bioihbjkbjnl/mcl2 huggingface dataset:
Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia
Condition: Balanced Anesthesia
Study type: Interventional

Summary: 
      The aim of the present study was to compare SPI guided analgesia with standard clinical
      practise during general anesthesia using a balanced setting of sevoflurane and sufentanil
      anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular
      stability, less use of analgetics and shorter recovery from anesthesia.
    

Detailed description: 
      General anesthesia can be considered as a combination of hypnosis, antinociception, and
      immobility. The monitoring of hypnosis and immobility has been established in clinical
      practise, however for the evaluation of antinociception a valid monitoring is missing.

      The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate
      index derived non invasively from finger plethysmographic signal. It has been demonstrated to
      correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA
      our group could show beneficial effects of SPI guided analgesia in terms of remifentanil
      consumption, hemodynamic stability and incidence of unwanted events.

      Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be
      transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and
      the opioid sufentanil.

      The following hypotheses have been made:

        1. SPI guided analgesia will result in less sufentanil consumption

        2. SPI guided analgesia will result in more hemodynamic stability and faster recovery of
           the patient after anesthesia, and less opioid use in post operative period
    

Intervention name(s): administration of sufentanil; sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): 10 microgram sufentanil were given when SPI above 50 for more then 20 sec; sufentanil was given at standard practise
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anesthesia General; Anesthetics Inhalation; Diagnostic techniques and procedures
Factors Affecting the Time to Start Postoperative Chemotherapy in Colorectal Cancer
Condition: the Time to Start Postoperative Chemotherapy
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Colorectal cancers are common tumors and have undergone a great change in the last 20 years
      in terms of treatment principles. Significantly improved results in local recurrence and
      overall survival have begun to be obtained with chemotherapy protocols given after surgery,
      which is the main element of the treatment system (1). It is known that postoperative
      chemotherapy protocols are commonly given within 6-8 weeks and this period is optimal.
      However, it was found that this period was prolonged in approximately 20% of these patients
      in the methanalysis performed (2). It has been shown that delay in applied chemotherapy
      causes a decrease in overall survival (3,4). The factors causing this delay have not been
      adequately examined in the literature. It is necessary to investigate these factors that
      affect the overall survival outcomes, which are the main pillars of treatment principles, and
      to regulate the factors that have the opportunity to improve.

      In this study, our aim is to investigate the perioperative (preop-perop-postop) factors
      affecting the duration of postoperative chemotherapy initiation in patients with colorectal
      cancer treated in our hospital.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients who underwent colorectal resection at General Surgery Clinic in Kayseri state
        hospital between January 2013 and July 2020
      
Keywords: Laparoscopy; overall survival; local recurrence; tumor; chemotherapy; colorectal cancer
Caffeine Intake and Additive Effects on Cognition
Condition: Healthy
Study type: Interventional

Summary: 
      Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant
      properties, and their intake when in moderate doses seem to produce positive effects on
      stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be
      displayed also on cognition, as caffeine, when in proper proportions, the investigators do
      not know if the joining of the two strategies into a single activity would be able to promote
      additional effects enhancing cognitive processes related to memory, attention, and motor
      reaction time.
    

Detailed description: 
      Determine if 500 mg of caffeine can generate additional effects to 30 minutes of aerobic
      exercise enhancing cognitive memory tasks (Rey Auditory Verbal Learning Test - RAVLT),
      attention (sustained attention span; working speed; Percentual of errors by confusion) and
      simple reaction time (SRT).
    

Intervention name(s): Caffeine Intake; Placebo Intake
Intervention type(s): Other; Other
Intervention description(s): The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.; The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.
Other intervention name(s): Caffeine; Placebo
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Cognitive; Aerobic Exercise; Performance
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
Condition: Solid Organ Transplant Recipient (Liver, Kidney, Heart); Rheumatologic Disorder; Human Immunodeficiency Virus (HIV); Bone Marrow Transplant (BMT); Dialysis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Rheumatic Diseases; Collagen Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Fluzone High Dose increases the immune
      response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone
      in immunocompromised children and young adults. Safety and efficacy data will also be
      collected.
    


Intervention name(s): Fluzone High Dose; Fluzone
Intervention type(s): Biological; Biological
Intervention description(s): A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm; A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
Other intervention name(s): high-dose influenza vaccine; influenza vaccine; influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera
Condition: Diarrhea; Cholera
MeSH terms: Cholera; Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are
      grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients.
      This is not a hypothesis-driven research study.
    

Detailed description: 
      This study will be conducted in two parts.

      The first part (Part A) will evaluate the pharmacokinetics, safety and tolerability of
      iOWH032 in healthy, adult Bangladeshi volunteers.

