bioihbjkbjnl/mcl2 huggingface dataset:
INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria
Condition: Hypertension; Diabetes Mellitus, Type 2
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, active control trial to determine the safety, efficacy and
      pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with
      hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.
    

Detailed description: 
      A multicenter, randomized, double-blind, parallel-group, active-control trial is designed to
      evaluate the safety and efficacy of INV-144 versus losartan plus placebo co-administered once
      daily for 12 weeks in subjects who have type 2 diabetes and hypertension with nephropathy as
      evidenced by albuminuria.

      Approximately 92 adult subjects will be enrolled and randomized in a 1:1 ratio to receive
      either INV-144 or losartan plus placebo once daily for 12 weeks. The goal is to have
      approximately 80 subjects complete the entire study.

      The trial will consist of a 4-week open-label losartan run-in period, a 12-week double-blind
      active treatment period, and a 4-week safety follow-up period. Efficacy will be evaluated by
      measurement of UACR, systolic and diastolic blood pressure, and the HOMA-IR ratio. Safety
      will be monitored throughout the study by evaluation of adverse events (AEs), physical
      examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs).

      Blood samples for PK analysis will be obtained in a subset of approximately 22 subjects, at 2
      to 4 sites, to ensure that PK data are obtained from a minimum of 9 subjects in each
      treatment arm.
    

Intervention name(s): Active Control; INV-144
Intervention type(s): Drug; Drug
Intervention description(s): Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg); INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Diabetes mellitis; Nephropathy; Albuminuria
The Detection of Circulating Tumor Cells (CTCs) in Patients With Prostatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Condition: Neoplastic Cells, Circulating
MeSH terms: Neoplastic Cells, Circulating; Prostatic Neoplasms
Study type: Observational

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      prostatic cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers. In view of these facts, the
      investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting
      human tumor cells of prostatic cancer in normal peripheral blood after cryosurgery with or
      without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators
      also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)
      method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with prostatic cancer and healthy volunteers. The blood of the healthy volunteers will be
      used to evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage prostatic cancer come to Fuda Hospital for treatment.
      
Keywords: Prostatic Neoplasms; Circulating TUmor Cells
A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the
      past decade and has widely replaced conventional open prostatectomy in many institutions due
      to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay.
      However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation,
      which leads to increased intraocular pressure (IOP). In particular, robot-assisted
      laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position
      and often prolonged insufflation times, which is known to effect the increase in IOP during
      surgery and may result in ophthalmic complications such as postoperative vision loss (POVL).
      The majority of patients undergoing RALRP is old aged and often present with comorbidities.
      Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient
      vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having
      undiagnosed glaucoma is also increased, and therefore methods to prevent such complications
      are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have
      been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous
      humour outflow to some extent. Among these agents, propofol has been reported to be more
      effective than other inhalational anesthetics in decreasing IOP. The goal of this
      prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane
      on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide
      pneumoperitoneum.
    


Intervention name(s): Total intravenous anesthesia; Inhalation Anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia induction with intravenous propofol (effect site concentration 2.5 µg/mL) and remifentanil (effect site concentration 3 ng/mL) using target controlled infusion (TCI). Anesthesia maintenance with propofol effect site concentration 1.5~4 µg/mL and remifentanil effect site concentration 2~5 ng/mL.; Anesthesia induction with intravenous propofol bolus of 1.5~2.5 mg/kg and remifentanil (effect site concentration 3 ng/mL)using target controlled infusion (TCI). Anesthesia maintenance with sevoflurane 1.5~2.0 % and remifentanil effect site concentration 2~5 ng/mL.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy
The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)
Condition: Periapical Diseases; Periapical Cyst
MeSH terms: Radicular Cyst; Periapical Diseases
Study type: Interventional

Summary: 
      The goal of this triple blinded randomized clinical trial is to evaluate the effect of
      combining different bioactive root end filling materials with composite bone graft
      (xenogeneic mixed with autogenous bone fragments) on the healing process of periapical
      tissues after endodontic micro-surgery procedure on patients with small to moderate sized
      lesions. The main questions it aims to answer are:

      Will the use of Totalfill in Endodontic surgeries show comparable results to the gold
      standard MTA? Will the addition of composite bone graft (Xenogenic and Autogenous) affect the
      healing of small to moderate sized lesions? Is there any interaction between composite bone
      graft and different bioactive root-end filling materials? Participants were allocated to 4
      different groups according to the root-end filling material used with or without bone graft.

