bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second
      line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated
      previously with Docetaxel.
    


Intervention name(s): Docetaxel; Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles; Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
Other intervention name(s): Taxotere
Intervention MeSH terms: Carboplatin; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer; 2nd line chemotherapy; Docetaxel
A Study of BRII-297 in Healthy Adult Subjects
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics
      of BRII-297 in healthy adult subjects. The main aim of the study is to evaluate the safety
      and tolerability after single dose intramuscular administration of BRII-297. The study also
      aims at characterizing the PK profiles of BRII-297 and brexanolone after single dose
      intramuscular administration.

      Participants will be enrolled in 6 cohorts (3 planned and 3 optional) with 6 participants per
      cohort [(4 active: 2 placebo) - Cohorts 1 & 2] and 10 participants per cohort [(8 active: 2
      placebo) - Cohorts 3 to 6].

      Randomization for each cohort will be a two-step process. Sentinel subjects for each cohort
      will include 2 female subjects randomized 1:1 to BRII-297 or placebo who will be observed for
      at least 24 hours to ensure no significant safety events before administering study drug to
      the remaining non-sentinel subjects.

      The estimated total duration for each subject is up to 43 days, including screening period
      (28 days), dosing period (1 day), and post-dose follow-up period (14 days). IM injections
      will be administered in the gluteal muscle.

      Each participant in all cohorts will begin their inpatient stay at the clinical
      investigational site on Day -1 and remain as an inpatient at the site for sample collection
      and assessments for 15 days post dose (Day 15). Participants will be released at the end of
      the inpatient period.
    


Intervention name(s): BRII-297; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses of BRII-297 will be given in different cohorts i.e., Cohorts 1 through 6; Escalating doses of placebo will be given in different cohorts i.e., Cohorts 1 through 6
Other intervention name(s): Escalating doses of BRII-297; Placebo to match
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
MASIMO Radical 7 and Laboratory Measurement
Condition: Major Hepatic Surgery
Study type: Observational

Summary: 
      Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin
      concentrations through compared with laboratory measurement during major hepatic surgery, and
      to determine the source of discordance between two methods.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult patients, American Society of Anesthesiologists Physical Status Ⅰor Ⅱ, scheduled for
        potentially hemorrhagic major hepatic resection under general anesthesia and requiring an
        arterial line
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
Condition: Dentine Hypersensitivity; Tooth Erosion
MeSH terms: Dentin Sensitivity; Tooth Erosion; Hypersensitivity
Study type: Interventional

Summary: 
      Tooth hypersensitivity due to dental erosion is one of the most common problem related to
      swimming in improper pH chlorinated pools. Because the teeth are exposed to acidic water for
      a long time, which cause the loss of dental hard tissue. Tooth hypersensitivity can lead to a
      negative effect on daily life such as dietary selection, maintaining optimal dental hygiene
      and beauty aspects. It has been found that using mouthguard while swimming can prevent the
      teeth directly contact to chlorinated water, so it can protect tooth structure and decrease
      tooth hypersensitivity. Moreover, using mouthguard with viscous products can seal the gaps
      between mouthguard and teeth which can help to protect tooth structure and decrease dental
      hypersensitivity more effectively. At present, there are many desensitizing products such as
      toothpaste, mouthwash and chewing gum. Desensitizing toothpaste is the most common
      over-the-counter (OTC) materials in desensitizing. Many research has endorsed the properties
      of desensitizing toothpaste that can reduce tooth tissue loss and helps to reduce tooth
      hypersensitivity effectively. So it can be hypothesize that when use the combination of
      mouthguard with desensitizing toothpaste, it might have synergistic effect on reducing tooth
      hypersensitivity in swimmers.
    

Detailed description: 
      Tooth erosion is the loss of dental hard tissue due to acidic agents without bacteria
      involvement.

      Mouthguard is a protective appliance use for covering the teeth and gums to prevent the teeth
      from acidic chlorinated water.

      Desensitizing toothpaste is toothpaste containing 8 percent arginine and calcium carbonate
      that can reduce tooth demineralization and promote remineralization.
    

Intervention name(s): mouthguard; mouthguard with desensitizing toothpaste
Intervention type(s): Device; Device
Intervention description(s): mouthguard; mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Dentine Hypersensitivity; Toothpaste; Tooth erosion
Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety, tolerability, and immune response to
      killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected
      individuals.
    


Intervention name(s): SAV001-H
Intervention type(s): Biological
Intervention description(s): A whole-killed HIV
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV; Vaccine; HIV-1 infections
Dexmedetomidine Premedication in Children
Condition: Premedication
MeSH terms: Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral
      dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the
      young children underwent complete dental treatment.
    

Detailed description: 
      One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental
      rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine
      in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation
      Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and
      Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from
      their patient file. Premedication period was 45 minutes and measurements of RSS and
      hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were
      transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two
      sample t- tests, chi-square tests and ANOVA.
    

