Periodontal Regeneration
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as
      an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis
      patients.
    

Detailed description: 
      In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose
      aspirin would augment the results following regenerative therapy of furcation defects in
      chronic periodontitis patients.
    

Intervention name(s): Regenerative therapy (omega 3 PUFA plus low dose aspirin); Sugar pill
Intervention type(s): Other; Drug
Intervention description(s): Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin; 3 times daily
Other intervention name(s): Omega; Fish oil; ASA; low dose aspirin; DFDBA; Gelatinous capsules
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bone allograft; IL-1; IL-10; periodontal regeneration; omega-3; aspirin
GSK2190915 Safety and Pharmacokinetic Study in Healthy Japanese Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2190915 is currently in development for the treatment of asthma. This study aims to assess
      the safety and tolerability of single doses of GSK2190915 in healthy Japanese subjects. The
      study will also look at the pharmacokinetics (PK) and pharmacodynamics (PD) of single doses
      of GSK2190915 and aims to characterise the PK/PD relationship in healthy Japanese subjects.
      Twelve healthy Japanese subjects will take part in this single escalating dose study and
      subjects will receive one of five possible treatments, 10 mg, 50 mg, 150 mg, 450 mg
      GSK2190915 or placebo in each treatment period. Blood samples (for safety, pharmacokinetics
      and pharmacodynamics), urine samples (for safety and pharmacodynamics) and ECGs, blood
      pressure readings, physical examinations and a review of adverse events will take place at a
      number of timepoints pre and post each dose. A minimum 7 day washout between treatment
      periods will be required. Regardless if a subject completes or prematurely withdraws from the
      study, a follow up visit will be completed 7-10 days following last dose.
    


Intervention name(s): GSK2190915; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor.; Matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Japanese
Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study divided in 2 parts and 3 cohorts to determine the concentration
      of Avibactam and Ceftazidime in the lining of the lungs and the blood.
    

Detailed description: 
      A Phase I Open-Label, 2-Part, 3-Cohort, Single-Centre Study to Assess the Concentration of
      Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma Using at Least Two Different
      Dosing Regimens in Healthy Volunteers
    

Intervention name(s): CAZ104; CAZ104
Intervention type(s): Drug; Drug
Intervention description(s): IV Infusion; IV Infusion
Other intervention name(s): CAZ104 (2000mg Ceftazidime/500mg Avibactam); CAZ104 (3000mg Ceftazidime/1000mg Avibactam)
Intervention MeSH terms: Ceftazidime; Avibactam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; open label; healthy male and female (post menopausal) volunteers; Pharmacokinetics; CAZ104; Avibactam; Ceftazidime; open label, at least 2 different regimens, concentration of investigational product (IP), CAZ104, Avibactam, Ceftazidime, Cmax, tmax
A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will develop and evaluate the effectiveness of a self-management program for
      adults living with both schizophrenia and a co-occurring medical condition.
    

Detailed description: 
      Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans
      each year. Schizophrenia can be extremely disabling, causing people to hear voices,
      experience paranoia or hallucinations, and believe that others are controlling their
      thoughts. People with schizophrenia also experience increased rates of concurrent medical
      conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a
      job or even caring for oneself very difficult. The purpose of this study is to develop and
      evaluate a self-management program for adults living with both schizophrenia and a concurrent
      medical condition.

      Participants in this open-label study will attend 10 to 16 group sessions led by two group
      leaders. Group sessions will meet each week for an hour during which participants will learn
      new skills to help them take responsibility for the daily management of chronic medical
      conditions. In addition to learning how to communicate more effectively with medical
      providers, participants will learn about healthy eating, the importance of physical activity,
      addictive behaviors that can worsen health conditions, and proper use of medications.
      Homework will be assigned weekly for participants to review skills learned in each session.
      After each session, participants will complete a survey to evaluate the session's
      effectiveness. At the end of the study, participants will attend one additional group meeting
      and an individual interview to discuss the overall effectiveness of the intervention and
      their experiences in the group sessions. The results of this study will be used to evaluate
      and improve the self-management program for future use.
    

Intervention name(s): Self-management program for chronic illness
Intervention type(s): Behavioral
Intervention description(s): Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: medical co-morbidity; diabetes; heart disease; respiratory illness
The Role of Spreader Flaps in Preventing of Nasal Obstruction
Condition: Nasal Obstruction
MeSH terms: Nasal Obstruction
Study type: Interventional
Phase: Phase 3

Summary: 
      Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft
      is the gold standard. More recently, the spreader flap technique has been espoused as an
      alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a
      randomized trial setting.
    

Detailed description: 
      Rhinoplasty is a common facial plastic surgery procedure, one complication of which is nasal
      vault narrowing and consequent nasal obstruction. Recently, researchers have paid much
      attention to nasal valve area and especially to the role of upper lateral cartilage (ULC) in
      preserving of nasal patency, since a possible consequence of destructive techniques was
      permanent functional problems for patients. In addition to functional problems, it can cause
      some aesthetic problems such as the inverted-V deformity . Accordingly, reconstruction of the
      midvault after dorsal reduction has been advocated and widely adopted.

      The gold standard for midvault reconstruction after dorsal reduction has been the spreader
      graft, first advocated by Sheen . Subsequently, its usage has been widened to include repair
      of the valve in the unoperated nose, and its efficacy well-documented. However, it can be a
      time-consuming procedure that requires the harvest of septal cartilage. Therefore, some
      authors proposed the spreader flap as an alternative technique. While the results of the
      above mentioned articles proposed the efficacy of spreader flaps, none of them was a
      randomized trial and subjective methods were used for measurement of nasal breathing after
      rhinoplasty.