      Reseachers compared between MTA only group, Totalfill only group, MTA with bone group, and
      Totalfill with bone group to evaluate healing of the periapical lesion using CBCT after 12
      months follow up period.
    


Intervention name(s): Apical microsurgery
Intervention type(s): Procedure
Intervention description(s): inoculation of the periapical or the periradicular lesion with the sectioning of the apical 3mm of the root followed by root-end cavity preparation and retro-filling with the MTA or TotalFill with or without composite bone grafting according to patient allocation.
Other intervention name(s): apicoectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apicoectomy; Bone graft; Endodontic surgery; MTA; TotalFill; Apical lesions
Multisensory Stimulation in Infants for Eye Examination
Condition: Premature Retinopathy; Pain, Eye
MeSH terms: Retinopathy of Prematurity
Study type: Interventional

Summary: 
      This study aimed to evaluate the effects of multisensory stimulation on pain and
      physiological parameters resulting from ROP examination in preterm newborns.

      It was planned as a randomized controlled trial. trying to reach 80 newborns in total.
      Multisensory stimulation will be applied to the intervention group during the examination. In
      the control group, routine care will be applied during the examination.
    

Detailed description: 
      Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this
      population undergoes eye examinations at regular intervals. This procedure is painful
      procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it
      was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized
      controlled trial and routine care were planned in the control group. Neonatal pain will be
      assessed using the PIPP scale.
    

Intervention name(s): Multisensorial Stimulation
Intervention type(s): Behavioral
Intervention description(s): Strategies such as touching, calling, making sense of smell, entering the eye area, and activating the sense of taste will be applied to activate the five senses of the newborn.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: preterm infants; Multisensorial stimulation
The Effect of a Blue Light Filtering IOL
Condition: to Compare the Effect of Two Types of IOLs; on the Incidence of Cystoid Macular Edema; After Cataract Surgery
MeSH terms: Cataract; Macular Edema; Capsule Opacification
Study type: Interventional

Summary: 
      To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation
      of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light
      filtering intraocular lens(UV-filtering IOL).
    

Detailed description: 
      The following parameters were measured for evaluation of blood retinal barrier disruption.

        -  the incidence of macular leakage by fluorescence angiography (FA)

        -  the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)

        -  the thickness of the macula by optical coherence tomography (OCT)

      Results

        -  the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12
           months) in the blue-filtering IOL group (P<0.05), and was significantly lower compared
           with the UV-filtering IOL group at 12 months.

        -  the VFP significantly decreased in both group from 3 to 12 months.

        -  the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL
           group.
    

Intervention name(s): intraocular lens implantation
Intervention type(s): Procedure
Intervention description(s): Intraocular lens implantation
Other intervention name(s): a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan); an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: macula edema; intraocular lens; prospective randomized parallel clinical design
Potassium Citrate to Prevent Age Related Bone Loss
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Osteoporosis, a disease in which the bones become weak and are more likely to break, is a
      major health problem in the United States. Too much acid in the body appears to be linked to
      loss of calcium via urine, bone loss, and muscle breakdown. The purpose of this study is to
      determine the effect of various doses of potassium citrate, a supplement that can neutralize
      acid, on bone density and muscle mass in older, healthy adults.
    

Detailed description: 
      Over 10 million adults in the United States have osteoporosis, and another 18 million have
      low bone mass, a risk factor for developing this disease. Each year, approximately 1.5
      million fractures are associated with osteoporosis. Adequate intake of calcium and vitamin D
      is the current nutritional approach to preventing age-related bone loss. However, even with
      sufficient levels of these nutrients, bone loss can still occur. Too much acid in the body,
      caused by diet, aging, and protein metabolism, appears to be linked to loss of calcium via
      urine, bone loss, and muscle breakdown. Potassium citrate can neutralize acids. The purpose
      of this study is to determine the effect of various doses of potassium citrate on bone
      density and muscle mass in older, healthy adults.