Intervention name(s): Dexmedetomidine; apple juice
Intervention type(s): Drug; Other
Intervention description(s): 1µg/kg dexmedetomidine oral; apple juice
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Retrospective study
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Dexmedetomidine; child; premedication; emergence delirium; dental treatment
Tablet Distraction for Pain Control During Venipuncture
Condition: Pain Relief
Study type: Interventional
Phase: Phase 3

Summary: 
      Venipuncture is one of the painful procedures most frequently performed in children. Pain and
      distress management in children, during needle related procedures, is warranted.

      The base for pain management starts with behavioural and environmental support and
      distraction. Distraction is a cognitive strategy trying to divert the child's attention from
      a noxious stimulus. Active distraction involves the child in a different performance, e.g.
      playing, during pain procedures. Passive distraction redirects the child's attention to
      visual or auditory stimuli using toys, songs, movies or blowing bubbles.

      Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a
      limited time. Patients usually arrive without a pharmacological premedication and go away
      immediately after procedure. In this context distraction is an excellent pain relief tool.

      The aim of the study is to compare the effectiveness of an active distraction (playing a
      videogame using a computer tablet) with a passive distraction technique in pain relief during
      venipuncture in a blood-drawing centre.
    


Intervention name(s): Active distraction using a tablet; Passive distraction
Intervention type(s): Other; Other
Intervention description(s): Playing a videogame using a computer tablet; A nurses singing a song, reading a book, blowing bubbles and playing a puppet show
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Procedural pain; Phlebotomy; Distraction; Videogame; Computer tablet; Child
Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Single ascending dose first time in human study for GZR18 in healthy subjects
    

Detailed description: 
      A double-blind, randomized, placebo-controlled, sequential, single, ascending dose study to
      evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of
      subcutaneous injections of GZR18 in healthy subjects
    

Intervention name(s): GZR-18; Placebo
Intervention type(s): Drug; Other
Intervention description(s): As previously described in Arms; Placebo will be dosed in an identical manner to active study drug.
Other intervention name(s): Placebo Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blinded, randomized, placebo-controlled, sequential, dose-escalating, single-dose study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.
    

Detailed description: 
      To investigate the safety and tolerability of escalating single doses of CAM-3001 in patients
      with RA; To investigate the pharmacokinetics of single doses of CAM-3001 in RA patients; To
      investigate the pharmacodynamics of single doses of CAM-3001 in RA patients; To investigate
      the preliminary clinical effects of CAM-3001 on the signs and symptoms of RA.
    

Intervention name(s): CAM-3001; CAM-3001; CAM-3001; CAM-3001; CAM-3001; CAM-3001; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): A single patient shall be dosed with a dose of 0.01mg/kg of CAM-3001 followed no sooner than 24 hours later by a second patient at a dose of 0.03mg/kg.; Dosed at 0.1mg/kg.; Dosed at 0.3mg/kg; Dosed at 1.0 mg/kg.; Dosed at 3.0 mg/kg.; Dosed at 10 mg/kg.; Active: Placebo 5:1 for arms 2-6
Other intervention name(s): Mavrilimumab; Mavrilimumab; Mavrilimumab; Mavrilimumab; Mavriliumab; Mavrilimumab
Intervention MeSH terms: Mavrilimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors
Condition: Rhabdomyosarcoma and Other Soft Tissue Sarcomas; Ewing's Sarcoma Family of Tumors; Osteosarcoma; Neuroblastoma; Brain Tumors
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safest and most effective oral dose
      combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e.
      relapsed or refractory.
    

Detailed description: 
      Sorafenib, a multi-kinase inhibitor of several targets felt to be important in tumor growth
      and angiogenesis, has been well studied and shown promising clinical results in adult cancer
      patients and the Maximum Tolerated Dose or MTD has been determined in pediatric patients.
      Irinotecan is known to be effective and is widely used in pediatric malignancies. The
      combination of sorafenib with irinotecan is of interest as these agents have different
      mechanisms of action. In addition, the combination has been evaluated in adult patients and
      deemed tolerable without alterations in the pharmacokinetic (PK) profile at the MTD. The
      trial we are proposing also offers the advantage of being a completely oral regimen, adding
      convenience and cost effectiveness. Given these considerations, if the sorafenib/irinotecan
      combination proves tolerable in phase I studies and shows efficacy in phase II studies, it
      would be an attractive combination to incorporate into existing chemotherapy regimens for
      pediatric cancer.
    

Intervention name(s): sorafenib; irinotecan
Intervention type(s): Drug; Drug
Intervention description(s): sorafenib (50 and 200 mg tablets) orally twice daily, on a continuous schedule at a starting dose of 150mg/m2/dose.; irinotecan (70 mg/m2/dose) orally, concurrently, once daily,starting at the beginning of the 21 day cycle,repeated every 21 days
Intervention MeSH terms: Irinotecan; Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sora./Irino. combination therapy
Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves or Corresponding Dorsal Root Ganglia?
Condition: Post-Mastectomy Chronic Pain Syndrome
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      neuropathic pain can occur following any surgical procedure on the breast ..
    

Detailed description: 
      chronic pain affects the daily lives of post-surgical breast cancer patients. many of these
      patients were undertreated for pain and generally obtained poor pain relief.treated patients
      with chronic thoracic segmental pain including patients with post-mastectomy pain syndrome by
      radiofrequency for dorsal root ganglion reported longterm pain relief.
    