      Nasal obstruction can be evaluated in different methods, both quantitative and subjective,
      the validity of each debated. For example, while the numeric form of Visual Analogue Scale
      (VAS) is commonly used, it is ultimately related to patients' subjective perception.
      Alternatively, objective evaluation of nasal patency is also of common interest to many
      researchers, and various methods for objective measurement exist. Among these different
      methods, acoustic rhinomanometry is an effective tool. However, some researchers debate the
      reliability of these results. Herein we examine the efficacy of the spreader flap in
      preventing nasal obstruction after dorsal reduction using a randomized trial with both
      objective and subjective measures.
    

Intervention name(s): spreader flap
Intervention type(s): Procedure
Intervention description(s): producing of upper lateral cartilage flap as a spreader flap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
Condition: Total Knee Arthroplasty; Total Knee Replacement; Femoral Nerve Block; Adductor Canal Block
Study type: Interventional

Summary: 
      The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after
      total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by
      femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital
      stays are extended.

      An alternative method could be an adductor canal block (ACB). Anatomical studies of the
      adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure
      sensory nerve for medial and anterior aspects of the knee and the tibia without any motor
      function.

      This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on
      quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).

      We expect the ACB to be superior in muscle strength but equal in pain score. Both groups
      receive an additional anterior sciatic nerve block for complete sensory block of the operated
      knee
    


Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.
Condition: Advanced Malignancies
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in
      participants With normal renal function and participants with renal impairment.
    


Intervention name(s): parsaclisib
Intervention type(s): Drug
Intervention description(s): parsaclisib will be administered orally after 8 hours of fasting.
Other intervention name(s): INCB050465
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women
Condition: Normal Drug Tolerance
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult
      subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving
      seven (7) doses of 1.0 mg/kg IV TP-434.
    

Detailed description: 
      This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult
      subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving
      seven (7) doses of 1.0 mg/kg IV TP-434. Dosing will be twice daily (q12h) for three
      consecutive days beginning on day one (1) and a morning dose on day four (4).

      Approximately 20 subjects will be enrolled into the study at one (1) investigational site.
      The population for this study is healthy male and female subjects 18 to 65 years of age.

      This study includes a Screening Period of up to 30 days, a 4 day, open-label Treatment
      Period, and a two week Follow-up Period. There will be one 6 day/5 night inpatient stay (Days
      -1 to 5) during the Treatment Period and one outpatient visit at the end of the Follow-up
      Period. Excluding the Screening Period, the total duration of confinement (in the Clinical
      Research Center) will be approximately six (6) days and the total study duration, not
      including screening, will be approximately three (3) weeks.

      Participants will be admitted to the Clinical Research Center on Day -1. Participants will
      receive four (4) days of intravenous TP-434 1.0 mg/kg of body weight twice daily (q12h) for
      three consecutive days and a morning dose on day four (4) (for a total of 7 doses) starting
      on Day 1. Blood and urine samples, ECGs, and vital signs will be collected for safety
      analysis at specified time points.

      Pharmacokinetic blood sampling will occur on Day 4before and after the Day 4 dose of TP-434
      at specified time points.

      Participants will be randomized to a single BAL procedure time point. Bronchoscopy and BAL
      will be performed at the following time points after dosing of TP-434 on Day 4: two (2), four
      (4), six (6), and 12 hours after start of infusion. Bronchoscopy and BAL will be conducted
      for up to five (5) different participants at each time point. Each subject will undergo
      bronchoscopy and BAL only once.
    

Intervention name(s): TP-434 (Eravacycline) reconstituted and administered via an IV infusion
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis
Study type: Observational [Patient Registry]

Summary: 
      Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression
      and high mortality rates. Significant risk factors for the development of HCC are metabolic
      syndrome, obesity and type 2 diabetes mellitus(T2DM). Dysregulation of adipose tissue derived
      hormones(adipocytokines/adipokines) might also be involved in obesity-related liver
      carcinogenesis & due to the wide spectrum of visfatin and vaspin activities ,we focus in this
      study on their potential role in patients with HCV-related liver cirrhosis with and without
      HCC on top.
    

Detailed description: 
      Despite improvements in HCC therapy, the prognosis for HCC patients remains poor due to a
      high incidence of recurrence. Early diagnosis can significantly improve the overall survival
      of HCC patients. However, currently available diagnostic markers are still inadequate and
      limited by their low sensitivity and specificity. For instance, the gold standard marker
      alpha-fetoprotein (AFP) has a false negative rate up to 40% for early stage of HCC. It is
      worthy to mention that the level of AFP was reported in a normal range of 25% of patients
      with advanced HCC.

      As such, AFP has been excluded from being a marker for the diagnosis of HCC by Practice
      Guidelines of the American Association for the study of Liver Diseases (AASLD) and confirmed
      by other studies.

      These discrepancies suggest the need of discovering new reliable diagnostic markers for
      patients with HCC. An improved understanding of the pathogenesis of HCC development would
      facilitate the development of more effective outcomes for the diagnosis and treatment of HCC
      at earlier stages.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 70 patients with HCV-related liver cirrhosis attending the outpatient clinic or
        inpatient section of the department will be included in the study, patients will be
        categorized into 2 groups:

          -  40 HCV-related liver cirrhosis patients with HCC on top (Group 1).

          -  30 HCV-related liver cirrhosis patients(Group 2).

          -  In addition, 20 healthy volunteers will be included as controls(Group 3).
      
Biospecimen description: 
      serum sample of each participant