bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or
      intravenous (IV) routes in healthy subjects.

      Part 1 of this study will involve an initial assessment of safety, tolerability and
      pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a
      predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will
      occur which will assess key comparability criteria to inform progression to Part 2 of the
      study.

      Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or
      close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes
      of administration, in sequential manner, respectively. An interim data review will also occur
      after completion of Part 2, where all data accumulated previously will be assessed to examine
      appropriateness to progress to Part 3.

      Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous
      routes using the same dose administered in Part 2.
    


Intervention name(s): Single IV dose of GSK2862277; Matching placebo single dose IV infusion; Single IH dose of GSK2862277; Matching placebo single dose IH; Repeat IV dose of GSK2862277; Matching placebo repeat dose IV infusion; Repeat IH dose selected of GSK2862277 from Part 2; Matching placebo repeat dose IH
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK2862277 solution available in a 40 mg vial for IV administration.; Matching placebo solution available for IV administration.; GSK2862277 nebulised solution available in a 40 mg vial for IH administration.; Matching placebo nebulised solution available for IH administration.; GSK2862277 solution available in a 40 mg vial for IV administration.; Matching placebo solution available for IV administration.; GSK2862277 nebulised solution available in a 40 mg vial for IH administration.; Matching placebo nebulised solution available for IH administration.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: healthy volunteer; TNFR1; domain antibody; Lung injury
Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
Condition: Anesthesia, Caudal; Anatomy; Ultrasonography; Pediatrics
Study type: Observational [Patient Registry]

Summary: 
      Detailed study of ultrasonographic caudal epidural anatomy
    

Detailed description: 
      Caudal epidural block is one of the most common methods to provide analgesia for an
      infraumbilical surgery in children. Although it can be carried out safely and easily, many
      complications have been described so far, because of inaccurate needle injections. To perform
      a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography
      is an important tool to perform pediatric regional blocks, including caudal blocks. We
      believe that caudal epidural ultrasound evaluation can be an important option to decrease
      complications and to achieve a successful attempt; due to that we will try to describe caudal
      epidural ultrasound imaging and changes from one month to 84 months.
    

Intervention name(s): Caudal Epidural Ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasonographic Measurement
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients who are admitted to operating room for any pediatric surgery
      
Keywords: Caudal block; Ultrasound; Children; Regional block anatomy
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of
      PBT2 administered to healthy volunteers in the presence and absence of food.
    

Detailed description: 
      The study will be conducted in 2 dosing periods, with participants being randomised to
      receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day
      washout period before receiving the opposite fed/fasted condition to that allocated in the
      first dosing period. Pharmacokinetic samples will be collected during each dosing period,
      along with safety monitoring assessments.
    

Intervention name(s): Fed Cohort PBT2; Fasted Cohort PBT2
Intervention type(s): Drug; Drug
Intervention description(s): PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.; PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants
      as a relapse prevention for opiate addicted inmates about to be released from prison. The
      experimental group is compared with a control group that commences methadone maintenance
      treatment before release.

      The hypothesises are that quality of life and criminal behaviour improve significantly in
      both groups compared to the month before incarceration. The experimental group is going to
      have significant less days with opioid use compared to the MMT group.

      We hypothesize furthermore that the implants can prevent death related to opiate overdose up
      to 6 months after commenced treatment.
    

Detailed description: 
      The probability of quick relapse to criminal activity and substance abuse after prison
      release is high among incarcerated opiate addicts.

      We attempt to prevent relapse to opiate abuse by two different means:

      Methadone Maintenance Treatment (MMT) versus Naltrexone implants, randomly allocated to two
      groups by sealed envelopes.

      All participants may choose in which group to continue after 6 (and again after 12) months,
      when the implants supposedly stop releasing naltrexone.

      The total treatment period is 18 months, continuation with MMT is optional after study
      termination.
    

Intervention name(s): Naltrexone; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): surgically implanted naltrexone releasing during 5 to 6 months; Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
Intervention MeSH terms: Naltrexone; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: naltrexone implant; methadone; inmates; randomized controlled trial
The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
Condition: Quality of Life; Spinal Deformity; Scoliosis
MeSH terms: Scoliosis; Congenital Abnormalities
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to translate and culturally adapt the quality of life profile
      for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of
      Turkish version of QLPSD in patients with adolescent idiopathic scoliosis.
    

Detailed description: 
      The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in
      adolescents with spinal deformities. It contains 21 items in five dimensions: psychosocial
      functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4
      items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The
      possible score range is 21-105.