Intervention name(s): radiofrequency; radiofrequency
Intervention type(s): Procedure; Procedure
Intervention description(s): The procedure will be done under propofol sedation, under fluoroscopic guidance. The image intensifier will be rotated in a cephalo-caudal direction until the endplates of the thoracic vertebrae are aligned and the transverse processes became discernable from the ribs.
For the intercostal nerve group, the radiofrequency needle 10 cm with 10 ml active tip will then inserted to contact the lower edge of the transverse process of (T2-T5), the needle is walked off to obtain sensory stimulation between 0.3-0.6 mv and motor stimulation less than 1.2 mv .five cycle of pulsed radiofrequency will be delivered.; The procedure will be done under propofol sedation, under fluoroscopic guidance.for dorsal root ganglion group, radiofrequency needle 10 cm with 10 ml active tip will inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walked into the thoracic intervertebral foramen. Once correct needle position is confirmed, test stimulation will be performed at 50 Hz, during which time the needles will slightly redirected to optimize stimulation, the point of maximum stimulation will be designated to be the location of the dorsal root ganglion. five cycle of pulsed radiofrequency will be delivered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Comparison Between 22-gauge and 27-guage Needles
Condition: Anesthesia; Pain; Caudal Block; Pediatric Anesthesia; Abdominal Surgeries
Study type: Interventional

Summary: 
      Ultrasound (US) has facilitated the use of caudal block in children and visualization of the
      needle during insertion. This prospective clinical trial study compares between two different
      sizes of the used needles, in terms of success rate, number of punctures, detection of the US
      signs (visualization of the needle, dural displacement, turbulence, and distention), and
      complications in pediatrics aging between 6-36 months requiring elective lower abdominal and
      perineal surgeries.
    

Detailed description: 
      Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial
      assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to
      the dural sac ending. Real-time US allows visualization of the needle during insertion to
      reach the dural sac, and to see the turbulence and distention of the layers during injection
      of the local anesthetic drug.

      This prospective clinical trial study compares between two different sizes of the used
      needles, in terms of success rate, number of punctures, detection of the US signs
      (visualization of the needle, dural displacement, turbulence, and distention), and
      complications in pediatrics aging between 6-36 months requiring elective lower abdominal and
      perineal surgeries.
    

Intervention name(s): The use of classical Gauge 22 needle; The use of classical Gauge 27 needle
Intervention type(s): Device; Device
Intervention description(s): After induction of general anesthesia, patients will undergo caudal block by using classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz.; After induction of general anesthesia, patients will undergo caudal block by using Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Caudal block; Ultrasound; Pediatric anesthesia; Pain
Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
Condition: Septic Shock; Acute Kidney Injury
MeSH terms: Shock, Septic; Acute Kidney Injury; Shock
Study type: Interventional

Summary: 
      Although norepinephrine is commonly used and is the recommended agent for the treatment of
      hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be
      added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to
      decrease exposure to norepinephrine. The aim of the work is to compare the effect of
      norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue
      perfusion in septic shock patients.
    

Detailed description: 
      Study which was performed on 90 adult of either sex in intensive care unit who developed
      septic shock.45 patients in each group according to the drugs used, by the single blind
      technique as the treating physician only is aware of the drugs used.

      Group 1: patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min).

      Group 2: patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min).
      +Vasopressin infusion at the rate of (0.03 unit/min).

      A comparison was done between both groups as regard:Hemodynamics,Tissue perfusion, C-Reactive
      Protein (mg/L) ,WBC, UREA (mg/dL),CREATININE (mg/dl), NGAL (Neutrophil gelatinase associated
      Lipocalin) (ng/ml). Comparison was done at baseline, then every 6 hours for 48 h as regard
      hemodynamics and tissue perfusion, and at base line then, 24 h and 48 h as regard sepsis
      biomarkers and renal biomarkers.
    

Intervention name(s): norepinephrine / Vasopressin
Intervention type(s): Drug
Intervention description(s): • The drug infusion was prepared as 100 IU of AVP (Pressyn; Ferring Inc., Toronto, Ontario, Canada) in 250 ml D5W, infused at the rate of 4.5 ml/h for 0.03 IU/min and 15 mg of Norepinephrine (Arterenol; Sanofi-Aventis, Frankfurt, Germany) in 250 ml D5W infused at the rate of 10 ml/h for 10 mcg/min using infusion pump.
Other intervention name(s): norepinephrine
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Children's Use of the Built Environment for Physical Activity
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The study aims are to develop and test the feasibility of a pediatric physical activity
      intervention that incorporates personal information on use of the built environment, and test
      the intervention's preliminary efficacy at increasing physical activity. The investigators
      hypothesize that it will be feasible to incorporate and measure changes in empiric GIS
      (geographic information system), GPS (global positioning system), and accelerometer feedback
      in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data
      collection (primary measure of feasibility), ii) Participation rates among adolescents in the
      intervention group compared to the control group, and iii) Acceptability to patients as
      measured by adolescent satisfaction.
    


Intervention name(s): built environment use counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Overweight; Physical Activity; Built Environment; counseling