bioihbjkbjnl/mcl2 huggingface dataset:
Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether COLAL-PRED is a safe and effective
      treatment for patients with moderate to severe ulcerative colitis.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, placebo-controlled, parallel-design,
      dose-ranging study. Eligible patients with a DAI score of 6 to 10 (inclusive), plus
      endoscopic evidence of moderate to severe ulcerative colitis as assessed by flexible
      sigmoidoscopy, unless colonoscopy is clinically indicated, and rectal bleeding will be
      randomized to placebo or one of four doses of COLAL-PRED (equivalent to 40, 60, 80, or 120 mg
      of prednisolone). The effectiveness and safety of COLAL-PRED will be evaluated at baseline,
      and after 2 weeks and 4 weeks of treatment. Additional follow-up measurements will take place
      7 days post cessation of treatment.

      The systemic absorption of COLAL-PRED will be determined by measuring blood levels of
      prednisolone, prednisolone sodium metasulfobenzoate (PMSBS) and metasulfobenzoate at Week 4.

      Hypothalamic-pituitary-adrenocortical (HPA) axis response will be monitored by measuring
      morning serum cortisol levels at Baseline, Week 2, Week 4, and at follow-up visit and
      cortisol levels following adrenocorticotrophic hormone (ACTH) stimulation testing at Baseline
      and Week 4.
    

Intervention name(s): Placebo; COLAL-PRED
Intervention type(s): Drug; Drug
Intervention description(s): Placebo solid capsule dosage form administered orally once daily.; The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
Other intervention name(s): prednisolone sodium metasulfobenzoate (PMSBS); prednisolone sodium metasulfobenzoate (PMSBS)
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: colitis; ulcerative; moderate; severe
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in
      combination with Sintilimab in advanced solid tumor patients.
    

Detailed description: 
      IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21-day cycle. The
      DLT observation period is 21 days starting with the first dose taken on day 1. In the Phase
      Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be
      tested. In the Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg), in
      combination with Sintilimab 200mg, will be tested. After completion of the dose escalation
      phase, two combination dose cohorts (IBI101 3mg/kg and 6mg/kg, in combination with Sintilimab
      200mg) will be expanded to 10 patients each.

      IBI101 is a recombinant fully humanized IgG1 anti-tumor necrosis factor receptor superfamily
      member 4 (OX40) monoclonal antibody.

      Sintilimab is a recombinant fully humanized anti-programmed death 1 (PD1) monoclonal
      antibody.
    

Intervention name(s): IBI101; IBI101; Sintilimab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.01 mg/kg; 0.1 mg/kg; 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg; 15 mg/kg iv infusion day 1 of every 21 days; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days; 200mg iv infusion day 1 of every 21 days
Other intervention name(s): IBI308
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Senofilcon A Investigational Manufacturing Process
Condition: Visual Acuity; Comfort; Overall Vision
Study type: Interventional

Summary: 
      To evaluate the impact of a new contact lens hydration process
    

Detailed description: 
      To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an
      alternate hydration process and compare the performance with senofilcon A lenses manufactured
      using the current process.
    

Intervention name(s): senofilcon A; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): Control, senfilcon A; Test, senofilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery
Condition: Laryngologic Surgical Procedures
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether selected, short laryngologic surgical
      procedures can be safely and potentially more effectively performed without the use of
      endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas
      exchange will be supported by rapid insufflation of high-flow oxygen through specialized
      nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange
      (THRIVE).
    


Intervention name(s): THRIVE; Endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): active nasal oxygen delivery system; a plastic tube for mechanical ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: airway management; high flow nasal oxygen; high flow nasal cannula; THRIVE
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This is a prospective, randomized, controlled, two-armed multi-center pre-market trial.
      Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress
      urinary incontinence (SUI), will be considered as potential study participants. After written
      informed consent has been acquired, a medical and surgical history, a physical examination
      (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed,
      followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling
      all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or
      the standard of care (SoC) group.
    


Intervention name(s): TVS
Intervention type(s): Device
Intervention description(s): Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vaginal; Medical Device; Female Stress Urinary Incontinence
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of the consumption of a food supplement (live
      saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.
    


Intervention name(s): Saccharomyces cerevisiae; Lynside Wall Basic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Live Saccharomyces cerevisiae; yeast cell walls; Maize starch and magnesium stearate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women
Condition: Quadriceps Muscle
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of antibacterial mouthwash on muscle
      speed and power in healthy young men and women. We have previously demonstrated that drinking
      beetroot juice, a source of dietary nitrate and therefore nitric oxide, increases muscle
      function in this population. Antibacterial mouthwash has been shown to interfere with the
      conversion of dietary nitrate to nitric oxide. We therefore hypothesize that it will diminish
      nitric oxide bioavailability and inhibit muscle contractility.
    

Detailed description: 
      Study Visit One:

      During an initial visit, subjects will complete the informed consent process, be instructed
      on the requirements of the study, and practice the exercise protocol (see below).

      Study Visit Two:

      Subjects will be tested after they have avoided exercise, caffeine, alcohol, chewing gum, and
      foods high in nitrate (e.g., spinach, beets, collard greens) for at least 24 hours. They will
      also be asked to not use any mouthwash products during this period. They will then provide
      provide a saliva sample for subsequent measurement of nitrate and nitrite concentrations and
      have their breath nitric oxide levels measured using a portable analyzer. The maximal knee
      extensor speed and power of their knee extensor muscles will then be measured using an
      isokinetic dynamometer. This machine can control the speed of movement while measuring the
      maximal force (torque) that a subject can voluntarily produce.

      Subjects will then be randomly assigned to receive either an antibacterial mouthwash
      (Cepacol©, Reckitt Benckiser, Parsippany, NJ) or, as a control solution, an alcohol-free
      "natural" mouthwash (Tom's of Maine©, Kennebunk, ME). Participants will be asked to rinse
      their mouth as directed on the product's packaging for 30 s twice per day for 7 (+/-2) days
      and to record the usage of the mouthwash on a provided form. Subjects will then return for
      Study Visit 3 (see below). This is considered a single-blind study, which means that the
      investigators will not know what type of mouthwash a subject is receives.

      Study Visit Three:

      At the end of the treatment period, subjects will be asked to return to undergo the same
      procedures as described for Study Visit Two.
    

Intervention name(s): Cepacol; Tom's Natural Mouthwash
Intervention type(s): Device; Device
Intervention description(s): Twice-daily use of Cepacol per the manufacturer's guidelines; Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: muscle power; nitric oxide; muscle speed; oral microbiome
Hypovitaminosis D Prediction Score
Condition: Vitamin D Status
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey
      conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of
      subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency
      (<10ng/ml).

      Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the
      number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5
      million € in 2011, and with it the costs for health insurance. However, there is currently no
      consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.

      We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate
      assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected
      through a self-administered questionnaire.
    


Intervention name(s): Blood sampling; self-administered questionnaire
Intervention type(s): Biological; Other
Intervention description(s): Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.; Patients will fill a self-administered questionnaire the day of inclusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
Condition: Streptococcal Infection; Gram-positive Bacterial Infection; Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Streptococcal Infections; Gram-Positive Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigated the immune response induced by the Group B streptococcus vaccine in
      healthy pregnant women. In addition, the study investigated the amount of vaccine induced
      antibodies which were transferred to the newborn.
    


Intervention name(s): Group B Streptococcus Trivalent Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.; Pregnant women who received one injection of saline solution administered intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Group B streptococcus; GBS; Vaccine; Prevention of group B streptococcus infection
Network-Level Effects of Nitrous Oxide in the Human Brain
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on
      the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is
      limited knowledge on how this drug affects functional networks in the brain.
    

Detailed description: 
      The objective of this study is to identify the network transformations that account for the
      analgesic effects of nitrous oxide. Our hypothesis is that analgesic doses of nitrous oxide
      increase network efficiency and disrupt normal pain processingOur approach is to administer
      subanesthetic nitrous oxide during the acquisition of fMRI (functional magnetic resonance
      imaging) and EEG (electroencephalogram).
    

Intervention name(s): Nitrous Oxide Gas for Inhalation
Intervention type(s): Drug
Intervention description(s): Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanesthetic levels (35% inhaled concentration) over 40 minutes.
Intervention MeSH terms: Nitrous Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With HCV Infection
Condition: HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      antiviral activity of single and multiple ascending doses of SH229 in patients with chronic
      hepatitis C Virus infection.
    

Detailed description: 
      A total of 30 evaluable patients will be enrolled in this study. The planned dose levels are
      400, 600, and 800 mg.
    

