bioihbjkbjnl/mcl2 huggingface dataset:
Detection of Cannabis Impairment With an Eye Tracker
Condition: Cannabis Intoxication
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cannabis is one of the widely used psychoactive substances in the world. With increasing
      legalization, the prevalence of driving under the influence of cannabis will undoubtedly
      rise. At present, roadside detection of cannabis intoxication is largely dependent on drug
      recognition experts who rely on changes in eye movements when impaired. In this regard, use
      of eye trackers can help to detect impairment in drivers. The purpose of the present study is
      to determine the feasibility of the use of eye trackers in detecting impairment in
      participants who smoked a cannabis cigarette.
    

Detailed description: 
      Participants will attend one study session after determination of eligibility. During this
      session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator.
      Driving will be assessed prior to smoking cannabis and at 7 time points after smoking
      cannabis. Eye tracking measures will also be taken while driving after smoking cannabis.
      Blood will be drawn for determination of levels of the psychoactive substance THC and its
      metabolites. Saliva tests, urine tests and subjective tests will also be performed at various
      times points after smoking cannabis.
    

Intervention name(s): Cannabis Sativa
Intervention type(s): Drug
Intervention description(s): 750 mg cannabis cigarette with 12.5% THC
Other intervention name(s): Marijuana
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis
Condition: Peritonitis; Acute; Appendicitis; Postoperative Pain; Surgery
MeSH terms: Appendicitis; Peritonitis
Study type: Observational

Summary: 
      The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of
      analgesics, operating time, and length of stay in adults during robotic and laparoscopic
      procedures.

      The investigators would like to know if these allegations also apply to children.
    

Detailed description: 
      From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had
      an appendicular peritonitis treated by laparoscopic appendectomy.

      The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard
      insufflation.

      On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew
      which type of insufflation was used.

      On the other hand, the patient, his parents and the nurses in the pediatric department did
      not know which type of insufflation was used.

      The participants were divided in two groups: the Airseal group (A) and the standard group
      (S). In each group, the investigators studied and compared the postoperative pain, the
      consumption of analgesics, the operating time, and the length of stay for each participant.
    

Intervention name(s): Laparoscopic appendectomy
Intervention type(s): Device
Intervention description(s): Laparoscopic appendectomy with Airseal or with standard insufflation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged between 4 and 17 years old, who underwent laparoscopic appendectomy for
        appendicular peritonitis using the Airseal® or a Standard Insufflation, from 2022/01/1st to
        2022/12/31st.
      
Keywords: Valve-less Trocar; Standard insufflation; Prospective study; Laparoscopic Appendectomy; Appendicular Peritonitis
The Metabolite Identification and Material Balance Study of SP2086
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the Metabolite identification and material balance
      of SP2086 in healthy adult volunteers.
    

Detailed description: 
      All subjects were given SP2086 100mg only one time, and blood sample should be collected
      before and 96 hours after medicine taken.
    

Intervention name(s): SP2086
Intervention type(s): Drug
Intervention description(s): SP2086 was taken only one time at 100mg dose in health volunteers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SP2086; Metabolite identification; Material balance
Study to Evaluate the Dosage and Safety of Two Intramuscular Injections of an Investigational Clade B HIV Vaccine
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of
      two different dosages of an investigational clade B HIV vaccine.
    


Intervention name(s): Investigational HIV vaccine dose A; Investigational HIV vaccine dose B
Intervention type(s): Biological; Biological
Intervention description(s): The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3; The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone
      (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;
      now marketed as oxazepam (generic) only).

      This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine
      Use Disorder (CUD).
    

Detailed description: 
      This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, study
      to compare the safety and efficacy of EMB-001 with a placebo control in approximately 80
      subjects with moderate-to-severe CUD. Subjects will receive investigational medicinal product
      (IMP) during a 12-week, double-blind Treatment Period (Week 2 through Week 13) and a 1-week,
      double-blind Taper Period (Week 14).

      After undergoing study procedures during the Screening and Baseline Periods, subjects who
      meet inclusion and exclusion criteria will then be randomized in a 1:1 ratio (n=40/arm) to
      one of the following for the Treatment Period (weeks 2 - 13) on Study Day 8:

        -  EMB-001 720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg
           metyrapone and 48 mg oxazepam (Active Group)

        -  Placebo BID, (Placebo Group)

      During the Taper Period (week 14), subjects in the Active Group will receive EMB-001 240/8 mg
      BID; and the Placebo Group will continue to receive placebo. Both groups will change from
      taking three capsules BID (twice daily) to one capsule BID (twice daily).

      There will be a follow-up visit for safety assessments at Week 18.
    

Intervention name(s): EMB-001; EMB-001 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 720 mg metyrapone/24 mg oxazepam mg BID; Inactive comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine
A HR20031 FE Study on Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824,
      SP2086 and metformin in the HR20031 FDC tablets in healthy subjects.
    


Intervention name(s): HR20031 FDC; HR20031 FDC; HR20031 FDC; HR20031 FDC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fed state .; Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fast state.; Subjects will receive treatment S HR20031 FDC 5/50/750 mg*2 in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state.; Subjects will receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 in the fast state.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: There will be two independent cohorts of subjects who will each receive two treatments (high dose strength and low dose strength), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP to complete at least 32 evaluable subjects.
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds
Condition: Chronic Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous
      system stimulation on vital parameters of wound healing in diabetics. It is investigated if
      auricular vagal nerve stimulation has an effect on heart rate variability as well as
      peripheral local blood perfusion, and if this effect depends on the health status of the
      study participants (diseased/healthy).
    


Intervention name(s): PrimeStim
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Introduction:

      The purpose of the pivotal In Home study is to collect clinical data on the safety and
      efficacy of the Paradigm LGS System in the actual use environment and by the intended use
      population. ASPIRE is a multi-center, in home, randomized parallel adaptive study design with
      type 1 diabetes. The study will compare A1C and CGM based nocturnal hypoglycemic events in a
      treatment arm to a control arm. Arms are defined as:

        -  Treatment Arm (LGS ON) using Paradigm® VEO™ Pump

        -  Control Arm (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump

      The study's objectives are two-fold:

        1. The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS)
           is safe and is not associated with glycemic deterioration, as measured by change in A1C
           from baseline to end of study participation.

        2. The second study objective is to demonstrate that home use of Low Glucose Suspend (LGS)
           is associated with reduction in nocturnal hypoglycemia when patients fail to respond.

      Primary Safety Endpoint:

      The change in A1C from randomization to the end of the treatment period will be used to
      demonstrate that the automatic insulin delivery suspension (LGS ON) does not result in an
      unacceptable worsening of glycemic control.
    


Intervention name(s): Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature; Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
Intervention type(s): Device; Device
Intervention description(s): Automatic suspension of insulin delivery when glucose is low.; No Automatic suspension of insulin delivery when glucose is low.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function and Immune Modulation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      In the present pilot study, the investigators will study the effects of a novel synbiotic,
      which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain
      fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the
      gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that
      the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and
      modulate the immune system in humans.
    


Intervention name(s): Ecologic 825/scFOS; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Synbiotics; Intestinal permeability; Microbiota; Immune response
A Social Media Intervention on Promoting Oral Heath Among Iranian Adolescents
Condition: Health Behavior; Adolescent Behavior; Parent-Child Relations
Study type: Interventional

Summary: 
      Online social networking sites, such as Telegram, possess a number of useful features that
      could enhance oral health promotion interventions, including the ability of users to share
      personal information, which is aggregated and displayed to other users .This study is a
      longitudinal controlled trial that is designed to investigate the effectiveness of a
      multi-component intervention on improving oral health in adolescents and their mothers.
      Participants will be allocated in three groups with a) an intervention group in which mothers
      and children receive the intervention and questionnaires via Telegram, b) only the children
      receive the intervention via Telegram and mothers and children receive the questionnaires,
      and c) mothers and children are in active control group and only receive the questionnaires.
      The intervention package contains behavior change techniques targeting outcome expectancy,
      self-efficacy, action planning, coping planning, and self-monitoring. The active control
      group receives an information sheet regarding recommendations on Oral health behaviors. There
      will be 3 assessment points in time, baseline, 1 month and 6 months after the interventions.

      The primary outcome of this study is to estimate the dyadic mechanisms between mothers and
      their children regarding improving oral health. Secondary outcome is to investigate whether
      oral health behavior did improve in the intervention groups in general and also to find the
      psychological mechanism behind the changes during the time of the study.
    


Intervention name(s): mothers and adolescents; adolescents; active control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The intervention package will be sent to mothers and adolescents via Telegram social media. It contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. There will be 3 assessment points in time, baselines, 1 month and six months after interventions.; The intervention package will be sent to only adolescents via Telegram social media. It contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. There will be 3 assessment points in time, baselines, 1 month and six months after interventions.; The active control group receives an information sheet regarding recommendations on oral health behavior via telegram. There will be 3 assessment points in time, with 1 month and six months in between.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Web-based Bystander Education Program
Condition: Sexual Violence
Study type: Interventional

Summary: 
      This is a study to determine whether a theoretically-driven web-based 3-hour intervention
      designed for male college students called RealConsent is effective in increasing prosocial
      intervening behaviors and in preventing sexual violence perpetration. Sexual violence
      programs for this population have been implemented for decades in the United States, but a
      program that is web-based and incorporates the bystander education model has never been
      implemented or tested. In this study, male college students will be recruited online,
      enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the
      intervention, investigators will ask questions about their intervening and sexually coercive
      behaviors and other theoretical and empirical factors related to the study outcomes.
      Investigators will survey the young men again at post-intervention, and at 6-months follow-up
      to determine whether young men in the RealConsent program intervened more often and engaged
      in less sexual violence compared to young men in the comparison condition. The main
      hypotheses are: (1) college men in the RealConsent program will report more instances of
      prosocial intervening; and (2) college men in the RealConsent program will report less sexual
      violence against women.
    


Intervention name(s): Bystander & Sexual Violence Prevention; General Health Promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place.; This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise.
Other intervention name(s): RealConsent; Stress & Mood Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is comparing the concentration of a single dose of insulin icodec when
      administered in the belly, upper arm and thigh on different occasions.

      Participants will receive one injection of insulin icodec on three different occasions, each
      time injected at a different site, i.e. either on our belly, upper arm or thigh.

      The study will last for about 34 weeks. Participants will have 23 visits with the study
      doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two
      different days. The informed consent visit may be performed via telephone to minimize
      personal contact with site staff during the coronavirus outbreak.

      Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the
      study period.
    


Intervention name(s): Insulin icodec
Intervention type(s): Drug
Intervention description(s): A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of Memantine on Pharmacokinetics, Safety and Tolerability of Single Dose RO5313534 in Healthy Volunteers, and the Effect of RO5313534 on Safety and Tolerability of Steady State Memantine
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, fixed sequence, two-period study will assess the effect of memantine on the
      pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect
      of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will
      receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a
      washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment
      Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks
      after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.
    


Intervention name(s): RO5313534; memantine
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose; multiple doses to steady state
Intervention MeSH terms: Memantine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Low back pain (LBP) is a complex and common problem with major societal repercussions.
      Clinical evaluations, and especially functional assessments, are necessary for proper
      diagnosis and decisions on the most appropriate treatment. The assessment of lumbar
      kinematics has been frequently described. For instance, measures of range of motion (ROM),
      angular velocities and acceleration of the total lumbar spine (TLx) have demonstrated some
      differences between healthy subjects and LBP patients. However, recent evidence has suggested
      that models evaluating the TLx are insufficient. In fact, regional differences in kinematics
      have been described between the upper lumbar spine and the lower lumbar spine.

      The aim of this study is to evaluate the differences in spinal kinematics between healthy
      subjects and LBP patients using a multi-segment model of the spine that allows regional
      analysis.
    

Detailed description: 
      A case-controlled study will be performed to compare asymptomatics subjects and patients with
      low back pain. ROM, angular velocities and coordination of the spine will be collected in a
      laboratory with a camera-based system (VICON). Subjects will have to perform normal ROM
      assessment in the three anatomical planes, as well as different functional activities such as
      sit to stand, step and walking. The measurement session will occur on one occasion for each
      participant.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with recurrent low back pain (more than months in duration) recruited through
        physiotherapy practices and medical consultations in the area of Lausanne, Switzerland.
      
Keywords: Spinal kinematics