      This study will last 6 months. Baseline measurements will take place from Weeks 1 through 4.
      During this time, participants will first receive a placebo over a 2-week period.
      Participants will then undergo a calcium balance study, involving consumption of certain
      study foods for 12 days and an overnight stay at the research unit for a calcium absorption
      test. The calcium balance study will be followed by blood collection. At Week 5, participants
      will be randomly assigned to receive either potassium citrate or placebo daily. For the first
      9 weeks of treatment, there will be weekly blood collection and periodic urine collection for
      all participants. At Month 6, blood and urine will again be collected, and participants will
      complete questionnaires on diet and physical activity, and a second calcium balance study.
    

Intervention name(s): Potassium citrate
Intervention type(s): Dietary Supplement
Intervention description(s): kcitrate
Intervention MeSH terms: Potassium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Calcium balance
A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of food on the pharmacokinetics (how the
      drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a
      single dose in healthy male volunteers.
    

Detailed description: 
      This is an open-label (identity of assigned study drug will be known), randomized (treatment
      sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg
      administered orally (by mouth) in approximately 36 healthy male participants under fasted and
      fed conditions. Three doses of abiraterone acetate will be administered with a 7-day washout
      period between each dose. The total study duration for each participant will be 21 days.
      Participants will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB,
      CBA): Treatment A = abiraterone acetate 1000 mg administered after a high-fat meal; Treatment
      B = abiraterone acetate 1000 mg administered after a low-fat meal; Treatment C = abiraterone
      acetate 1000 mg administered in the fasted state. No food will be ingested for 4 hours
      post-dose. Participants will be confined at the clinical research unit from the day prior to
      dosing until clinic discharge on the day following dosing in each treatment period. Serial
      pharmacokinetic samples will be collected and safety will be monitored throughout the study.
    

Intervention name(s): Treatment A: abiraterone acetate; Treatment B: abiraterone acetate; Treatment C: abiraterone acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal; 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal; 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Abiraterone acetate; Pharmacokinetics
Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children
Condition: Intraoperative Complications; Postoperative Complications
MeSH terms: Postoperative Complications; Intraoperative Complications
Study type: Observational

Summary: 
      The purpose of this study is to see if the surgical safety checklist is associated with a
      reduction in perioperative complications for children undergoing surgery in Ontario, Canada.
    


Intervention name(s): Surgical Safety Checklist
Intervention type(s): Other
Intervention description(s): An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Surgical interventions performed in Ontario for children
      
Keywords: Surgical safety checklist; perioperative complications; pediatric
Users Study Of The Caverject Delivery System
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Usability testing of the dual-chambered syringe in conjunction with the proposed patient
      instructions for use.
    

Detailed description: 
      Usability testing of the dual-chambered syringe in conjunction with the proposed patient
      instructions for use
    

Intervention name(s): dual-chamber syringe
Intervention type(s): Other
Intervention description(s): dual-chamber syringe for mock injection
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: usability study
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult, male and female human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India and the corresponding Reference
      Product: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA, under
      fasting condition in normal, healthy, adult, male and female human subjects in a randomized
      crossover study.

      The study was conducted with 40 healthy adult subjects. In each study period, a single 40 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 19 days including washout period of 15
      days between administrations of study drug in each study period.
    

Intervention name(s): Lisinopril Tablets 40 mg; Lisinopril
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg tablet once a day; 40 mg tablet once a day
Other intervention name(s): Test Product; Zestril® (Lisinopril) 40 mg Tablets
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vorinostat and Palliative Radiotherapy
Condition: Pelvic Cancer; Radiotherapy
MeSH terms: Pelvic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study. Side-effects when combined with standard palliative radiotherapy.
    


Intervention name(s): Vorinostat
Intervention type(s): Drug
Intervention description(s): Increasing dosing, phase I
Intervention MeSH terms: Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Palliative treatment; Max. tolerable dose