bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of steady-state (constant concentration of
      medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is
      absorbed in the body, distributed within the body, and removed from the body) of a single
      dose of metformin, over time, in healthy adult participants.
    

Detailed description: 
      This is a phase I, open-label (all people know the identity of the intervention) and
      sequential study (study medication is given in a sequence) in healthy participants, to
      investigate the pharmacokinetic interaction between steady-state rilpivirine and a single
      dose of metformin. The study consists of 3 phases including, the screening phase (28 days
      before enrollment), treatment phase (19 days), and the follow-up phase (7 days after the last
      intake of study medication). All participants will receive study medications in two sessions
      in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by
      washout period (period when no treatment is received) of 4 days and then session 2
      (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). The duration of
      the study is approximately 54 days. Safety evaluations including adverse events, clinical
      laboratory tests, electrocardiogram, vital signs, and physical examination (including skin
      examination) will be monitored throughout the study.
    

Intervention name(s): Metformin; Rilpivirine
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15.; Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17.
Intervention MeSH terms: Metformin; Rilpivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Rilpivirine; Metformin; Pharmacokinetics
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in
      the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main
      efficacy parameter is the proportion of patients responding to treatment by an increase of
      platelet count to ≥ 50 x 10^9/L.
    


Intervention name(s): Immunoglobulin Intravenous (Human)
Intervention type(s): Biological
Intervention description(s): A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
Other intervention name(s): Privigen; IgPro10
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Immune Thrombocytopenic Purpura; Chronic Idiopathic Thrombocytopenic Purpura; Werlhofs Disease; Autoimmune Thrombocytopenia; Immunglobulin Intravenous; Chronic ITP; Platelet count; Thrombocytopenia
Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Condition: Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as
      well as intrathecal morphine after cesarean delivery, with fewer side effects.
    

Detailed description: 
      Intrathecal morphine has long been the standard pain medication used in cesarean sections.
      Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative.
      Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post
      cesarean section pain and possibly with less side effects than morphine.

      One side effect of morphine is respiratory depression occurring hours after the start of
      morphine use. Respiratory depression occurs when air being taken into the lungs is less than
      normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood
      stream. Because hydromorphone dosages are lower and it has a quicker onset of action than
      morphine, it is believed that the use of hydromorphone should decrease the possibility of
      delayed respiratory depression.
    

Intervention name(s): Hydromorphone; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Injection of 100 mcg hydromorphone into the intrathecal space; Injection of 200 mcg of intrathecal morphine
Other intervention name(s): DILAUDID® INJECTION; Duramorph
Intervention MeSH terms: Morphine; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hydromorphone; Morphine; cesarean delivery; pain management; respiratory depression
Effects of Oxygen Status on Endotoxemia Induced Inflammation and Hypoxia Inducible Factor-1α
Condition: Hypoxia; Normoxia; Hyperoxia
MeSH terms: Endotoxemia; Inflammation; Hypoxia; Hyperoxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oxygen is a widely available gas that is cheap, easy to get and extensively used in medicine.
      From animal studies it has become apparent that increasing or lowering the degree of oxygen
      in the blood, the inflammatory response can be altered. We will investigate of this is also
      true in humans by increasing, lowering or keeping oxygen levels normal while giving healthy
      subjects a short inflammatory stimulus.
    

Detailed description: 
      The primary objective of the study is to determine the effects of hyperoxia and hypoxia
      compared to normoxia in the human endotoxemia model on the innate immune reponse in healthy
      volunteers.

      A parallel, randomized study in healthy male volunteers. The subjects will be randomized to
      hypoxia, hyperoxia, or normoxia, and will all undergo experimental human endotoxemia
      (administration of 2 ng/kg LPS iv).

      In the hypoxia group: the subjects will breathe an individualized mix of nitrogen and room
      air for 3.5 hours using an air-tight respiratory helmet. The gas mixture will be adjusted to
      achieve a saturation of 80-85%. In the hyperoxia group, subjects will breathe 100% oxygen for
      3.5 hours using the same respiratory helmet. In the normoxia group, subjects will breathe
      room air (21% oxygen, 79% nitrogen) also wearing the respiratory helmet. 1 hour after oxygen
      status adjustment (t=0), all subject will be administered an intravenous bolus (2ng/kg) of
      LPS derived from E coli O:113. 2.5 hours after LPS administration, the helmets will be
      removed and all subjects will breathe ambient room air.

      The primary study endpoint is the difference in plasma cytokines between the hypoxia and
      normoxia group, and between the hyperoxia and normoxia group. Secondary objectives include
      HIF-1α protein and mRNA, aHIF mRNA expression in circulating leukocytes, measures of ROS,
      leukocyte phagocytosis, and cytokine production by leukocytes stimulated ex vivo with various
      inflammatory stimuli, and measurement of basic hemodynamic and ventilatory parameters and
      temperature.
    

Intervention name(s): Lipopolysaccharide
Intervention type(s): Drug
Intervention description(s): LPS is used to elicit an inflammatory response in all subjects
Other intervention name(s): Purified LPS from Escherischa coli (O:113)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxygen; Hypoxia; Hyperoxia; Inflammation; Innate immunity
Important Factors in Integration of Vocational Rehabilitation in Mental Health
Condition: Psychiatric Patients Experiences of Vocational Rehabilitation During Admittance in Hospital
Study type: Observational

Summary: 
      The purpose of this study is to explore, through a qualitative approach, how a group of
      people with serious mental illness experienced the integration of a vocational rehabilitation
      intervention during their admittance in hospital.
    

Detailed description: 
      People with serious mental illness admitted to hospital face significant barriers to gain
      both education and employment. Norway is a high-income welfare society with low unemployment
      rates, but the employment rates are very high in the population with psychosis and
      schizophrenia. Norway have a strategy for work and mental health, and through this strategy,
      the government has supported some pilot projects which focus on new ways of supporting people
      with serious mental illness in gaining employment. This study focuses on a representative
      sample participating in a pilot study. The sample consists of admitted patients who have
      received vocational rehabilitation under admittance. The study design is qualitative in
      nature with open- ended questions to allow the sample to express their opinions, attitudes
      and thoughts about the assistance they have had during their rehabilitation stay in hospital.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Admitted or discharged hospital patient, who also receives vocational rehabilitation
High Omega-3/Low Omega-6 Treatment Diet for Aspirin-exacerbated Respiratory Disease (AERD)
Condition: ASA Triad; Asthma, Nasal Polyps, And Aspirin Intolerance
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Nasal Polyps
Study type: Interventional

Summary: 
      The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6
      fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal
      symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease
      (AERD).
    


Intervention name(s): Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Omega-3 fatty acids; Omega-6 fatty acids; aspirin exacerbated respiratory disease; AERD; Samter's Triad; nasal polyp; aspirin; diet; leukotriene
Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
Condition: Suicide; Sexual Violence
MeSH terms: Suicide
Study type: Interventional

Summary: 
      Sources of Strength is an evidence based program for youth suicide that trains student key
      leaders to strengthen social connectedness and healthy norms school-wide and is listed on the
      National Registry of Evidence Based Programs and Practices (NREPP). This project will expand
      the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in
      a randomized controlled trial (RCT) in twenty-four high schools.
    

Detailed description: 
      At present few programs systematically address broader social-ecological factors such as
      school-wide norms and youth-adult connectedness that research identifies as major drivers of
      sexual violence. To address this gap, this application proposes a large-scale RCT evaluation
      of Sources of Strength to evaluate for sexual violence perpetration outcomes. Sources of
      Strength is an evidence based program for youth suicide that trains student key leaders to
      strengthen social connectedness and healthy norms school-wide and is listed on the National
      Registry of Evidence Based Programs and Practices (NREPP). This project will expand the
      existing evidence base by evaluating Sources of Strength for sexual violence outcomes, which
      has never been done before. Twenty-four high schools will be recruited and stratified (rural
      or urban) and randomly assigned to one of two conditions: (a) immediate Sources of Strength
      intervention, (b) wait-list for Sources of Strength Implementation after 16 months.
    

Intervention name(s): Sources of Strength (SOS) Prevention Program
Intervention type(s): Behavioral
Intervention description(s): Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Fluid Therapy During Brain Tumor Resection in Children
Condition: Brain Neoplasms
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Fluid management of children during neurosurgery is not well established. Hypotonic
      solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse
      operative conditions. This study compares two different isotonic solutions administered
      perioperatively regarding acid base and fluid electrolyte disturbances.
    


Intervention name(s): balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride); 0.9% sodium chloride
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: crystalloid solutions; acid-base imbalance; water-electrolyte Imbalance
Behavioral Family Therapy and Type One Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Behavioral family therapy, specifically focused on insuring support for the primary caregiver
      of a child with type one diabetes mellitus and healthy family dynamics, may improve the
      child's glycemic control as measured by hemoglobin A1c level (HbA1c).
    

Detailed description: 
      The success or failure of type 1 diabetes mellitus (T1D) management in children depends not
      only on access to care, diabetes technologies and diabetes education, but also on the
      abilities of the patient and his/her family to carry out complex demands. Recent data show
      that family dynamics play a critical role in determining glycemic control in pediatric
      patients with T1D. The investigators prior work (Loomba-Albrecht and Glaser, unpublished
      data) suggests that the strongest determinants of glycemic control are factors related to the
      primary caregiver's involvement in supportive relationships with others, either a spouse or
      other family members. This provides a potential therapeutic target to improve outcomes for
      children with T1D.
    

Intervention name(s): Online Learning Modules
Intervention type(s): Behavioral
Intervention description(s): The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
The Relationship Between Q Angle and Quadriceps Muscle Activation on Dynamic Balance in Women
Condition: Physiotherapy and Rehabilitation
Study type: Interventional

Summary: 
      The quadriceps angle (Q angle) is significant for the lower extremity alignment. Anatomical
      alignment of Q angle is related to Quadriceps muscle strength. Women have consistently been
      found to have larger Q angles than men and are more often affected due to patellofemoral
      problems. Quadriceps muscle activation and lower extremity alignment affect musculoskeletal
      health in women.The aim of this study wa s to determine the relationship between Q angle and
      quadriceps muscle activation on dynamic balance in women.
    

Detailed description: 
      Objective: To determine the relationship between Q angle and quadriceps muscle activation on
      dynamic balance in women. Design: Correlational Study. Setting: University. Participants:
      Forth women will be included in the study. Interventions: Q angle in standing and supine
      positions, quadriceps muscle activation, static and dynamic balance and functionality were
      measured. Main Outcome Measurements: Q angle will measured with a tape measure; muscle
      activation will measured with Surface Electromyography (EMG) static balance will measured
      with Flamingo Balance Test (FBT); dynamic balance will measured with ProKin 252 Techno Body
      device; and, functionality will measured with Short Form Musculoskeletal Assessment (SFMA).
      Before the evaluation of EMG amplitude on dynamic balance position, the Q angle will measured
      in supine and standing positions. The EMG signals collected by measuring the muscle
      activation of the Vastus Medialis and Vastus Lateralis during dynamic balance position on the
      ProKin device will recorded.
    

Intervention name(s): Evaluation of Q angle and Quadriceps muscle activation on dynamic balance position
Intervention type(s): Other
Intervention description(s): Evaluation of Q angle, Quadriceps muscle activation, static and dynamic balance and functionality of all individuals was done.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Q angle; Quadriceps muscle activation; EMG; Balance
Immunogenicity and Safety Study of NBP615 in Healthy Female
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll
      200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9
      to 13 years.
    

Detailed description: 
      In order to confirm the safety, 80 healthy adult were enrolled first. Eligible subjects were
      randomized into 1:1 ratio to receive three doses of either test vaccine (NPB615) or
      comparator vaccine (Gardasil). The safety of the test vaccine (NBP615) was confirmed by 2nd
      vaccination in adult subjects. After that, enrolment of 120 adolescent subjects proceeded.
      Eligible subjects who previously agreed to participate in the study were screened and only
      those subjects who met the inclusion/exclusion criteria were randomized in to 1:1 to receive
      two doses of test vaccine (NBP615) or comparator (Gardasil pre-filled syringe). 0.5 ml
      Intramuscular injection at were given at each vaccination and two blood sample, pre vaccine
      and post vaccine 4 weeks after completion of vaccine were collected to assess the
      immunogenicity of NBP615 and Gardasil, comparator vaccine. Solicited adverse events occurred
      up to 7 days after each dose of the investigational product were collected in the diary card.
      Unsolicited adverse events occurred up to 28 days after each dose of the investigational
      product were collated in the diary card. Serious adverse events were collected during the
      entire study period. In addition to this safety data was collected through the study period
      by active contact with the study participants by doing home visit or by telephone contact.
    

Intervention name(s): NBP615; Gardasil
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 0.5ml; Intramuscular injection, 0.5ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses
Condition: Refractive Error - Myopia Bilateral
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The study will compare the short-term clinical performance and wearer and practitioner
      acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens
      to a currently marketed spherical DD hydrogel soft contact lens.
    

Detailed description: 
      This randomized clinical trial will compare the short-term clinical performance, and wearer
      acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against
      marketed DD lenses in a short cross-over clinical trial.

      The primary outcome variable for this study is overall subjective comfort.
    

Intervention name(s): Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
Intervention type(s): Device
Intervention description(s): Daily disposable contact lens wear for 1 week
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over with 1 week of lens wear with each contact lens type.
Masking: Single (Care Provider)
Primary purpose: Treatment