      The second part (Part B) will evaluate the pharmacokinetics, safety and tolerability of
      iOWH032 in adult Bangladeshi patients with cholera. While female participants will be
      included in Part A, only male patients will be enrolled in Part B. The rationale for
      excluding women in Part B is the difficulty in separating urine from stool in severely
      dehydrated females with rapid rates of purging. Moreover, it has been difficult to retain
      adult females in the hospital after improvement of their diarrhoea because of their household
      responsibilities, which might impact compliance in this small study. Further, no sex
      differences in the pharmacokinetics of iOWH032 were found in the study conducted in healthy
      subjects in the US, which included 42 males and females, nor have sex differnces been
      observed in preclinical studies.
    

Intervention name(s): iOWH032
Intervention type(s): Drug
Intervention description(s): Part A: Participants will be randomized at a 3:1 ratio to receive treatment with iOWH032 or placebo. A randomisation code will be generated. Each participant will be assigned the next participant number available and thereby will be assigned randomly. Active treatment will consist of an oral tablet containing 300 mg of iOWH032. The placebo will consist of identical looking tablets.
Part B: There will be no randomization during this trial. All eligible patients will receive 300 mg of iOWH032.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholera; V. Cholerae O1; iOWH032; diarrhoea; pharmacokinetic; Bangladesh
A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in
      subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.
    

Detailed description: 
      After a screening visit, eligible subjects will enter a run-in period. Subjects will receive
      a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the
      beginning of the run-in and for the whole duration of the study. Each eligible subject will
      then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections
      of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be
      conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3
      subjects will leave the clinical site and continue the treatment with IMP for the next 3
      weeks. On Day 23 subjects will come back for a MMT on Day 24.

      This study is constituted of 2 parts. In the first part (Part A), only subjects with daily
      prandial insulin dose ≤ 40 U/day will be enrolled.

      Following the completion of the part A, an extension part (Part B) will be conducted to
      particularly assess the safety and tolerability of higher daily doses of ADO09 in patients
      with insulin requirements ≥ 40 U/day.

      The clinical conduct and procedures will not change for the Extension Part of the study.
    

Intervention name(s): ADO09 formulation; NovoRapid®
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection of ADO09 formulation; Subcutaneous injection of insulin aspart
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
2ccPA Study in Patients With Symptomatic Knee Osteoarthritis
Condition: Osteoarthritis (OA) of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is designed to determine safety and tolerability as well as the MTD of a
      single-dose 2ccPA and PK data in symptomatic knee OA.
    

Detailed description: 
      Osteoarthritis (OA) is a degenerative disease frequently associated with symptoms such as
      inflammation, stiffness, muscle weakness, joint swollen and joint pain. 2-carba-cyclic
      phosphatidic acid (2ccPA) is the derivative of natural occurring phospholipid mediator,
      cyclic phosphatidic acid (cPA). Previous studies suggested that 2ccPA inhibits inflammation
      and may relieve the pain caused by osteoarthritis.

      This clinical study aims to assess the safety, tolerability, and pharmacokinetics as well as
      the maximal tolerated dose (MTD) of a single-dose 2ccPA in symptomatic knee OA. Safety and
      efficacy data for the design and conduction of subsequent studies will also be collected.
    

Intervention name(s): 2ccPA; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four dose cohorts (50 μg, 200 μg, 800 μg, and 2,400 μg) are planned in this study sequentially.
study group: one dose intra-articular on day1; A total of 8 subjects will be recruited and randomized in each dose cohort with a 3:1 ratio (6 subjects in the 2ccPA treatment arm and 2 subjects in the placebo arm).
control group: one dose intra-articular on day 1
Other intervention name(s): 2-carba-cyclic phosphatidic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 2ccPA
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to evaluate the ease of use and technical challenges encountered during
      subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human
      hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery
      systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these
      delivery systems is also being evaluated.
    


Intervention name(s): hylenex-facilitated subcutaneous Lactated Ringer's infusion
Intervention type(s): Drug
Intervention description(s): single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other intervention name(s): hylenex; rHuPH20; LR; LR solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dehydration; fluid therapy; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20
Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray
Condition: Rhinitis, Allergic, Perennial and Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess any effect in children with seasonal and/or perennial
      allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on
      growth using knemometry.
    


Intervention name(s): GW685698X
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GW685698X; seasonal allergic rhinitis; perennial allergic rhinitis; knemometry; children
Rates of Fetal Extractions Between Only Vaginal Touch Usually Realized and Vaginal Touch + Echography
Condition: Assisted Delivery
Study type: Interventional

Summary: 
      The main objective of this study is to compare the rate of fetal extractions between a
      systematic practice of an echography of presentation and the vaginal touch only one usually
      realized during the labor.
    

Detailed description: 
      The main objective is to compare the rate of fetal extractions between a systematic practice
      of an echography of presentation and the vaginal touch only one usually realized during the
      labor.

      It is a prospective, randomized study. After randomization, the patients will be assigned to
      one of following both groups:

        -  Diagnosis of the variety of presentation of the fetal head by the usual examination,
           that is the only vaginal touch allowing the palpation of the sutures of the fetal head
           to locate the axis and the orientation of this one in the maternal pond. However, this
           clinical examination can be completed by an echography if the team considers that this
           information is necessary to optimize the coverage delivery in case of extraction by pair
           of forceps or suction cup.

        -  Diagnosis of the variety of presentation of the fetal head by the vaginal touch,
           confirmed by the systematic practice of an abdominal echography completed by a perineal
           echography from 8 cms of dilation, and made for a maximal extension of 15 minutes
           following the vaginal touch. This echography will be at the need repeated

           1900 patients (that is 950 by group) have to allow to detect a decrease of 25 % of the
           rate of deliveries assisted in the experimental group (systematic echography) with
           regard to the control group (TV), that is a decrease absolved from the rate from 20 % to
           15 %, with a 80 % power and a risk of 5 % (bilateral test).

      Duration of participation in the study: = 2 days Duration of the inclusions: 36 months

      Criteria of efficiency Rate of deliveries attended defined by a composite criteria:
      deliveries by caesarian from a dilation of the cervix = 8 cms, and instrumental extractions
      by pair of forceps or suction cup.
    

Intervention name(s): echography
Intervention type(s): Other
Intervention description(s): echography during labor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: vaginal touch; deliveries assisted; echography; assisted delivery
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of the oral administration of
      setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males
      with androgenetic alopecia (AGA).
    


Intervention name(s): Setipiprant; Placebo; Finasteride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Setipiprant tablets, orally, BID for 24 weeks.; Placebo tablets, orally, BID for 24 weeks.; Finasteride tablet, orally, once daily for 24 weeks.
Other intervention name(s): KYTH-105; AGN-241679
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
Condition: Meningococcal
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide
      vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and
      active surveillance.
    


Intervention name(s): A dose of ACYW135 meningococcal polysaccharide vaccine
Intervention type(s): Biological
Intervention description(s): A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; vaccine
Assessment of the Safety, Tolerability, and Pharmacokinetic of GMA106
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, Phase 1, placebo-control, randomized, double-blind, sequential
      single and multiple ascending dose study to assess the safety, tolerability, and PK of GMA106
      in healthy, overweight or obese subjects.
    

Detailed description: 
      The objective of the study is to assess the safety, tolerability, and PK of single and
      multiple GMA106 SC injection. The study design is a standard design for this type of study.

      This SAD study will consist of 6 cohorts (1 cohort per dose level). Within each cohort, 8
      subjects will be randomized in a 3:1 ratio to receive under fasting conditions, either the
      study drug GMA106, or matching placebo. In each cohort, 6 subjects will be administered
      GMA106 and 2 subjects will receive the matching placebo, for a total of 48 subjects planned
      for evaluation in this study. One randomization scheme will be produced for each cohort
      separately.

      There will be 3 cohorts in the MAD study. Dose groups in MAD are consisted of 20 mg, 40 mg
      and 80mg. Subjects will be dosed once a week in fasting conditions for 12 weeks. In 20 mg
      multiple doses group (Cohort 7), 4 subjects will be randomized in a 3:1 ratio to receive
      GMA106 or matching placebo throughout the course of 12 weeks. In 40 mg (Cohort 8) and 80 mg
      (Cohort 9) multiple doses groups, 7 subjects will be randomized in a 6:1 ratio, respectively.
      A total of 18 subjects planned for evaluation in the MAD study. A randomization system will
      be created for the MAD study.
    

Intervention name(s): GMA106 Injection; GMA106 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GMA106 solution for injection. Subjects in each cohort will receive a single injection of GMA106 or matching placebo under fasting conditions and at the following target dose levels.; Matching Placebo for GMA106
Other intervention name(s): GMA106; Matching placebo for GMA106
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase 1 - divided in 2 stages:
The 1st stage: single ascending dose (SAD) The 2nd stage: multiple ascending doses (MAD)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      A study of the ability of montelukast to improve signs and symptoms of seasonal allergic
      rhinitis compared with placebo. Loratadine is included in the study as an active control.
    


Intervention name(s): montelukast sodium; Comparator: loratadine; Comparator: placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks; loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks; placebo tablet, taken orally once daily at bed time for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment