bioihbjkbjnl/mcl2 huggingface dataset:
Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Condition: Sedative; Mechanical Ventilation
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term
      sedation during invasive mechanical ventilation in intensive care units
    


Intervention name(s): Remimazolam besylate; Propofol; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0~2.0mg/kg/h; 0.3~4.0mg/kg/h; 1.5~12μg/kg/h
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Application of Specific Frequencies to Stimulate the Spinocerebellar Tract in Subjects With Unilateral Dysafferentation
Condition: Somatosensory Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of Power Plate vibration therapy on
      balance as measured by the NeuroCom Balance Master.
    

Detailed description: 
      Acute and chronic equilibrium disorders result in over five million patient visits per year
      in the United States with unknown additional individuals not seeking care. Symptoms of
      dizziness, vertigo, and lack of balance are among the most common symptoms reported to
      physicians. Equilibrium disorders not exclusively due to visual or vestibular conditions are
      typically due to problems in proprioception. Proprioception is the specialized sensory
      modality that informs the body as to movement, position, and spatial orientation through
      mechanisms that track sensations accompanying joint movement and position. Mechanoreceptors
      in joints, along with vestibular, visual, muscle spindle, Golgi tendon organ, ligament and
      tendon sensory receptors, comprise the propriosensory system, which conveys information to
      the motor system to maintain equilibrium on a reflexive, automatic basis. Alterations in
      somatosensory input from mechanoreceptors have been identified as causing aberrant muscle
      firing patterns.

      The NeuroCom Balance Master is an FDA approved device designed to both measure and treat
      balance problems and evaluate the neuromuscular control by quantifying the ability to
      maintain dynamic postural stability. The NeuroCom Unit is a microprocessor controlled balance
      unit that provides quantitative data regarding the patient's ability to control the platform.
      This unit is widely used throughout the country in both university and clinical settings to
      help patients restore their balance.
    

Intervention name(s): Vibration Plate Therapy
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Somatosensory dysfunction
Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will examine the safety and immune response to a two-part HIV vaccine. Healthy
      volunteers who are at low risk of HIV infection will receive either active vaccine or a
      placebo.
    

Detailed description: 
      The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine
      strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost. The DNA
      plasmid and fowlpox vector contain HIV genes. However, these vaccines contain only some HIV
      genes and cannot themselves cause HIV or AIDS.

      Eligible volunteers at low risk of HIV infection will be randomized to receive either active
      vaccine or placebo injections at Day 0, Week 4, and Week 8. Intensive immunologic and safety
      monitoring will be done during the first 16 weeks of the study. Follow-up will continue to
      Week 52.
    

Intervention name(s): HIV DNA plasmid vaccine plus recombinant fowlpox vector
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
DWP05195 in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.
    


Intervention name(s): DWP05195
Intervention type(s): Drug
Intervention description(s): tablets, oral administration, single and multiple administrations
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Chronic Care Management/Patient Relationship Management Proof of Concept
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This proof of concept study proposes to evaluate the feasibility of a
      communications-technology-based chronic care and patient relationship management program to
      improve diabetes self management among adult diabetic patients in an urban safety net
      population by providing between-visit reminders and chronic disease support through cell
      phone text messaging.

      The investigators hypothesize that diabetic patients enrolled in the program will be less
      likely to miss scheduled appointments and will have greater perceived self-efficacy and
      improved patient satisfaction concerning chronic disease management. No-show rates among
      patients enrolled in the program are expected to be lower than among patients receiving
      standard care.
    


Intervention name(s): Patient Relationship Management (PRM) Program
Intervention type(s): Behavioral
Intervention description(s): Patients will be contacted through SMS text messaging under the following circumstances:
7 days, 2 days, and 1 day before scheduled appointments. Messages will contain the date, time, and location where the appointment is scheduled. Patients will be prompted to respond with 'YES' if they are able to keep their appointment, and 'NO' if they need to reschedule. An acknowledgement of receipt will be sent in response to all patient-initiated messages.
3 days per week to request that patients respond with fasting blood sugar measurements. An acknowledgement of receipt will be sent in response to all patient-initiated messages.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation
      of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in
      support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the
      safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and
      safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected
      for assessment in Phase C. Phase C of this study is designed to define the dose-exposure
      relationship of the selected form and to provide information that will permit a comparison of
      the risk-benefit ratio of several doses of the study drug to enable optimal dose selection
      for later studies.
    


Intervention name(s): Iloperidone crystalline formulation; Iloperidone microparticle formulation; Oral iloperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Iloperidone was formulated as 100 µm crystals for IM depot injection.; Iloperidone was formulated as microparticles for IM depot injection.; Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone to stable doses of 12 to 24 mg daily. In Phase A, oral iloperidone dosing lasted for at least 7 days and, in Phases B and C, for at least 10 to 14 days.
Intervention MeSH terms: Iloperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Iloperidone; Depot; Injection
A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this multiple-dose, adaptive design study is to evaluate the effect
      of hepatic impairment on the pharmacokinetics (PK) of relacorilant relative to healthy
      matched control male and female subjects (Part 1).
    

Detailed description: 
      If an obvious effect of moderate hepatic impairment on exposure to relacorilant is observed
      in Part 1, optional Part 2 of the study will be conducted. In Part 2, the effect of mild
      hepatic impairment on the PK of relacorilant will be evaluated, using control data from the
      same healthy control subjects who were matched to the subjects in Part 1.

      Secondary objectives of the study are 1) evaluation of the effect of hepatic impairment on
      the PK of relacorilant metabolites, and 2) evaluation of safety and tolerability of
      relacorilant on healthy subjects and those with hepatic impairment.
    

Intervention name(s): Relacorilant
Intervention type(s): Drug
Intervention description(s): Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration
Other intervention name(s): CORT125134
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Litramine on Fat Excretion
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy
      subjects, to provide more comprehensive and robust clinical evidence in its mode of action
      for the treatment of obesity and weight management through dietary fat binding.
    


Intervention name(s): Litramine; Placebo
Intervention type(s): Device; Device
Intervention description(s): 2 tablets 3 times daily (oral consumption, 30 minutes after meal); 2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Fat excretion
Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
Condition: Acinetobacter Baumannii-calcoaceticus Complex Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to determine the routes and rates of excretion of radio label
      arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514
      administered intravenously in healthy participants.
    


Intervention name(s): ETX2514; 14C-ETX2514
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion; intravenous infusion
Intervention MeSH terms: Durlobactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acinetobacter baumannii-calcoaceticus; complex infections; ETX2514; excretion; metabolism
A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease
Condition: Renal Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of YPEG rhEPO, a
      recombinant human erythropoietin pegylated by Y shape polyethylene glycol, in patients with
      anemia due to Chronic Kidney Disease (CKD), assessed by hemoglobin maintenance, adverse
      events and health-related quality of life.
    


Intervention name(s): YPEG-rhEPO; YPEG-rhEPO; YPEG-rhEPO; YPEG-rhEPO
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.; YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks.; YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks.; YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: YPEG rhEPO; rhEPO; erythropoietin; anemia; dialysis; hemodialysis; chronic kidney disease
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Approximately 45 patients suffering from mild to moderate ulcerative colitis will be
           examined for any side effects (safety and tolerability) that may occur when taking
           GLPG0974 or matching placebo (2:1 ratio) for 28 days.

        -  During the course of the study, patients will also be evaluated for improvement of
           disease activity by different efficacy measures, the amount of GLPG0974 present in the
           blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the
           blood, colon biopsies and faeces will be explored.
    


Intervention name(s): GLPG0974; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule in the morning and 1 capsule in the evening with food during 28 days; 1 capsule in the morning and 1 capsule in the evening with food during 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered
      orally compared to intravenously on the maximum acid output in subjects with symptoms of
      Gastroesophageal reflux disease (GERD).
    


Intervention name(s): Esomeprazole
Intervention type(s): Drug
Intervention description(s): Oral and Intravenous
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux disease; Nexium; Esomeprazole; Administration methods.
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact
      lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may
      experience blur while driving. The purpose of this study is to determine if correcting small
      amounts of astigmatism with contact lenses will improve driving safety.
    

Detailed description: 
      The purpose of this randomized control trial is to compare visual performance and simulated
      driving performance of adults with astigmatism when wearing 1*DAY ACUVUE® MOIST for
      ASTIGMATISM (toric), 1*DAY ACUVUE® MOIST (spherical control), and 1*DAY ACUVUE® MOIST
      (placebo) contact lenses. Adult subjects with nearsightedness and astigmatism will wear three
      types of soft contact lenses (placebo, spherical and toric in randomized order). Each subject
      will read letters on standard eye charts and complete vision and driving tests in a driving
      simulator. Subjects will repeat these tests with each lens type. Analyses will include an
      ANOVA to look for a main effect of lens condition, and separate contrasts to compare toric
      vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. Investigating the lenses
      under simulated driving conditions, which involve eye movement demands, will lend insight
      into the potential advantages of toric over spherical contact lenses for driving safety.
    

Intervention name(s): Placebo Lenses; Spherical Lenses; Toric Lenses
Intervention type(s): Device; Device; Device
Intervention description(s): AcuVue Oasys Bandage Lenses with no prescription; 1-DAY ACUVUE® MOIST contact lenses; 1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: astigmatism, contact lens, driving
Body Temperature in Persons With Tetraplegia When Exposed to Heat
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Quadriplegia
Study type: Observational

Summary: 
      The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However,
      the consequences of impaired regulation of normal body temperature on cognitive performance
      of persons with tetraplegia is not known. This study will provide the preliminary findings
      necessary for future work to design and explore physical and medical interventions to improve
      temperature regulation in those with tetraplegia with the goal of improved clinical care,
      health, and quality of life.

      The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10
      controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours.
      Physiological as well as psychological processes will be monitored in all subjects during the
      study for safety and to determine differences in responses to exposure to hot ambient
      temperatures
    

Detailed description: 
      After a cervical spinal cord injury (SCI) the motor, sensory and autonomic deficits cause,
      among other detriments, a blunted ability to maintain a constant core temperature. Impaired
      thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than
      able-bodied persons (AB). There has been a paucity of work addressing the thermoregulatory
      responses of persons with SCI to hot ambient temperatures, and even less study addressing the
      effect of these temperatures on cognitive performance. The goals of this pilot study are: to
      improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia
      when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on
      cognitive performance during exposure to 35°C for up to 2 hours. In order to address our
      goals we have designed a study methodology which consists of comparing the physiological and
      psychological responses of the two study groups (tetraplegia versus AB controls) from
      thermoneutral (27°C) to hot (35°C) environments.
    

Intervention name(s): Heat Exposure
Intervention type(s): Other
Intervention description(s): Heat exposure of 95 degrees F for up to 2 hours.
Other intervention name(s): 95 degrees F for up to 2 hours.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 subjects with tetraplegia (SCI, C4-T1), ages 18-65 years old and 10 age- and
        gender-matched, able-bodied controls will be accepted for participation.
      
Biospecimen description: 
      Venous blood samples
    
Keywords: Spinal cord injury; Body temperature; Executive function; Sweat
A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva
      /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during
      maintenance of general anesthesia.
    

Detailed description: 
      This is multicenter, open-label (identity of assigned study drug will be known) one-arm study
      in pediatric participants receiving general anesthesia. The participants are children aged
      1-15 years old, planned to undergo head and neck, thoracic (except heart), urological,
      orthopedic or plastic surgery. Approximately 80 participants will be enrolled in this study.
      These participants are divided into two groups by age (1-6 and 7-15 years old).
      Pharmacokinetic (what the body does to the drug,) blood samples will be collected from at
      least 3 participants between the ages of 1 and 6 years and at least 3 participants between
      the ages of 7 and 15 years from 15 minutes after the start of infusion to the end of infusion
      of the study drug . The study consists of 4 phases: screening phase, treatment phase,
      recovery phase and follow-up phase. Screening for eligible participants will be performed
      within 14 days before administration of the study drug. The safety and tolerability of study
      drug will be evaluated by physical examinations, electrocardiogram (ECG), clinical laboratory
      tests, vital signs, and adverse events (AEs) according to the Time and Events Schedule.
      Participants safety will be monitored throughout the study.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): After intubation, continuous intravenous infusion of remifentanil (0.25 µg/kg/min) is started, while anesthesia is maintained with inhaled or intravenous anesthetics. In cases where sedation by general anesthetics and analgesia by lidocaine does not seem to provide a sufficient means of analgesia at the time of intubation, remifentanil may be used, beginning before intubation. The rate of infusion may be adjusted while monitoring the subject's general condition in 25% to 100% increments or in 25% to 50% decrements every 2 to 5 minutes, but should not exceed 1.3 µg/kg/min.
Other intervention name(s): remifentanil hydrochloride (JNJ-268229)
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anesthesia; Remifentanil; Ultiva
The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional
Phase: Phase 4

Summary: 
      The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo
      when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.
    


Intervention name(s): Ropivacain; Saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.; Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor Canal Block (ACB); Anterior Cruciate Ligament (ACL) Reconstruction; Saphenous nerve; Pain; Ultrasound block