bioihbjkbjnl/mcl2 huggingface dataset:
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
Condition: Enterotoxigenic Escherichia Coli Infection; Diarrhea
MeSH terms: Escherichia coli Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge
      study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.
    

Detailed description: 
      This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge
      study designed to confirm a human challenge model with E. coli strain LSN03-016011/A (LT+
      (Labile toxin), ST- (Stable toxin), CS17), as well as collect expanded safety and
      immunogenicity data.

      The study will be carried out in two phases:

      Vaccination phase: up to 34 subjects will be randomized 1:1 to receive 2 doses of either
      VLA1701 or placebo orally. The doses will be given 7 days apart and subjects will be followed
      as an outpatient for safety.

      Challenge Phase: 30 Subjects, out of the 34 subjects, will be challenged.

      After challenge, subjects will be monitored for diarrhea and other signs/symptoms of enteric
      illness by daily medical checks, vital sign determinations, grading and weighing of all
      stools.
    

Intervention name(s): VLA1701; Placebo; Challenge Strain
Intervention type(s): Biological; Biological; Other
Intervention description(s): VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli); buffer component of VLA1701; LSN03-016011/A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group,
      dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release
      Capsule) in children 6-12 years of age with ADHD.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm,
      parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of
      SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of
      Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are
      randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg,
      200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of
      SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder
      Rating Scale, 4th Edition (ADHD-RS-IV).
    

Intervention name(s): Placebo; 100mg SPN-812; 200mg SPN-812; 300mg SPN-812; 400mg SPN-812
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo was administered once daily; 100mg SPN-812 was administered once daily and compared to placebo; 200mg SPN-812 was administered once daily and compared to placebo; 300mg SPN-812 was administered once daily and compared to placebo; 400mg SPN-812 was administered once daily and compared to placebo
Other intervention name(s): PBO; SPN-812, Low Dose; SPN-812, Low-Medium Dose; SPN-812, Medium-High Dose; SPN-812, High Dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cannabinol Use in Patients With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to investigate the acute effects of cannabinol (CBN) 30 mg and 300 mg, versus
      placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with
      chronic insomnia disorder.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled, three-arm, crossover, single-centre,
      proof-of-concept study in twenty participants with chronic insomnia disorder (as per
      clinician diagnosis and Insomnia Severity Index [ISI] Score ≥15). Across three overnight
      treatment sessions, participants will receive single dose oral liquid 30 mg cannabinol (CBN),
      300 mg CBN, and matched placebo. Participants will undergo overnight sleep assessment using
      in-laboratory polysomnography (PSG) to examine CBN-related changes to sleep parameters; and
      various objective and subjective measures of sleep and next-day neurobehavioral function.
      Each treatment session will be separated by the two-week washout period.
    

Intervention name(s): 30 mg Cannabinol (CBN); 300 mg Cannabinol (CBN); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a 2 mL oral dose of 'ECS 310' (1.5%), an oral formulation of CBN (15 mg/mL) suspended in medium chain triglycerides (MCT) oil.; Participants will receive a 2 mL oral dose of 'ECS 310' (15%), an oral formulation of CBN (150 mg/mL) suspended in medium chain triglycerides (MCT) oil.; Participants will receive a 2 mL oral dose of placebo. Placebo contains the same excipient, medium chain triglycerides (MCT) oil, as the investigational products but does not contain cannabinoids.
Other intervention name(s): ECS 310 (1.5%); ECS 310 (15%)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single site allocation: Randomised Intervention model: Crossover Masking: Double-blind (participant, investigator) Primary purpose: Pilot
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabinol; CBN; cannabinoid; medicinal cannabis; primary insomnia; chronic insomnia disorder; sleep architecture; wake after sleep onset; polysomnography; next-day function; randomised controlled trial; placebo-controlled; crossover; double-blinded
Short-term Health Effects of Wild Blueberry Juice Consumption
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Researchers at the University of Prince Edward Island want to learn about the health effects
      of wild blueberry juice.
    


Intervention name(s): Wild blueberry juice; Placebo wild blueberry juice
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain
Condition: Pain, Acute; Analgesia; Nociceptive Pain
MeSH terms: Acute Pain; Nociceptive Pain
Study type: Interventional

Summary: 
      Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring
      peri-operative pain and to guide intra-operative opioid administration during various
      surgeries.

      Propofol injection pain (PIP) is a common problem and can be very distressing to the patient.
    

Detailed description: 
      This study aimed to the association of preanesthetic ANI scores and PIP in patients who
      scheduled for general anesthesia.

      Before propofol administration in remifentanil group, preanesthetic ANI values (instant and
      mean) were checked after remifentanil to a target Ce of 4 ng/ml.

      Control group received the same volume of saline as remifentanil group. Heart rate and
      bispectral index were checked as ANI. Point biserial correlation and ROC curve were analyzed.
    

Intervention name(s): Analgesia/Nociception Index (ANI)
Intervention type(s): Device
Intervention description(s): V1 and V5 electrocardiographic positions as per the manufacturer's recommendations. The ANI was continuously recorded and displayed with a frequency of 1 Hz. ANI scores measured immediately before propofol administration, half-dose administration (1mg/kg), and full-dose administration (2mg/kg)of propofol.
Other intervention name(s): ANI MOC-9
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized and controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12
      months in women with endometriosis from study M01-398.
    

Detailed description: 
      Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive,
      estrogen-dependent disease that occurs in menstruating women of reproductive age. Although
      all major endometriosis therapies are effective for the treatment of pain, no single
      treatment is superior to others in terms of efficacy. The major drawbacks of the current
      medical therapies are severe side effects such as hot flushes and osteoporosis. The objective
      of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in
      women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be
      based on assessments of the endometrium, lipid profiles, adverse events, and changes from
      baseline laboratory values and vital signs.
    

Intervention name(s): Asoprisnil
Intervention type(s): Drug
Intervention description(s): 5mg Tablet, oral Daily for 12 months
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic pain; Dysmenorrhea; Dyspareunia; Infertility; asoprisnil
EEG Characteristics of Different Sedation Depths in Neurosurgery Patients
Condition: Electroencephalography
Study type: Observational

Summary: 
      Gliomas are the most common primary intracranial malignancy, and behavioral experiments in
      patients with supratentorial gliomas under sedation have shown potential neurological
      abnormalities; however, these behavioral experiments are susceptible to external influences.
      Therefore, more objective evidence is needed to support and extend the existing conclusions.
      The purpose of this study is to compare the EEG signatures (such as the EEG signal power) at
      various levels of anesthetics induced sedation in patients with supratentorial glioma in
      frontal lobe and in patients without intracranial-occupying lesion.
    


Intervention name(s): OAA/S=5; OAA/S=3; OAA/S=1
Intervention type(s): Other; Other; Other
Intervention description(s): Prior to anesthesia induciton, EEG signatures will be recorded at Observer's Assessment of Alertness/Sedation (OAA/S) score of 5 (awake, eye-close state) for few minutes.; Given sedative anesthetics (propofol, midazolam or dexmetomidine), EEG signatures will be recorded after reaching steady state of OAA/S=3 (responds only after name called loudly and/or repeatedly) for few minutes.; Increasing drug concentration, EEG signatures will be recorded after reaching steady state of OAA/S=1 (does not respond to noxious stimuli) for few minutes.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged between 18 and 60 years with American Society of Anesthesiology status I or
        II who were scheduled to receive elective surgery under general anesthesia. Patients with
        supratentorial glioma in right frontal lobe diagnosed by magnetic resonance imaging were
        included in the glioma group while patients requiring general anesthesia without
        intracranial-occupying lesion were included in the control group.
A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled,
      single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics
      (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667
      (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in
      healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK
      of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the
      relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of
      food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label,
      randomized, crossover design.
    


Intervention name(s): GLPG3667 oral suspension; Placebos; GLPG3667 capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLPG3667 oral suspension; Placebo oral suspension; GLPG3667 capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to investigate the safety and the antiviral activity of ascending
      multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic
      hepatitis B infection.
    

Detailed description: 
      LB80380, an oral prodrug, is a promising candidate nucleoside analogue with antiviral
      activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life
      Sciences for use in the treatment of chronic HBV infection and for treatment of
      lamivudine-resistant disease.

      In this study, the treatment period was divided into two parts: a 4-week treatment period
      with dose escalation assessment (Part 1), followed by an 8-week extension period (Part 2).

      During Part 1, patients received LB80380 and LVD 100 mg once daily for 4 weeks. Each patient
      was then given only LB80380 for an additional 8 weeks (Part 2) unless dose-limiting toxicity
      (DLT) was observed during Part 1. At each dose level, all patients were to complete at least
      Part 1 of the treatment period before enrolment into the next Dose Group could commence. Dose
      escalation to the next group was not to be initiated if more than two patients experienced
      DLT during Part 1 in the previous Dose Group. Additionally, patients enrolled in LB80380
      150mg and 240mg groups who agreed to participate in the pharmacokinetic (PK) analyses visited
      the study site the day before Week 12 for blood sampling. Follow-up period was 24 weeks, and
      patients were treated with adefovir dipivoxil during the follow-up period. During the study,
      patients were evaluated for changes from baseline in serum HBV DNA. Safety was evaluated on
      the basis of occurrence of AEs and changes from baseline in clinical laboratory parameters,
      physical examination findings, and vital signs.
    

Intervention name(s): LB80380
Intervention type(s): Drug
Intervention description(s): Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; Lamivudine resistant; YMDD mutant type
Assessment of an iPhone Application on Glycemic Control in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to assess whether an electronic self-management tool,
      specifically an iPhone application entitled bant, can improve glycemic control in Adolescents
      who have Type 1 Diabetes Mellitus (T1DM).
    

Detailed description: 
      Type 1 Diabetes Mellitus (T1DM) is among the most common chronic diseases affecting children,
      adolescents and adults. While intensive patient self-management can optimize Blood Glucose
      (BG) to near-normal levels, it is a challenge for many TIDM patients to continuously achieve
      this. These difficulties are compounded in the adolescent population, who struggle with daily
      self-management and therefore may increase their risk of T1DM complications.

      Due to this observation an electronic self-management tool, in the form of an iPhone
      application called bant, was developed. This app guides the analysis of BG data and suggests
      changes in treatment, while also using social network and rewards to encourage and reinforce
      self-care behaviors, such as frequent self-monitoring of blood glucose levels (SMBG). By
      primarily measuring changes in HbA1C levels, the study will assess if bant and its features
      are associated with improved glycemic control in the adolescents who use it.
    

Intervention name(s): bant iPhone application
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhoea
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a
      third of these suffer from diarrhoea, which severely impairs their quality of life. Previous
      studies in Nottingham have suggested that some patients with diarrhoea may have an excess of
      a chemical called serotonin in their gut. Serotonin stimulates secretion and propulsion in
      the gut and contributes to diarrhoea. We are interested to see whether a drug, Ondansetron,
      which blocks the effect of serotonin, would improve symptoms in patients with IBS and
      diarrhoea. We think the drug may work better in people with a specific gene type so your
      genetic makeup may be of influence and we would like to test this. Because IBS symptoms
      fluctuate, one way to determine whether Ondansetron is effective is to perform a randomised
      placebo controlled trial in which neither the patient nor the doctor knows which medication
      is being taken in each part of the study.
    


Intervention name(s): Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Over-encapsulated 4mg ondansetron tablets. Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days. For 5 weeks.; Capsule matching over-encapsulated experimental drug. 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days. For 5 weeks.
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IBS D
Relative Bioavailability of Dabigatran and Atorvastatin in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioavailability of dabigatran with and without concomitant administration
      of atorvastatin and the bioavailability of atorvastatin with and without concomitant
      administration of dabigatran etexilate
    


Intervention name(s): Dabigatran; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix
Condition: Tubal Patency
Study type: Observational

Summary: 
      Tubal patency testing is essential for infertility evaluation. Standard tests are
      hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble
      suction test was described in apparently normal tubes. However, the efficacy of bubble
      suction test in abnormal tubes like hydrosalpnix has not been studied.
    

Detailed description: 
      Nowadays, hysteroscopy is extensively used for fertility assessment. In a previous study, it
      is recommended to add hysteroscopy to the routine infertility work-up to achieve a better
      assessment of infertility cases.

      In 2016, hysteroscopy as a predictor test of tubal patency and tubal peristalsis was
      introduced. It is concluded that hysteroscopic bubble suction test is a good initial
      screening test for tubal patency nearly comparable to HSG and DL. It should be attempted in
      every case of OH prior to referral for more invasive HSG or laparoscopic chromopertubation
      test.

      Thereafter, some authors tried the same idea of bubble suction test and were
      over-enthusiastic with this test and considered it superior to hysterosalpingography (HSG) in
      detection of tubal patency in infertile women. They wrongly described HSG as a historic tool
      despite being recommended as a basic infertility test by many organizations. Some authors
      criticized the results of these studies and underestimated their clinical implication. One of
      the objections were lack of differentiation between normal tubes and damaged or narrowed but
      still patent tubes.

      Aim of the work:

      To test whether bubble suction test and osteal peristalsis are preserved or lost in cases
      with hydrosalpnix.

      Design: A prospective double blinded randomized controlled trial.
    

Intervention name(s): Bubble suction test and tubal peristalsis
Intervention type(s): Diagnostic Test
Intervention description(s): Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Infertile women with a history of HSG
      
Keywords: laparoscopy; hysteroscopy,; tubal patency,; bubble test,; peristalsis