Intervention name(s): SH229; Placebos; SH229; Placebos; SH229; Placebos
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet, oral, 400 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, 600 mg once daily for 3 days; tablet, oral, once daily for 3 days; tablet, oral, 800 mg once daily for 3 days; tablet, oral, once daily for 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HCV; NS5B; SH229
Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse
      over time, but how quickly it progresses varies a lot from person to person. Some symptoms of
      PD are tremors, stiffness, and slowness of movement. The purpose of this study is to see how
      feasible and how satisfied participants/caregivers/investigators are with video-assisted
      telenursing use in nurse support programs with LCIG.

      LCIG is an approved drug to treat PD. Approximately 50 adult participants with advanced PD
      will be enrolled in the study at approximately 10 sites across the world.

      The study has 2 groups. In one group, around 25 participants will receive nurse support using
      video devices. In the second group, around 25 participants will receive nurse support without
      using video devices. All participants will attend a baseline visit and follow up visits at
      Week 4 and Week 12. The planned observation period will be 12 weeks.

      Participants who are prescribed LCIG by their physicians will have three study related
      visits. Participants, caregivers, and investigators will be asked to complete questionnaires
      for the study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult participants with advanced Parkinson's Disease
      
Keywords: Levodopa-Carbidopa; LCIG; FACILITATE-CARE
Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.
Condition: Preeclampsia Severe
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      The neurological alterations associated with preeclampsia depend on cerebral autoregulation,
      a theory that outlines the mechanisms by which the nervous system controls cerebral
      perfusion. However, with the loss of autoregulation, increased blood flow, edema and
      eventually increased intracranial pressure are triggered and may be translated into
      neurological manifestations such as symptoms of vasospasm, one of the criteria for severity
      in preeclampsia.

      Nervous system manifestations frequently found in preeclampsia are headache, blurred vision,
      scotomas and hyperreflexia. Although uncommon, temporary blindness (lasting a few hours to a
      week) may also accompany severe preeclampsia and eclampsia.

      The optic nerve, as part of the central nervous system, is surrounded by cerebrospinal fluid
      and dura mater, which forms the optic nerve sheath. Due to the connection with the
      intracranial subarachnoid space, the diameter of the optic nerve sheath is influenced by
      variations in cerebrospinal fluid pressure. Increased intracranial pressure is transmitted to
      the subarachnoid space surrounding the optic nerve, causing its expansion.

      Recent studies suggest that an optic nerve sheath diameter greater than 5 mm correlates 100%
      with ICP (intracerebral pressure) greater than 20 mm Hg. Due to the simple nature of the test
      and the limited time required to perform it, it is an ideal non-invasive test to assess
      changes in mental status, severe headache, and to take the necessary measures aimed at
      reducing intracranial pressure.

      The diagnosis of elevated intracranial pressure is challenging and critical, because early
      recognition and treatment are essential to prevent brain damage or death since preeclampsia
      with severe data remains one of the most frequent complications in our institution.

      These values are not taken from the obstetric population, so this study proposes the
      description of a standard value for the pregnant population. There are few studies that
      describe a value to help us define cases of this pathology and correlate it with the signs
      and symptoms of severity in patients with preeclampsia.
    


Intervention name(s): Transorbital ultrasound of the optic nerve sheet
Intervention type(s): Procedure
Intervention description(s): Measurement of the optic nerve sheet with a linear transducer (7,5 MHz).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A transorbital ultrasound to measure the optic nerve sheet will be performed in patients with severe preeclampsia and then compared with normal controls.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Severe preeclampsia; Optic nerve sheet; Intracranial pressure
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Condition: Pregnancies at Increased Risk of Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have
      not had their baby by 14 or more days after being given a single course of antenatal
      corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational
      age lower the risk of illness or death in babies compared to repeated courses of placebo.
      Children are assessed at 2 years and 5 years for neurodevelopmental impairment.
    

Detailed description: 
      In women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain
      undelivered 14 or more days following a single course of antenatal corticosteroids (ACS), are
      multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of
      perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo.

      18-24 Month Follow-up: Children (18-24 months corrected gestational age) are assessed with
      the Bayley Scales of Infant Development (Second Edition) to determine neurodevelopmental
      impairment.

      5 Year Follow-up (MACS-5): Children are assessed using the Child Behaviour Checklist (1 1/2 -
      5) and the Behaviour Rating Inventory of Executive Function (Preschool version) to determine
      neurocognitive function.
    

Intervention name(s): Multiple vs. single courses of antenatalcorticosteroids
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antenatal corticosteroids; preterm birth; multiple versus single doses; follow-up