      The QLPSD has shown good validity and reliability. English, French and Persian versions of
      the QLPSD have been developed and validated. Good reliability and ease of use are mentioned
      in these versions. The QLPSD was designed to examine adolescents with spinal deformities and
      measure the effect of orthotic and surgical treatments on QoL. This questionnaire is
      practical and suitable for patients with spinal deformities. As a result we choose to
      translate the QLPSD into Turkish as it is less costly, practical and time consuming than
      developing a new tool. QLPSD may be preferred during follow-up of the results of conservative
      and / or surgical treatments for spinal deformities.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL.
Other intervention name(s): the Quality of Life Profile for Spinal Deformities
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Aged between 10-16years old with scoliosis who treated by conservative management.
      
Keywords: quality of life; scoliosis; spine; validation; adaptation
Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
Condition: Premenstrual Syndrome; Dysmenorrhoea
MeSH terms: Syndrome; Dysmenorrhea; Premenstrual Syndrome
Study type: Interventional

Summary: 
      Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow
      of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are
      used in the prospective observational trial. The study has interventional and control groups.
      There are changes in premenstrual syndrome complaints and dysmenorrhoea complaints during the
      study period.The deegre of menstrual pain and self-awareness improve during the period of
      study. The ultrasound examination shows changes in genital blood flow after exercise.
    

Detailed description: 
      Subject of the study:

      Examination of premenstrual syndrome and dysmenorrhoea treatment results with Aviva exercise
      intervention.

      Method of the study:

      Prospective observational trial with the participation of volunteers.

      Questionnaires:

        1. PRISM calendar: Prospective Record of the Impact and Severity of Menstrual Symptoms
           (Reid, 1995). The participants have to fill out this every day,

        2. The Body Awareness Questionnaire Shields, S. A., Mallory, M.E., & Simon, A. (1989). The
           Body Awareness Questionnaire: Reliability and validity. Journal of Personality
           Assessment, 53(4), 802-815

        3. Examination to measure the intensity of menstrual pain: Numeric Rating Scale

        4. Heart rate monitoring and documentation before and after the exercises; completion of
           the Borg Scale of Perceived Exertion to measure exercise intensity;

        5. Questionnaire of life style

        6. Beck depression questionnaire

      Ultrasound examination:

      Doing the Aviva exercises, ultrasound measurements are performed in Robert Hospital
      (Budapest) on the patients participating in the study. The first measurement is performed for
      each person before starting the exercises. When the first subject has finished the exercise,
      a control ultrasound measurement will be carried out.

      In the control group there is also twice ultrasound examination for the individuals.

      Measured parameters: PI (pulsatility index) of uterine artery transvaginal ultrasound
      measurement followed by statistical evaluation of the results.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 30 minute long exercises twice a week
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational study. The study has interventional and control groups.
Masking: None (Open Label)
Primary purpose: Treatment
Novel Support Surface to Alleviate Pressure Ulcer
Condition: Immobility Syndrome; Pressure Ulcer; Pressure Injury
MeSH terms: Pressure Ulcer; Ulcer; Crush Injuries
Study type: Interventional

Summary: 
      A prototype support surface has been designed which aims to successfully redistributes the
      pressures exerted and provides sufficient support to human soft tissue

      We want to prove the effectiveness of the prototype support surface by enlisting patients in
      a clinical trial, where we will assess the presence of pressure ulcers, and the ability of
      the patients to tolerate the support surface, and also measure the pressure over time and
      compare them to when the patients are using standard mattresses.
    


Intervention name(s): Novel support surface
Intervention type(s): Device
Intervention description(s): This is a magnetorheological elastomer that can dynamically redistribute the pressure over a bony prominence to be lower than the critical closing pressure while at the same time providing sufficient support.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Essential Oils in Aromatherapy on Emotional Relaxation
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to examine and compare electroencephalography (EEG) changes in
      human subjects directly after inhalation of essential oils from five Thai aromatherapies. The
      investigators hypothesize that essential oils from Thai aromatherapies may influence the
      human EEG involving emotional relaxation particularly alpha wave EEG.
    

Detailed description: 
      The subjects consisted of 22 male and 26 female subjects , ages between 20 to 30 years (mean
      age, 23.3 years). They were screened for excessive nasal congestion, drug and food taken, and
      neurological disorders prior to participation in the experiment. The experiments were
      approved by the Ethical Committee for Research Involving Human Research Subject, Naresuan
      University. All subjects read and signed an informed consent before participation.
    

Intervention name(s): Aromatherapy; Pure water
Intervention type(s): Other; Other
Intervention description(s): Subject will assigned inhale aromatherapy; Subject will assigned inhale Pure water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Volunteer
A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to determine whether the test product, Methotrexate 40 mg/mL solution for
      injection administered subcutaneously by the prefilled and needle-free delivery system
      Zeneo®, and the reference product, Methotrexate Biodim® 25 mg/mL, solution for injection
      administered subcutaneously by a conventional syringe with needle are bioequivalent.
    

Detailed description: 
      ABSTRACT Objective: Zeneo1 is a needle-free injection device. We performed a pharmacokinetic
      study to investigate the bioequivalence of methotrexate administered subcutaneously using
      either the needle-free injection device or a conventional needle and syringe.

      Research design and methods: This was a single-dose, open-label, laboratory-blind, randomized
      crossover study performed in adult healthy volunteers. Each participant received two
      methotrexate injections (each 25mg), one via needle-free injection device and one via
      conventional injection, with a 21-28 day wash-out interval between dosing. For each
      participant, the administration site for both injections was either the abdomen or the thigh.

      Main outcome measures: The primary pharmacokinetic outcome parameters were AUC(0-t) and Cmax.

      Bioequivalence was assessed by standard criteria: whether 90% confidence intervals of
      geometric mean ratios for the two administration methods were within 80-125%.

      Results: Fifty-two individuals completed the study. Bioequivalence criteria were met for
      AUC(0-t), for the overall analysis (both injection sites: 90% confidence interval:
      99.4-103.1%), and for each injection site separately. Bioequivalence was similarly
      demonstrated with AUC(0-1). Bioequivalence criteria for Cmax were fulfilled for abdominal
      administration but not for the overall analysis. Injection via the needle- free injection
      device was well tolerated.

      Limitations: Limitations include conducting the study in healthy volunteers and the
      relatively small subject number (albeit satisfactory for bioequivalence).

      Conclusions: This study shows that methotrexate injection via needle-free injection device is
      bioequivalent to a conventional needle and syringe in relation to AUC(0-t) and AUC(0-1).
      Studies of needle-free injection device use in patients requiring methotrexate therapy are
      planned.
    

Intervention name(s): Zeneo® - Methotrexate; Methotrexate Biodim®
Intervention type(s): Other; Drug
Intervention description(s): 0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system; 1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dermatopharmacokinetic Trial of LEO 90100 Foam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount
      of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.
    


Intervention name(s): LEO 90100 foam; Dovobet® ointment
Intervention type(s): Drug; Drug
Intervention description(s): A foam formulation of the active comparator Dovobet® ointment; Ointment formulation containing same active ingredients as LEO 90100 foam
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: A single application of LEO 90100 foam and Dovobet® ointment will be applied to multiple test sites on the innerside of both arms of trial subjects. The trial consists of 2 parts. The first part, (pilot part) will evaluate the pharmacokinetic profile of LEO 90100 foam and Dovobet® ointment by measuring the amount of each of the active ingredients in the stratum corneum and determine conditions for the second part of the trial. The second part (pivotal part) will compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 90100 foam and Dovobet® ointment. The sample size and the number of application sites in the pivotal part will be determined based on the results of the pilot part.
Masking: None (Open Label)
Primary purpose: Other
Melatonin to Prevent Brain Injury in Unborn Growth Restricted Babies
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 4

Summary: 
      Intrauterine growth restriction is the term used to describe a condition where an unborn baby
      does not reach its optimum size. In the short and long term, intrauterine growth restricted
      babies have a higher risk of serious disease and even death. It is well established that very
      low levels of oxygen in the baby's blood can harm the baby's health through a state known as
      oxidative stress. Currently, there is no established treatment available to treat
      intrauterine growth restriction or its complications. In experimental animal studies however,
      the naturally occuring hormone, melatonin, has been shown to significantly reduce oxidative
      stress and improve health of the unborn babies that have suffered from intrauterine growth
      restriction. This study aims to find out if the use melatonin twice per day throughout
      pregnancies affected by intrauterine growth restriction will lower the level of oxidative
      stress experienced by the unborn baby. If this is the case melatonin may help protect the
      unborn baby from damage caused by oxidative stress, this will be studied in a separate future
      study.
    


Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): 4mg prolonged release melatonin oral tablets twice daily
Other intervention name(s): Circadin
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Normative Data of Intra-epidermal Nerve Fiber Density
Condition: Healthy
Study type: Interventional

Summary: 
      Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this
      density is used to diagnose small fiber neuropathy, despite the absence of normative data in
      a selected normal population. To establish a normative set of data matched for age and sex is
      absolutely needed to evaluate the sensibility and specificity of this test.
    


Intervention name(s): Biopsy
Intervention type(s): Procedure
Intervention description(s): 3 mm punch biopsy of the skin at the distal leg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: volunteer
Association Between the Menstrual Cycle and Weight Loss
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This is a research study to look at the association between weight loss and the menstrual
      cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a
      reduced-calorie diet and exercise plan for 3 months.
    

Detailed description: 
      Two different reduced calorie diet and exercise plans will be compared. One plan changes diet
      and exercise prescription with the phases of the menstrual cycle, while the other is a
      standard reduced calorie diet and exercise plan based on MyPyramid.gov website.
    

Intervention name(s): Reduced calorie diet and exercise plan; Different reduced calorie diet and exercise plan
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive written diet and exercise instructions to follow for the duration of the study.; Participants will receive written diet and exercise instructions to follow for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment